natgillin/translations-raw huggingface dataset:
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.
Vihuma 3000 IU contains approximately 1200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nakon rekonstitucije Vihuma 3000 IU sadrži približno 1200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Vihuma 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 500 IU powder and solvent for solution for injection.
Vihuma 500 IU prašak i otapalo za otopinu za injekciju
Vihuma 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Vihuma 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Tablica 4. Farmakokinetički parametri za Vihuma (Doza: 50 IU/kg) u prethodno liječene djece u dobi od 2 do 5 godina s teškom hemofilijom A (n = 13)
Attach the provided infusion set to the syringe.
Pričvrstite isporučeni infuzijski set na štrcaljku.
Vihuma 500 IU contains approximately 200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nakon rekonstitucije Vihuma 500 IU sadrži približno 200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nakon rekonstitucije Vihuma 1000 IU sadrži približno 400 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
Vihuma 4000 IU contains approximately 1600 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Nakon rekonstitucije Vihuma 4000 IU sadrži približno 1600 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
How to store Vihuma 6.
Moguće nuspojave 5. Kako čuvati Vihuma
STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 1000 međunarodnih jedinica simoktokoga alfa (400 IU/ml nakon rekonstitucije).
NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 2500 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
IVR (%/IU/kg) 2.5 (1.7 - 3.2)
(78,2 IU/kg naspram 41,7 IU/kg).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 2500 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
AUTHORISATION
Profilaksa
The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Prije primjene vizualno pregledajte rekonstituirani lijek i provjerite da ne sadrži čestice te da nije došlo do promjene boje.
NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 500 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 250 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 250 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
NAME OF THE MEDICINAL PRODUCT Vihuma 250 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 250 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT Vihuma 4000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 4000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 500 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 500 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 1000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 1000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
Attach the threaded end of the plunger rod to the solvent syringe plunger.
Pričvrstite kraj s navojima potisnog klipa na potisni klip štrcaljke s otapalom.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 3000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 3000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 4000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 4000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
NAME OF THE MEDICINAL PRODUCT Vihuma 3000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 3000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/007
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/007
Vihuma 1000 IU powder and solvent for solution for injection.
Vihuma 1000 IU prašak i otapalo za otopinu za injekciju
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/005
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/005
NAME OF THE MEDICINAL PRODUCT Vihuma 1000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 1000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/002
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vihuma 2000 International Units powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII).
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 2000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/006
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/006
NAME OF THE MEDICINAL PRODUCT Vihuma 2000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Vihuma 2000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/004
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/004
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/001
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/001
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/003
Chromogenic assay
Izraženija hemartroza,
Break off the tamper-proof plastic tip from the solvent syringe by snapping the perforation of the cap. Do not touch the inside of the cap or the syringe tip.
Odvojite sigurnosni plastični vršak sa štrcaljke s otapalom tako da slomite perforirani dio zatvarača.
Package size
Veličina pakovan ja
The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.
Preporučena doza je 0,25 mg svaka 24 sata, a uzima se ujutro ili navečer.
Further information on Cetrotide can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cetrotide.
Više informacija o lijeku Cetrotide dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/cetrotide.
What is Cetrotide and what is it used for?
Što je Cetrotide i za što se koristi?
Cetrotide (cetrorelix)
Cetrotide (cetroreliks)
Further injections may be given by the patient herself, as long as she is made aware of the signs of allergic reaction and what to do if they appear.
Daljnje injekcije bolesnica si može davati sama, dok god je upoznata sa znakovima alergijske reakcije i što treba poduzeti ako se oni pojave.