FrancophonIA/ELRC3.0 huggingface dataset:
English: Silapo is a biosimilar medicinal product.
Croatian: Silapo je biosličan lijek.
English: Treatment of adult patients with low- or intermediate-1-risk MDS
Croatian: Liječenje odraslih bolesnika s mijelodisplastičnim sindromom niskog ili srednjeg-1 rizika
English: Adverse Reaction (Preferred Term Level)
Croatian: Nuspojava (preporučeni pojam)
English: If the haemoglobin has increased by at least 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40 000 cells/µl above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
Croatian: Ukoliko se nakon 4 tjedna liječenja hemoglobin poveća za najmanje 1 g/dl (0,62 mmol/l) ili se broj retikulocita poveća na ≥40 000 stanica/µl iznad početne vrijednosti, treba nastaviti s primjenom doze od 150 IU/kg 3 puta tjedno ili 450 IU/kg jedanput tjedno.
English: 6.6 Special precautions for disposal and other handling
Croatian: Posebne mjere za zbrinjavanje i druga rukovanja lijekom
English: If the haemoglobin increase is < 1 g/dl (< 0.62 mmol/l) and the reticulocyte count has increased < 40 000 cells/µl above baseline, increase the dose to 300 IU/kg 3 times per week.
Croatian: Ukoliko se hemoglobin poveća za <1 g/dl (<0,62 mmol/l) ili se broj retikulocita poveća za <40 000 stanica/µl, treba povećati dozu na 300 IU/kg 3 puta tjedno.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment (see section 4.4).
Croatian: Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne (vidjeti dio 4.4.).
English: INSTRUCTIONS ON USE
Croatian: Upute o primjeni
English: Maintenance dose between
Croatian: Doza održavanja između 25 i
English: ≤2 RBC Units ˃2 and ≤4 RBC Units ˃4 RBC Units No one subject did not have sEPO data in the ≥200 mU/ml stratum there were 13 subjects in the epoetin alfa group and 6 subjects in the placebo group
Croatian: Ne jedan ispitanik nije imao podatke za sEPO u sloju s vrijednostima ≥ 200 mU/ml 13 ispitanika bilo je u skupini koja je primala epoetin alfa, a 6 ispitanika u skupini koja je primala placebo
English: Adult patients with low- or intermediate-1-risk MDS
Croatian: Odrasli bolesnici s mijelodisplastičnim sindromom niskog ili srednjeg-1 rizika
English: In cancer patients receiving chemotherapy, the 2-3 week delay between erythropoietin administration and the appearance of erythropoietin-induced red cells should be taken into account when assessing if Silapo therapy is appropriate (patient at risk of being transfused).
Croatian: U procijeni prikladnosti terapije Silapom (pacijenti pod rizikom od transfuzije) kod pacijenata s malignim bolestima koji primaju kemoterapiju, treba voditi računa o kašnjenju od 2-3 tjedna između primjene eritropoetina i pojave crvenih krvnih stanica potaknutih eritropoetinom.
English: Adult patients on haemodialysis
Croatian: Odrasli pacijenti na hemodijalizi
English: Silapo should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl (6.2 mmol/l).
Croatian: Silapo treba primijeniti supkutanim putem pacijentima s anemijom (npr. koncentracija hemoglobina ≤10 g/dl (6,2 mmol/l).
English: Silapo should be withheld when the haemoglobin concentration exceeds 12 g/dl (7.5 mmol/l).
Croatian: Primjenu Silapa treba prekinuti kada koncentracija hemoglobina premaši 12 g/dl (7,5 mmol/l).
English: The solution contains 40 000 IU Epoetin zeta per ml.
Croatian: Otopina sadrži 40 000 IU epoetina zeta po ml.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane hiperkalijemija manje često
English: Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Croatian: Prijavljeni su ozbiljni kožni osipi, uključujući Stevens-Johnsonov sindrom i toksičnu epidermalnu nekrolizu, povezani s liječenjem epoetinom.
English: Silapo should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤10 g/dl (6.2 mmol/l)).
Croatian: Silapo se primjenjuje u bolesnika sa simptomatskom anemijom (npr. koncentracija hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
English: Increases in blood potassium have happened in isolated cases.
Croatian: U izoliranim slučajevima došlo je do povećanja kalija u krvi.
English: You may be given iron supplements before and during Silapo treatment to make it more effective.
Croatian: Možda ćete dobivati preparate sa željezom prije ili za vrijeme liječenja Silapom kako bi se poboljšao učinak liječenja.
English: The solution contains 10 000 IU Epoetin zeta per ml.
Croatian: Otopina sadrži 10 000 IU epoetina zeta po ml.
English: Silapo contains sodium
Croatian: Silapo sadrži natrij
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Croatian: Prijavljene su ozbiljne kožne reakcije, uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom.
English: • Cough
Croatian: • kašalj
English: Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Croatian: Potrebno je prilagoditi dozu i intervale doziranja radi održavanja vrijednosti hemoglobina (Hb) na željenoj razini: Hb između 10 i 12 g/dl (6,2-7,5 mmol/l).
English: No evidence exists that indicates an interaction between epoetin alfa and G-CSF or GM-CSF with regard to haematological differentiation or proliferation of tumour biopsy specimens in vitro.
Croatian: Granulocyte Macrophage Colony-Stimulating Factor) u odnosu na hematološku diferencijaciju ili in vitro proliferaciju uzoraka tumora uzetih biopsijom.
English: Correction phase: Starting dose of 50 IU/kg 2 times per week.
Croatian: Liječenje je podijeljeno u dvije faze: Faza korekcije: 50 IU/kg 3 puta na tjedan.
English: If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of Silapo, treatment with Silapo must not be restarted in this patient at any time.
Croatian: U slučaju da se zbog primjene Silapo u bolesnika pojave teške kožne reakcije kao što su StevensJohnsonov sindrom ili toksična epidermalna nekroliza, ni u jednom trenutku ne smije se ponovno započeti liječenje tog bolesnika lijekom Silapo.
English: Maintenance phase: Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Croatian: Faza održavanja: Prilagodba doze radi održanja vrijednosti hemoglobina (Hb) na željenoj razini, između 10 i 12 g/dl (6,2-7,5 mmol/l).
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Croatian: Popis pomoćnih tvari natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat natrijev klorid kalcijev klorid dihidrat polisorbat 20 glicin leucin izoleucin treonin glutaminska kiselina fenilalanin voda za injekcije natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: Common: may affect up to 1 in 10 people
Croatian: Često: mogu se javiti u manje od 1 na 10 osoba.
English: Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Croatian: Kod kirurških pacijenata s kardiovaskularnim bolestima mogu se pojaviti trombotički ili vaskularni događaji nakon ponovljene flebotomije, neovisno o liječenju eritropoetinom.
English: Major elective orthopaedic surgery
Croatian: Veliki elektivni ortopedski kirurški zahvat
English: All other causes of anaemia (iron deficiency, haemolysis, blood loss, vitamin B12- or folate deficiencies) should be considered and treated prior to initiating and during therapy with Silapo.
Croatian: Prije početka ili za vrijeme terapije Silapom potrebno je razmotriti i liječiti sve druge uzroke anemija (zbog nedostatka željeza, hemolize, gubitka krvi, nedostatka vitamina B12 ili folata).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe
Croatian: Silapo 1 000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki Silapo 2 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Silapo 3 000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki Silapo 4 000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki Silapo 5 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Silapo 6 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Silapo 8 000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki Silapo 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Silapo 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Silapo 30 000 IU/0,75 ml otopina za injekciju u napunjenoj štrcaljki Silapo 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje često: mogu se javiti u manje od 1 na 100 osoba.
English: 1 pre-filled syringe contains 8 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 8 000 IU epoetina zeta
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 8 000 IU/0,8 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe contains 5 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 5 000 IU epoetina zeta
English: 3H-thymidine incorporation in the erythroid nucleated spleen cells has been found in vitro (mouse spleen cell culture) after incubation with erythropoietin.
Croatian: 3H-timidina u eritroidne stanice slezene nakon inkubacije eritropoetinom.
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Croatian: Variranje hemoglobina treba tretirati kroz ispravno doziranje, uzimajući u obzir ciljni raspon hemoglobina od 10 g/dl (6,2 mmol/l) do 12 g/dl (7,5 mmol/l).
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija, bol u kosti, mialgija, bol u ekstremitetu često
English: Leucine
Croatian: • proljev
English: Changing from injecting into a vein to injecting under the skin (from intravenous into subcutaneous injection)
Croatian: Promjena od iniciranja u venu u injiciranje pod kožu (od intravenske u supkutanu injekciju) Jedanput kad je postignuta kontrola vašeg stanja primat ćete uobičajene doze Silapa.
English: Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13 933 patients) and for the cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and 10 441 patients).
Croatian: Meta-analizom podataka o ukupnom preživljenju dobiven je omjer rizika od 1,06 u korist kontrolne skupine (95% CI:1,00, 1,12; 53 ispitivanja i 13 933 pacijenata).
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 30 000 IU/0,75 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe of 0.75 ml solution for injection 4 pre-filled syringes of 0.75 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,75 ml otopine za injekciju 4 napunjenih štrcaljki s 0,75 ml otopine za injekciju
English: Use in kidney disease patients
Croatian: Primjena kod pacijenata s bolestima bubrega
English: Patients scheduled for major elective orthopaedic surgery
Croatian: Bolesnici koji će biti podvrgnuti velikim elektivnim ortopedskim kirurškim zahvatima
English: Alternatively, Silapo can be administered at an initial dose of 450 IU/kg subcutaneously once weekly.
Croatian: Druga mogućnost je primijeniti Silapo jedanput tjedno supkutano u početnoj dozi od 450 IU/kg.
English: Chills, Influenza like illness, Injection site reaction, Oedema peripheral
Croatian: Opći poremećaji i reakcije na mjestu primjene pireksija vrlo često zimica, bolest nalik gripi, reakcija na mjestu primjene, periferni edem često neučinkovitost lijeka nepoznato
English: 1 pre-filled syringe contains 20 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 20 000 IU epoetina zeta
English: Chronic renal failure patients
Croatian: Pacijenti s kroničnim zatajenjem bubrega
English: 1 pre-filled syringe contains 6 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 6 000 IU epoetina zeta
English: Serum electrolytes (substances in your blood) should be monitored in chronic renal failure patients.
Croatian: Kod pacijenata s kroničnim zatajenjem bubrega potrebno je kontrolirati elektrolite u serumu (tvari u krvi).
English: Cytotoxic actions of erythropoietin on bone marrow cells could not be detected.
Croatian: Nije primijećen citotoksični učinak eritropoetina na koštanu srž.
English: Silapo should be given after the patient has received a dialysis session.
Croatian: Silapo treba dati nakon završetka postupka dijalize.
English: In clinical trials, an increased risk of death, serious cardiovascular events or cerebrovascular events including stroke were observed when ESAs were administered to target a haemoglobin of greater than 12 g/dl (7.5 mmol/l).
Croatian: Kod pacijenata s kroničnim zatajenjem bubrega, održavana koncentracija hemoglobina ne bi trebala prijeći gornju granicu ciljne koncentracije hemoglobina preporučene u odjeljku 4.2. U kliničkim ispitivanjima primijećen je povećan rizik od smrti, teških kardiovaskularnih ili cerebrovaskularnih događaja uključujući inzult, ako su ESA lijekovi primijenjeni za postizanje ciljnog hemoglobina većeg od 12 g/dl (7,5 mmol/l).
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/432/013
Croatian: Silapo 8 000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/013
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 0.8 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 8 000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki 0,8 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 30 000 IU/0.75 ml solution for injection in pre-filled syringe 0.75 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 30 000 IU/0,75 ml otopina za injekciju u napunjenoj štrcaljki 0,75 ml otopine za injekciju u napunjenoj štrcaljki, staklo tipa I, s pričvršćenom čeličnom iglom za injiciranje i čepom klipa obloženim politetrafluoroetilenom (PTFE-om).
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Croatian: Za vrijeme liječenja eritropoetinom može doći do umjerenog, o dozi ovisnog, porasta broja trombocita unutar normalnog raspona.
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 5 000 IU/0,5 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe contains 10 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 10 000 IU epoetina zeta
English: 1 pre-filled syringe contains 40 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 40 000 IU epoetina zeta
English: Excipient with known effect Each pre-filled syringe contains 0.38 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,38 mg fenilalanina.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Croatian: Prijavljene su teške kožne nuspojave (SCAR), uključujući Stevens-Johnsonov sindrom (SJS) i toksičnu epidermalnu nekrolizu (TEN), povezane s liječenjem epoetinom, koje mogu biti opasne po život ili smrtonosne.
English: Patients who develop Pure Red Cell Aplasia (PRCA) following treatment with any erythropoietin must not receive Silapo or any other erythropoietin (see section 4.4).
Croatian: - Pacijenti koji nakon liječenja bilo kojim eritropoetinom razviju čistu aplaziju crvenih stanica (eng.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Croatian: Silapo 8 000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,8 ml otopine za injekciju sadrži 8 000 internacionalnih jedinica (IU) epoetina zeta (rekombinantni humani eritropoetin).
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Croatian: Silapo 8 000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki 1 napunjena štrcaljka s 0,8 ml otopine za injekciju sadrži 8 000 internacionalnih jedinica (IU) epoetina zeta* (rekombinantni humani eritropoetin).
English: 1 pre-filled syringe of 1 ml solution for injection 4 pre-filled syringes of 1 ml solution for injection
Croatian: 1 napunjena štrcaljka s 1 ml otopine za injekciju 4 napunjenih štrcaljki s 1 ml otopine za injekciju
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/009
Croatian: Silapo 5 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/009
English: Frequency
Croatian: Raspon
English: 1 pre-filled syringe contains 30 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 30 000 IU epoetina zeta
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/011
Croatian: Silapo 6 000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/011
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 4 000 IU/0,4 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/019
Croatian: Silapo 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/019
English: Silapo 5 000 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 5 000 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: Silapo 8 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 8 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe EU/1/07/432/018
Croatian: Silapo 30 000 IU/0,75 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/018
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe EU/1/07/432/005
Croatian: Silapo 3 000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/005
English: Silapo 5 000 IU Injection Epoetin zeta iv/sc use
Croatian: Silapo 5 000 IU injekcija epoetin zeta i.v./s.c. primjena
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 6 000 IU/0,6 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe of 1 ml solution for injection 6 pre-filled syringes of 1 ml solution for injection
Croatian: 1 napunjena štrcaljka s 1 ml otopine za injekciju 6 napunjenih štrcaljki s 1 ml otopine za injekciju
English: 1 pre-filled syringe contains 4 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 4 000 IU epoetina zeta
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 0.4 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 4 000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki 0,4 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 40 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 40 000 IU/1 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe of 0.9 ml solution for injection 6 pre-filled syringes of 0.9 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,9 ml otopine za injekciju 6 napunjenih štrcaljki s 0,9 ml otopine za injekciju
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 3 000 IU/0,9 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: 1 pre-filled syringe of 0.5 ml solution for injection 4 pre-filled syringes of 0.5 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,5 ml otopine za injekciju 4 napunjenih štrcaljki s 0,5 ml otopine za injekciju
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 20 000 IU/0,5 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe EU/1/07/432/007
Croatian: Silapo 4 000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/007
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/017
Croatian: Silapo 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/432/017
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 0.9 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 3 000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki 0,9 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 3 000 IU Epoetin zeta
Croatian: 1 napunjena štrcaljka sadrži 3 000 IU epoetina zeta
English: Excipient with known effect Each pre-filled syringe contains 0.20 mg phenylalanine.
Croatian: Pomoćna tvar s poznatim učinkom Jedna napunjena štrcaljka sadrži 0,20 mg fenilalanina.
English: 1 pre-filled syringe of 0.8 ml solution for injection 6 pre-filled syringes of 0.8 ml solution for injection
Croatian: 1 napunjena štrcaljka s 0,8 ml otopine za injekciju 6 napunjenih štrcaljki s 0,8 ml otopine za injekciju
English: Pure red cell aplasia Thrombocythemia
Croatian: Poremećaji krvi i limfnog sustava čista aplazija crvenih krvnih stanica rijetko trombocitemija
English: Depending on how the anaemia responds, the dose may be adjusted approximately every 4 weeks until the condition is controlled.
Croatian: Doza se može prilagođavati približno svaka 4 tjedna ovisno o odgovoru anemije na liječenje sve dok se ne postigne kontrola stanja
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Croatian: Silapo 10 000 IU/1 ml, otopina za injekciju u napunjenoj štrcaljki epoetin zeta