FrancophonIA/ELRC3.0 huggingface dataset:
English: If no satisfactory control is achieved at doses above 30 mg/kg, treatment at such doses should not be maintained and alternative treatment options should be considered whenever possible.
Icelandic: Ef ekki næst fullnægjandi stjórn með stærri skömmtum en 30 mg/kg skal ekki halda áfram meðferð með slíkum skömmtum og íhuga skal aðra meðferðarkosti sé þess kostur.
English: Adult patients
Icelandic: Fullorðnir:
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with film-coated tablet doses above 21 mg/kg cannot be excluded.
Icelandic: á nýru hafi komið fram eftir skammtaaukningu EXJADE dreifitaflna í stærri skammta en 30 mg/kg í klínískum rannsóknum, er ekki hægt að útiloka aukna hættu á aukaverkunum á nýru við stærri skammta en 21 mg/kg af filmuhúðuðum töflum.
English: EXJADE 360 mg granules EU/1/06/356/022
Icelandic: EXJADE 360 mg kyrni EU/1/06/356/022
English: EXJADE is also indicated for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients with non-transfusion-dependent thalassaemia syndromes aged 10 years and older.
Icelandic: EXJADE er einnig ætlað til meðferðar við langvarandi járnofhleðslu sem þarfnast klóbindingarmeðferðar þegar ekki má nota deferoxamin eða meðferð með deferoxamini er ófullnægjandi, hjá sjúklingum, 10 ára og eldri, með dvergkornablóðleysi sem ekki er háð blóðgjöfum.
English: EXJADE 180 mg film-coated tablets EU/1/06/356/014
Icelandic: EXJADE 180 mg filmuhúðaðar töflur EU/1/06/356/014
English: • Adults and Paediatrics: remain >33% above baseline or creatinine clearance <LLN (90 ml/min)
Icelandic: Fullorðnir og börn: helst >33% hærra en upphafsgildi eða útskilnaður kreatíníns <neðri mörk eðlilegra gilda (90 ml/mín.).
English: EXJADE 90 mg granules EU/1/06/356/020
Icelandic: EXJADE 90 mg kyrni EU/1/06/356/020
English: For patients in whom the dose was increased to >10 mg/kg, dose reduction to 10 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Icelandic: Ráðlagt er að minnka skammta í 10 mg/kg eða minna hjá sjúklingum sem skammtur hefur verið aukinn í >10 mg/kg hjá, þegar þéttni járns í lifur er <7 mg Fe/g þurrvigt eða sermisþéttni ferritins er ≤2.000 µg/l.
English: For patients in whom the dose was increased to >7 mg/kg, dose reduction to 7 mg/kg or less is recommended when LIC is <7 mg Fe/g dw or serum ferritin is ≤2,000 µg/l.
Icelandic: Ráðlagt er að minnka skammta í 7 mg/kg eða minna hjá sjúklingum sem skammtur hefur verið aukinn í >7 mg/kg hjá, þegar þéttni járns í lifur er <7 mg Fe/g þurrvigt eða sermisþéttni ferritins er ≤2.000 µg/l.
English: Medium blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 180 on the other).
Icelandic: Millibláar, sporöskjulaga filmuhúðaðar töflur, kúptar báðum megin með sniðbrún og áletrun (NVR á annarri hliðinni og 180 á hinni hliðinni).
English: Exjade 180 mg film-coated tablets deferasirox
Icelandic: Exjade 180 mg filmuhúðaðar töflur deferasirox
English: >33% above pretreatment average and Decreases <LLN* (<90 ml/min)
Icelandic: >33% hærri en upphafsgildi og úthreinsun kreatíníns <neðri mörk eðlilegra gilda (90 ml/mín.).
English: Do not swallow whole or chew.
Icelandic: Hvorki má gleypa töflurnar í heilu lagi né tyggja þær.
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation (see section 5.2).
Icelandic: EXJADE kyrni hefur meira aðgengi en EXJADE dreifitöflur (sjá kafla 5.2).
English: Each dispersible tablet contains 125 mg of deferasirox.
Icelandic: Hver dreifitafla inniheldur 125 mg deferasirox.
English: Optic neuritis
Icelandic: Ónæmiskerfi
English: 3.5 - 7 mg/kg/day 5-10 mg/kg/day
Icelandic: 3,5 - 7 mg/kg/sólarhring
English: EXJADE granules should be taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple).
Icelandic: Taka skal EXJADE kyrnið með því að dreifa öllum skammtinum í mjúkan mat, t.d. jógúrt eða eplamauk (maukuð epli).
English: Starting dose The recommended initial daily dose of EXJADE granules is 14 mg/kg body weight.
Icelandic: Ráðlagður upphafsskammtur af EXJADE kyrni er 14 mg/kg líkamsþunga.
English: EXJADE 90 mg film-coated tablets EU/1/06/356/011
Icelandic: EXJADE 90 mg filmuhúðaðar töflur EU/1/06/356/011
English: Exjade 90 mg film-coated tablets deferasirox
Icelandic: Exjade 90 mg filmuhúðaðar töflur deferasirox
English: • The need for annual auditory and ophthalmic testing
Icelandic: Nauðsyn þess að framkvæma sjón- og heyrnarmælingar árlega.
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with granule doses above 21 mg/kg cannot be excluded.
Icelandic: á nýru hafi komið fram eftir skammtaaukningu EXJADE dreifitaflna í stærri skammta en 30 mg/kg í klínískum rannsóknum, er ekki hægt að útiloka aukna hættu á aukaverkunum á nýru við stærri skammta en 21 mg/kg af kyrni.
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 125 on the other).
Icelandic: Hvítar eða gulleitar, kringlóttar, flatar töflur með sniðbrún og áletrun (NVR á annarri hliðinni og J 125 á hinni hliðinni).
English: EXJADE 90 mg granules Each sachet contains 90 mg deferasirox.
Icelandic: EXJADE 90 mg kyrni Hver skammtapoki inniheldur 90 mg deferasirox.
English: How to take EXJADE
Icelandic: Hvernig nota á EXJADE
English: The film-coated tablets are ovaloid and biconvex.
Icelandic: Filmuhúðuðu töflurnar eru sporöskjulaga og kúptar báðum megin.
English: • Description of available deferasirox formulations (e.g. dispersible tablets, film-coated tablets and granules) o Different posology regimen o Different conditions of administration o Dose conversion table when switching from one formulation to another
Icelandic: o Að til séu mismunandi lyfjaform til inntöku (þ.e. dreifitöflur, filmuhúðaðar töflur og kyrni) og helsti munur á þessum lyfjaformum (t.d. mismunandi skammtar, mismunandi skilyrði við lyfjagjöf einkum með tilliti til fæðu)
English: Light blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 90 on the other).
Icelandic: Ljósbláar, sporöskjulaga filmuhúðaðar töflur, kúptar báðum megin með sniðbrún og áletrun (NVR á annarri hliðinni og 90 á hinni hliðinni).
English: INTERMEDIATE CARTON OF MULTIPACK (without blue box)
Icelandic: INNRI ASKJA FJÖLPAKKNINGA (án „blue box“)
English: EXJADE 360 mg granules Each sachet contains 360 mg deferasirox.
Icelandic: EXJADE 360 mg kyrni Hver skammtapoki inniheldur 360 mg deferasirox.
English: • Each dispersible tablet of EXJADE 125 mg contains 125 mg deferasirox.
Icelandic: Hver EXJADE 125 mg dreifitafla inniheldur deferasirox 125 mg.
English: Exjade 360 mg granules deferasirox
Icelandic: Exjade 360 mg kyrni deferasirox
English: 28 dispersible tablets
Icelandic: 28 dreifitöflur
English: • EXJADE 180 mg film-coated tablets are medium blue and stamped “180” on one side and
Icelandic: EXJADE 180 mg filmuhúðaðar töflur eru millibláar og á þær er stimplað „180“ á aðra hliðina og „NVR“ á hina hliðina.
English: Exjade 90 mg granules deferasirox
Icelandic: Exjade 90 mg kyrni deferasirox
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 250 on the other).
Icelandic: Hvítar eða gulleitar, kringlóttar, flatar töflur með sniðbrún og áletrun (NVR á annarri hliðinni og J 250 á hinni hliðinni).
English: EU/1/06/356/022 30 sachets
Icelandic: EU/1/06/356/022 30 skammtapokar
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet Deferasirox
Icelandic: EXJADE 90 mg kyrni í skammtapoka EXJADE 180 mg kyrni í skammtapoka EXJADE 360 mg kyrni í skammtapoka Deferasirox
English: An initial daily dose of 10 mg/kg may be considered for patients who do not require reduction of body iron levels and who are also receiving less than 7 ml/kg/month of packed red blood cells (approximately <2 units/month for an adult).
Icelandic: Íhuga má að nota upphafsskammtinn 10 mg/kg handa sjúklingum ef ekki þarf að draga úr auknu járnmagni í líkama þeirra og þeir fá einnig minna en 7 ml/kg/mánuð af pökkuðum rauðum blóðkornum (um það bil <2 einingar/mánuð handa fullorðnum).
English: EU/1/06/356/021 30 sachets
Icelandic: EU/1/06/356/021 30 skammtapokar
English: Dark blue, ovaloid, biconvex film-coated tablet with bevelled edges and imprints (NVR on one face and 360 on the other).
Icelandic: Dökkbláar, sporöskjulaga filmuhúðaðar töflur, kúptar báðum megin með sniðbrún og áletrun (NVR á annarri hliðinni og 360 á hinni hliðinni).
English: EXJADE granules demonstrate higher bioavailability compared to the EXJADE dispersible tablet formulation.
Icelandic: EXJADE kyrni hefur meira aðgengi en EXJADE dreifitöflur.
English: EXJADE 125 mg dispersible tablets EU/1/06/356/001
Icelandic: EXJADE 125 mg dreifitöflur EU/1/06/356/001
English: While no increase in renal adverse events was observed after dose escalation of EXJADE dispersible tablets to doses above 30 mg/kg in clinical studies, an increased risk of renal adverse events with EXJADE dispersible tablet doses above 30 mg/kg cannot be excluded.
Icelandic: á nýru hafi komið fram eftir skammtaaukningu EXJADE dreifitaflna í stærri skammta en 30 mg/kg í klínískum rannsóknum, er ekki hægt að útiloka aukna hættu á aukaverkunum á nýru við stærri skammta en 30 mg/kg af EXJADE dreifitöflum.
English: Exjade 180 mg granules deferasirox
Icelandic: Exjade 180 mg kyrni deferasirox
English: Hypersensitivity reactions (including anaphylactic reactions and angioedema) Metabolism and nutrition disorders Not known:
Icelandic: Ofnæmisviðbrögð (þar með talið bráðaofnæmisviðbrögð og ofsabjúgur)
English: EU/1/06/356/020 30 sachets
Icelandic: EU/1/06/356/020 30 skammtapokar
English: White to slightly yellow, round, flat tablets with bevelled edges and imprints (NVR on one face and J 500 on the other).
Icelandic: Hvítar eða gulleitar, kringlóttar, flatar töflur með sniðbrún og áletrun (NVR á annarri hliðinni og J 500 á hinni hliðinni).
English: EXJADE 180 mg granules Each sachet contains 180 mg deferasirox.
Icelandic: EXJADE 180 mg kyrni Hver skammtapoki inniheldur 180 mg deferasirox.
English: EXJADE 250 mg dispersible tablets EU/1/06/356/003
Icelandic: EXJADE 250 mg dreifitöflur EU/1/06/356/003
English: EXJADE 180 mg film-coated tablets Each film-coated tablet contains 180 mg deferasirox.
Icelandic: Hver EXJADE 180 mg filmuhúðuð tafla inniheldur deferasirox 180 mg.
English: If you are switching from the dispersible tablets to these granules, you will need an adjustment of the dose.
Icelandic: Ef þú ert að skipta af meðferð með dreifitöflum yfir á þetta kyrni þarf að breyta skammtinum hjá þér.
English: EXJADE 90 mg film-coated tablets Each film-coated tablet contains 90 mg deferasirox.
Icelandic: Hver EXJADE 90 mg filmuhúðuð tafla inniheldur deferasirox 90 mg.
English: • Each dispersible tablet of EXJADE 250 mg contains 250 mg deferasirox.
Icelandic: Hver EXJADE 250 mg dreifitafla inniheldur deferasirox 250 mg.
English: EXJADE 500 mg dispersible tablets EU/1/06/356/005
Icelandic: EXJADE 500 mg dreifitöflur EU/1/06/356/005
English: EXJADE contains lactose
Icelandic: ASKJA FYRIR STAKAR PAKKNINGAR
English: • The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE filmuhúðuðum töflum í upphafi meðferðar hjá sjúklingum sem fá reglulegar blóðgjafir er 14 mg fyrir hvert kg líkamsþyngdar.
English: What EXJADE contains
Icelandic: EXJADE inniheldur
English: • The usual daily dose for EXJADE film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE filmuhúðuðum töflum í upphafi meðferðar hjá sjúklingum sem ekki fá reglulegar blóðgjafir er 7 mg fyrir hvert kg líkamsþyngdar.
English: Laryngeal pain Gastrointestinal disorders Common:
Icelandic: Lifur og gall Algengar:
English: - if you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes
Icelandic: - ef þú færð einhver af eftirtöldum einkennum samtímis: útbrot, rauða húð, blöðrumyndun á vörum, í augum eða munni, húðflögnun, háan hita, flensulík einkenni eða eitlastækkun (einkenni alvarlegra húðviðbragða, sjá einnig kafla 4 „Hugsanlegar aukaverkanir“).
English: 3.5 - 7 mg/kg/day 5-10 mg/kg/day Decrease
Icelandic: Minnkun 3,5 - 7 mg/kg/sólarhring
English: EXJADE 360 mg film-coated tablets Each film-coated tablet contains 360 mg deferasirox.
Icelandic: Hver EXJADE 360 mg filmuhúðuð tafla inniheldur deferasirox 360 mg.
English: An initial daily dose of 30 mg/kg may be considered for patients who require reduction of elevated body iron levels and who are also receiving more than 14 ml/kg/month of packed red blood cells (approximately >4 units/month for an adult).
Icelandic: 30 mg/kg handa sjúklingum ef draga þarf úr auknu járnmagni í líkama þeirra og þeir fá einnig meira en 14 ml/kg/mánuð af pökkuðum rauðum blóðkornum (um það bil >4 einingar/mánuð handa fullorðnum).
English: Each tablet contains 360 mg of deferasirox.
Icelandic: Hver skammtapoki inniheldur 360 mg deferasirox.
English: In paediatric patients with non-transfusion-dependent thalassaemia syndromes, dosing should not exceed 10 mg/kg.
Icelandic: Hjá börnum með dvergkornablóðleysi sem ekki er háð blóðgjöfum á ekki að nota stærri skammta en 10 mg/kg.
English: EXJADE 500 mg dispersible tablets Each dispersible tablet contains 500 mg deferasirox.
Icelandic: Hver EXJADE 500 mg dreifitafla inniheldur deferasirox 500 mg.
English: EXJADE 90 mg granules in sachet EXJADE 180 mg granules in sachet EXJADE 360 mg granules in sachet
Icelandic: EXJADE 90 mg kyrni í skammtapoka EXJADE 180 mg kyrni í skammtapoka EXJADE 360 mg kyrni í skammtapoka
English: Each tablet contains 180 mg of deferasirox.
Icelandic: Hver skammtapoki inniheldur 180 mg deferasirox.
English: Granules in sachet (granules)
Icelandic: Kyrni í skammtapoka (kyrni)
English: Interruption of EXJADE therapy should be considered in patients who develop metabolic acidosis.
Icelandic: Íhuga skal að gera hlé á meðferð með EXJADE hjá sjúklingum sem fá efnaskiptablóðsýringu.
English: The recommended initial daily dose of EXJADE film-coated tablets in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Icelandic: Ráðlagður upphafsskammtur af EXJADE filmuhúðuðum töflum á sólarhring, hjá sjúklingum með dvergkornablóðleysi sem ekki er háð blóðgjöfum, er 7 mg/kg líkamsþunga.
English: • The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients receiving regular blood transfusions is 20 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE dreifitöflum í upphafi meðferðar hjá sjúklingum sem fá reglulegar blóðgjafir er 20 mg fyrir hvert kg líkamsþyngdar.
English: Each tablet contains 90 mg of deferasirox.
Icelandic: Hver skammtapoki inniheldur 90 mg deferasirox.
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE kyrni í upphafi meðferðar hjá sjúklingum sem ekki fá reglulegar blóðgjafir er 7 mg fyrir hvert kg líkamsþyngdar.
English: • The usual daily dose for EXJADE dispersible tablets at the start of the treatment for patients not receiving regular blood transfusions is 10 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE dreifitöflum í upphafi meðferðar hjá sjúklingum sem ekki fá reglulegar blóðgjafir er 10 mg fyrir hvert kg líkamsþyngdar.
English: The recommended initial daily dose of EXJADE dispersible tablets in patients with non-transfusion-dependent thalassaemia syndromes is 10 mg/kg body weight.
Icelandic: Ráðlagður upphafsskammtur af EXJADE dreifitöflum á sólarhring, hjá sjúklingum með dvergkornablóðleysi sem ekki er háð blóðgjöfum, er 10 mg/kg líkamsþunga.
English: • Recommendations for treatment of non-transfusion-dependent thalassaemia (NTDT) syndromes: o Information that only one course of treatment is proposed for NTDT patients o A warning on the necessity of closer monitoring of liver iron concentration and serum ferritin in the paediatric population o A warning on the currently unknown safety consequences of long-term treatment in the paediatric population
Icelandic: o Upplýsingar um að einungis sé lagt til að gefin sé ein meðferðarlota hjá sjúklingum með dvergkornablóðleysi sem ekki er háð blóðgjöfum o Varnaðarorð um nauðsyn þess að hafa náið eftirlit með þéttni járns í lifur og sermisþéttni ferritins hjá börnum.
English: EXJADE 125 mg dispersible tablets deferasirox
Icelandic: EXJADE 125 mg dreifitöflur deferasirox
English: 10 mg/kg/day
Icelandic: 10 mg/kg/sólarhring
English: Hepatic function
Icelandic: Höfuðverkur.
English: 28 mg/kg/day 40 mg/kg/day
Icelandic: 28 mg/kg/sólarhring
English: The bioavailability of deferasirox was increased to a variable extent when taken along with food.
Icelandic: Aðgengi deferasirox jókst mismikið þegar það var tekið með mat.
English: • The usual daily dose for EXJADE granules at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight.
Icelandic: Venjulegur dagsskammtur af EXJADE kyrni í upphafi meðferðar hjá sjúklingum sem fá reglulegar blóðgjafir er 14 mg fyrir hvert kg líkamsþyngdar.
English: • The maximum recommended daily dose for EXJADE granules:
Icelandic: Ráðlagður hámarksskammtur á sólarhring af EXJADE kyrni er:
English: 30 mg/kg/day
Icelandic: 30 mg/kg/sólarhring
English: • The importance of measuring creatinine clearance
Icelandic: Mikilvægi þess að mæla úthreinsun kreatíníns.
English: OUTER CARTON OF MULTIPACK (including blue box)
Icelandic: YTRI ASKJA FJÖLPAKKNINGA (MEÐ „BLUE BOX“)
English: • 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.
Icelandic: 28 mg fyrir hvert kg líkamsþyngdar hjá sjúklingum sem fá reglulegar blóðgjafir, 14 mg fyrir hvert kg líkamsþyngdar hjá fullorðnum sjúklingum sem ekki fá reglulegar blóðgjafir, 7 mg fyrir hvert kg líkamsþyngdar hjá börnum og unglingum sem ekki fá reglulegar blóðgjafir.
English: Each dispersible tablet contains 250 mg of deferasirox.
Icelandic: Hver dreifitafla inniheldur 250 mg deferasirox.
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE film-coated tablets that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE film-coated tablets).
Icelandic: 40 mg/kg/dag af deferoxamini 5 daga í viku (eða samsvarandi) getur byrjað á daglegum upphafsskammti af EXJADE filmuhúðuðum töflum sem er 14 mg/kg/dag).
English: • Each sachet of EXJADE 180 mg granules contains 180 mg deferasirox.
Icelandic: Hver skammtapoki af EXJADE 180 mg kyrni inniheldur deferasirox 180 mg.
English: Breast-feeding while taking EXJADE is not recommended.
Icelandic: Ekki er mælt með því að barn sé haft á brjósti á meðan EXJADE er notað.
English: • Severe upper stomach pain (pancreatitis)
Icelandic: EXJADE inniheldur laktósa (mjólkursykur)
English: Creatinine clearance
Icelandic: Úthreinsun kreatíníns
English: 14 mg/kg/day 20 mg/kg/day
Icelandic: 14 mg/kg/sólarhring
English: In duplicate prior to therapy.
Icelandic: Tvítekið fyrir meðferð.
English: Each dispersible tablet contains 500 mg of deferasirox.
Icelandic: Hver dreifitafla inniheldur 500 mg deferasirox.
English: Monthly
Icelandic: Vikulega
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE dispersible tablets that is numerically half that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 20 mg/kg/day of EXJADE dispersible tablets).
Icelandic: 40 mg/kg/dag af deferoxamini 5 daga í viku (eða samsvarandi) getur byrjað á daglegum upphafsskammti af EXJADE dreifitöflum sem er 20 mg/kg/dag).
English: Hepatic failure Skin and subcutaneous tissue disorders Common:
Icelandic: Lyfjaútbrot með eósínfíklafjöld og altækum einkennum
English: o The need to consider renal biopsy:
Icelandic: o Nauðsyn þess að íhuga að taka vefjasýni úr nýrunum:
English: Oesophagitis
Icelandic: o Heyrnartap.
English: EXJADE 250 mg dispersible tablets deferasirox
Icelandic: EXJADE 250 mg dreifitöflur deferasirox
English: In case of switching from dispersible tablets to granules, the dose of the granules should be 30% lower than the dose of the dispersible tablets, rounded to the nearest whole sachet.
Icelandic: Ef skipt er úr dreifitöflum yfir í kyrni á skammturinn af kyrninu að vera 30% lægri en skammturinn af dreifitöflunum, námundað að skammti næsta heila skammtapoka.
English: For patients already well managed on treatment with deferoxamine, a starting dose of EXJADE granules that is numerically one third that of the deferoxamine dose could be considered (e.g. a patient receiving 40 mg/kg/day of deferoxamine for 5 days per week (or equivalent) could be transferred to a starting daily dose of 14 mg/kg/day of EXJADE granules).
Icelandic: 40 mg/kg/dag af deferoxamini 5 daga í viku (eða samsvarandi) getur byrjað á daglegum upphafsskammti af EXJADE kyrni sem er 14 mg/kg/dag).
English: Dispersible tablet
Icelandic: Filmuhúðuð tafla.
English: • Each sachet of EXJADE 90 mg granules contains 90 mg deferasirox.
Icelandic: Hver skammtapoki af EXJADE 90 mg kyrni inniheldur deferasirox 90 mg.
English: The recommended initial daily dose of EXJADE granules in patients with non-transfusion-dependent thalassaemia syndromes is 7 mg/kg body weight.
Icelandic: Ráðlagður upphafsskammtur af EXJADE kyrni á sólarhring, hjá sjúklingum með dvergkornablóðleysi sem ekki er háð blóðgjöfum, er 7 mg/kg líkamsþunga.
English: • Each sachet of EXJADE 360 mg granules contains 360 mg deferasirox.
Icelandic: Hver skammtapoki af EXJADE 360 mg kyrni inniheldur deferasirox 360 mg.
English: EXJADE 500 mg dispersible tablets deferasirox
Icelandic: EXJADE 500 mg dreifitöflur deferasirox
English: Laryngeal pain
Icelandic: Natríumlárýlsúlfat
English: Transfusional iron overload:
Icelandic: Járnofhleðsla vegna blóðgjafa:
English: • Persistent abnormality in another marker of renal function (e.g. proteinuria, Fanconi Syndrome).
Icelandic: Annað merkiefni fyrir nýrnastarfsemi (t.d. próteinmiga, Fanconi heilkenni) er viðvarandi óeðlilegt.
English: Exjade 360 mg granules in sachet deferasirox
Icelandic: Exjade 360 mg kyrni í skammtapoka deferasirox
English: Granules in sachet
Icelandic: Rof í meltingarvegi
English: constipation, indigestion
Icelandic: Hiti, bjúgur, þreyta.
English: Starting dose 14 mg/kg/day 20 mg/kg/day After 20 units (about 100 ml/kg) of PRBC
Icelandic: Eftir 20 einingar (u.þ.b. 100 ml/kg af pökkuðum rauðum blóðkornum eða >1.000 µg/l
English: Sodium laurilsulfate Silica, colloidal anhydrous
Icelandic: Gildi Cmax og AUC0-24 klst.
English: Exjade 180 mg granules in sachet deferasirox
Icelandic: Exjade 180 mg kyrni í skammtapoka deferasirox
English: Exjade 90 mg granules in sachet deferasirox
Icelandic: Exjade 90 mg kyrni í skammtapoka deferasirox
English: In the event of contact, wash with clean water.
Icelandic: Ef það gerist, skal þvo það af með hreinu vatni.
English: These reactions will resolve within a maximum of 23 days.
Icelandic: Þessi viðbrögð hverfa eftir allt að 23 daga.
English: ATCvet code: QJ01DD90.
Icelandic: QJ01DD90.
English: Allergic reactions to these substances may occasionally be serious.
Icelandic: Ofnæmisviðbrögð vegna þessara efna geta einstaka sinnum verið alvarleg.