FrancophonIA/ELRC3.0 huggingface dataset:
English: MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 667 micgrograms/ml
Icelandic: Ein áfyllt sprauta inniheldur 200 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 667 míkrógrömm/ml.
English: Intravenous route:
Icelandic: Sprautað í æð:
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 150 míkróg/0,3 ml
English: Fully insert the needle into the skin in a quick, “dart-like” motion.
Icelandic: Stingið nálinni á kaf í húðina með snöggri hreyfingu, eins og þegar pílu er kastað.
English: INFORMATION IN BRAILLE mircera 100 mcg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI mircera 100 mcg
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 200 mcg/0.3 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 200 míkróg/0,3 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 75 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 250 míkróg/0,3 ml
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 360 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/018
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/018
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/022
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/022
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/023
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/023
English: Pharmacotherapeutic group: Other antianemic preparations, ATC code: B03XA03
Icelandic: Önnur blóðskortslyf, ATC flokkur:
English: • pulmonary embolism.
Icelandic: • blóðflagnafæð • segamyndun
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 120 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 75 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 100 microgram pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 100 míkrógramma áfyllt sprauta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/021
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/021
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30 micrograms pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 30 míkrógramma áfyllt sprauta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 200 micrograms pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 200 míkrógramma áfyllt sprauta
English: MATERIALS Included in the pack: A pre-filled syringe of MIRCERA and a separate injection needle
Icelandic: Áfyllt sprauta með MIRCERA og nál til inndælingar
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 150 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/024
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/024
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/012
English: • Your doctor will check your blood pressure before and during your MIRCERA treatment.
Icelandic: Læknirinn fylgist með blóðþrýstingi fyrir meðferð með MIRCERA og meðan á henni stendur.
English: MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 50 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 167 míkrógrömm/ml.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 250 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 250 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 75 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 75 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: A slight decrease in platelet counts remaining within the normal range was observed in clinical studies.
Icelandic: Í klínískum rannsóknum varð vart við lítils háttar fækkun á blóðflögum sem þó var innan eðlilegra marka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/013
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/013
English: Survival and tumour progression have been examined in five large controlled studies involving a total of 2,833 patients, of which four were double-blind placebo-controlled studies and one was an openlabel study.
Icelandic: Fjórar af rannsóknununum voru tvíblindar samanburðarrannsóknir með lyfleysu og ein var opin rannsókn.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 60 micrograms pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 60 míkrógramma áfyllt sprauta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 360 mcg/0.6 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 360 μg/0,6 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: INFORMATION IN BRAILLE mircera 50 mcg
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI mircera 50 mcg
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 250 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 360 míkrógrömm/0,6 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/011
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/017
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mcg/0.3 ml
Icelandic: INNIHALD TILGREINT SEM ÞYNGD, RÚMMÁL EÐA FJÖLDI EININGA 100 míkróg/0,3 ml
English: MIRCERA 75 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 250 micrograms/ml
Icelandic: Ein áfyllt sprauta inniheldur 75 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 250 míkrógrömm/ml.
English: MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 133 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 40 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 133 míkrógrömm/ml.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 150 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 200 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/010
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/010
English: Tell your doctor if you are pregnant, think you are pregnant or intend to become pregnant.
Icelandic: Látið lækninn vita um þungun, hugsanlega þungun eða áform um þungun.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/019
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/019
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
Icelandic: MARKAÐSLEYFISNÚMER EU/1/07/400/020
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 30 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 333 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 100 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 333 míkrógrömm/ml.
English: Table 2: Adverse reactions attributed to the treatment with MIRCERA in CKD patients .
Icelandic: Aukaverkanir sem rekja má til meðferðar með MIRCERA hjá sjúklingum með langvinnan nýrnasjúkdóm.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 40 micrograms pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 40 míkrógramma áfyllt sprauta
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 50 micrograms pre-filled syringe
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 50 míkrógramma áfyllt sprauta
English: MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 500 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 150 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 500 míkrógrömm/ml.
English: • If you are currently being treated with another ESA Your doctor may replace your current medicine with MIRCERA.
Icelandic: Verið getur að læknirinn skipti lyfinu sem verið er að nota út fyrir MIRCERA.
English: MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta*at a concentration of 600 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 360 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 600 míkrógrömm/ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 120 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 120 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 200 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 200 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: swollen tongue, face or throat, or swelling around the injection site, or make you feel light headed, faint or cause you to collapse).
Icelandic: hitasteypur ofnæmi (ofnæmisviðbrögð sem geta valdið óvenjulegum önghljóðum við hlustun eða öndunarerfiðleikum; bólgu í tungu, andliti eða hálsi eða bólgu kringum stungustað eða sundli, svima eða yfirliði).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 40 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: • headache
Icelandic: Hitasteypur
English: It can be injected subcutaneously in the abdomen, arm or thigh.
Icelandic: Gefa má lyfið undir húð á kvið, handlegg eða læri.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 40 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 40 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 200 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 40 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 100 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 100 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 100 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 250 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: Sodium dihydrogen phosphate monohydrate Sodium sulphate
Icelandic: Natríum tvíhýdrógenfosfat einhýdrat Natríum súlfat
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 60 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 60 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 60 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta* at a concentration of 400 micrograms/ml.
Icelandic: Ein áfyllt sprauta inniheldur 120 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta* í styrkleikanum 400 míkrógrömm/ml.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 30 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 30 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 30 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 50 míkrógrömm/0,3 ml stungulyf, lausn í áfylltri sprautu metoxýpólýetýlen glýkól-epóetín beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 100 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: • maculo-papular rash (red skin reaction that can include pimples or spots)
Icelandic: • útbrot með örðudröfnum (húðroði með nöbbum eða blettum)
English: What you need to know before you use MIRCERA
Icelandic: Áður en byrjað er að nota MIRCERA
English: Hypersensitivity
Icelandic: Háþrýstingsheilakvilli
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 150 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 150 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 50 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Icelandic: MIRCERA 60 μg/0,3 ml stungulyf metoxýpólýetýlen glýkól-epóetín beta s.c./i.v.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Icelandic: VIRK(T) EFNI Ein áfyllt sprauta inniheldur 50 míkrógrömm af metoxýpólýetýlen glýkól-epóetín beta.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 75 micrograms
Icelandic: YTRI UMBÚÐUM YTRI ASKJA 75 míkrógramma
English: This may be associated with life-threatening cardiovascular complications.
Icelandic: Í tengslum við hana geta komið fram lífshættulegir fylgikvillar í hjarta og æðum.
English: EU/1/19/1398/001 (pack of 1 vial) EU/1/19/1398/002 (pack of 5 vials) EU/1/19/1398/003 (pack of 10 vials)
Icelandic: EU/1/19/1398/001 (pakkning með 1 hettuglasi) EU/1/19/1398/002 (pakkning með 5 hettuglösum) EU/1/19/1398/003 (pakkning með 10 hettuglösum)
English: Arsenic trioxide Accord is normally given by a doctor or a nurse.
Icelandic: Arsenic trioxide Accord er venjulega gefið af lækni eða hjúkrunarfræðingi.
English: ATRA + Arsenic trioxide (n = 77)
Icelandic: ATRA + arsenik þríoxíð (n=77)
English: Arsenic trioxide Accord is not recommended in children and adolescents below 18 years of age.
Icelandic: Arsenic trioxide Accord er ekki ætlað börnum og unglingum yngri en 18 ára.
English: Each pack contains 1, 5 or 10 vials.
Icelandic: Í hverjum pakka eru 1, 5 eða 10 hettuglös.
English: Lutomierska 50, 95-200 Pabianice, Poland
Icelandic: Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice, Pólland
English: There are no restrictions on your food or drink while you are receiving Arsenic trioxide Accord.
Icelandic: Engar takmarkanir eru fyrir hendi hvað varðar mat eða drykk á meðan þú notar Arsenic trioxide Accord.
English: While on treatment with Arsenic trioxide Accord, you may experience some of the following reactions:
Icelandic: Meðan á meðferð með Arsenic trioxide Accord stendur gætir þú fengið einhverjar af eftirfarandi aukaverkunum:
English: If you experience discomfort or if you feel unwell after a Arsenic trioxide Accord injection, you should wait until the symptoms go away before driving or using machines.
Icelandic: Ef þú finnur fyrir óþægindum eða líður ekki vel eftir inndælingu Arsenic trioxide Accord, skaltu bíða þar til einkennin eru liðin hjá áður en þú ekur eða stjórnar vél.
English: Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.
Icelandic: Arsenik þríoxíð veldur einnig skaða eða skerðingu samrunapróteinsins PML/RAR alfa.
English: Your doctor will decide exactly how long you must continue on therapy with Arsenic trioxide Accord.
Icelandic: Læknirinn ákveður nákvæmlega hversu lengi þú þarft að halda áfram að fá meðferð með Arsenic trioxide Accord.
English: APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
Icelandic: APL = brátt formerglingshvítblæði; ATRA = all-trans-retinoinsýra
English: For storage conditions after dilution or first opening of the medicinal product, see section 6.3.
Icelandic: Geymsluskilyrði eftir þynningu eða fyrstu opnun lyfsins, sjá kafla 6.3.
English: The safety and efficacy of Arsenic trioxide in children aged up to 17 years has not been established.
Icelandic: Ekki hefur verið sýnt fram á öryggi og verkun arsenik þríoxíðs hjá börnum að 17 ára aldri.
English: Thereafter, penicillamine at a daily dose ≤ 1 gm per day may be given.
Icelandic: Eftir það má gefa daglegan ≤ 1 mg penicillamín skammt á dag.
English: Patients who are receiving, or who have received, medicinal products known to cause hypokalemia or hypomagnesaemia, such as diuretics or amphotericin B, may be at higher risk for torsade de pointes.
Icelandic: Sjúklingar sem fá eða hafa fengið lyf sem vitað er að valda kalíumbresti eða magnesíumskorti, svo sem þvagræsilyf eða amfóterísín B, geta verið í meiri hættu að fá Torsade de pointes.
English: If this happens, treatment with Arsenic trioxide Accord must be stopped immediately and your doctor will treat the arsenic overdose.
Icelandic: Ef það gerist verður að stöðva Arsenic trioxide Accord meðferð tafarlaust og læknirinn gefur þér meðferð við arsenik ofskömmtun.
English: You may experience convulsions, muscle weakness and confusion.
Icelandic: Þú gætir fundið fyrir krömpum, vöðvaslappleika og ringlun.
English: Concentrate for solution for infusion 1 vial of 10 ml (10 mg/10 ml) 5 vials of 10 ml (10 mg/10 ml) 10 vials of 10 ml (10 mg/10 ml)
Icelandic: Innrennslisþykkni, lausn 1 hettuglas með 10 ml (10 mg/10 ml) 5 hettuglös með 10 ml (10 mg/10 ml) 10 hettuglös með 10 ml (10 mg/10 ml)
English: In such cases, treatment must resume at 50% of the preceding daily dose.
Icelandic: Í slíkum tilfellum verður að hefja meðferð á ný með 50% fyrri dagskammts.
English: Arsenic trioxide Accord with food and drink
Icelandic: Notkun Arsenic trioxide Accord með mat eða drykk
English: The daily dose can be escalated back to 100% of the original dose if no prolongation occurs.
Icelandic: Hækka má dagsskammtinn aftur í 100% af upphaflegum skammti ef engin lenging á sér stað.
English: Because Arsenic trioxide Accord can harm nursing infants, do not breast-feed while on Arsenic trioxide Accord.
Icelandic: Þar sem Arsenic trioxide Accord getur skaðað börn á brjósti skal ekki vera með barn á brjósti meðan á meðferð með Arsenic trioxide Accord stendur.
English: 10-50 x 10
Icelandic: 10-50 x 103/µl
English: Confusional state
Icelandic: Ruglingslegt ástand
English: 95 % CI for the difference, 2-22 percentage points p<0.001 for noninferiority p = 0.02 for superiority of ATRA+Arsenic trioxide
Icelandic: öryggisbil hvað varðar mun, 2-22 prósentustig p<0,001 fyrir jafngildi p=0,02 fyrir yfirburði ATRA+ arsenik þríoxíð
English: If QTc prolongation does not recur within 7 days of restarting treatment at the reduced dose, treatment with arsenic trioxide can be resumed at 0.11 mg/kg body weight per day for a second week.
Icelandic: Ef QTc lenging á sér ekki stað innan 7 daga eftir að meðferð er hafin að nýju með minni skammti skal hefja meðferð með arsenik þríoxíði á ný með 0,11 mg/kg líkamsþyngdar á dag í aðra viku.
English: You must talk to your doctor or nurse before using Arsenic trioxide Accord, if - you have impaired kidney function.
Icelandic: Þú verður að leita ráða hjá lækninum eða hjúkrunarfræðingnum áður en byrjað er að nota Arsenic trioxide Accord ef - þú ert með skerta nýrnastarfsemi - þú ert með lifrarkvilla.
English: Tell your doctor or nurse straight away if you notice the following side effects, as these may be signs of a severe condition called “differentiation syndrome”, which might be fatal:
Icelandic: Láttu lækninn eða hjúkrunarfræðing vita strax ef þú færð einhverja af eftirtöldum aukaverkunum, þar sem þær geta verið merki um alvarlegt, lífshættulegt ástand sem kallast hvítkornafjölgunarheilkenni (differentiation syndrome):
English: Arsenic trioxide is indicated for induction of remission, and consolidation in adult patients with:
Icelandic: Arsenik þríoxíð er ætlað til innleiðslu- og upprætingarmeðferðar hjá fullorðnum sjúklingum með:
English: Of 7 patients less than 18 years of age (range 5 to 16 years) treated with arsenic trioxide at the recommended dose of 0.15 mg/kg/day, 5 patients achieved a complete response (see section 4.2).
Icelandic: Af 7 sjúklingum yngri en 18 ára (á aldrinum 5 til 16 ára) sem voru meðhöndlaðir með arsenik þríoxíði í ráðlögðum 0,15 mg/kg/dag skammti náðu 5 sjúklingar fullri svörun (sjá kafla 4.2).
English: PVC-free plastic bags should be used.
Icelandic: Nota skal plastpoka án PVC.
English: What Arsenic trioxide Accord is and what it is used for What you need to know before you use Arsenic trioxide Accord How to use Arsenic trioxide Accord Possible side effects
Icelandic: Upplýsingar um Arsenic trioxide Accord og við hverju það er notað Áður en byrjað er að nota Arsenic trioxide Accord Hvernig nota á Arsenic trioxide Accord Hugsanlegar aukaverkanir
English: Must be diluted before use.
Icelandic: Verður að þynna fyrir notkun.