FrancophonIA/ELRC3.0 huggingface dataset:
English: Silapo 20 000 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 20 000 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 bullustappa með PTFE húð.
English: 1 pre-filled syringe of 0.8 ml solution for injection 6 pre-filled syringes of 0.8 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,8 ml stungulyf, lausn 6 áfylltar sprautur með 0,8 ml stungulyf, lausn
English: MedDRA System Organ Classification (SOC)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe EU/1/07/432/005
Icelandic: Silapo 3 000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/005
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe EU/1/07/432/003
Icelandic: Silapo 2 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/003
English: The starting dose may be adjusted by your doctor until your condition is controlled.
Icelandic: Læknirinn þinn getur aðlagað upphafsskammtinn uns jafnvægi hefur verið náð.
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: If after an additional 4 weeks of therapy at 300 IU/kg 3 times per week, the haemoglobin has increased ≥ 1 g/dl (0.62 mmol/l) or the reticulocyte count has increased ≥ 40 000 cells/µl the dose should remain at 300 IU/kg 3 times per week.
Icelandic: Hafi blóðrauðinn aukist um ≥ 1 g/dl (0,62 mmól/l) eða netfrumum fjölgað ≥ 40 000/µl eftir aðra 4 vikna meðferð með 300 a.e./kg þrisvar í viku á að halda skammtinum í 300 a.e./kg þrisvar í viku.
English: Excipient with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,45 mg fenýlalanín
English: 6.1 List of Excipients
Icelandic: 4.1 Ábendingar
English: Serious skin reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with epoetin treatment.
Icelandic: Í tengslum við epóetín meðferð hefur verið tilkynnt um alvarleg húðviðbrögð, þ.m.t. Stevens-Johnson heilkenni og eitrunardreplos í húðþekju.
English: Silapo 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: Silapo 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: Silapo 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: Silapo 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: Adult surgery patients in an autologous predonation programme
Icelandic: Fullorðnir skurðsjúklingar sem taka þátt í sjálfgjafaráætlun blóðs
English: Excipient with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,30 mg fenýlalanín
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
Icelandic: Tvínatríumfosfatdíhýdrat Natríumtvívetnisfosfatdíhýdrat Natríumklóríð
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 10 000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/432/015
Icelandic: Silapo 10 000 a.e./1 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/015
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 40 000 a.e./1 ml stungulyf, lausn í áfylltri sprautu
English: Silapo 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: Silapo 4 000 a.e./0,4 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,4 ml stungulyf, lausn inniheldur 4 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
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 lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,5 ml stungulyf, lausn inniheldur 5 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Intravenous route
Icelandic: SPRAUTUÁLETRANIR
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 3 000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,9 ml lausn til inndælingar inniheldur 3 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Silapo 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: Silapo 30 000 a.e./0,75 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,75 ml stungulyf, lausn inniheldur 30 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Excipient with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,40 mg fenýlalanín
English: Silapo 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: Silapo 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: Silapo 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: Silapo 20 000 a.e./0,5 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,5 ml stungulyf, lausn inniheldur 20 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 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 6 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu 0,6 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Glycine
Icelandic: Lyfleysa
English: These adverse reactions are most commonly headache and a dose dependent increase in blood pressure.
Icelandic: Algengastar eru höfuðverkur og skammtatengd aukning á blóðþrýstingi.
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 40 000 a.e./1 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 1 ml lausn til inndælingar inniheldur 40 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Following subcutaneous injection, serum levels of erythropoietin are much lower than the levels achieved following intravenous injection, the levels increase slowly and reach a peak between 12 and 18 hours postdose.
Icelandic: Eftir gjöf undir húð mælist rauðkornavakastyrkur í sermi mikið lægri en sá sem fæst eftir dælingu í bláæð.
English: Dose information
Icelandic: Almennar upplýsingar
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 0.6 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 2 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu 0,6 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Silapo 3 000 IU/0.9 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 3 000 a.e./0,9 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,9 ml stungulyf, lausn inniheldur 3 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Glutamic acid
Icelandic: Vaxtarlíkur æxla
English: 1 pre-filled syringe of 0.3 ml solution for injection 6 pre-filled syringes of 0.3 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,3 ml stungulyf, lausn 6 áfylltar sprautur með 0,3 ml stungulyf, lausn
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 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: Respiratory tract congestion
Icelandic: Blóðkalíumhækkun
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 6 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,6 ml lausn til inndælingar inniheldur 6 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Arthralgia, Bone pain, Myalgia, Pain in extremity
Icelandic: Liðbólga, beinverkir, vöðvaverkir, verkur í útlimum
English: Your doctor may initiate treatment with Silapo if your haemoglobin level is 10 g/dl or less.
Icelandic: Notkun hjá fullorðnum sjúklingum sem fá krabbameinslyfjameðferð Hugsanlegt er að læknirinn hefji meðferð með Silapo ef blóðrauðagildi þín eru 10 g/dl eða lægri.
English: Silapo 5 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 5 000 a.e. stungulyf Epoetín zeta
English: A sustained haemoglobin level of greater than 12 g/dl should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Icelandic: Fara skal eftir leiðbeiningum um viðeigandi skammtaaðlögun þegar blóðrauðaþéttni fer yfir 12 g/dl (7,5 mmól/l) eins og fram kemur hér á eftir.
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/432/001
Icelandic: Silapo 1 000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu EU/1/07/432/001
English: Nervous system disorders
Icelandic: Teppa í öndunarvegi
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe Epoetin zeta
Icelandic: Silapo 1 000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu
English: Silapo 40 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 40 000 a.e./1 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 1 ml stungulyf, lausn inniheldur 40 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 0.3 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 1 000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu 0,3 ml lausn í áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð.
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 2 000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,6 ml lausn til inndælingar inniheldur 2 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta* (recombinant human erythropoietin).
Icelandic: Silapo 1 000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,3 ml lausn til inndælingar inniheldur 1 000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Silapo 20 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 20 000 a.e. stungulyf Epoetín zeta
English: Excipient with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,50 mg fenýlalanín
English: Take special care with other products that stimulate red blood cell production: Silapo is one of a group of products that stimulate the production of red blood cells like the human protein erythropoietin does.
Icelandic: Silapo tilheyrir hópi lyfja sem örva myndun rauðra blóðkorna eins og mannapróteinið erýtrópóíetin gerir.
English: in adult patients on peritoneal dialysis to treat symptomatic anaemia associated with chronic renal failure (kidney disease).
Icelandic: Fyrir fullorðna í kviðskilun, til meðferðar blóðskorts með einkennum sem tengist langvinnri nýrnabilun.
English: Silapo may be given during the dialysis session or after you have received a dialysis session.
Icelandic: Gefa má Silapo á meðan á skiluninni stendur eða eftir að skiluninni er lokið.
English: Solution for injection in pre-filled syringe.
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐIR
English: Silapo 8 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 8 000 a.e. stungulyf Epoetín zeta
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 benda einnig stöðugt til marktækt aukinnar, hlutfallslegrar hættu á segareki hjá krabbameinssjúklingum sem fá raðbrigða rauðkornavaka úr mönnum (sjá kafla 4.4).
English: Silapo 6 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 6 000 a.e./0,6 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,6 ml stungulyf, lausn inniheldur 6 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Silapo 10 000 IU/1 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 10 000 a.e./1 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 1 ml stungulyf, lausn inniheldur 10 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Haemoglobin levels should be monitored regularly.
Icelandic: Blóðrauðamagn skal mæla reglulega.
English: 1 pre-filled syringe of 0.4 ml solution for injection 6 pre-filled syringes of 0.4 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,4 ml stungulyf, lausn 6 áfylltar sprautur með 0,4 ml stungulyf, lausn
English: In the indication "increasing the yield of autologous blood": myocardial infarction or stroke in the month preceding treatment, unstable angina pectoris, increased risk of deep venous thrombosis such as history of venous thromboembolic disease.
Icelandic: Hjartadrep eða heilablóðfall mánuðinn fyrir meðferð, hvikul hjartaöng, aukin hætta á bláæðadjúpsegamyndun t.d. saga um segarek í bláæðum.
English: 1 pre-filled syringe of 0.6 ml solution for injection 6 pre-filled syringes of 0.6 ml solution for injection
Icelandic: 1 áfyllt sprauta með 0,6 ml stungulyf, lausn 6 áfylltar sprautur með 0,6 ml stungulyf, lausn
English: This regresses during the course of continued therapy.
Icelandic: Draga mun úr þessu með áframhaldandi meðhöndlun.
English: Silapo 4 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 4 000 a.e. stungulyf Epoetín zeta
English: Silapo 1 000 IU/0.3 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 1 000 a.e/0,3 ml stungulyf, lausn í áfylltri sprautu 1 áfyllt sprauta með 0,3 ml stungulyf, lausn inniheldur 1 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: In chronic renal failure patients, correction for anaemia may lead to increased appetite, and potassium and protein intake.
Icelandic: Úrbætur við blóðleysi geta leitt til aukinnar matarlystar sjúklinga með langvinna nýrnabilun og aukinnar neyslu kalíum og eggjahvítuefna.
English: Uncontrolled hypertension.
Icelandic: Ofnæmisviðbrögð.
English: Silapo 2 000 IU/0.6 ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: Silapo 2 000 a.e/0,6 ml lausn stungulyfs í áfylltri sprautu 1 áfyllt sprauta með 0,6 ml stungulyf, lausn inniheldur 2 000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Common in dialysis
Icelandic: Algeng í skilun
English: Silapo 2 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 2 000 a.e. stungulyf Epoetín zeta
English: Gastrointestinal disorders
Icelandic: Samantektargreiningar á klínískum rannsóknum
English: Paediatric patients on haemodialysis
Icelandic: Sjúklingar á barnsaldri í blóðskilun
English: Silapo 10 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 10 000 a.e. stungulyf Epoetín zeta
English: Mean
Icelandic: Silapo
English: Depending on how the anaemia responds, the dose may be adjusted approximately every 4 weeks until the condition is controlled.
Icelandic: Eftir því hvernig blóðleysið bregst við meðferð má aðlaga skammtinn á u.þ.b. 4 vikna fresti uns jafnvægi hefur verið náð.
English: PC: SN: NN:
Icelandic: PC:
English: Independent of erythropoietin treatment, thrombotic and vascular events may occur in surgical patients with underlying cardiovascular disease following repeated phlebotomy.
Icelandic: Óháð rauðkornavakameðferð geta æðastíflur og æðakvillar komið fram hjá skurðsjúklingum með undirlæga hjarta og æðasjúkdóma í kjölfar endurtekinnar blóðtöku.
English: Maintenance phase: Dose adjustment in order to maintain haemoglobin (Hb) values at the desired level: Hb between 10 and 12 g/dl (6.2-7.5 mmol/l).
Icelandic: Hb á milli 10 og 12 g/dl (6,2-7,5 mmól/l).
English: Non response to erythropoietin therapy should prompt a search for causative factors.
Icelandic: Engin svörun við rauðkornavakameðferð á að kalla á leit að orsökum þess.
English: Silapo 40 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 40 000 a.e. stungulyf Epoetín zeta
English: Chronic renal failure patients
Icelandic: Sjúklingar með langvinna nýrnabilun
English: Silapo 30 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 30 000 a.e. stungulyf Epoetín zeta
English: Silapo 6 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 6 000 a.e. stungulyf Epoetín zeta
English: Haemoglobin concentration
Icelandic: 13. LOTUNÚMER
English: General
Icelandic: Bil
English: Silapo 3 000 IU Injection Epoetin zeta iv/sc use
Icelandic: Silapo 3 000 a.e. stungulyf Epoetín zeta
English: 1 cartridge + 1 pack with 3 pen needles
Icelandic: 1 rörlykja + 1 pakki með 3 pennanálum
English: This should be discussed with your doctor.
Icelandic: Þetta þarf að ræða við lækninn.
English: For additional details see section 4.5.
Icelandic: Fyrir nánari upplýsingar, sjá kafla 4.5.
English: - had a serious heart problem during the past 6 months
Icelandic: - hefur verið með alvarlegan hjartasjúkdóm síðastliðna sex mánuði.
English: Suicide*
Icelandic: Sjálfsvíg*
English: General information about taking this medicine:
Icelandic: Almennar upplýsingar um notkun lyfsins:
English: Genotype 2/3
Icelandic: Arfgerð 2/3
English: - Pregnancy (see sections 4.4, 4.6 and 5.3).
Icelandic: - Meðganga (sjá kafla 4.4, 4.6 og 5.3).
English: • Girl or woman of childbearing age:
Icelandic: Stúlka eða kona á barneignaraldri:
English: In addition some patients may experience vomiting.
Icelandic: Auk þess geta sumir sjúklingar fengið uppköst.
English: You should brush your teeth thoroughly twice daily and have regular dental examinations.
Icelandic: Bursta skal tennurnar vandlega tvisvar á dag og fara reglulega í skoðun hjá tannlækni.
English: There are no data in children or adolescents with a history of cardiac disease.
Icelandic: Engar upplýsingar liggja fyrir um börn og unglinga með sögu um hjartasjúkdóm.
English: No data are available in children below 3 years of age.
Icelandic: Engar upplýsingar liggja fyrir um notkun hjá börnum yngri en 3 ára.
English: Study 22
Icelandic: Rannsókn 22
English: Of these, sixty-three were sustained responders.
Icelandic: Sextíu og þrjú þeirra voru með viðvarandi svörun.
English: Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse.
Icelandic: Því verður reglulega fylgst með blóði þínu til þess að tryggja að HIV sýking versni ekki.
English: In all cases the treatment was for one year with a follow-up of six months.
Icelandic: Í öllum tilfellum stóð meðferðin í eitt ár og eftirfylgni í sex mánuði.
English: • have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.
Icelandic: - ert með HIV (human immunodeficiency virus) eða hefur einhvern tíma haft aðra kvilla í ónæmiskerfinu.
English: Long-term efficacy data - Adults
Icelandic: Upplýsingar um virkni til lengri tíma - fullorðnir
English: Ribavirin was active in the Balb/3T3 in vitro transformation assay.
Icelandic: Ríbavírin var virkt í Balb/3T3 in vitro ummyndunarprófi (transformation assay).
English: If you have this reaction, be sure to rinse your mouth thoroughly afterwards
Icelandic: Ef það gerist verður að skola munninn vandlega á eftir.
English: You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour
Icelandic: Þú gætir íhugað að biðja ættingja eða náinn vin um að hjálpa þér að vera á varðbergi gagnvart einkennum um þunglyndi eða breytingum í hegðun þinni.
English: > 4 mg/dL (adults)
Icelandic: > 4 mg/dl (fullorðnir)
English: < 12 g/dL despite 4 weeks at reduced dose
Icelandic: < 12 g/dl þrátt fyrir 4 vikur á minnkuðum skammti
English: 30 to 50 mL/min
Icelandic: 30 til 50 ml/mín
English: Take/administer the missed dose as soon as possible during the same day.
Icelandic: Taka/gefa skal skammtinn sem gleymdist eins fljótt og auðið er á sama degi.