FrancophonIA/ELRC3.0 huggingface dataset:
English: How to use ADVATE
Croatian: Kako primjenjivati ADVATE
English: Instructions for reconstitution
Croatian: Upute za pripremu otopine
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Baxter AG
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Baxter AG
English: ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology.
Croatian: ADVATE kao djelatnu tvar sadrži oktokog alfa, ljudski koagulacijski faktor VIII proizveden tehnologijom rekombinantne DNK.
English: Cleanse stoppers with alcohol swabs.
Croatian: Očistite čepove koristeći vate natopljene alkoholom.
English: Please record the end of the 6 months storage at room temperature on the product carton.
Croatian: Na kutiju lijeka potrebno je zabilježiti kraj šestomjesečnog čuvanja lijeka na sobnoj temperaturi.
English: What ADVATE looks like and contents of the pack ADVATE is a white to off-white friable powder.
Croatian: ADVATE je rastresit prašak bijele do gotovo bijele boje.
English: How to store ADVATE
Croatian: Kako čuvati ADVATE
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sterilised water for injections
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Sterilizirana voda za injekcije
English: Major
Croatian: Veći
English: Fig. 3
Croatian: Slika 3
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava limfangitis anafilaktička reakcija nepoznato
English: Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE.
Croatian: Pri primjeni lijeka ADVATE zabilježene su reakcije preosjetljivosti alergijskog tipa, uključujući anafilaksiju.
English: You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness.
Croatian: Zbog toga morate znati prepoznati rane znakove alergijskih reakcija kao što su osip, koprivnjača, opći svrbež, naticanje usana i jezika, poteškoće u disanju, piskanje, stezanje u prsima, opći osjećaj slabosti te omaglica.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000
Croatian: NAZIV LIJEKA ADVATE 2000
English: Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for 3 - 4 days or more until pain and acute disability are resolved.
Croatian: Injekcije ponavljati svakih 12 do 24 sata (8 do 24 sata u bolesnika mlađih od 6 godina života) tijekom 3 - 4 dana ili više, sve do prestanka boli i akutne onesposobljenosti.
English: Use only the sterilised water for injections and the reconstitution device for preparation of the solution that are provided with each package of ADVATE.
Croatian: Za pripremu otopine smiju se koristiti samo priložena sterilizirana voda za injekcije i uređaj za pripremu otopine koji se nalaze u svakom pakiranju lijeka ADVATE.
English: INFORMATION IN BRAILLE ADVATE 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 2000
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM)
Croatian: PODACI KOJE MORAJU NAJMANJE SADRŽAVATI BLISTER ILI STRIP NALJEPNICA NA BLISTERU (SUSTAV BAXJECT III)
English: The administration of ADVATE in children (intravenously) does not differ from the administration in adults.
Croatian: Primjena lijeka ADVATE u djece (u venu) jednaka je kao u odraslih.
English: Connect the syringe to BAXJECT II / BAXJECT III.
Croatian: Spojite štrcaljku na uređaj BAXJECT II / sustav BAXJECT III.
English: Fig. 2
Croatian: Slika 2
English: If you are unsure about this, ask your doctor.
Croatian: U slučaju nejasnoća, obratite se svom liječniku.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Baxter AG
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Baxter AG
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500
Croatian: NAZIV LIJEKA ADVATE 1500
English: With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device.
Croatian: Bočicu s otapalom, na koju je pričvršćen uređaj BAXJECT II, okrenite naopako tako da bočica s otapalom bude iznad uređaja.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician.
Croatian: Bolesnike je potrebno upozoriti da u slučaju pojave simptoma preosjetljivosti odmah prestanu uzimati ovaj lijek te da se bez odgode obrate liječniku.
English: The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Croatian: Brzinu primjene treba odrediti prema stupnju ugode bolesnika, a ona ne smije biti veća od 10 ml/min.
English: ADVATE 250 IU powder and solvent for solution for injection
Croatian: ADVATE 250 IU prašak i otapalo za otopinu za injekciju
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 5 ml solvent are preassembled with the system for reconstitution).
Croatian: - ADVATE u sustavu BAXJECT III: Jedno pakiranje sastoji se od sustava BAXJECT III spremnog za uporabu, u hermetički zatvorenom blisteru (bočica s praškom i bočica s 5 ml otapala već su pričvršćene na sustav za rekonstituciju).
English: After reconstitution the solution should be clear, colourless and free from foreign particles.
Croatian: Nakon rekonstitucije, otopina treba biti bistra, bezbojna i bez vidljivih čestica.
English: Keep the blister with the product in the outer carton in order to protect from light.
Croatian: Blister s lijekom čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Connect the syringe to BAXJECT III.
Croatian: Spojite štrcaljku na sustav BAXJECT III.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250
Croatian: NAZIV LIJEKA ADVATE 250
English: INFORMATION IN BRAILLE ADVATE 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 250
English: Powder vial and 2 ml solvent preassembled in BAXJECT III system.
Croatian: Bočica s praškom i 2 ml otapala već pričvršćeni na sustav BAXJECT III.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000
Croatian: NAZIV LIJEKA ADVATE 3000
English: Calcium chloride Trometamol Polysorbate 80
Croatian: Prašak manitol natrijev klorid histidin trehaloza kalcijev klorid trometamol polisorbat 80 glutation (reducirani)
English: ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection ADVATE 2000 IU powder and solvent for solution for injection ADVATE 3000 IU powder and solvent for solution for injection
Croatian: ADVATE 500 IU prašak i otapalo za otopinu za injekciju ADVATE 1000 IU prašak i otapalo za otopinu za injekciju ADVATE 1500 IU prašak i otapalo za otopinu za injekciju ADVATE 2000 IU prašak i otapalo za otopinu za injekciju ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (SUSTAV BAXJECT III)
English: - ADVATE in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister (the powder vial and the vial containing 2 ml solvent are preassembled with the system for reconstitution).
Croatian: - ADVATE u sustavu BAXJECT III: Jedno pakiranje sastoji se od sustava BAXJECT III spremnog za uporabu, u hermetički zatvorenom blisteru (bočica s praškom i bočica s 2 ml otapala već su pričvršćene na sustav za rekonstituciju).
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000
Croatian: NAZIV LIJEKA ADVATE 1000
English: Powder vial and 5 ml solvent preassembled in BAXJECT III system.
Croatian: Bočica s praškom i 5 ml otapala već pričvršćeni u sustav BAXJECT III.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (UREĐAJ BAXJECT II)
English: Do not remove the blue cap from the BAXJECT II device.
Croatian: Ne uklanjajte plavi zatvarač s uređaja BAXJECT II.
English: INFORMATION IN BRAILLE ADVATE 1500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 1500
English: INFORMATION IN BRAILLE ADVATE 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 1000
English: Both the powder vial and the vial containing 5 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Croatian: Bočica s praškom i bočica s 5 ml otapala su od stakla tipa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500
Croatian: NAZIV LIJEKA ADVATE 500
English: The product may not be returned to refrigerated storage after storage at room temperature.
Croatian: Nakon čuvanja na sobnoj temperaturi, lijek se ne smije vratiti u hladnjak.
English: Both the powder vial and the vial containing 2 ml solvent are of type I glass closed with chlorobutyl rubber stoppers.
Croatian: Bočica s praškom i bočica s 2 ml otapala su od stakla tipa
English: INFORMATION IN BRAILLE ADVATE 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 3000
English: Allergic type reactions include anaphylaxis and have been manifested by dizziness, paresthesias, rash, flushing, face swelling, urticaria, and pruritus.
Croatian: Zabilježene su sljedeće reakcije preosjetljivosti alergijskog tipa, uključujući anafilaksiju: omaglica, parestezije, osip, crvenilo praćeno osjećajem vrućine, naticanje lica, urtikarija i svrbež.
English: Use the product immediately once the powder is completely dissolved.
Croatian: Nakon potpunog otapanja praška, lijek se mora odmah primijeniti.
English: Fig. d
Croatian: Slika d
English: Marketing Authorisation Holder Baxter AG
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Baxter AG
English: INFORMATION IN BRAILLE ADVATE 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU ADVATE 500
English: - For administration the use of a luer-lock syringe is required.
Croatian: Za primjenu lijeka koristiti luer-lock štrcaljku.
English: On demand treatment
Croatian: NAČIN PRIMJENE LIJEKA
English: Remove caps from powder and solvent vials.
Croatian: Uklonite zatvarače s bočica u kojima su prašak i otapalo.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 2000
English: Always take ADVATE exactly as your doctor has told you.
Croatian: Ako primijenite više ADVATE nego što ste trebali Uvijek uzmite ADVATE točno onako kako Vam je rekao liječnik.
English: Remove the blue cap from BAXJECT II / BAXJECT III.
Croatian: Uklonite plavi zatvarač s uređaja BAXJECT II / sustava BAXJECT III.
English: Frequency a
Croatian: Slika a
English: ADVATE 250 IU powder and solvent for solution for injection ADVATE 500 IU powder and solvent for solution for injection ADVATE 1000 IU powder and solvent for solution for injection ADVATE 1500 IU powder and solvent for solution for injection
Croatian: ADVATE 250 IU prašak i otapalo za otopinu za injekciju ADVATE 500 IU prašak i otapalo za otopinu za injekciju ADVATE 1000 IU prašak i otapalo za otopinu za injekciju ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a
Croatian: Ukupni AUC (IU*h/dl) Prilagođeni prirast po jedinici doze pri Cmax (IU/dl po IU/kg)a
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1500
English: Misapplication of ADVATE
Croatian: Kriva primjena lijeka ADVATE
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II).
Croatian: - ADVATE s uređajem BAXJECT II: Jedno pakiranje sastoji se od bočice s praškom, bočice s 2 ml otapala i uređaja za rekonstituciju (BAXJECT II).
English: - ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II).
Croatian: - ADVATE s uređajem BAXJECT II: Jedno pakiranje sastoji se od bočice s praškom, bočice s 5 ml otapala i uređaja za rekonstituciju (BAXJECT II).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 3000
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 250
English: Remove the blue cap from BAXJECT III.
Croatian: Uklonite plavi zatvarač sa sustava BAXJECT III.
English: Adjusted Incremental
Croatian: Prijavljivanje nuspojava
English: Life threatening haemorrhages.
Croatian: Krvarenja opasna po život.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 3000 IU oktokoga alfa, približno 600 IU/ml nakon pripreme otopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1000
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3000 IU oktokoga alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 IU oktokoga alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 250 IU oktokoga alfa, približno 125 IU/ml nakon pripreme otopine.
English: Steady State (dl/kg)
Croatian: Volumen distribucije u stanju dinamičke ravnoteže (dl/kg)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 500
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 2000 IU prašak i otapalo za otopinu za injekciju
English: Migraine
Croatian: Krvarenje
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU oktokoga alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 2000 IU oktokoga alfa, približno 400 IU/ml nakon pripreme otopine.
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months.
Croatian: Lijek se može čuvati na sobnoj temperaturi (do 25°C) u jednom razdoblju ne duljem od 6 mjeseci.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1500 IU oktokoga alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU oktokoga alfa
English: During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Croatian: Unutar roka valjanosti, blister s lijekom se može čuvati na sobnoj temperaturi (do 25°C) u jednokratnom razdoblju ne duljem od 6 mjeseci.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1500 IU oktokoga alfa, približno 300 IU/ml nakon pripreme otopine.
English: Fig. e
Croatian: Slika e
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Croatian: Otopina je nakon pripreme bistra, bezbojna i ne sadrži vidljive čestice.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 250 IU prašak i otapalo za otopinu za injekciju
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija A je spolno vezani nasljedni poremećaj koagulacije krvi zbog smanjene aktivnosti faktora VIII.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 1000 IU prašak i otapalo za otopinu za injekciju
English: Remove the blue cap from BAXJECT II.
Croatian: Uklonite plavi zatvarač s uređaja BAXJECT II.
English: Laboratory test abnormal
Croatian: Pretrage abnormalni rezultati laboratorijskih ispitivanja komplikacije nakon zahvata krvarenje nakon zahvata
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1500 IU oktokoga alfa, približno 750 IU/ml nakon pripreme otopine.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 500 IU oktokoga alfa, približno 250 IU/ml nakon pripreme otopine.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 3000 IU prašak i otapalo za otopinu za injekciju
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 500 IU oktokoga alfa, približno 100 IU/ml nakon pripreme otopine.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU oktokoga alfa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (SUSTAV BAXJECT III)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 500 IU prašak i otapalo za otopinu za injekciju
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 250 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 250 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 2000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 500 IU/ml nakon pripreme otopine.
English: Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/016
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 200 IU/ml nakon pripreme otopine.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (UREĐAJ BAXJECT II)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 250 IU oktokoga alfa, približno 50 IU/ml nakon pripreme otopine.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA ADVATE 1500 IU prašak i otapalo za otopinu za injekciju
English: ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 750 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately.
Croatian: Stvaranje inhibitora poznata je komplikacija u liječenju hemofilije A.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 1500 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 250 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: - Do not refrigerate the preparation after reconstitution.
Croatian: • Nakon pripreme otopine, lijek se ne smije vratiti u hladnjak.
English: Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa.
Croatian: Jedna bočica nominalno sadrži 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
English: The product may not be returned to refrigerated storage again.
Croatian: - Nakon rekonstitucije, lijek se ne smije vratiti u hladnjak.