FrancophonIA/ELRC3.0 huggingface dataset:
English: PRCA has been very rarely reported mostly in patients with kidney disease after months to years of treatment with Silapo and other products that stimulate red blood cell production.
Croatian: U bolesnika s bolešću bubrega, nakon mjeseci do godina liječenja Silapom i drugim lijekovima koji stimuliraju proizvodnju crvenih krvnih stanica, čista aplazija crvenih krvnih stanica prijavljena je vrlo rijetko.
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 2 000 IU/0,6 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: Silapo 20 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 20 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 0,5 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: 1 pre-filled syringe contains 2 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 2 000 IU epoetina zeta
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 5 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,5 ml otopine za injekciju sadrži 5 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: 1 pre-filled syringe contains 1 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 1 000 IU epoetina zeta
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 30 000 IU/0,75 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,75 ml otopine za injekciju sadrži 30 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/003
Croatian: Silapo 2 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/003
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: 1 pre-filled syringe of 0.5 ml solution for injection 6 pre-filled syringes of 0.5 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,5 ml otopine za injekciju 6 napunjenih štrcaljki s 0,5 ml otopine za injekciju
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 4 000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,4 ml otopine za injekciju sadrži 4 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 5 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,5 ml otopine za injekciju sadrži 5 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/015
Croatian: Silapo 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/015
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 4 000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,4 ml otopine za injekciju sadrži 4 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: Excipient with known effect Each pre-filled syringe contains 0.25 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,25 mg fenilalanina.
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,5 ml otopine za injekciju sadrži 20 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Excipient with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,15 mg fenilalanina.
English: Your doctor may initiate treatment with Silapo if your haemoglobin is 10 g/dl or less.
Croatian: Primjena kod odraslih pacijenata koji su na kemoterapiji Vaš liječnik može započeti liječenje Silapom ako je Vaš hemoglobin 10 g/dl ili manje.
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 1 ml otopine za injekciju sadrži 40 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Blood and lymphatic system disorders
Croatian: • krvni ugrušak u sustavu za dijalizu.
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,5 ml otopine za injekciju sadrži 20 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Excipient with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,45 mg fenilalanina.
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 1 ml otopine za injekciju sadrži 40 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 3 000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,9 ml otopine za injekciju sadrži 3 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 6 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 0,6 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/432/001
Croatian: Silapo 1 000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/001
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 2 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 0,6 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: Excipient with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,40 mg fenilalanina.
English: Silapo 40 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 40 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 3 000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,9 ml otopine za injekciju sadrži 3 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: 1 pre-filled syringe of 0.4 ml solution for injection 6 pre-filled syringes of 0.4 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,4 ml otopine za injekciju 6 napunjenih štrcaljki s 0,4 ml otopine za injekciju
English: 1 pre-filled syringe of 0.3 ml solution for injection 6 pre-filled syringes of 0.3 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,3 ml otopine za injekciju 6 napunjenih štrcaljki s 0,3 ml otopine za injekciju
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 30 000 IU/0,75 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,5 ml otopine za injekciju sadrži 30 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 30 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 30 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 0.3 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Croatian: Silapo 1 000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki 0,3 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 6 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 6 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 6 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 6 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 1 ml otopine za injekciju sadrži 10 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 1 000 IU/0,3 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 1 000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 1 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 6 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 6 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Excipient with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,30 mg fenilalanina.
English: Silapo 10 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 10 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Median
Croatian: FARMACEUTSKI
English: Excipient with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,50 mg fenilalanina.
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 1 000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 1 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 1 ml otopine za injekciju sadrži 10 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: 1 pre-filled syringe of 0.6 ml solution for injection 6 pre-filled syringes of 0.6 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,6 ml otopine za injekciju 6 napunjenih štrcaljki s 0,6 ml otopine za injekciju
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 2 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 2 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Appropriate dose adjustments should be made to maintain haemoglobin concentrations within the target range of 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l).
Croatian: Kako bi se koncentracije hemoglobina održale unutar ciljanog raspona od 10 g/dl do 12 g/dl (od 6,2 do 7,5 mmol/l) potrebne su odgovarajuće prilagodbe doze.
English: Silapo 4 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 4 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 3 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 3 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 2 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 2 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: ESAs are not indicated for use in this patient population.
Croatian: Faktori koji stimuliraju eritropoezu nisu indicirani za primjenu kod ove grupe pacijenata.
English: Anaemia symptoms and sequelae may vary with age, gender and overall burden of disease; a physician´s evaluation of the individual patient´s clinical course and condition is necessary.
Croatian: Simptomi anemije i njezine posljedice mogu varirati s obzirom na dob, spol i sveukupnu težinu bolesti.
English: Serum electrolytes should be monitored in chronic renal failure patients.
Croatian: Kod pacijenata s kroničnih zatajenjem bubrega potrebno je pratiti elektrolite u serumu.
English: Silapo 1 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 1 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 2 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 2 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: The use of Silapo in patients scheduled for major elective orthopaedic surgery and not participating in an autologous blood predonation programme is contraindicated in patients with severe coronary, peripheral arterial, carotid or cerebral vascular disease, including patients with recent myocardial infarction or cerebral vascular accident.
Croatian: Pure Red Cell Aplasia, PRCA) ne smiju primiti Silapo niti bilo koji drugi eritropoetin (vidjeti dio 4.4). - nekontrolirana hipertenzija. - u indikaciji ˝povećanje količine autologne krvi˝: infarkt miokarda ili inzult mjesec dana prije početka uzimanja lijeka, nestabilna angina pektoris, povećan rizik od duboke venske tromboze kao što je prethodna venska tromboembolijska bolest. - primjena Silapa u bolesnika u kojih se planira veliki elektivni ortopedski kirurški zahvat i koji ne sudjeluju u programu autologne predonacije krvi je kontraindicirana ako imaju tešku bolest koronarnih arterija, perifernih arterija, karotida ili cerebralnu vaskularnu bolest, uključujući bolesnike s nedavnim infarktom miokarda ili cerebrovaskularnim incidentom. - pacijenti koji iz bilo kojeg razloga ne mogu primiti adekvatnu antitrombotičku profilaksu.
English: Kidney disease patients
Croatian: Pacijenti s bolestima bubrega
English: Target Hb (10 - 12 g/dl)
Croatian: porast broja retikulocita ≥40 000/µl ili porast Hb ≥ 1 g/dl ciljna vrijednost Hb (10 - 12 g/dl)
English: Decreasing the dose by one dosing step should be considered if there is a rapid increase in haemoglobin (>2g/dlover 4weeks).
Croatian: U slučaju brzog porasta hemoglobina (> 2 g/dl tijekom 4 tjedna) potrebno je razmotriti smanjenje doze za jedan dozni korak.
English: Reticulocyte count increase < 40 000/μl and Hb increase < 1 g/dl
Croatian: < 40.000/µL i hemoglobina < 1 g/dL
English: The starting dose may be adjusted by your doctor depending on how your anaemia responds to treatment; you will usually receive Silapo until 1 month after the end of chemotherapy.
Croatian: Liječnik može prilagoditi početnu dozu ovisno o odgovoru anemije na liječenje.
English: Convulsion
Croatian: Predoziranje
English: It should never be injected into a vein.
Croatian: Nikada se ne smije ubrizgavati u venu.
English: The injection should be carried out shortly before or after a meal or snack.
Croatian: Injekciju treba dati neposredno prije ili nakon obroka ili užine.
English: Increlex mecasermin
Croatian: Increlex mekasermin
English: Increlex has been authorised under ‘Exceptional Circumstances'.
Croatian: Increlex je odobren u „iznimnim okolnostima”.
English: Because the disease is rare, many of the children were included in more than one of the studies.
Croatian: Budući da je bolest rijetka, mnoga od te djece bila su uključena u više od jednog ispitivanja.
English: Treatment should be interrupted if the patient cannot eat for any reason.
Croatian: Terapiju trena prekinuti ako bolesnik ne može jesti iz nekog razloga.
English: The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
Croatian: Ispitivanja su trajala između 15 mjeseci i osam godina, a glavna mjera djelotvornosti bila je brzina rasta.
English: This summary was last updated in 05-2015.
Croatian: Sažetak je posljednji put ažuriran u 05. 2015.
English: IGF-1 is important in determining how tall a child grows.
Croatian: IGH-1 je važan za utvrđivanje kako će dijete rasti.
English: Increlex must not be used in premature babies or newborns.
Croatian: Increlex se ne smije koristiti u prerano rođenih beba ili u novorođenčadi.
English: Increlex caused the speed of growth to increase.
Croatian: Increlex je uzrokovao povećanje brzine rasta.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Increlex on 3 August 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Increlex na snazi u Europskoj uniji od 3. kolovoza 2007.
English: Some of the studies also included children who had defects in the gene for growth hormone (GH) and who had developed antibodies against GH.
Croatian: Pojedina ispitivanja uključila su također djecu koja su imala nedostatke u genu hormona rasta (GH) te koji su razvili protutijela protiv GH.
English: Increlex is given by injection under the skin, and the injection site should be changed with each injection.
Croatian: Increlex se primjenjuje injekcijom pod kožu, a mjesto injekcije treba mijenjati prilikom svake injekcije.
English: When the results of the studies were looked at together, the average growth rate was 2.8 cm per year before treatment.
Croatian: Kada su se rezultati ispitivanja zajedno promatrali, prosječna brzina rasta iznosila je 2,8 cm na godinu prije terapije.
English: Increlex has been studied in five studies involving a total of 76 children aged between one and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
Croatian: Increlex je ispitan u pet ispitivanja koja su obuhvatila ukupno 76 djece u dobi između jedne godine i 15 godina s teškim oblikom primarne deficijencije IGF-1, od kojih je devetoro primilo drugi tip rekombinatne IGF-1 prije nego što su se pridružili ovim ispitivanjima.
English: This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
Croatian: Ovo je povećano na 8,0 cm u prvoj godini terapije i na 5,8 cm u drugoj godini.
English: The company will also supply dose calculators to help doctors and patients (or their carers) to work out the appropriate dose.
Croatian: Tvrtka će također dostaviti kalkulator za dozu kako bi se pomoglo liječnicima i bolesnicima (ili njihovim pružateljima skrbi) da izračunaju primjerenu dozu.
English: Increlex works in the same way as natural IGF-1, replacing the missing hormone and helping the child to grow taller.
Croatian: Increlex djeluje na isti način kao prirodni IGHF-, zamjenjujući hormon koji nedostaje i pomažući djetetu da naraste.
English: What measures are being taken to ensure the safe and effective use of Increlex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Increlex?
English: The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Croatian: Preporučena početna doza iznosi 0,04 mg po kilogramu tjelesne težine dva puta na dan.