FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/009
Maltese: EU/1/07/400/008 EU/1/07/400/009
English: Do not use MIRCERA
Maltese: Mediċini oħra u MIRCERA
English: In a post-authorisation safety study with long treatment exposure of up to 8.4 years, baseline platelet counts below 100 x 109/l was present in 2.1% of patients in the MIRCERA group and 2.4% of patients in other ESAs group.
Maltese: Fi studju dwar is-sigurtà wara lawtorizzazzjoni b'esponiment għat-trattament fit-tul għal perjodu sa 8.4 snin, għadd tal-plejtlits fil linja bażi taħt 100 x 109/l kien preżenti fi 2.1% tal-pazjenti fil-grupp ta' MIRCERA u fi 2.4% talpazjenti fil-grupp ta' ESAs oħra.
English: In patients with a poor haemoglobin response to epoetins, alternative explanations for the poor response should be considered (see section 4.2 and 5.1).
Maltese: F'pazjenti b'rispons ta' emoglobina batut għall-epoetins, għandhom jiġu kkunsidrati spjegazzjonijiet alternattivi għar-rispons batut (ara sezzjoni 4.2 u 5.1).
English: There is no evidence that MIRCERA alters the metabolism of other medicinal products.
Maltese: M'hemmx evidenza li MIRCERA jbiddel il-metaboliżmu ta'
English: Platelet counts below 100 x 109/l were observed in 7% of patients treated with MIRCERA and 4% of patients treated with other ESAs during clinical development.
Maltese: Waqt l-iżvilupp kliniku kienu osservati għadd tal-plejtlits taħt 100 x 109/l f'7% tal-pazjenti ttrattati b'MIRCERA u f'4% tal-pazjenti ttrattati b'ESAs oħra.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 360 micrograms/0.6 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 360 mikrogramma/0.6 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: MIRCERA is indicated to treat only the symptomatic anaemia caused by chronic kidney disease.
Maltese: MIRCERA huwa indikat biex jikkura l-anemija sintomatika kkawżata minn mard kroniku tal-kliewi biss.
English: Two controlled clinical studies in which epoetins were administered to patients with various cancers including head and neck cancers, and breast cancer, have shown an unexplained excess mortality.
Maltese: Żewġ studji kliniċi kkontrollati fejn epoetins ġew amministrati lill-pazjenti b'diversi kanċers, inkluż kanċers fir-ras u fl-għonq, u kanċer tas-sider, urew żjieda mhux spjegata ta' mortalità.
English: The rashes may progress to widespread peeling of the skin and life-threatening complications.
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Mhux komuni
English: Thrombocytopenia*
Maltese: Mhux magħrufa Reazzjoni anafilattika*
English: Please contact your doctor or pharmacist if you used too large a dose of MIRCERA as it may be necessary to perform some blood tests and interrupt your treatment.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma twettaq l-ebda studju ta' interazzjoni.
English: The safety and efficacy of MIRCERA therapy has not been established in patients with haemoglobinopathies, seizures, bleeding or a recent history of bleeding requiring transfusions or with platelet levels greater than 500 x 109/l.
Maltese: Is-sigurtà u l-effikaċja ta' terapija b'MIRCERA ma ġewx stabbiliti f'pazjenti b'emoglobinopatiji, aċċessjonijiet, fsada, jew fsada reċenti li kellha bżonn transfużjoni jew b'livelli ta' plejtlits ogħla minn 500 x 109/l.
English: Caution should be exercised with escalation of MIRCERA doses in patients with chronic renal failure since high cumulative epoetin doses may be associated with an increased risk of mortality, serious cardiovascular and cerebrovascular events.
Maltese: mortalità, u avvenimenti kardjovaskulari u ċerebrovaskulari serji.
English: MIRCERA comes in pre-filled syringes with laminated plunger stopper and tip cap with one needle 27G1/2.
Maltese: MIRCERA huwa disponibbli f'siringi mimlija għal-lest b'tapp tal-planġer laminat u għatu tat-tarf b'labra 27G1/2 waħda.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 75 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 75 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/020
Maltese: EU/1/07/400/019 EU/1/07/400/020
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 360 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 360 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 200 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 200 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: A patient-level data analysis has also been performed on more than 13,900 cancer patients (chemo-, radia-, chemoradia-, or no therapy) participating in 53 controlled clinical trials involving several epoetins.
Maltese: radju-, kimoradju-, jew l-ebda terapija) li ħadu sehem f'53 prova klinika kkontrollata li nvolvew bosta epoetins.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 120 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 120 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: Throw away the needle shield in the punctureresistant container or sharps container.
Maltese: korrezzjoni kienu għolja u komparabbli mal-komparaturi.
English: In a single dose study, after intravenous administration, the pharmacokinetics of methoxy polyethylene glycol-epoetin beta are similar in patients with severe hepatic impairment as compared to healthy subjects (see section 4.2).
Maltese: Fi studju b'doża waħda, wara għoti fil-vini, il-farmakokinetika ta' methoxy polyethylene glycolepoetin beta kienet simili f'pazjenti b'indeboliment sever tal-fwied meta mqabbla ma' individwi f'saħħithom (ara sezzjoni 4.2).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 150 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 150 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 120 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 120 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: See leaflet for further details.
Maltese: Ma sarux studji ta' interazzjoni.
English: A sustained haemoglobin level of greater than 12 g/dl (7.45 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.45 mmol/l) are observed are described below.
Maltese: (7.45 mmol/l) għandu jiġi evitat; gwida għall-aġġustament xieraq tad-doża għal meta jiġu osservati valuri tal-emoglobina li jaqbżu 12 g/dl (7.45 mmol/l) hija deskritta isfel.
English: Following subcutaneous administration to CKD patients on dialysis, the maximum serum concentrations of methoxy polyethylene glycol-epoetin beta were observed 72 hours (median value) after administration.
Maltese: Wara amministrazzjoni taħt il-ġilda lill-pazjenti b'CKD fuq dijalisi, il-konċentrazzjonijiet massimi fisserum ta' methoxy polyethylene glycol-epoetin beta kienu osservati wara 72 siegħa (valur medjan).
English: Keep the syringe in the box to protect it from light and allow it to reach room temperature for at least 30 minutes.
Maltese: Żomm issiringa fil-kaxxa sabiex tipproteġiha mid-dawl u ħalliha tilħaq temperatura tal-kamra għal mill-inqas 30 minuta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 100 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 100 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 30 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 30 mikrogramma ta' methoxy polyethylene glycol epoetin 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
Maltese: MIRCERA 75 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: Pure Red Cell Aplasia caused by anti-erythropoietin antibodies has been reported in association with all ESAs, including MIRCERA.
Maltese: Aplasija Pura taċ-Ċelluli l-Ħomor ikkawżata minn antikorpi anti-eritropoetin, kienet irrappurtata f'assoċjazzjoni mal-ESAs kollha, inkluż MIRCERA.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 150 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 150 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
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
Maltese: MIRCERA 75 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Siringa waħda mimlija għal-lest fiha 75 mikrogramma ta' methoxy polyethylene glycol-epoetin beta*
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 60 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 60 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 250 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: Each pre-filled syringe contains 0.3 ml or 0.6 ml.
Maltese: Kull siringa mimlija għal-lest fiha 0.3 ml jew 0.6 ml.
English: The carcinogenic potential of methoxy polyethylene glycol-epoetin beta has not been evaluated in long-term animal studies.
Maltese: Il-potenzjal karċinoġeniku ta' methoxy polyethylene glycol-epoetin beta ma ġiex evalwat fi studji fittul fuq l-annimali.
English: Do not shake.
Maltese: Għatu ta'
English: The average molecular mass is approximately 60 kDa of which the protein moiety plus the carbohydrate part constitutes approximately 30 kDa.
Maltese: Il-piż molekulari medju huwa ta' madwar 60 kDa li minnu il-parti tal-proteina flimkien mal-parti tal-karboidrat jagħmlu madwar 30 kDa.
English: There is no evidence that MIRCERA interacts with other medicines.
Maltese: M'hemmx evidenza li MIRCERA tinteraġixxi ma' mediċini oħra.
English: It did not induce a proliferative response in non-haematological tumor cell lines in vitro.
Maltese: Huwa ma kkawżax rispons proliferattiv f'razez ta' ċelluli tat-tumur mhux ematoloġiċi in vitro.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/400/008
English: • A condition called Pure Red Cell Aplasia (PRCA, stopped or reduced production of red blood cells) due to anti-erythropoietin antibodies was observed in some patients treated with erythropoiesis stimulating agents (ESAs), including MIRCERA.
Maltese: Kundizzjoni magħrufa bħala Aplasija Pura taċ-Ċelluli l-Ħomor (PRCA, produzzjoni mwaqqfa jew imnaqqsa taċ-ċelluli ħomor tad-demm) ikkawżata minn antikorpi anti-eritropoetin kienet osservata f'uħud mill-pazjenti kkurati b'sustanzi li jistimulaw l-eritropoesi (ESAs), inkluż MIRCERA.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 50 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 50 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 200 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 200 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 250 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 250 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: Patients should be monitored closely to ensure that the lowest approved effective dose of MIRCERA is used to provide adequate control of the symptoms of anaemia whilst maintaining a haemoglobin concentration below or at 12 g/dl (7.45 mmol/l).
Maltese: Il-pazjenti għandhom jiġu ssorveljati mill-viċin sabiex jiġi assigurat li tiġi wżata l-inqas doża effettiva approvata ta' MIRCERA biex jiġi pprovdut kontroll adegwat tas-sintomi tal-anemija waqt li lkonċentrazzjoni tal-emoglobina tinżamm taħt jew f'livell ta' 12 g/dl (7.45 mmol/l).
English: • hypertensive encephalopathy (very high blood pressure that can result in headache, especially sudden, stabbing, migraine-like headache, confusion, speech disturbances, fits or convulsions).
Maltese: speċjalment uġigħ ta' ras bħall-emikranja li jitfaċċa f'daqqa u jtektek, konfużjoni, disturbi fid diskors, aċċessjonijiet jew konvulżjonijiet). · emboliżmu pulmonari
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 30 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 30 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 mcg/0.3 ml
Maltese: INDIVIDWALI 250 mcg/0.
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 50 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: NAME OF THE MEDICINAL PRODUCT MIRCERA 40 micrograms/0.3 ml solution for injection in pre-filled syringe methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 40 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol-epoetin beta
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 40 micrograms of methoxy polyethylene glycol-epoetin beta.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Siringa waħda mimlija għal-lest fiha 40 mikrogramma ta' methoxy polyethylene glycol epoetin beta.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 75 mcg/0.3 ml
Maltese: INDIVIDWALI 75 mcg/0.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 100 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 100 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 60 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 60 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: Each pack contains 3 pre-filled syringes of 0.3 ml and 3 needles
Maltese: Kull pakkett fih 3 siringi mimlija għal-lest ta' 0.3 ml u 3 labriet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/017
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/400/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/400/012
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/400/012
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION MIRCERA 50 mcg/0.3 ml injection methoxy polyethylene glycol-epoetin beta
Maltese: MIRCERA 50 mikrogramma/0.3 ml soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest methoxy polyethylene glycol epoetin beta
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mcg/0.3 ml
Maltese: MIRCERA 150 mcg/0.
English: Conventional Cytogenetics [t(15;17)]
Maltese: Ċitoġenetiċi Konvenzjonali [t(15;17)]
English: 10 mg/10 ml
Maltese: INDIVIDWALI 10 mg/10 mL
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)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/19/1398/001 (pakkett ta' kunjett 1) EU/1/19/1398/002 (pakkett ta' 5 kunjetti) EU/1/19/1398/003 (pakkett ta' 10 kunjetti)
English: RT-PCR for PML/ RARα
Maltese: RT-PCR għal PML/ RAR
English: Gamma-glutamyltransferase increased*
Maltese: Żieda f'gamma-glutamyltransferase*
English: Lutomierska 50, 95-200 Pabianice, Poland
Maltese: Lutomierska 50, 95-200
English: 10-50 x 10
Maltese: 10-50 x 103/µL
English: > 50 x 10
Maltese: >50 x 103/µL
English: Each pack contains 1, 5 or 10 vials.
Maltese: Kull pakkett fih 1, 5 jew 10 kunjetti.
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)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1 ta' 10 ml (10 mg/10 mL) 5 kunjetti ta' 10 ml (10 mg/10 ml) 10 kunjetti ta' 10 ml (10 mg/10 ml)
English: See section 2, “Arsenic trioxide Accord contains sodium”.
Maltese: Ara sezzjoni 2, “Arsenic trioxide Accord fih sodium”.
English: APL = acute promyelocytic leukemia; ATRA = all-trans-retinoic acid
Maltese: ATRA = all-trans-retinoic acid
English: The active ingredient of Arsenic trioxide Accord, arsenic trioxide, is a human carcinogen.
Maltese: Is-sustanza attiva ta' Arsenic trioxide Accord, arsenic trioxide, hija karċinoġenu uman.
English: Multicentre trial N=40
Maltese: Studju multiċentriku N=40
English: Arsenic trioxide dose, mg/kg/day (median, range) Complete remission
Maltese: Doża ta' arsenic trioxide, mg/kg/kuljum (medjana, firxa)
English: Renal failure
Maltese: Indeboliment renali
English: Biotransformation The metabolism of arsenic trioxide involves oxidation of arsenious acid (AsIII), the active species of arsenic trioxide, to arsenic acid (AsV), as well as oxidative methylation to monomethylarsonic acid (MMAV) and dimethylarsinic acid (DMAV) by methyltransferases, primarily in the liver.
Maltese: Il-metaboliżmu ta' arsenic trioxide jinvolvi ossidazzjoni ta' arsenious acid (AsIII), l-ispeċi attiva ta' arsenic trioxide, għal arsenic acid (AsV), kif ukoll il-metilazzjoni ossidattiva għal monomethylarsonic acid (MMAV) u dimethylarsinic acid (DMAV) permezz ta' methyltransferases, primarjament fil-fwied.
English: Alanine amino transferase increased
Maltese: Investigazzjonijiet Żieda f'alanine aminotransferase
English: Multicentre trial N with CR = 34
Maltese: Esperiment multiċentriku N ma' KR=34
English: Arsenic trioxide also causes damage or degradation of the fusion protein PML/RAR alpha.
Maltese: L-Arsenic trioxide jikkawża wkoll dannu jew degradazzjoni fil-protein tal-fużjoni PML/RAR alpha.
English: Arsenic trioxide can cause QT interval prolongation (see section 4.4).
Maltese: Arsenic trioxide jista' jikkaġuna titwil tal-intervall QT (ara sezzjoni 4.4).
English: Cytogenetic confirmation of conversion to a normal genotype and reverse transcriptase - polymerase chain reaction (RT-PCR) detection of PML/RARα conversion to normal are shown in table 5 below.
Maltese: Konfirmazzjoni ċitoġenetika tal-bidla għal ġenotip normali u l-bidla ta' Rreverse transcriptasepolymerase chain reaction (RT-PCR) detection of PML/RAR għan-normal huma murija fit-tabella 5 hawn taħt.
English: Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block.
Maltese: L-arsenic trioxide jista' jikkawża titwil tal-intervall QT u l-imblokkar komplet atrijoventrikulari.
English: Other antileukaemic medicinal products
Maltese: Prodotti mediċinali antilewkemiċi oħra
English: • Relapsed/refractory acute promyelocytic leukaemia (APL)(Previous treatment should have included a retinoid and chemotherapy) characterised by the presence of the t(15;17) translocation and/or the presence of the promyelocytic leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene.
Maltese: • Lewkimja promijeloċitika li tirkadi/refrattarja (APL) (It-trattament li ngħata qabel kellu jinkludi retinojd u kimoterapija) karatterizata mill-preżenza tat-translokazzjoni t(15;17) u/jew ilpreżenza tal-ġene ta' lewkimja promijeloċitika/riċettur tal-aċidu retinojku-alfa (PML/RAR-alfa).
English: • Newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) (white blood cell count, ≤ 10 x 103/µl) in combination with all-trans-retinoic acid (ATRA)
Maltese: • Lewkimja promijeloċitika akuta (APL - acute promyelocytic leukaemia) ta' riskju baxx sa intermedju ddijanjostikata għall-ewwel darba (għadd ta' ċelluli bojod tad-demm, ≤ 10 x 103/µL) flimkien ma' all-trans-retinoic acid (ATRA)
English: In newly diagnosed patients, with low to intermediate risk APL, QTc prolongation was observed in 15.6 %.
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba, b'APL ta' riskju baxx sa intermedju, kien osservat titwil ta' QTc f'15.6 %.
English: The methylated metabolites of AsIII (MMAV, DMAV) are primarily excreted in the urine.
Maltese: Il-metaboliti metilati ta' AsIII (MMAV, DMAV) huma mneħħija primarjament fl-awrina.
English: Arsenic trioxide Accord is normally given by a doctor or a nurse.
Maltese: Arsenic trioxide Accord normalment jingħata minn tabib jew infermier.
English: Arsenic trioxide Accord contains sodium:
Maltese: Arsenic trioxide Accord fih sodium:
English: No data are available on patient with variant translocations like t(11;17) (PLZF/RAR alpha).
Maltese: M'hemm l-ebda data disponibbli dwar pazjenti bi traslokazzjonijiet varjanti bħal t(11;17) (PLZF/RAR alfa).
English: Patients in the ATRA+ arsenic trioxide treatment group received oral ATRA at 45 mg/m2 daily and iv arsenic trioxide at 0.15 mg/kg daily until CR.
Maltese: Pazjenti fil-grupp ta' trattament b'ATRA+ arsenic trioxide rċevew 45 mg/m2 ATRA orali kuljum u 0.15 mg/kg arsenic trioxide IV kuljum sa remissjoni kompleta.
English: Herpes zoster
Maltese: Infezzjonijiet u infestazzjonijiet Herpes zoster
English: Arsenic trioxide causes morphological changes and deoxyribonucleic acid (DNA) fragmentation characteristic of apoptosis in NB4 human promyelocytic leukaemia cells in vitro.
Maltese: Arsenic trioxide jikkawża tibdil morfoloġikali u fragmentazzjoni ta' deoxyribonucleic acid (DNA) li huma karatteristika ta' apoptożi f'ċelluli in vitro tal-lewkimja promijeloċitika umana
English: There is no experience on the effect of arsenic trioxide on the variant APL containing the t(11;17) and t(5;17) chromosomal translocations.
Maltese: M'hemmx esperjenza fuq l-effett ta' arsenic trioxide fuq il-varjant APL li fih it-t(11;17) u t(5;17) translokazzjoni kromożomali.
English: In newly diagnosed patients with low to intermediate risk APL leukocytosis developed during induction therapy in 35 of 74 (47 %) patients (see section 4.8).
Maltese: F'pazjenti ddijanjostikati għall-ewwel darba b'APL ta' riskju baxx sa intermedju, żviluppat lewkoċitożi matul it-terapija ta' induzzjoni f'35 minn 74 (47%) pazjent (ara sezzjoni 4.8).
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar il-preparazzjoni tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: One vial of 10 ml contains 10 mg of arsenic trioxide.
Maltese: Kunjett wieħed fih 10 mg ta' arsenic trioxide.
English: After dilution in intravenous solutions, Arsenic trioxide Accord is chemically and physically stable for 24 hours at 25°C and 48 hours at refrigerated (2-8°C) temperatures.
Maltese: Wara d-dilwazzjoni fis-soluzzjoni fil-vina, Arsenic trioxide Accord hu kemikalment u fiżikament stabbli għal 24 siegħa f'25°C u 48 siegħa f'temperaturi fil-friġġ (2-8°C).