FrancophonIA/ELRC3.0 huggingface dataset:
English: If you forget to use Vihuma
Slovenian: Če ste prenehali uporabljati zdravilo Vihuma
English: See package leaflet for further information.
Slovenian: Za nadaljnje informacije glejte navodila za uporabo.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII:C. Posledice so obsežne krvavitve v sklepe, mišice ali notranje organe.
English: AUC = Area under the curve (FVIII:C), T1/2 = Terminal half-life, IVR = Incremental in vivo recovery, CL = Clearance, SD = Standard deviation
Slovenian: AUC = Površina pod krivuljo (FVIII:C), T1/2 = Končna razpolovna doba,
English: Visually inspect the final solution for particles before administration.
Slovenian: Pred uporabo vizualno preglejte končno raztopino, da ne vsebuje delcev.
English: AUC (hr*IU/ml) 22.6 ± 8.0 T1/2 (hr)
Slovenian: AUC (h*i.e./ml) T1/2 (hr)
English: However, in some cases, especially in younger patients, more frequent injections or higher doses may be necessary.
Slovenian: Vendar pa bodo v nekaterih primerih, zlasti pri mlajših bolnikih, morda potrebni krajši presledki med odmerki ali pa večji odmerki.
English: Remove the plastic flip-top cap from the powder vial to expose the central portions of the rubber stopper.
Slovenian: Odstranite plastično zaporko z viale s praškom, da se vam prikaže osrednji del gumijastega zamaška.
English: The vial adapter and the syringe are for single use only.
Slovenian: Vmesnik za vialo in injekcijska brizga sta namenjena enkratni uporabi.
English: Remove the adapter packaging and discard.
Slovenian: Odstranite embalažo vmesnika in jo zavrzite.
English: How to store Vihuma 6.
Slovenian: Shranjevanje zdravila Vihuma 6.
English: Turn the vial attached to the syringe upside down, and slowly draw the final solution into the syringe.
Slovenian: Vialo, pritrjeno na brizgo, obrnite navzdol in gotovo raztopino počasi povlecite v brizgo.
English: In total 986 bleeding episodes were treated with a median dose of 30.9 IU/kg.
Slovenian: V drugi klinični študiji je bilo 22 odraslih bolnikov zdravljenih po potrebi, Skupno je bilo zdravljenih 986 krvavitev z mediano odmerka 30.9 i.e./kg.
English: INFORMATION IN BRAILLE Vihuma 2000
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 2000
English: Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188
Slovenian: Pomožne snovi: saharoza, natrijev klorid, kalcijev klorid dihidrat, argininijev klorid, natrijev citrat dihidrat, poloksamer 188
English: Press down firmly the adapter package until the adapter spike penetrates the rubber stopper.
Slovenian: Močno pritisnite na embalažo vmesnika, dokler konica vmesnika ne predre gumijastega zamaška.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby temporarily enabling a correction of the factor VIII deficiency and correction of the bleeding tendencies.
Slovenian: S tem se začasno korigira pomanjkanje faktorja VIII in zmanjša nagnjenost h krvavitvam.
English: Usually, treatment for haemophilia A is a life-long treatment.
Slovenian: Zdravljenje za hemofilijo A je navadno vseživljenjsko.
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.
Slovenian: V času do izteka roka uporabnosti je zdravilo lahko shranjeno pri sobni temperaturi (do 25 °C) za enkratno obdobje, ki ni daljše od 1 meseca.
English: Each pack of Vihuma 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 Vihuma 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 - 1 iglo z držalom v obliki metuljčka - 2 alkoholna zloženca
English: Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and acute disability are resolved.
Slovenian: ur 3 do 4 dni ali več, dokler ne mineta bolečina in akutna onesposobljenost.
English: Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial.
Slovenian: Odstranite injekcijsko brizgo z vmesnika za vialo z vrtenjem v nasprotni smeri urinega kazalca in prazno vialo zavrzite.
English: Very common side effects may affect more than 1 in 10 people Factor VIII inhibitors in previously untreated patients.
Slovenian: Zelo pogosti neželeni učinki se lahko pojavijo pri več kot 1 od 10 bolnikov
English: Vihuma 250 IU powder and solvent for solution for injection Vihuma 500 IU powder and solvent for solution for injection Vihuma 1000 IU powder and solvent for solution for injection Vihuma 2000 IU powder and solvent for solution for injection Vihuma 2500 IU powder and solvent for solution for injection Vihuma 3000 IU powder and solvent for solution for injection Vihuma 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Vihuma 500 i.e. prašek in vehikel za raztopino za injiciranje Vihuma 1000 i.e. prašek in vehikel za raztopino za injiciranje Vihuma 2000 i.e. prašek in vehikel za raztopino za injiciranje Vihuma 2500 i.e. prašek in vehikel za raztopino za injiciranje Vihuma 3000 i.e. prašek in vehikel za raztopino za injiciranje Vihuma 4000 i.e. prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Če ste pozabili uporabiti zdravilo Vihuma Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Adipose (n=2)
Slovenian: Debelost (n=2)
English: In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage.
Slovenian: V primeru ,da raztopine ne boste takoj porabili, napolnjeno brizgo zaprite z zaščitno plastično konico in jo shranite.
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite katerikoli neželeni učinek, se posvetujte z zdravnikom.
English: Animal reproduction studies have not been conducted with Vihuma.
Slovenian: Študij vpliva na sposobnost razmnoževanja pri živalih ob uporabi faktorja VIII niso izvedli.
English: IVR (%/IU/kg) 2.5 ± 0.4 CL (ml/hr/kg)
Slovenian: IVR (%/i.e./kg) CL (ml/h/kg)
English: Please record the date from when you start to store Vihuma at room temperature on the product carton.
Slovenian: Na škatlo zdravila zapišite datum začetka shranjevanja zdravila Vihuma pri sobni temperaturi.
English: Chromogenic assay Median (range)
Slovenian: Kromogeni preizkus Povprečje ± SD Mediana (razpon)
English: Slowly inject all solvent into the powder vial by pressing down the plunger rod.
Slovenian: S pritiskanjem na bat počasi vbrizgajte ves vehikel v vialo s praškom.
English: Name and address of the manufacturer(s) of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin)
English: Turn the plunger rod clockwise until a slight resistance is felt.
Slovenian: Ročaj bata obrnite v smeri urinega kazalca, dokler ne začutite rahlega upora.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Vihuma ne vpliva na sposobnost vožnje in upravljanja s stroji.
English: Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt.
Slovenian: Brizgo z vehiklom dobro priključite na vmesnik za vialo z vrtenjem v smeri urinega kazalca, dokler ne začutite upora.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: Hypersensitivity or allergic reactions (which may include angiooedema, burning and stinging at the infusion site, chills, flushing, headache, hives, hypotension, lethargy, nausea, rash, restlessness, tachycardia, tightness of the chest, tingling, urticaria, including generalised urticaria, vomiting, wheezing) have rarely been observed with FVIII preparations and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: Preobčutljivost ali alergijske reakcije (med katere sodijo angioedem, pekoč in zbadajoč občutek na mestu infundiranja, mrzlica, pordelost, glavobol, koprivnica, hipotenzija, letargija, navzea, izpuščaj,
English: INFORMATION IN BRAILLE Vihuma 2500
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 2500
English: You must contact your doctor immediately if you notice any of the following symptoms:
Slovenian: Če opazite katerega izmed naslednjih simptomov, takoj pokličite svojega zdravnika:
English: Before the Vihuma 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 Vihuma shranjujete pri sobni temperaturi (do 25 °C), in sicer za enkratno obdobje, ki ni daljše od 1 meseca.
English: 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: However depending on your body weight and your dose of Vihuma, 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 Vihuma 1000
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 1000
English: Chromogenic assay Mean ± SD
Slovenian: Kromogeni preizkus Povprečje ± SD
English: INFORMATION IN BRAILLE Vihuma 250
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 250
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečina v hrbtu občasni*
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema hemoragična anemija zaviranje faktorja VIII
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH 2.5 ML WATER FOR INJECTIONS
Slovenian: OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA Z 2,5 ML VODE ZA INJEKCIJE
English: What you need to know before you use Vihuma
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Vihuma Ne uporabljajte zdravila Vihuma:
English: Vihuma 250 IU powder and solvent for solution for injection.
Slovenian: Vihuma 250 i.e. prašek in vehikel za raztopino za injiciranje
English: Nervous system disorders
Slovenian: MedDRA standardna klasifikacija po organskih sistemih
English: INFORMATION IN BRAILLE Vihuma 4000
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 4000
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection 1 Powder vial, 1 pre-filled syringe, 1 vial adapter, 1 butterfly needle, 2 alcohol swabs 1 Pre-filled syringe contains 2.5 ml water for injections.
Slovenian: 1 viala s praškom, 1 napolnjena injekcijska brizga, 1 vmesnik za vialo, 1 igla z držalom v obliki metuljčka, 2 alkoholna zloženca
English: Place the powder vial on an even surface and hold it. Take the adapter package and place the vial adapter over the centre of the rubber stopper of the powder vial.
Slovenian: Vzemite embalažo vmesnika in namestite vmesnik za vialo nad sredino gumijastega zamaška viale s praškom.
English: What Vihuma looks like and contents of the pack Vihuma is provided as powder and solvent for solution for injection.
Slovenian: Zdravilo Vihuma je na voljo kot prašek in vehikel za raztopino za injiciranje.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2000 i.e./vialo
English: The adapter snaps to the vial when done.
Slovenian: Vmesnik se na koncu namesti na vialo.
English: Uncommon* Uncommon (PTPs) # Very common (PUPs)#
Slovenian: zelo pogosti (PNB)#
English: Vihuma contains the active substance human recombinant coagulation factor VIII (simoctocog alfa).
Slovenian: - Učinkovina je humani rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: Peel back the paper cover from the vial adapter package.
Slovenian: Odlepite papirnati pokrov z embalaže vmesnika za vialo.
English: INFORMATION IN BRAILLE Vihuma 3000
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 3000
English: Vihuma contains sodium
Slovenian: OVOJNINAH VIALA S PRAŠKOM
English: INFORMATION IN BRAILLE Vihuma 500
Slovenian: PODATKI V BRAILLOVI PISAVI Vihuma 500
English: Median (range)
Slovenian: telesna masa (kg)
English: Paraesthesia Headache Dizziness
Slovenian: Bolezni živčevja parestezija glavobol omotica občasni* občasni* občasni*
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 250 i.e./vialo
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Vihuma
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo Vihuma voda za injekcije
English: How to store Vihuma
Slovenian: Shranjevanje zdravila Vihuma
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Vihuma.
Slovenian: Pri bolnikih s hemofilijo A, ki se zdravijo s faktorjem VIII, vključno z zdravilom Vihuma, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: Peel back the paper cover from the pre-filled syringe package.
Slovenian: Odstranite papirnati pokrov z embalaže napolnjene injekcijske brizge.
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.
Slovenian: nemir, tahikardija, tiščanje v prsih, ščemenje, urtikarija, vključno z generalizirano urtikarijo, bruhanje,
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: mesta in obsega krvavitve ter od bolnikovega kliničnega stanja.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2500 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2500 i.e./vialo
English: * Calculated as patients with ADR per total number of 280 trial patients, of which 190 previously treated patients (PTPs) and 90 previously untreated patients (PUPs).
Slovenian: od katerih jih je bilo 190 predhodno zdravljenih in 90 predhodno nezdravljenih.
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Slovenian: Farmakokinetični parametri za zdravilo Vihuma (Odmerek: 50 i.e./kg) pri predhodno zdravljenih otrocih (starost 6 do 12 let) s hudo obliko hemofilije A (n = 12)
English: Weight-adjusted PK parameters for Vihuma (Dose: 50 IU/kg) in adult previously treated patients (age 18-65 years) with severe haemophilia A (n = 20)
Slovenian: Farmakokinetični parametri za zdravilo Vihuma (Odmerek: 50 i.e./kg) pri odraslih predhodno zdravljenih bolnikih (starost 18-65 let) s hudo obliko hemofilije A (n = 20)
English: Immune system disorders
Slovenian: Bolezni imunskega sistema preobčutljivost pogosti*
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e./vialo
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 International Units simoctocog alfa (800 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 2000 mednarodnih enot simoktokoga alfa (800 i.e./ml po rekonstituciji).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e./vialo
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 International Units simoctocog alfa (1000 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 2500 mednarodnih enot simoktokoga alfa (1000 i.e./ml po rekonstituciji).
English: Vihuma 2000 IU contains approximately 800 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 2000 i.e. vsebuje po rekonstituciji približno 800 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 International Units simoctocog alfa (1200 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 3000 mednarodnih enot simoktokoga alfa (1200 i.e./ml po rekonstituciji).
English: Uncommon* Uncommon* Uncommon*
Slovenian: občasni* občasni (PZB) #
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Slovenian: Farmakokinetični parametri za zdravilo Vihuma (Odmerek: 50 i.e./kg) pri predhodno zdravljenih otrocih (starost 2 do 5 let) s hudo obliko hemofilije A (n = 13)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4000 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4000 i.e./vialo
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 International Units simoctocog alfa (16000 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 4000 mednarodnih enot simoktokoga alfa (1600 i.e./ml po rekonstituciji).
English: Vihuma 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: What Vihuma contains Powder: - The active substance is recombinant human coagulation factor VIII (simoctocog alfa).
Slovenian: Kaj je zdravilo Vihuma in za kaj ga uporabljamo Zdravilo Vihuma vsebuje učinkovino humani rekombinantni koagulacijski faktor VIII (simoktokog alfa).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 250 International Units simoctocog alfa (100 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 250 mednarodnih enot simoktokoga alfa (100 i.e./ml po rekonstituciji).
English: Vihuma 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: Weight adjusted subgroups
Slovenian: Podskupine, razdeljene glede na telesno maso
English: Vihuma 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: Life threatening haemorrhages
Slovenian: Smrtno nevarne krvavitve
English: Vihuma 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3000 IU/vial
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3000 i.e./vialo
English: Vihuma 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: Vihuma 2500 IU contains approximately 1000 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 2500 i.e. vsebuje po rekonstituciji približno 1000 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Vihuma 250 IU contains approximately 100 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 250 i.e. vsebuje po rekonstituciji približno 100 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Vihuma 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 500 mednarodnih enot simoktokoga alfa (200 i.e./ml po rekonstituciji).
English: Common side effects may affect up to 1 in 10 people Hypersensitivity, fever.
Slovenian: Pogosti neželeni učinki se lahko pojavijo pri največ 1 od 10 bolnikov
English: Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Slovenian: Vihuma 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: Vihuma 4000 IU contains approximately 1600 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 4000 i.e. vsebuje po rekonstituciji približno 1600 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Vihuma 3000 IU contains approximately 1200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 3000 i.e. vsebuje po rekonstituciji približno 1200 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Vihuma 2500 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)
English: Common* Uncommon* Uncommon* Uncommon*
Slovenian: občasni* občasni* občasni*
English: PC:
Slovenian: Profilaksa:
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
Slovenian: 1 viala s praškom vsebuje 1000 mednarodnih enot simoktokoga alfa (400 i.e./ml po rekonstituciji).
English: Vihuma 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Slovenian: Zdravilo Vihuma 1000 i.e. vsebuje po rekonstituciji približno 400 i.e./ml humanega koagulacijskega faktorja VIII (rDNK), simoktokoga alfa.
English: Attach the threaded end of the plunger rod to the solvent syringe plunger.
Slovenian: Pritrdite navojni konec ročaja bata na bat brizge z vehiklom.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Slovenian: Vihuma 500 mednarodnih enot prašek in vehikel za raztopino za injiciranje simoktokog alfa (humani rekombinantni koagulacijski faktor VIII)