natgillin/translations-raw huggingface dataset:
Non-clinical data with other epoetins reveal no special hazard for humans based on conventional studies of genotoxicity and toxicity to reproduction.
Predklinični podatki za druge epoetine na osnovi običajnih študij genotoksičnosti in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 2,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 3,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 2000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 3000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Biopoin 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi
If the haemoglobin level continues to increase, therapy should be interrupted until the haemoglobin level begins to decrease, at which point therapy should be restarted at a dose approximately 25% below the previously administered dose.
Če se raven hemoglobina še vedno viša, je treba zdravljenje prekiniti, dokler se raven hemoglobina ne začne nižati.
The needle shield will retract completely when you insert the needle into the skin (see picture 10).
Zaščita igle se bo povsem umaknila, ko boste iglo vstavili v kožo
- Put used syringes into the puncture-proof container and keep this container out of the sight and reach of children.
- Uporabljene igle dajte v vsebnik, odporen proti vbodom, in ga shranjujte nedosegljivo otrokom.
Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe and a piece of gauze bandage or a sterile gauze swab).
Vse potrebne pripomočke imejte pri roki (napolnjeno injekcijsko brizgo z zdravilom Biopoin, alkoholni čistilni robček in košček povoja iz gaze ali sterilno vatno blazinico).
Put everything you need within easy reach (the Biopoin pre-filled syringe, an alcohol wipe, a piece of gauze bandage or a sterile gauze swab and the puncture-proof container).
Vse potrebne pripomočke imejte pri roki (napolnjeno injekcijsko brizgo z zdravilom Biopoin, alkoholni čistilni robček, košček povoja iz gaze ali sterilno vatno blazinico in vsebnik, odporen proti vbodom).
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.
Če je pri bolniku zaradi uporabe epoetina theta prišlo do hude kožne reakcije, kot sta SJS ali TEN,
In the case of overdose, polycythaemia can occur.
Ob prevelikem odmerjanju se lahko pojavi policitemija.
To give yourself an injection into the tissue under the skin you will need: - a pre-filled syringe of Biopoin, - an alcohol wipe, - a piece of gauze bandage or a sterile gauze swab.
Za injiciranje zdravila v tkivo pod kožo boste potrebovali: - napolnjeno injekcijsko brizgo zdravila Biopoin,
Allergic reactions such as skin rash, raised areas of the skin that itch and severe allergic reactions with weakness, drop in blood pressure, difficulty breathing and swelling of the face have been reported (not known, frequency cannot be estimated from the available data).
poročali so (neznana, pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) o alergijskih reakcijah, kot so kožni izpuščaj in izbočena srbeča območja na koži, ter hudih alergijskih reakcijah s šibkostjo, padcem krvnega tlaka, oteženim dihanjem in otekanjem obraza.
Blood pressure should be controlled adequately before initiation and during therapy to avoid acute complications, such as hypertensive crisis with encephalopathy-like symptoms (e.g. headaches, confused state, speech disturbances, impaired gait) and related complications (seizures, stroke), which may also occur in individual patients with otherwise normal or low blood pressure.
Pred začetkom zdravljenja in med njim je treba zadostno nadzorovati krvni tlak, da se izognete akutnim zapletom, kot so hipertenzivna kriza s simptomi, podobnimi encelopatiji, (npr. glavoboli,
Packs of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Pakiranja z 1, 4 in 6 napolnjenimi injekcijskimi brizgami; 1, 4 in 6 napolnjenih injekcijskih brizg z varnostno iglo ali 1, 4 in 6 napolnjenih injekcijskih brizg z varnostnim pripomočkom.
The syringe has a scale on the syringe barrel.
Na cevi brizge je lestvica.
The maximum dose should not exceed 700 IU per kg of bodyweight per week.
Največji odmerek ne sme presegati 700 i.e. na kg telesne mase na teden.
The solution for injection should not be shaken.
Raztopine za injiciranje ne stresajte.
Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin target range of 10 g/dl (6.21 mmol/l) to 12 g/dl (7.45 mmol/l).
Te razlike vrednosti hemoglobina je treba obravnavati, tako da se spreminja odmerek, pri čemer je treba upoštevati razpon hemoglobina od 10 g/dl (6,21 mmol/l) do 12 g/dl
6 pre-filled syringes with safety device containing 0.5 ml.
6 napolnjenih injekcijskih brizg z varnostnim pripomočkom, ki vsebujejo 0,5 ml.
Pack sizes of 1, 4 and 6 pre-filled syringes; 1, 4 and 6 pre-filled syringes with safety needle or 1, 4 and 6 pre-filled syringes with safety device.
Pakiranje s po 1, 4 in 6 napolnjenimi injekcijskimi brizgami; 1, 4 in 6 napolnjenih injekcijskih brizg z varnostno iglo ali 1, 4 in 6 napolnjenih injekcijskih brizg z varnostnim pripomočkom.
The initial dose for injections into veins is 40 IU per kg of bodyweight, given 3 times per week.
Začetni odmerek za injiciranje v veno je 40 i.e. na kg telesne mase trikrat na teden.
Biopoin 20,000 IU/1 ml
Biopoin 20.000 i.e./1 ml
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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 20.000 mednarodnih enot (i.e.) (166,7 µg) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 20.000 i.e. (166,7 µg) epoetina theta na ml.
Do not pick up the pre-filled syringe by the plunger or tip cap.
Ne prijemajte napolnjene injekcijske brizge za bat ali vrhnjo zaporko.
- Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
- Vsebnike, odporne proti vbodom, odstranite skladno z navodili zdravnika, farmacevta ali medicinske sestre.
One pre-filled syringe contains 30,000 international units (IU) (250 micrograms) epoetin theta in 1 ml solution for injection corresponding to 30,000 IU (250 micrograms) epoetin theta per ml.
Ena napolnjena injekcijska brizga vsebuje 30.000 mednarodnih enot (i.e.) (250 mikrogramov) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 30.000 i.e. (250 mikrogramom) epoetina theta na ml.
Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Epoetin theta should be administered by the subcutaneous route to patients with anaemia (e.g. haemoglobin concentration ≤ 10 g/dl [6.21 mmol/l]).
Epoetin theta je treba subkutano dajati bolnikom z anemijo (npr. koncentracijo hemoglobina ≤ 10 g/dl
Data from three placebo-controlled clinical studies in 586 anaemic cancer patients conducted with epoetin theta, showed no negative effect of epoetin theta on survival.
Podatki treh s placebom nadzorovanih kliničnih študij pri 586 anemičnih bolnikih z rakom,
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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 30.000 mednarodnih enot (i.e.) (250 µg) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 30.000 i.e. (250 µg) epoetina theta na ml.
One pre-filled syringe contains 20,000 international units (IU) (166.7 micrograms) epoetin theta in 1 ml solution for injection corresponding to 20,000 IU (166.7 micrograms) epoetin theta per ml.
Ena napolnjena injekcijska brizga vsebuje 20.000 mednarodnih enot (i.e.) (166,7 mikrograma) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 20.000 i.e. (166,7 mikrograma) epoetina theta na ml.
EU/1/09/565/017 1 pre-filled syringe EU/1/09/565/018 1 pre-filled syringe with safety device EU/1/09/565/019 4 pre-filled syringes EU/1/09/565/020 4 pre-filled syringes with safety device EU/1/09/565/021 6 pre-filled syringes EU/1/09/565/022 6 pre-filled syringes with safety device EU/1/09/565/037 1 pre-filled syringe with safety needle EU/1/09/565/038 4 pre-filled syringes with safety needle EU/1/09/565/039 6 pre-filled syringes with safety needle
EU/1/09/565/021 6 napolnjenih injekcijskih brizg EU/1/09/565/022 6 napolnjenih injekcijskih brizg z varnostnim pripomočkom EU/1/09/565/037 1 napolnjena injekcijska brizga z varnostno iglo EU/1/09/565/038 4 napolnjene injekcijske brizge z varnostno iglo EU/1/09/565/039 6 napolnjenih injekcijskih brizg z varnostno iglo
What Biopoin is used for
Za kaj uporabljamo zdravilo Biopoin
Very common:
Pogosti:
How you should inject yourself
Kako si injicirate zdravilo
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.
Ena napolnjena injekcijska brizga vsebuje 5000 mednarodnih enot (i.e.) (41,7 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 mikrograma) epoetina theta na 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.
Ena napolnjena injekcijska brizga vsebuje 10.000 mednarodnih enot (i.e.) (83,3 mikrograma) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 mikrograma) epoetina theta na ml.
Biopoin 30,000 IU/1 ml
Biopoin 30.000 i.e./1 ml
The dose may be increased after 4 weeks to 40 IU/kg, 3 times per week, if the increase in haemoglobin is not adequate (< 1 g/dl [0.62 mmol/l] within 4 weeks).
Po štirih tednih se lahko odmerek poveča na 40 i.e./kg trikrat na teden, če povečanje vrednosti hemoglobina ni zadostno
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.
Ena napolnjena injekcijska brizga vsebuje 2000 mednarodnih enot (i.e.) (16,7 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 4000 i.e. (33,3 mikrograma) epoetina theta na 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.
Ena napolnjena injekcijska brizga vsebuje 4000 mednarodnih enot (i.e.) (33,3 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 8000 i.e. (66,7 mikrograma) epoetina theta na 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).
- trebuh, razen območja okrog popka (glejte siva območja na sliki 6).
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
- Hudi kožni izpuščaji: v povezavi z zdravljenjem z epoetini so poročali o hudih kožnih izpuščajih, vključno s StevensJohnsonovim sindromom in toksično epidermalno nekrolizo.
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 i.e./1 ml: ena napolnjena injekcijska brizga vsebuje 10.000 mednarodnih enot (i.e.) (83,3 mikrograma) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 10.000 mednarodnim enotam (i.e.) (83,3 mikrograma) na 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 5).
- trebuh, razen območja okrog popka (glejte siva območja na sliki 5).
Biopoin 10,000 IU/1 ml
Biopoin 10.000 i.e./1 ml
Packs of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Pakiranja s 6 napolnjenimi injekcijskimi brizgami; 6 napolnjenih injekcijskih brizg z varnostno iglo ali 6 napolnjenih injekcijskih brizg z varnostnim pripomočkom.
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.
Ena napolnjena injekcijska brizga vsebuje 3000 mednarodnih enot (i.e.) (25 mikrogramov) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 6000 i.e. (50 mikrogramom) epoetina theta na 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 IU (16.7 micrograms) epoetin theta per ml.
Ena napolnjena injekcijska brizga vsebuje 1000 mednarodnih enot (i.e.) (8,3 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 2000 i.e. (16,7 mikrograma) epoetina theta na 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 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 5000 mednarodnih enot (i.e.) (41,7 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 10.000 mednarodnim enotam (i.e.) (83,3 mikrograma) na ml.
Frequency
Pogosti
How to store Biopoin
Shranjevanje zdravila Biopoin
It is unknown whether the active substance in this medicine passes over to the breast milk.
Ni znano, ali zdravilna učinkovina v tem zdravilu prehaja v materino mleko, zato se bo zdravnik morda odločil, da tega zdravila ne smete uporabljati, če dojite.
Do not increase the dose your doctor has given you.
Če ste uporabili večji odmerek zdravila Biopoin, kot bi smeli Ne povečajte odmerka, ki vam ga je predpisal zdravnik.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/017
Biopoin 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/017
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 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 4000 mednarodnih enot (i.e.) (33,3 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 8000 mednarodnim enotam (i.e.) (66,7 mikrograma) na ml.
6 pre-filled syringes with safety device containing 1 ml.
6 napolnjenih injekcijskih brizg z varnostnim pripomočkom, ki vsebujejo 1 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 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 10.000 mednarodnih enot (i.e.) (83,3 µg) epoetina theta v 1 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 µg) epoetina theta na ml.
Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/023
Biopoin 30.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/023
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 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 1000 mednarodnih enot (i.e.) (8,3 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 2000 mednarodnim enotam (i.e.) (16,7 mikrograma) na ml.
Not known in cancer patients (frequency cannot be estimated from the available data) - Thromboembolic events, e.g. increase in blood clots.
Neželeni učinek neznane pogostnosti pri bolnikih z rakom (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
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 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 2000 mednarodnih enot (i.e.) (16,7 mikrograma) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 4000 mednarodnim enotam (i.e.) (33,3 mikrograma) na ml.
Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Pakiranje s po 6 napolnjenimi injekcijskimi brizgami; 6 napolnjenih injekcijskih brizg z varnostno iglo ali 6 napolnjenih injekcijskih brizg z varnostnim pripomočkom.
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 i.e./0,5 ml: ena napolnjena injekcijska brizga vsebuje 3000 mednarodnih enot (i.e.) (25 mikrogramov) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 6000 mednarodnim enotam (i.e.) (50 mikrogramom) na ml.
Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe 30 months
Biopoin 5000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
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 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 4000 mednarodnih enot (i.e.) (33,3 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 8000 i.e. (66,7 µg) epoetina theta na 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 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 5000 mednarodnih enot (i.e.) (41,7 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 10.000 i.e. (83,3 µg) epoetina theta na 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 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 3000 mednarodnih enot (i.e.) (25 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 6000 i.e. (50 µg) epoetina theta na ml.
Influenza-like illness*
Splošne težave in spremembe na mestu aplikacije bolezen, podobna gripi*
1 pre-filled syringe with safety device containing 1 ml.
1 napolnjena injekcijska brizga z varnostnim pripomočkom, ki vsebuje 1 ml.
4 pre-filled syringes with safety device containing 1 ml.
4 napolnjene injekcijske brizge z varnostnim pripomočkom, ki vsebujejo 1 ml.
Biopoin 1,000 IU/0.5 ml solution for injection in pre-filled syringe One pre-filled syringe contains 1,000 international units (IU) (8.3 µg) epoetin theta in 0.5 ml solution for injection corresponding to 2,000 IU (16.7 µg) epoetin theta per ml.
Biopoin 1000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 1000 mednarodnih enot (i.e.) (8,3 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 2000 i.e. (16,7 µg) epoetina theta na ml.
Biopoin 4,000 IU/0.5 ml
Biopoin 4000 i.e./0,5 ml
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 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi Ena napolnjena injekcijska brizga vsebuje 2000 mednarodnih enot (i.e.) (16,7 µg) epoetina theta v 0,5 ml raztopine za injiciranje, kar ustreza 4000 i.e. (33,3 µg) epoetina theta na ml.
6 pre-filled syringes with safety needle containing 0.5 ml.
6 napolnjenih injekcijskih brizg, ki vsebujejo 0,5 ml. 6 napolnjenih injekcijskih brizg z varnostno iglo, ki vsebujejo 0,5 ml.
In the event of polycythaemia, epoetin theta should be temporarily withheld.
Če se ta pojavi, je treba začasno prekiniti zdravljenje z epoetinom theta.
Biopoin 5,000 IU/0.5 ml
Biopoin 5000 i.e./0,5 ml
Contents of the pack and other information 7.
Shranjevanje zdravila Biopoin Vsebina pakiranja in dodatne informacije Informacije za samostojno injiciranje
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).
Pri bolnikih s kronično ledvično odpovedjo (na dializi, ne na dializi, s sladkorno boleznijo, brez sladkorne bolezni) so izvedli združene post-hoc analize kliničnih študij epoetinov.
Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/011
Biopoin 10.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/011
Biopoin 3,000 IU/0.5 ml
Biopoin 3000 i.e./0,5 ml
EU/1/09/565/007 6 pre-filled syringes
EU/1/09/565/007 6 napolnjenih injekcijskih brizg
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 in posledice anemije se lahko razlikujejo glede na starost, spol in splošno breme bolezni.
Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/007
Biopoin 4000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/09/565/007
Biopoin 5,000 IU/0.5 ml injection Epoetin theta
Biopoin 5000 i.e./0,5 ml injekcija epoetin theta s.c., i.v.
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe Epoetin theta
Biopoin 20.000 i.e./1 ml raztopina za injiciranje v napolnjeni injekcijski brizgi epoetin theta
Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe 30 months
Biopoin 20.000 i.e./0,5 ml raztopina za injiciranje v napolnjeni injekcijski brizgi 30 mesecev
If the rise in haemoglobin is greater than 2 g/dl (1.24 mmol/l) in 4 weeks or the haemoglobin level exceeds 12 g/dl (7.45 mmol/l), the dose should be reduced by 25 to 50%.
12 g/dl (7,45 mmol/l), je treba odmerek zmanjšati za od 25 do 50 %.
Biopoin 20,000 IU/1 ml injection Epoetin theta
Biopoin 20.000 i.e./1 ml injekcija epoetin theta s.c., i.v.