FrancophonIA/ELRC3.0 huggingface dataset:
English: Data show that Helixate NexGen has been used to induce immune tolerance.
Croatian: NexGen primjenjivao za izazivanje imunološke tolerancije.
English: If you use more Helixate NexGen 250 IU than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Croatian: Ako primijenite više lijeka Helixate NexGen 250 IU nego što ste trebali Nije zabilježen niti jedan slučaj predoziranja rekombinantnim koagulacijskim faktorom VIII.
English: Under certain circumstances larger amounts than those calculated may be required, especially for the initial dose.
Croatian: U određenim okolnostima, pogotovo za početnu dozu, može biti potrebna primjena većih količina od izračunatih.
English: The speed of administration should be based on the patient's comfort, but should not be faster than 2ml/min maximum rate of infusion.
Croatian: Brzina injiciranja određuje se prema tome koju brzinu bolesnik može podnijeti, ali ne smije biti veća od 2 ml/min.
English: Place the product vial on an even and firm surface.
Croatian: Postavite bočicu s lijekom na ravnu i čvrstu površinu.
English: For calculation of ml/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/ml).
Croatian: Da biste izračunali brzinu izraženu u ml/h, brzinu infuzije izraženu u IU/h/kg pomnožite s tjelesnom težinom/koncentracija otopine (IU/ml).
English: Inject air into the product vial.
Croatian: Ubrizgajte zrak u bočicu s lijekom.
English: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Parenteralne lijekove prije primjene treba vizualno pregledati na prisutnost čestica i promjenu boje.
English: What Helixate NexGen 250 IU contains
Croatian: Što Helixate NexGen 250 IU sadrži
English: • dysgeusia
Croatian: • omaglicu
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per ml, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with Helixate NexGen.
Croatian: Ako je prisutna razina inhibitora manja od 10 Bethesda jedinica (BU) po ml, dodatna primjena rekombinantnog koagulacijskog faktora VIII
English: Other medicines and Helixate NexGen 250 IU
Croatian: Drugi lijekovi i Helixate NexGen 250 IU
English: On demand treatment
Croatian: Trajanje liječenja
English: Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors within 20 exposure days.
Croatian: Inhibitori su se razvili unutar 20 dana izloženosti u 5 od 37 (14%) prethodno neliječenih bolesnika te u 4 od 23 (17%) minimalno liječena pedijatrijska bolesnika koji su primali Helixate NexGen.
English: What Helixate NexGen 250 IU is and what it is used for What you need to know before you use Helixate NexGen 250 IU How to use Helixate NexGen 250 IU Possible side effects
Croatian: Što je Helixate NexGen 250 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 250 IU
English: CSL Behring ΜΕΠΕ, Τηλ: +30-210 7255 660
Croatian: Τηλ: +30-210 7255 660
English: What Helixate NexGen 2000 IU contains
Croatian: Što Helixate NexGen 2000 IU sadrži
English: If you forget to use Helixate NexGen 250 IU
Croatian: Ako ste zaboravili primijeniti Helixate NexGen 250 IU
English: Common: may affect up to 1 in 10 users:
Croatian: Često: mogu se javiti u do 1 na 10 korisnika
English: Do not use Helixate NexGen 2000 IU
Croatian: Nemojte primjenjivati Helixate NexGen 2000 IU
English: INFORMATION IN BRAILLE Helixate NexGen 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 2000
English: Do not use Helixate NexGen 250 IU
Croatian: Nemojte primjenjivati Helixate NexGen 250 IU
English: Inhibitor Formation to FVIII (reported in PUPs and MTPs)*
Croatian: Razvoj inhibitora faktora VIII (zabilježen u PNB i
English: INFORMATION IN BRAILLE Helixate NexGen 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 250
English: Do not use Helixate NexGen 500 IU
Croatian: Nemojte primjenjivati Helixate NexGen 500 IU
English: The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the treatment of patients with haemophilia A. Your doctor may wish to carry out tests to monitor inhibitor development.
Croatian: Stvaranje neutralizirajućih antitijela za faktor VIII (inhibitora) poznata je komplikacija prilikom terapije za oboljele od hemofilije A.
English: Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
Croatian: Nemojte vaditi Mix2Vial iz blister pakovanja!
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting.
Croatian: Bočicu s lijekom držite uspravno te priključite štrcaljku na priključak "luer" uređaja Mix2Vial.
English: What you need to know before you use Helixate NexGen 250 IU
Croatian: Što morate znati prije nego počnete primjenjivati Helixate NexGen 250 IU
English: METHOD OF ADMINISTRATION For reconstitution of Helixate NexGen, see package leaflet.
Croatian: Upute za pripremu za primjenu lijeka Helixate NexGen pročitajte u uputi o lijeku.
English: Do not use Helixate NexGen 1000 IU
Croatian: Nemojte primjenjivati Helixate NexGen 1000 IU
English: Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes.
Croatian: Otprilike 2 minute na ispruženoj ruci čvrsto držite rupčić na mjestu injiciranja.
English: Other medicines and Helixate NexGen 2000 IU
Croatian: Drugi lijekovi i Helixate NexGen 2000 IU
English: Not known: frequency cannot be estimated from the available data
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka • disgeuzija (poremećaj osjeta okusa)
English: METHOD OF ADMINISTRATION Read the package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitati Uputu o lijeku.
English: Other medicines and Helixate NexGen 1000 IU
Croatian: Drugi lijekovi i Helixate NexGen 1000 IU
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Croatian: Preokrenite bočicu s otapalom i priključenim kompletom uređaja Mix2Vial te šiljak prozirnog kraja adaptera ugurajte ravno prema dolje kroz čep bočice s lijekom.
English: He/she should always adjust the amount of this medicine to be administered and the frequency of administration according to your individual needs.
Croatian: Količinu i učestalost primjene ovog lijeka liječnik uvijek mora odrediti prema potrebama pojedinačnog bolesnika.
English: Take special care with Helixate NexGen 250 IU
Croatian: Budite posebno oprezni s lijekom Helixate NexGen 250 IU
English: • hypersensitivity reactions including severe sudden allergic reaction (which may include hives, nausea, urticaria, angioedema, chills, flushing, headache, lethargy, wheezing or difficulty breathing, restlessness, tachycardia, tingling or anaphylactic shock, e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)
Croatian: letargiju, piskanje pri disanju ili otežano disanje, nemir, ubrzani otkucaji srca, trnce ili anafilaktički šok, npr. stezanje u prsima/osjećaj opće slabosti, omaglica i mučnina te blago sniženi krvni tlak zbog kojeg je moguća omaglica prilikom ustajanja)
English: What Helixate NexGen 250 IU looks like and content of the pack
Croatian: Kako Helixate NexGen 250 IU izgleda i sadržaj pakiranja
English: Do not use Helixate NexGen 3000 IU
Croatian: Nemojte primjenjivati Helixate NexGen 3000 IU
English: Very common: may affect more than 1 in 10 users
Croatian: mogu se javiti u više od 1 na 10 korisnika
English: Other medicines and Helixate NexGen 500 IU
Croatian: Drugi lijekovi i Helixate NexGen 500 IU
English: What Helixate NexGen 2000 IU looks like and content of the pack
Croatian: Kako Helixate NexGen 2000 IU izgleda i sadržaj pakiranja
English: Take special care with Helixate NexGen 500 IU
Croatian: Budite posebno oprezni s lijekom Helixate NexGen 500 IU
English: INFORMATION IN BRAILLE Helixate NexGen 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 1000
English: If you forget to use Helixate NexGen 1000 IU
Croatian: Ako ste zaboravili primijeniti Helixate NexGen 1000 IU
English: What Helixate NexGen 1000 IU contains
Croatian: Što Helixate NexGen 1000 IU sadrži
English: If you forget to use Helixate NexGen 2000 IU
Croatian: Ako ste zaboravili primijeniti Helixate NexGen 2000 IU
English: How to store Helixate NexGen 250 IU Contents of the pack and other information
Croatian: Kako čuvati Helixate NexGen 250 IU Sadržaj pakiranja i druge informacije
English: The vial with powder contains 250 IU (International Units) of octocog alfa.
Croatian: Bočica s praškom sadrži 250 IU (međunarodnih jedinica) oktokoga alfa.
English: Take special care with Helixate NexGen 1000 IU
Croatian: Budite posebno oprezni s lijekom Helixate NexGen 1000 IU
English: Uncommon may affect up to 1 in 100 users
Croatian: mogu se javiti u do 1 na 100 korisnika
English: What Helixate NexGen 500 IU is and what it is used for What you need to know before you use Helixate NexGen 500 IU How to use Helixate NexGen 500 IU Possible side effects
Croatian: Što je Helixate NexGen 500 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 500 IU
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer Pharma AG 13342 Berlin Germany
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer Pharma AG
English: What Helixate NexGen 2000 IU is and what it is used for What you need to know before you use Helixate NexGen 2000 IU How to use Helixate NexGen 2000 IU Possible side effects
Croatian: Što je Helixate NexGen 2000 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 2000 IU
English: INFORMATION IN BRAILLE Helixate NexGen 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 500
English: Take special care with Helixate NexGen 2000 IU
Croatian: Budite posebno oprezni s lijekom Helixate NexGen 2000 IU
English: II.
Croatian: B.
English: Warnings and precautions Talk to your doctor or pharmacist before using Helixate NexGen 250 IU.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helixate NexGen 250 IU.
English: What you need to know before you use Helixate NexGen 2000 IU
Croatian: Što morate znati prije nego počnete primjenjivati Helixate NexGen 2000 IU
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 250 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Helixate NexGen 250 IU prašak i otapalo za otopinu za injekciju.
English: What you need to know before you use Helixate NexGen 500 IU
Croatian: Što morate znati prije nego počnete primjenjivati Helixate NexGen 500 IU
English: What Helixate NexGen 3000 IU contains
Croatian: Što Helixate NexGen 3000 IU sadrži
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU octocog alfa (100 IU/ml after reconstitution).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 250 IU oktokoga alfa (100 IU/ml nakon pripreme za primjenu).
English: What Helixate NexGen 500 IU contains
Croatian: Što Helixate NexGen 500 IU sadrži
English: INFORMATION IN BRAILLE Helixate NexGen 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Helixate NexGen 3000
English: Helixate NexGen 1000 IU contains the active substance human recombinant coagulation factor VIII (octocog alfa).
Croatian: Helixate NexGen 1000 IU kao djelatnu tvar sadrži ljudski rekombinantni koagulacijski faktor VIII (oktokog alfa).
English: How to store Helixate NexGen 2000 IU Contents of the pack and other information
Croatian: Kako čuvati Helixate NexGen 2000 IU Sadržaj pakiranja i druge informacije
English: If you have used more Helixate NexGen 250 IU than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka Helixate NexGen 250 IU nego što ste trebali, obavijestite svojeg liječnika.
English: Speed of administration
Croatian: Brzina primjene
English: Other medicines and Helixate NexGen 3000 IU
Croatian: Drugi lijekovi i Helixate NexGen 3000 IU
English: One ml of Helixate NexGen 250 IU contains approximately 100 IU (250 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Croatian: Jedan ml lijeka Helixate NexGen 250 IU nakon pripreme za primjenu sadrži približno 100 IU (250 IU / 2,5 ml) ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: The vial with powder contains 2000 IU (International Units) of octocog alfa.
Croatian: Bočica s praškom sadrži 2000 IU (međunarodnih jedinica) oktokoga alfa.
English: What Helixate NexGen 1000 IU looks like and content of the pack
Croatian: Kako Helixate NexGen 1000 IU izgleda i sadržaj pakiranja
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU octocog alfa (600 IU/ml after reconstitution).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 3000 IU oktokoga alfa (600 IU/ml nakon pripreme za primjenu).
English: How to store Helixate NexGen 500 IU
Croatian: Kako čuvati Helixate NexGen 500 IU
English: What Helixate NexGen 500 IU looks like and content of the pack
Croatian: Kako Helixate NexGen 500 IU izgleda i sadržaj pakiranja
English: One ml of Helixate NexGen 3000 IU contains approximately 600 IU (3000 IU / 5.0 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Croatian: Jedan ml lijeka Helixate NexGen 3000 IU nakon pripreme za primjenu sadrži približno 600 IU (3000 IU / 5,0 ml) ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: One ml of Helixate NexGen 500 IU contains approximately 200 IU (500 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Croatian: Jedan ml lijeka Helixate NexGen 500 IU nakon pripreme za primjenu sadrži približno 200 IU (500 IU / 2,5 ml) ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: What Helixate NexGen 3000 IU is and what it is used for What you need to know before you use Helixate NexGen 3000 IU How to use Helixate NexGen 3000 IU Possible side effects
Croatian: Što je Helixate NexGen 3000 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 3000 IU
English: How to store Helixate NexGen 250 IU
Croatian: Kako čuvati Helixate NexGen 250 IU
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU octocog alfa (200 IU/ml after reconstitution).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 500 IU oktokoga alfa (200 IU/ml nakon pripreme za primjenu).
English: What you need to know before you use Helixate NexGen 1000 IU
Croatian: Što morate znati prije nego počnete primjenjivati Helixate NexGen 1000 IU
English: How to store Helixate NexGen 2000 IU
Croatian: Kako čuvati Helixate NexGen 2000 IU
English: The vial with powder contains 3000 IU (International Units) of octocog alfa.
Croatian: Bočica s praškom sadrži 3000 IU (međunarodnih jedinica) oktokoga alfa.
English: The vial with powder contains 500 IU (International Units) of octocog alfa.
Croatian: Bočica s praškom sadrži 500 IU (međunarodnih jedinica) oktokoga alfa.
English: If you forget to use Helixate NexGen 3000 IU
Croatian: Ako ste zaboravili primijeniti Helixate NexGen 3000 IU
English: One ml of Helixate NexGen 1000 IU contains approximately 400 IU (1000 IU / 2.5 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Croatian: Jedan ml lijeka Helixate NexGen 1000 IU nakon pripreme za primjenu sadrži približno 400 IU (1000 IU / 2,5 ml) ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: The degree and duration of aPTT normalisation observed after administration of Helixate NexGen is similar to that achieved with plasma-derived factor VIII.
Croatian: Stupanj i vrijeme normalizacije APTV-a zabilježeni nakon primjene lijeka Helixate
English: Take special care with Helixate NexGen 3000 IU
Croatian: Budite posebno oprezni s lijekom Helixate NexGen 3000 IU
English: 4.5 Interactions with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu zabilježene interakcije lijeka Helixate NexGen s drugim lijekovima.
English: One ml of Helixate NexGen 2000 IU contains approximately 400 IU (2000 IU / 5.0 ml) of human coagulation factor VIII (INN: octocog alfa) after reconstitution.
Croatian: Jedan ml lijeka Helixate NexGen 2000 IU nakon pripreme za primjenu sadrži približno 400 IU (2000 IU / 5,0 ml) ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: How to use Helixate NexGen 2000 IU
Croatian: Kako primjenjivati Helixate NexGen 2000 IU
English: How to store Helixate NexGen 1000 IU Contents of the pack and other information
Croatian: Kako čuvati Helixate NexGen 1000 IU Sadržaj pakiranja i druge informacije
English: If you have used more Helixate NexGen 2000 IU than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka Helixate NexGen 2000 IU nego što ste trebali, obavijestite svojeg liječnika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa (200 IU/ml after reconstitution).
Croatian: TVARI 1 bočica: 500 IU oktokoga alfa (200 IU/ml nakon pripreme za primjenu).
English: How to use Helixate NexGen 250 IU
Croatian: Kako primjenjivati Helixate NexGen 250 IU
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa (100 IU/ml after reconstitution).
Croatian: TVARI 1 bočica: 250 IU oktokoga alfa (100 IU/ml nakon pripreme za primjenu).
English: Each vial contains nominally 250 IU human coagulation factor VIII (INN: octocog alfa).
Croatian: Svaka bočica sadrži nominalnu količinu od 250 IU ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: How to store Helixate NexGen 500 IU Contents of the pack and other information
Croatian: Kako čuvati Helixate NexGen 500 IU Sadržaj pakiranja i druge informacije
English: The vial with powder contains 1000 IU (International Units) of octocog alfa.
Croatian: Bočica s praškom sadrži 1000 IU (međunarodnih jedinica) oktokoga alfa.
English: If you want to stop using Helixate NexGen 2000 IU Do not stop using Helixate NexGen without consulting your doctor.
Croatian: Nemojte prestati uzimati Helixate NexGen bez savjetovanja s liječnikom.
English: What Helixate NexGen 1000 IU is and what it is used for What you need to know before you use Helixate NexGen 1000 IU How to use Helixate NexGen 1000 IU Possible side effects
Croatian: Što je Helixate NexGen 1000 IU i za što se koristi Što morate znati prije nego počnete primjenjivati Helixate NexGen 1000 IU
English: How to use Helixate NexGen 500 IU
Croatian: Kako primjenjivati Helixate NexGen 500 IU
English: If you have used more Helixate NexGen 500 IU than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka Helixate NexGen 500 IU nego što ste trebali, obavijestite svojeg liječnika.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 3000 IU octocog alfa (600 IU/ml after reconstitution).
Croatian: TVARI 1 bočica: 3000 IU oktokoga alfa (600 IU/ml nakon pripreme za primjenu).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU octocog alfa (400 IU/ml after reconstitution).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1000 IU oktokoga alfa (400 IU/ml nakon pripreme za primjenu).
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.
Croatian: Prije otvaranja pakovanja s uređajem Mix2Vial uklonite zatvarače lijeka i otapala te čepove obradite aseptičkom otopinom i osušite.
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 2000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Helixate NexGen 2000 IU prašak i otapalo za otopinu za injekciju.
English: What Helixate NexGen 3000 IU looks like and content of the pack
Croatian: Kako Helixate NexGen 3000 IU izgleda i sadržaj pakiranja
English: What you need to know before you use Helixate NexGen 3000 IU
Croatian: Što morate znati prije nego počnete primjenjivati Helixate NexGen 3000 IU
English: a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: 7 dana da bi se aktivnost faktora VIII održavala na razini od 30% do 60% (IU/dl).
English: Warnings and precautions Talk to your doctor or pharmacist before using Helixate NexGen 2000 IU.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helixate NexGen 2000 IU.
English: How to store Helixate NexGen 3000 IU Contents of the pack and other information
Croatian: Kako čuvati Helixate NexGen 3000 IU Sadržaj pakiranja i druge informacije
English: How to store Helixate NexGen 1000 IU
Croatian: Kako čuvati Helixate NexGen 1000 IU
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 3000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Helixate NexGen 3000 IU prašak i otapalo za otopinu za injekciju.
English: Degree of haemorrhage/ Type of surgical procedure
Croatian: vrsta kirurškog zahvata
English: If you have used more Helixate NexGen 3000 IU than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka Helixate NexGen 3000 IU nego što ste trebali, obavijestite svojeg liječnika.
English: If you have used more Helixate NexGen 1000 IU than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka Helixate NexGen 1000 IU nego što ste trebali, obavijestite svojeg liječnika.
English: How to store Helixate NexGen 3000 IU
Croatian: Kako čuvati Helixate NexGen 3000 IU
English: Warnings and precautions Talk to your doctor or pharmacist before using Helixate NexGen 500 IU.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helixate NexGen 500 IU.
English: Each vial contains nominally 500 IU human coagulation factor VIII (INN: octocog alfa).
Croatian: Svaka bočica sadrži nominalnu količinu od 500 IU ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: After reconstitution with the water for injection, each vial contains octocog alfa 600 IU/ml.
Croatian: Svaka bočica nakon pripreme vodom za injekciju sadrži 600 IU/ml oktokoga alfa.
English: Warnings and precautions Talk to your doctor or pharmacist before using Helixate NexGen 1000 IU.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite Helixate NexGen 1000 IU.
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 1000 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Helixate NexGen 1000 IU prašak i otapalo za otopinu za injekciju.
English: How to use Helixate NexGen 1000 IU
Croatian: Kako primjenjivati Helixate NexGen 1000 IU
English: After reconstitution with the water for injection, each vial contains octocog alfa 400 IU/ml.
Croatian: Svaka bočica nakon pripreme vodom za injekciju sadrži 400 IU/ml oktokoga alfa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU octocog alfa (400 IU/ml after reconstitution).
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2000 IU oktokoga alfa (400 IU/ml nakon pripreme za primjenu).
English: Each vial contains nominally 3000 IU human coagulation factor VIII (INN: octocog alfa).
Croatian: Svaka bočica sadrži nominalnu količinu od 3000 IU ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: NAME OF THE MEDICINAL PRODUCT Helixate NexGen 500 IU powder and solvent for solution for injection.
Croatian: NAZIV LIJEKA Helixate NexGen 500 IU prašak i otapalo za otopinu za injekciju.
English: How much Helixate NexGen 2000 IU you should use and how often you should use it depends on many factors such as your weight, the severity of your haemophilia, where the bleed is and how serious it is, whether you have inhibitors and how high the inhibitor titre is and the factor VIII level that is needed.
Croatian: Količina i učestalost uzimanja lijeka Helixate NexGen 2000 IU ovise o brojnim čimbenicima kao što su tjelesna težina, stupanj hemofilije, mjesto i težina krvarenja, prisutnost inhibitora, visina titra inhibitora te potrebna razina faktora VIII.