natgillin/translations-raw huggingface dataset:
6 pre-filled syringes with safety needle containing 0.5 ml.
6 napunjenih štrcaljki sa sigurnosnom iglom koje sadrže 0,5 ml.
How to store Biopoin
Kako čuvati Biopoin
Do not use this medicine if you notice it is cloudy or there are particles in it. Do not throw away any medicines via wastewater or household waste.
Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
Biopoin 10,000 IU/1 ml: One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml.
Biopoin 10 000 IU/1 ml: Jedna napunjena štrcaljka sadrži 10 000 internacionalnih jedinica (IU) (83,3 mikrograma) epoetina theta u 1 ml otopine za injekciju što odgovara 10 000 internacionalnih jedinica (IU) (83,3 mikrograma) po ml.
4 pre-filled syringes containing 1 ml.
4 napunjenih štrcaljki koje sadrže 1 ml.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 30,000 international units (IU) (250 µg) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 µg) epoetin theta per ml.
Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 30 000 internacionalnih jedinica (IU) (250 μg) epoetina theta u 1 ml otopine za injekciju, što odgovara 30 000 IU (250 μg) epoetina theta po ml.
One pre-filled syringe contains 10,000 international units (IU) (83.3 micrograms) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 10 000 internacionalnih jedinica (IU) (83,3 mikrograma) epoetina theta u 1 ml otopine za injekciju, što odgovara 10 000 IU (83,3 mikrograma) epoetina theta po ml.
One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 5000 internacionalnih jedinica (IU) (41,7 mikorgrama) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 10 000 IU (83,3 mikrograma) epoetina theta po ml.
1 pre-filled syringe containing 1 ml.
1 napunjena štrcaljka koja sadrži 1 ml.
One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 3000 internacionalnih jedinica (IU) (25 mikrograma) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 6000 IU (50 mikrograma) epoetina theta po ml.
EU/1/09/565/023 1 pre-filled syringe EU/1/09/565/024 1 pre-filled syringe with safety device EU/1/09/565/025 4 pre-filled syringes EU/1/09/565/026 4 pre-filled syringes with safety device EU/1/09/565/027 6 pre-filled syringes EU/1/09/565/028 6 pre-filled syringes with safety device EU/1/09/565/040 1 pre-filled syringe with safety needle EU/1/09/565/041 4 pre-filled syringes with safety needle EU/1/09/565/042 6 pre-filled syringes with safety needle
EU/1/09/565/023 1 napunjena štrcaljka EU/1/09/565/024 1 napunjena štrcaljka sa sigurnosnom napravom EU/1/09/565/025 4 napunjenih štrcaljki EU/1/09/565/026 4 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/027 6 napunjenih štrcaljki EU/1/09/565/028 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/040 1 napunjena štrcaljka sa sigurnosnom iglom EU/1/09/565/041 4 napunjene štrcaljke sa sigurnosnom iglom EU/1/09/565/042 6 napunjenih štrcaljki sa sigurnosnom iglom
6 pre-filled syringes with safety device containing 0.5 ml.
6 napunjenih štrcaljki sa sigurnosnom napravom koje sadrže 0,5 ml.
One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 4000 internacionalnih jedinica (IU) (33,3 mikrograma) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 8000 IU (66,7 mikrograma) epoetina theta po ml.
Not known in patients with chronic renal failure (frequency cannot be estimated from the available data) - Cases of a condition called pure red cell aplasia (PRCA) have been reported.
Nepoznato u bolesnika s kroničnim zatajenjem bubrega (učestalost se ne može procijeniti iz dostupnih podataka)
The most suitable places to inject yourself are: - the top of your thighs, - the abdomen, except for the area around the navel (see grey areas in picture 5).
- trbuh, osim područja oko pupka (vidjeti siva područja na slici 5).
Table 1: Adverse reactions System organ class
Tablica 1: Nuspojave
Subcutaneous administration: The initial posology is 20 IU/kg body weight 3 times per week.
Supkutana primjena: Početna doza je 20 IU/kg tjelesne težine, 3 puta tjedno.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 20,000 international units (IU) (166.7 µg) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 µg) epoetin theta per ml.
Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 20 000 internacionalnih jedinica (IU) (166,7 μg) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 20 000 IU (166,7 μg) epoetina theta po ml.
The most suitable places to inject yourself are: - the top of your thighs, - the abdomen, except for the area around the navel (see grey areas in picture 6).
- trbuh, osim područja oko pupka (vidjeti siva područja na slici 6).
In patients with chronic renal failure, neutralising anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) associated with epoetin theta therapy has been reported in post marketing setting.
Nakon stavljanja lijeka u promet, u bolesnika s kroničnim zatajenjem bubrega zabilježena je izolirana aplazija crvene krvne loze posredovana neutralizirajućim antieritropoetinskim antitijelima povezana s terapijom epoetinom theta.
Biopoin 1,000 IU/0.5 ml: One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 international units (IU) (16.7 micrograms) per ml.
Biopoin 1000 IU/0,5 ml: Jedna napunjena štrcaljka sadrži 1000 internacionalnih jedinica (IU) (8,3 mikrograma) epoetina theta u 0,5 ml otopine za injekciju što odgovara 2000 internacionalnih jedinica (IU) (16,7 mikrograma) po ml.
One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 2000 internacionalnih jedinica (IU) (16,7 mikrograma) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 4000 IU (33,3 mikograma) epoetina theta po ml.
Contents of the pack and other information 7.
Sadržaj pakiranja i druge informacije Informacije za samoprimjenu injekcije
One pre-filled syringe contains 1,000 international units (IU) (8.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 micrograms) epoetin theta per ml.
Jedna napunjena štrcaljka sadrži 1000 internacionalnih jedinica (IU) (8,3 mikrograma) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 2000 IU (16,7 mikrograma) epoetina theta po ml.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe One pre-filled syringe contains 10,000 international units (IU) (83.3 µg) epoetin theta in 1 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 10 000 internacionalnih jedinica (IU) (83,3 μg) epoetina theta u 1 ml otopine za injekciju, što odgovara 10 000 IU (83,3 μg) epoetina theta po ml.
Biopoin 5,000 IU/0.5 ml: One pre-filled syringe contains 5,000 international units (IU) (41.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 international units (IU) (83.3 micrograms) per ml..
Biopoin 5000 IU/0,5 ml: Jedna napunjena štrcaljka sadrži 5.000 internacionalnih jedinica (IU) (41,7 mikrograma) epoetina theta u 0,5 ml otopine za injekciju što odgovara 10 000 internacionalnih jedinica (IU) (83,3 mikrograma) po ml.
Biopoin 3,000 IU/0.5 ml: One pre-filled syringe contains 3,000 international units (IU) (25 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 international units (IU) (50 micrograms) per ml.
Biopoin 3000 IU/0,5 ml: Jedna napunjena štrcaljka sadrži 3000 internacionalnih jedinica (IU) (25 mikrograma) epoetina theta u 0,5 ml otopine za injekciju što odgovara 6000 internacionalnih jedinica (IU) (50 mikrograma) po ml.
Biopoin 4,000 IU/0.5 ml: One pre-filled syringe contains 4,000 international units (IU) (33.3 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 international units (IU) (66.7 micrograms) per ml.
Biopoin 4000 IU/0,5 ml: Jedna napunjena štrcaljka sadrži 4000 internacionalnih jedinica (IU) (33,3 mikrograma) epoetina theta u 0,5 ml otopine za injekciju što odgovara 8000 internacionalnih jedinica (IU) (66,7 mikrograma) po ml.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/023
Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/023
Biopoin 2,000 IU/0.5 ml: One pre-filled syringe contains 2,000 international units (IU) (16.7 micrograms) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 international units (IU) (33.3 micrograms) per ml.
Biopoin 2000 IU/0,5 ml: Jedna napunjena štrcaljka sadrži 2000 internacionalnih jedinica (IU) (16,7 mikrograma) epoetina theta u 0,5 ml otopine za injekciju što odgovara 4000 internacionalnih jedinica (IU) (33,3 mikrograma) po ml.
The angle between the syringe and skin should not be too narrow (at least 45°, see picture 9).
Kut između štrcaljke i kože ne smije biti preuzak (najmanje 45°,
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/017
Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/017
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 4,000 international units (IU) (33.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 8,000 IU (66.7 µg) epoetin theta per ml.
Biopoin 4000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 4000 internacionalnih jedinica (IU) (33,3 μg) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 8000 IU (66,7 μg) epoetina theta po ml.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 5,000 international units (IU) (41.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 10,000 IU (83.3 µg) epoetin theta per ml.
Biopoin 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 5000 internacionalnih jedinica (IU) (41,7 μg) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 10 000 IU (83,3 μg) epoetina theta po ml.
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 3,000 international units (IU) (25 µg) epoetin theta in 0.5 ml solution for injection corresponding to 6,000 IU (50 µg) epoetin theta per ml.
Biopoin 3000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 3000 internacionalnih jedinica (IU) (25 μg) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 6000 IU (50 μg) epoetina theta po ml.
In patients with chronic renal failure, the maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
U bolesnika s kroničnim zatajenjem bubrega, održavana vrijednost koncentracije hemoglobina ne smije prijeći gornju granicu ciljne koncentracije hemoglobina preporučene u dijelu 4.2 U kliničkim ispitivanjima povećani rizik od smrti i ozbiljnih kardiovaskularnih događaja zabilježen je tijekom primjene epoetina za postizanje razina hemoglobina viših od 12 g/dl (7,45 mmol/l).
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 2,000 international units (IU) (16.7 µg) epoetin theta in 0.5 ml solution for injection corresponding to 4,000 IU (33.3 µg) epoetin theta per ml.
Biopoin 2000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka sadrži 2000 internacionalnih jedinica (IU) (16,7 μg) epoetina theta u 0,5 ml otopine za injekciju, što odgovara 4000 IU (33,3 μg) epoetina theta po ml.
Only use each syringe for one injection.
Za svaku primjenu koristite drugu štrcaljku.
Pure red cell aplasia (PRCA)
Izolirana aplazija crvene krvne loze
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 30 mjeseci
Biopoin 20,000 IU/1 ml injection Epoetin theta
Biopoin 20 000 IU/1 ml injekcija epoetin theta s.c. i.v.
1 pre-filled syringe with safety device containing 1 ml.
1 napunjena štrcaljka sa sigurnosnom napravom koja sadrži 1 ml.
Pull straight as shown in picture 4.
Povucite ravno kao što je prikazano na slici 4. Igla je okružena štitnikom za iglu koji se uvlači.
Do not pick up the pre-filled syringe by the plunger or tip cap.
Kad vadite napunjenu štrcaljku iz blistera nemojte je držati za klip ili zatvarač vrha.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 30 mjeseci
1 pre-filled syringe with safety needle containing 1 ml.
1 napunjena štrcaljka sa sigurnosnom iglom koja sadrži 1 ml.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/011
Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/011
6 pre-filled syringes with safety needle containing 1 ml.
6 napunjenih štrcaljki sa sigurnosnom iglom koje sadrže 1 ml.
Anaemia in cancer patients
Anemija u bolesnika sa zloćudnom bolesti
Biopoin 10,000 IU/1 ml injection Epoetin theta
Biopoin 10 000 IU/1 ml injekcija epoetin theta s.c. i.v.
Polysorbate 20
Dornierstraße 10
Biopoin 5,000 IU/0.5 ml injection Epoetin theta
Biopoin 5000 IU/0,5 ml injekcija epoetin theta s.c. i.v.
4 pre-filled syringes with safety device containing 1 ml.
4 napunjenih štrcaljki sa sigurnosnom napravom koje sadrže 1 ml.
6 pre-filled syringes with safety device containing 1 ml.
6 napunjenih štrcaljki sa sigurnosnom napravom koje sadrže 1 ml.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki 30 mjeseci
4 pre-filled syringes with safety needle containing 1 ml.
4 napunjene štrcaljke sa sigurnosnom iglom koje sadrže 1 ml.
Biopoin 30,000 IU/1 ml injection Epoetin theta
Biopoin 30 000 IU/1 ml injekcija epoetin theta s.c. i.v.
Symptomatic anaemia associated with chronic renal failure 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.
Simptomi i posljedice anemije mogu varirati s obzirom na dob, spol i sveukupnu težinu bolesti;
EU/1/09/565/004 6 pre-filled syringes with safety device EU/1/09/565/030 6 pre-filled syringes with safety needle
EU/1/09/565/003 6 napunjenih štrcaljki EU/1/09/565/004 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/030 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/007
Biopoin 4000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/007
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 20 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
EU/1/09/565/002 6 pre-filled syringes with safety device EU/1/09/565/029 6 pre-filled syringes with safety needle
EU/1/09/565/001 6 napunjenih štrcaljki EU/1/09/565/002 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/029 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 4,000 IU/0.5 ml injection Epoetin theta
Biopoin 4000 IU/0,5 ml injekcija epoetin theta s.c. i.v.
Biopoin 1,000 IU/0.5 ml injection Epoetin theta
Biopoin 1000 IU/0,5 ml injekcija epoetin theta s.c. i.v.
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 2 godine
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 4000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 2 godine
Biopoin 3,000 IU/0.5 ml injection Epoetin theta
Biopoin 3000 IU/0,5 ml injekcija epoetin theta s.c. i.v.
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki
Adverse reaction
Supkutana primjena
EU/1/09/565/010 6 pre-filled syringes with safety device EU/1/09/565/033 6 pre-filled syringes with safety needle
EU/1/09/565/009 6 napunjenih štrcaljki EU/1/09/565/010 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/033 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 10 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/009
Biopoin 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/009
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
Biopoin 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 0,5 ml otopine u napunjenoj štrcaljki (staklo tip I) sa zatvaračem vrha (bromobutil guma), čepom klipa (teflonizirana klorobutil guma) i injekcijskom iglom (nehrđajući čelik) ili injekcijskom iglom
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/005
Biopoin 3000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/005
EU/1/09/565/006 6 pre-filled syringes with safety device EU/1/09/565/031 6 pre-filled syringes with safety needle
EU/1/09/565/005 6 napunjenih štrcaljki EU/1/09/565/006 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/031 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 30 000 IU/1 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 4000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
EU/1/09/565/008 6 pre-filled syringes with safety device EU/1/09/565/032 6 pre-filled syringes with safety needle
EU/1/09/565/007 6 napunjenih štrcaljki EU/1/09/565/008 6 napunjenih štrcaljki sa sigurnosnom napravom EU/1/09/565/032 6 napunjenih štrcaljki sa sigurnosnom iglom
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/003
Biopoin 2000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/003
See also section 2.
vidjeti sliku 9).
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 5000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 3000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 2 godine
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe 2 years
Biopoin 2000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki 2 godine
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe 1 ml solution in a pre-filled syringe (type I glass) with a tip cap (bromobutyl rubber), a plunger stopper (teflonised chlorobutyl rubber) and an injection needle (stainless steel) or an injection needle (stainless steel) with a safety shield (safety needle) or an injection needle (stainless steel) with a safety device.
1 ml otopine u napunjenoj štrcaljki (staklo tip I) sa zatvaračem vrha (bromobutil guma), čepom klipa (teflonizirana klorobutil guma) i injekcijskom iglom (nehrđajući čelik) ili injekcijskom iglom (nehrđajući čelik) sa sigurnosnim štitnikom (sigurnosna igla) ili injekcijskom iglom (nehrđajući čelik)
Biopoin 2,000 IU/0.5 ml injection Epoetin theta
Biopoin 2000 IU/0,5 ml injekcija epoetin theta s.c. i.v.
Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 2000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 3000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki epoetin theta
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/001
Biopoin 1000 IU/0,5 ml otopina za injekciju u napunjenoj štrcaljki EU/1/09/565/001
How you should inject yourself
Kako primijeniti injekciju
It needs to be treated at once.
To zahtijeva neodgodivo liječenje.
Batch
Nuspojava
Hydrochloric acid (6 M) (for pH adjustment) Water for injections
6.1 Popis pomoćnih tvari natrijev dihidrogenfosfat dihidrat natrijev klorid polisorbat 20 trometamol kloridna kiselina (6 M) (za podešavanje pH) voda za injekcije
Do not touch the needle or push the plunger.
Povucite ravno kao što je prikazano na slici 5. Ne smijete dodirivati iglu ili gurati klip.
If the patient has developed a severe cutaneous skin reaction such as SJS or TEN due to the use of epoetin theta, treatment with epoetin theta must not be restarted in this patient at any time.
Stevens-Johnsonov sindrom ili toksična epidermalna nekroliza, ni u jednom trenutku ne smije se ponovno započeti liječenje tog bolesnika lijekom epoetin theta.
Pooled post-hoc analyses of clinical studies of epoetins have been performed in chronic renal failure patients (on dialysis, not on dialysis, in diabetic and non-diabetic patients).
U bolesnika s kroničnim zatajenjem bubrega (koji su na dijalizi, koji nisu na dijalizi, koji imaju ili nemaju dijabetes) provedene su post-hoc analize objedinjenih podataka iz kliničkih ispitivanja epoetina.
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This is expected and may last for a few months.
Ovo je očekivano i može trajati nekoliko mjeseci.
Each pack contains one bottle.
Jedno pakiranje sadrži jednu bocu.
• if you have ever had or might now have a hepatitis B infection.
• ako ste ikada imali ili možda sada imate infekciju hepatitisom B.
• Tell your doctor immediately if you become pregnant.
• Odmah obavijestite liječnika ako zatrudnite.
Repeat CT scans required to confirm response.
Ponovljeni CT skenovi radi potvrde odgovora.
Do not stop taking this medicine unless your doctor tells you.
Nemojte prestati uzimati ovaj lijek osim ako Vam to ne kaže Vaš liječnik.
Your doctor may adjust your dose.
Liječnik Vam može prilagoditi dozu.
Some of these infections have been associated with hospitalisation and death.
Neke od navedenih infekcija bile su povezane s hospitalizacijom i smrti.
48-month follow-up
48-mjesečno praćenje
The incidence for the 5-year period was 11%.
Incidencija za 5-godišnje razdoblje iznosila je 11%.
Final Analysis at 65-month follow-up
Završna analiza u 65-mjesečnom praćenju
This means you should tell your doctor if you take other medicines that increase your risk of bleeding.
To znači da morate reći svom liječniku uzimate li druge lijekove koji povećavaju rizik od krvarenja.
Patients should be closely monitored.
Bolesnike se mora pažljivo pratiti.