FrancophonIA/ELRC3.0 huggingface dataset:
English: It is strongly recommended that every time that Nuwiq is administered, the name and batch number of the product are recorded in order to maintain a link between you and the batch of the medicinal product.
Slovenian: Močno priporočamo, da vsakič, ko prejmete zdravilo Nuwiq, zabeležite ime in številko serije zdravila, da ohranite povezavo med vami in serijo zdravila.
English: During clinical studies with Nuwiq in previously treated paediatric (2 to 11 years, n = 58), adolescent (12 to 17 years, n = 3) and adult patients (n = 129) with severe haemophilia A, a total of 12 adverse drug reactions (ADRs) (8 in adults, 4 in children) were reported in 8 patients (4 adults, 4 children).
Slovenian: Med kliničnimi študijami z zdravilom Nuwiq pri predhodno zdravljenih otrocih (od 2 do 11 let, n = 58), mladostnikih (od 12 do 17 let, n = 3) in odraslih bolnikih (n = 129) s hudo hemofilijo A so pri 8 bolnikih (4 odraslih, 4 otrocih) poročali o skupno 12 neželenih učinkih zdravila (8 pri odraslih, 4 pri otrocih).
English: IVR = Incremental in vivo recovery, CL = Clearance, SD = Standard deviation
Slovenian: IVR = Vrednost prirastnega zvečanja aktivnosti, CL = Očistek, SD = standardni odklon
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
Slovenian: Potrebno število enot = telesna masa (kg) x želeno zvišanje faktorja VIII (%) (i.e./dL) x 0,5 (i.e./kg na i.e./dL)
English: Factor VIII level required (%) (IU/dL)
Slovenian: Potrebna koncentracija faktorja VIII (%) (i.e./dL)
English: Warnings and precautions Talk to your doctor before using Nuwiq.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila Nuwiq se posvetujte z zdravnikom.
English: The powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) using the supplied injection set.
Slovenian: Prašek je treba pripraviti le s priloženim vehiklom (2,5 mL vode za injekcije), z uporabo priloženega pribora za injiciranje.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Each reconstituted solution contains approximately 100, 200, 400, 800, 1000, 1200 or 1600 IU/mL of simoctocog alfa.
Slovenian: Vsaka rekonstituirana raztopina vsebuje približno 100, 200, 400, 800, 1000, 1200 ali 1600 i.e./mL simoktokoga alfa.
English: Expected factor VIII rise (% of normal) = 2 x administered IU body weight (kg)
Slovenian: Pričakovano zvišanje faktorja VIII (% od normale) = 2 x dani odmerek i.e. telesna masa (kg)
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Slovenian: Nastanek protiteles, ki nevtralizirajo faktor VIII (zaviralci), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti zaviralci so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na mL
English: What Nuwiq looks like and contents of the pack
Slovenian: Izgled zdravila Nuwiq in vsebina pakiranja
English: The solvent is water for injections in a glass pre-filled syringe.
Slovenian: Vehikel je voda za injekcije v stekleni napolnjeni injekcijski brizgi.
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).
Slovenian: Višja mediana odmerka zdravila Nuwiq je bila potrebna za zdravljenje krvavitev pri otrocih (43,9 i.e./kg) kot pri odraslih (33,0 i.e./kg) in višja mediana odmerka je bila potrebna za zdravljenje zmernih do večjih kot pa manjših krvavitev
English: CL (mL/hr/kg)
Slovenian: CL (mL/h/kg)
English: AUC (hr*IU/mL)
Slovenian: AUC (h*i.e./mL)
English: Octapharma Nordic AB (Sweden)
Slovenian: Octapharma Nordic AB (Sweden) Teл.
English: Driving and using machines Nuwiq has no influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Nuwiq ne vpliva na vašo sposobnost upravljanja vozil in strojev.
English: Record the date from when you start to store Nuwiq at room temperature on the product carton.
Slovenian: Na škatlo zdravila zapišite datum začetka shranjevanja zdravila Nuwiq pri sobni temperaturi.
English: In pre-clinical studies, Nuwiq was used to safely and effectively restore haemostasis in dogs with haemophilia.
Slovenian: 5.3 Predklinični podatki o varnosti V predkliničnih raziskavah je bilo zdravilo Nuwiq uporabljeno za varno in učinkovito obnavljanje hemostaze pri psih s hemofilijo.
English: What Nuwiq is and what it is used for
Slovenian: Kaj je zdravilo Nuwiq in za kaj ga uporabljamo
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.
Slovenian: Zdravljenje z zdravilom Nuwiq bo začel zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika ali medicinske sestre.
English: Nuwiq contains sodium
Slovenian: Zdravilo Nuwiq vsebuje natrij
English: Other medicines and Nuwiq Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katerokoli drugo zdravilo.
English: Can be stored at room temperature (up to 25°C) for a single period of up to 1 month.
Slovenian: Zdravilo je lahko shranjeno pri sobni temperaturi (do 25 °C) za enkratno obdobje, ki ni daljše od 1 meseca.
English: Nuwiq is provided as powder and solvent for solution for injection.
Slovenian: Zdravilo Nuwiq je na voljo kot prašek in vehikel za raztopino za injiciranje.
English: How to use Nuwiq
Slovenian: Kako uporabljati zdravilo Nuwiq
English: Deutschland Octapharma GmbH Tel: +49 2173 9170
Slovenian: Octapharma GmbH Tel: +49 2173 9170
English: MedDRA Standard System
Slovenian: MedDRA standardna klasifikacija po organskih sistemih
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Nuwiq in one or more subsets of the paediatric population in treatment of haemophilia A (congenital factor VIII deficiency) (see section 4.2 for information on paediatric use).
Slovenian: Nuwiq za eno ali več podskupin pediatrične populacije pri zdravljenju hemofilije A (prirojeno pomanjkanje faktorja VIII) (za podatke o uporabi pri pediatrični glejte poglavje 4.2).
English: AUC (hr*IU/mL) 22.6 ± 8.0 T1/2 (hr)
Slovenian: AUC (h*i.e./mL) T1/2 (hr)
English: When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Slovenian: Po injiciranju faktorja VIII bolniku s hemofilijo se faktor VIII v krvnem obtoku veže na Willebrandov faktor.
English: Nuwiq contains traces of human host cell proteins other than factor VIII.
Slovenian: Zdravilo Nuwiq vsebuje poleg faktorja VIII sledi beljakovin humanih gostiteljskih celic.
English: Store vial in the original package in order to protect from light.
Slovenian: Vialo shranjujte v originalni ovojnini, za zagotovitev zaščite pred svetlobo.
English: The powder is a white to off-white powder in a glass vial.
Slovenian: Prašek je bel ali belkast prašek v stekleni viali.
English: Before the Nuwiq powder is reconstituted, it may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month.
Slovenian: Pred pripravo lahko prašek zdravila Nuwiq shranjujete pri sobni temperaturi (do 25 °C), in sicer za enkratno obdobje, ki ni daljše od 1 meseca.
English: Remove the plastic flip-off cap from the powder vial to expose the central portions of the rubber stopper.
Slovenian: Odstranite plastično dvižno zaporko z viale s praškom, da se vam prikaže osrednji del gumijastega zamaška.
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).
Slovenian: Občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov Mravljinčenje ali omrtvelost (parestezija), glavobol, vnetje na mestu injiciranja, bolečina na mestu injiciranja, bolečina v hrbtu, vrtoglavica, suha usta, omotica, neopredeljiv občutek telesnega neugodja,
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
Slovenian: Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 1000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 2000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 2500 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 3000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 4000 i.e. prašek in vehikel za raztopino za injiciranje
English: If you stop using Nuwiq Do not stop using Nuwiq without consulting your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Nuwiq, ne da bi se posvetovali z zdravnikom.
English: Nuwiq has no influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Nuwiq ne vpliva na sposobnost vožnje in upravljanja s stroji.
English: If you forget to use Nuwiq
Slovenian: Če ste prenehali uporabljati zdravilo Nuwiq
English: How to store Nuwiq
Slovenian: Shranjevanje zdravila Nuwiq
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Študij medsebojnega delovanja zdravila Nuwiq z drugimi zdravili niso izvedli.
English: Very common side effects may affect more than 1 in 10 people Factor VIII inhibition in previously untreated patients.
Slovenian: Zelo pogosti neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov
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
Slovenian: Eno pakiranje zdravila Nuwiq vsebuje: - 1 vialo s praškom z 250, 500, 1000, 2000, 2500, 3000 ali 4000 i.e. simoktokoga alfa - 1 napolnjeno injekcijsko brizgo z 2,5 mL vode za injekcije - 1 vmesnik za vialo
English: 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 simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 1000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 2000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 2500 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 3000 i.e. prašek in vehikel za raztopino za injiciranje Nuwiq 4000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
English: 1 powder vial, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs
Slovenian: 1 viala s praškom, 1 napolnjena injekcijska brizga z 2,5 mL vode za injekcije, 1 vmesnik za vialo,
English: However, depending on your body weight and your dose of Nuwiq, you could receive more than one vial.
Slovenian: Vendar pa lahko glede na telesno maso in odmerjanje prejmete več kot eno vialo.
English: INFORMATION IN BRAILLE Nuwiq 2000
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 2000
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
Slovenian: Normalna telesna masa: ITM 18,5-25 kg/m2, Predadipoznost: ITM 25-30 kg/m2, Debelost: ITM > 30 kg/m2, SD = standardni odklon
English: INFORMATION IN BRAILLE Nuwiq 250
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 250
English: Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Švedska Za kakršne koli informacije o zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Nuwiq.
Slovenian: Pri bolnikih s hemofilijo A, ki se zdravijo s faktorjem VIII, vključno z zdravilom Nuwiq, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: INFORMATION IN BRAILLE Nuwiq 2500
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 2500
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.
Slovenian: Profilaksa: V klinični študiji 32 odraslih bolnikov s hudo hemofilijo A je bila mediana porabe zdravila
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerek zdravila in trajanje nadomestne terapije sta odvisna od stopnje pomanjkanja faktorja VIII,
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Nuwiq
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo Nuwiq voda za injekcije
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (mL/hr/kg) 3.0 ± 1.2
Slovenian: IVR (%/i.e./kg) CL (mL/h/kg)
English: What Nuwiq contains Powder: - The active substance is recombinant human coagulation factor VIII (simoctocog alfa).
Slovenian: Kaj vsebuje zdravilo Nuwiq Prašek: - Učinkovina je humani rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: INFORMATION IN BRAILLE Nuwiq 500
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 500
English: Nuwiq contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Slovenian: Zdravilo Nuwiq vsebuje učinkovino humani rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: INFORMATION IN BRAILLE Nuwiq 1000
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 1000
English: What you need to know before you use Nuwiq
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Nuwiq Ne uporabljajte zdravila Nuwiq:
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo Nuwiq Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: INFORMATION IN BRAILLE Nuwiq 4000
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 4000
English: INFORMATION IN BRAILLE Nuwiq 3000
Slovenian: PODATKI V BRAILLOVI PISAVI Nuwiq 3000
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 IU simoctocog alfa (800 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 2000 i.e. simoktokoga alfa (800 i.e./mL po rekonstituciji).
English: Name and address of the manufacturer(s) responsible for batch release Octapharma AB
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
English: Non-neutralising antibody positive (in PTPs)
Slovenian: kratka sapa, hemoragična anemija, pozitiven izvid za nenevtralizirajoča protitelesa (pri PZB).
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)
Slovenian: Farmakokinetični parametri za zdravilo Nuwiq (Odmerek: 50 i.e./kg) pri odraslih predhodno zdravljenih bolnikih (starost 18-65 let) s hudo obliko hemofilije A (n = 20)
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Slovenian: Farmakokinetični parametri za zdravilo Nuwiq (Odmerek: 50 i.e./kg) pri predhodno zdravljenih otrocih (starost 6 do 12 let) s hudo obliko hemofilije A (n = 12)
English: Uncommon* Uncommon*
Slovenian: občasni* občasni (PZB) #
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 IU simoctocog alfa (16000 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 4000 i.e. simoktokoga alfa (1600 i.e./mL po rekonstituciji).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 powder vial contains 250 IU simoctocog alfa (100 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 250 i.e. simoktokoga alfa (100 i.e./mL po rekonstituciji).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 IU simoctocog alfa (1200 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 3000 i.e. simoktokoga alfa (1200 i.e./mL po rekonstituciji).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 IU simoctocog alfa (1000 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 2500 i.e. simoktokoga alfa (1000 i.e./mL po rekonstituciji).
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Slovenian: Farmakokinetični parametri za zdravilo Nuwiq (Odmerek: 50 i.e./kg) pri predhodno zdravljenih otrocih (starost 2 do 5 let) s hudo obliko hemofilije A (n = 13)
English: Nuwiq 2000 IU contains approximately 800 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Nuwiq 2000 i.e. vsebuje po rekonstituciji približno 800 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
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
Slovenian: Eno pakiranje vsebuje: - 1 vialo s praškom z 250, 500, 1000, 2000, 2500, 3000 ali 4000 i.e. simoktokoga alfa v viali iz stekla tipa 1, zaprti z obloženim bromobutilnim zamaškom in zaščiteni z aluminijasto snemljivo zaporko - Vehikel: 1 napolnjena borosilikatna steklena injekcijska brizga z 2,5 mL vode za injekcije - 1 sterilen vmesnik za vialo za rekonstitucijo z 1 iglo z držalom v obliki metuljčka in 2 alkoholna zloženca
English: Nuwiq 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Nuwiq 2500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2500 i.e. humanega koagulacijskega faktorja 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.
Slovenian: Nuwiq 4000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 4000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Nuwiq 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 IU simoctocog alfa (200 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 500 i.e. simoktokoga alfa (200 i.e./mL po rekonstituciji).
English: Nuwiq 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja 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.
Slovenian: Nuwiq 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
Slovenian: 1 viala s praškom vsebuje 1000 i.e. simoktokoga alfa (400 i.e./mL po rekonstituciji).
English: Nuwiq 2500 IU contains approximately 1000 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Nuwiq 2500 i.e. vsebuje po rekonstituciji približno 1000 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Nuwiq 3000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 3000 i.e. humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 250 IU contains approximately 100 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Nuwiq 250 i.e. vsebuje po rekonstituciji približno 100 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 3000 IU contains approximately 1200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Nuwiq 3000 i.e. vsebuje po rekonstituciji približno 1200 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Nuwiq 4000 IU contains approximately 1600 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Nuwiq 4000 i.e. vsebuje po rekonstituciji približno 1600 i.e./mL humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 250 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Nuwiq 250 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Nuwiq 2500 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Nuwiq 500 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)