FrancophonIA/ELRC3.0 huggingface dataset:
English: - For cancer patients, iron supplementation (elemental iron 200 to 300 mg/day orally) is recommended if transferrin saturation is below 20%.
Croatian: 300 mg/dan peroralno) ako je zasićenost transferina manja od 20 %.
English: 1 pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 1 ml sadrži 2000 međunarodnih jedinica (IU) što odgovara 16,8 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/009
Croatian: Epoetin alfa HEXAL 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/009
English: If signs and symptoms suggestive of these reactions appear, Epoetin alfa HEXAL should be withdrawn immediately and an alternative treatment considered.
Croatian: potrebno je odmah prekinuti primjenu Epoetin alfa HEXALa i razmisliti o zamjenskom liječenju.
English: Haemoglobin variability should be addressed through dose management, with consideration for the desired haemoglobin concentration range between 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Croatian: Variranje vrijednosti hemoglobina treba kontrolirati prilagođavanjem doze, uzimajući u obzir željeni raspon koncentracije hemoglobina između 10 g/dl (6,2 mmol/l) i 12 g/dl (7,5 mmol/l).
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 7000 IU/0,7 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: A pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 1 ml sadrži 2000 međunarodnih jedinica (IU), što odgovara 16,8 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each syringe contains 0.3 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 3000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 0,3 ml otopine za injekciju.
English: Common Respiratory tract congestion Uncommon
Croatian: prsišta i sredoprsja kašalj često kongestija dišnog sustava manje često
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe EU/1/07/411/017
Croatian: Epoetin alfa HEXAL 7000 IU/0,7 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/017
English: 1 pre-filled syringe of 0.8 mL 6 pre-filled syringes of 0.8 mL 1 pre-filled syringe of 0.8 mL with a needle safety guard 6 pre-filled syringes of 0.8 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,8 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,8 ml sa zaštitnim mehanizmom za iglu
English: 1 pre-filled syringe of 0.5 mL 6 pre-filled syringes of 0.5 mL 1 pre-filled syringe of 0.5 mL with a needle safety guard 4 pre-filled syringes of 0.5 mL with a needle safety guard 6 pre-filled syringes of 0.5 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,5 ml sa zaštitnim mehanizmom za iglu 4 napunjene štrcaljke od 0,5 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,5 ml sa zaštitnim mehanizmom za iglu
English: Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/021
Croatian: Epoetin alfa HEXAL 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/021
English: 1 pre-filled syringe of 0.3 mL contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 0,3 ml sadrži 3000 međunarodnih jedinica (IU) što odgovara 25,2 mikrograma epoetina alfa.
English: The mean CL/F for the 150 IU/kg, 3 times-per-week and 40,000 IU, once-weekly regimens in the anaemic cancer subjects were 45.8 and 11.3 mL/h/kg, respectively.
Croatian: u anemičnih onkoloških ispitanika za režim doziranja od 150 IU/kg 3 puta tjedno bila je 45,8 ml/h/kg,
English: 1 pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 1 ml sadrži 10 000 međunarodnih jedinica (IU) što odgovara 84,0 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe Each syringe contains 0.5 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 0,5 ml otopine za injekciju.
English: 1 pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 0,5 ml sadrži 1000 međunarodnih jedinica (IU) što odgovara 8,4 mikrograma epoetina alfa.
English: 1 pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 1 ml sadrži 40 000 međunarodnih jedinica (IU) što odgovara 336,0 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 7000 IU/0,7 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe Each syringe contains 0.5 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 0,5 ml otopine za injekciju.
English: A pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 0,5 ml sadrži 1000 međunarodnih jedinica (IU), što odgovara 8,4 mikrograma epoetina alfa.
English: Pregnancy
Croatian: • Napadaji
English: Adverse Reaction (Preferred Term Level)
Croatian: Nuspojava (preporučeni pojam) Učestalost
English: Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe EU/1/07/411/007
Croatian: Epoetin alfa HEXAL 4000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/007
English: A pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 1 ml sadrži 10 000 međunarodnih jedinica (IU), što odgovara 84,0 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/411/025
Croatian: Epoetin alfa HEXAL 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/025
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe EU/1/07/411/005
Croatian: Epoetin alfa HEXAL 3000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/005
English: A pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 1 ml sadrži 40 000 međunarodnih jedinica (IU), što odgovara 336,0 mikrograma epoetina alfa.
English: 1 pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 0,75 ml sadrži 30 000 međunarodnih jedinica (IU) što odgovara 252,0 mikrograma epoetina alfa.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 1,000 IU/0.5 mL 17.
Croatian: Epoetin alfa HEXAL 1000 IU/0,5 ml
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 8000 IU/0,8 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment)
Croatian: glicin, polisorbat 80, kloridna kiselina (za podešavanje pH), natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe Each syringe contains 0.5 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 0,5 ml otopine za injekciju.
English: 1 pre-filled syringe of 0.7 mL 6 pre-filled syringes of 0.7 mL 1 pre-filled syringe of 0.7 mL with a needle safety guard 6 pre-filled syringes of 0.7 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,7 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,7 ml sa zaštitnim mehanizmom za iglu
English: Epoetin alfa HEXAL should be administered to patients with symptomatic anaemia (e.g. haemoglobin concentration ≤ 10 g/dL (6.2 mmol/L)).
Croatian: Liječenje odraslih bolesnika s MDS-om niskog ili srednjeg-1 rizika Lijek Epoetin alfa HEXAL treba primijeniti u bolesnika sa simptomatskom anemijom (npr. koncentracija hemoglobina ≤ 10 g/dl (6,2 mmol/l)).
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe Each syringe contains 1 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 40 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1 ml otopine za injekciju.
English: A pre-filled syringe of 0.3 mL contains 3,000 international units (IU) corresponding to 25.2 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 0,3 ml sadrži 3000 međunarodnih jedinica (IU), što odgovara 25,2 mikrograma epoetina alfa.
English: 1 pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa.
Croatian: 1 napunjena štrcaljka od 0,4 ml sadrži 4000 međunarodnih jedinica (IU) što odgovara 33,6 mikrograma epoetina alfa.
English: and Hb increase < 1 g/dL
Croatian: < 40 000/µl i povećanje Hb < 1 g/dl prekinuti terapiju
English: Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 4000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: In paediatric patients the recommended haemoglobin concentration range is between 9.5 g/dL to 11 g/dL (5.9 to 6.8 mmol/L).
Croatian: U pedijatrijskih bolesnika preporučen je raspon koncentracije hemoglobina između 9,5 g/dl i 11 g/dl
English: A pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 0,75 ml sadrži 30 000 međunarodnih jedinica (IU), što odgovara 252,0 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 3000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/411/003
Croatian: Epoetin alfa HEXAL 2000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/003
English: Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin values at the desired level: haemoglobin between 10 g/dL and 12 g/dL (6.2 to 7.5 mmol/L).
Croatian: Potrebno je napraviti odgovorajuću prilagodbu doze i intervala doziranja radi održavanja vrijednosti hemoglobina na željenoj razini: hemoglobin između 10 g/dl i 12 g/dl (6,2-7,5 mmol/l).
English: Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe Each syringe contains 1 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1 ml otopine za injekciju.
English: 1 pre-filled syringe of 1 mL 6 pre-filled syringes of 1 mL 1 pre-filled syringe of 1 mL with a needle safety guard 6 pre-filled syringes of 1 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 1 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 1 ml sa zaštitnim mehanizmom za iglu
English: Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 9000 IU/0,9 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: • breathlessness.
Croatian: • nedostatak zraka.
English: Instructions on how to inject Epoetin alfa HEXAL yourself
Croatian: Upute za samostalno injiciranje Epoetin alfa HEXALa
English: A pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa.
Croatian: Napunjena štrcaljka od 0,4 ml sadrži 4000 međunarodnih jedinica (IU), što odgovara 33,6 mikrograma epoetina alfa.
English: Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/411/015
Croatian: Epoetin alfa HEXAL 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/015
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin values at the desired level between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Croatian: Potrebno je napraviti odgovarajuću prilagodbu doze radi održavanja vrijednosti hemoglobina na željenoj razini između 10 g/dl i 12 g/dl (6,2 i 7,5 mmol/l).
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 10,000 IU/1 mL 17.
Croatian: Epoetin alfa HEXAL 10 000 IU/1 ml
English: - If the haemoglobin concentration 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: - Ako se koncentracija hemoglobina povećala za najmanje 1 g/dl (0,62 mmol/l) ili se broj retikulocita povećao za ≥ 40 000 stanica/µl iznad početne vrijednosti nakon 4 tjedna liječenja,
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe Each syringe contains 1 mL of solution for injection.
Croatian: Epoetin alfa HEXAL 2000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 1 ml otopine za injekciju.
English: Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 20 000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/001
Croatian: Epoetin alfa HEXAL 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/07/411/001
English: Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 6000 IU/0,6 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: 1 pre-filled syringe of 0.9 mL 6 pre-filled syringes of 0.9 mL 1 pre-filled syringe of 0.9 mL with a needle safety guard 6 pre-filled syringes of 0.9 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,9 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,9 ml sa zaštitnim mehanizmom za iglu
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin concentrations within the desired concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Croatian: Potrebno je napraviti odgovarajuću prilagodbu doze radi održavanja koncentracija hemoglobina unutar željenog raspona koncentracije između 10 g/dl i 12 g/dl (6,2 i 7,5 mmol/l).
English: Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 4000 IU/0,4 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: Excipients
Croatian: Oblik
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 3000 IU/0,3 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
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: Potrebno je na odgovarajući način prilagoditi dozu kako bi se održala koncentracija hemoglobina unutar ciljanog raspona 10 g/dl do 12 g/dl (6,2 do 7,5 mmol/l).
English: per week.
Croatian: najviše 3 dana.
English: Urticaria3
Croatian: PRILOG III.
English: Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe Each mL of solution contains 10,000 IU of epoetin alfa* corresponding to 84.0 micrograms per mL
Croatian: Epoetin alfa HEXAL 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedan ml otopine sadrži 10 000 IU epoetina alfa*, što odgovara 84,0 mikrograma po ml.
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin values within the desired concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Croatian: Potrebno je učiniti odgovarajuću prilagodbu doze radi održavanja vrijednosti hemoglobina unutar željenog raspona koncentracije između 10 g/dl i 12 g/dl (6,2 i 7,5 mmol/l).
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: Uncommon side effects These may affect up to 1 in 100 people.
Croatian: Mogu se javiti u do 1 na 100 osoba.
English: 1 pre-filled syringe of 0.5 mL 6 pre-filled syringes of 0.5 mL 1 pre-filled syringe of 0.5 mL with a needle safety guard 6 pre-filled syringes of 0.5 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,5 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,5 ml sa zaštitnim mehanizmom za iglu
English: Epoetin alfa HEXAL 10,000 IU/1 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: The most frequently occurring adverse drug reactions observed in clinical trials of epoetin alfa are diarrhoea, nausea, vomiting, pyrexia and headache.
Croatian: Nuspojave čije je pojavljivanje najčešće opaženo u kliničkim ispitivanjima epoetina alfa su proljev,
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe
Croatian: Epoetin alfa HEXAL 2000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki epoetin alfa
English: 1 pre-filled syringe of 0.6 mL 6 pre-filled syringes of 0.6 mL 1 pre-filled syringe of 0.6 mL with a needle safety guard 6 pre-filled syringes of 0.6 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,6 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,6 ml sa zaštitnim mehanizmom za iglu
English: 1 pre-filled syringe of 0.4 mL 6 pre-filled syringes of 0.4 mL 1 pre-filled syringe of 0.4 mL with a needle safety guard 6 pre-filled syringes of 0.4 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,4 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,4 ml sa zaštitnim mehanizmom za iglu
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva artralgija, bol u kostima, mialgija, bol u udovima često
English: 1 pre-filled syringe of 0.3 mL 6 pre-filled syringes of 0.3 mL 1 pre-filled syringe of 0.3 mL with a needle safety guard 6 pre-filled syringes of 0.3 mL with a needle safety guard
Croatian: 1 napunjena štrcaljka od 0,3 ml sa zaštitnim mehanizmom za iglu 6 napunjenih štrcaljki od 0,3 ml sa zaštitnim mehanizmom za iglu
English: Epoetin alfa HEXAL is used to treat symptomatic anaemia caused by kidney disease: • in children on haemodialysis
Croatian: Epoetin alfa HEXAL je indiciran za liječenje simptomatske anemije (koncentracija hemoglobina
English: Epoetin alfa HEXAL.
Croatian: Kako čuvati Epoetin alfa HEXAL.
English: You may still be able to use Epoetin alfa HEXAL, but discuss it with your doctor first:
Croatian: Možda ćete i dalje moći primati Epoetin alfa HEXAL, ali prvo razgovarajte o tome sa svojim liječnikom: • ako ste trudni, ili mislite da biste mogli biti trudni.
English: What Epoetin alfa HEXAL contains
Croatian: Sadržaj pakiranja i druge informacije Što Epoetin alfa HEXAL sadrži
English: A bone marrow examination should also be considered for diagnosis of PRCA.
Croatian: Potrebno je razmotriti i pretragu koštane srži zbog dijagnoze izolirane aplazije crvene loze.
English: FeLV recombinant Canarypox virus (vCP97) ≥ 10 7.2 CCID50 (cell culture infective dose)
Croatian: FeLV rekombinantni virus boginja kanarinca (vCP97) ≥ 10 7.2 CCID50 (količina virusa koja zarazi 50% stanica kulture u koju je dodan virus
English: Target Species
Croatian: Ciljna vrsta životinja
English: Packaging Content
Croatian: Način primjene Pakovanje Sadržaj
English: Package Size
Croatian: Veličina pakovanja
English: Some of these symptoms can be serious.
Croatian: Neki od ovih simptoma mogu biti ozbiljni.
English: • hair loss: in most cases normal hair growth should return.
Croatian: • gubitak kose: u većini slučajeva trebao bi se vratiti normalan rast kose.
English: • allergic reactions as described above
Croatian: • alergijske reakcije kao što je opisano gore
English: Tumour size ≤2 cm >2 cm
Croatian: Veličina tumora 2 cm >2 cm
English: However, the distribution of OS was not significantly different between the 2 groups.
Croatian: Međutim, distribucija OS nije se značajno razlikovala u te dvije skupine.
English: Other appropriate symptomatic measures should be taken, as needed.
Croatian: Prema potrebi treba poduzeti ostale odgovarajuće simptomatske mjere.
English: • change or absence of menstrual period
Croatian: • promjene ili izostanak menstruacijskog ciklusa
English: The dose will depend on your weight and your general condition.
Croatian: Doza će ovisiti o Vašoj težini i Vašem općem stanju.
English: Tell them immediately if you notice any of these effects.
Croatian: Odmah ih obavijestite ako zamijetite bilo koju od ovih nuspojava.
English: TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
Croatian: TTP = vrijeme do progresije bolesti; "ne" pokazuje da se nije moglo procijeniti ili da još nije bilo dostignuto
English: Date of latest renewal: 23 February 2017
Croatian: Datum posljednje obnove odobrenja: 23. veljače 2017.
English: Summary of the safety profile for all indications
Croatian: Sažetak sigurnosnog profila za sve indikacije
English: • low blood pressure.
Croatian: • nizak krvni tlak.
English: The events were spontaneously reversible within 3 months.
Croatian: Događaji su se spontano povukli unutar 3 mjeseca.
English: Neuro-motor events are mainly characterised by weakness.
Croatian: Neuromotorički događaji uglavnom su karakterizirani slabošću.
English: Statistical analysis
Croatian: Statistička analiza
English: Consideration should be given to possible effects on the central nervous system.
Croatian: Potrebno je voditi računa o mogućim učincima na središnji živčani sustav.
English: These reactions sometimes appear during the infusion of the medicinal product.
Croatian: Te se reakcije ponekad pojavljuju tijekom infuzije lijeka.
English: 73% of the cutaneous reactions were reversible within 21 days.
Croatian: 73% kožnih reakcija bilo je reverzibilno unutar 21 dana.