natgillin/translations-raw huggingface dataset:
Repeat injections every 8 to 24 hours (6 to 12 hours for patients under the age of 6) until threat is resolved. 
Injekcije ponavljati svakih 8 do 24 sata (6 do 12 sati u bolesnika mlađih od 6 godina života) sve do otklanjanja životne opasnosti.
If you or your child's bleeding is not being controlled with ADVATE, tell your doctor immediately. 
Ako krvarenje niste uspjeli staviti pod nadzor s lijekom ADVATE, odmah se obratite svom liječniku.
Powder: White to off-white friable powder. 
Prašak: bijeli do gotovo bijeli rastresiti prašak.
- Do not use if the BAXJECT II device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration. 
- Ne upotrebljavati ako su uređaj BAXJECT II, njegov sterilni zaštitni sustav ili pakiranje oštećeni ili pokazuju bilo koji znak dotrajalosti.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. 
Bolesnike treba upoznati s ranim znacima reakcija preosjetljivosti kao što su koprivnjača, generalizirana urtikarija, stezanje u prsima, piskanje, hipotenzija i anafilaksija.
Fig. 1 
Slika 1
After reconstitution, from a microbiological point of view, the product should be used immediately. 
S mikrobiološkog stajališta, lijek je potrebno primijeniti odmah nakon rekonstitucije.
Fig. b 
Slika b
Factor VIII inhibition 
Infekcije i infestacije laringitis inhibicija faktora VIII
Instructions for injection For administration the use of a luer-lock syringe is required. 
Upute za primjenu injekcije Za primjenu lijeka koristiti luer-lock štrcaljku.
Each powder vial contains nominally 250, 500, 1000, or 1500 IU octocog alfa. 
Jedna bočica s praškom sadrži nominalno 250, 500, 1000 ili 1500 IU oktokoga alfa.
Haemostasis was maintained at all times during this period and both plasma factor VIII levels and clearance rates returned to appropriate levels by postoperative day 15. 
Tijekom cijelog tog vremena održavala se hemostaza te su se do 15. dana nakon kirurškog zahvata razine faktora VIII u plazmi i klirens vratili u normalne vrijednosti.
Repeat injections every 12 to 24 hours (8 to 24 hours for patients under the age of 6) for at least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved. 
Injekcije ponavljati svakih 12 do 24 sata (8 do 24 sata u bolesnika mlađih od 6 godina života) tijekom najmanje 1 dana, sve dok se krvarenje, na koje ukazuje bol, ne zaustavi ili ne dođe do zacjeljenja.
Solvent vial: 2 ml sterilised water for injections 
Bočica s otapalom: 2 ml sterilizirane vode za injekcije
Solvent vial: 5 ml sterilised water for injections 
Bočica s otapalom: 5 ml sterilizirane vode za injekcije
ADVATE with BAXJECT II device: Keep the product vial in the outer carton in order to protect from light. 
ADVATE s uređajem BAXJECT II: Bočicu lijeka čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
For reconstitution only the sterilised water for injections and the reconstitution device provided in the pack should be used. 
Za rekonstituciju se smiju koristiti samo sterilizirana voda za injekcije i uređaj za rekonstituciju priloženi u pakiranju.
Haematocrit decreased 
Tablični sažetak nuspojava
How ADVATE is given 
Kako se daje ADVATE
Remove the BAXJECT III system from the blister. 
Izvadite sustav BAXJECT III iz blistera.
Connect the syringe to BAXJECT II (Fig. d). 
Spojite štrcaljku na uređaj BAXJECT II (slika d).
B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2) 
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
How to use ADVATE 
Kako primjenjivati ADVATE
Instructions for reconstitution 
Upute za pripremu otopine
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Baxter AG 
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Baxter AG
ADVATE contains the active substance octocog alfa, human coagulation factor VIII produced by recombinant DNA technology. 
ADVATE kao djelatnu tvar sadrži oktokog alfa, ljudski koagulacijski faktor VIII proizveden tehnologijom rekombinantne DNK.
Cleanse stoppers with alcohol swabs. 
Očistite čepove koristeći vate natopljene alkoholom.
Please record the end of the 6 months storage at room temperature on the product carton. 
Na kutiju lijeka potrebno je zabilježiti kraj šestomjesečnog čuvanja lijeka na sobnoj temperaturi.
What ADVATE looks like and contents of the pack ADVATE is a white to off-white friable powder. 
ADVATE je rastresit prašak bijele do gotovo bijele boje.
How to store ADVATE 
Kako čuvati ADVATE
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Sterilised water for injections 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Sterilizirana voda za injekcije
Major 
Veći
Fig. 3 
Slika 3
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava limfangitis anafilaktička reakcija nepoznato
Allergic type hypersensitivity reactions, including anaphylaxis, have been reported with ADVATE. 
Pri primjeni lijeka ADVATE zabilježene su reakcije preosjetljivosti alergijskog tipa, uključujući anafilaksiju.
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. 
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.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 
NAZIV LIJEKA ADVATE 2000
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. 
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.
Use only the sterilised water for injections and the reconstitution device for preparation of the solution that are provided with each package of ADVATE. 
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.
INFORMATION IN BRAILLE ADVATE 2000 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 2000
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER LABEL (BAXJECT III SYSTEM) 
PODACI KOJE MORAJU NAJMANJE SADRŽAVATI BLISTER ILI STRIP NALJEPNICA NA BLISTERU (SUSTAV BAXJECT III)
The administration of ADVATE in children (intravenously) does not differ from the administration in adults. 
Primjena lijeka ADVATE u djece (u venu) jednaka je kao u odraslih.
Connect the syringe to BAXJECT II / BAXJECT III. 
Spojite štrcaljku na uređaj BAXJECT II / sustav BAXJECT III.
Fig. 2 
Slika 2
If you are unsure about this, ask your doctor. 
U slučaju nejasnoća, obratite se svom liječniku.
NAME OF THE MARKETING AUTHORISATION HOLDER Baxter AG 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Baxter AG
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 
NAZIV LIJEKA ADVATE 1500
With BAXJECT II attached to the solvent vial, invert the system so that the solvent vial is on top of the device. 
Bočicu s otapalom, na koju je pričvršćen uređaj BAXJECT II, okrenite naopako tako da bočica s otapalom bude iznad uređaja.
If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician. 
Bolesnike je potrebno upozoriti da u slučaju pojave simptoma preosjetljivosti odmah prestanu uzimati ovaj lijek te da se bez odgode obrate liječniku.
The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min. 
Brzinu primjene treba odrediti prema stupnju ugode bolesnika, a ona ne smije biti veća od 10 ml/min.
ADVATE 250 IU powder and solvent for solution for injection 
ADVATE 250 IU prašak i otapalo za otopinu za injekciju
- 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). 
- 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).
After reconstitution the solution should be clear, colourless and free from foreign particles. 
Nakon rekonstitucije, otopina treba biti bistra, bezbojna i bez vidljivih čestica.
Keep the blister with the product in the outer carton in order to protect from light. 
Blister s lijekom čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Connect the syringe to BAXJECT III. 
Spojite štrcaljku na sustav BAXJECT III.
NAME OF THE MEDICINAL PRODUCT ADVATE 250 
NAZIV LIJEKA ADVATE 250
INFORMATION IN BRAILLE ADVATE 250 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 250
Powder vial and 2 ml solvent preassembled in BAXJECT III system. 
Bočica s praškom i 2 ml otapala već pričvršćeni na sustav BAXJECT III.
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 
NAZIV LIJEKA ADVATE 3000
Calcium chloride Trometamol Polysorbate 80 
Prašak manitol natrijev klorid histidin trehaloza kalcijev klorid trometamol polisorbat 80 glutation (reducirani)
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 
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)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT III SYSTEM) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (SUSTAV BAXJECT III)
- 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). 
- 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).
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 
NAZIV LIJEKA ADVATE 1000
Powder vial and 5 ml solvent preassembled in BAXJECT III system. 
Bočica s praškom i 5 ml otapala već pričvršćeni u sustav BAXJECT III.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (BAXJECT II DEVICE) 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (UREĐAJ BAXJECT II)
Do not remove the blue cap from the BAXJECT II device. 
Ne uklanjajte plavi zatvarač s uređaja BAXJECT II.
INFORMATION IN BRAILLE ADVATE 1500 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 1500
INFORMATION IN BRAILLE ADVATE 1000 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 1000
Both the powder vial and the vial containing 5 ml solvent are of type I glass closed with chlorobutyl rubber stoppers. 
Bočica s praškom i bočica s 5 ml otapala su od stakla tipa
NAME OF THE MEDICINAL PRODUCT ADVATE 500 
NAZIV LIJEKA ADVATE 500
The product may not be returned to refrigerated storage after storage at room temperature. 
Nakon čuvanja na sobnoj temperaturi, lijek se ne smije vratiti u hladnjak.
Both the powder vial and the vial containing 2 ml solvent are of type I glass closed with chlorobutyl rubber stoppers. 
Bočica s praškom i bočica s 2 ml otapala su od stakla tipa
INFORMATION IN BRAILLE ADVATE 3000 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 3000
Allergic type reactions include anaphylaxis and have been manifested by dizziness, paresthesias, rash, flushing, face swelling, urticaria, and pruritus. 
Zabilježene su sljedeće reakcije preosjetljivosti alergijskog tipa, uključujući anafilaksiju: omaglica, parestezije, osip, crvenilo praćeno osjećajem vrućine, naticanje lica, urtikarija i svrbež.
Use the product immediately once the powder is completely dissolved. 
Nakon potpunog otapanja praška, lijek se mora odmah primijeniti.
Fig. d 
Slika d
Marketing Authorisation Holder Baxter AG 
Nositelj odobrenja za stavljanje gotovog lijeka u promet Baxter AG
INFORMATION IN BRAILLE ADVATE 500 
16. PODACI NA BRAILLEOVOM PISMU ADVATE 500
- For administration the use of a luer-lock syringe is required. 
Za primjenu lijeka koristiti luer-lock štrcaljku.
On demand treatment 
NAČIN PRIMJENE LIJEKA
Remove caps from powder and solvent vials. 
Uklonite zatvarače s bočica u kojima su prašak i otapalo.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 2000
Always take ADVATE exactly as your doctor has told you. 
Ako primijenite više ADVATE nego što ste trebali Uvijek uzmite ADVATE točno onako kako Vam je rekao liječnik.
Remove the blue cap from BAXJECT II / BAXJECT III. 
Uklonite plavi zatvarač s uređaja BAXJECT II / sustava BAXJECT III.
Frequency a 
Slika a
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 
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)
Adjusted Incremental Recovery at Cmax (IU/dL per IU/kg)a 
Ukupni AUC (IU*h/dl) Prilagođeni prirast po jedinici doze pri Cmax (IU/dl po IU/kg)a
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1500
Misapplication of ADVATE 
Kriva primjena lijeka ADVATE
- ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 2 ml solvent and a device for reconstitution (BAXJECT II). 
- ADVATE s uređajem BAXJECT II: Jedno pakiranje sastoji se od bočice s praškom, bočice s 2 ml otapala i uređaja za rekonstituciju (BAXJECT II).
- ADVATE with BAXJECT II device: Each pack contains a powder vial, a vial containing 5 ml solvent and a device for reconstitution (BAXJECT II). 
- ADVATE s uređajem BAXJECT II: Jedno pakiranje sastoji se od bočice s praškom, bočice s 5 ml otapala i uređaja za rekonstituciju (BAXJECT II).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 3000
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 250
Remove the blue cap from BAXJECT III. 
Uklonite plavi zatvarač sa sustava BAXJECT III.
Adjusted Incremental 
Prijavljivanje nuspojava
Life threatening haemorrhages. 
Krvarenja opasna po život.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa, approx. 600 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 3000 IU oktokoga alfa, približno 600 IU/ml nakon pripreme otopine.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1000
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3000 IU oktokoga alfa
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 IU oktokoga alfa
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 125 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 250 IU oktokoga alfa, približno 125 IU/ml nakon pripreme otopine.
Steady State (dl/kg) 
Volumen distribucije u stanju dinamičke ravnoteže (dl/kg)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 500
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 2000 IU prašak i otapalo za otopinu za injekciju
Migraine 
Krvarenje
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU oktokoga alfa
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 2000 IU octocog alfa, approx. 400 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 2000 IU oktokoga alfa, približno 400 IU/ml nakon pripreme otopine.
Can be stored at room temperature (up to 25 °C) for a single period up to 6 months. 
Lijek se može čuvati na sobnoj temperaturi (do 25°C) u jednom razdoblju ne duljem od 6 mjeseci.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1500 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1500 IU oktokoga alfa
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU oktokoga alfa
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. 
Unutar roka valjanosti, blister s lijekom se može čuvati na sobnoj temperaturi (do 25°C) u jednokratnom razdoblju ne duljem od 6 mjeseci.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1500 IU oktokoga alfa, približno 300 IU/ml nakon pripreme otopine.
Fig. e 
Slika e
After reconstitution, the solution is clear, colourless and free from foreign particles. 
Otopina je nakon pripreme bistra, bezbojna i ne sadrži vidljive čestice.
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 250 IU prašak i otapalo za otopinu za injekciju
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. 
Hemofilija A je spolno vezani nasljedni poremećaj koagulacije krvi zbog smanjene aktivnosti faktora VIII.
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 1000 IU prašak i otapalo za otopinu za injekciju
Remove the blue cap from BAXJECT II. 
Uklonite plavi zatvarač s uređaja BAXJECT II.
Laboratory test abnormal 
Pretrage abnormalni rezultati laboratorijskih ispitivanja komplikacije nakon zahvata krvarenje nakon zahvata
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 750 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1500 IU oktokoga alfa, približno 750 IU/ml nakon pripreme otopine.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 500 IU oktokoga alfa, približno 250 IU/ml nakon pripreme otopine.
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 3000 IU prašak i otapalo za otopinu za injekciju
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 500 IU oktokoga alfa, približno 100 IU/ml nakon pripreme otopine.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa 
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU oktokoga alfa
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (SUSTAV BAXJECT III)
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 500 IU prašak i otapalo za otopinu za injekciju
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 250 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 250 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 2000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 500 IU/ml nakon pripreme otopine.
Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/016
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 200 IU/ml nakon pripreme otopine.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (UREĐAJ BAXJECT II)
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution. 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 250 IU oktokoga alfa, približno 50 IU/ml nakon pripreme otopine.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection. 
NAZIV LIJEKA ADVATE 1500 IU prašak i otapalo za otopinu za injekciju
ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 750 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
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. 
Stvaranje inhibitora poznata je komplikacija u liječenju hemofilije A.
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.