FrancophonIA/ELRC3.0 huggingface dataset:
English: A paradoxical decrease in haemoglobin and development of severe anaemia associated with low reticulocyte counts should prompt to discontinue treatment with epoetin zetaand perform anti-erythropoietin antibody testing.
Icelandic: Mótsagnakennd lækkun blóðrauða og þróun alvarlegs blóðleysis í tengslum við lágan netfrumufjölda eiga að knýja á um að meðferð með epóetín alfa sé stöðvuð og að prófað verði fyrirandrauðkornavakamótefni.
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 að framgangi sjúkdóms samkvæmt mati óháðrar nefndar var 8,0 mánuðir hjá hópnum sem fékk epóetín alfa ásamt hefðbundinni meðferð og 8,3 mánuðir hjá hópnum sem fékk eingöngu hefðbundna meðferð (HR 1,033; 95% CI: 0,924; 1,156).
English: Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 5.000 a.e./0,5 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Treatment of patients with chemotherapy-induced anaemia
Icelandic: Meðferð sjúklinga með blóðleysi af völdum krabbameinslyfja
English: • If you are allergic to epoetin zeta or any of the other ingredients of this medicine (listed in section
Icelandic: Ekki má nota Retacrit: • ef um er að ræða ofnæmi fyrir epóetín zeta eða öðrum innihaldsefnum lyfsins (talin upp í kafla 6).
English: 1 pre-filled syringe without needle guard containing 0.9 ml solution for injection 6 pre-filled syringes without needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle guard containing 0.9 ml solution for injection 6 pre-filled syringes with needle guard containing 0.9 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.9 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.9 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,9 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,9 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,9 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,9 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,9 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,9 ml stungulyf, lausn
English: 1 pre-filled syringe without needle guard containing 1 ml solution for injection 4 pre-filled syringes without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection 4 pre-filled syringes with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection 4 pre-filled syringes with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 1 ml stungulyf, lausn 4 áfylltar sprautur án nálaröryggisbúnaðar með 1 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 1 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 1 ml stungulyf, lausn 4 áfylltar sprautur með nálaröryggisbúnaði með 1 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 1 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 1 ml stungulyf, lausn 4 áfylltar sprautur með nálargildru með 1 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 1 ml stungulyf, lausn
English: Excipients with known effect Each pre-filled syringe contains 0.25 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,25 mg fenýlalanín.
English: 1 pre-filled syringe contains 2 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 2.000 a.e. epoetín zeta.
English: Use an antiseptic swab on the injection site, to disinfect it.
Icelandic: Settu notuðu sprautuna í nálaboxið.
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: Retacrit 40.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: Haemoglobin levels should be monitored regularly.
Icelandic: Blóðrauðagildi skal mæla reglulega.
English: Each pre-filled syringe contains 0.4 ml solution.
Icelandic: Hver áfyllt sprauta inniheldur 0,4 ml lausn.
English: Excipients with known effect Each pre-filled syringe contains 0.15 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,15 mg fenýlalanín.
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 kjörþéttni blóðrauða er á bilinu 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l).
English: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: Retacrit 10.000 a.e./1 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: What you need to know before you use Retacrit
Icelandic: Áður en byrjað er að nota Retacrit
English: 1 pre-filled syringe contains 4 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 4.000 a.e. epoetín zeta.
English: 1 pre-filled syringe contains 3 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 3.000 a.e. epoetín zeta.
English: • Retacrit is used to treat symptomatic anaemia caused by kidney disease
Icelandic: Retacrit er notað til að meðhöndla blóðleysi með einkennum af völdum nýrnasjúkdóms
English: Anaemia symptoms and sequelae may vary with age, gender and co-morbid medical conditions; 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 öðrum samhliða sjúkdómum.
English: More severe cases have been observed with long-acting epoetins.
Icelandic: Greint hefur verið frá alvarlegri tilvikum með langverkandi epóetín-lyfjum.
English: 1 pre-filled syringe with 0.5 ml solution for injection contains 20 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,5 ml stungulyf, lausn inniheldur 20.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Adults on chemotherapy
Icelandic: Fullorðnir sem fá krabbameinslyfjameðferð
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe
Icelandic: 8.000 a.e./0,8 ml lausn stungulyfs í áfylltri sprautu
English: EU/1/07/431/077 4 pre-filled syringes with needle-trap EU/1/07/431/078 6 pre-filled syringes with needle-trap
Icelandic: EU/1/07/431/061 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)
English: Excipients with known effect Each pre-filled syringe contains 0.45 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,45 mg fenýlalanín.
English: 1 pre-filled syringe with 0.4 ml solution for injection contains 4 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,4 ml stungulyf, lausn inniheldur 4.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 3.000 a.e./0,9 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
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: Taka skal á mismunandi blóðrauðagildum með skammtastjórnun og miða skal við blóðrauðaþéttnina 10 g/dl (6,2 mmól/l) til 12 g/dl (7,5 mmól/l).
English: The needle guard will NOT activate unless the ENTIRE dose has been given.
Icelandic: EKKI fyrr en ALLUR skammturinn hefur verið gefinn.
English: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 6.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: 1 pre-filled syringe with 0.9 ml solution for injection contains 3 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,9 ml stungulyf, lausn inniheldur 3.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe EU/1/07/431/017 1 pre-filled syringe EU/1/07/431/020 4 pre-filled syringes EU/1/07/431/021 6 pre-filled syringes EU/1/07/431/042 1 pre-filled syringe with needle guard EU/1/07/431/045 4 pre-filled syringes with needle guard EU/1/07/431/046 6 pre-filled syringes with needle guard EU/1/07/431/051 6 (6 x 1) pre-filled syringes (multipack) EU/1/07/431/070 1 pre-filled syringe with needle-trap EU/1/07/431/071 4 pre-filled syringes with needle-trap EU/1/07/431/072 6 pre-filled syringes with needle-trap
Icelandic: EU/1/07/431/042 1 áfyllt sprauta með nálaröryggisbúnaði EU/1/07/431/045 4 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/046 6 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/051 6 (6 x 1) áfylltar sprautur (fjölpakkning) EU/1/07/431/070 1 áfyllt sprauta með nálaröryggisbúnaði (nálargildra) EU/1/07/431/071 4 áfylltar sprautur með nálaröryggisbúnaði (nálargildra) EU/1/07/431/072 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)
English: 1 pre-filled syringe with 0.6 ml solution for injection contains 6 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,6 ml stungulyf, lausn inniheldur 6.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: 1 pre-filled syringe with 1 ml solution for injection contains 40 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 1 ml lausn til inndælingar inniheldur 40.000 alþjóðlegar einingar (a.e.) epoetín zeta* (raðbrigða rauðkornavaki manna; recombinant erythropoietin).
English: Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe
Icelandic: Retacrit 30.000 a.e./0,75 ml stungulyf, lausn í áfylltri sprautu
English: Retacrit 4 000 IU/0.4 ml solution for injection in pre-filled syringe
Icelandic: 4.000 a.e./0,4 ml lausn stungulyfs í áfylltri sprautu
English: Retacrit 20 000 IU/0.5 ml solution for injection in pre-filled syringe
Icelandic: Retacrit 20.000 a.e./0,5 ml lausn stungulyfs í áfylltri sprautu
English: Excipients with known effect Each pre-filled syringe contains 0.30 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,30 mg fenýlalanín.
English: Multipack: 4 (4 x 1) pre-filled syringes.
Icelandic: 4 (4 pakkar með 1) áfylltar sprautur.
English: 1 pre-filled syringe 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 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 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 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,5 ml stungulyf, lausn 1 áfyllt sprauta 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 6 áfylltar sprautur með nálargildru með 0,5 ml stungulyf, lausn
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 2.000 a.e./0,6 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: 1 pre-filled syringe without needle guard containing 0.4 ml solution for injection 6 pre-filled syringes without needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle guard containing 0.4 ml solution for injection 6 pre-filled syringes with needle guard containing 0.4 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.4 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.4 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,4 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,4 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,4 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,4 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,4 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,4 ml stungulyf, lausn
English: 1 pre-filled syringe contains 10 000 IU epoetin zeta.
Icelandic: 1 áfyllt sprauta inniheldur 10.000 a.e. epoetín zeta.
English: In addition, thrombocythaemia above the normal range has been reported.
Icelandic: Þar að auki hefur verið tilkynnt um blóðflagnafjölgun yfir eðlilegum mörkum.
English: Retacrit 5 000 IU/0.5 ml solution for injection in pre-filled syringe
Icelandic: 5.000 a.e./0,5 ml lausn stungulyfs í áfylltri sprautu
English: Retacrit 30 000 IU/0.75 ml solution for injection in pre-filled syringe EU/1/07/431/018 1 pre-filled syringe EU/1/07/431/022 4 pre-filled syringes EU/1/07/431/023 6 pre-filled syringes EU/1/07/431/043 1 pre-filled syringe with needle guard EU/1/07/431/047 4 pre-filled syringes with needle guard EU/1/07/431/048 6 pre-filled syringes with needle guard EU/1/07/431/052 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/073 1 pre-filled syringe with needle-trap EU/1/07/431/074 4 pre-filled syringes with needle-trap EU/1/07/431/075 6 pre-filled syringes with needle-trap
Icelandic: EU/1/07/431/043 1 áfyllt sprauta með nálaröryggisbúnaði EU/1/07/431/047 4 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/048 6 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/052 4 (4 x 1) áfylltar sprautur (fjölpakkning) EU/1/07/431/073 1 áfyllt sprauta með nálaröryggisbúnaði (nálargildra) EU/1/07/431/074 4 áfylltar sprautur með nálaröryggisbúnaði (nálargildra) EU/1/07/431/075 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)
English: 1 pre-filled syringe without needle guard containing 0.3 ml solution for injection 6 pre-filled syringes without needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle guard containing 0.3 ml solution for injection 6 pre-filled syringes with needle guard containing 0.3 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.3 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.3 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,3 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,3 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,3 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,3 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,3 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,3 ml stungulyf, lausn
English: Excipients with known effect Each pre-filled syringe contains 0.40 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,40 mg fenýlalanín.
English: Caution should be exercised with escalation of erythropoiesis-stimulating agent (ESA) doses in patients with chronic renal failure.
Icelandic: Gæta skal varúðar þegar skammtar lyfja sem örva rauðkornamyndun (ESA lyf) eru auknir hjá sjúklingum með langvinna nýrnabilun.
English: 1 pre-filled syringe without needle guard containing 1 ml solution for injection 6 pre-filled syringes without needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle guard containing 1 ml solution for injection 6 pre-filled syringes with needle guard containing 1 ml solution for injection 1 pre-filled syringe with needle-trap containing 1 ml solution for injection 6 pre-filled syringes with needle-trap containing 1 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 1 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 1 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 1 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 1 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 1 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 1 ml stungulyf, lausn
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe EU/1/07/431/019 1 pre-filled syringe EU/1/07/431/024 4 pre-filled syringes EU/1/07/431/025 6 pre-filled syringes EU/1/07/431/044 1 pre-filled syringe with needle guard EU/1/07/431/049 4 pre-filled syringes with needle guard EU/1/07/431/050 6 pre-filled syringes with needle guard EU/1/07/431/053 4 (4 x 1) pre-filled syringes (multipack) EU/1/07/431/076 1 pre-filled syringe with needle-trap
Icelandic: EU/1/07/431/044 1 áfyllt sprauta með nálaröryggisbúnaði EU/1/07/431/049 4 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/050 6 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/053 4 (4 x 1) áfylltar sprautur (fjölpakkning) EU/1/07/431/076 1 áfyllt sprauta með nálaröryggisbúnaði (nálargildra) EU/1/07/431/077 4 áfylltar sprautur með nálaröryggisbúnaði (nálargildra) EU/1/07/431/078 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)
English: 1 pre-filled syringe with 0.3 ml solution for injection contains 1 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,3 ml stungulyf, lausn inniheldur 1.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: 1 pre-filled syringe without needle guard containing 0.6 ml solution for injection 6 pre-filled syringes without needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle guard containing 0.6 ml solution for injection 6 pre-filled syringes with needle guard containing 0.6 ml solution for injection 1 pre-filled syringe with needle-trap containing 0.6 ml solution for injection 6 pre-filled syringes with needle-trap containing 0.6 ml solution for injection
Icelandic: 1 áfyllt sprauta án nálaröryggisbúnaðar með 0,6 ml stungulyf, lausn 6 áfylltar sprautur án nálaröryggisbúnaðar með 0,6 ml stungulyf, lausn 1 áfyllt sprauta með nálaröryggisbúnaði með 0,6 ml stungulyf, lausn 6 áfylltar sprautur með nálaröryggisbúnaði með 0,6 ml stungulyf, lausn 1 áfyllt sprauta með nálargildru með 0,6 ml stungulyf, lausn 6 áfylltar sprautur með nálargildru með 0,6 ml stungulyf, lausn
English: Appropriate adjustment of dose and dose intervals should be made in order to maintain haemoglobin values at the desired level: haemoglobin between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Icelandic: Aðlaga skal skammta og bilið á milli skammta eftir þörfum, í því skyni að viðhalda blóðrauðagildum á æskilegu bili: blóðrauði á milli 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l).
English: Retacrit 3 000 IU/0.9 ml solution for injection in pre-filled syringe
Icelandic: 3.000 a.e./0,9 ml lausn stungulyfs í áfylltri sprautu
English: Anaemia in chronic renal failure patients before initiation of dialysis or on peritoneal dialysis
Icelandic: Blóðleysi hjá sjúklingum með langvinna nýrnabilun áður en blóðskilun hefst eða sem eru í kviðskilun
English: Treatment of adult surgery patients in an autologous predonation programme
Icelandic: Meðferð fyrir skurðaðgerð hjá fullorðnum sjúklingum sem taka þátt í sjálfsgjafaráætlun blóðs
English: Retacrit 40 000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Retacrit 40.000 a.e./1 ml lausn stungulyfs í áfylltri sprautu
English: Excipients with known effect Each pre-filled syringe contains 0.50 mg phenylalanine.
Icelandic: Hver áfyllt sprauta inniheldur 0,50 mg fenýlalanín.
English: Retacrit 6 000 IU/0.6 ml solution for injection in pre-filled syringe
Icelandic: 6.000 a.e./0,6 ml lausn stungulyfs í áfylltri sprautu
English: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe
Icelandic: Retacrit 10.000 a.e./1 ml lausn stungulyfs í áfylltri sprautu
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe EU/1/07/431/001 1 pre-filled syringe EU/1/07/431/002 6 pre-filled syringes EU/1/07/431/026 1 pre-filled syringe with needle guard EU/1/07/431/027 6 pre-filled syringes with needle guard EU/1/07/431/054 1 pre-filled syringe with needle-trap EU/1/07/431/055 6 pre-filled syringes with needle-trap
Icelandic: EU/1/07/431/026 1 áfyllt sprauta með nálaröryggisbúnaði EU/1/07/431/027 6 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/054 1 áfyllt sprauta með nálaröryggisbúnaði (nálargildra) EU/1/07/431/055 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)
English: 1 pre-filled syringe with 0.6 ml solution for injection contains 2 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 0,6 ml stungulyf, lausn inniheldur 2.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
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: Retacrit 10 000 IU/1 ml solution for injection in pre-filled syringe Pre-filled syringe Type I glass with a fixed steel injection needle and a plunger stopper with PTFE coating with or without a needle guard or needle-trap device.
Icelandic: Áfylltri sprautu úr gleri af gerð I með áfastri stálnál og bullutappa með PTFE húð með eða án nálaröryggisbúnaðar eða nálargildru.
English: 1 pre-filled syringe with 1 ml solution for injection contains 10 000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Icelandic: 1 áfyllt sprauta með 1,0 ml stungulyf, lausn inniheldur 10.000 alþjóðlegar einingar (a.e.) epoetín zeta (raðbrigða rauðkornavaki manna).
English: Retacrit 1 000 IU/0.3 ml solution for injection in pre-filled syringe epoetin zeta
Icelandic: 1.000 a.e./0,3 ml stungulyf, lausn í áfylltri sprautu epoetín zeta
English: 11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Icelandic: Dagsetning fyrstu útgáfu markaðsleyfis:
English: Retacrit 2 000 IU/0.6 ml solution for injection in pre-filled syringe
Icelandic: 2.000 a.e/0,6 ml lausn stungulyfs í áfylltri sprautu
English: ask your doctor or pharmacist for advice before taking this medicine.
Icelandic: Leitið til læknisins, lyfjafræðings eða hjúkrunarfræðingsins ef þörf er á frekari upplýsingum um lyfið.
English: Moreover, in patients with a baseline haemoglobin of >13 g/dL (>8.1 mmol/L), the possibility that epoetin zeta treatment may be associated with an increased risk of postoperative thrombotic/vascular events cannot be excluded.
Icelandic: Enn fremur er ekki hægt að útiloka að Retacrit meðferð geti tengst aukinni hættu á segamyndun/æðaáföllum eftir aðgerð ef upphafsgildi blóðrauða var > 13g/dl (> 8,1 mmól/l).
English: Appropriate adjustment of the dose should be made in order to maintain haemoglobin values within the desired concentration range between 10 g/dL to 12 g/dL (6.2 to 7.5 mmol/L).
Icelandic: Gera skal viðeigandi skammtaaðlögun í því skyni að viðhalda blóðrauðagildum innan æskilegs þéttnibils, á milli 10 g/dl til 12 g/dl (6,2 til 7,5 mmól/l).
English: • Hives
Icelandic: CLAS.
English: Retacrit 8 000 IU/0.8 ml solution for injection in pre-filled syringe EU/1/07/431/013 1 pre-filled syringe EU/1/07/431/014 6 pre-filled syringes EU/1/07/431/038 1 pre-filled syringe with needle guard EU/1/07/431/039 6 pre-filled syringes with needle guard EU/1/07/431/066 1 pre-filled syringe with needle-trap EU/1/07/431/067 6 pre-filled syringes with needle-trap
Icelandic: EU/1/07/431/038 1 áfyllt sprauta með nálaröryggisbúnaði EU/1/07/431/039 6 áfylltar sprautur með nálaröryggisbúnaði EU/1/07/431/066 1 áfyllt sprauta með nálaröryggisbúnaði (nálargildra) EU/1/07/431/067 6 áfylltar sprautur með nálaröryggisbúnaði (nálargildra)