FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Icelandic: Tilkynnt hefur verið um hreinan rauðkornabrest af völdum hlutleysandi mótefna gegn rauðkornavökum (PRCA) eftir markaðssetningu í tengslum við meðferð með epóetín teta hjá sjúklingum með langvarandi nýrnabilun.
English: 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]).
Icelandic: Epóetín teta skal gefa undir húð sjúklingum með blóðleysi (t.d. blóðrauðastyrk ≤ 10 g/dl [6,21 mmól/l]).
English: Misuse of epoetin theta by healthy persons may lead to an excessive increase in haemoglobin and haematocrit.
Icelandic: Ef heilbrigðir einstaklingar misnota epóetín teta getur slíkt leitt til óeðlilega mikillar aukningar blóðrauða og blóðkornaskila.
English: - Dispose of the full puncture-proof container as instructed by your doctor, pharmacist or nurse.
Icelandic: - Fargið fullum nálaboxum í samræmi við fyrirmæli læknisins, lyfjafræðings eða hjúkrunarfræðingsins.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Icelandic: Safngreiningar gefa einnig staðfast til kynna verulega aukningu á hlutfallslegri hættu á segareki hjá krabbameinssjúklingum sem fengu raðbrigða rauðkornavaka úr mönnum (sjá kafla 4.4).
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see sections 4.2 and
Icelandic: Hjá sjúklingum með lélega blóðrauðasvörun gagnvart epóetínum skal íhuga aðrar ástæður fyrir lélegri svörun (sjá kafla 4.2 og 5.1).
English: Otherwise the increased number of red blood cells may cause blocking of the arterio-venous fistula (an artificial connection between an artery and a vein which is surgically prepared in dialysis patients).
Icelandic: Að öðrum kosti kann aukið magn rauðra blóðkorna að valda stíflu í slag- og bláæðarfistli (tilbúin tenging með skurðaðgerð á milli slagæðar og bláæðar sem gerð er á skilunarsjúklingum).
English: 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.
Icelandic: Hafi sjúklingurinn fengið alvarleg húðviðbrögð svo sem Stevens-Johnson heilkenni eða eitrunardreplos í húðþekju vegna notkunar epóetín teta má hann aldrei nota lyfið aftur.
English: The maximum dose should not exceed 700 IU per kg of bodyweight per week.
Icelandic: Hámarksskammtastærð ætti ekki að fara fram úr 700 a.e. á hvert kg líkamsþyngdar á viku.
English: In the presence of hypertension or existing cardiovascular, cerebrovascular or peripheral vascular diseases, the increase in haemoglobin and the target haemoglobin value should be determined individually taking into account the clinical picture.
Icelandic: Þegar háþrýstingur eða hjarta- og æðasjúkdómar, æðasjúkdómar í heila eða útæðasjúkdómar eru til staðar skal ákvarða aukningu blóðrauða og markgildi blóðrauða á einstaklingsbundinn hátt og taka mið af klínískum upplýsingum.
English: Caution should be exercised with escalation of epoetin theta doses in patients with chronic renal failure.
Icelandic: Gæta skal varúðar þegar skammtar af epóetín teta eru auknir hjá sjúklingum með langvinna nýrnabilun.
English: Hypertension occurs in chronic renal failure patients more often during the correction phase than during the maintenance phase.
Icelandic: Háþrýstingur kemur oftar fram á leiðréttingarstiginu en á viðhaldsstiginu.
English: Do not pick up the pre-filled syringe by the plunger or tip cap.
Icelandic: Haldið ekki í bulluna eða hettuna þegar áfyllta sprautan er tekin upp.
English: The haemoglobin levels remained within the desired target range and epoetin theta was well tolerated over a period of up to 15 months.
Icelandic: Blóðrauðastyrkurinn hélst innan æskilegra marka og sjúklingarnir þoldu epóetín teta vel í allt að 15 mánuði.
English: 6 pre-filled syringes with safety device containing 0.5 ml.
Icelandic: 6 áfylltar sprautur með öryggisnál sem innihalda 0,5 ml. 6 áfylltar sprautur með öryggisbúnaði sem innihalda 0,5 ml.
English: A rise in haemoglobin of greater than 2 g/dl (1.24 mmol/l) over a four week period should be avoided.
Icelandic: Forðast skal meiri hækkun blóðrauða en sem nemur 2 g/dl (1,24 mmól/l) á fjögurra vikna tímabili.
English: Subcutaneous injections should be given into the abdomen, arm or thigh.
Icelandic: Inndælingar undir húð á að gefa í kvið, handlegg eða læri.
English: In patients with cancer receiving chemotherapy the aetiology of anaemia is multifactorial.
Icelandic: Hjá krabbameinssjúklingum í krabbameinslyfjameðferð er uppruni blóðleysis margþættur.
English: 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.
Icelandic: Tíðni ekki þekkt hjá sjúklingum með langvinna nýrnabilun (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum)
English: Biopoin 20,000 IU/1 ml
Icelandic: Biopoin 20.000 a.e./1 ml
English: End of 7 days period at room temperature: __/__/____
Icelandic: Lok 7 daga tímabils við stofuhita:
English: 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).
Icelandic: Setjið allt sem þörf er á í seilingarfjarlægð (áfylltu sprautuna með Biopoin, sprittþurrku og sárabindisgrisju eða dauðhreinsaða grisju ásamt nálaboxinu).
English: If, after 4 weeks of therapy, the haemoglobin value has increased by at least 1 g/dl (0.62 mmol/l), the current dose should be continued.
Icelandic: Ef blóðrauðastyrkur hefur aukist um lágmark 1 g/dl (0,62 mmól/l) eftir 4 vikna meðferð, skal halda sama skammti áfram.
English: In these patients, erythropoietin deficiency and a reduced response of erythroid progenitor cells to endogenous erythropoietin both contribute significantly towards their anaemia.
Icelandic: Hjá þessum sjúklingum hafa bæði skortur á rauðkornavökum og minnkuð svörun forverafrumna rauðra blóðkorna veruleg áhrif á blóðleysið.
English: EU/1/09/565/011 1 pre-filled syringe EU/1/09/565/012 1 pre-filled syringe with safety device EU/1/09/565/013 4 pre-filled syringes EU/1/09/565/014 4 pre-filled syringes with safety device EU/1/09/565/015 6 pre-filled syringes EU/1/09/565/016 6 pre-filled syringes with safety device EU/1/09/565/034 1 pre-filled syringe with safety needle EU/1/09/565/035 4 pre-filled syringes with safety needle EU/1/09/565/036 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/565/011 1 áfyllt sprauta EU/1/09/565/012 1 áfyllt sprauta með öryggisbúnaði EU/1/09/565/013 4 áfylltar sprautur EU/1/09/565/014 4 áfylltar sprautur með öryggisbúnaði EU/1/09/565/015 6 áfylltar sprautur EU/1/09/565/016 6 áfylltar sprautur með öryggisbúnaði EU/1/09/565/034 1 áfyllt sprauta með öryggisnál EU/1/09/565/035 4 áfylltar sprautur með öryggisnál EU/1/09/565/036 6 áfylltar sprautur með öryggisnál
English: If the frequency of administration is changed, haemoglobin level should be monitored closely and dose adjustments may be necessary.
Icelandic: Ef tíðni lyfjagjafar er breytt skal hafa náið eftirlit með blóðrauðastyrk og nauðsynlegt getur reynst að aðlaga skammtana.
English: 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
Icelandic: EU/1/09/565/017 1 áfyllt sprauta EU/1/09/565/018 1 áfyllt sprauta með öryggisbúnaði EU/1/09/565/019 4 áfylltar sprautur EU/1/09/565/020 4 áfylltar sprautur með öryggisbúnaði EU/1/09/565/021 6 áfylltar sprautur EU/1/09/565/022 6 áfylltar sprautur með öryggisbúnaði EU/1/09/565/037 1 áfyllt sprauta með öryggisnál EU/1/09/565/038 4 áfylltar sprautur með öryggisnál EU/1/09/565/039 6 áfylltar sprautur með öryggisnál
English: You may remove Biopoin from the refrigerator and store it not above 25 °C for a single period of up to 7 days without exceeding the expiry date.
Icelandic: Taka má Biopoin úr kæli og geyma það við eða undir 25°C í allt að 7 daga í röð innan fyrningartímans.
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin and perform anti-erythropoietin antibody testing.
Icelandic: Ef vart verður við mótsagnakennda lækkun blóðrauða og þróun alvarlegs blóðleysis ásamt fækkun netfrumna skal hætta meðferð með epóetíni og framkvæma and-rauðkorna mótefnapróf.
English: 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
Icelandic: Biopoin 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Biopoin 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Biopoin 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: 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).
Icelandic: Setjið allt sem þörf er á í seilingarfjarlægð (áfylltu sprautuna með Biopoin, sprittþurrku, sárabindisgrisju eða dauðhreinsaða grisju ásamt nálaboxinu).
English: If the frequency of administration is changed, dose adjustments may be necessary.
Icelandic: Ef tíðni lyfjagjafar er breytt getur þurft að laga skammtastærðina að því.
English: Take one blister with a pre-filled syringe out of the refrigerator.
Icelandic: Takið eina þynnupakkningu með áfylltri sprautu úr kæli.
English: In cancer patients with non-myeloid malignancies receiving chemotherapy epoetin theta should be administered by the subcutaneous route only.
Icelandic: Krabbameinssjúklingar með illkynja sjúkdóma, aðra en í merg, sem eru í krabbameinslyfjameðferð eiga aðeins að fá epóetín teta undir húð.
English: In pre-dialysis patients with chronic renal failure following subcutaneous injection of 40 IU/kg body weight, the protracted absorption results in a concentration plateau, whereby the maximum concentration is reached after an average of approximately 14 hours.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun sem ekki hafa enn gengist undir skilun veldur inndæling undir húð, 40 a.e./kg líkamsþyngdar, stöðugum styrk með lengdu frásogi og hámarksstyrk er náð eftir u.þ.b. 14 klst. að meðaltali.
English: Epoetin theta should be administered either subcutaneously or intravenously in order to increase haemoglobin level to not greater than 12 g/dl (7.45 mmol/l).
Icelandic: Epóetín teta má gefa hvort sem er undir húð eða í bláæð til að auka blóðrauðastyrk í hámark 12 g/dl (7,45 mmól/l).
English: 6 pre-filled syringes with safety device containing 1 ml.
Icelandic: 6 áfylltar sprautur með öryggisnál sem innihalda 1 ml. 6 áfylltar sprautur með öryggisbúnaði sem innihalda 1 ml.
English: 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
Icelandic: EU/1/09/565/023 1 áfyllt sprauta EU/1/09/565/024 1 áfyllt sprauta með öryggisbúnaði EU/1/09/565/025 4 áfylltar sprautur EU/1/09/565/026 4 áfylltar sprautur með öryggisbúnaði EU/1/09/565/027 6 áfylltar sprautur EU/1/09/565/028 6 áfylltar sprautur með öryggisbúnaði EU/1/09/565/040 1 áfyllt sprauta með öryggisnál EU/1/09/565/041 4 áfylltar sprautur með öryggisnál EU/1/09/565/042 6 áfylltar sprautur með öryggisnál
English: It is recommended that haemoglobin measurement, a complete blood count and platelet count be performed regularly.
Icelandic: Ráðlagt er að framkvæma reglulega mælingar á blóðrauða, heildar blóðhag og blóðflagnafjölda.
English: Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/017
Icelandic: Biopoin 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/09/565/017
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/023
Icelandic: Biopoin 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/09/565/023
English: Pack sizes of 6 pre-filled syringes; 6 pre-filled syringes with safety needle or 6 pre-filled syringes with safety device.
Icelandic: Pakkningastærðir með 6 áfylltum sprautum; 6 áfylltum sprautum með öryggisnál eða 6 áfylltum sprautum með öryggisbúnaði.
English: - Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Icelandic: - Meðferð við blóðleysi með einkennum, hjá fullorðnum sjúklingum sem fá krabbameinslyfjameðferð vegna illkynja sjúkdóma annarra en í merg.
English: The initial dose for injections under the skin is 20 IU per kg of bodyweight, given 3 times per week.
Icelandic: Byrjunarskammtur fyrir inndælingu undir húð er 20 a.e.
English: Symptomatic anaemia associated with chronic renal failure
Icelandic: Blóðleysi með einkennum, í tengslum við langvinna nýrnabilun
English: Epoetin theta is a protein produced by biotechnology.
Icelandic: Epóetín teta er prótein sem er framleitt með líftækni.
English: 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.
Icelandic: Ekki má skola lyfjum niður í frárennslislagnir eða fleygja þeim með heimilissorpi.
English: Due to intra-patient variability, occasional individual haemoglobin values for a patient above and below the desired haemoglobin level may be observed.
Icelandic: Þar sem munur er á sjúklingum geta einstaka sinnum komið fram blóðrauðagildi hjá sjúklingum sem eru yfir eða undir æskilegum blóðrauðastyrk.
English: There is therefore consistent evidence to suggest that there may be significant harm to patients with cancer who are treated with recombinant human erythropoietin.
Icelandic: Áreiðanleg gögn benda því til skaðvænlegra áhrifa á krabbameinssjúklinga af gjöf raðbrigða rauðkornavakalyfja.
English: Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment.
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðútbrot, þ.m.t. StevensJohnson heilkenni og eitrunardreplos í húðþekju.
English: Biopoin 30,000 IU/1 ml
Icelandic: Biopoin 30.000 a.e./1 ml
English: Before you give yourself an Biopoin injection, you must do the following: Hold the syringe and gently remove the cover from the needle without twisting.
Icelandic: Haldið á sprautunni og fjarlægið varlega hlífina af nálinni án þess að snúa henni.
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 20.000 alþjóðlegar einingar (a.e.) (166,7 míkrógrömm) af epóetín teta í 1,0 ml af stungulyfi, lausn, sem jafngildir 20.000 alþjóðlegum einingum (a.e.) (166,7 míkrógrömm) á ml.
English: Excipients
Icelandic: Liðverkir
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 30.000 alþjóðlegar einingar (a.e.) (250 míkrógrömm) af epóetín teta í 1 ml af stungulyfi, lausn, sem jafngildir 30.000 alþjóðlegum einingum (a.e.) (250 míkrógrömm) á ml.
English: Biopoin 2,000 IU/0.5 ml injection Epoetin theta
Icelandic: Biopoin 2.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: 4 pre-filled syringes with safety device containing 1 ml.
Icelandic: 4 áfylltar sprautur með öryggisnál sem innihalda 1 ml. 4 áfylltar sprautur með öryggisbúnaði sem innihalda 1 ml. 6 áfylltar sprautur sem innihalda 1 ml.
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe EU/1/09/565/011
Icelandic: Biopoin 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/09/565/011
English: Break the labelled seal and remove the cap (see picture 1).
Icelandic: Brjótið innsiglið með áletruninni og fjarlægið lokið (sjá mynd 1).
English: Biopoin 10,000 IU/1 ml
Icelandic: Biopoin 10.000 a.e./1 ml
English: Depending on your individual situation a blood transfusion may be preferable.
Icelandic: Blóðgjöf kann að vera heppilegri í þínu tilviki.
English: Biopoin 4,000 IU/0.5 ml
Icelandic: 4.000 a.e./0,5 ml
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 1.000 alþjóðlegar einingar (a.e.) (8,3 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 2.000 alþjóðlegum einingum (a.e.) (16,7 míkrógrömm) á ml.
English: Biopoin 5,000 IU/0.5 ml
Icelandic: 5.000 a.e./0,5 ml
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 2.000 alþjóðlegar einingar (a.e.) (16,7 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 4.000 alþjóðlegum einingum (a.e.) (33,3 míkrógrömm) á ml.
English: EXP
Icelandic: Biopoin
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 5.000 alþjóðlegar einingar (a.e.) (41,7 µg) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 10.000 a.e. (83,3 µg) af epóetín teta á ml.
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 4.000 alþjóðlegar einingar (a.e.) (33,3 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 8.000 alþjóðlegum einingum (a.e.) (66,7 míkrógrömm) á ml.
English: Biopoin 10,000 IU/1 ml, Biopoin 20,000 IU/1 ml and Biopoin 30,000 IU/1 ml: Each pre-filled syringe contains 1 ml of solution.
Icelandic: Biopoin 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu Biopoin 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Biopoin 4,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/007
Icelandic: 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/565/007
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy
Icelandic: Blóðleysi með einkennum, hjá krabbameinssjúklingu m með illkynja sjúkdóma aðra en í merg sem fá krabbameinslyfjameðferð
English: Biopoin 20,000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Biopoin 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Biopoin 1,000 IU/0.5 ml, Biopoin 2,000 IU/0.5 ml, Biopoin 3,000 IU/0.5 ml, Biopoin 4,000 IU/0.5 ml and Biopoin 5,000 IU/0.5 ml: Each pre-filled syringe contains 0.5 ml of solution.
Icelandic: Biopoin 4.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Biopoin 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Human erythropoietin is an endogenous glycoprotein hormone that is the primary regulator of erythropoiesis through specific interaction with the erythropoietin receptor on the erythroid progenitor cells in the bone marrow.
Icelandic: Rauðkornavaki úr mönnum er innrænt glýkópróteinahormón sem sér að mestu leyti um að stilla rauðkornamyndun með sérhæfðri milliverkun við rauðkornavakaviðtaka á forverafrumum rauðra blóðkorna í beinmerg.
English: Biopoin 3,000 IU/0.5 ml
Icelandic: 3.000 a.e./0,5 ml
English: EU/1/09/565/004 6 pre-filled syringes with safety device EU/1/09/565/030 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/565/003 6 áfylltar sprautur EU/1/09/565/004 6 áfylltar sprautur með öryggisbúnaði EU/1/09/565/030 6 áfylltar sprautur með öryggisnál
English: Biopoin 4,000 IU/0.5 ml injection Epoetin theta
Icelandic: Biopoin 4.000 a.e./0,5 ml stungulyf Epóetín teta s.c. i.v.
English: 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.
Icelandic: Ein áfyllt sprauta inniheldur 10.000 alþjóðlegar einingar (a.e.) (83,3 µg) af epóetín teta í 1 ml af stungulyfi, lausn, sem jafngildir 10.000 a.e. (83,3 µg) af epóetín teta á ml.
English: EU/1/09/565/002 6 pre-filled syringes with safety device EU/1/09/565/029 6 pre-filled syringes with safety needle
Icelandic: EU/1/09/565/001 6 áfylltar sprautur EU/1/09/565/002 6 áfylltar sprautur með öryggisbúnaði EU/1/09/565/029 6 áfylltar sprautur með öryggisnál
English: Biopoin 30,000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Biopoin 30.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Biopoin 5,000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/09/565/009
Icelandic: 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/09/565/009
English: Biopoin 20,000 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.
Icelandic: Biopoin 20.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 ml lausn í áfylltri sprautu (gler af gerð I) með nálarhettu (brómóbútýlgúmmí), bullutappa (teflon klóróbútýlgúmmí) og nál (ryðfrítt stál) eða nál (ryðfrítt stál) með öryggishlíf (öryggisnál) eða nál (ryðfrítt stál) með öryggisbúnaði.
English: Biopoin 2,000 IU/0.5 ml
Icelandic: 2.000 a.e./0,5 ml
English: IU
Icelandic: Fyrnist
English: Symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy Effect on tumour growth
Icelandic: Blóðleysi með einkennum, hjá krabbameinssjúklingum með illkynja sjúkdóma aðra en í merg sem fá krabbameinslyfjameðferð
English: 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..
Icelandic: Ein áfyllt sprauta inniheldur 5.000 alþjóðlegar einingar (a.e.) (41,7 míkrógrömm) af epóetín teta í 0,5 ml af stungulyfi, lausn, sem jafngildir 10.000 alþjóðlegum einingum (a.e.) (83,3 míkrógrömm) á ml.
English: Hypersensitivity reactions
Icelandic: LYFJAGERÐARFRÆÐILEGAR UPPLÝSINGAR
English: Biopoin 10,000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Biopoin 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: EU/1/09/565/025 EU/1/09/565/026 EU/1/09/565/027 EU/1/09/565/028 EU/1/09/565/040 EU/1/09/565/041 EU/1/09/565/042
Icelandic: EU/1/09/565/001 EU/1/09/565/002 EU/1/09/565/029
English: Maintenance phase
Icelandic: FYRNINGARDAGSETNING