FrancophonIA/ELRC3.0 huggingface dataset:
English: • one pre-filled syringe of solvent, 5 ml sterile 0.234% sodium chloride solution for injection for reconstitution, with one plunger rod
Croatian: • jedna napunjena štrcaljka s otapalom, 5 ml sterilne 0,234% otopine natrijevog klorida za injekciju za pripremu otopine, s jednim potisnikom klipa
English: BeneFIX is an injectable clotting (coagulation) factor IX product that is produced by recombinant DNA technology.
Croatian: BeneFIX je lijek s faktorom IX za zgrušavanje (koagulaciju) krvi, koji se proizvodi tehnologijom rekombinantne DNK i daje injekcijom.
English: A kidney disorder has been reported following high doses of plasma-derived factor IX to induce immune tolerance in haemophilia B patients with factor IX inhibitors and a history of allergic reactions (see also “Warnings and precautions”).
Croatian: Prijavljen je poremećaj bubrega nakon visokih doza faktora IX dobivenog iz plazme za izazivanje imunološke tolerancije u bolesnika s hemofilijom B s inhibitorima faktora IX i alergijskim reakcijama u povijesti bolesti (vidjeti također “Upozorenja i mjere opreza”).
English: Allergic-type hypersensitivity reactions are possible with BeneFIX.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa s BeneFIX-om.
English: Strength of BeneFIX per ml prepared solution
Croatian: Tablica 1. Jačina BeneFIX-a po ml pripremljene otopine
English: BeneFIX works by replacing factor IX in haemophilia B patients to enable their blood to clot.
Croatian: BeneFIX djeluje tako da nadomješta faktor IX u bolesnika s hemofilijom B i omogućuje im zgrušavanje krvi.
English: Agglutination of red blood cells in the tube/syringe There have been reports of agglutination of red blood cells in the tube/syringe with the administration of BeneFIX.
Croatian: Aglutinacija crvenih krvnih stanica u cjevčici/štrcaljki Zabilježeni su slučajevi aglutinacije crvenih krvnih stanica u cjevčici/štrcaljki kod primjene BeneFIXa.
English: 1 vial with 250 IU nonacog alfa 1 vial with 500 IU nonacog alfa 1 vial with 1000 IU nonacog alfa 1 vial with 1500 IU nonacog alfa 1 vial with 2000 IU nonacog alfa 1 vial with 3000 IU nonacog alfa
Croatian: 1 bočica s 250 IU nonakoga alfa 1 bočica s 500 IU nonakoga alfa 1 bočica s 1000 IU nonakoga alfa 1 bočica s 1500 IU nonakoga alfa 1 bočica s 2000 IU nonakoga alfa 1 bočica s 3000 IU nonakoga alfa
English: Because of the risk of allergic reactions with factor IX concentrates, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Croatian: Zbog rizika od alergijskih reakcija kod primjene koncentrata faktora IX, početne primjene faktora IX treba, sukladno procjeni nadležnog liječnika, provoditi pod medicinskim nadzorom na mjestu gdje se može osigurati odgovarajuća medicinska skrb za alergijske reakcije.
English: • Infusion site cellulitis (pain and redness of the skin)
Croatian: • celulitis na mjestu infuzije (bol i crvenilo kože)
English: Therefore, close monitoring of factor IX plasma activity (which measures the ability of your blood to form clots) has to be performed to adjust doses as appropriate.
Croatian: Stoga se aktivnost faktora IX u plazmi (čime se mjeri sposobnost krvi da stvara ugruške) mora pažljivo pratiti kako bi se primjereno prilagodile doze.
English: The rate of administration should be determined by the patient's comfort level.
Croatian: Brzinu primjene treba odrediti tako da bolesniku bude ugodno.
English: There have been post-marketing reports of thrombotic events, including life-threatening superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion BeneFIX through a central venous catheter (see also section 4.8).
Croatian: Nakon stavljanja lijeka u promet prijavljeni su trombotski događaji, uključujući po život opasan sindrom gornje šuplje vene, u kritično bolesne novorođenčadi dok su primala BeneFIX kontinuiranom infuzijom kroz centralni venski kateter (vidjeti također dio 4.8).
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: U literaturi su prijavljeni slučajevi koji pokazuju korelaciju između razvoja inhibitora faktora IX i alergijskih reakcija.
English: BeneFIX is provided as a powder for injection in a glass vial and a solvent provided in pre-filled syringe.
Croatian: BeneFIX se isporučuje kao prašak za injekciju u staklenoj bočici i otapalo u napunjenoj štrcaljki.
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom B (urođeni nedostatak faktora IX).
English: - It is recommended that evey time you use BeneFIX, you record the name and batch number of the product.
Croatian: - Preporučuje se da kod svake primjene lijeka BeneFIX zabilježite ime i broj serije lijeka.
English: In two open-label studies BeneFIX was found to be safely administered at 100 IU/kg once-weekly.
Croatian: U dva otvorena ispitivanja utvrđeno je da se BeneFIX može sigurno primjenjivati u dozi od 100 IU/kg jednom tjedno.
English: BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for solution for injection with sterile 0.234% sodium chloride solution (see section 6.6).
Croatian: BeneFIX se primjenjuje intravenskom infuzijom nakon rekonstitucije liofiliziranog praška za otopinu za injekciju sa sterilnom 0,234% otopinom natrijevog klorida (vidjeti dio 6.6).
English: Children 6 to < 12
Croatian: Djeca 6 do < 12
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for BeneFIX
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA
English: How to take BeneFIX
Croatian: Kako primjenjivati BeneFIX
English: Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening while firmly pushing and turning the syringe clockwise until the connection is secured.
Croatian: Spojite štrcaljku s otapalom na nastavak za bočicu tako što ćete umetnuti vrh štrcaljke u otvor nastavka i istovremeno čvrsto pritisnuti i zakrenuti štrcaljku u smjeru kazaljke na satu sve dok se čvrsto ne spoje.
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Savjetuje se određivati razine faktora IX tijekom trajanja liječenja na odgovarajući način i time se rukovoditi u određivanju doze koja se primjenjuje i učestalosti ponavljanja infuzija.
English: The potency (IU) is determined using the European Pharmacopoeia one-stage clotting assay.
Croatian: Jačina (IU) je određena pomoću jednofaznog testa zgrušavanja krvi prema Europskoj farmakopeji.
English: • one vial of BeneFIX 250, 500, 1000, 1500, 2000 or 3000 IU powder
Croatian: • jedna bočica BeneFIX praška od 250, 500, 1000, 1500, 2000 ili 3000 IU
English: There have been reports of clumping (agglutination) of red blood cells in the tube/syringe with the administration of BeneFIX.
Croatian: Prijavljeni su slučajevi sljepljivanja (aglutinacije) crvenih krvnih stanica u cjevčici/štrcaljki kod primjene BeneFIX-a.
English: Somnolence; tremor
Croatian: • pospanost, drhtanje
English: - The active substance is nonacog alfa (recombinant coagulation factor IX).
Croatian: - Djelatna tvar je nonakog alfa (rekombinantni koagulacijski faktor IX).
English: Slowly depress the plunger rod to inject all the solvent into the BeneFIX vial
Croatian: Sporim pritiskom na klip ubrizgajte cijelu količinu otapala u bočicu BeneFIX-a.
English: Treatment failure can occur as a consequence of human coagulation factor IX adsorption to the internal surfaces of some infusion equipment.
Croatian: Adsorpcija ljudskog koagulacijskog faktora IX na unutarnje površine neke opreme za infuziju može dovesti do neuspjeha liječenja.
English: Including tooth extraction Major
Croatian: Manji: uključujući vađenje zuba
English: BeneFIX will be administered by intravenous infusion (IV) after reconstitution with sterile solvent for injection.
Croatian: BeneFIX će se primijeniti intravenskom infuzijom (i.v.) nakon pripreme sa sterilnim otapalom za injekciju.
English: As one PTP treated with BeneFIX developed a clinically relevant low responding inhibitor during clinical studies and experience on antigenicity with recombinant factor IX is still limited, patients treated with BeneFIX should be carefully monitored for the development of factor IX inhibitors that should be titrated in Bethesda Units using appropriate biological testing.
Croatian: Razvoj inhibitora je manje česti događaj u prethodno liječenih bolesnika koji primaju lijekove koji sadrže faktor IX. Budući da je jedan prethodno liječeni bolesnik liječen BeneFIX-om razvio klinički značajan inhibitor sa slabim odgovorom tijekom kliničkih ispitivanja, a iskustvo s antigenošću rekombinantnog faktora IX još je ograničeno, bolesnike liječene BeneFIX-om treba pažljivo pratiti zbog razvoja inhibitora faktora IX, čiji titar treba mjeriti u Bethesda jedinicama pomoću odgovarajućeg biološkog testa.
English: If clumping of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package.
Croatian: Ako se opazi sljepljivanje crvenih krvnih stanica u cjevčici/štrcaljki, bacite sav taj materijal (cjevčice, štrcaljku i otopinu BeneFIX-a) i nastavite primjenu s novim pakiranjem.
English: • Periodic Safety Update Reports
Croatian: • Periodička izvječća o neškodljivosti lijeka
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma).
Croatian: Broj jedinica primijenjenog faktora IX izražava se u međunarodnim jedinicama (IU), koje se odnose na važeći standard Svjetske zdravstvene organizacije za lijekove s faktorom IX. Aktivnost faktora IX u plazmi izražava se ili kao postotak (u odnosu na normalnu ljudsku plazmu) ili u međunarodnim jedinicama (u odnosu na međunarodni standard za faktor IX u plazmi).
English: The final solution should be inspected visually for fine particles before administration.
Croatian: 12. Konačnu otopinu treba vizualno pregledati prije primjene da ne sadrži sitne čestice.
English: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU powder and solvent for solution for injection
Croatian: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU prašak i otapalo za otopinu za injekciju Prašak i otapalo za otopinu za injekciju
English: Potentially life-threatening anaphylactic/anaphylactoid reactions have occurred with factor IX products, including BeneFIX.
Croatian: Nastupile su potencijalno smrtonosne anafilaktičke/anafilaktoidne reakcije s lijekovima koji sadrže faktor IX, uključujući BeneFIX.
English: Aseptic technique (meaning clean and germ free) should be used during the reconstitution procedure.
Croatian: Tijekom postupka pripreme potrebno je primjenjivati aseptičku tehniku (što znači čisto i bez mikroba).
English: A solvent (0.234% sodium chloride solution) is also supplied for reconstitution.
Croatian: Priloženo je i otapalo (0,234% otopina natrijevog klorida) za pripremu otopine.
English: If agglutination of red blood cells in the tubing/syringe is observed, discard all this material (tubing, syringe and BeneFIX solution) and resume administration with a new package.
Croatian: Ako se opazi aglutinacija crvenih krvnih stanica u cjevčici/štrcaljki, potrebno je baciti sav taj materijal (cjevčice, štrcaljku i otopinu BeneFIX-a) i nastaviti primjenu s novim pakiranjem.
English: 2 alcohol swabs 1 plaster 1 gauze pad
Croatian: 1 sterilni set za infuziju 2 vatice natopljene alkoholom 1 flaster
English: Store below 30 ºC.
Croatian: Čuvati na temperaturi ispod 30ºC.
English: Other sterile disposable syringes may be used for administration.
Croatian: Za primjenu se mogu upotrijebiti druge sterilne štrcaljke za jednokratnu uporabu.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Croatian: Nefrotski sindrom prijavljen je nakon pokušaja indukcije imunološke tolerancije u bolesnika koji imaju hemofiliju B s inhibitorima faktora IX i alergijskim reakcijama u anamnezi.
English: BeneFIX should be administered using the pre-filled solvent syringe provided or a single sterile disposable plastic luer lock syringe.
Croatian: BeneFIX treba primijeniti pomoću priložene napunjene štrcaljke s otapalom ili sterilne plastične štrcaljke s luer lock-om za jednokratnu uporabu.
English: Inadequate factor IX recovery p,
Croatian: Pretrage neodgovarajući povrat faktora IX
English: Store below 30C.
Croatian: Čuvati na temperaturi ispod 30C.
English: BeneFIX is administered by intravenous (IV) infusion after reconstitution of the powder for injection with the supplied solvent (a sodium chloride (salt) solution) in the pre-filled syringe.
Croatian: BeneFIX se primjenjuje intravenskom (i.v.) infuzijom nakon pripreme praška za injekciju pomoću priloženog otapala (otopina natrijevog klorida (soli)) u napunjenoj štrcaljki.
English: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU of powder in a 10 mL vial (type 1 glass) with a stopper (chlorobutyl) and a flip-off seal (aluminium) and 5 mL of clear, colourless solvent in a prefilled syringe (type 1 glass) with a plunger stopper (bromobutyl), a tip-cap (bromobutyl) and a sterile vial adapter reconstitution device, a sterile infusion set, two alcohol swabs, a plaster, and a gauze pad.
Croatian: BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU prašak i otapalo za otopinu za injekciju BeneFIX 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU, 3000 IU praška u bočici od 10 ml (staklo tipa 1) s čepom (klorobutil) i prstenom (aluminij) i 5 ml bistrog, bezbojnog otapala u napunjenoj štrcaljki (staklo tipa 1) s čepom klipa (brombutil), zatvaračem vrha (bromobutil) i sterilnim nastavkom za bočicu za rekonstituciju, sterilni set za infuziju, dvije vatice natopljene alkoholom, flaster i jastučić od gaze.
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Croatian: Čuvati na temperaturi ispod 30°C.
English: Early signs of allergic reactions include difficulty breathing, shortness of breath, swelling, hives, itching, generalised urticaria, tightness of the chest, wheezing, low blood pressure, blurred vision and anaphylaxis (severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands).
Croatian: Rani znakovi alergijskih reakcija uključuju otežano disanje, nedostatak zraka, oticanje, koprivnjaču, svrbež, generaliziranu urtikariju, stezanje u prsima, piskanje pri disanju, nizak krvni tlak, zamagljen vid i anafilaksiju (teška alergijska reakcija koja može uzrokovati otežano gutanje i/ili disanje, crvenilo ili otečenost lica i/ili šaka).
English: m including injection site pain, infusion-site discomfort n including infusion-site pruritus, infusion-site erythema o including chest pain and chest tightness p
Croatian: uključujući bol na mjestu injekcije, nelagodu na mjestu infuzije uključujući pruritus na mjestu infuzije, eritem na mjestu infuzije uključujući bol u prsima i stezanje u prsima
English: BeneFIX is administered by intravenous infusion after reconstitution of the lyophilised powder for injection with the supplied solvent (0.234% w/v sodium chloride solution) in the pre-filled syringe (see also section 3 of the package leaflet for reconstitution instructions).
Croatian: BeneFIX se primjenjuje intravenskom infuzijom nakon rekonstitucije liofiliziranog praška za injekciju s priloženim otapalom (0,234% m/V otopina natrijevog klorida) u napunjenoj štrcaljki (vidjeti također dio 3 Upute o lijeku za upute za rekonstituciju).
English: BeneFIX contains recombinant coagulation factor IX, (nonacog alfa).
Croatian: BeneFIX sadrži rekombinantni koagulacijski faktor IX (nonakog alfa).
English: Patients should be informed of early signs of hypersensitivity reactions including difficult breathing, shortness of breath, swelling, hives, generalised urticaria, itching, tightness of the chest, bronchospasm, laryngospasm, wheezing, hypotension, blurred vision, and anaphylaxis.
Croatian: Bolesnike treba obavijestiti o ranim znakovima reakcija preosjetljivosti uključujući otežano disanje, nedostatak zraka, oticanje, koprivnjaču, generaliziranu urtikariju, svrbež, stezanje u prsima, bronhospazam, laringospazam, zviždanje u plućima, hipotenziju, zamagljen vid i anafilaksiju.
English: METHOD OF ADMINISTRATION Single use injection.
Croatian: Injekcija za jednokratnu primjenu.
English: Life-threatening haemorrhages
Croatian: Krvarenja opasna po život
English: Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (PUPs) with BeneFIX.
Croatian: Nema dovoljno podataka iz kliničkih ispitivanja BeneFIX-a o liječenju prethodno neliječenih bolesnika.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Zabilježene su reakcije preosjetljivosti ili alergijske reakcije (koje mogu obuhvaćati angioedem, pečenje i žarenje na mjestu infuzije, zimicu, crvenilo uz osjećaj vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje, piskanje) i u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: How to store BeneFIX
Croatian: Kako čuvati BeneFIX
English: Tlf: +47 67 52 61 00
Croatian: Pfizer Norge AS Tlf: +47 67 52 61 00
English: Infusion-site cellulitis a
Croatian: Infekcije i infestacije celulitis na mjestu infuzije
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip k; urtikarija
English: While holding the adapter in the package, place the vial adapter over the vial.
Croatian: Dok držite nastavak u pakiranju, postavite nastavak za bočicu iznad bočice.
English: BeneFIX contains recombinant coagulation factor IX, (INN = nonacog alfa).
Croatian: BeneFIX sadrži rekombinantni koagulacijski faktor IX, (INN = nonakog alfa).
English: Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin.
Croatian: Aktivirani faktor IX, u kombinaciji s aktiviranim faktorom VIII, aktivira faktor X.
English: Such reactions may include swelling of the face or throat, burning and stinging at the infusion site, chills, flushing, itching, headache, hives, low blood pressure, lethargy, nausea, restlessness, fast heart rate, tightness of the chest, tingling, vomiting, wheezing).
Croatian: Takve reakcije mogu uključivati oticanje lica ili grla, žarenje i pečenje na mjestu infuzije, zimicu, crvenilo uz osjećaj vrućine, svrbež, glavobolju, koprivnjaču, niski krvni tlak, letargiju, mučninu, nemir, ubrzani puls, stezanje u prsima, trnce, povraćanje, piskanje.
English: • Phlebitis (pain and redness of veins), flushing
Croatian: • flebitis (bol i crvenilo vena), crvenilo uz osjećaj vrućine
English: If such inhibitors occur, a sign may be an increase in the amount of BeneFIX typically required to treat a bleed and or continued bleeding after treatment.
Croatian: Bolesnici s hemofilijom B mogu razviti neutralizirajuća protutijela (inhibitore) na faktor IX. Znak da su se stvorili takvi inhibitori može biti veća količina BeneFIX-a no obično koja je potrebna za liječenje krvarenja i/ili kontinuirano krvarenje nakon liječenja.
English: BeneFIX should be administered at a slow infusion rate.
Croatian: BeneFIX treba primjenjivati sporom infuzijom.
English: What BeneFIX contains
Croatian: Što BeneFIX sadrži
English: In addition, the solution should be withdrawn from the vial using the vial adapter.
Croatian: Osim toga, otopinu treba izvući iz bočice pomoću nastavka za bočicu.
English: Pfizer PFE, spol.
Croatian: Pfizer PFE, spol. s.r.o.
English: BeneFIX may be administered for long term prophylaxis against bleeding in patients with severe haemophilia B. In a clinical study for routine secondary prophylaxis the average dose for previously treated patients (PTP) was 40 IU/kg (range 13 to 78 IU/kg) at intervals of 3 to 4 days.
Croatian: U kliničkom ispitivanju primjene za rutinsku sekundarnu profilaksu, prosječna doza prethodno liječenih bolesnika bila je 40 IU/kg (raspon od 13 do 78 IU/kg) u intervalima od 3 do 4 dana.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava inhibicija faktora IX
English: Attach the plunger rod to the solvent syringe by pushing and turning firmly.
Croatian: Spojite klip na štrcaljku s otapalom tako što ćete ga pritisnuti i čvrsto zakrenuti.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: U pothranjenih bolesnika ili bolesnika prekomjerne tjelesne težine može biti potrebno prilagoditi dozu na temelju tjelesne težine.
English: Patients who have specific mutations of their factor IX gene such as major deletion may be more likely to develop an inhibitor to factor IX and/or experience allergic reactions.
Croatian: - Stvaranje faktora IX u tijelu kontrolira gen za faktor IX. Kod bolesnika koji imaju posebne mutacije gena za faktor IX, kao što su velike delecije, postoji veća vjerojatnost od razvoja inhibitora faktora IX i/ili alergijskih reakcija.
English: 1 vial: 2000 IU nonacog alfa (approx. 400 IU/ml after reconstitution).
Croatian: 1 bočica: 2000 IU nonakoga alfa (pribl. 400 IU/ml nakon pripreme).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 5 ml of 0.234% sodium chloride solution for injection
Croatian: Sadrži 5 ml 0,234% otopine natrijevog klorida za injekciju
English: 1 vial: 500 IU nonacog alfa (approx. 100 IU/ml after reconstitution).
Croatian: 1 bočica: 500 IU nonakoga alfa (pribl. 100 IU/ml nakon pripreme).
English: Recombinant coagulation factor IX is a single chain glycoprotein with an approximate molecular mass of 55,000 Daltons that is a member of the serine protease family of vitamin K-dependent coagulation factors.
Croatian: Rekombinantni koagulacijski faktor IX je jednolančani glikoprotein približne molekularne mase od 55 000 Daltona i pripada obitelji serinskih proteaza, koagulacijskih faktora ovisnih o vitaminu K. Rekombinantni koagulacijski faktor IX je terapijski protein dobiven tehnologijom rekombinantne DNK, koji ima strukturne i funkcionalne značajke usporedive s endogenim faktorom IX. Faktor IX se aktivira faktorom VII/kompleksom tkivnih faktora u vanjskom putu te faktorom XIa u unutarnjem putu koagulacije.
English: Rash k; urticaria
Croatian: • osip, koprivnjača
English: Detach the syringe from the vial adapter by gently pulling and turning the syringe counter-clockwise.
Croatian: Odvojite štrcaljku od nastavka za bočicu tako što ćete nježno povući i zakrenuti štrcaljku u smjeru suprotnom od smjera kazaljke na satu.
English: (CYPRUS BRANCH)
Croatian: PFIZER ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
English: • one sterile vial adapter reconstitution device
Croatian: • jedan sterilni nastavak za bočicu za pripremu otopine
English: EXP Use immediately or within 3 hours of reconstitution.
Croatian: Rok valjanosti Primijeniti odmah ili u roku od 3 sata od pripreme.
English: Record of use
Croatian: Način primjene