FrancophonIA/ELRC3.0 huggingface dataset:
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
Icelandic: Hver pakkning af Nuwiq inniheldur: - 1 hettuglas með 250, 500, 1000, 2000, 2500, 3000 eða 4000 a.e. af simoctocog alfa - 1 áfyllta sprautu með 2,5 ml af vatni fyrir stungulyf - 1 millistykki fyrir hettuglas - 1 fiðrildanál - 2 sprittþurrkur
English: Nuwiq 250 IU powder and solvent for solution for injection Nuwiq 500 IU powder and solvent for solution for injection Nuwiq 1000 IU powder and solvent for solution for injection Nuwiq 2000 IU powder and solvent for solution for injection Nuwiq 2500 IU powder and solvent for solution for injection Nuwiq 3000 IU powder and solvent for solution for injection Nuwiq 4000 IU powder and solvent for solution for injection
Icelandic: Nuwiq 250 a.e. stungulyfsstofn og leysir, lausn Nuwiq 500 a.e. stungulyfsstofn og leysir, lausn Nuwiq 1000 a.e. stungulyfsstofn og leysir, lausn Nuwiq 2000 a.e. stungulyfsstofn og leysir, lausn Nuwiq 2500 a.e. stungulyfsstofn og leysir, lausn Nuwiq 3000 a.e. stungulyfsstofn og leysir, lausn Nuwiq 4000 a.e. stungulyfsstofn og leysir, lausn
English: CL (mL/hr/kg)
Icelandic: CL (ml/klst./kg)
English: Animal reproduction studies have not been conducted with Nuwiq.
Icelandic: Ekki hafa verið gerðar æxlunarrannsóknir á dýrum með Nuwiq.
English: However depending on the body weight and posology, the patient could receive more than one vial (see section 2 for information on content per vial).
Icelandic: Samt sem áður gæti sjúklingi verið gefið meira en eitt hettuglas en það fer eftir líkamsþyngd og skömmtum (upplýsingar um innihald í hverju hettuglasi má finna í kafla 2).
English: Prophylaxis: In a clinical study in 32 adult patients with severe haemophilia A, the median consumption of Nuwiq for prophylaxis was 468.7 IU/kg/month.
Icelandic: Í klínískri rannsókn hjá 32 fullorðnum sjúklingum með alvarlega dreyrasýki A var miðgildi notkunar á Nuwiq í fyrirbyggjandi meðferð 468,7 a.e./kg/mánuði.
English: The powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) using the supplied injection set.
Icelandic: Aðeins skal blanda stungulyfsstofninn með meðfylgjandi leysi (2,5 ml vatn fyrir stungulyf) og nota til þess meðfylgjandi innrennslisbúnað.
English: How to use Nuwiq
Icelandic: Hvernig nota á Nuwiq
English: The specific activity of Nuwiq is approximately 9500 IU/mg protein.
Icelandic: Eðlisvirkni Nuwiq er u.þ.b. 9.500 a.e./mg af prótíni.
English: Nuwiq contains traces of human host cell proteins other than factor VIII.
Icelandic: Nuwiq inniheldur leifar af prótínum hýsilfrumu úr mönnum öðrum en storkuþætti VIII.
English: If you have the impression that the effect of Nuwiq is insufficient, talk to your doctor.
Icelandic: Ef þér finnst þú ekki fá fulla verkun af Nuwiq skaltu hafa samband við lækninn.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Nuwiq.
Icelandic: Myndun hlutleysandi mótefni (hemla) getur komið fram hjá sjúklingum með dreyrasýki A sem fá meðferð með storkuþætti VIII, þ.m.t. Nuwiq.
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Icelandic: Myndun hemla (mótefna) er þekktur fylgikvilli sem getur komið fram við meðferð með öllum lyfjum sem innihalda storkuþátt VIII.
English: Uncommon side effects may affect up to 1 in 100 people Tingling or numbness (paraesthesia), headache, injection site inflammation, injection site pain, back pain, vertigo, dry mouth, dizziness, a vague feeling of bodily discomfort, shortness of breath, haemorrhagic anaemia, non-neutralising antibody positive (in PTPs).
Icelandic: Sjaldgæfar aukaverkanir geta komið fyrir hjá allt að 1 af hverjum 100 einstaklingum Stingir eða doði (náladofi), höfuðverkur, bólga á stungustað, verkur á stungustað, bakverkur, svimi, munnþurrkur, sundl, óljós tilfinning um líkamleg óþægindi, mæði, blóðleysi vegna blæðingar, myndun mótefna sem ekki eru hlutleysandi (hjá sjúklingum sem hafa fengið meðferð áður).
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dL.
Icelandic: Útreikningur á nauðsynlegum skammti af storkuþætti VIII er byggður á reynslu sem hefur sýnt að 1 alþjóðleg eining (a.e.) af storkuþætti VIII á hvert kg líkamsþyngdar auki virkni storkuþáttar VIII í plasma um u.þ.b. 2% af eðlilegri virkni eða um 2 a.e./dl.
English: Specific studies with long-term repeated administration such as reproduction toxicity, chronic toxicity, and carcinogenicity were not performed with Nuwiq due to the immune response to heterologous proteins in all non-human mammalian species.
Icelandic: á Nuwiq með endurteknum gjöfum í lengri tíma eins og rannsóknir á eiturverkun á æxlun, langvinnum eiturverkunum og krabbameinsvaldandi áhrifum vegna ónæmissvörunar við óhliðstæðum prótínum hjá öllum spendýrategundum, að mönnum undanskildum.
English: The way Nuwiq is used in children and adolescents does not differ from the way it is used in adults.
Icelandic: Notkun Nuwiq hjá börnum er sams konar og hjá unglingum.
English: Record the date from when you start to store Nuwiq at room temperature on the product carton.
Icelandic: Skrifið á öskjuna dagsetninguna þegar byrjað er að geyma Nuwiq við stofuhita.
English: AUC (hr*IU/mL) 22.6 ± 8.0 T1/2 (hr)
Icelandic: AUC (klst.*a.e./ml) T1/2 (klst.)
English: Warnings and precautions Talk to your doctor before using Nuwiq.
Icelandic: Leitið ráða hjá lækninum áður en Nuwiq er notað.
English: If your plasma factor VIII fails to reach expected levels with Nuwiq, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors.
Icelandic: Sjúklingar sem mynda mótefni gegn storkuþætti VIII Ef storkuþáttur VIII í plasma nær ekki þeim gildum sem búist er við með Nuwiq, eða ef ekki tekst að ná viðeigandi stjórn á blæðingu, gæti það verið vegna myndunar mótefna gegn storkuþætti VIII.
English: How to store Nuwiq
Icelandic: Hvernig geyma á Nuwiq
English: Nuwiq is provided as powder and solvent for solution for injection.
Icelandic: Nuwiq er afhent sem stungulyfsstofn og leysir, lausn.
English: When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Icelandic: Þegar sjúklingum með dreyrasýki er gefið lyfið í æð binst storkuþáttur VIII við von Willebrands-storkuþátt í blóðrás sjúklingsins.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Icelandic: Lyfið inniheldur minna en 1 mmól (23 mg) af natríum í hverju hettuglasi.
English: 1 powder vial, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs
Icelandic: 1 hettuglas með stungulyfsstofni, 1 áfyllt sprauta með 2,5 ml af vatni fyrir stungulyf, 1 millistykki fyrir hettuglas, 1 fiðrildanál, 2 sprittþurrkur
English: Τηλ: +46 8 56643000
Icelandic: Teл.: +46 8 56643000
English: Nuwiq contains sodium
Icelandic: Nuwiq inniheldur natríum
English: Can be stored at room temperature (up to 25°C) for a single period of up to 1 month.
Icelandic: Má geyma við stofuhita (allt að 25°C) í eitt 1 mánaðar tímabil.
English: No interaction studies have been performed with Nuwiq.
Icelandic: Ekki hafa verið gerðar neinar rannsóknir á milliverkunum við Nuwiq.
English: INFORMATION IN BRAILLE Nuwiq 2000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 2000
English: Clinical efficacy and in vivo recovery of Nuwiq was not affected in this patient.
Icelandic: Hjá sjúklingnum komu ekki fram áhrif á klíníska virkni Nuwiq og heimtur in vivo.
English: INFORMATION IN BRAILLE Nuwiq 2500
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 2500
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life,
Icelandic: AUC = flatarmál undir ferli (storkuþáttur VIII:C), T1/2 = lokahelmingunartími, IVR = stigvaxandi heimtur in vivo, CL = úthreinsun,
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)
Icelandic: Tafla 5. Lyfjahvarfabreytur Nuwiq aðlagaðar eftir þyngd (skammtur: 50 a.e./kg) hjá fullorðnum sjúklingum (18-65 ára) með alvarlega dreyrasýki A sem hafa fengið meðferð áður (n = 20)
English: Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper.
Icelandic: Fjarlægið plastsmellhettuna af hettuglasinu með duftinu þannig að miðhluti gúmmítappans sjáist.
English: INFORMATION IN BRAILLE Nuwiq 250
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 250
English: MedDRA Standard System
Icelandic: MedDRA - Flokkun eftir líffærum
English: Nuwiq is for intravenous use.
Icelandic: Nuwiq er til notkunar í bláæð.
English: What you need to know before you use Nuwiq 3.
Icelandic: Áður en byrjað er að nota Nuwiq 3. Hvernig nota á Nuwiq
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
Icelandic: 1 áfyllt sprauta úr bórósílíkatgleri sem inniheldur 2,5 ml af vatni fyrir stungulyf - 1 sæft millistykki fyrir hettuglas til notkunar við blöndun með 1 fiðrildanál og 2 sprittþurrkum
English: Nuwiq 250 IU powder and solvent for solution for injection
Icelandic: Nuwiq 250 a.e. stungulyfsstofn og leysir, lausn
English: INFORMATION IN BRAILLE Nuwiq 500
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 500
English: INFORMATION IN BRAILLE Nuwiq 1000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 1000
English: INFORMATION IN BRAILLE Nuwiq 4000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 4000
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (mL/hr/kg) 3.0 ± 1.2
Icelandic: IVR (%/a.e./kg) CL (ml/klst./kg)
English: Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe.
Icelandic: Hvolfið hettuglasinu sem er fest við sprautuna og dragið endanlegu lausnina hægt upp í sprautuna.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 IU simoctocog alfa (800 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 2000 a.e. af simoctocog alfa (800 a.e./ml eftir blöndun).
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.
Icelandic: Meðferð með Nuwiq verður hafin af lækni með reynslu af umönnun sjúklinga með dreyrasýki A.
English: Octapharma Handelsgesellschaft m.b.H.
Icelandic: Octapharma S.A.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection
Icelandic: Leiðbeiningar fyrir blöndun og lyfjagjöf
English: Clean the chosen injection site with one of the provided alcohol swabs.
Icelandic: Hreinsið valda stungustaðinn með einni af meðfylgjandi þurrkum, vættri í alkóhóli.
English: INFORMATION IN BRAILLE Nuwiq 3000
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI Nuwiq 3000
English: If you have injected more Nuwiq than you should, please inform your doctor.
Icelandic: Láttu lækninn vita ef þú hefur sprautað inn meira af Nuwiq en mælt er fyrir um.
English: Haemorrhagic anaemia Factor VIII inhibition
Icelandic: Blóðleysi vegna blæðingar Hömlun á storkuþætti VIII
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 IU simoctocog alfa (1200 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 3000 a.e. af simoctocog alfa (1200 a.e./ml eftir blöndun).
English: Octapharma S.A. Tel: +34 91 6487298
Icelandic: Octapharma Handelsgesellschaft m.b.H. Tel: +43 1 610321222
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 IU simoctocog alfa (16000 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 4000 a.e. af simoctocog alfa (1600 a.e./ml eftir blöndun).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 powder vial contains 250 IU simoctocog alfa (100 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 250 a.e. af simoctocog alfa (100 a.e./ml eftir blöndun).
English: Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 2000 a.e. um það bil 800 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Icelandic: Nuwiq inniheldur virka innihaldsefnið raðbrigðastorkuþátt VIII úr mönnum (simoctocog alfa).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 IU simoctocog alfa (1000 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 2500 a.e. af simoctocog alfa (1000 a.e./ml eftir blöndun).
English: Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 3000 a.e. um það bil 1200 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Icelandic: 50 a.e./kg) hjá börnum á aldrinum 6-12 ára með alvarlega dreyrasýki A sem hafa fengið meðferð áður (n = 12) Lyfjahvarfabreyta
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 IU simoctocog alfa (200 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 500 a.e. af simoctocog alfa (200 a.e./ml eftir blöndun).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
Icelandic: VIRK(T) EFNI 1 hettuglas með stungulyfsstofni inniheldur 1000 a.e. af simoctocog alfa (400 a.e./ml eftir blöndun).
English: Nuwiq 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 2500 a.e. um það bil 1000 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: Nuwiq 4000 IU contains approximately 1600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 4000 a.e. um það bil 1600 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: For children and adolescents not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients).
Icelandic: Mjög algengt (hjá fleiri en 1 af hverjum 10 sjúklingum) er að mótefni (sjá kafla 2) myndist hjá börnum og unglingum sem ekki hafa áður fengið meðferð með lyfjum sem innihalda storkuþátt VIII.
English: Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 250 a.e. um það bil 100 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 2000 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/005
English: Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 1000 a.e. um það bil 400 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/002
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 250 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2.5 mL
Icelandic: 2,5 ml
English: What you need to know before you use Nuwiq
Icelandic: Áður en byrjað er að nota Nuwiq
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/007
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 4000 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Icelandic: Eftir blöndun inniheldur Nuwiq 500 a.e. um það bil 200 a.e./ml af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 250 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 3000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 3000 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 2500 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 1000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 1000 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 2000 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 500 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Icelandic: Nuwiq 2500 a.e. stungulyfsstofn og leysir, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/006
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 500 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: Younger children in general required higher median doses (6-12 years: 43.9 IU/kg; 2-5 years: 52.6 IU/kg).
Icelandic: 43,9 a.e./kg; 2-5 ára:
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 4000 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/004
English: Octapharma AS Tlf: +47 63988860
Icelandic: Sími: +47 63988860
English: Name and address of the manufacturer(s) of the biological active substance(s) Octapharma AB
Icelandic: Heiti og heimilisfang framleiðenda líffræðilegra virkra efna
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Icelandic: Hvert hettuglas inniheldur 3000 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/001
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/001
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 3000 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
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.
Icelandic: HEITI LYFS OG ÍKOMULEIÐ(IR) Nuwiq 1000 a.e. stungulyfsstofn, lausn simoctocog alfa (raðbrigðastorkuþáttur VIII úr mönnum)
English: Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Icelandic: Hvert hettuglas inniheldur 4000 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: Nuwiq 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Icelandic: Hvert hettuglas inniheldur 2500 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: Frequency of adverse drug reactions (ADRs) in clinical trials
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Icelandic: Hvert hettuglas inniheldur 250 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
Icelandic: MARKAÐSLEYFISNÚMER EU/1/14/936/003
English: Nuwiq 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Icelandic: Hvert hettuglas inniheldur 1000 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog 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.
Icelandic: Hvert hettuglas inniheldur 500 tilgreindar a.e. af storkuþætti VIII úr mönnum (rDNA), simoctocog alfa.
English: It is important that both men and women read the information.
Icelandic: Mikilvægt er að konur og karlar lesi upplýsingarnar.
English: It is very important that you complete the full course of treatment.
Icelandic: Mjög mikilvægt er að ljúka meðferðinni.
English: Then take your next dose at your usual time.
Icelandic: Taktu síðan næsta skammt á venjulegum tíma.
English: • check if your treatment has worked and you are free of hepatitis C
Icelandic: • athuga hvort meðferðin skili árangri og hvort þú sért laus við lifrarbólgu C
English: Number of isolates tested: a=5, b=4, c=14, d=10, e=9
Icelandic: Fjöldi prófaðra stofna: a=5, b=4, c=14, d=10, e=9
English: Fluvastatin Lovastatin Simvastatin
Icelandic: Fluvastatin Lovastatin
English: ZEPATIER for 12 weeks
Icelandic: ZEPATIER í 12 vikur
English: Each carton contains a total of 28 tablets.
Icelandic: Í hverri öskju eru alls 28 töflur.