KROK ZA KROKEM: Step-by-Step guide to pRepARAtioN ANd AdMiNiStRAtioN NÁVOD NA PŘÍPRAVU A PODÁNÍ INJEKCE PŘÍPRAVKU NPLATE® of the NplAte® iNjectioN AObrázkový visual aid for your home-administration of Nplate® průvodce svépomocným podáváním přípravku Nplate® doma this youcelým through all the steps you’ll need to perform to successfully prepare and administer your weekly Nplate® injection at home. Tatobooklet příručkawill vásguide provede procesem přípravy a podávání pravidelné týdenní injekce přípravku Nplate® v domácím prostředí. during your healthcare professional will ze have shownkteré you jste all ofabsolvovali the steps inu svého this Step-by-step When you at home,podávat this booklet Všechnytraining, kroky popsané v tomto návodu již znáte školení, ošetřujícíhoguide. zdravotníka. Až siadminister budete přípravek sami doma, will remind of all thevám preparation andjak administration steps, so you can bepostupovat, confident you’re step příručka Krokyou za krokem připomene, přesně při přípravě a podávání abysteperforming si mohli býtevery jistí, že jstecorrectly. všechny kroky provedli správně. Pokud se u Vás vyskytne kterýkoli z nežádoucích účinků, sdělte to svému lékaři nebo lékárníkovi. Stejně postupujte i v případě jakýchkoli nežádoucích účinků, které nejsou uvedeny v příbalové informaci. Nežádoucí účinky můžete hlásit také přímo prostřednictvím národního systému hlášení nežádoucích účinků. Podrobnosti o hlášení najdete na: http://www.olecich.cz/hlaseni-pro-sukl/nahlasit-nezadouci-ucinek Adresa pro zasílání je Státní ústav pro kontrolu léčiv, oddělení farmakovigilance, Šrobárova 48, Praha 10, 100 41, email:
[email protected]. Je třeba doplnit i přesný obchodní název a číslo šarže. Nahlášením nežádoucích účinků můžete přispět k získání více informací o bezpečnosti tohoto přípravku. Tato informace může být také hlášena společnosti Amgen s.r.o.
BUDETE-LI MÍT JAKÉKOLIV DOTAZY OBAVY, KONTAKTUJTE PROSÍM Please contact your doctor with ČI any questions or concerns youSVÉHO have LÉKAŘE
KROK Step 1
KROK Step 2
KROK Step 3
KROK Step 4
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KROK Step 9
DŘÍVE ZAČNETE befoReNEŽ you begiN Read all instructions for use thoroughly. Pozorně si přečtěte všechny pokyny Pokyny uvedené inv návodu Krok za krokem určeny pacientům, byli zdravotnickým pracovníkem vyškoleni,byjak si svépomocně podat injekci. the instructions this Step-by-step guide jsou are intended for patientskteří whojižhave already been trained in self-injection their healthcare professional. Pokud jste takové školení ještěplease neabsolvovali, neprovádějte aplikaci Nplate®Nplate®. a kontaktujte nejprve svého ošetřujícího zdravotníka. if you have not been trained, contact your healthcaresvépomocnou professional and do notpřípravku self-administer Několik poznámek týkajících se skladování a použití A few notes on storage and use Přípravek až package do okamžiku použití v originálním Keep yourNplate® Nplate®uchovávejte in the original and in the refrigerator untilbalení you’rev chladničce. ready to use it • Přípravek Nplate® nesmí zmrznout. • Nplate® should not be frozen • Chraňte přípravek Nplate® před světlem. should be protected light prostředí (v chladničce při teplotě 2 °C až 8 °C). Přípravek nesmí zmrznout. Po vyjmutí z chladničky •• U Nplate® chovávejte přípravek Nplate®from v chladném pokojové teplotě 25 °C)butmaximálně skladovat délethenež 24 hodin, for musíte ho vrátit • můžete Nplate®přípravek should beskladovat kept coolpři(refrigerated at 2ºC(do to 8ºC), should not24behodin. frozen.Budete-li Nplate® přípravek may be removed from refrigerator do chladničky. a maximum period of 24 hours at room temperature (up to 25°c). it must be returned to the refrigerator for storage longer than 24 hours • N epoužívejte přípravek po uplynutí data spotřeby. Datum spotřeby je uvedeno na papírové krabičce a na štítku ampulky vedle písmen EXP. • Doporučené Do not use this medicine after the expiryden date. The expiryměsíce. date is stated on the carton and vial label after EXP. The expiry date refers to the last day datum spotřeby je poslední příslušného of that month Rozpuštěný přípravek Nplate® je nutné okamžitě podat. once Nplate® has been dissolved, inject immediately. Je možné, že vám po podání předepsané dávky část připraveného roztoku Nplate® zbude. Zbytky přípravku Nplate® nejsou určeny k dalšímu you mayJakmile have excess Nplate® leftpostup over after administering your prescribed do not re-use Nplate®! Any excess dissolved must be podávání. provedete celý podání injekce, okamžitě zlikvidujtedose. veškeré zbytky rozpuštěného přípravku Nplate®. Nplate® Zbytky přípravku thrownv ampulce away immediately after completing the injection process. left over Nplate® in vial must NeVeR be re-used for another injection. Nplate® se nesmí NIKDY používat k dalšímu podání injekce.
KROK 1: PŘIPRAVTE SI POMŮCKY NA PODÁNÍ INJEKCE Nejprve si připravte plochu a podložku na přípravu Nplate®: Step 1: Setpracovní up MAteRiAlS foR AN iNjectioN 0AMUS012_55_MAT_L18alt:250/500 0AMUS012_55_MAT_L18alt:2 50/500 mcg mcg
NPL PODATE LOŽ®KAPRE ATIO NAPAR N UMAT PŘÍP RAV PŘÍPRAVKU NPLATE®
first, prepare yourpodložku workspace and the Nplate® preparation Položte na čistý, dobře osvícený, plochý mat: povrch (např. stůl).
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Předmust svépom You be ocným trainepodává nímhealth d by your přípravcare ku Nplate® providmusíte absolvo er before youvat caninstruk admintáž svého ošetřuj ister Nplate ®. ícího zdravotníka.
Product Preparation and Injection Ref erence Mat
DŘÍVE NEŽ ZAČNETE BEFORE YOU BEGIN POZNÁMKA: • You Pečlivě must trained celý your návod You must sibe healthcare na použití. bepročtěte trained by provider by your healthcare you or or your your caregiver provider before NOTE: caregiver can before you can administer administer product. product. •• Read all instructio Při práci s podložkou a přípravě injekce Nplate® se prosím Doporuču jeme ns for use thoroughly. režim, a to i v případě, Before Before you you begin begin zavést pravidelný léčebný že budete cestovat. Please use this mat along with the Step-by-steřiďte •• You You should establish will instrukcemi need: a regular Ujistěte uvedenými v návodu Krok za krokem anebo v p guide treatmenmateriály se, že máte všechny potřebné You will need: t schedule, even when travelling . (viz níže uvedené ■ and/or obrázky). Product Package leaflet and Self-administration DVD to Vial (500 ■ Patients should establish (Visual Productsure A) Vial (500 ■ mcg) •• ■■Make regular treatment (Visual Patients should establish aa regular treatment schedule, A) supplies that youmcg) schedule, have Příbalovém letáku a Instruktážní all the Zkontrolu jte you data even when will DVD. Možná budete muset spotřeby when need traveling. na ■ One všech to the One Prefilled ampulkác even images below). Prefilled Sterile traveling. prepare your Nplate®minjection. Sterile Water h. ■(refer Water Syringe B-1 Syringe and and and Plunger B-2) Plunger (Visuals (Visuals You may be required to B-1 and B-2) ■ One Make sure you you have •• ■Check have all 11 mL all the Syringe ■ Make sure the supplies supplies that theejte One Disposable užít více nežusejednu expiration that you Disposable C) you will will need. need. dates mLpřípravek Syringe (Visual Nepoužív injekci on (Visual all vials. C) Nplate®. Pokud Ifvám po uplynutí more ■ ■ thanpřípravku doby one injection použitelnosti Check the expiration expiration of Nplate®. ■ Safety nebo dates ■ Check ondéle pokuddates all vials. yourlékař Safety Needle: vials.než D) doctor Needle: 27 the byl 27 G, G, ½ ½ inch inch (Visual on You must (Visual all D) trained by your Do • not Do healthcare use Youbemust not if expired. předepsal ■ use be trained by your healthcare providerprovider if(Visual expired One užívat skladován Do not use if expired. before you více než jednu or pokojové left at room ■24 hodin or your injekci One Vial has temperature for■ Wash caregiver přípravku Vial Adapter instructed teplotě. Adapter can administe Nplate®, before (Visual E) you to E) při take more you or připravte more than r product. your caregiver than one 24 hours. injection can administer of your hands with ■ with soap. product. ■ Wash your hands soap. Swab Packages ■ Alcohol (Visual Alcohol F) Swab Packages Before you • (Visual Wash a begin aplikujte F) your Umyjte si hands celou si ■ ruce předepsano Nplate®, with Before mýdlem. Use soap. follow the usteps alcohol swab you begin dávku swab to ■ přípravkuinpodle to clean clean the ■ Use alcohol as defined the surface surface where where you pokynů p the Step-by-ste you will ■ Sharps will Sharps Container Container (not (not supplied) supplied) (Visual (Visual G) be preparing G) You will You product. need: be preparing product. will need: Enter • ■■Use uvedených your guide required to complete Tampone v injection příručce volume Enteran swab your Krok m s youralcohol za prescribed alkoholem here to krokem. required clean (from HCP): dose Budete injection the vyčistěte ________m of ■ Product Vial (500 mcg) surface product k volume tomu here povrch, muset where (from HCP): ________m použít you na kterém ■ Patients should establish will (Visual be preparing ■ Product Vial (500 budete LL přípravekproduct. regular treatment připravovat. ■ Patients shouldaestablish mcg)A)(Visual A) schedule, schedule, a regular treatment NOTE: ■ One Prefilled Sterile Water using even wheneven new self-admini A.Product vždy novouA.Product traveling. NOTE: You You may Vial stration saduapro may be Syringe be required ■ One Prefilled Sterile required to kit(s). svépomocn to use Plunger use more more than when traveling. é podávání than one Vial one injection injection of E.One has instructed Waterand One instructed you to take more than one and B-2) přípravku. Vial Adapter of product.If Syringe product.If your the steps as defined in and(Visuals your doctor Plunger B-1 doctor has E. (Visuals
0AMUS012_55_MAT_L18alt:250/500 0AMUS012_55_MAT_L18alt:2mcg 6/14/10 7:53 PM Page 50/500 mcg 6/14/10 7:53 1 PM
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Produc
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Prefilled Sterile Sterile Water Water Syringe B-2. One Prefilled Syringe
Page Page 11
Product Preparation and Injection Reference Mat
mayprovider recommend *Yourprovider healthcare a smaller 29-a or NOTE: 31-gauge may recommend NOTE:You for injection. Youmay smaller maybe 29- orneedle berequired requiredtotouse 31-gauge needle for injection. usemore Store morethan productStore thanone vialsproduct oneinjection inyou theirvials injectionofofproduct.If carton tomore protect product.Ifyour has from light until yourdoctor doctor in their the carton hasinstructed instructed to protect than fromuse. you to one lightof thesteps to take take stepsasasdefined use. more definedininthe than product,follow one injection thePatient injection PatientInstructions ofuntil Instructionsfor product,follow forUse Usetotocomplete completeyour yourprescribed prescribeddose doseofofproduct product using using aa new new reconstitution reconstitution kit(s). kit(s).
Preparati Preparation on and and Administ Administration ration of of Product Product
1.1. Remove Removethe thecover coverfrom fromthe theproduct productvial vial(A) (A) and andclean cleanthe therubber rubber stopper stopperwith withan analcohol alcoholswab swab(F) (F).. 2.2. Peel Peeloff offthe theprotective protectivecover coverofofthe thevial vialadapter adapter(E) (E),but ,butdo donot notremove remove ititfrom fromthe thepackage.Keep package.Keeping vial ingthe (A) theproduct on product a table,push vial (A) the on a table,push the vial vialadapter adapter(E) (E)down downonto ontothe thecenter centerofofthe thevial’ vial’ssrubber rubberstopper stopperuntil until ititisisfirmly firmlyininplace. place. 3.3. To Toassemble assemblethe theprefilled prefilledsterile sterilewater watersyringe B-2) syringe(B-1, ,attach (B-1, the B-2) ,attach the plunger plungerrod rod(B-1) (B-1)totothe thesyringe syringe(B-2) (B-2)by bytwisting twistingthe theplunger plungerrod rod (B-1) (B-1)clockwise clockwiseonto ontothe thesyringe syringe(B-2) (B-2)until untilyou youfeel feelaaslight slight resistance. resistance. 4.4. ToToremove removethe thewhite whiteplastic plasticcover coverofofthe theprefilled prefilledsyringe (B-2) ,hold syringe (B-2) ,hold the syringe at its the syringe at itsbase basewith withone onehand handand andbend bendthe thetip tipofofthe thewhite white plastic plasticcover coverdownward downwardwith withyour yourother otherhand.This hand.Thiswill willbreak breakthe theseal seal ofofthe thewhite whiteplastic plasticcover. cover. 5.5. Double-check Double-checkthat thatthe thevial vialadapter adapter(E) (E)isissecurely securelyininplace,and place,andremove remove the thepackaging.Ke packaging.Keeping the eping theproduct productvial vial(A) (A)on onthe thetable,attach table,attachthe the water-filled water-filledsyringe B-2) syringe(B-1, to the (B-1, B-2) to thevial vialadapter adapter(E) (E) by bytwisting twistingthe the syringe syringetip tipclockwise clockwiseonto ontothe thevial vialadapter adapteruntil untilyou youfeel feelaaslight slight resistance. resistance. 6.6. Slowly Slowlyand andgently gentlyexpel expelwater waterinto intothe theproduct productvial vial(A) (A).Water .Watershould should flow flowslowly slowlyonto ontothe thepowder.Do powder.Donot force water not force waterinto intothe thevial. vial. 7.7. Gently Gentlyswirl swirlthe theproduct productvial vialtotodissolve dissolvethe thepowder.Do powder.Donot notshake shakethe the vial.This vial.Thismay maytake takeasaslong longasas22minutes.Once minutes.Oncefully fullydissolved, dissolved,product product should shouldbe beclear clearand andcolorless. colorless. 8.8. Once Oncethe thepowder powderisiscompletely completelydissolved,rem dissolved,remove ovethe thesyringe syringe(B-1, (B-1, B-2) B-2)from fromthe thevial vialadapter adapter(E) (E)by bytwisting twistingcounterclockw counterclockwise.Discard ise.Discard the thesyringe syringe(B-1, (B-1,B-2) B-2)into intothe thesharps sharpscontainer container(G) (G).. 9.9. Remove Removethe the11mL mLsyringe syringe(C) (C)from fromits itspackage packageand andpull pullthe theplunger plungertoto the the11mL mLmarking.Do marking.Donot notpull pullplunger plungerpast pastthe the11mL mLmarking. marking.
Please Pleasecall callX-XXX-XXX-XX X-XXX-XXX-XXXX XX(X-XXX-XXX-X (X-XXX-XXX-XXXX) XXX)for formore moreinformation. information. *Your *Yourhealthcare healthcareprovider providermay mayrecommend recommendaasmaller smaller2929-oror31-gauge 31-gaugeneedle needlefor forinjection. injection. Store Storeproduct productvials vialsinintheir theircarton cartontotoprotect protectfrom fromlight lightuntil untiluse. use.
10. 10. Attach Attachthe the 11 mL mL syringe syringe (C) to the vial adapter (E) of reconstituted solution solutionby bytwisting twisting the the syringe tip clockwise onto the vial adapter until untilyou youfeel feel aa slight slight resistance,and slowly expel air into the vial (A). 11. 11. Keeping Keepingthe the plunger plunger at at the base of the syringe (C),turn vial (A) assembly syringe assemblyand and syringe upside down,so the vial is above the syringe. 12. Withdraw 12. Withdrawall all ofof the the liquid liquid into the syringe (C).Do not pull plunger past pastthe the11mL mL marking. marking. 13. Remove all 13. Remove allair airbubbles bubblesby gently tapping the barrel of the syringe (C). Once Oncethe theair airbubbles bubbles have have risen to the top,gently push them back backinto intothe the vial vial (A) by by slowly pushing the plunger. 14. 14. Ensure Ensurethe thesyringe syringe (C) has the correct amount for your dose (doublecheck injection checkthe the injection volume volume entered above) by pushing the plunger ofofthe expel thesyringe syringe to to expel any excess liquid back into the vial (A). 15. 15. Remove Removesyringe (C) syringe from from the vial adapter (E) by twisting counterclockw counterclockwise,but ise,but make make sure to keep the syringe in your hand. 16. 16. While Whileholding holding the the syringe syringe (C) in your hand with the tip facing up, remove removethe the27 27 GG needle* needle*(D) from its packaging by peeling apart the thetabs. tabs. 17. 17. Attach Attachthe (D) theneedle onto needle onto the filled syringe (C) by twisting clockwise clockwiseuntil until you you feel feel a slight resistance.Pull back the pink needle safety safetyshield,and shield,and then then remove remove the white needle cover by pinching it firmly firmlyand andpulling pulling inin the the opposite direction of the syringe assembly. 18. 18. Open Openaanew newalcohol alcohol swab swab package (F) and clean the injection site. When Whengiving givingthe the injection,use injection,use one hand to gently pinch the cleaned area areaofofskin skinand andhold holdititfirmly.With firmly.Withthe other hand,hold the syringe (C) atataa45-degree 45-degree angle angle to to the skin. 19. 19. After Afterinjecting injecting your your product product dose,activate the pink needle safety shield shield(D) (D) with with one one hand hand until you hear it click into place,and then place placethe theentire entire syringe syringe assembly assembly (C,D) into the sharps container (G).
A.Product Vial (500 mcg)
E. One Vial Adapter F. Alcohol Swab Packages NOTE: These images areimages for reference NOTE: These are foronly. reference only. © 2010 Company. AllCompany. rights reserved. 5/10 © 2010 MC50370-A Store P44178 All rights product reserved. vials in their 5/10 MC50370-A Ampulky cartonažtodo P44178 s přípravkem protect skladujte from použití light until okamžiku use. This papírové medicinekrabici, v originální may bekterá removed fromproti the světlu. refrigerator je chrání for a maximum period of 24mimo Přípravek hourschladničku skladován at room temperature může být to 25°C). při pokojové(up It mustmaximálně teplotě be returnedpotodobu (do 25 °C) the refrigerator storage longer 24 hodin. Přiforskladování than 24 hours. NOTE: These POZNÁMKA: Obrázky Your přesahujícím healthcare are for reference 24 hodin musí být přípravek mají images pouze informativní znovuprovider only. recommend umístěn may a different do chladničky. charakter needle forpracovník Ošetřující injection.vám může doporučit jinou zdravotnický jehlu pro podání injekce.
B-1. One Plunger Rod
B-2. One Prefilled Sterile Water Syringe
Plastic cover Plastic cover
MYOÍSUR TO PREP O PŘ ARÍPATRA IOVU N AR LÉEA KU
C. One Disposable 1 mL Syringe
G. Sharps Container (not supplied)
D. Safety Needle: 27 G, ½ inch
Kód zadání: NPO-IHQ-AMG-079-2012 Datum vyhotovení: Job code: NPO-IHQ-AMG-079-2012 Date of prep: květen 2012 May 2012
NOTE: These images are for reference only.
Step 1 KROK
Plastic cover Plastic cover
Preparatio n and Administra Preparatio tion of Product n and Administra tion of Product 1. Remove the cover from
by gently 13. Remove all air bubbles by gently tapping (B-1) clockwise onto the tapping the the barrel barrel of the syringe of the the syringe syringe (B-2) syringe (C) (B-2) until (C).. until you you feel feel aa slight slight resistance. Once the the air air bubbles bubbles have have risen risen to resistance. Once to the the top,gently top,gently push push them them the product back into 1. Remove the cover vialproduct into the (A) and clean the rubber the vial 4. vial (A) (A) by by slowly slowly pushing from the back pushing the 4. To the plunger. To remove plunger. remove the the white white plastic theAttach 1 mL syringe plastic cover stopper with cover of (C)syringe of the an alcohol the prefilled to the vial prefilled syringe swab adapter syringe (B-2) (F). swab (F). vial (A) and clean the rubber 10. Attach10. the 1 mL (B-2),hold of reconstituted stopper ,hold 14. Ensure with an Ensure the (C) to the syringe alcohol the vial(E)adapter syringe (C) (C) has has the 14. (E)the the correct the of syringe correct amount reconstituted syringe at solution bysolution amount for at its its base base with for your twistingbythe with one your dose dose (doubleone hand the hand and white (doublesyringethe 2. Peel off2.thePeel and bend tipsyringe bend the clockwise the tip protective tip of onto of the cover of thecover twisting the white vial adapter plastic check vial adapter cover the tip injection off the protective downward clockwise (E) ,but volume do with onto not plastic entered your the check remove vialcover of the vial adapter (E),but do not remove until you feel the injection volume entered above) above) by adapter downward with your other by pushing pushing the the plunger resistance,and plunger other hand.This it from theitpackage.Keepin hand.This will slowly expel untila slight will break you feel break the air into the seal a slight resistance,and g the product seal theair of of the the the syringe (A) white syringe to . vial from the package.Keepin vialproduct plastic (A) onvial slowly to expel expel any a table,push expel any excess excess liquid ofvial of the into the g the white liquid the plastic back into the (A).cover. cover. the vial (A) on a table,push vial (A) (A).. plungertheatplunger vial adaptervial Plastic back cover into the11. Keeping the baseatofthe (E)adapter down onto 11.the thebase Keeping syringe the center B-1. (C)syringe ,turn vial One B-1. of the Plunger 5. 15. Remove cover vial’sofrubber (A) Remove syringe (E) down Rod syringe (C) stopper of the onto the until from the center 5.(C)Double-check 15. the vial Double-check ,turn vial (A) that vial adapter the vial’ adapter (E) (E) isis securely B-2. One s rubber that the (E) Plastic the vial by twisting stopper until assembly and in Prefilled from twisting it is firmly in vial adapter syringeand adapterOne upside Sterile(C)Water (E) Plunger down,so securelyRod by assembly Syringe B-2. in place,and vial is above place,and remove One Prefilled it isplace. syringe remove firmly in place. syringe. the upsidethe counterclockwi Sterile down,so Water se,but the vialtheis above Syringe make the packaging.Kee counterclockwi sure packaging.Keep the syringe. ping to keep keep the syringe se,but syringe in 12. Withdraw ing the make the product in your product vial your hand. sure hand. 3. To assemble to all of the liquid vial (A) (A) on the on the the table,attach table,attach the prefilledthesterile the syringe 12. Withdraw the (C)syringe water-filled water .Do not(C) 3. Tothe all of into syringe pull.Doplunger assemble the liquid 16. While syringe (B-1, While holding into the B-2)(B-1, holding the prefilled ,attach water-filled the syringe sterile the,attach the past the syringe (C) vial water 16. syringe (B-1, adapter (C) in not pull plunger syringe in your (B-1, B-2) your hand (E) B-2) to by hand with twisting B-2) to the with 1 the mL the vial plunger rodplunger the marking. tip adapter facing (E) (B-1) to up, by twisting the past syringe the the the tip syringe (B-2) 1 facing mL marking. by tip up, rod (B-1) to the syringetwisting remove the plungertherodplunger rod 13. Remove the 27 syringe tip clockwise 27 GG needle* needle* (D) clockwise onto (B-2) bythetwisting (D) from remove from its onto the C. One its packaging One Disposable packaging by the vial Disposable 11 mL vial adapter adapter until by peeling (B-1) clockwise peeling apart until you mL Syringe you feel apart C. Syringe air bubbles feel aa slight slight the syringe gently tapping resistance. (B-2) 13.allRemove (B-1) onto until(B-2) clockwise you feel barrel of all airbybubbles the tabs. tabs. onto the syringe resistance. by gentlythetapping syringe (C)syringe . the untila slight the you feel a slight barrel of the resistance.resistance. Once the airOnce (C) . bubbles Cthethem Disposable risen have to therisen top,gently 1 ml 6. the airhave Slowly push bubbles 1ml and stříkačka 17. gently Attach expel the 6. to water the needle Slowly top,gently into (D) and the 17. onto gently push them Attach the needle (D) onto the the filled expel water into the product filled syringe back into the syringe (C) (C) by 4. To remove by twisting product vial twisting (A)thebyvial vial (A) theremove slowly (A).Water white plastic .Water should pushing should backvialinto the cover plunger. flow of thecover 4. To slowly prefilled (A) onto by clockwise the white slowly syringe the powder.Do pushing (B-2) until plastic flow ,hold you slowly the not feel plunger. force syringe onto of a slight the water clockwise Safety needle: the prefilled resistance.Pull powder.Do into with the until syringe vial. you not (B-2),hold 14. Ensure14. feel a slight resistance.Pull back back the force water into the vial. 27 G*,2713G*,mm the syringethe naGently the pink jedno pink needle theEnsure needle D Bezpečnost at its syringethe použití base with (C)syringe ní jehla: has the(C) correct amount syringe 13 (1) 7. mm (1) safety shield,and at its one your dose tip swirl basehand of the shield,and then the withand white has the (doubleproduct onebend then remove handthe correctforamount 7. remove vial Gently and safety to dissolve bend the swirl white the for the the your tip needle product powder.Do of dose the cover plastic cover white vial (doublecheck to not by dissolve the pinching the shake injection white downward the the it needle cover by pinching it powder.Do not shake the with your other entered Luer-lok plastic cover downward check thevolume hand.This by pushing (1)take vial.This firmly and injection and pulling break the may volumeabove) pulling in splunger with your koncovkou You entered in the the opposite other will opposite direction vial.This above) bythe firmly hand.This direction of may pushing take as willseal of the break the seal of the syringe You must as long the plunger the syringe long as of the whiteofplastic syringe assembly. must be as 22 minutes.Once minutes.Once fully assembly. be trained to expel trained by cover. fully dissolved, dissolved, product by your your healthca liquid product of the backliquid white healthcarree provider before you syringeany into the plastic cover. to excess expel any 18. Open (A)should . vialbe Open aa new excess or yourthethatcaregiver new alcohol should alcohol swab backvialinto be swab package clear 18. the and colorless. package (F) colorless. (A)clear (F) and . and can and clean clean the 5. Double-check 15. Remove the injection injection site. Luerlock er product. site. (C)syringe the vialthat (1) from the adapter 5. Double-check 15.syringe adapter (E)adapter Remove isadminist securely 8. Once by twisting When giving place,and (C)vial giving the the vial from the injection,use the vial(E)adapter injection,use one 8. twisting (E) isinsecurely Once the When the powder one hand (E) by powder isis completely hand to in remove place,and remove counterclockwi to gently gently pinch completely dissolved,remo the the packaging.Kee pinch the syringe dissolved,remove the cleaned (B-1, cleaned se,but make ping the product ve the syringe sure to Before vial the (B-1, keep counterclockwi (A) packaging.Keep the on syringe B-2) the area table,attach from of se,but in begin skin ing your the and make the Before you hand. vial the hold product adapter sure it firmly.With the to keep the syringe vial (A) on the table,attach the 16. While holding B-2) you begin area of skin and hold it firmly.With fromhand. the other the vial adapter (E) other hand,hold in your hand,hold the water-filledwater-filled (E) by the syringe by twisting syringe (C) twisting counterclockwi syringe (B-1, (C) counterclockwise.Discard B-2)(B-1, theholding to theB-2) se.Discard syringethe vial adapter (C)syringe in your(C) the syringe at aa 45-degree (E)adapter syringe 45-degree angle by twisting hand (B-1, B-2) withhand angle to the tipwith to the vial to the facing the skin. theup, at skin. syringe in your (E) bythetwisting the remove16.theWhile B-2) into into the syringe tipsyringe .. the the sharps tip sharps container facing(B-1, clockwise container (G) up, C. You the vial 27 G needle* adapter until tiponto from its(D)packaging clockwise you feel Youwill One (C)C. remove willneed: onto 9. 19. After the 27 G(D) need: Remove the vial After injecting by peeling injecting your needle* adapter 1 mL and(G) 11 mL apart your product untila slight from its packaging product dose,activate 9. by 19. you feel a slight Remove Oneits dose,activate the the resistance.resistance. package mL syringe peelingthe syringe Disposable the pink mLthe pink needle apart (C) from Syringe the tabs. the tabs. needle safety from plunger safety itsDisposable packageSyringe and1pull pull the plunger to to ■ the shield (D) (D) with with one D. Safety one hand Safety Needle: hand until ■Product the 11 mL shield until you Needle: 27 mL marking.Do you hear marking.Do not hear itit click 27 G, ProductVial G, ½ D. click ½ inch inch not pull 6.■ Patients into place,and Vial(500 pull plunger place,and (500mcg) plunger past and should G. Sharps ■Slowly mcg)(Visual 17. Attach17. gentlyand thenContainer past the establish (VisualA) the 11 mL expel Patients into theAttach mL marking. waterexpel needlethe A) aa regular marking. into 6. Slowly (not supplied) should (D)needle the product then treatment onto the establish G.Container Sharps gently vialproduct place the (A)schedule, the entire regular .Water entire syringe water (C)syringe should treatment syringe assembly byPlease into (not supplied) twisting (D)filled the assembly (C,D) place ontosyringe schedule, the filled (C,D) into vial (A) into the .Water should clockwise the sharps ■ (C) sharps E flow by slowly call twisting Vial container X-XXX-XXX-XXX even onto adapter (G) the when powder.Do ■One (1) Please X traveling. (X-XXX-XXX-XXX until call Adaptér container you not X-XXX-XXX-XXX flow OnePrefilled feel Water force even a slowly PrefilledSterile (G) slight X) water when na for .. Syringe onto the powder.Do not force ampulku resistance.Pull into water X (X-XXX-XXX-XXX traveling. clockwise until you feel Sterile Water Syringeand the vial. (1) X) for more back*Your the pink more information. a slight resistance.Pull information. andPlunger into the vial. Plunger(Visuals Alcoholtamponů (Visuals B-1 backneedle swab packages theprovider pink needle B-1 and F Balení and B-2) safety shield,andshield,and may B-2) 7.■■Gently swirlGently *Your healthcare the (x4) (4×) product then remove provider vial s alkoholem to dissolve ■ may recommend theremove recommend aa smaller white needle swirl powder.Do Make the smaller 29cover product then ■One notneed. 29- or byhealthcare you pinching or 31-gauge vial tothedissolve shakenot 31-gauge needle Sharps container theshake the firmly and safety the white OneDisposable all Make7.sure needle for the Disposable11mL thewill sure for injection. supplies needle powder.Do injection. G Nádoba Store you covervials product have that (1; notý odpad byitpinching mLSyringe you allas Syringe(Visual the vial.This supplied) in na zdravotnick supplies it to (VisualC) Store may pullingand product takehave that protect C) asmay in the you vials longtake from will in their opposite their carton light 2asminutes.Once need. carton until vial.This direction firmly use. to protect of fully pulling the from dissolved, syringe light in long the until assembly. opposite product as use. 2 minutes.Once direction ■ of the syringe assembly. ■ fully dissolved, product18. Open a new alcohol Check ■Safety ■should expiration clear andbecolorless. SafetyNeedle: Checkbethe Needle:27 the on expiration should swab 27G, G,½½inch package cleardates dates 18. Open a new inch(Visual and colorless. on all (VisualD) and clean není all vials. vials. NOTE:(1; alcohol součástí D) These swab(F) images sady)only. package are for (F) the for reference NOTE: reference andinjection These clean thesite. only. images injection site. are Do 8. Once When giving use the8.powder expired. the giving ■ isexpired. injection,use completely Do not not use dissolved,remo one hand to Onceififthe When ■One powder is completely ve the syringe the injection,use OneVial VialAdapter the cleaned (B-1, Adapter(Visual dissolved,remo onegently handpinch (VisualE)E) to gently ve the pinch the cleaned syringe (B-1, B-2) from area of skinarea thehands andofhold vial adapter firmly.With (E) ■ by twisting B-2) the other hand,hold from skinitand the vial hold it firmly.With your adapter ■Wash the syringethe se.Discard se.Discard (E) bycounterclockwi ■ with (C)syringe (C) Wash twisting counterclockwi the other hand,hold soap. your hands ■ Alcohol with soap. the at AlcoholSwab syringe a 45-degree (B-1, SwabPackages angle B-2) F) Packages(Visual to into the the skin. (Visual F) the syringe (B-1, B-2)sharps at a 45-degree angle to the skin. container . into the sharps(G) container (G). Use ■Remove swab 9.■ 19. After injecting ■ Use alcohol alcohol the 1 mL syringe swab product ■Sharps to1 clean (C)syringe clean from 9.theRemove 19. Afteryour theitssurface SharpsContainer package will surface injecting theto the pink needle Container(not and mL where yourdose,activate pullyou product dose,activate theand you (notsupplied) plunger (C) safety will from where supplied)(Visual its package (VisualG) the pink pull thetoplunger to shield (D) shield needle safety D. Safety Needle: G) be the mL marking.Do product. with one be1preparing preparing not pull plunger you hear the 1 mL product. G, ½ inch (D)hand marking.Do the 1 mL clickhear withuntil intoitplace,and D. Safety27 one hand not pullpast untilityou Needle: ■ then plunger 27 G, ½ inch pastmarking. the 1 mL marking. click into place,and ■Enter then Enteryour place the entire yourrequired requiredinjection assembly injectionvolume place syringe volumehere the entire into (C,D) the sharps here(from Please call X-XXX-XXX-XXX syringe(C,D) (fromHCP): container assembly HCP):________ ________mL . into the X (X-XXX-XXX-XXX Please call X-XXX-XXX-XXX sharps (G) mL container X) for moreX)information. (G). X (X-XXX-XXX-XXX for more information. *Your healthcare
0AMUS012_5 0AMUS012_55_MAT_L18a 5_MAT_L18alt:250/500 lt:250/500 mcg mcg 6/14/10 6/14/10 7:53 7:53 PM PM
Alcohol Swab SwabPackages Packages F.F.Alcohol
© 2010 Company. All rights reserved. 5/10 MC50370-A P44178
G.Sharps Sharps Container Container(not (notsupplied) G. supplied)
©2010 2010 Company. Company. All Allrights rightsreserved. reserved. 5/10 © 5/10 MC50370-A MC50370-A P44178 P44178
KROK SI POMŮCKY INJEKCE Step 1: PŘIPRAVTE Set up MAteRiAlS foR NA PODÁNÍ AN iNjectioN Jakmile bude pracovní plocha vyčištěná a připravená, vyjměte sadu na svépomocné podávání Nplate® z chladničky. once your workspace is clean and ready, take the Nplate® self-injection kit out of the refrigerator. Pečlivě si prohlédněte prášek Nplate® v ampulce a zkontrolujte, zda není zmrzlý. Pokud je zmrzlý, nepoužívejte ho. Budete-li mít jakékoliv Look closely the powder in the Nplate® vial,kontaktujte to see if it’ssvého frozen.ošetřujícího Do not usezdravotníka, if frozen. ifkterý you vám havedá anydalší questions dotazy at týkající se skladování přípravku, pokyny.about storage, contact your healthcare professional for further instructions. Zkontrolujte datum spotřeby na sadě pro svépomocné podávání přípravku. Pokud již toto datum uplynulo, nesmíte přípravek Checkpoužívat. the expiry date on the self-injection the expiry zdravotníka. date has passed, do not use. Stop and contact your healthcare professional. Zastavte přípravu a kontaktujte kit. svéhoIf ošetřujícího Note: if yourPokud healthcare professional has instructed you that your Nplate® dose dávka requiresNplate® more than injection of Nplate®, you will need tojeuse morepoužít than one Poznámka: vás ošetřující zdravotník upozornil, že vaše předepsaná budeone muset být podána ve více injekcích, nutné víceselfsad injection kit. followpodávání the stepspřípravku as described in this Step-by-step guide návodu and use as many self-injection kits astolik necessary complete your prescribed dose of Nplate®. pro svépomocné Nplate®. Postupujte podle Krok za krokem a použijte sad protosvépomocnou aplikaci přípravku, kolik bude 0AMUS012_55_MAT_L18alt:250/500 mcg 6/14/10 7:53 PM Page 1 k podání předepsané dávky přípravku Nplate® nutné. 0AMUS012_55_MAT_L18alt:250/500 mcg
6/14/10
7:53 PM
Page 1
Product Preparation and Injection Reference Mat Product Preparation and Injection Reference Mat You must be trained by your healthcare provider before you or your caregiver can administer product.
Before You mustyou bebegin trained by your healthcare provider before you or your caregiver can administer product. You will need:
Before you begin ■ Product Vial (500 mcg) (Visual A)
■ Patients should establish a regular treatment schedule,
d Injection Reference Mat d Injection Reference Mat
even when traveling.
You willPrefilled need: Sterile Water Syringe and Plunger (Visuals B-1 and B-2) ■ One ■ Makeshould ■ Patients sure you have all the supplies thatschedule, you will need. establish a regular treatment ■ Vial (5001mcg) (Visual (Visual A) ■Product One Disposable mL Syringe C) even whenthe traveling. ■ Check expiration dates on all vials. ■ Prefilled Sterile Syringe andD)Plunger (Visuals B-1 and B-2) ■ MakeDosure ■One Safety Needle: 27 G,Water ½ inch (Visual all the supplies that you will need. notyou usehave if expired. ■ One Disposable 1 mL Syringe (Visual C) ■ One Vial Adapter (Visual E) ■ Check ■ the expiration dates all vials. Wash your hands withon soap. ver can administer product. ■ Safety Needle: G, ½ inch (VisualF)D) Do■not use if expired. ■ Alcohol Swab 27 Packages (Visual Use alcohol swab to clean the surface where you will ■ One Vial Adapter (Visual E) ■ Wash hands with soap. beyour preparing product. Container (not supplied) (Visual G) er can administer■ Sharps product.
■ Alcohol Swab Packages (Visual F) Use alcohol swabwill to clean the surface where youand will administer Nplate®. these items are organised the same way Make sure have the following items. are the■ items you need to prepare ■ Enter youryou required injection volume here (from HCP):these ________mL A.Productstejně Vial jako na podložce be preparingk přípravě product. ■ Sharps Container E. One na přípravu Vial Adapter (notmáte supplied) (Visual G)následující pomůcky potřebné Zkontrolujte, zda všechny a podání přípravku Nplate®. Jsou uspořádány ish a regular treatment schedule, they are on your Nplate® preparation mat, which you should use whenever you prepare your Nplate® injection. Note: do not open items until directed to (500 mcg) ■ NOTE: may be required to use volume more thanhere one(from injection of product.If your doctor has instructed you to take more than one injection of product,follow EnterYou your required injection HCP): ________mL A.Product Vial v návodu nedostanete Nplate®, kterou používat každé injekce Nplate®. Poznámka: neotevírejte, dokud k tomu pokyn. E. One Vial Adapter using a newofreconstitution kit(s).Pomůcky theso steps asthe defined in byste the Patientměli Instructions for use Use topři complete your přípravě prescribed dose of product doschedule, in instructions. do not components that have evidence tampering or damage. do not re-use items. the Sharps container is not included supplies that you will need. (500 mcg) hl the a regular treatment NOTE: You may be required to use more than one injection of product.If your doctor has instructed you to take more than one injection of product,follow Nepoužívejte žádné pomůcky jevící známky manipulace či poškození. Všechny pomůcky jsou určeny k jednorázovému použití. Nádoba na nebezpečný odpad using a new reconstitution kit(s). steps asself-administration defined in the Patient Instructions for Useof to complete your prescribed dose of product dates on all vials. inthe Preparation and Administration Product your pack, and should be obtained before initiating self-administration. the will need. . supplies that younení součástí sady na svépomocné podávání Zajistěte sitheji dříve než(C)začnete svépomocné přípravy a aplikace přípravku. 10. Attach 1 mL syringe 1. Remove and the cover from the product vial and clean thepřípravku. rubber to the vial provádět adapter (E) of postup reconstituted Preparation Administration of (A) Product
on all vials. htes soap. stopper with an alcohol swab (F). solution by twisting the syringe tip clockwise onto the vial adapter Remove the cover from the product vial (A) and clean the do rubber (C)resistance,and to the vial adapter (E)expel of reconstituted 10. Attach theyou 1 mL until feelsyringe a slight slowly air into the vial (A). B2 prefilled water syringe (1) ean the surface whereA you1.2.will cover of the vial adapter (E) ,but not remove Peel off the protective product vial (1) swab (F). B1 plunger rod (1)tip clockwise stopper with an alcohol solution by twisting the syringe onto the vial adapter B-2. One Prefilled Sterile WaterPlastic Sy B-1. One Plunger Rod oap. (C) ,turn vial (A) it from the package.Keeping the product vial (A) on a table,push the 11. Keeping the plunger at the base of the syringe until you feel apístu slight resistance,and slowly expel air into the vial (A). B2 ˝Předplněná stříkačka se sterilní vodou (1) the protective thecenter vial adapter do notstopper removeuntil A will2.A itPeel mpulka B1 Táhlo (1) upside down,so an the surface where you (E) downcover ontoofthe of the (E) vial’,but s rubber assembly and syringe the vial is above the syringe. B-1. One Plunger Rod vial off adapter B-2. One Prefilled Sterile Water Syringe the package.Keeping theA.Product product vial (A) 11. Keeping the plunger at the base of the syringe (C),turn vial (A) F. Alcohol Swab Packages Vialon a table,push the itfrom is firmly in place. Adapter 12. Withdraw all of the liquiddown,so into thethe syringe .Dothe notsyringe. pull plunger s přípravkem (1) onto the center vial adapter (E) down of the vial’s rubber stopper until E. One Vial assembly and syringe upside vial is(C) above 3. itTois assemble the prefilled sterile water past the 1 mL marking. (500syringe mcg) (B-1, B-2),attach the e than one injection of product,follow firmly in place. Withdraw all of the liquid into the syringe (C).Do not pullF.plunger A.Product Vial Swab E. One Vial12. Adapter rodthe (B-1) to thesterile syringe (B-2) by twisting the,attach plungertherod (C). Packages 13. Remove air bubbles by gently tapping the barrel of Alcohol the syringe onstitution kit(s). 3. Toplunger assemble prefilled water syringe (B-1, B-2) past the 1 mLallmarking. (500 mcg) (B-1) clockwise onto the syringe (B-2) until you feel a slight than one injection of product,follow Once the air bubbles have risen to the top,gently push them plunger rod (B-1) to the syringe (B-2) by twisting the plunger rod 13. Remove all air bubbles by gently tapping the barrel of the syringe (C). resistance. stitution kit(s). intobubbles the vialhave (A)risen by slowly thepush plunger. (B-1) clockwise onto the syringe (B-2) until you feel a slight Onceback the air to thepushing top,gently them 4. resistance. To remove the white plastic cover of the prefilled syringe (B-2),hold (C) has the correct amount for your dose (double14. Ensure the syringe back into the vial (A) by slowly pushing the plunger. syringe (C) to the vial adapter (E) of reconstituted syringe atwhite its base withcover one of hand bendsyringe the tip(B-2) of the,hold white check injection volume entered above) pushing the plunger 4. onto Totheremove plastic theand prefilled (C) has the correct amount forby your dose (double14. Ensure thethe syringe ing the syringe tip clockwise the cover vialtheadapter plastic downward with your other hand.This will break the seal Plastic cover of the syringe to expel any excess liquid back into the vial (A). (C) to the vial adapter (E) of reconstituted ringe the syringe at its base with one hand and bend the tip of the white check the injection volume entered above) by pushing the plunger ight resistance,and slowly expelofair into theplastic vial (A)cover. . white g the syringe tip clockwise ontoplastic thethe vialcover adapter downward with yourB-1. other hand.This will break the seal (C) from the vial adapter (E) by twisting 15. Remove syringe of theB-2. syringe expel any excess backSyringe into the vial (A). OnetoPrefilled Sterileliquid Water One Plunger Rod Plastic cover (C) ,turn (A) nger at the base ofslowly the syringe 5. air Double-check that. cover. the vial adapter (E) is securely in place,and remove ht resistance,and expel into thevial vial (A) of the white plastic counterclockwise,but make to keep syringe in your hand. 15. Remove syringe (C) from the vial sure adapter (E) bythetwisting ringe upside down,so the vial isthe above the syringe. B-2. One Prefilled Sterile Water Syringe B-1. One Plunger (A) onRod the table,attach the product ,turnpackaging.Keeping vial (A) that the vialthe er at the base of the syringe5.(C)Double-check (E)vial is securely in place,and remove adapter (C) in your hand with facing up, 16. While holding the syringe counterclockwise,but make sure to keep the syringe in the yourtip hand. not pull plunger he liquid the syringe C. One Disposable 1 mL Syringe water-filled syringe (B-1, to the adapter (E) by twisting nge upsideinto down,so the vial(C) is .Do above the syringe. (A) on the table,attach the the the packaging.Keeping theB-2) product vial vial from its with packaging peeling G needle* 16. Whileremove holdingthethe27syringe (C) in(D) your hand the tipby facing up, apart arking. C. One Disposable 1 mL Syringe syringe tipsyringe clockwise onto thetovial until(E) youbyfeel a slightthe (B-1, B-2) theadapter vial adapter twisting e liquid into the syringe (C).Do water-filled not pull plunger the the tabs.27 G needle* (D) from its packaging by peeling apart remove (C)onto . the vial adapter until you feel a slight ubbles of the resistance. syringe tip syringe clockwise king. by gently tapping the barrel the tabs. 17. Attach the needle (D) onto the filled syringe (C) by twisting bles have risentapping to thexthe top,gently themgently C barrel 1 ml D Safety needle: 27 g, 13 mm (1) resistance. 6.disposable Slowly and bles by gently ofpush the syringe (C) . expel water into the product vial (A).Water should 17. Attach the needle filled resistance.Pull syringe (C) by twisting clockwise until(D) youonto feelthe a slight back the pink needle les(A) by slowly pushing the plunger. C 1 ml stříkačka D Bezpečnostní jehla: 27 G*, 13 mm (1) 6.syringe Slowly andwith gently water into not the force product vial into (A).Water should flowthem slowly onto expel the powder.Do water the vial. have risen to the top,gently push clockwise until you feel a slight resistance.Pull back the pink needle safety shield,and then remove the white needle cover by pinching it has thepushing correctthe amount for your dose (doublege flow slowly onto the powder.Do not force water into the vial. A)(C) by slowly plunger. 7.na jedno Gently swirl the product vial to dissolve the powder.Do not shake the safety shield,and then remove the whitedirection needle cover pinching it firmly and pulling in the opposite of thebysyringe assembly. použití on above) by pushing the(doubleplunger 7. Gently swirl the product vial to the powder.Do not shakeproduct the vial.This may take as long as dissolve 2 minutes.Once fully dissolved, (C)volume has theentered correct amount forluer-lok your dose firmly andapulling in the opposite direction ofand theclean syringe assembly. 18. Open new alcohol swab package (F) the injection site. anyentered excessabove) liquid back into thethevial (A) . and s koncovkou vial.This may take as colorless. long as 2 minutes.Once fully dissolved, product nexpel volume by pushing plunger should be clear 18. OpenWhen a newgiving alcoholtheswab package (F)one andhand cleantothe injection site. injection,use gently pinch the cleaned should be (C) from the vial adapter by twisting xpel any excess liquid back (E) into the vialthe (A)clear . andiscolorless. When giving theand injection,use one handthe to other gentlyhand,hold pinch the cleaned 8.Luerlock Once powder completely dissolved,remove the syringe (B-1, (1) area of skin hold it firmly.With the syringe (C) e,but sureadapter to keep(E)theby infrom your hand. 8.syringe Once powder is completely the syringe (B-1, C) frommake the vial twisting areaatof askin and holdangle it firmly.With the other hand,hold the syringe (C) B-2)the the vial adapter (E)dissolved,remove by twisting counterclockwise.Discard 45-degree to the skin. from the(B-1, vial (E)the by twisting counterclockwise.Discard but make sure keephand the syringe insyringe your hand. at a 45-degree angleyour to the skin. dose,activate the pink needle safety (C) into your withB-2) the tip facing up,adapter e syringe the B-2) into container (G)1. mL Syringe 19. After injecting product C.sharps Onecontainer Disposable D. Safety Needle: 27 G, ½ inch the syringe into(C) the from sharps (G) . pull the plunger to needle*(C) (D)infrom packaging by peeling apart syringe your its hand with9.the tip facing up, 19. Aftershield injecting your product dose,activate the pink safetyG. Sharps supplied) Remove the(B-1, 1 mLB-2) syringe its package and (D) with one hand until you hear it clickneedle into place,and then Container D. Safety(not Needle: 27 G, ½ inch C.from OneitsDisposable 1 pull mLthe Syringe 9. by Remove the 1 mL syringe (C) package and plunger to eedle* (D) from its packaging peeling apart (D) with one hand until you hear it click into place,and then shield Sharps Container the 1 mL marking.Do not pull plunger past the 1 mL marking. place the entire syringe assembly (C,D) into theG. sharps container (G). (not supplied) the 1 mL marking.Do not pull plunger past the 1 mL marking. place the entire syringe assembly (C,D) into the sharps container (G). e (D) onto the filled syringe (C) by twisting Please call X-XXX-XXX-XXXX (X-XXX-XXX-XXXX) for more information. E (C)call Vial adapter (1) FTampony Alcohols alkoholem swabs (x4)(4×) Sharps container (1; not supplied) (D)feel ontoa slight the filled syringe byback twisting ou resistance.Pull the pink needle Please X-XXX-XXX-XXXX (X-XXX-XXX-XXXX) for more information. E Adaptér na ampulku (1) F G NGádoba na nebezpečný odpad *Your healthcare provider may recommend a smaller 29- or 31-gauge needle for injection. ud feel slight resistance.Pull back the pink needle it thena remove the white needle cover by pinching *Your healthcare provider may recommend a smaller 29- or 31-gauge needle for injection. Storeproduct vialspinching inassembly. theircarton carton protect from light until use. NOTE: These images are for reference only. není součástí sady) remove the white needle cover by it totoprotect ghen in the opposite direction ofproduct the syringe © 2010 Co Store vials in their from light until use. NOTE:(1; These images are for reference only. in the opposite direction of clean the syringe assembly. hol swab package (F) and the injection site. olinjection,use swab packageone (F)hand and clean the injection to gently pinch thesite. cleaned njection,use one hand to gently pinch the hold it firmly.With the other hand,hold thecleaned syringe (C) ld it firmly.With ngle to the skin.the other hand,hold the syringe (C) gle to the skin. our product dose,activate the pink needle safety D. Safety Needle: 27 G, ½ inch r product dose,activate pinkinto needle safety then D. Safety Needle: 27 G, ½ inch one hand until you hearthe it click place,and e hand until you hear it click into place,and then syringe assembly (C,D) into the sharps container (G). ringe assembly (C,D) into the sharps container (G).
rence Mat rence Mat
Vial )
OneVial VialAdapter Adapter E.E.One
Step 1 KROK
NOTE: images for reference NOTE: TheseThese images are forare reference only. only.
F. Alcohol Swab Packages F. Alcohol Swab Packages
© 2010 Company. All rights reserved. 5/10 MC50370-A P44178 © 2010 Company. All rights reserved. 5/10 MC50370-A P44178
KROK SI AMPULKU NASAĎTE NA NI ADAPTÉR Step 2: PŘIPRAVTE pRepARe ViAl foR uSe,–AttAch ViAl AdApteR V tomto kroku budete potřebovat 1 tampon s alkoholem (pomůcka F), 1 ampulku Nplate® (pomůcka A) This step usesna ampulku 1 alcohol swab (item F),E)1 Nplate® vial (item A), and 1 vial adapter (item E) a 1 adaptér (pomůcka ejměte zred ampulky červené or blue • S Remove (250 micrograms) plastové víčko. plastic cap from vial (500 micrograms)
epoužitým s alkoholem •• NUsing a new tamponem alcohol swab clean očistěte zátku ampulky. vial stopper átky po očištění už nedotýkejte. •• ZDo notsetouch vial stopper after cleaning it
omalu papírovou •• PPeel offodtrhněte paper backing slowlyčást from vial obalu adaptéru na ampulku tak, abyin adapter while keeping vial adapter adaptér zůstal v plastovém obalu. the plastic package edotýkejte zátky ampulky ani •• NDo not touchsevial stopper or spike hrotu of vialadaptéru. adapter
F LI P
O FF
Alcohol Prep Pad
• Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcoo
Alcohol Prep Pad
• Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcool • Sterile Tampon de preparation a l’alcoo
• N •echte ampulku postavenou na stole a nevybalujte Keeping the vial on a table, and keeping the vialzatím adapter adaptér z plastového obalu. Nastavte hrot adaptéru nad in the plastic packaging, line up spike on the vial střed zátky ampulky. adapter to the centre of the stopper on the vial • Tlačte adaptér do ampulky, dokud sethe nezastaví. pevně • Push the vial adapter down onto vial untilMusí it isbýt firmly nasazen. in place and you can’t push down any more
Step 2 KROK
• •S ejměte obal z adaptéru. Nechte přitom Lift offplastový plastic vial adapter packaging, adaptér na ampulce. leavingnasazený vial adapter on vial • •N edotýkejte se spojky pro stříkačku. Do not touch the syringe connector
KROK SI STŘÍKAČKU STERILNÍ VODOU Step 3: PŘIPRAVTE pRepARe SteRile WAteRSESyRiNge This step kroku uses 1 budete plungerpotřebovat rod (item B-1) and 1pístu pre-filled water B-1) syringe B-2) stříkačku se sterilní vodou (pomůcka B-2) V tomto 1 táhlo (pomůcka a 1 (item předplněnou Dříve provádět kroknote 3, dobře si prosím uvědomte, že MUSÍTE vždy do předplněné stříkačky se sterilní vodouthe nasadit plastové Beforenež youzačnete begin step 3 please the following: The clear plastic plunger rodnejprve MUST always be attached first before breaking whiteprůhledné tip off of the táhlo pístuwater a teprve pak odlomit špičku krytu pre-filled syringe. performbílou step 3a before stepstříkačky. 3b. Proveďte nejprve krok 3a a pak teprve pokračujte krokem 3b. •• KStep 3a: Nasaďte Attach clear plastic plunger to pre-filled sterile water rok 3a: průhledné plastovérod táhlo pístu do předplněné syringe byseplacing thevodou. threaded end oftáhlo the plunger into the závitem syringe and stříkačky sterilní Zasuňte koncemrod opatřeným carefully twisting the rod onto thehodinových grey syringeručiček, plunger,dokud until se you do stříkačky a opatrně jímclockwise otáčejte ve směru feel a slight resistance. not overŠroubujte, tighten dokud neucítíte mírný odpor. nespojí s šedým pístem do stříkačky. Neutahujte příliš velkou silou.
• K rok• 3b: stříkačku v jednéwith ruceone a druhou StepDržte 3b: Holding the syringe rukouhand, ohněte špičku bend the tipbílého of theplastového white plastickrytu směrem Tímto způsobem spoj držící coverdolů. downward with yourzlomíte other hand. bílý plastový this willkryt breakstříkačky. the seal of the white plastic cover • Jakmile bude spoj zlomený, můžete bílý plastový kryt • Once the seal is broken, pull the white plastic sejmout ze stříkačky. V jejím hrdle uvidíte šedou pryž. cover off. You will see grey rubber in the cap
KROK 4: VSTŘÍKNĚTE ZE STŘÍKAČKY DO AMPULKY A ROZPUSŤTE PŘÍPRAVEK NPLATE® Step 4: diSSolViNgVODU NplAte® by iNjectiNg WAteR iNto ViAl
V tomto kroku budete potřebovat stříkačku, kterou jste sestavili v kroku 3, a ampulku s nasazeným adaptérem, kterou jste si připravili v kroku 2 This step uses the syringe you just assembled in step 3, plus the vial and adapter assembly from step 2 Dříve provádět kroknote 4, uvědomte si prosím, že přípravek je nutné a opatrně. proteinový přípravekcana obsahuje beforenež youzačnete begin step 4 please the following: do dissolve Nplate® powderrozpouštět slowly andpomalu carefully. this is aNplate® protein jeproduct and proteins be easily tudíž bílkoviny, které by se nesprávným nebo přílišným třesením snadno poškodily. damaged by improper mixing andmícháním excessive shaking. • Keeping the viala nasaďte on the table, attach water-filled • Ampulku nechte stát na stole do adaptéru stříkačku se sterilní vodou. syringe toadaptér vial adapter holding the side of the vial adapter Jednou rukou přidržujte z bokubya druhou rukou našroubujte špičku stříkačky with oneručiček hand and twisting theŠroubujte, syringe tip clockwise onto themírný odpor. ve směru hodinových do adaptéru. dokud neucítíte adapter with the other hand until you feel a slight resistance
Step 3 KROK
Step 4 KROK
KROK VODU ZEbySTŘÍKAČKY PŘÍPRAVEK NPLATE® Step 4: VSTŘÍKNĚTE diSSolVe NplAte® iNjectiNgDO AMPULKY WAteR iNtoA ROZPUSŤTE ViAl
••Velmi a mírně stlačujte píst on a vstříkněte veškerou vodu Very pomalu slowly and gently push down plunger rod to inject zeallstříkačky musívial. na prášek pomalu. water indo ampulky. the syringe Voda into the Waterstékat must flow slowly onto powder • Nevstřikujte vodu do ampulky prudce. • Do not force the water into the vial Note: AfterPíst injecting the water into vial it is common the se zpátky. Poznámka: má po vstříknutí vodythe do stříkačky tendenciforvracet plunger to movekroku back 4up.není younutné do notdržet havepíst to maintain Při dokončování stlačený. pressure on the plunger for the rest of step 4.
Správný Correct postup
Nesprávný Incorrectpostup
before continuing: Dříve než budete do ensure that all waterse, pokračovat: Ujistěte iszdainjected from the jste do ampulky syringe into the vial vstříkli veškerou vodu before dissolving. ze stříkačky. Teprve poté můžete začít rozpouštět přípravek.
Holdingampulku the areamezi where thev místě vial andjejího vial adapter between ••Uchopte prsty spojení connect s adaptérem. Pomalu your fingers, gently swirl the vial by rotating your wrist until all of the otáčejte zápěstím a kružte ampulkou, dokud se všechen prášek v ampulce powder has dissolved andkapalina the liquidv ampulce in the vialčirá is clear and colourless nerozpustí a dokud nebude a bezbarvá.
•• Netřepejte Do not shakeampulkou. the vial • Netočte Do not roll vial between palms ampulkou mezi dlaněmi.
Note: itPoznámka: may take upÚplné to 2 minutes forprášku the powder completely dissolve rozpuštění může to trvat až 2 minuty.
KROK Step 4
KROK VODU ZEbySTŘÍKAČKY PŘÍPRAVEK NPLATE® Step 4: VSTŘÍKNĚTE diSSolVe NplAte® iNjectiNgDO AMPULKY WAteR iNtoA ROZPUSŤTE ViAl ež budete pokračovat: •• NBefore continuing: –– do Proveďte roztoku v ampulce. Nesmíand/or obsahovat pevné částečky visuallyvizuální inspectkontrolu the dissolved liquid for particles discolouration. jednotnou barvu. Tekutina být čirá a bezbarvá a prášek úplně ita musí must mít be clear and colourless and fullymusí dissolved rozpuštěný. – Note: if there is any colour or particles in the liquid, contact your healthcare – professional Poznámka: Pokud roztok nemá jednotnou barvu nebo v něm vidíte plavat pevné částice, kontaktujte zdravotnického pracovníka. – do make sure liquid is fully dissolved before removing syringe – Před odpojením stříkačky se ujistěte, že je prášek v roztoku zcela rozpuštěný. •• TWhen completely remove thestříkačku empty syringe twisting it tak, že ji eprveNplate® až budeisNplate® úplnědissolved, rozpuštěný, můžete odpojitbyod adaptéru anti-clockwise off ofsměru the vial adapter ručiček. budete otáčet proti hodinových
llocal image to be inserted
rázdnou vyhoďteinto do nádoby nebo nebezpečný •• PDiscard thestříkačku empty syringe sharps orna zdravotnický hazard container. Keep the dissolved odpad. Ampulku s roztokem Nplate® nechte stát na podložce. Okamžitě si Nplate® vial. Immediately prepare new syringe for injection připravte novou stříkačku na injekci. • Do not delay injecting Nplate® • Podání injekce Nplate® neodkládejte.
KROK 5: PŘIPRAVTE SI NOVOU STŘÍKAČKU NA INJEKCI V tomto kroku budete potřebovat ampulku s čirým roztokem rozpuštěného přípravku Nplate®, adaptér ampulky z kroku 4, a 1ml stříkačku (pomůcka C)
Step 5: pRepARe NeW SyRiNge foR iNjectioN
Než budete pokračovat: Dříve než začnete provádět tento krok, zkontrolujte si předepsanou dávku přípravku. Poznámka: Roztok Nplate® je vysoce účinný, This step uses the vialdodržet of clear, dissolved Nplate®dávku plus the vial adapter from stepzkontrolujte, 4, and the zda 1 mljstesyringe (item C) a proto je důležité přesně a odměřit předepsanou přípravku. Před aplikací injekce ze stříkačky odstranili všechny vzduchové bubliny. before continuing: do check your dose before starting this step. Note: the Nplate® liquid is highly potent which is why accuracy and dose measurement are important. do make sure that all air bubbles are removed before injection. •• VRemove ml syringe fromz obalu. package yjměte11ml stříkačku asajte •• NDraw airdo stříkačky into syringe tovzduch 1 ml až ke značce marking pro 1 ml. píst dál nežtoke značce •• NDoevytahujte not pull plunger back more pro 1 ml. than 1 ml
Attach1ml 1 mlstříkačku syringe tok adapvial • P• řipojte adapter of thes rozpuštěným dissolved téru na ampulce Nplate® byNplate®. twistingStříkačku the přípravkem syringe tipšpičkou clockwise onto the našroubujte do adaptéru. vial adapter until you feel a Šroubujte po směru hodinových slight dokud resistance ručiček, neucítíte mírný odpor.
•• A. Vytlačte Push air vzduch into vialze stříkačky do ampulky. píst pressure stlačený.on plunger •• B. Držte Maintain točtevialampulku s nasazenou dnem •• C.C. OTurn assembly and syringestříkačkou upside down, aby bylaabove ampulka přímo nad sovzhůru the vialtak, is directly the syringe stříkačkou.
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KROK SI NOVOU STŘÍKAČKU NA INJEKCI Step 5: PŘIPRAVTE pRepARe NeW SyRiNge foR iNjectioN asajte všechnu do stříkačky. • NWithdraw the fulltekutinu amountz ampulky of liquid into the syringe –– M aximální objem tekutiny volume u ampulky the maximum deliverable for s obsahem the 250 mikrogramů přípravku je 0,5 ml. 250 mcg vial is 0.5 ml and for the 500 mcg
pístthe ze plunger stříkačky.remains in the syringe •• Nevytahujte Do ensure that
vial is 1 ml • Do not pull the plunger out of the back of the syringe
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• •Píst musíand zůstat ve stříkačce. Check remove all air bubbles from the syringezda ve stříkačce nejsou vzduchové • Zkontrolujte, bubliny a případně všechnywith odstraňte. – gently tap thejesyringe your fingers – Jemně poklepejte na stříkačku to separate the bubbles from theprstem, liquid aby se bublinky oddělily od tekutiny. – Slowly push the plunger up to force – Pomalu nahoru the air posouvejte bubbles outpíst of the syringe a vytlačte ze stříkačky všechny vzduchové bubliny.
• P Check odívejte sedose do karty your by looking at your s předepsaným dávkováním dose card a zkontrolujte předepsanou • Slowly push back on the plunger dávku˝. to leave only the amount prescribed • P by omalu tak, aby yourposouvejte healthcarepíst professional ve stříkačce zůstala přesná dávka předepsaná lékařem.
rcholsure zátkythe pístu v jednéhead rovině •• VMake topmusí of thebýt plunger se značkou na válci stříkačky odpovídající lines up with the syringe marking předepsané Tekutinu případně that matchesdávce. your prescribed dose. if vytlačte Objem necessaryzpátky push do ampulky. liquid back into the musí vial odpovídat dávce. to achieve předepsané the desired dose a ujistěte •• PDoroveďte a finalposlední check to kontrolu ensure the correct se, zda jste do stříkačky natáhli amount of liquid for your dose issprávný in the objem tekutiny a zda jste z ní odstranili syringe and all air bubbles have been všechny removedvzduchové bubliny. 0.1
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before continuing: do make sure the correct amount Dříve než budete pokračovat: Znovu se of liquid for your dose remains in the syringe. do make přesvědčte, že je ve stříkačce správná dávka sure all air bubbles are removed from the syringe. přípravku. Znovu se přesvědčte, že jste ze stříkačky vytlačili všechny vzduchové bubliny.
Step 5 KROK
KROK NOVOU STŘÍKAČKU NA INJEKCI Step 5: PŘIPRAVTE pRepARe A SINeW SyRiNge foR iNjectioN akmile bubliny a stříkačka •• JOnce all odstraníte air bubbles všechny are removed and syringe is filled with bude naplněna předepsanou dávkou přípravku, your correct dose, twist off syringe from vial adapter vyšroubujte stříkačku z adaptéru.
aplněnou a nedotýkejte se •• N Keep filledstříkačku syringe indržte yourv ruce hand and do not touch špičky stříkačky. syringe tip aplněnou stříkačku po odpojení •• N Do not set filled syringe down afterod adaptéru removing from vial ampulky nepokládejte.
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KROK 6: PŘIPRAVTE SI JEHLU Step 6: pRepARe iNjectioN Needle
V tomto kroku budete potřebovat stříkačku naplněnou naměřenou dávkou Nplate® a bezpečnostní jehlu (pomůcka D) This step uses the syringe filled with measured Nplate® dose plus the safety needle (item D) •• Holding the syringe in theruky palmtak, of your Držte stříkačku v dlani aby hand špičkawith the tip facing up,nahoru, removea vyjměte the safetybezpečnostní needle from the směřovala package jehlu z obalu.
•• Attach safety needle to filled Apply strong N asaďte bezpečnostní jehlusyringe. na naplněnou force while Našroubujte twisting to attach the safety needle stříkačku. ji na stříkačku silou,onto aby syringe. Turn clockwise to lockjehlou into thepo směru syringe tip bylo spojení pevné. Otáčejte (luer-lok) hodinových ručiček, dokud se nezamkne v koncovce • The product isLuerlock. now ready for injection. IMMEDIATELY • continue P řípravektojeStep nyní 7 přípraven k aplikaci.
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OKAMŽITĚ přejděte k provádění kroku 7.
KROK Step 5
KROK Step 6
KROK 7: VYBERTE A PŘIPRAVTE VPICHU Site Step chooSe ANd pRepAReMÍSTO AN iNjectioN This step kroku uses a budete new alcohol swab (item V tomto potřebovat novýE)tampon s alkoholem (pomůcka E)DIATE
Vyberte místo pro podání injekce Nplate®. Doporučujeme následující • •Select your injection site. Three recommended sites for Nplate® are: tři místa vpichu: – –front přední strana střední části stehen of the middle thighs – –Abdomen, břicho kromě 5cmforoblasti kolem pupkuarea around the navel except the 5-centimetre – –ifpokud vámelse injekci podává lze jithey aplikovat douse vnější pažearms someone is giving youjiná theosoba, injection, can also thečásti outerhorní areapoloviny of the upper •–M ísta vpichuthe pravidelně střídejte. do rotate site for each injection
• • • •
not injectinjekci into areas wheresetheslabou, skin iszhmožděnou tender, bruised andtvrdou hard kůží. •Do Neaplikujte v místech nebo not injectinjekci into areas withpoškozené scars or stretch marks •Do Neaplikujte do kůže jizvami či striemi. the site where Nplate® be injected with anjím alcohol using circularinjekci motionNplate® podávat. •Wipe Vezměte alkoholový tamponisatokrouživým pohybem otřeteswab, místo, kama budete notpodáním touch this area again before giving the injection •Do Před injekce se již tohoto místa nedotýkejte.
KROK 8: PODEJTE SI INJEKCI ROZTOKU NPLATE® Step 8: iNjectiNg the NplAte® liquid
V tomto kroku budete potřebovat stříkačku naplněnou roztokem Nplate® s nasazenou jehlou This step uses the filled syringe and needle assembly •• OPull back on the pink needle safety coverkryt dklopte z jehly růžový bezpečnostní (toward the away from the needle) (směrem od syringe jehly keand stříkačce).
• • Remove clear needle shield the D ržte stříkačku v jedné rucebya holding druhou rukou syringe one hand and carefully pulling opatrněinsejměte průhledný kryt jehly. straightinjekce off withjeyour other hand • shield P řed aplikací nutné tento průhledný sejmout. • Do remove kryt the clear shield before injecting
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Step 7 KROK
Step 8 KROK
KROK SI the INJEKCI ROZTOKU NPLATE® Step 8: PODEJTE iNjectiNg NplAte® liquid J ednou očištěnou • •With onerukou hand,jemně gentlysevřete pinch the cleaned částofkůže pevně ji stiskněte. Druhou area skina and hold it firmly. With the rukouhand, držtehold stříkačku (jako tužku) other the syringe (like ave 45° sklonu vůči kůži. angle to the skin pencil) at a 45-degree K rátkým, prudkým pohybempush zaveďte • •With a short, sharp motion, the jehlu do kůže. needle into the skin
stříkněte předepsanou •• VInject the prescribed dosedávku přípravku pod kůži podle pokynů svého subcutaneously as directed by your lékaře, sestry nebo lékárníka. doctor, zdravotní nurse or pharmacist
Jakmile stříkačka prázdná, • • When thebude syringe is empty, pull the needle vytáhněte jehlubeing z kůže. Nezapomeňte, out of the skin, careful to keep it žethe musíte vytahovat at samejehlu anglez kůže as inserted ve v jakém jste jiat the – stejném there mayúhlu, be a little bleeding zaváděli. injection site. you can press a cotton –ball Místo můžethemírně krvácet. or vpichu gauze over injection site Lze10hoseconds překrýt kouskem vaty či gázy for a deset vteřin držet místo stisknuté. – Do not rub the injection site. –ifMneeded, ísto vpichu netřete. you may cover the V případě potřeby zakryjte místo vpichu injection site with a plaster náplastí.
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P o aplikaci injekce palcem (nebo • •After injecting, use your thumb (or špičkou prstu) zatlačte růžovýthe kryt tip of your finger) to activate směrem dopředu jehle, dokud pink safety cover byk pushing the cover neuslyšíte anebo cvaknutí, forward using the neucítíte same hand until you kteréand/or je signálem, že kryt na své hear feel it click andzapadl lock into místo.over the needle place
rohlédněte, jestlithat je špička jehlytip •• PVisually confirm the needle zakrytá. Jehlu stříkačky před is covered. Always coverjethe needle with likvidací the pink vždy safetynutné coverzakrýt beforerůžovým disposal bezpečnostním krytem.
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Step 8 KROK
KROK POMŮCKY Step 9: ZLIKVIDUJTE diSpoSiNg of SupplieS
Proveďte následující kroky: Do the following: • S•tříkačku s jehlou chráněnou krytem okamžitě vyhoďte do nádoby na zdravotnický odpad. Immediately discard syringe with covered needle into a sharps container • Použitou ampulku Nplate® okamžitě vyhoďte do příslušné nádoby na odpad • Immediately discard used Nplate® vial into an appropriate • Všechny ostatní materiály musí být vyhozeny do příslušných nádob na odpad waste container • Make sure all other materials are discarded into proper containers podávání injekce vial ani ampulka s přípravkem ThePomůcky injectionna device and Nplate® must NeVeR be reusedNplate® nesmí být NIKDY použity opakovaně. • Použité jehlyofa the stříkačky vyhoďte do nádoby odolné proti propíchnutí. • Do dispose used needle and syringe in a puncture-resistant container • Veškeré zbytky přípravku Nplate® vyhoďte do příslušné nádoby na odpad. Zbytky přípravku Nplate® v ampulce se nesmí NIKDY použít • Do aplikaci dispose ofinjekce. any left-over Nplate® in proper waste container. k další Left-over Nplate® in the vial must NEVER be re-used for another injection
POKUD BUDETE K APLIKACI PŘEDEPSANÉ DÁVKY POTŘEBOVAT if you NeedPŘÍPRAVKU MoRe NplAte® to coMplete youR doSe... VÍCE INJEKCÍ NPLATE®… • Take a new self-administration kit and a new vial of Nplate® product • Vezměte si novou sadu pro svépomocnou aplikaci přípravku a novou ampulku s přípravkem Nplate®. • Return to the beginning of this Step-by-step guide and follow all the preparation and administration steps with a new self-administration kit • Vraťte se na začátek návodu Krok za krokem a postupně znovu provádějte všechny kroky přípravy a podávání. Použijte k tomu novou sadu pro svépomocné podávání přípravku.
ViSuAl of locAl Self AdMiNiStRAtioN Kit to be iNSeRted
KROK Step 9
© 2012 2012 Amgen. Amgen. All Allrights rightsreserved. reserved. ©
Job code: nPo-ihq-aMG-077-2012 date of prep: July 2012
