natgillin/translations-raw huggingface dataset:
For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients). 
bolesnika) mogu nastati inhibitorna protutijela (vidjeti dio 2); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Vihuma. 
Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijek Vihuma.
Biotest AG (Germany) Teл. 
Biotest AG (Germany)
The European Medicines Agency has deferred the obligation to submit the results of studies with Vihuma 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). 
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Vihuma u jednoj ili više podskupina pedijatrijske populacije u liječenju hemofilije A (urođeni nedostatak faktora
Keep this medicine out of the sight and reach of children. 
Kako čuvati Vihuma Lijek čuvajte izvan pogleda i dohvata djece.
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. 
Bolesnike je potrebno informirati o ranim simptomima i znakovima reakcija preosjetljivosti kao što su osip, generalizirana urtikarija, stezanje u prsištu, piskanje pri disanju, hipotenzija i anafilaksija.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
Unutar svake skupine učestalosti nuspojave su prikazane silaznim redoslijedom ozbiljnosti.
Visually inspect the final solution for particles before administration. 
Vizualno provjerite postoje li čestice u završnoj otopini prije primjene.
Can be stored at room temperature (up to 25°C) for a single period up to 1 month. 
Može se čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
How to use Vihuma 
Kako primjenjivati Vihuma
Make sure that the entire content of the vial is transferred to the syringe. 
Provjerite jeste li čitav sadržaj bočice uvukli u štrcaljku.
Animal reproduction studies have not been conducted with Vihuma. 
Nisu provedena ispitivanja na životinjama za lijek Vihuma.
Excipient related considerations (sodium content) 
Napomene povezane s pomoćnom tvari (sadržaj natrija)
If your plasma factor VIII fails to reach expected levels with Vihuma, or if bleeding is not adequately controlled, it could be due to the development of factor VIII inhibitors. 
Ako faktor VIII u plazmi ne dostigne očekivanu razinu uz lijek Vihuma, ili ako se ne postigne odgovarajuća kontrola krvarenja, možda ste razvili inhibitore faktora VIII.
Adipose (n=2) 
Pretilost (n=2)
Inject the solution into the vein at a slow speed, not faster than 4 ml per minute. 
17. Polako ubrizgajte otopinu u venu, brzinom do 4 ml po minuti.
A higher median dose of Vihuma 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). 
Veći medijan doze lijeka Vihuma 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
The solvent is water for injections in a pre-filled glass syringe. 
Otapalo je voda za injekcije u napunjenoj staklenoj štrcaljki.
Excipient(s) with known effect 7.35 mg sodium per ml reconstituted solution (18.4 mg sodium per vial). 
7,35 mg natrija po ml rekonstituirane otopine (18,4 mg natrija po bočici).
Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries. 
Moguće su razlike u odgovoru pojedinačnih bolesnika na faktor VIII u smislu razlika u poluvijeku lijeka te in vivo povrata.
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. 
Potentnost (IU - međunarodne jedinice) se određuje kromogenim testom prema Europskoj farmakopeji.
Name and address of the manufacturer(s) of the biological active substance 
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Nisu provedena ispitivanja interakcija za lijek Vihuma.
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. 
Prije rekonstitucije Vihuma prašak može se čuvati na sobnoj temperaturi (do najviše 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
It is strongly recommended that every time that Vihuma 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. 
Izrazito se preporučuje da se prilikom svake primjene lijeka Vihuma zabilježe naziv i broj serije lijeka kako bi se održala poveznica između Vas i primijenjene serije lijeka.
Patients developing factor VIII inhibitors 
Razvoj inhibitora faktora VIII kod bolesnika
Blood and lymphatic system disorders 
Poremećaji krvi i limfnog sustava Hemoragična anemija
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered. 
Ako postoji potreba za centralnim venskim kateterom, potrebno je razmotriti rizik od komplikacija povezanih s takvim uređajem, uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu ulaska katetera.
Driving and using machines Vihuma has no influence on your ability to drive and use machines. 
Vihuma ne utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
Check with your doctor or nurse if you are not sure. 
Provjerite navedeno s liječnikom ili medicinskom sestrom u slučaju dvojbi.
Only the provided injection sets should be used because treatment failure can occur as a consequence of human coagulation factor VIII adsorption to the internal surfaces of some injection equipment. 
Koristite isključivo isporučene setove za injekcije jer adsorpcija ljudskog faktora zgrušavanja VIII na unutarnje površine neke opreme za injekcije može dovesti do neuspjeha liječenja.
Slowly inject all solvent into the powder vial by pressing down the plunger rod. 
Polako ubrizgajte sve otapalo u bočicu s praškom tako da pritisnete potisni klip.
Expected factor VIII rise (% of normal) = 2 x administered IU body weight (kg) 
Očekivano povećanje faktora VIII (% u odnosu na normalni) = 2 x primijenjene IU
However depending on the body weight and posology, the patient could receive more than one vial. 
Međutim, ovisno o tjelesnoj težini i doziranju, možda ćete primiti više od jedne bočice.
These data were corroborated by a long-term follow-up of 49 of these children who were treated for an additional median period of approximately 30 months (range from 9.5 to 52 months); during this period 45% of children had no spontaneous bleeds 
Ove rezultate potvrdilo je dugoročno praćenje 49 od te djece koja su bila liječena tijekom dodatnog razdoblja s medijanom od približno 30 mjeseci (raspon od
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. 
osip, koprivnjača, crvenilo, generalizirani svrbež, oticanje usana i jezika, teškoće prilikom disanja, zviždanje pri disanju, stezanje u prsnom košu,
Turn the plunger rod clockwise until a slight resistance is felt. 
Okrećite potisni klip u smjeru kazaljke na satu dok ne osjetite blagi otpor.
Please record the beginning of storage at room temperature on the product carton. 
Zabilježite datum početka čuvanja lijeka na sobnoj temperaturi na kutiji lijeka.
The vial should be gently rotated until all powder is dissolved. 
Nježno zakrećite bočicu dok se ne otopi sav prašak.
Wipe the top of the vial with an alcohol swab. 
Obrišite vrh bočice jastučićem natopljenim alkoholom.
Injection site inflammation Injection site pain Malaise 
Upala na mjestu injekcije Bol na mjestu injekcije Malaksalost
If you or your child´s bleeding is not being controlled with Vihuma, tell your doctor immediately. 
Vašeg djeteta ne može kontrolirati pomoću lijeka Vihuma, odmah se obratite liječniku.
Please record the date from when you start to store Vihuma at room temperature on the product carton. 
Zabilježite datum početka čuvanja lijeka Vihuma na sobnoj temperaturi na kutiji lijeka.
Excipients: Sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188 
Pomoćne tvari: saharoza, natrijev klorid, kalcijev klorid dihidrat, argininklorid, natrijev citrat dihidrat, poloksamer 188
If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered. 
Ako morate upotrijebiti centralni venski kateter, potrebno je razmotriti rizik od komplikacija povezanih sa centralnim venskim kateterom, uključujući lokalne infekcije, prisutnost bakterija u krvi i trombozu na mjestu uvođenja katetera.
Common* 
Često*
factor VIII binds to von Willebrand factor in the patient's circulation. 
Nakon infuzije bolesniku s hemofilijom faktor VIII veže se na von Willebrandov faktor u bolesnikovoj cirkulaciji.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast feeding is not available. 
Zbog rijetke pojave hemofilije A kod žena nema dostupnih iskustva u pogledu primjene faktora VIII
It is strongly recommended that every time that Vihuma 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. 
Preporučuje se da prilikom svake primjene lijeka Vihuma bolesniku evidentirate naziv i broj serije lijeka kako bi se mogla utvrditi veza između bolesnika i serije lijeka.
If you stop using Vihuma Do not stop using Vihuma without consulting your doctor or pharmacist. 
Nemojte prestati s primjenom lijeka Vihuma bez prethodnog savjetovanja s liječnikom ili ljekarnikom.
Detach the filled syringe from the vial adapter by turning counter clockwise and discard the empty vial. 
Odvojite napunjenu štrcaljku od nastavka za bočicu okretanjem u smjeru suprotnom od kazaljke na satu i zatim bacite praznu bočicu.
Firmly connect the solvent syringe to the vial adapter by turning clockwise until resistance is felt. 
Čvrsto spojite štrcaljku s otapalom na nastavak za bočicu tako da je okrećete u smjeru kazaljke na satu dok ne osjetite otpor.
AUC (hr*IU/ml) 22.6 ± 8.0 T1/2 (hr) 
AUC(h*IU/ml) T1/2 (h)
Each powder vial contains 250, 500, 1000, 2000, 2500, 3000 or 4000 IU of simoctocog alfa. 
Jedna bočica praška sadrži 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa.
How often you need an injection will depend on how well Vihuma is working for you. 
Učestalost potrebe za injekcijom ovisit će o učinku lijeka Vihuma na Vas.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
Chromogenic assay Median (range) 
Kromogeni test Medijan (raspon)
Do not store Vihuma in the refrigerator again after it has been stored at room temperature. 
Nakon čuvanja na sobnoj temperaturi, Vihuma se ne smije ponovno čuvati u hladnjaku.
Haemorrhagic anaemia Factor VIII inhibition 
Inhibicija faktora VIII
If you use more Vihuma than you should 
Ako ste ubrizgali više lijeka Vihuma nego što ste trebali,
IVR (%/IU/kg) 2.5 ± 0.4 CL (ml/hr/kg) 
IVP (%/IU/kg) CL (ml/h/kg)
Remove the plastic flip-top cap from the powder vial to expose the central portions of the rubber stopper. 
Uklonite plastični zatvarač s bočice s praškom tako da se vidi središnji dio gumenog čepa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Vihuma 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Vihuma
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 
Svako pakiranje lijeka Vihuma 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
- The other ingredients are sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate and poloxamer 188. 
- Drugi sastojci su saharoza, natrijev klorid, kalcijev klorid dihidrat, argininklorid, natrijev citrat dihidrat i poloksamer 188. Pogledajte dio 2, "Vihuma sadrži natrij".
In case the solution is not used immediately close the filled syringe with the tamper-proof plastic tip for storage. 
Ako nećete odmah upotrijebiti otopinu, zatvorite punu štrcaljku sigurnosnim plastičnim vrškom i pohranite je.
During the shelf-life, the product may be kept at room temperature (up to 25°C) for a single period not exceeding 1 month. 
Unutar roka valjanosti lijek se može čuvati na sobnoj temperaturi (do 25°C) tijekom jednokratnog razdoblja od najviše 1 mjesec.
Press down firmly the adapter package until the adapter spike penetrates the rubber stopper. 
Čvrsto pritisnite pakiranje s nastavkom prema dolje dok šiljak nastavka ne probode gumeni čep.
Vihuma contains the active substance human recombinant coagulation factor VIII (simoctocog alfa). 
Vihuma sadrži djelatnu tvar ljudski rekombinantni koagulacijski faktor VIII (simoktokog alfa).
Early haemarthrosis, muscle bleeding or oral bleeding 
Rana hemartroza, krvarenje u mišiće ili usta
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). 
tahikardiju, stezanje u prsištu, trnce, urtikariju, uključujući generaliziranu urtikariju, povraćanje, piskanje pri disanju) koje se u nekim slučajevima mogu razviti u tešku anafilaksiju (uključujući anafilaktički šok).
Powder: white to off-white friable powder. 
Prašak: rastresit prašak bijele do prljavo bijele boje.
INFORMATION IN BRAILLE Vihuma 2000 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 2000
PK parameter 
Farmakokinetički parametar
Do not use any other way to heat the vial and pre-filled syringe. 
Nemojte zagrijavati bočicu i napunjenu štrcaljku ni na koji drugi način.
INFORMATION IN BRAILLE Vihuma 2500 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 2500
Vihuma contains traces of human host cell proteins other than factor VIII. 
Pored faktora VIII, Vihuma sadrži proteine ljudskih stanica domaćina u tragovima.
Do not use the product in case you notice visible signs of deterioration of the tamper proof of packaging especially of the syringe and/or the vial. 
Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove oštećenja na sigurnosnom pakiranju,
INFORMATION IN BRAILLE Vihuma 250 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 250
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. 
Uzmite pakiranje s nastavkom i postavite nastavak za bočicu iznad središta gumenog čepa bočice s praškom.
INFORMATION IN BRAILLE Vihuma 1000 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 1000
Pre-adipose (n=4) 
Prekomjerna tjelesna težina (n=4)
Each pack contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa in a type 1 
- 1 bočicu praška s 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa u staklenoj
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. 
1 bočica praška, 1 napunjena štrcaljka, 1 nastavak za bočicu, 1 igla s krilcima, 2 jastučića natopljena alkoholom
INFORMATION IN BRAILLE Vihuma 4000 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 4000
INFORMATION IN BRAILLE Vihuma 500 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 500
Clinical efficacy and in-vivo recovery of Vihuma was not affected in this patient. 
Kod ovog bolesnika nije bilo utjecaja na kliničku djelotvornost i in vivo povrat za lijek Vihuma.
Remove the adapter packaging and discard. 
Uklonite pakiranje nastavka i zbrinite ga u otpad.
INFORMATION IN BRAILLE Vihuma 3000 
16. PODACI NA BRAILLEOVOM PISMU Vihuma 3000
Peel back the paper cover from the pre-filled syringe package. 
Uklonite papirnati pokrov s pakiranja napunjene štrcaljke.
What Vihuma looks like and contents of the pack Vihuma is provided as powder and solvent for solution for injection. 
Vihuma dolazi u obliku praška i otapala za otopinu za injekciju.
Chromogenic assay Mean ± SD 
Kromogeni test Srednja vrijednost ± SD
The dose of Vihuma is calculated depending on your body weight and the factor VIII levels to be achieved. 
Vaše tjelesne težine i željene razine faktora VIII.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 International Units simoctocog alfa (800 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 2000 međunarodnih jedinica simoktokoga alfa (800 IU/ml nakon rekonstitucije).
Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden 
Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Švedska Za sve informacije o ovom lijeku kontaktirajte s lokalnim predstavnikom nositelja odobrenja za stavljanje lijeka u promet:
The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products. 
Broj jedinica faktora VIII koje se primjenjuju izražen je u međunarodnim jedinicama (International
Vihuma 2500 IU powder and solvent for solution for injection. 
Vihuma 2500 IU prašak i otapalo za otopinu za injekciju
Vihuma 2000 IU contains approximately 800 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. 
Nakon rekonstitucije Vihuma 2000 IU sadrži približno 800 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 250 IU powder and solvent for solution for injection. 
Vihuma 250 IU prašak i otapalo za otopinu za injekciju
Vihuma 4000 IU powder and solvent for solution for injection. 
Vihuma 4000 IU prašak i otapalo za otopinu za injekciju.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 International Units simoctocog alfa (1200 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 3000 međunarodnih jedinica simoktokoga alfa (1200 IU/ml nakon rekonstitucije).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 250 International Units simoctocog alfa (100 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 250 međunarodnih jedinica simoktokoga alfa (100 IU/ml nakon rekonstitucije).
Vihuma 2000 IU powder and solvent for solution for injection. 
Vihuma 2000 IU prašak i otapalo za otopinu za injekciju
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) 
Tablica 2. Farmakokinetički parametri za Vihuma (Doza: 50 IU/kg) u prethodno liječenih odraslih bolesnika (u dobi od 18 do 65 godina) s teškom hemofilijom A (n = 20)
Vihuma 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa. 
Vihuma 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 250 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa. 
Vihuma 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12) 
Tablica 3. Farmakokinetički parametri za Vihuma (Doza: 50 IU/kg) u prethodno liječene djece u dobi od 6 do 12 godina s teškom hemofilijom A (n = 12)
Vihuma 250 IU contains approximately 100 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. 
Nakon rekonstitucije Vihuma 250 IU sadrži približno 100 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa. 
Vihuma 4000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 4000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 International Units simoctocog alfa (16000 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 4000 međunarodnih jedinica simoktokoga alfa (1600 IU/ml nakon rekonstitucije).
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 International Units simoctocog alfa (1000 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 2500 međunarodnih jedinica simoktokoga alfa (1000 IU/ml nakon rekonstitucije).
glass vial, closed with coated bromobutyl stopper and sealed with aluminium flip-off cap - Solvent: 2.5 ml water for injections in a pre-filled borosilicate glass syringe - 1 sterile vial adapter for reconstitution with 1 butterfly needle and 2 alcohol swabs 
- 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
Vihuma 3000 IU powder and solvent for solution for injection. 
Vihuma 3000 IU prašak i otapalo za otopinu za injekciju.
Vihuma 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa. 
Vihuma 2500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution). 
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 500 međunarodnih jedinica simoktokoga alfa (200 IU/ml nakon rekonstitucije).
Vihuma 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 Vihuma injection, but only after receiving adequate training. 
Vaš liječnik ili medicinska sestra s iskustvom u liječenju bolesnika s hemofilijom A obično će ubrizgati lijek Vihuma u venu (intravenski).
Vihuma 2500 IU contains approximately 1000 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution. 
Nakon rekonstitucije Vihuma 2500 IU sadrži približno 1000 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa. 
Vihuma 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.