FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate dose adjustments should be made to maintain haemoglobin concentrations within the target range of 10 g/dl to 12 g/dl (6.2 to 7.5 mmol/l).
Icelandic: Viðeigandi skammtaaðlögun skal gera til að viðhalda blóðrauðaþéttni innan viðmiðunarmarka sem eru 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l).
English: A haemoglobin concentration 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: Adult patients with low- or intermediate-1-risk MDS
Icelandic: Fullorðir sjúklingar með heilkenni mergmisþroska (MDS) með væga- eða miðlungsmikla-1- hættu
English: Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Icelandic: Meðhöndlun blóðleysis og minnkun þarfar á blóðgjöf handa fullorðnum sjúklingum sem fá krabbameinslyfjameðferð við krabbameinsæxli, illkynja eitilæxli eða mergæxlageri og eiga á hættu að þurfa blóðgjöf sem skapast af almennu ástandi sjúklings (þ.e. ástandi hjarta og æða eða blóðleysi sem til staðar var fyrir meðferð).
English: Respiratory tract congestion, which includes events of upper respiratory tract congestion, nasal congestion and nasopharyngitis, have been reported in studies with extended interval dosing in adult patients with renal insufficiency not yet undergoing dialysis.
Icelandic: Tilkynnt hefur verið um teppu í öndunarvegi, þ.m.t. teppu í efri hluta öndunarvegar, teppu í nösum og nefkoksbólgu, í rannsóknum þar sem skammtar voru gefnir með löngu millibili hjá fullorðnum sjúklingum með vanstarfsemi nýrna sem eru ekki í skilunarmeðferð.
English: 6 000 IU/0.6 ml
Icelandic: 6 000 a.e./0,6 ml
English: Depending on how your anaemia responds, the dose may be adjusted approximately every 4 weeks until your condition is controlled.
Icelandic: Eftir því hvernig blóðleysið þitt bregst við má aðlaga skammtinn u.þ.b. á 4 vikna fresti uns stjórn á ástandi þínu hefur verið náð.
English: Common: may affect up to 1 in 10 people
Icelandic: Algengar: geta haft áhrif á allt að 1 af hverjum 10 einstaklingum.
English: Mean haemoglobin levels were similar for the two treatment groups throughout the postsurgical period.
Icelandic: Miðgildi blóðrauðagilda voru svipuð í meðferðarhópunum tveimur eftir aðgerð.
English: 1 pre-filled syringe contains 20 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 20 000 a.e.
English: How to store Silapo
Icelandic: Hvernig geyma á Silapo
English: Silapo should be administered either under the skin (subcutaneously) or as an injection either into a vein or a tube that goes into a vein.
Icelandic: Notkun hjá sjúklingum með nýrnasjúkdóm Silapo á að gefa undir húð eða sem inndælingu annaðhvort í bláæð eða í æðalegg sem fer inn í bláæð.
English: Excipient with known effect Each pre-filled syringe contains 0.38 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,38 mg fenýlalanín
English: Erythropoietin is a growth factor that primarily stimulates red cell production.
Icelandic: Rauðkornavaki er vaxtarþáttur sem fyrst og fremst örvar framleiðslu rauðra blóðkorna.
English: 1 pre-filled syringe contains 8 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 8 000 a.e.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 8 000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu
English: Patients scheduled for major elective orthopaedic surgery should receive adequate antithrombotic prophylaxis, as thrombotic and vascular events may occur in surgical patients, especially in those with underlying cardiovascular disease.
Icelandic: Sjúklingar sem eiga að fara í stóra, valbundna bæklunaraðgerð þurfa fyrirbyggjandi segavarnir við hæfi, þar sem segamyndun og aðrir æðafylgikvillar geta komið fram hjá sjúklingum eftir aðgerð, sér í lagi ef um undirliggjandi hjarta- eða æðasjúkdóm er að ræða.
English: The solution contains 40 000 IU Epoetin zeta per ml.
Icelandic: 40 000 a.e. epoetín zeta í hverjum ml.
English: In patients with chronic renal failure, maintenance haemoglobin concentration should not exceed the upper limit of the target haemoglobin concentration recommended in section 4.2.
Icelandic: Hjá sjúklingum með langvinna nýrnabilun á viðhaldsþéttni blóðrauða ekki að fara fram úr efri blóðrauðamörkum sem stefnt er að og ráðlögð eru í kafla 4.2.
English: Treatment of patients with chemotherapy induced anaemia
Icelandic: Notkun hjá sjúklingum með blóðleysi af völdum krabbameinslyfjameðferðar
English: Subjects were stratified by serum erythropoetin (sEPO) level and prior transfusion status at screening.
Icelandic: Einstaklingum var raðað eftir gildum rauðkornavaka í sermi (sEPO) og stöðu, hvað varðar fyrri blóðgjafir, við skimun.
English: 2 000 IU/0.6 ml
Icelandic: 2 000 a.e./0,6 ml
English: Cases of antibody-mediated PRCA have been very rarely reported in chronic renal failure patients with erythropoietin administered by the subcutaneous route.
Icelandic: Dæmi um rauðkornskímfrumnafæð af mótefnum (antibody-mediated PRCA) hafa komið fram í sjúklingum með langvarandi nýrnabilun sem hafa fengið rauðkornavaka undir húð.
English: Thrombotic/vascular events, such as myocardial ischaemia, myocardial infarction, cerebrovascular accidents (cerebral haemorrhage and cerebral infarction), transient ischaemic attacks, deep vein thrombosis, arterial thrombosis, pulmonary emboli, aneurysms, retinal thrombosis, and clotting of an artificial kidney have been reported in patients receiving erythropoietic agents.
Icelandic: Sega-/æðamein, s.s. hjartablóðþurrð, hjartadrep, heilablóðföll (heilablæðing og heiladrep), skammvinnt blóðþurrðarkast í heila, djúpsegamein, slagæðarsegi, lungnasegarek, slagæðagúlpar, sjónusegamein og storknun í gervinýra hafa verið tilkynnt hjá sjúklingum sem fengið hafa rauðkornavaka.
English: SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk.
Icelandic: Fyrstu einkenni Stevens-Johnson heilkennis og eitrunardreploss í húðþekju geta sést á bolnum sem rauðleitir afmarkaðir eða hringlaga blettir oft með blöðrumyndun í miðjunni.
English: Silapo should also be used with caution in the presence of epilepsy and chronic liver failure.
Icelandic: Einnig á að nota Silapo með varúð þegar um er að ræða flogaveiki eða langvinna lifrarbilun.
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Icelandic: Sjá leiðbeiningar í kafla 6.6 um meðhöndlun lyfsins fyrir gjöf.
English: 1 pre-filled syringe contains 40 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 40 000 a.e.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/432/013
Icelandic: Silapo 8 000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/013
English: 1 pre-filled syringe contains 30 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 30 000 a.e.
English: Pure red cell aplasia Thrombocythemia
Icelandic: Einkenni rauðkornskímfrumnafæðar (pure red cell aplasia, PRCA).
English: 1 pre-filled syringe contains 6 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 6 000 a.e.
English: Severe cutaneous adverse reactions
Icelandic: Alvarleg húðviðbrögð
English: Anti-erythropoeitin antibody positive
Icelandic: Jákvæð mótefni gegn erýtrópóetíni Mjög sjaldgæfar
English: Its use in this indication must be balanced against the reported risk of thromboembolic events.
Icelandic: Notkun með þessum hætti verður að vega gegn mögulegri hættu á segarekstilfellum.
English: Depending on how your anaemia responds to treatment, the dose may be adjusted approximately every 4 weeks until your condition is controlled.
Icelandic: Eftir því hvernig blóðleysið þitt bregst við meðferð má aðlaga skammtinn u.þ.b. á 4 vikna fresti uns jafnvægi er náð.
English: 1 pre-filled syringe of 0.75 ml solution for injection 4 pre-filled syringes of 0.75 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,75 ml stungulyf, lausn 4 áfylltar sprautur með 0,75 ml stungulyf, lausn
English: Erythropoietin is a glycoprotein that stimulates, as a mitosis-stimulating factor and differentiating hormone, the formation of erythrocytes from precursors of the stem cell compartment.
Icelandic: Rauðkornavaki er glýkóprótín sem hvetur, sem mítósuhvataefni og sérhæfingarhormón, myndun rauðra blóðkorna af undanförum stofnfrumu.
English: Isoleucine
Icelandic: Ísóleucín
English: Headache
Icelandic: Ógleði.
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 30 000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu
English: • Cerebral haemorrhages.
Icelandic: Blóðkekkir í gervinýra.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 0.8 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Icelandic: Silapo 8 000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu 0,8 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: 1 pre-filled syringe contains 2 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 2 000 a.e.
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 4 000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu
English: 1 pre-filled syringe contains 4 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 4 000 a.e.
English: An increased
Icelandic: Æðar
English: Each pack contains 1 or 4 pre-filled syringes.
Icelandic: 1 eða 4 áfylltar sprautur.
English: After administration of erythropoietin, the number of erythrocytes, the Hb values and reticulocyte counts increase as well as the
Icelandic: Eftir gjöf rauðkornavaka er fjöldi rauðra blóðkorna talinn, Hb gildi og fjöldaaukning netfrumna sem og
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 5 000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: o Treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4).
Icelandic: o Meðhöndlun blóðleysis sem tengist langvinnri nýrnabilun hjá fullorðnum og börnum í blóðskilun og fullorðunum í kviðskilun (sjá kafla 4.4).
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 verið lífshættuleg eða banvæn, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju.
English: 1 pre-filled syringe contains 10 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 10 000 a.e.
English: Serum electrolytes should be monitored in chronic renal failure patients.
Icelandic: Blóðsöltum þarf að fylgjast með hjá sjúklingum með langvinna nýrnabilun.
English: There may be a moderate dose-dependent rise in the platelet count within the normal range during treatment with erythropoietin.
Icelandic: Hófleg skammtaháð hækkun á blóðflögfjölda innan eðlilegra marka getur orðið meðan á meðferð með rauðkornavaka stendur.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 8 000 a.e./0,8 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,8 ml lausn til inndælingar inniheldur 8 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: - blood clotting (thrombotic vascular events) (see section “Warnings and precautions”).
Icelandic: Krabbameinssjúklingar, þ.m.t. fullorðnir sjúklingar með heilkenni mergmisþroska - Blóðkekkjun (æðasegamyndun) (sjá kaflann „Varnaðarorð og varúðarreglur“).
English: The rate of increase in haemoglobin should be approximately 1 g/dl (0.62 mmol/l) per month and should not exceed 2 g/dl (1.25 mmol/l) per month to minimise the risk of developing or worsening of hypertension.
Icelandic: Hraði blóðrauðaaukningarinnar á að vera u.þ.b. 1 g/dl (0,62 mmól/l) á mánuði til að lágmarka hættuna á þróun eða aukningu háþrýstings.
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe 0.75 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Icelandic: Silapo 30 000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu 0,75 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Silapo 8 000 IU/0.8 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 8 000 a.e./0,8 ml lausn stungulyfs í áfylltri sprautu 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 contains 3 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 3 000 a.e.
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/009
Icelandic: Silapo 5 000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/009
English: Clear, colourless solution.
Icelandic: Stungulyf, lausn til í áfylltri sprautu Glær, litarlaus lausn.
English: Each pack contains 1 or 6 pre-filled syringes.
Icelandic: 1 eða 6 áfylltar sprautur.
English: Excipient with known effect Each pre-filled syringe contains 0.20 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,20 mg fenýlalanín
English: Anaphylactic reaction
Icelandic: Ofnæmisviðbrögð
English: Haemoglobin variability should be addressed through dose management with consideration for the haemoglobin target range of 10 g/dl (6.2 mmol/l) to 12 g/dl (7.5 mmol/l).
Icelandic: Taka skal á mismunandi blóðrauðagildum með skammtastjórnun og miða skal við blóðrauðamarkþéttnina 10 g/dl (6,2 mmól/l) til 12 g/dl (7,5 mmól/l).
English: The dose should be administered over at least 1-5 minutes, depending on the total dose.
Icelandic: 1-5 mínútum, eftir því hver heildarskammturinn er.
English: Hypertensive crisis with encephalopathylike symptoms can occur.
Icelandic: Háþrýstingskreppa með einkennum líkum heilakvilla getur átt sér stað.
English: There is no accumulation: the levels remain the same, whether they are determined 24 hours after the first injection or 24 hours after the last injection.
Icelandic: Þéttni er sú sama hvort sem mæld eru 24 klst.
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/011
Icelandic: Silapo 6 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/011
English: 1 pre-filled syringe of 0.5 ml solution for injection 4 pre-filled syringes of 0.5 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,5 ml stungulyf, lausn 4 áfylltar sprautur með 0,5 ml stungulyf, lausn
English: Good injection sites are the top of the thigh and around the tummy (abdomen) but away from the navel.
Icelandic: Góður stungustaður er á ofanverðu læri eða á maganum ekki of nálægt naflanum.
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 20 000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu
English: Cytotoxic actions of erythropoietin on bone marrow cells could not be detected.
Icelandic: Engin frumudrepandi áhrif rauðkornavaka á beinmergsfrumurr sáust.
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 3 000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu
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. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju.
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 6 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu
English: 1 pre-filled syringe of 1 ml solution for injection 4 pre-filled syringes of 1 ml solution for injection
Icelandic: 1 áfyllt sprauta með 1 ml stungulyf, lausn 4 áfylltar sprautur með 1 ml stungulyf, lausn
English: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe 0.4 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Icelandic: Silapo 4 000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu 0,4 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: The recommended starting dose is 50 IU/kg.
Icelandic: Ráðlagður skammtur er 50 a.e./kg.
English: If an elevated (or rising) serum potassium level is detected, your doctor may consider to stop the treatment with Silapo until the level is back to normal.
Icelandic: Ef blóðvatnskalíummagn er hátt (eða hækkandi) á að íhuga að hætta Silapogjöf þar til blóðvatnskalíummagnið hefur verið leiðrétt.
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: Silapo 4 000 IU/0.4 ml solution for injection in pre-filled syringe EU/1/07/432/007
Icelandic: Silapo 4 000 a.e./0,4 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/007
English: Silapo must not be administered by intravenous infusion.
Icelandic: Silapo má ekki gefa sem bláæðadreypilyf.
English: • Respiratory tract congestion, such as stuffy nose and sore throat, has been reported in patients with kidney disease not yet on dialysis.
Icelandic: Tilkynnt hefur verið um teppu í öndunarvegi, svo sem nefstíflu og hálsbólgu, hjá sjúklingum með nýrnasjúkdóm sem enn þurfa ekki á skilunarmeðferð að halda.
English: The starting dose is 450 IU per kilogram bodyweight once a week.
Icelandic: Einnig má gefa upphaflegan Silapo skammt 450 a.e./kg undir húð einu sinni í viku.
English: Patients scheduled for major elective orthopaedic surgery
Icelandic: Sjúklingar sem eiga að fara í meiriháttar bæklunarvalaðgerð
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 2 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 0.9 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Icelandic: Silapo 3 000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu 0,9 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Excipient with known effect Each pre-filled syringe contains 0.25 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,25 mg fenýlalanín
English: These reports are based on in vitro findings from human tumour samples, but are of uncertain significance in the clinical situation.
Icelandic: Misvísandi álit um hvort rauðkornavaki gegni mikilvægu hlutverki sem vaxtarþáttur æxla hafa komið fram í birtum vísindagreinum, sem byggja á in vitro niðurstöðum úr æxlissýnum úr mönnum, en óvíst er um klínískt vægi þeirra.
English: Adult surgery patients in an autologous predonation programme.
Icelandic: Meðferð fyrir skurðaðgerð hjá fullorðnum sjúklingum sem taka þátt í sjálfsgjafaráætlun blóðs
English: Use in adult patients receiving haemodialysis Your doctor will maintain your haemoglobin concentration between 10 and 12 g/dl (6.2 - 7.5 mmol/l).
Icelandic: Læknirinn mun viðhalda blóðrauðagildum þínum á bilinu 10 til 12 g/dl (6,2 - 7,5 mmól/l).
English: Use in adult patients receiving chemotherapy
Icelandic: Notkun hjá fullorðnum sjúklingum með heilkenni mergmisþroska
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Icelandic: Samantekt á aukaverkunum, settar upp í töflu
English: Silapo should be withheld when the haemoglobin concentration exceeds 12 g/dl (7.5 mmol/l).
Icelandic: Gera skal hlé á gjöf Silapo þegar blóðrauðaþéttni er meiri en 12 g/dl (7,5 mmól/l).
English: Silapo 5 000 IU/0.5 ml solution for injection in pre-filled syringe 0.5 ml solution for injection in pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating.
Icelandic: Silapo 5 000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu 0,5 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Excipient with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,15 mg fenýlalanín
English: Silapo 20 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/432/017
Icelandic: Silapo 20 000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/017
English: 1 pre-filled syringe of 0.9 ml solution for injection 6 pre-filled syringes of 0.9 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,9 ml stungulyf, lausn 6 áfylltar sprautur með 0,9 ml stungulyf, lausn
English: Silapo 6 000 IU
Icelandic: 6.2 Ósamrýmanleiki
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/019
Icelandic: Silapo 40 000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/019
English: Silapo 30 000 IU/0.75 ml solution for injection in pre-filled syringe EU/1/07/432/018
Icelandic: Silapo 30 000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/018
English: 1 pre-filled syringe contains 1 000 IU Epoetin zeta
Icelandic: 1 áfyllt sprauta inniheldur 1 000 a.e.
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 (see section 4.4).
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðviðbrögð (SCARs), sem geta verið lífshættuleg eða banvæn, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju (sjá kafla
English: Maintenance phase: During the maintenance phase, Silapo can be administered either 3 times per week, and in the case of subcutaneous administration, once weekly or once every 2 weeks.
Icelandic: Á viðhaldsstigi má gefa Silapo annaðhvort 3 sinnum í viku, eða annaðhvort vikulega eða aðra hverja viku ef lyfið er gefið undir húð.
English: Other medicines and Silapo
Icelandic: 1 000 a.e. Silapo
English: What you need to know before you use Silapo
Icelandic: Áður en byrjað er að nota Silapo
English: 1 pre-filled syringe of 1 ml solution for injection 6 pre-filled syringes of 1 ml solution for injection
Icelandic: 1 áfyllt sprauta með 1 ml stungulyf, lausn 6 áfylltar sprautur með 1 ml stungulyf, lausn
English: Silapo 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: Silapo 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: 1 pre-filled syringe of 0.5 ml solution for injection 6 pre-filled syringes of 0.5 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,5 ml stungulyf, lausn 6 áfylltar sprautur með 0,5 ml stungulyf, lausn