FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE Vihuma 2000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 2000
English: PK parameter
Croatian: Farmakokinetički parametar
English: Do not use any other way to heat the vial and pre-filled syringe.
Croatian: Nemojte zagrijavati bočicu i napunjenu štrcaljku ni na koji drugi način.
English: INFORMATION IN BRAILLE Vihuma 2500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 2500
English: Vihuma contains traces of human host cell proteins other than factor VIII.
Croatian: Pored faktora VIII, Vihuma sadrži proteine ljudskih stanica domaćina u tragovima.
English: 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.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite vidljive znakove oštećenja na sigurnosnom pakiranju,
English: INFORMATION IN BRAILLE Vihuma 250
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 250
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.
Croatian: Uzmite pakiranje s nastavkom i postavite nastavak za bočicu iznad središta gumenog čepa bočice s praškom.
English: INFORMATION IN BRAILLE Vihuma 1000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 1000
English: Pre-adipose (n=4)
Croatian: Prekomjerna tjelesna težina (n=4)
English: Each pack contains: - 1 powder vial with 250, 500, 1000, 2000, 2500, 3000 or 4000 IU simoctocog alfa in a type 1
Croatian: - 1 bočicu praška s 250, 500, 1000, 2000, 2500, 3000 ili 4000 IU simoktokoga alfa u staklenoj
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.
Croatian: 1 bočica praška, 1 napunjena štrcaljka, 1 nastavak za bočicu, 1 igla s krilcima, 2 jastučića natopljena alkoholom
English: INFORMATION IN BRAILLE Vihuma 4000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 4000
English: INFORMATION IN BRAILLE Vihuma 500
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 500
English: Clinical efficacy and in-vivo recovery of Vihuma was not affected in this patient.
Croatian: Kod ovog bolesnika nije bilo utjecaja na kliničku djelotvornost i in vivo povrat za lijek Vihuma.
English: Remove the adapter packaging and discard.
Croatian: Uklonite pakiranje nastavka i zbrinite ga u otpad.
English: INFORMATION IN BRAILLE Vihuma 3000
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Vihuma 3000
English: Peel back the paper cover from the pre-filled syringe package.
Croatian: Uklonite papirnati pokrov s pakiranja napunjene štrcaljke.
English: What Vihuma looks like and contents of the pack Vihuma is provided as powder and solvent for solution for injection.
Croatian: Vihuma dolazi u obliku praška i otapala za otopinu za injekciju.
English: Chromogenic assay Mean ± SD
Croatian: Kromogeni test Srednja vrijednost ± SD
English: The dose of Vihuma is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Vaše tjelesne težine i željene razine faktora VIII.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2000 International Units simoctocog alfa (800 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 2000 međunarodnih jedinica simoktokoga alfa (800 IU/ml nakon rekonstitucije).
English: Marketing Authorisation Holder and Manufacturer Octapharma AB, Lars Forssells gata 23, 112 75 Stockholm, Sweden
Croatian: 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:
English: 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.
Croatian: Broj jedinica faktora VIII koje se primjenjuju izražen je u međunarodnim jedinicama (International
English: Vihuma 2500 IU powder and solvent for solution for injection.
Croatian: Vihuma 2500 IU prašak i otapalo za otopinu za injekciju
English: Vihuma 2000 IU contains approximately 800 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 2000 IU sadrži približno 800 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 250 IU powder and solvent for solution for injection.
Croatian: Vihuma 250 IU prašak i otapalo za otopinu za injekciju
English: Vihuma 4000 IU powder and solvent for solution for injection.
Croatian: Vihuma 4000 IU prašak i otapalo za otopinu za injekciju.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 3000 International Units simoctocog alfa (1200 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 3000 međunarodnih jedinica simoktokoga alfa (1200 IU/ml nakon rekonstitucije).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 250 International Units simoctocog alfa (100 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 250 međunarodnih jedinica simoktokoga alfa (100 IU/ml nakon rekonstitucije).
English: Vihuma 2000 IU powder and solvent for solution for injection.
Croatian: Vihuma 2000 IU prašak i otapalo za otopinu za injekciju
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)
Croatian: 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)
English: Vihuma 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 250 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 6 to 12 years with severe haemophilia A (n = 12)
Croatian: 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)
English: Vihuma 250 IU contains approximately 100 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 250 IU sadrži približno 100 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 4000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 4000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 4000 International Units simoctocog alfa (16000 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 4000 međunarodnih jedinica simoktokoga alfa (1600 IU/ml nakon rekonstitucije).
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 2500 International Units simoctocog alfa (1000 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 2500 međunarodnih jedinica simoktokoga alfa (1000 IU/ml nakon rekonstitucije).
English: 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
Croatian: - 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
English: Vihuma 3000 IU powder and solvent for solution for injection.
Croatian: Vihuma 3000 IU prašak i otapalo za otopinu za injekciju.
English: Vihuma 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 2500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 2500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 500 International Units simoctocog alfa (200 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 500 međunarodnih jedinica simoktokoga alfa (200 IU/ml nakon rekonstitucije).
English: 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.
Croatian: Vaš liječnik ili medicinska sestra s iskustvom u liječenju bolesnika s hemofilijom A obično će ubrizgati lijek Vihuma u venu (intravenski).
English: Vihuma 2500 IU contains approximately 1000 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 2500 IU sadrži približno 1000 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 3000 IU contains approximately 1200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 3000 IU sadrži približno 1200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 500 IU powder and solvent for solution for injection.
Croatian: Vihuma 500 IU prašak i otapalo za otopinu za injekciju
English: Vihuma 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Croatian: Vihuma 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica sadrži nominalno 500 IU ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: PK parameters for Vihuma (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Croatian: 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)
English: Attach the provided infusion set to the syringe.
Croatian: Pričvrstite isporučeni infuzijski set na štrcaljku.
English: Vihuma 500 IU contains approximately 200 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 500 IU sadrži približno 200 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 1000 IU contains approximately 400 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 1000 IU sadrži približno 400 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: Vihuma 4000 IU contains approximately 1600 IU/ml of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Croatian: Nakon rekonstitucije Vihuma 4000 IU sadrži približno 1600 IU/ml ljudskog koagulacijskog faktora VIII (rDNK), simoktokoga alfa.
English: How to store Vihuma 6.
Croatian: Moguće nuspojave 5. Kako čuvati Vihuma
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 International Units simoctocog alfa (400 IU/ml after reconstitution).
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 bočica praška sadrži 1000 međunarodnih jedinica simoktokoga alfa (400 IU/ml nakon rekonstitucije).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 2500 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: IVR (%/IU/kg) 2.5 (1.7 - 3.2)
Croatian: (78,2 IU/kg naspram 41,7 IU/kg).
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 2500 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: AUTHORISATION
Croatian: Profilaksa
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene vizualno pregledajte rekonstituirani lijek i provjerite da ne sadrži čestice te da nije došlo do promjene boje.
English: NAME OF THE MEDICINAL PRODUCT Vihuma 500 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 500 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 250 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 250 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 250 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT Vihuma 4000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 4000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 500 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 1000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: Attach the threaded end of the plunger rod to the solvent syringe plunger.
Croatian: Pričvrstite kraj s navojima potisnog klipa na potisni klip štrcaljke s otapalom.
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 3000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 4000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: NAME OF THE MEDICINAL PRODUCT Vihuma 3000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 3000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/007
English: Vihuma 1000 IU powder and solvent for solution for injection.
Croatian: Vihuma 1000 IU prašak i otapalo za otopinu za injekciju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/005
English: NAME OF THE MEDICINAL PRODUCT Vihuma 1000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 1000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/002
English: 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).
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Vihuma 2000 međunarodnih jedinica prašak za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/006
English: NAME OF THE MEDICINAL PRODUCT Vihuma 2000 International Units powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Croatian: Vihuma 2000 međunarodnih jedinica prašak i otapalo za otopinu za injekciju simoktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/004
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1168/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1168/003
English: Chromogenic assay
Croatian: Izraženija hemartroza,
English: 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.
Croatian: Odvojite sigurnosni plastični vršak sa štrcaljke s otapalom tako da slomite perforirani dio zatvarača.
English: Package size
Croatian: Veličina pakovan ja
English: The recommended dose is 0.25 mg given every 24 hours, either in the morning or in the evening.
Croatian: Preporučena doza je 0,25 mg svaka 24 sata, a uzima se ujutro ili navečer.
English: Further information on Cetrotide can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/cetrotide.
Croatian: Više informacija o lijeku Cetrotide dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/cetrotide.
English: What is Cetrotide and what is it used for?
Croatian: Što je Cetrotide i za što se koristi?
English: Cetrotide (cetrorelix)
Croatian: Cetrotide (cetroreliks)
English: 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.
Croatian: Daljnje injekcije bolesnica si može davati sama, dok god je upoznata sa znakovima alergijske reakcije i što treba poduzeti ako se oni pojave.
English: Because of the risk of severe allergic reactions, the first injection should be supervised by a doctor, and the patient closely watched for 30 minutes.
Croatian: Zbog rizika od teških alergijskih reakcija, davanje prve injekcije treba biti pod nadzorom liječnika, pri čemu je stanje bolesnice potrebno pažljivo pratiti 30 minuta.
English: Other information about Cetrotide
Croatian: Ostale informacije o lijeku Cetrotide
English: The medicine should be injected slowly at different places on the abdomen every day.
Croatian: Lijek se treba svakodnevno davati sporim injiciranjem na različita mjesta na abdomenu.
English: Results showed that between 95 and 97% of the patients receiving Cetrotide had no LH surge, compared with 98% for buserelin and 97% for triptorelin.
Croatian: Rezultati pokazuju da između 95 % i 97 % bolesnica koje su primale lijek Cetrotide nisu imale porast LH-a, u usporedbi s 98 % kad je riječ o buserelinu i 97 % kad je riječ o triptorelinu.
English: What measures are being taken to ensure the safe and effective use of Cetrotide?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cetrotide?
English: Once the assisted-reproduction procedure was completed, 23% of patients who received Cetrotide became pregnant, compared with 32% in the comparator groups.
Croatian: Nakon dovršetka postupka medicinski potpomognute oplodnje, 23 % bolesnica koje su primale lijek Cetrotide zatrudnjelo je, u usporedbi s 32 % u usporednim skupinama.
English: Cetrotide can only be obtained with a prescription and treatment should be carried out by a doctor who has experience in this type of fertility treatment.
Croatian: Lijek se izdaje samo na recept, a liječenje mora provoditi liječnik s iskustvom u ovakvoj vrsti liječenja neplodnosti.
English: Treatment starts usually on day 5 or 6 of ovarian stimulation, continued throughout the ovarian stimulation period, until the evening before or the morning of the day when the induction of ovulation (the release of eggs) is planned.
Croatian: Liječenje obično počinje 5. ili 6. dana stimulacije jajnika i nastavlja se tijekom cijelog razdoblja stimulacije jajnika, sve do večeri prije ili jutra onoga dana kada se planira induciranje ovulacije (otpuštanje jajnih stanica).
English: Side effects reported with Cetrotide are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Cetrotide pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Cetrotide received a marketing authorisation valid throughout the EU on 13 April 1999.
Croatian: Lijek Cetrotide dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. travnja 1999.
English: What are the risks associated with Cetrotide?
Croatian: Koji su rizici povezani s lijekom Cetrotide?
English: The European Medicines Agency therefore decided that Cetrotide's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Cetrotide nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: As for all medicines, data on the use of Cetrotide are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Cetrotide kontinuirano se prate.
English: It must not be used in women who are pregnant or breastfeeding, or in patients with severe kidney disease.
Croatian: Lijek se ne smije primjenjivati u žena koje su trudne ili doje, kao ni u bolesnica s teškom bolesti bubrega.