FrancophonIA/ELRC3.0 huggingface dataset:
English: It is strongly recommended that every time that Nuwiq is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Preporučuje se da prilikom svake primjene lijeka Nuwiq bolesniku evidentirate naziv i broj serije lijeka kako bi se mogla utvrditi veza između bolesnika i serije lijeka.
English: When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Croatian: Nakon infuzije bolesniku s hemofilijom faktor VIII veže se na von Willebrandov faktor u bolesnikovoj cirkulaciji.
English: Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili primijeniti Nuwiq Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Octapharma Nordic AB (Sweden)
Croatian: Octapharma Benelux (Belgium)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Nuwiq
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Nuwiq
English: A higher median dose of Nuwiq was required to treat bleedings in children (43.9 IU/kg) than in adults (33.0 IU/kg), and a higher median dose was required to treat moderate to major than minor bleedings (78.2 IU/kg vs. 41.7 IU/kg).
Croatian: Veći medijan doze lijeka Nuwiq bio je potreban za liječenje krvarenja u djece (43,9 IU/kg) u odnosu na odrasle (33,0 IU/kg) te je veći medijan doze bio potreban za liječenje srednjih do obilnih krvarenja u odnosu na slabija krvarenja
English: Deutschland Octapharma GmbH Tel: +49 2173 9170
Croatian: Octapharma GmbH Tel: +49 2173 9170
English: Warnings and precautions Talk to your doctor before using Nuwiq.
Croatian: Obratite se svom liječniku prije nego primijenite Nuwiq.
English: MedDRA Standard System
Croatian: Standardna klasifikacija organskih sustava prema MedDRA-i
English: How to use Nuwiq
Croatian: Kako primjenjivati Nuwiq
English: If you use more Nuwiq than you should
Croatian: Ako ste ubrizgali više lijeka Nuwiq nego što ste trebali,
English: 1 powder vial, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs
Croatian: 1 bočica praška, 1 napunjena štrcaljka s 2,5 ml vode za injekcije, 1 nastavak za bočicu, 1 igla s krilcima, 2 jastučića natopljena alkoholom
English: AUC (hr*IU/mL) 22.6 ± 8.0 T1/2 (hr)
Croatian: AUC(h*IU/ml) T1/2 (h)
English: Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper.
Croatian: Uklonite plastični zatvarač s bočice s praškom tako da se vidi središnji dio gumenog čepa.
English: If you or your child´s bleeding is not being controlled with Nuwiq, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka Nuwiq, odmah se obratite liječniku.
English: How to store Nuwiq
Croatian: Kako čuvati Nuwiq
English: Do not store Nuwiq in the refrigerator again after it has been stored at room temperature.
Croatian: Nakon čuvanja na sobnoj temperaturi, Nuwiq se ne smije ponovno čuvati u hladnjaku.
English: Name and address of the manufacturer(s) of the biological active substance(s) Octapharma AB
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
English: Each pack of Nuwiq contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa - 1 pre-filled syringe with 2.5 mL water for injections - 1 vial adapter - 1 butterfly needle - 2 alcohol swabs
Croatian: Svako pakiranje lijeka Nuwiq sadrži: - 1 bočicu praška s 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa - 1 napunjenu štrcaljku s 2,5 ml vode za injekcije
English: Frequency, type and severity of adverse reactions in children and adolescents are assumed to be the same as in adults.
Croatian: Pedijatrijska populacija Pretpostavlja se da su učestalost, vrsta i težina nuspojava u djece i adolescenata jednaki kao u odraslih.
English: During the shelf-life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month.
Croatian: Unutar roka valjanosti lijek se može čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 1 mjeseca.
English: What Nuwiq contains Powder: - The active substance is recombinant human coagulation factor VIII (simoctocog alfa).
Croatian: Što Nuwiq sadrži Prašak: - Djelatna tvar je rekombinantni ljudski koagulacijski faktor VIII (simoktokog alfa).
English: Suomi/Finland Octapharma Nordic AB Puh/Tel: +358 9 85202710
Croatian: Nordic AB Puh/Tel: +358 9 85202710
English: - The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188.
Croatian: - Drugi sastojci su saharoza, natrijev klorid, kalcijev klorid dihidrat, argininklorid, natrijev citrat dihidrat i poloksamer 188. Pogledajte dio 2, „Nuwiq sadrži natrij“.
English: Nuwiq 250 IU powder and solvent for solution for injection
Croatian: Nuwiq 250 IU prašak i otapalo za otopinu za injekciju
English: 4.5 Interaction with other medicinal products and other forms of interaction
Croatian: 4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija za lijek Nuwiq.
English: Clinical efficacy and in vivo recovery of Nuwiq was not affected in this patient.
Croatian: Kod ovog bolesnika nije bilo utjecaja na kliničku djelotvornost i in vivo povrat za lijek Nuwiq.
English: Do not use the medicine in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove oštećenja na sigurnosnom pakiranju,
English: At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Ponovite svakih 12 - 24 sati najmanje 1 dan, dok se ne zaustavi epizoda krvarenja na koju upućuje bol ili dok ne dođe do zacjeljivanja.
English: If you forget to use Nuwiq
Croatian: Ako prestanete primjenjivati Nuwiq
English: If you stop using Nuwiq Do not stop using Nuwiq without consulting your doctor.
Croatian: Nemojte prestati s primjenom lijeka Nuwiq bez prethodnog savjetovanja s liječnikom.
English: Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Croatian: Nuwiq sadrži djelatnu tvar ljudski rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Croatian: Octapharma AB Lars Forssells gata 23 11275 Stockholm Švedska
English: Chromogenic assay Median (range) AUC (hr*IU/mL) 22.3 (8.4 - 38.1) 21.2 (8.4 - 32.6) 23.3 (17.4 - 35.5) 33.5 (28.9 - 38.1) T1/2 (hr) IVR (%/IU/kg) 2.5 (1.7 - 3.2) CL (mL/hr/kg) 2.7 (1.5 - 6.4) Normal weight: BMI 18.5-25 kg/m2, Pre-adipose: BMI 25-30 kg/m2, Adipose: BMI > 30 kg/m2, SD = Standard deviation
Croatian: Normalna težina: ITM 18,5 - 25 kg/m2, Prekomjerna tjelesna težina: ITM 25 - 30 kg/m2, Pretilost: ITM > 30 kg/m2, SD = standardna devijacija
English: INFORMATION IN BRAILLE Nuwiq 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 2000
English: Excipient related considerations (sodium content) This medicinal product contains less than 1 mmol sodium (23 mg) per vial.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici.
English: INFORMATION IN BRAILLE Nuwiq 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 250
English: Nuwiq contains traces of human host cell proteins other than factor VIII.
Croatian: Pored faktora VIII, Nuwiq sadrži proteine ljudskih stanica domaćina u tragovima.
English: Nuwiq is provided as powder and solvent for solution for injection.
Croatian: Nuwiq dolazi u obliku praška i otapala za otopinu za injekciju.
English: INFORMATION IN BRAILLE Nuwiq 2500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 2500
English: What Nuwiq is and what it is used for 2.
Croatian: Što se nalazi u ovoj uputi: 1. Što je Nuwiq i za što se koristi
English: Octapharma Handelsgesellschaft m.b.H.
Croatian: Octapharma S.A.
English: INFORMATION IN BRAILLE Nuwiq 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 1000
English: Treatment with Nuwiq will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor or nurse has told you.
Croatian: Liječenje lijekom Nuwiq započet će liječnik s iskustvom u liječenju bolesnika s hemofilijom A.
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (mL/hr/kg) 3.0 ± 1.2
Croatian: IVP (%/IU/kg) CL (ml/h/kg)
English: Remove the adapter packaging and discard.
Croatian: Uklonite pakiranje nastavka i bacite ga u otpad.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 IU simoctocog alfa (800 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 2000 IU simoktokoga alfa (800 IU/ml nakon rekonstitucije).
English: INFORMATION IN BRAILLE Nuwiq 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 500
English: INFORMATION IN BRAILLE Nuwiq 4000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 4000
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 IU simoctocog alfa (1200 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 3000 IU simoktokoga alfa (1200 IU/ml nakon rekonstitucije).
English: Nuwiq is usually injected into a vein (intravenously) by your doctor or a nurse who are experienced in the care of patients with haemophilia A. You or someone else might also give your Nuwiq injection, but only after receiving adequate training.
Croatian: Vaš liječnik ili medicinska sestra s iskustvom u liječenju bolesnika s hemofilijom A obično će ubrizgati lijek Nuwiq u venu (intravenski).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 powder vial contains 250 IU simoctocog alfa (100 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 250 IU simoktokoga alfa (100 IU/ml nakon rekonstitucije).
English: Frequency of adverse drug reactions (ADRs) in clinical trials
Croatian: Učestalost nuspojava u kliničkim ispitivanjima
English: INFORMATION IN BRAILLE Nuwiq 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Nuwiq 3000
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 IU simoctocog alfa (16000 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 4000 IU simoktokoga alfa (1600 IU/ml nakon rekonstitucije).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 IU simoctocog alfa (1000 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 2500 IU simoktokoga alfa (1000 IU/ml nakon rekonstitucije).
English: The dose of Nuwiq is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Doza lijeka Nuwiq se izračunava na temelju
English: rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, dizziness and loss of consciousness.
Croatian: zimicu, navale crvenila, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, osip, nemir,
English: Weight-adjusted PK parameters for Nuwiq (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Croatian: Tablica 2. Farmakokinetički parametri za Nuwiq (Doza: 50 IU/kg) u prethodno liječenih odraslih bolesnika (u dobi od 18 do 65 godina) s teškom hemofilijom A (n = 20)
English: Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 2000 IU sadrži približno 800 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Name and address of the manufacturer(s) responsible for batch release Octapharma AB
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 IU simoctocog alfa (200 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 500 IU simoktokoga alfa (200 IU/ml nakon rekonstitucije).
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Croatian: Tablica 3. Farmakokinetički parametri za Nuwiq (Doza: 50 IU/kg) u prethodno liječene djece u dobi od 6 do 12 godina s teškom hemofilijom A (n = 12)
English: Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 4000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 4000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: If you have injected more Nuwiq than you should, please inform your doctor.
Croatian: Ako primijenite više lijeka Nuwiq nego što ste trebali Nisu prijavljeni simptomi predoziranja.
English: Nuwiq 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 2500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Common side effects may affect up to 1 in 10 people Hypersensitivity, fever.
Croatian: Česte nuspojave - mogu se javiti u do 1 na 10 osoba
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 3000 IU sadrži približno 1200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Croatian: Tablica 4. Farmakokinetički parametri za Nuwiq (Doza: 50 IU/kg) u prethodno liječene djece u dobi od 2 do 5 godina s teškom hemofilijom A (n = 13)
English: Nuwiq 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 2500 IU sadrži približno 1000 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 250 IU sadrži približno 100 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Nuwiq 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Nuwiq 4000 IU contains approximately 1600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 4000 IU sadrži približno 1600 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Gastrointestinal disorders
Croatian: Kromogeni test Medijan (raspon)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 250 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 500 IU sadrži približno 200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: See package leaflet for further information.
Croatian: Za više informacija vidjeti uputu o lijeku.
English: Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije, Nuwiq 1000 IU sadrži približno 400 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
Croatian: 1 bočica praška sadrži 1000 IU simoktokoga alfa (400 IU/ml nakon rekonstitucije).
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 2500 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 4000 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 2500 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 250 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 250 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 500 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 3000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 3000 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: Octapharma S.A. Tel: +34 91 6487298
Croatian: Octapharma Handelsgesellschaft m.b.H. Tel: +43 1 610321222
English: Attach the provided infusion set to the syringe.
Croatian: 17. Pričvrstite isporučeni infuzijski set na štrcaljku.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 4000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 4000 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 500 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 2000 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 2000 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 3000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 3000 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 1000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Nuwiq 1000 IU prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/005
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 1000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Nuwiq 1000 IU prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) Za intravensku primjenu nakon rekonstitucije.
English: glass vial, closed with coated bromobutyl stopper and sealed with aluminium flip-off cap - Solvent: 1 borosilicate pre-filled glass syringe containing 2.5 mL water for injections - 1 sterile vial adapter for reconstitution with 1 butterfly needle and 2 alcohol swabs
Croatian: - 1 sterilan nastavak za bočicu za rekonstituciju s 1 iglom s krilcima i 2 jastučića natopljena alkoholom 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/004
English: Tel: +48 22 2082734
Croatian: Tél/Tel: +32 2 3730890
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/936/003
English: What happened during the re-examination?
Croatian: Što se dogodilo za vrijeme ponovnog razmatranja?
English: At the request of the company, the CHMP re-examined its opinion.
Croatian: Na zahtjev tvrtke, CHMP je ponovno razmotrio svoje mišljenje.