FrancophonIA/ELRC3.0 huggingface dataset:
English: Istodax was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2005 for the treatment of peripheral T-cell lymphoma (nodal, other extranodal and leukaemic/disseminated).
Maltese: Istodax kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-28 ta' Ottubru 2005 għall-kura ta' limfoma periferali taċ-ċelloli-T (nodali, extranodali oħra u lewkemika/disseminata).
English: The active substance in Istodax, romidepsin, is expected to work by blocking the activity of proteins called histone deacetylases, which are involved in turning genes ‘on' and ‘off' within cells.
Maltese: Is-sustanza attiva f'Istodax, romidepsin, hija mistennija li taħdem billi timblokka l-attività ta' proteini msejħa histone deacetylases, li huma involuti fit-tibdil tal-ġeni fiċ-ċelloli f'‘mixgħulin' u ‘mitfija'.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Maltese: Wara li kkunsidra r-raġunijiet għal din it-talba, is-CHMP eżamina mill-ġdid l-opinjoni inizjali, u kkonferma r-rifjut tal-awtorizzazzjoni għat-tqegħid fissuq fil-15 ta' Novembru 2012.
English: What was Istodax expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Istodax?
English: On 19 July 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Istodax, intended for the treatment of peripheral T-cell lymphoma.
Maltese: Fid-19 ta' Lulju 2012, il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Istodax, maħsub għall-kura ta' limfoma periferali taċ-ċelloli-T.
English: Therefore it was not possible to conclude that the benefits of the medicine outweigh the risks and the CHMP confirmed its initial negative opinion.
Maltese: Għalhekk ma kienx possibbli li jiġi konkluż li lbenefiċċji tal-mediċina jegħlbu r-riskji u s-CHMP ikkonferma l-opinjoni negattiva inizjali tiegħu.
English: The effects of Istodax were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Istodax ġew l-ewwel ittestjati fuq mudelli sperimentali qabel ma ġew studjati fil-bnedmin.
English: In July 2012, the CHMP noted that the main study showed that Istodax had anti-tumour activity in terms of patients' response to treatment.
Maltese: F'Lulju 2012, is-CHMP innota li l-istudju ewlieni wera li Istodax kellu attività kontra t-tumuri f'termini ta' rispons tal-pazjenti għall-kura.
English: The company presented the results from one main study with Istodax involving 131 patients with peripheral T-cell lymphoma who had received previous treatment.
Maltese: Il-kumpanija ppreżentat ir-riżultati minn studju ewlieni wieħed b'Istodax li fih ħadu sehem 131 pazjent b'limfoma periferali taċ-ċelloli-T li kienu rċevew kura preċedenti.
English: The exact way that romidepsin works in peripheral T-cell lymphoma is not known, but its effects on genes that regulate cell proliferation and cell death are expected to lead to a reduction in the rate of growth and division of the cancer cells.
Maltese: Il-mod eżatt kif jaħdem romidepsin fil-limfoma periferali taċ-ċelloli-T mhuwiex magħruf, imma l-effetti tiegħu fuq il-ġeni li jirregolaw il-proliferazzjoni taċ-ċelloli u l-mewt taċ-ċelloli huma mistennija li jwasslu għal tnaqqis fir-rata ta' tkabbir u ta' diviżjoni tal-ċelloli tal-kanċer.
English: Istodax was expected to be used for the treatment of adults with peripheral T-cell lymphoma that no longer responds to or has come back after at least two previous therapies.
Maltese: Istodax kien mistenni li jintuża għall-kura ta' adulti b'limfoma periferali taċ-ċelloli-T li ma għadhiex tirrispondi jew li reġgħet tfaċċat wara tal-anqas żewġ terapiji preċedenti.
English: How is Istodax expected to work?
Maltese: Kif huwa mistenni li jaħdem Istodax?
English: It was to be available as a powder and solvent to be made into a solution for infusion (drip into a vein).
Maltese: Kienet se tkun disponibbli bħala trab u solvent biex jiġu magħmula f'soluzzjoni għal infużjoni (dripp ġo vina).
English: Peripheral T-cell lymphoma is a cancer of a type of white blood cells called T-cells, which are part of the immune system.
Maltese: Il-limfoma periferali taċċelloli-T hija kanċer ta' tip ta' ċelloli tad-demm bojod msejħa ċelloli-T, li huma parti mis-sistema immuni.
English: Dovato (dolutegravir / lamivudine)
Maltese: Dovato (dolutegravir / lamivudina)
English: Dovato (dolutegravir / lamivudine) EMA/276259/2019
Maltese: Dovato (dolutegravir / lamivudina) EMA/276259/2019
English: Other information about Dovato
Maltese: Informazzjoni oħra dwar Dovato
English: Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1) in adults and adolescents over 12 years old who weigh at least 40 kg.
Maltese: Dovato huwa mediċina għall-kura ta' infezzjoni bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1) f'adulti u adoloxxenti ta' aktar minn 12-il sena li jiżnu mill-inqas 40 kg.
English: Dovato is available as tablets containing 50 mg of dolutegravir and 300 mg of lamivudine.
Maltese: Dovato jiġi bħala pilloli li fihom 50 mg ta' dolutegravir u 300 mg ta' lamivudina.
English: In these studies, 91% of patients with HIV-1 who took the Dovato combination no longer had detectable levels of HIV (below 50 copies per ml) after 48 week compared with 93% of those who were taking the triple combination.
Maltese: F'dawn l-istudji, 91 % tal-pazjenti li kellhom HIV-1 li ħadu l-kombinazzjoni ta' Dovato ma kellhomx aktar livelli ta' identifikazzjoni tal-HIV (inqas minn 50 kopja għal kull ml) wara 48 ġimgħa meta mqabbla ma' 93 % ta' dawk li kienu qed jieħdu l-kombinazzjoni tripla.
English: What are the risks associated with Dovato?
Maltese: X'inhuma r-riskji assoċjati ma' Dovato?
English: Dolutegravir stops the activity of an enzyme called integrase (and is known as an integrase inhibitor), while lamivudine stops the activity of reverse transcriptase (and is known as a nucleoside reverse transcriptase inhibitor or NRTI).
Maltese: Id-dolutegravir twaqqaf l-attività ta' enzima msejħa integrażi (u hija magħrufa bħala inibitur tal-integrażi), filwaqt li l-lamivudina twaqqaf l-attività tattranskrittażi inversa (u hija magħrufa bħala inibitur nukleosidiku tat-transkrittażi inversa jew NRTI).
English: Both active substances have already been authorised in the European Union as separate tablets: dolutegravir in 2014 and lamivudine in 1996.
Maltese: Iż-żewġ sustanzi attivi diġà ġew awtorizzati fl-Unjoni Ewropea bħala pilloli separati: id-dolutegravir fl2014 and l-lamivudina fl-1996.
English: Two main studies, involving 1,441 patients, have shown that the combination of the two active substances in Dovato is as effective at lowering the amount of HIV in the blood as a triple combination therapy (dolutegravir plus tenofovir plus emtricitabine).
Maltese: Żewġ studji ewlenin, li involvew 1,433 pazjent, urew li l-kombinazzjoni taż-żewġ sustanzi attivi f'Dovato hija effettiva biex jitnaqqas l-ammont ta' HIV fid-demm bħala terapija kombinata tripla (dolutegravir flimkien ma' tenofovir u ma' emtriċitabina).
English: As for all medicines, data on the use of Dovato are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Dovato hija ssorveljata kontinwament.
English: The two active substances in Dovato, dolutegravir and lamivudine, block the activity of enzymes that the virus uses to make new copies of itself.
Maltese: Iż-żewġ sustanzi attivi f'Dovato, id-dolutegravir u l-lamivudina, jimblukkaw l-attività ta' enzimi li l-virus juża biex jagħmel kopji ġodda tiegħu nnifsu.
English: Dovato received a marketing authorisation valid throughout the EU on 1 July 2019 Further information on Dovato can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/dovato This overview was last updated in 08-2019.
Maltese: ema.europa.eu/medicines/human/EPAR/dovato
English: The most common side effects with Dovato (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea and difficulty sleeping.
Maltese: L-effetti sekondarji l-aktar komuni b'Dovato (li jistgħu jaffettwaw sa persuna 1 minn 10) huma wġigħ ta' ras, dijarea, nawżja u diffikultà biex torqod.
English: Dovato does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Dovato ma jikkurax l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: This medicine contains the active substances dolutegravir and lamivudine and is used to treat infections that are not resistant to medicines of the same class as dolutegravir or to lamivudine.
Maltese: Din il-mediċina fiha s-sustanzi attivi dolutegravir u lamivudina u tintuża għall-kura ta' infezzjonijiet li mhumiex reżistenti għal mediċini tal-istess klassi bħal dolutegravir jew għal lamivudina.
English: Side effects reported with Dovato are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Dovato huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: How does Dovato work?
Maltese: Kif jintuża Dovato?
English: What measures are being taken to ensure the safe and effective use of Dovato?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Dovato?
English: The most common serious side effects (which may affect up to 1 in 100 people) are allergic reactions, including rash and severe liver problems.
Maltese: L-effetti sekondarji serji l-aktar komuni (li jistgħu jaffettwaw sa persuna 1 minn kull 100) jinkludu reazzjonijiet allerġiċi li jinkludu raxx jew ħsara filfwied.
English: In two main studies, the Dovato combination was just as effective as a triple combination in patients with HIV-1, with no cases of resistance developing in these patients.
Maltese: F'żewġ studji ewlenin, il-kombinazzjoni ta' Dovato kienet effettiva daqs kombinazzjoni tripla f'pazjenti bl-HIV-1, bl-ebda każ ta' żvilupp ta' reżistenza f'dawn il-pazjenti.
English: 1 inhaler (120 actuations)
Maltese: inalatur 1 (120 attwazzjoni)
English: 3 (3x1) inhalers (360(3x120) actuations) (multipack)
Maltese: (360(3x120) attazzjoni) pakkett multiplu
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA Isem (ivvintat) Qawwa
English: MA (EU) number (Invented) name
Maltese: Mnejn għandu jingħata Il-pakkett li jmiss mal-prodott Daqs tal-pakkett EU/1/16/1152/001 Roteas
English: Linearity/non-linearity
Maltese: Linearita`/ non-linearita`
English: 117, Allée des Parcs 69800 Saint-Priest France
Maltese: 117, Allée des Parcs 69800 Saint-Priest Franza
English: C/ Castelló no1, Pol. Las Salinas 08830, Sant Boi de Llobregat, Barcelona Spain
Maltese: C/ Castelló no1, Pol. Las Salinas 08830, Sant Boi de Llobregat, Barcelona Spanja
English: Synthon Hispania S.L., C/ Castelló no1, Pol. Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Spain
Maltese: Synthon Hispania S.L., C/ Castelló no1, Pol. Las Salinas, 08830, Sant Boi de Llobregat, Barcelona, Spanja
English: 6.5 Nature and contents of container oPA/Al/PVC/Al.
Maltese: OPA/Al/PVC/Al.
English: • dizziness (vertigo)
Maltese: • sturdament (vertigo)
English: Manufacturer Mylan Hungary Kft, Mylan utca 1
Maltese: Manifattur Mylan Hungary Kft, Mylan utca 1
English: The metabolism of rasagiline proceeds through two main pathways: N-dealkylation and/or hydroxylation to yield: 1-Aminoindan, 3-hydroxy-N-propargyl-1 aminoindan and 3-hydroxy-1-aminoindan.
Maltese: N-dialkajlazzjoni u/jew idroxilazzjoni biex jipproduċi: 1Aminoindan, 3-hydroxy-N-propargyl-1 aminoindan u 3-hydroxy-1-aminoindan.
English: - The other ingredients are microcrystalline cellulose, tartric acid, maize starch, pregelatinized maize starch, talc, stearic acid.
Maltese: rasagiline - Sustanzi oħra jinkludu microcrystalline cellulose, tartric acid, maize starch, pregelatinized maize starch, talc, stearic acid.
English: Blister packs of 7, 10, 28, 30, 100 or 112 tablets PVC/PVDC/Al.
Maltese: Pakketti ta' folji ta' 7, 10, 28, 30, 100 jew 112 pilloli PVC/PVDC/Al.
English: 7 tablets 10 tablets 28 tablets 30 tablets 100 tablets 112 tablets 7 x 1 tablets 10 x 1 tablets 28 x 1 tablets 30 x 1 tablets 100 x 1 tablets 112 x 1 tablets
Maltese: 7 pilloli 10 pilloli 28 pillola 30 pillola 100 pillola 112-il pillola 7 x 1 pilloli 10 x 1 pilloli 28 x 1 pillola 30 x 1 pillola 100 x 1 pillola 112 x 1 pillola
English: Common: dermatitis (2.0% vs. 0%)
Maltese: Komuni: dermatite (2.0% vs. 0%)
English: Cellulose, microcrystalline Tartaric acid
Maltese: Cellulose, microcrystalline
English: • abnormal movements (dyskinesia)
Maltese: • movimenti abnormali (diskajneżja)
English: EU/1/16/1090/001 (7 tablets - oPA/alu/PVC/alu) EU/1/16/1090/002 (10 tablets - oPA/alu/PVC/alu) EU/1/16/1090/003 (28 tablets - oPA/alu/PVC/alu) EU/1/16/1090/004 (30 tablets - oPA/alu/PVC/alu) EU/1/16/1090/005 (100 tablets - oPA/alu/PVC/alu) EU/1/16/1090/006 (112 tablets - oPA/alu/PVC/alu) EU/1/16/1090/007 (7 tablets - PVC/PVDC/alu) EU/1/16/1090/008 (10 tablets - PVC/PVDC/alu) EU/1/16/1090/009 (28 tablets - PVC/PVDC/alu) EU/1/16/1090/010 (30 tablets - PVC/PVDC/alu) EU/1/16/1090/011 (100 tablets - PVC/PVDC/alu) EU/1/16/1090/012 (112 tablets - PVC/PVDC/alu) EU/1/16/1090/013 (7 x 1 tablets - PVC/PVDC/alu) EU/1/16/1090/014 (10 x 1 tablets - PVC/PVDC/alu) EU/1/16/1090/015 (28 x 1 tablets - PVC/PVDC/alu) EU/1/16/1090/016 (30 x 1 tablets - PVC/PVDC/alu) EU/1/16/1090/017 (100 x 1 tablets - PVC/PVDC/alu) EU/1/16/1090/018 (112 x 1 tablets - PVC/PVDC/alu)
Maltese: EU/1/16/1090/001 (7 pilloli - oPA/alu/PVC/alu) EU/1/16/1090/002 (10 pilloli - oPA/alu/PVC/alu) EU/1/16/1090/003 (28 pillola - oPA/alu/PVC/alu) EU/1/16/1090/004 (30 pillol - oPA/alu/PVC/alu) EU/1/16/1090/005 (100 pillola - oPA/alu/PVC/alu) EU/1/16/1090/006 (112-il pillola - oPA/alu/PVC/alu) EU/1/16/1090/007 (7 pilloli - PVC/PVDC/alu) EU/1/16/1090/008 (10 pilloli - PVC/PVDC/alu) EU/1/16/1090/009 (28 pillola - PVC/PVDC/alu) EU/1/16/1090/010 (30 pillola - PVC/PVDC/alu) EU/1/16/1090/011 (100 pillola - PVC/PVDC/alu) EU/1/16/1090/012 (112-il pillola - PVC/PVDC/alu) EU/1/16/1090/013 (7 x 1 pilloli - PVC/PVDC/alu) EU/1/16/1090/014 (10 x 1 pilloli - PVC/PVDC/alu) EU/1/16/1090/015 (28 x 1 pillola - PVC/PVDC/alu) EU/1/16/1090/016 (30 x 1 pillola - PVC/PVDC/alu) EU/1/16/1090/017 (100 x 1 pillola - PVC/PVDC/alu) EU/1/16/1090/018 (112 x 1-il pillola - PVC/PVDC/alu)
English: Impulse control disorders
Maltese: Disturbi fil-kontroll tal-impuls
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: 117, Allée des Parcs, 69800 Saint-Priest France
Maltese: 117, Allée des Parcs, 69800
English: Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Maltese: Meta rasagiline u ciprofloxacin (impeditur ta' CYP1A2) ittieħdu flimkien, l-AUC ta' rasagiline żdied b' 83%.
English: Common: dystonia (2.4% vs. 0.8%), carpal tunnel syndrome (1.3% vs. 0%), balance disorder (1.6% vs. 0.3%)
Maltese: Komuni: distonja (2.4% vs. 0.8%), sindromu ta' carpal tunnel (1.3% vs. 0%), disturb fil-bilanċ (1.6%vs. 0.3%)
English: Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors, ATC code: N04BD02
Maltese: Mediċini kontra l-marda ta' Parkinson, impedituri ta' monoamine oxidase -B, Kodiċi ATC:
English: What Rasagiline Mylan contains - The active substance is rasagiline.
Maltese: - Is-sustanza attiva hi rasagiline.
English: In vitro studies showed that rasagiline at a concentration of 1 μg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Maltese: Studji in vitro wrew li rasagiline f'konċentrazzjoni ta' 1 µg/ml (ekwivalenti għal livell li hu 160 darba iżjed mill-medja ta' Cmax ~ 5.9-8.5 ng/ml f' pazjenti bil-marda ta' Parkinson wara dożi multipli ta' rasagiline 1 mg), ma jinibixxix iżoenzimi cytochrome P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 u CYP4A.
English: In subjects with moderate hepatic impairment, AUC and Cmax were increased by 568% and 83%, respectively (see section 4.4).
Maltese: F'suġġetti b' indeboliment moderat tal-fwied, AUC u Cmax żdiedu b'568% u 83%, rispettivament (ara sezzjoni 4.4).
English: Uncommon: angina pectoris (0.5% vs. 0%)
Maltese: Mhux komuni: anġina pektoris (0.5% vs. 0%)
English: Adverse reactions are ranked under headings of frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Maltese: Ir-reazzjonijiet avversi huma maqsuma skond il-frekwenza permezz ta' dawn il-konvenzjonijiet: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Common: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%) Nervous system disorders
Maltese: Komuni: dipressjoni (5.4% vs. 2%), alluċinazzjonijiet (1.3% vs. 0.7%) Disturbi fis-sistema nervuża
English: Very common: dyskinesia (10.5% vs. 6.2%)
Maltese: Komuni ħafna: diskajneżja (10.5% vs. 6.2%)
English: 1-Aminoindan is an active major metabolite and it is not a MAO-B inhibitor.
Maltese: 1-Aminoindan, prodott attiv ewlieni tal-metabolizmu, m'huwiex impeditur ta' MAO-B.
English: • irritation of the skin (dermatitis)
Maltese: • irritazzjoni tal-ġilda (dermatite)
English: Renal impairment: Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
Maltese: Il-karatteristiċi farmakokinetiċi ta' rasagiline f'suġġetti b' indeboliment ħafif (CLcr 50-80 ml/min) u b'indeboliment moderat (CLcr 30-49 ml/min), kienu simili ta' dawk f'suġġetti f'saħħithom.
English: Rasagiline Mylan 1 mg tablets
Maltese: RASAGILINE MYLAN 1 mg pilloli
English: • blistering rash (vesiculobullous rash)
Maltese: • raxx bl-infafet ( raxx vexxikulobullożu)
English: Perforated unit dose blister packs of 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 or 112 x 1.
Maltese: Pakketti bil-folji perforati tal-unità li jkun fih 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 jew 112 x 1 pillola.
English: In the rasagiline clinical program overall, 1,361 patients were treated with rasagiline for 3,076.4 patient years.
Maltese: Fil-programm kliniku ta' rasagiline, b'kollox 1,361 pazjent irċievew trattament b'rasagiline għal total ta' 3,076.4 l-sena bejn il-pazjenti kollha.
English: 597 678 01 Blansko Czech Republic
Maltese: Synthon s.r.o Brněnská 32/čp. 597 678 01 Blansko Ir-Repubblika Ċeka
English: The following side effects have been reported in placebo controlled clinical trials:
Maltese: L-effetti sekondarji li ġejjin ġew irrapportati fi provi kliniċi kkontrollati:
English: Hepatic impairment: In subjects with mild hepatic impairment, AUC and Cmax were increased by 80% and 38%, respectively.
Maltese: F'suġġetti b'indeboliment ħafif tal-fwied, AUC u Cmax żdiedu b' 80% u 38%, rispettivament.
English: • chest pain (angina pectoris)
Maltese: • uġigħ fis-sider (anġina pektoris)
English: With MAO inhibitors there have been reports of medicinal product interactions with the concomitant use of sympathomimetic medicinal products.
Maltese: B'impedituri MAO, kien hemm rapporti ta' interazzjonijiet ta' mediċini bl-użu fl-istess ħin ta' prodotti mediċinali simpatomimetiċi.
English: The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Maltese: II: għal-rasagiline 1 mg mqabbel ma' plaċebo -2.7, 95% CI [-3.87,-1.55], p<0.0001; għal rasagiline 2 mg meta mqabbel ma' plaċebo -1.68, 95% CI [-2.85,0.
English: Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Maltese: Sintomi rrapportati wara doża eċċessiva ta' rasagiline f'dożi li jvarjaw minn 3 mg sa 100 mg kienu jinkludu disforja, ipomanija, kriżi ipertensiva u s-sindromu ta' serotonin.
English: Common: allergy (1.3% vs. 0.7%)
Maltese: Komuni: allerġija (1.3% vs. 0.7%)
English: • musculoskeletal pain
Maltese: • uġigħ muskolu-skeltrali
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertlità, tqala u treddigħ
English: In vitro metabolism studies have indicated that cytochrome P450 1A2 (CYP1A2) is the major enzyme responsible for the metabolism of rasagiline.
Maltese: Studji dwar il-metaboliżmu in vitro indikaw li cytochrome P450 1A2 (CYP1A2) huwa l-enzim prinċipali risponsabli għall-metaboliżmu ta' rasagiline.
English: There were no cases of serotonin syndrome in the rasagiline clinical program in which 115 patients were exposed concomitantly to rasagiline and tricyclics and 141 patients were exposed to rasagiline and SSRIs/ SNRIs.
Maltese: Ma kien hemm ebda każ ta' sindromu ta' serotonin filprogramm kliniku ta' rasagiline fejn 115-il pajent ġew esposti fl-istess ħin għal rasagiline u triċikliċi u 141 pazjent ġew esposti għal rasagiline u SSRIs/ SNRIs.
English: A similar pattern of impulse control disorders has been reported post-marketing with rasagiline, which also included compulsions, obsessive thoughts and impulsive behaviour (see section 4.4).
Maltese: Mudell simili ta' disturbi fil-kontroll tal-impuls ġie rrappurtat wara t-tqegħid fis-suq b'rasagiline, li kien jinkludi wkoll kompulsjonijiet, ħsibijiet ossessivi u imġieba impulsiva (ara sezzjoni 4.4).
English: • heart attack (myocardial infarction)
Maltese: • attakk tal-qalb (infart mijokardijaku)
English: Rasagiline Mylan 1 mg tablets rasagiline
Maltese: Rasagiline Mylan 1 mg pilloli rasagiline
English: Serious adverse reactions have been reported with the concomitant use of pethidine and MAO inhibitors including another selective MAO-B inhibitor.
Maltese: Reazzjonijiet serji avversi ġew irrapportati waqt l-użu flimkien ta' pethidine u impedituri ta' MAO inkluż impeditur ieħor selettiv għal MAO-B.
English: Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Maltese: Reazzjonijiet serji avversi kienu rraportati bl-użu fl-istess ħin ta' SSRIs, SNRIs, antidepressanti triċikliċi / tetraċikliċi u impedituri ta' MAO.
English: Other medicines and Rasagiline Mylan
Maltese: Mediċini oħra u Rasagiline Mylan
English: • numbness and muscle weakness of the hand (carpal tunnel syndrome)
Maltese: • tirżiħ u dgħjufija fil-muskoli tal-idejn (sindromu ta' carpal tunnel)
English: Similar reports of ICDs have also been received post-marketing with rasagiline.
Maltese: Rapporti simili ta' ICDs waslu wkoll wara t-tqegħid fis-suq b'rasagiline.
English: Common: conjunctivitis (2.7% vs. 0.7%)
Maltese: Komuni: konġuntivite (2.7% vs. 0.7%)
English: • urinary urgency
Maltese: • urġenza awrinali
English: Rasagiline clinical trials did not allow concomitant use of fluoxetine or fluvoxamine with rasagiline, but the following antidepressants and doses were allowed in the rasagiline trials: amitriptyline ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily.
Maltese: Fl-istudji kliniċi ta' rasagiline ma kienx permess l-użu fl-istess ħin ta' fluoxetine jew fluvoxamine ma' rasagiline iżda d-dożi u l-antidipressivi li ġejjin kienu tħallew fl-istudji kliniċi ta' rasagiline: amitriptyline ≤ 50 mg/kuljum, trazodone ≤ 100 mg/kuljum, citalopram ≤ 20 mg/kuljum, sertraline ≤ 100 mg/kuljum, u paroxetine ≤ 30 mg/kuljum.