FrancophonIA/ELRC3.0 huggingface dataset:
English: There are a number of known interactions between non-selective MAO inhibitors and other medicinal products.
Maltese: Hemm numru ta' interazzjonijiet bejn impedituri mhux selettivi ta' MAO u prodotti mediċinali oħrajn.
English: The list below includes adverse reactions which were reported with a higher incidence in placebo controlled studies in patients receiving 1 mg/day rasagiline (rasagiline group n=380, placebo group n=388).
Maltese: Il-lista ta' hawn taħt tinkludi reazzjonijiet avversi li kienu rrapportati b'inċidenza ogħla f'istudji kkontrollati bil-plaċebo, f'pazjenti li kienu jirċievu 1 mg/ġurnata ta' rasagiline (grupp ta' rasagiline n=380, grupp ta' plaċebo n=388).
English: The list below includes adverse reactions which were reported with a higher incidence in placebo controlled studies, in patients receiving 1 mg/day rasagiline (rasagiline group n=149, placebo group n=151).
Maltese: Il-lista hawn taħt tinkludi reazzjonijiet avversi li kienu rrapportati b'inċidenza ogħla f'studji kkontrollati bil-plaċebo, f'pazjenti li kienu jirċievu 1 mg/ġurnata ta' rasagiline (grupp ta' rasagiline n=149, grupp ta' plaċebo n=151).
English: For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotonin-norepinephrine reuptake inhibitors (SNRIs) in clinical trials, see section 4.8.
Maltese: Għall-użu flimkien, fi studji kliniċi, ta' rasagiline ma' inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs)/ inibituri selettivi tal-ġbir mill-ġdid ta' serotonin-norepinephrine (SNRIs) ara sezzjoni 4.8.
English: Adverse reactions with at least 2% difference over placebo are in italics.
Maltese: Reazzjonijiet avversi b'inċidenza ta' mill-inqas differenza ta' 2% mill-plaċebo huma miktubin b'italics.
English: Tyramine/rasagiline interaction: Results of five tyramine challenge studies (in volunteers and PD patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Maltese: Risultati ta' ħames studji ta' ċalinġ fuq tyramine (f'voluntiera u pazjenti b' PD), flimkien ma' risultati ta' monitoraġġ id-dar ta' l-pressjoni ta'd-demm wara l-ikel (ta' 464 pazjent li rċievew 0.5 jew 1 mg/ġurnata ta' rasagiline jew plaċebo bħala terapija miżjuda ma' levodopa għal sitt xhur mingħajr restrizzjonijiet għal tyramine), flimkien ma' l-fatt li ma kienx hemm rapporti ta' interazzjoni bejn tyramine/rasagiline fl-istudji kliniċi mingħajr restrizzjonijiet għal tyramine, wrew li rasagiline jista' jintuża mingħajr periklu bla restizzjonijiet ta' tyramine fid-dieta.
English: In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Maltese: Kanċer fil-ġilda ġie wkoll rappurtat f'madwar 1% tal-pazjenti fi provi kliniċi kontrollati b'plaċebo.
English: - pethidine (a strong pain killer).
Maltese: - pethidine (mediċina qawwija ta' kontra l-uġigħ).
English: In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144-213-times the expected plasma exposure in humans at 1 mg/day.
Maltese: Fil-ġrieden, żieda fl-inċidenza ta' adenoma bronkjolari/alvejolari u/jew karċinoma kienu osservati f'espożizzjonijiet sistemiċi, 144-213 l-darba iżjed mill-espożizzjonijiet tal-plażma mistennija fil-bniedem b'1 mg kuljum.
English: Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) the antibiotic ciprofloxacin used against infections the cough suppressant dextromethorphan sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Maltese: impedituri selettivi tal-ġbir mill-ġdid ta' serotonin-norepinephrine, mediċini triċikliċi u tetraċikliċi kontra d-depressjoni) - l-antibijotiku ciprofloxacin li jintuża kontra l-infezzjonijiet - il-mediċina kontra s-sogħla dextromethorphan - simpatomimetiċi bħal dawk fit-taqtir tal-għajnejn, f'dekonġestjonanti ta' l-imnieħer u f'dawk li jittieħdu mill-ħalq u prodotti mediċinali kontra l-irjiħat li fihom ephedrine u pseudoephedrine.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: skin carcinoma (1.3% vs. 0.7%) Blood and lymphatic system disorders Common: leucopenia (1.3% vs. 0%)
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċesti u polipi) Komuni: karċinoma tal-ġilda (1.3% vs. 0.7%) Disturbi tad-demm u tas-sistema limfatika Komuni: lewkopenja (1.3% vs. 0%)
English: Common: influenza (4.7% vs. 0.7%)
Maltese: Komuni: influwenza (4.7% vs. 0.7%)
English: • Not known (frequency cannot be estimated from the available data)
Maltese: • Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: In vitro experiments indicate that both routes of rasagiline metabolism are dependent on cytochrome P450 system, with CYP1A2 being the major iso-enzyme involved in rasagiline metabolism.
Maltese: Esperimenti in vitro juru li ż-żewġ rotot ta' metaboliżmu ta' rasagiline jiddependu fuq is-sistema ta' cytochrome P450, u li CYP1A2 huwa l-iżoenzim prinċipali involut fil-metaboliżmu ta' rasagiline.
English: Rasagiline was shown to be a potent, irreversible MAO-B selective inhibitor, which may cause an increase in extracellular levels of dopamine in the striatum.
Maltese: Rasagiline kien muri li huwa impeditur selettiv ħafna u rriversibli ta' MAO-B, li jista' jikkawża żieda fil-livelli extra-ċellulari ta' dopamine fl-istriatum.
English: Rasagiline did not present genotoxic potential in vivo and in several in vitro systems using bacteria or hepatocytes.
Maltese: Rasagiline ma kellux potenzjal għall-ġenotossiċita` in vivo u f'bosta sistemi in vitro b'batteri u epatoċiti.
English: Rasagiline pharmacokinetics are linear with dose over the range of 0.5-2 mg. Its terminal half-life is 0.6-2 hours.
Maltese: Il-karatteristiċi farmakokinetiċi ta' rasagiline huma lineari mad-doża fuq medda ta' 0.5-2 mg.
English: Uncommon: cerebrovascular accident (0.5% vs. 0.3%) Cardiac disorders
Maltese: Mhux komuni: inċident ċerebrovaskulari (0.5% vs. 0.3%) Disturbi fil-qalb
English: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets and in perforated blister packs containing 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 and 112 x 1 tablets.
Maltese: Il-pilloli issibhom f'folji ta' 7, 10, 28, 30, 100 jew 112 il-pillola jew perforati tal-unità li jkun ta 7 x 1, 10 x 1, 28 x 1, 30 x 1, 100 x 1 jew 112 x 1 pillola.
English: The concomitant administration of rasagiline and pethidine is contraindicated (see section 4.3).
Maltese: L-użu ta' rasagiline flimkien ma' pethidine huwa kontraindikat (ara sezzjoni 4.3).
English: Rasagiline is rapidly absorbed, reaching peak plasma concentration (Cmax) in approximately 0.5 hours.
Maltese: Rasagiline huwa assorbit malajr, u jilħaq l-ogħla konċentrazzjoni fil-plażma (Cmax ) f'bejn wieħed u ieħor 0.5 siegħa.
English: • flatulence
Maltese: • stitikezza
English: What Rasagiline Mylan looks like and contents of the pack Rasagiline tablets are presented as white to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE' on one side and ‘1' on the other side.
Maltese: Il-pilloli Rasagiline huma bojod għal offwajt, oblungi (madwar 11.5 mm x 6 mm) bikonvessi, imnaqqxa b'‘R9SE' fuq naħa waħda u ‘1' in-naħa l-oħra.
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Maltese: 78 sigħat, 95% CI [-1.18, -0.39], p=0.0001.
English: • joint inflammation (arthritis)
Maltese: • infjammazzjoni tal-ġogi (arttrite)
English: White to off-white, oblong (approximately 11.5 mm x 6 mm) biconvex tablets, debossed with ‘R9SE' on one side and ‘1' on the other side.
Maltese: Pilloli bojod għal offwajt, oblungi (madwar 11.5 mm x 6 mm) bikonvessi, tondi, ċatti, b'tarf imżerżaq, imnaqqxa b'‘R9SE' fuq naħa waħda u ‘1' n-naħa l-oħra.
English: H-2900 Komárom Hungary.
Maltese: Komárom L-Ungerija.
English: In the double blind placebo-controlled studies, 529 patients were treated with rasagiline 1 mg/day for 212 patient years and 539 patients received placebo for 213 patient years.
Maltese: F'studji kliniċi double-blind ikkontrollati bil-plaċebo, 529 lpazjent kienu trattati b'rasagiline 1 mg/ġurnata għal total ta' 212 sena bejn il-pazjenti kollha u 539 lpazjent irċievew plaċebo għal total ta' 213 sena bejn il-pazjenti kollha.
English: Hypersensitivity to the active substance or to any of the excipients (listed in section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal xi sustanzi mhux attivi (elenkati fis-sezzjoni 6.1).
English: The mean total daily decrease in the OFF time was similar in the entacapone group (-0.80h, 95% CI [-1.20, -0.41], p<0.0001) to that observed in the rasagiline 1 mg group.
Maltese: [-1.20, -0.41], p<0.0001) kien simili ta' dak osservat fil-grupp ta' rasagiline 1 mg.
English: Common: hallucinations (2.9% vs. 2.1%), abnormal dreams (2.1% vs. 0.8%) Uncommon: confusion (0.8% vs. 0.5%)
Maltese: 2.1%), ħolm mhux tas-soltu (2.1% vs. 0.8%) Mhux komuni: konfużjoni (0.8% vs. 0.5%) Disturbi fis-sistema nervuża
English: Rasagiline must not be administered along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Maltese: St.John's Wort) għaliex jista' jkun hemm riskju ta' inibizzjoni mhux selettiva ta' MAO li tista' twassal għal kriżi ipertensiva (ara sezzjoni 4.3).
English: The secondary measures of efficacy included global assessments of improvement by the examiner, Activities of Daily Living (ADL) subscale scores when OFF and UPDRS motor while ON. Rasagiline produced statistically significant benefit compared to placebo.
Maltese: Kejl sekondarji ta' l-effikaċja inkludew valutazzjonijiet globali għal titjib minn eżaminatur, l-għadd ta' punti ta' l-iskala sekondarja Attivitajiet tal-Ħajja ta' Kuljum (ADL) meta fi stat “OFF” u UPDRS talmoviment meta fi stat “ON”. Rasagiline ħalla titjib li huwa statistikament sinifikanti meta mqabbel ma' plaċebo.
English: • flu (influenza)
Maltese: • l-influwenza
English: • runny nose (rhinitis)
Maltese: • l-imnieħer iniżżel (rinite)
English: Parkinson's disease is associated with symptoms of hallucinations and confusion.
Maltese: Il-marda ta' Parkinson hija assoċjata ma' sintomi ta' alluċinazzjonijiet u konfużjoni.
English: • prolonged muscle contractions (dystonia)
Maltese: • kontrazzjonijiet muskolari mtawla (distownja)
English: C-labelled rasagiline, elimination occurred primarily via urine (62.6%) and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 38 days.
Maltese: Wara li ngħata rasagiline bit-tikketta 14C mill-ħalq, l-eliminazzjoni ta' rasagiline saret primarjament mill-awrina (62.6%) u sekondarjament mill-ippurgar (21.8%). 84.
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l.
Maltese: Il-volum ta' distribuzzjoni medju wara doża waħda ta' rasagiline fil-vina huwa ta' 243 l.
English: Dopamine is a chemical in the brain involved in movement control.
Maltese: Dopamine hija kimika fil-moħħ li hija involuta fil-kontroll tal-moviment.
English: Patients and carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated with rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Maltese: Il-pazjenti u min jieħu ħsiebhom għandhom ikunu konxji tas-sintomi talimġieba tad-disturbi fil-kontroll tal-impuls li kienu osservati f'pazjenti kkurati b'rasagiline, inklużi każijiet ta' kompulsjonijiet, ħsibijiet ossessivi, logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, imġieba impulsiva u nfiq ta' flus jew xiri kompulsiv.
English: In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
Maltese: Fi studju II, il-pazjenti kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (229 lpazjent), jew rasagiline 1 mg/ġurnata (231 l-pazjent) jew 200 mg ta' entacapone impeditur ta' catechol-O-methyl transferase (COMT) meħud flimkien ma' dożi skedati ta' levodopa (LD)/ impeditur ta' decarboxylase (227 pazjent).
English: Therefore, in view of the MAO inhibitory activity of rasagiline, the concomitant administration of rasagiline and dextromethorphan is not recommended (see section 4.4).
Maltese: Għaldaqstant, minħabba l-attivita` inibitorja ta' rasagiline għal MAO, mhuwiex rikkmandat l-użu ta' rasagiline flimkien ma' dextromethorphan (ara sezzjoni 4.4).
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
Maltese: L-użu ta' rasagiline flimkien ma' fluoxetine jew fluvoxamine għandu jiġi evitat (ara sezzjoni 4.5).
English: Common: orthostatic hypotension (3.9% vs. 0.8%) Gastrointestinal disorders
Maltese: Disturbi vaskulari komuni: ipotensjoni ortostatika (3.9% vs. 0.8%)
English: 5.1 Pharmacodynamic properties
Maltese: 3. GĦAMLA FARMAĊEWTIKA
English: Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5).
Maltese: Trattament flimkien ma' impedituri oħrajn ta' monoamine oxidase (MAO) (li jinkludu prodotti naturali u mediċinali li m'għandhomx bżonn ta' riċetta eż.
English: There is no specific antidote.
Maltese: M'hemmx antidotu speċifiku.
English: Rasagiline Mylan is indicated for the treatment of idiopathic Parkinson's disease (PD) as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Maltese: Rasagiline Mylan huwa indikat għat-trattament tal-marda ta' Parkinson (PD) idjopatika, bħala monoterapija (mingħajr levodopa) jew bħala terapija miżjuda (ma' levodopa) f'pazjenti b'tibdil filkundizzjoni tagħhom fl-aħħar tad-doża.
English: Rasagiline Mylan
Maltese: X'INHU RASAGILINE MYLAN
English: Musculoskeletal and connective tissue disorders Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%)
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue komuni: artralġja (2.4% vs.
English: Patients should be regularly monitored for the development of impulse control disorders.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati b'mod regolari għall-iżvilupp ta' disturbi fil-kontroll tal-impuls.
English: Uncommon: myocardial infarction (0.7% vs. 0%) Respiratory, thoracic and mediastinal disorders Common: rhinitis (3.4% vs. 0.7%)
Maltese: Komuni: anġina pektoris (1.3% vs. 0%); Mhux komuni: infart mijokardiku (0.7% vs. 0%) Disturbi respiratorji, toraċiċi u medjastinali
English: Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Maltese: Għaldaqstant, minħabba l-attivita` inibitorja ta' rasagiline għal MAO, mhuwiex rikkmandat l-użu ta' rasagiline flimkien ma' simpatomimetiċi inklużi dawk presenti f' dekonġestjonanti ta' l-imnieħer u dawk orali u prodotti mediċinali kontra l-irjiħat li fihom ephedrine jew pseudoephedrine (ara sezzjoni 4.4).
English: The use of Rasagiline Mylan together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Maltese: L-użu ta' Rasagiline Mylan flimkien ma' mediċini kontra d-depressjoni li fihom fluoxetine u fluvoxamine għandhom jiġu evitati.
English: How to store Rasagiline Mylan 6.
Maltese: Kif taħżen Rasagiline Mylan 6.
English: In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular undesirable reactions (including hypertension and postural hypotension) which resolved following treatment discontinuation.
Maltese: F'studju fejn kienet tiżdied id-doża f'pazjenti fuq terapija kronika b' levodopa li ngħataw 10 mg/ġurnata ta' rasagiline, kien hemm rapporti ta' reazzjonijiet kardjo-vaskulari mhux mixtieqa (inklużi pressjoni għolja u pressjoni posturali baxxa) li għaddew kif twaqqaf it-trattament.
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.4).
Maltese: L-użu ta' rasagiline flimkien ma' fluoxetine jew fluvoxamine għandu jkun evitat (ara sezzjoni 4.4).
English: In the post-marketing period, cases of serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants/SNRI concomitantly with rasagiline.
Maltese: Fil-perijodu wara li l-prodott tqiegħed fis-suq, ġew irrapportati każijiet ta' sindromu ta' serotonin flimkien ma' aġitazzjoni, konfużjoni, riġidità, deni u mijoklonus minn pazjenti kkurati b'antidipressivi/SNRI flimkien ma' rasagiline.
English: Rasagiline Mylan is used for the treatment of Parkinson's disease.
Maltese: Rasagiline Mylan jintuża għat-trattament tal-marda ta' Parkinson.
English: Each tablet contains rasagiline tartrate corresponding to 1 mg rasagiline.
Maltese: Kull pillola fiha rasagiline tartrate li jikkorrispondi għal 1 mg ta' rasagiline.
English: In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
Maltese: Fi studju I, 404 pazjent kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (138 lpazjent), rasagiline 1 mg/ġurnata (134 l-pazjent) jew rasagiline 2 mg/ġurnata (132 l-pazjent).
English: There is a risk that the plasma levels of rasagiline in smoking patients could be decreased, due to induction of the metabolising enzyme CYP1A2.
Maltese: Hemm riskju li f'pazjenti li jpejpu, l-livelli fil-plażma ta' rasagiline jistgħu jinżlu minħabba linduzzjoni ta' l-enzim CYP1A2 li hu risponsabli għall-metaboliżmu.
English: Adverse events were mild or moderate and not related to rasagiline treatment.
Maltese: Effetti avversi kienu ħfief jew moderati u ma kienux relatati ma' trattament b' rasagiline.
English: The robustness of the results for the primary efficacy end point, was confirmed in a battery of additional statistical models and was demonstrated in three cohorts (ITT, per protocol and completers).
Maltese: Il-qawwa tar-riżulati għall-konklużżjoni ta' l-effikaċja primarja kienet ikkonfermata b'sensiela ta' mudelli statistiċi addizzjonali u kienet murija fi tlett cohorts (ITT, skond ilprotokol u completers).
English: At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Maltese: Iridu jkunu għaddew mill-inqas 14 il-ġurnata bejn il-waqfien ta' trattament b'rasagiline u l-bidu ta' trattament b' fluoxetine u fluvoxamine.
English: Tel: + 49-(0) 6172 888 01
Maltese: Mylan dura GmbH Tel: + 49-(0) 61 72 888 01
English: • neck pain
Maltese: • ħalq xott
English: Uncommon: decreased appetite (0.7% vs. 0%) Psychiatric disorders
Maltese: Mhux komuni: inċident ċerebrovaskulari (0.7% vs. 0%) Disturbi fl-għajnejn
English: Impulse control disorders (ICDs) can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Maltese: Disturbi fil-kontroll tal-impuls (ICDs - impulse control disorders) jistgħu jseħħu f'pazjenti kkurati b'agonisti ta' dopamine u/jew kuri dopaminerġiċi.
English: In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 26 weeks.
Maltese: Fi studju III, il-pazjenti kienu maqsumin u magħżulin mingħajr ħsieb biex jingħataw plaċebo (159 lpazjent), rasagiline 0.5 mg/ġurnata (164 l-pazjent) jew rasagiline 1 mg/ġurnata (149 l-pazjent).
English: • fall
Maltese: • deni
English: Common: flatulence (1.3% vs.0%)
Maltese: Komuni: ammont eċċessiv ta' gass fl-istonku (1.3% vs.0%)
English: • headedness (orthostatic hypotension)
Maltese: • attakk ta' puplesija (aċċident ċerebro-vaskulari)
English: Do not store above 25°C
Maltese: Taħżinx f'temperatura ‘l fuq minn 25°C
English: In a single-dose study healthy volunteers received 20 mg/day and in a ten-day study healthy volunteers received 10 mg/day.
Maltese: F'studji ta' dożi singoli, voluntiera f'saħħithom irċievew 20 mg/ġurnata ta' rasagiline u f'studju li dam għaxart ijiem voluntieri f'saħħithom irċievew 10 mg/ġurnata.
English: If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.
Maltese: Biex tibda trattament b' fluoxetine jew fluvoxamine, trid tistenna mill-inqas 14 il-ġurnata minn meta twaqqaf Rasagiline Mylan.
English: Synthon s.r.o, Brněnská 32/čp.
Maltese: Synthon s.r.o, Brněnská 32/čp. 597 678 01 Blansko Ir-Repubblika Ċeka
English: Musculoskeletal and connective tissue disorders Common: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs.0.7%) Renal and urinary disorders
Maltese: 2.6%), uġigħ fl-għonq (2.7% vs. 0%), artrite (1.3%
English: Hepatic impairment
Maltese: Immaniġġjar
English: The efficacy of rasagiline was established in three studies: as monotherapy treatment in study I and as adjunct therapy to levodopa in the studies II and III.
Maltese: Mod ieħor prinċipali ta' eliminazzjoni huwa l-konjugazzjoni ta' rasagiline u l-prodotti ta' l-metaboliżmu biex jiffurmaw glukoronidi.
English: In this study, the primary measure of efficacy was the change from baseline in the total score of the Unified Parkinson's Disease Rating Scale (UPDRS, parts I-III).
Maltese: F'dan l-istudju, il-kejl primarju ta' effikaċja kien it-tibdil mill-linja bażi fl-għadd ta' l-punti totali ta' lIskala Unifikata ta' Klassifika għall-Marda ta' Parkinson (UPDRS, partijiet I-III).
English: Common: rash (1.1% vs. 0.3%)
Maltese: Komuni: rinite (3.4% vs. 0.7%)
English: Uncommon: vesiculobullous rash (0.7% vs. 0%)
Maltese: Komuni: uġigħ muskolu-skeltrali (6.7% vs.
English: • Rare (may affect up to 1 in 1,000 people)
Maltese: • Rari (jistgħu jaffettwaw sa 1 minn 1,000 persuna)
English: Synthon s.r.o Brněnská 32/čp.
Maltese: 4% tad-doża kienet rikoverata fuq perjodu ta' 38 ġurnata.
English: Rasagiline was not carcinogenic in rats at systemic exposure, 84-339 times the expected plasma exposures in humans at 1 mg/day.
Maltese: Ma kienx hemm riskju ta' kanċer fil-firien f'espożizzjoni tal-plażma 84-339 l-darba iżjed millespożizzjonijiet tal-plażma mistennija fil-bniedem b'1 mg kuljum.
English: Adjunct therapy
Maltese: FARMAĊEWTIKU
English: Hypersensitivity
Maltese: Ipersensitivita
English: *Sodium acetate is formed by titrating glacial acetic acid with sodium hydroxide.
Maltese: * Sodium acetate huwa magħmul permezz ta' ddożar ta' glacial acetic acid ma' sodium hydroxide.
English: Ristempa contains sorbitol.
Maltese: Ristempa fih sorbitol.
English: • have sickle cell anaemia.
Maltese: • għandek anemija sickle cell .
English: • have an allergy to latex.
Maltese: • għandek allerġija għal -latex .
English: Pharmacotherapeutic group: immunostimulants, colony stimulating factor; ATC Code: L03AA13
Maltese: Kategorija farmakoterapewtika:immunostimulanti, fattur li jistimola l-kolonji, Kodiċi ATC:
English: EU/1/15/996/001 1 pack EU/1/15/996/003 1 pack with needle guard
Maltese: EU/1/15/996/001 pakkett wieħed EU/1/15/996/003 Pakkett wieħed b'għatu ta' protezzjoni tal-labra