FrancophonIA/ELRC3.0 huggingface dataset:
English: In chronic renal failure patients, the half-life of intravenously administered erythropoietin is slightly prolonged, approximately 5 hours, compared to healthy subjects.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun er helmingunartími rauðkornavaka sem gefinn er í bláæð lítillega lengri, u.þ.b. 5 klst., samanborið við heilbrigða einstaklinga.
English: Retacrit 1 000 IU
Icelandic: Retacrit 1.000 a.e.
English: An increased incidence of thrombotic vascular events (TVEs) has been observed in patients receiving ESAs (see section 4.4).
Icelandic: Aukin tíðni blóðsegamyndunar (thrombotic vascular events) hefur komið fram hjá krabbameinssjúklingum sem fengið hafa ESA lyf (sjá kafla 4.4)
English: In paediatric patients with chronic renal failure where intravenous access is routinely available (haemodialysis patients) administration of Retacrit by the intravenous route is preferable.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun þar sem aðgangur í bláæð er fyrir hendi að staðaldri (sjúklingar í blóðskilun) er æskilegt að gefa Retacrit í bláæð.
English: 6 000 IU/0.6 ml
Icelandic: 6.000 a.e./0,6 ml
English: Retacrit 10 000 IU
Icelandic: Retacrit 10.000 a.e.
English: The injections should be given in the limbs or the anterior abdominal wall.
Icelandic: Inndælingar skal gefa í útlimi eða framanverðan kvið.
English: If the haemoglobin concentration has increased by at least 1 g/dL (0.62 mmol/L) or the reticulocyte count has increased ≥ 40 000 cells/µL above baseline after 4 weeks of treatment, the dose should remain at 150 IU/kg 3 times per week or 450 IU/kg once weekly.
Icelandic: 1 g/dl (0,62 mmól/l) eða netfrumufjöldinn um ≥ 40.000 frumur/µl yfir grunngildi eftir 4 vikna meðferð á að halda áfram að gefa 150 a.e./kg 3 sinnum í viku eða 450 a.e./kg einu sinni í viku.
English: 1 pre-filled syringe without needle guard containing 0.75 ml solution for injection 4 pre-filled syringes without needle guard containing 0.75 ml solution for injection 6 pre-filled syringes without needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle guard containing 0.75 ml solution for injection 4 pre-filled syringes with needle guard containing 0.75 ml solution for injection 6 pre-filled syringes with needle guard containing 0.75 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.75 ml solution for injection 4 pre-filled syringes with needle-trap containing 0.75 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.75 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,75 ml stungulyf, lausn 4 áfylltar sprautur án nálaröryggisbúnaðar með 0,75 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,75 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,75 ml stungulyf, lausn 4 áfylltar sprautur með nálaröryggisbúnaði með 0,75 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,75 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,75 ml stungulyf, lausn 4 áfylltar sprautur með nálargildru með 0,75 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,75 ml stungulyf, lausn
English: Epoetin zeta should be withheld when the haemoglobin concentration exceeds 12 g/dL (7.5 mmol/L).
Icelandic: Gera skal hlé á gjöf epóetíns zeta þegar blóðrauðaþéttni er meiri en 12 g/dl (7,5 mmól/l).
English: 1 pre-filled syringe contains 8 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 8.000 a.e. epoetín zeta.
English: Your pre-filled syringe has a passive needle guard device attached to it in order to protect you from needle stick injury.
Icelandic: Áfyllta sprautan er með áfastan öryggisbúnað fyrir nálina til að koma í veg fyrir nálarstungur fyrir slysni.
English: A half-life of approximately 6.2 to 8.7 hours has been reported in paediatric subjects with chronic renal failure following multiple dose intravenous administration of erythropoietin.
Icelandic: 6,2 til 8,7 klst. helmingunartíma hjá börnum með langvinna nýrnabilun eftir gjöf margra skammta af rauðkornavaka í bláæð.
English: • If you are due to have major elective orthopaedic surgery (such as hip or knee surgery), and you:
Icelandic: Eef þú ferð fljótlega í meiriháttar valbundna bæklunarkurðaðgerð (t.d. skipti á mjöðm eða hné) og þú:
English: Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Retacrit 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,75 ml lausn til inndælingar inniheldur 30.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Treatment of paediatric patients scheduled for major elective orthopaedic surgery
Icelandic: Meðferð hjá börnum sem eiga að fara í meiriháttar bæklunarvalaðgerð (elective orthopaedic surgery)
English: These include venous and arterial thrombosis and embolism (including some with fatal outcomes), such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, and myocardial infarction.
Icelandic: Meðal annars segamyndun í slagæðum og blóðrek (þar á meðal nokkur banvæn tilvik), svo sem segamyndun í djúpbláæðum, segarek í lungum, segamyndun í sjónu og hjartadrep.
English: Where intravenous access is not readily available Retacrit may be administered subcutaneously.
Icelandic: Þegar aðgengi í bláæð er ekki fyrir hendi má gefa Retacrit undir húð.
English: In the 16-week study (n=222), in the epoetin alfa-treated patients there was no statistically significant effect on patient-reported or parent-reported Paediatric Quality of Life Inventory or Cancer Module scores compared with placebo (primary efficacy endpoint).
Icelandic: Í 16 vikna rannsókninni (n=222) komu engin tölfræðilega marktæk áhrif fram hjá sjúklingum sem fengu epóetín alfa skv.
English: This includes patients on dialysis and patients not yet on dialysis.
Icelandic: Þetta á meðal annars við um sjúklinga sem eru í blóðskilun og sjúklinga sem eru ekki byrjaðir í blóðskilun.
English: • The starting dose is either 150 IU per kilogram bodyweight three times a week or 450 IU per kilogram bodyweight once a week.
Icelandic: Upphafsskammtur er annaðhvort 150 a.e. á hvert kílógramm líkamsþyngdar þrisvar í viku eða 450 a.e.
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 3.000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu Retacrit 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu Retacrit 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Retacrit 6.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu Retacrit 8.000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu Retacrit 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu Retacrit 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Retacrit 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu Retacrit 40.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: 2 000 IU/0.6 ml
Icelandic: 2.000 a.e./0,6 ml
English: Following subcutaneous injection, serum levels of erythropoietin reach a peak between 12 and 18 hours post-dose.
Icelandic: Eftir gjöf undir húð nær rauðkornavakastyrkur í sermi hámarki á milli 12 og 18 klst. eftir gjöf.
English: Retacrit should be administered in order to increase haemoglobin to not greater than 12 g/dL (7.5 mmol/L).
Icelandic: Gefa skal Retacrit til að hækka blóðrauðagildi en ekki umfram 12 g/dl (7,5 mmól/l).
English: The initial dose is 150 IU/kg subcutaneously, 3 times per week.
Icelandic: Upphafsskammtur er 150 a.e./kg undir húð, 3 sinnum í viku.
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: 3.000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu Retacrit 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu Retacrit 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Retacrit 6.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu Retacrit 8.000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu Retacrit 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu Retacrit 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu Retacrit 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu Retacrit 40.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: 1 pre-filled syringe contains 5 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 5.000 a.e. epoetín zeta.
English: Push it slowly and evenly, keeping the skin fold pinched.
Icelandic: Þrýstið hægt og með jöfnum hraða og klípið um húðfellinguna allan tímann.
English: Common in dialysis Includes arterial and venous, fatal and non fatal events, such as deep venous thrombosis, pulmonary emboli, retinal thrombosis, arterial thrombosis (including myocardial infarction), cerebrovascular accidents (including cerebral infarction and cerebral haemorrhage) transient ischaemic attacks, and shunt thrombosis (including dialysis equipment) and thrombosis within arteriovenous shunt aneurisms Addressed in the subsection below and/or in section 4.4
Icelandic: heilaáföll (þ.m.t. fleygdrep í heila og heilablæðing), skammvinn blóðþurrðarköst og segamyndun í hjáveitu (þ.m.t. í skilunarbúnaði) og segamyndun innan slagæðargúlps í slag- og bláæðarveitu (arteriovenous shunt aneurism)
English: Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,5 ml lausn til inndælingar inniheldur 5.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Solution for injection in pre-filled syringe (injection).
Icelandic: Stungulyf, lausn í áfylltri sprautu (stungulyf).
English: 1 pre-filled syringe contains 6 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 6.000 a.e. epoetín zeta.
English: After EPO binds to its cell surface receptor, it activates signal transduction pathways that interfere with apoptosis and stimulates erythroid cell proliferation.
Icelandic: Eftir að EPO hefur bundist frumuyfirborðsviðtaka, virkjar þaðumbreytingarferla sem hafa áhrif á stýrðan frumudauða og örva fjölgun rauðra blóðkorna.
English: Multipacks contain 4 (4 x 1) pre-filled syringes.
Icelandic: Fjölpakkning inniheldur 4 (4 pakkar með 1) áfylltar sprautur.
English: Treatment of adult patients with chemotherapy-induced anaemia
Icelandic: Meðferð hjá fullorðnum sjúklingum með blóðleysi af völdum krabbameinslyfjameðferðar
English: Retacrit 30 000 IU
Icelandic: Retacrit 30.000 a.e.
English: Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,4 ml lausn til inndælingar inniheldur 4.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: • if there has been a refrigerator failure.
Icelandic: • ef kælirinn hefur bilað.
English: Cancer patients being treated with epoetin zeta should have haemoglobin levels measured on a regular basis until a stable level is achieved, and periodically thereafter.
Icelandic: Mæla skal reglulega blóðrauðagildi krabbameinssjúklinga sem fá meðferð með epóetín zeta þar til stöðugum gildum hefur verið náð, og með jöfnu millibili eftir það.
English: Additionally, cerebrovascular accidents (including cerebral infarction, cerebral haemorrhage and transient ischaemic attacks) have been reported.
Icelandic: Auk þess hefur verið greint frá heilaslagi (þ.m.t. heilablóðfall, heilablæðing og skammvinn blóðþurrðarköst).
English: 1 pre-filled syringe contains 20 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 20.000 a.e. epoetín zeta.
English: Each pre-filled syringe contains 0.8 ml solution.
Icelandic: Hver áfyllt sprauta inniheldur 0,8 ml lausn.
English: Excipients with known effect Each pre-filled syringe contains 0.38 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,38 mg fenýlalanín.
English: Each pre-filled syringe contains 0.9 ml solution.
Icelandic: Hver áfyllt sprauta inniheldur 0,9 ml lausn.
English: Each pre-filled syringe contains 0.5 ml solution.
Icelandic: Hver áfyllt sprauta inniheldur 0,5 ml lausn.
English: Meta-analyses also indicate consistently a significantly increased relative risk of thromboembolic events in cancer patients receiving recombinant human erythropoietin (see section
Icelandic: Safngreining bendir einnig staðfastlega til marktækt aukinnar hlutfallslegrar hættu á segamyndun hjá krabbameinssjúklingum sem fá raðbrigða rauðkornavaka manna (sjá kafla 4.4).
English: The half-life for the subcutaneous route is estimated to be approximately 24 hours in healthy subjects.
Icelandic: Helmingunartími eftir gjöf undir húð er áætlaður u.þ.b. 24 klst. hjá heilbrigðum einstaklingum.
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 geta blóðrauðagildi einstaka sjúklings stundum farið yfir eða undir æskilega þéttni blóðrauða.
English: Renal impairment
Icelandic: Langvinn nýrnabilun
English: 1 pre-filled syringe contains 40 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 40.000 a.e. epoetín zeta.
English: 1 pre-filled syringe without needle guard containing 0.8 ml solution for injection 6 pre-filled syringes without needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle guard containing 0.8 ml solution for injection 6 pre-filled syringes with needle guard containing 0.8 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.8 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.8 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,8 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,8 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,8 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,8 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,8 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,8 ml stungulyf, lausn
English: Retacrit 30 000 IU/0.75ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: Retacrit 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Multipacks contain 6 (6 x 1) pre-filled syringes.
Icelandic: Fjölpakkning inniheldur 6 (6 pakkar með 1) áfylltar sprautur.
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 8.000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Retacrit 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,5 ml lausn til inndælingar inniheldur 20.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: In all patients, haemoglobin levels should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at haemoglobin levels above the concentration range for the indication of use.
Icelandic: Fylgjast skal náið með blóðrauðagildum hjá öllum sjúklingum vegna þess aðr hættan á blóðsegamyndun og dauðsföllum getur verið aukin þegar sjúklingar með blóðrauðagildi yfir ráðlögðu þéttnibili fá meðferð.
English: The half-life of erythropoietin following multiple dose intravenous administration is approximately 4 hours in healthy subjects.
Icelandic: Helmingunartími rauðkornavaka eftir endurtekna skammta í bláæð er u.þ.b. 4 klst. hjá heilbrigðum einstaklingum.
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 blóðrauðaþéttni á bilinu 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l)
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: Retacrit 20.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Of a total 3 417 subjects in 25 randomised, double-blinded, placebo or standard of care controlled studies, the overall safety profile of epoetin alfa was evaluated in 2 094 anaemic subjects.
Icelandic: Aukaverkanamynstur epóetín alfa var metið hjá 2.094 sjúklingum með blóðleysi í 25 slembiröðuðum, tvíblindum rannsóknum með samanburði við lyfleysu eða staðlaða meðferð, sem alls 3.417 einstaklingar tóku þátt í.
English: Epoetins are growth factors that primarily stimulate red blood cell (RBC) production.
Icelandic: Rauðkornavaki er vaxtarþáttur sem fyrst og fremst örvar framleiðslu rauðra blóðkorna.
English: 1 pre-filled syringe contains 30 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 30.000 a.e. epoetín zeta.
English: A sustained haemoglobin level of greater than 12 g/dL (7.5 mmol/L) should be avoided.
Icelandic: Forðast skal blóðrauðaþéttni sem er hærri en 12 g/dl (7,5 mmól/l).
English: 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,8 ml stungulyf, lausn inniheldur 8.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: 1 pre-filled syringe without needle guard containing 0.5 ml solution for injection 4 pre-filled syringes without needle guard containing 0.5 ml solution for injection 6 pre-filled syringes without needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle guard containing 0.5 ml solution for injection 4 pre-filled syringes with needle guard containing 0.5 ml solution for injection 6 pre-filled syringes with needle guard containing 0.5 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.5 ml solution for injection 4 pre-filled syringes with needle-trap containing 0.5 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.5 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,5 ml stungulyf, lausn 4 áfylltar sprautur án nálaröryggisbúnaðar með 0,5 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,5 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,5 ml stungulyf, lausn 4 áfylltar sprautur með nálaröryggisbúnaði með 0,5 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,5 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,5 ml stungulyf, lausn 4 áfylltar sprautur með nálargildru með 0,5 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,5 ml stungulyf, lausn
English: Excipients with known effect Each pre-filled syringe contains 0.20 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,20 mg fenýlalanín.
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 bendir til þess að dreifingarrúmmálið sé u.þ.b. 1,5 til 2 sinnum meira hjá fyrirburum en hjá heilbrigðum fullorðnum einstaklingum og að úthreinsun sé u.þ.b. 3 sinnum meiri hjá fyrirburum en hjá heilbrigðum fullorðnum einstaklingum.
English: 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.
Icelandic: Einkenni og afleiðingar blóðleysis geta verið mismunandi eftir aldri, kyni og sjúkdómsbyrði.
English: 1 pre-filled syringe with 0.75 ml solution for injection contains 30 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,75 ml stungulyf, lausn inniheldur 30.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 4.000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Each pre-filled syringe contains 0.3 ml solution.
Icelandic: Hver áfyllt sprauta inniheldur 0,3 ml lausn.
English: Hypersensitivity reactions, including cases of rash (including urticaria), anaphylactic reactions, and angioneurotic oedema have been reported (see section 4.4).
Icelandic: Tilkynnt hefur verið um ofnæmisviðbrögð, þ.m.t. tilfelli um útbrot (m.a. ofsakláði), bráðaofnæmisviðbrögð og ofnæmisbjúg (sjá kafla 4.4).
English: Diarrhoea, Nausea, Vomiting Very common
Icelandic: Niðurgangur, ógleði, uppköst
English: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Retacrit 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 1 ml lausn til inndælingar inniheldur 10.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
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 á öllum stigum þróunar rauðra blóðkorna og helstu áhrif þess eru við myndun forvera rauðra blóðkorna.
English: Erythropoietin (EPO) is a glycoprotein hormone produced primarily by the kidney in response to hypoxia and is the key regulator of red blood cell (RBC) production.
Icelandic: Rauðkornavaki (EPO) er glýkópróteinhormón aðallega framleitt í nýrum sem svörun við súrefnisskorti og er það efni sem helst stýrir framleiðslu rauðra blóðkorna.
English: 1 pre-filled syringe contains 1 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 1.000 a.e. epoetín zeta.
English: 1 pre-filled syringe with 0.5 ml solution for injection contains 5 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,5 ml stungulyf, lausn inniheldur 5.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).