FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of epoetin alfa in chronic renal failure patients with anaemia before initiation of dialysis or on peritoneal dialysis have not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun epóetíns alfa hjá sjúklingum með langvinna nýrnabilun og blóðleysi sem eru enn ekki komnir í blóðskilun eða eru í kviðskilun.
English: Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 9.000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu
English: The safety of epoetin alfa has not been established in patients with hepatic dysfunction.
Icelandic: öryggi epóetín alfa hjá sjúklingum með vanstarfsemi lifrar.
English: A pre-filled syringe of 0.6 mL contains 6,000 international units (IU) corresponding to 50.4 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,6 ml inniheldur 6.000 alþjóðlegar einingar (a.e.) eða 50,4 míkrógrömm af epóetíni alfa.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 7,000 IU/0.7 mL 17.
Icelandic: Epoetin alfa HEXAL 7.000 a.e./0,7 ml
English: The median TTP based on IRC-determined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI:
Icelandic: Miðgildi tíma til versnunar byggt á niðurstöðum óháðrar rannsóknarnefndar var 8,0 mánuðir í hópnum sem fékk epóetín alfa og staðlaða umönnun og 8,3 mánuðir í hópnum sem fékk eingöngu staðlaða umönnun (HR 1,033, 95% CI: 0,924, 1,156).
English: Epoetin alfa HEXAL 8,000 IU/0.8 mL solution for injection in a pre-filled syringe EU/1/07/411/013
Icelandic: Epoetin alfa HEXAL 8.000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/013
English: • if there has been a refrigerator failure.
Icelandic: • ef bilun hefur orðið í kæli.
English: or Hb increase ≥ 1 g/dL
Icelandic: ≥ 1 g/dl
English: Additional supportive care should be provided as necessary.
Icelandic: Veita skal frekari stuðningsmeðferð ef þarf.
English: These include venous and arterial thromboses and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Icelandic: Þar á meðal eru segamyndun og segarek í bláæðum og slagæðum (stundum banvænt), svo sem segamyndun í djúpbláæðum, lungnasegarek, segamyndun í sjónhimnu og hjartadrep.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 6,000 IU/0.6 mL 17.
Icelandic: Epoetin alfa HEXAL 6.000 a.e./0,6 ml
English: • Cough.
Icelandic: HEXAL.
English: Each graduation ring corresponds to a volume of 0.1 mL.
Icelandic: Hver hringur samsvarar rúmmálinu 0,1 ml. Lyfið er aðeins einnota.
English: A pre-filled syringe of 0.9 mL contains 9,000 international units (IU) corresponding to 75.6 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0.9 ml inniheldur 9.000 alþjóðlegar einingar (a.e.) eða 75,6 míkrógrömm af epóetíni alfa.
English: Hypertension, Venous and arterial thromboses2
Icelandic: Háþrýstingur, segamyndun í bláæðum og slagæðum2
English: In paediatric patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Epoetin alfa HEXAL by the intravenous route is preferable.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun þar sem aðgangur að bláæð er reglulega til staðar (sjúklingar í blóðskilun) er gjöf Epoetin alfa HEXAL í bláæð æskileg.
English: • epileptic seizures or fits;
Icelandic: • kláðaútbrot (ofsakláði).
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 4 pre-filled syringes of 1 mL with a needle safety guard 6 pre-filled syringes of 1 mL with a needle safety guard
Icelandic: 6 áfylltar sprautur með 1 ml 1 áfyllt sprauta með 1 ml með nálaröryggisbúnaði 4 áfylltar sprautur með 1 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 1 ml með nálaröryggisbúnaði
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 7.000 a.e./0,7 ml stungulyf, lausn í áfylltri sprautu
English: Epoetin alfa HEXAL is indicated for the treatment of symptomatic anaemia associated with chronic renal failure (CRF):
Icelandic: Epoetin alfa HEXAL er notað til meðferðar við blóðleysi með einkennum af völdum nýrnasjúkdóms:
English: A pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,5 ml inniheldur 20.000 alþjóðlegar einingar (a.e.) eða 168,0 míkrógrömm af epóetíni alfa.
English: 1 pre-filled syringe of 0.5 mL contains 20,000 international units (IU) corresponding to 168.0 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,5 ml inniheldur 20.000 alþjóðlegar einingar (a.e.) sem jafngilda 168,0 míkrógrömmum af epóetíni alfa.
English: Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 6.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu
English: Reticulocyte count increase < 40,000/µL and Hb increase < 1 g/dL
Icelandic: Fjölgun netfrumna < 40.000/µl og Hb-aukning
English: 1 pre-filled syringe of 0.7 mL contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,7 ml inniheldur 7.000 alþjóðlegar einingar (a.e.) sem jafngilda 58,8 míkrógrömmum af epóetíni alfa.
English: In most cases, the ferritin values in the serum fall simultaneously with the rise in packed cell volume.
Icelandic: Yfirleitt lækka sermisgildi ferritíns um leið og heildarrúmmál rauðkorna eykst.
English: Epoetin alfa HEXAL is a sterile but unpreserved product and is for single use only.
Icelandic: Epoetin alfa HEXAL er sæft, einnota lyf án rotvarnarefna.
English: A pre-filled syringe of 0.8 mL contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,8 ml inniheldur 8.000 alþjóðlegar einingar (a.e.) eða 67,2 míkrógrömm af epóetíni alfa.
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
Icelandic: 6 áfylltar sprautur með 0,7 ml 1 áfyllt sprauta með 0,7 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,7 ml með nálaröryggisbúnaði
English: 1 pre-filled syringe of 0.5 mL contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,5 ml inniheldur 5.000 alþjóðlegar einingar (a.e.) sem jafngilda 42,0 míkrógrömmum af epóetíni alfa.
English: 1 pre-filled syringe of 0.8 mL contains 8,000 international units (IU) corresponding to 67.2 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,8 ml inniheldur 8.000 alþjóðlegar einingar (a.e.) sem jafngilda 67,2 míkrógrömmum af epóetíni alfa.
English: If partial use of a syringe is required, remove unwanted solution before injection.
Icelandic: Hver hringur samsvarar rúmmálinu 0,1 ml. Ef aðeins á að nota hluta sprautunnar skal fjarlægja lausn sem ekki á að nota fyrir inndælingu.
English: The exposure of paediatric patients with chronic renal failure on haemodialysis in clinical trials and post-marketing experience is limited.
Icelandic: Takmarkaðar upplýsingar liggja fyrir um útsetningu hjá börnum með langvinna nýrnabilun sem eru í blóðskilun, í klínískum rannsóknum og eftir markaðssetningu.
English: A pre-filled syringe of 0.5 mL contains 5,000 international units (IU) corresponding to 42.0 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,5 ml inniheldur 5.000 alþjóðlegar einingar (a.e.) eða 42,0 míkrógrömm af epóetíni alfa.
English: Antibody-mediated PRCA has been reported after months to years of epoetin alfa treatment.
Icelandic: Komið hafa fram tilvik um mótefnamiðlaða rauðkornskímfrumnafæð eftir notkun epóetíns alfa mánuðum eða árum saman.
English: Treatment of adult patients scheduled for major elective orthopaedic surgery
Icelandic: Meðferð hjá fullorðnum sjúklingum sem þurfa að gangast undir stóra, valbundna bæklunaraðgerð
English: Epoetin alfa HEXAL 9,000 IU/0.9 mL solution for injection in a pre-filled syringe EU/1/07/411/019
Icelandic: Epoetin alfa HEXAL 9.000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/019
English: A pre-filled syringe of 0.7 mL contains 7,000 international units (IU) corresponding to 58.8 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,7 ml inniheldur 7.000 alþjóðlegar einingar (a.e.) eða 58,8 míkrógrömm af epóetíni alfa.
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
Icelandic: 6 áfylltar sprautur með 0,5 ml 1 áfyllt sprauta með 0,5 ml með nálaröryggisbúnaði 4 áfylltar sprautur með 0,5 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,5 ml með nálaröryggisbúnaði
English: Dose adjustment to maintain haemoglobin concentrations between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L)
Icelandic: Skammtaaðlögun til að viðhalda blóðrauðastyrk á bilinu 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l)
English: Treatment of symptomatic anaemia in adult chronic renal failure patients
Icelandic: Meðferð við blóðleysi með einkennum hjá fullorðnum sjúklingum með langvinna nýrnabilun
English: 1 pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,75 ml inniheldur 30.000 alþjóðlegar einingar (a.e.) sem jafngilda 252,0 míkrógrömmum af epóetíni alfa.
English: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening or fatal, have been reported in association with epoetin treatment.
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðviðbrögð (SCARs), sem geta veriðlífshættuleg eða banvæn, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju.
English: Porphyria acute3
Icelandic: B. FYLGISEÐILL
English: Epoetin alfa HEXAL 6,000 IU/0.6 mL solution for injection in a pre-filled syringe EU/1/07/411/011
Icelandic: Epoetin alfa HEXAL 6.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/011
English: Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a pre-filled syringe EU/1/07/411/023
Icelandic: Epoetin alfa HEXAL 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/023
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
Icelandic: 6 áfylltar sprautur með 0,9 ml 1 áfyllt sprauta með 0,9 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,9 ml með nálaröryggisbúnaði
English: Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu
English: Occlusion of the dialysis system is possible if heparinisation is not optimum.
Icelandic: Stíflur í skilunarsíum og slöngum geta myndast ef ekki er um fullnægjandi heparíngjöf að ræða.
English: A pre-filled syringe of 0.75 mL contains 30,000 international units (IU) corresponding to 252.0 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,75 ml inniheldur 30.000 alþjóðlegar einingar (a.e.) eða 252,0 míkrógrömm af epóetíni alfa.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 5,000 IU/0.5 mL 17.
Icelandic: Epoetin alfa HEXAL 5.000 a.e./0,5 ml
English: Due to intra-patient variability, occasional individual haemoglobin concentrations for a patient above and below the desired haemoglobin concentration range may be observed.
Icelandic: Þar sem mikill munur er á sjúklingum innbyrðis getur stundum orðið vart við að blóðrauðagildi sjúklings verði hærri eða lægri en sem nemur æskilegu þéttnibili.
English: Epoetin alfa HEXAL 7,000 IU/0.7 mL solution for injection in a pre-filled syringe EU/1/07/411/017
Icelandic: Epoetin alfa HEXAL 7.000 a.e./0,7 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/017
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/009
Icelandic: Epoetin alfa HEXAL 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/009
English: EPO is involved in all phases of erythroid development, and has its principal effect at the level of erythroid precursors.
Icelandic: EPO tekur þátt í öllum stigum þróunar rauðfrumna og megináhrif þess koma fram á stigi rauðfrumuforvera.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 4,000 IU/0.4 mL 17.
Icelandic: Epoetin alfa HEXAL 4.000 a.e./0,4 ml
English: You should check with your doctor or pharmacist if you are not sure.
Icelandic: - Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum.
English: In studies to explore extending the dosing interval (40,000 IU once weekly and 80,000, 100,000, and 120,000 IU biweekly), a linear but non-dose-proportional relationship was observed between mean Cmax and dose, and between mean AUC and dose at steady state.
Icelandic: 120.000 a.e. tvisvar í viku) varð vart við línulegt samband sem ekki var þó í hlutfalli við skammta á milli miðgildis Cmax og skammts og á milli miðgildis AUC og skammts við stöðugt ástand.
English: A pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,5 ml inniheldur 1.000 alþjóðlegar einingar (a.e.) eða 8,4 míkrógrömm af epóetíni alfa.
English: 1 pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 1 ml inniheldur 2.000 alþjóðlegar einingar (a.e.) sem jafngilda 16,8 míkrógrömmum af epóetíni alfa.
English: 1 pre-filled syringe of 0.5 mL contains 1,000 international units (IU) corresponding to 8.4 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,5 ml inniheldur 1.000 alþjóðlegar einingar (a.e.) sem jafngilda 8,4 míkrógrömmum af epóetíni alfa.
English: * Produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology For the full list of excipients, see section 6.1.
Icelandic: * Framleitt með raðbrigða erfðatækni í frumum úr eggjastokkum kínverskra hamstra (CHO)
English: Epoetin alfa HEXAL 30,000 IU/0.75 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu
English: Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe EU/1/07/411/021
Icelandic: Epoetin alfa HEXAL 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/021
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 3.000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu
English: The recommended desired haemoglobin concentration range is between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Icelandic: Ráðlögð blóðrauðaþéttni er á bilinu 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l).
English: erythropoietin suggested that distribution volume was approximately 1.5 to 2 times higher in the preterm neonates than in the healthy adults, and clearance was approximately 3 times higher in the preterm neonates than in healthy adults.
Icelandic: Rannsókn á 7 fyrirburum með mjög lága fæðingarþyngd og 10 heilbrigðum fullorðnum einstaklingum sem fengu rauðkornavaka í bláæð gaf til kynna að dreifingarrúmmál væri u.þ.b. 1,5 til 2 sinnum hærra hjá fyrirburunum en hjá heilbrigðum fullorðnum einstaklingum og úthreinsun var u.þ.b. 3 sinnum hærri hjá fyrirburunum en hjá heilbrigðum fullorðnum einstaklingum.
English: INFORMATION IN BRAILLE Epoetin alfa HEXAL 3,000 IU/0.3 mL 17.
Icelandic: Epoetin alfa HEXAL 3.000 a.e./0,3 ml
English: 1 pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 1 ml inniheldur 40.000 alþjóðlegar einingar (a.e.) sem jafngilda 336,0 míkrógrömmum af epóetíni alfa.
English: Epoetin alfa HEXAL 4,000 IU/0.4 mL solution for injection in a pre-filled syringe EU/1/07/411/007
Icelandic: Epoetin alfa HEXAL 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/007
English: How to store Epoetin alfa HEXAL
Icelandic: Hvernig geyma á Epoetin alfa HEXAL.
English: Epoetin alfa HEXAL 3,000 IU/0.3 mL solution for injection in a pre-filled syringe EU/1/07/411/005
Icelandic: Epoetin alfa HEXAL 3.000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/005
English: Epoetin alfa HEXAL 20,000 IU/0.5 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Epoetin alfa HEXAL 5,000 IU/0.5 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: 1 pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 0,4 ml inniheldur 4.000 alþjóðlegar einingar (a.e.) sem jafngilda 33,6 míkrógrömmum af epóetíni alfa.
English: Very rarely, development of or exacerbation of porphyria has been observed in epoetin alfa-treated patients.
Icelandic: Örsjaldan hefur orðið vart við versnun porfýríu hjá sjúklingum sem fengu meðferð með epóetíni alfa.
English: 1 pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.
Icelandic: 1 áfyllt sprauta með 1 ml inniheldur 10.000 alþjóðlegar einingar (a.e.) sem jafngilda 84,0 míkrógrömmum af epóetíni alfa.
English: A pre-filled syringe of 1 mL contains 10,000 international units (IU) corresponding to 84.0 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 1 ml inniheldur 10.000 alþjóðlegar einingar (a.e.) eða 84,0 míkrógrömm af epóetíni alfa.
English: What Epoetin alfa HEXAL contains
Icelandic: Epoetin alfa HEXAL inniheldur
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
Icelandic: 6 áfylltar sprautur með 0,4 ml 1 áfyllt sprauta með 0,4 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,4 ml með nálaröryggisbúnaði
English: Erythroid response was defined according to International Working Group (IWG) 2006 criteria as a haemoglobin increase ≥ 1.5 g/dL from baseline or a reduction of RBC units transfused by an absolute number of at least 4 units every 8 weeks compared to the 8 weeks prior to baseline, and a response duration of at least 8 weeks.
Icelandic: 2006 sem hækkun á blóðrauða um ≥ 1,5 g/dl frá grunngildi eða fækkun á gefnum einingum af rauðum blóðkornum með raunfjölda sem var a.m.k.
English: A pre-filled syringe of 1 mL contains 2,000 international units (IU) corresponding to 16.8 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 1 ml inniheldur 2.000 alþjóðlegar einingar (a.e.) eða 16,8 míkrógrömm af epóetíni alfa.
English: A pre-filled syringe of 1 mL contains 40,000 international units (IU) corresponding to 336.0 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 1 ml inniheldur 40.000 alþjóðlegar einingar (a.e.) eða 336,0 míkrógrömm af epóetíni alfa.
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
Icelandic: 6 áfylltar sprautur með 1 ml 1 áfyllt sprauta með 1 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 1 ml með nálaröryggisbúnaði
English: A pre-filled syringe of 0.4 mL contains 4,000 international units (IU) corresponding to 33.6 micrograms epoetin alfa.
Icelandic: Áfyllt sprauta með 0,4 ml inniheldur 4.000 alþjóðlegar einingar (a.e.) eða 33,6 míkrógrömm af epóetíni alfa.
English: • breathlessness.
Icelandic: • svimatilfinning,
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe Epoetin alfa
Icelandic: Epoetin alfa HEXAL 40.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Epoetin alfa HEXAL 1,000 IU/0.5 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 1.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe
Icelandic: Epoetin alfa HEXAL 2.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: • You may be given iron supplements before and during Epoetin alfa HEXAL treatment to make it more effective.
Icelandic: Hugsanlegt er að þú fáir járnuppbótarmeðferð áður en meðferð með Epoetin alfa HEXAL hefst og meðan á henni stendur til að auka árangur af meðferðinni.
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
Icelandic: 6 áfylltar sprautur með 0,6 ml 1 áfyllt sprauta með 0,6 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,6 ml með nálaröryggisbúnaði
English: Haemoglobin variability should be addressed through dose management, with consideration for the haemoglobin concentration range of 10 g/dL (6.2 mmol/L) to 12 g/dL (7.5 mmol/L).
Icelandic: Breytileika blóðrauðagilda skal stjórna með skömmtum og taka mið af blóðrauðaþéttnibilinu 10 g/dl (6,2 mmól/l) til 12 g/dl (7,5 mmól/l).
English: Epoetin alfa HEXAL 2,000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/411/003
Icelandic: Epoetin alfa HEXAL 2.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/003
English: Kolodvorska 27
Icelandic: Holzkirchen Þýskaland
English: Eighty-one percent of patients achieved the haemoglobin concentration level.
Icelandic: 95% allra sjúklinga svörun í formi klínískt marktækrar hækkunar blóðkornaskila.
English: Presentation
Icelandic: Pakkning
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 7,000 IU/0.7 mL injection Epoetin alfa
Icelandic: Epoetin alfa HEXAL 7.000 a.e./0,7 ml stungulyf Epóetín alfa i.v./s.c.
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
Icelandic: 6 áfylltar sprautur með 0,5 ml 1 áfyllt sprauta með 0,5 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,5 ml með nálaröryggisbúnaði
English: The use of epoetin alfa is not recommended in pregnant surgical patients participating in an autologous blood predonation programme.
Icelandic: Ekki er mælt með notkun epóetíns alfa fyrir konur með barn á brjósti sem taka þátt í undirbúningi eigin blóðgjafar og gangast eiga undir skurðaðgerð.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 8,000 IU/0.8 mL injection Epoetin alfa
Icelandic: Epoetin alfa HEXAL 8.000 a.e./0,8 ml stungulyf Epóetín alfa i.v./s.c.
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
Icelandic: 6 áfylltar sprautur með 0,3 ml 1 áfyllt sprauta með 0,3 ml með nálaröryggisbúnaði 6 áfylltar sprautur með 0,3 ml með nálaröryggisbúnaði
English: Adults scheduled for major orthopaedic surgery
Icelandic: Fullorðnir sem þurfa að gangast undir veigamikla bæklunaraðgerð
English: Epoetin alfa HEXAL 40,000 IU/1 mL solution for injection in a pre-filled syringe EU/1/07/411/025
Icelandic: Epoetin alfa HEXAL 40.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/07/411/025
English: • Redness, burning and pain at the site of injection.
Icelandic: Roði, brunatilfinning og verkir á stungustað.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Epoetin alfa HEXAL 6,000 IU/0.6 mL injection Epoetin alfa
Icelandic: Epoetin alfa HEXAL 6.000 a.e./0,6 ml stungulyf Epóetín alfa i.v./s.c.
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Icelandic: Liðverkir, beinverkir, vöðvaverkir, verkir í útlimum
English: • in adults on haemodialysis or peritoneal dialysis • in severely anaemic adults not yet undergoing dialysis
Icelandic: • við alvarlegu blóðleysi hjá fullorðnum sjúklingum sem ekki eru komnir í skilunarmeðferð.