FrancophonIA/ELRC3.0 huggingface dataset:
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 isoenzimi taċ-ċitokrom P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 u CYP4A.
English: Orthostatic hypotension*
Maltese: Pressjoni ortostatika baxxa*
English: Adverse reactions are listed below in Tables 1 and 2 by system organ class and 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), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma elenkati hawn taħt fit-Tabelli 1 u 2 skont il-klassi tas-sistemi u tal-organi u l-frekwenza bl-użu tal-konvenzjonijiet li ġejjin: 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), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: Impulse control disorders*
Maltese: Disturbi filkontroll talimpulsi*
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, - 0.51], p=0.0050).
English: - Pethidine (a strong pain killer).
Maltese: - Pethidine (mediċina qawwija ta' kontra l-uġigħ).
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 (see section 4.5).
Maltese: Provi kliniċi ta' rasagiline ma ppermettewx l-użu fl-istess waqt ta' fluoxetine jew fluvoxamine ma' rasagiline iżda kienu permessi l-antidepressanti u d-dożi li ġejjin fil-provi ta' rasagiline: amitriptyline ≤ 50 mg/jum, trazodone ≤ 100 mg/jum, citalopram ≤ 20 mg/jum, sertraline ≤ 100 mg/jum, u paroxetine ≤ 30 mg/jum (ara sezzjoni 4.5).
English: - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Maltese: - Uġigħ muskolu-skeletriku - Infjammazzjoni tal-ġogi (arttrite) - Tirżiħ u dgħjufija fil-muskoli tal-idejn (sindrome ta' carpal tunnel) - Tnaqqis fil-piż - Ħolm mhux normali - Diffikultà fil-koordinazzjoni muskolari (ataksja) - Depressjoni - Sturdament (vertigo) - Kontrazzjonijiet muskolari mtawla (distownja) - L-imnieħer iniżżel (rinite) - Irritazzjoni tal-ġilda (dermatite) - Raxx - Għajnejn ħomor (konġuntivite) - Urġenza biex tgħaddi l-awrina
English: 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: Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included 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 ipomanija, kriżi ipertensiva u s-sindrome ta' serotonin.
English: Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group.
Maltese: L-inċidenza ta' melanoma tal-ġilda fi studji kliniċi kkontrollati bi plaċebo kienet ta' 2/380 (0.5%) f'rasagiline 1 mg bħala terapija viċin il-grupp ta' terapija b'levodopa vs. inċidenza ta' 1/388 (0.3%) fil-grupp tal-plaċebo.
English: Dopaminergic effects
Maltese: Effetti dopaminerġiċi
English: Other cytochrome P450 isoenzymes
Maltese: Isoenzimi oħra taċ-ċitokrom P450
English: Agents that affect CYP1A2 activity
Maltese: Impedituri ta' CYP1A2
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: The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets, in perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets or in a bottle containing 30 tablets.
Maltese: Il-pilloli issibhom f'folji ta' 7, 10, 28, 30, 100 jew 112 pilloli, F'pakketti b'folji doża waħda perforati ta' 10 x 1, 30 x 1 u 100 x 1 pillola jew ġo flixkun ta' 30 pillola.
English: - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Maltese: Attakk ta' puplesija (aċċident ċerebro-vaskulari) Attakk tal-qalb (infart mijokardijaku) Raxx bl-infafet ( raxx vesikolubulluż)
English: NAME OF THE MEDICINAL PRODUCT Rasagiline ratiopharm 1 mg tablets
Maltese: Rasagiline ratiopharm 1 mg pilloli
English: The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
Maltese: Dawn li ġejjin kienu rrappurtati waqt esponiment wara t-tqegħid fis-suq bi frekwenza mhux magħrufa: impulsjonijiet, xiri kompulsiv, dermatillomanija, sindrome ta' problemi bil-kontroll ta' domapine, disturbi fil-kontroll tal-impulsi, imġiba impulsiva, kleptomanija, serq, ħsibijiet ossessivi, disturb ossessiv-kompulsiv, stereotipija, logħob tal-ażżard, logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, disturb psikosesswali, imġiba sesswali mhux xierqa.
English: Rasagiline selectively inhibits MAO-B and is not associated with increased tyramine sensitivity at the indicated dose (1 mg/day).
Maltese: Rasagiline jimpedixxi MAO-B b'mod selettiv u mhuwiex assoċjat ma' żieda fis-sensittività għal tyramine fid-doża indikata (1 mg/jum).
English: Rasagiline pharmacokinetics is linear with dose over the range of 0.5-2 mg in Parkinson's disease patients.
Maltese: Il-farmakokinetika ta' rasagiline hija lineari mad-doża fuq medda ta' 0.5-2 mg f'pazjenti bil-marda ta' Parkinson.
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 ċ-ċitokrom P450 1A2 (CYP1A2) huwa l-enzim prinċipali risponsabli għall-metaboliżmu ta' rasagiline.
English: Each tablet contains 1 mg rasagiline (as mesilate).
Maltese: Kull pillola fiha 1 mg rasagiline (bħala mesilate).
English: Skin carcinoma
Maltese: Karċinoma talġilda
English: Results of five tyramine challenge studies (in volunteers and Parkinson's disease 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 bil-marda ta' Parkinson), 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 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: Cerebrovascular accident
Maltese: Inċident ċerebrovaskulari
English: After oral administration of 14C-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: Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson's disease in adults.
Maltese: Rasagiline ratiopharm fih is-sustanza attiva rasagiline u jintuża għat-trattament tal-marda ta' Parkinson fl-adulti.
English: Patients should be cautioned about possible additive effects of sedating medicinal products, alcohol, or other central nervous system depressants (e.g. benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline, or when taking concomitant medications that increase plasma levels of rasagiline (e.g. ciprofloxacin) (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu avżati dwar l-effetti addittivi li jista' jkollhom prodotti mediċinali sedattivi, alkoħol, jew depressanti oħra tas-sistema nervuża ċentrali (eż. benzodiazepines, antipsikotiċi, antidepressanti) flimkien ma' rasagiline, jew meta jieħdu mediċini fl-istess waqt li jżiedu l-livelli ta' rasagiline fil-plażma (eż. ciprofloxacin) (ara sezzjoni 4.4).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rasagiline (as mesilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 1 mg ta' rasagiline (bħala mesilate).
English: Orthostatic hypotension
Maltese: Pressjoni ortostatika baxxa
English: ul.
Maltese: St.
English: For concomitant use of rasagiline with selective serotonin reuptake inhibitors (SSRIs)/selective serotoninnorepinephrine 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: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG, Belgium Tel/Tél: +32 3 820 73 73
Maltese: Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.
English: The use of Rasagiline ratiopharm together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
Maltese: L-użu ta' Rasagiline ratiopharm flimkien ma' mediċini kontra d-depressjoni li fihom fluoxetine u fluvoxamine għandhom jiġu evitati.
English: Symptoms reported following overdose of Rasagiline ratiopharm included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).
Maltese: Is-sintomi rrappurtati wara doża eċċessiva ta' Rasagiline ratiopharm jinkludu burdata kemmxejn ewforika (forma ħafifa ta' manija), pressjoni għolja ħafna u sindrome ta' serotonin (ara sezzjoni 4).
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 taċ-ċitokrom P450, u li CYP1A2 huwa l-iżoenzim prinċipali involut fil-metaboliżmu ta' rasagiline.
English: 4.5 Interaction with other medicinal products and other forms of interaction MAO Inhibitors
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Impedituri ta' MAO
English: There is no relevant use of Rasagiline ratiopharm in the paediatric population in the indication Parkinson's disease.
Maltese: M'hemm l-ebda użu rilevanti ta' Rasagiline ratiopharm fil-popolazzjoni pedjatrika għal indikazzjoni tal-marda ta' Parkinson.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain as back and neck pain, and arthralgia in both regimens.
Maltese: Fi studji kliniċi f'pazjenti bil-marda ta' Parkinson l-aktar reazzjonijiet avversi komuni kienu: uġigħ ta' ras, depressjoni, vertigo, u influwenza (influwenza u rinite) fil-monoterapija; diskajneżja, pressjoni ortostatika baxxa, waqgħat, uġigħ fl-addome, tqalligħ u rimettar, u nixfa fil-ħalq flimkien ma' terapija b'levodopa; uġigħ muskoluskeletriku, bħal uġigħ fid-dahar u l-għonq, u artralġja fiż-żewġ korsijiet.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: Vesiculobullous rash
Maltese: Mhux magħrufa
English: Levodopa and other Parkinson's disease medicinal products In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Maltese: F'pazjenti bil-marda ta' Parkinson li jirċievu rasagiline bħala terapija miżjuda ma' trattament kroniku b'levodopa, ma kien hemm l-ebda effett klinikament sinifikanti tat-trattament b'levodopa fuq ittneħħija ta' rasagiline.
English: Rasagiline is contraindicated 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: If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline ratiopharm treatment.
Maltese: Biex tibda trattament b' fluoxetine jew fluvoxamine, trid tistenna mill-inqas 14 il-ġurnata minn meta twaqqaf Rasagiline ratiopharm.
English: Myocardial infarction
Maltese: Anġina pektoris Infart mijokardiku
English: Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Maltese: Ma kien hemm ebda strument attiv biex iqabbel.
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes
Maltese: Episodji ta' ngħas eċċessiv matul il-ġurnata (EDS - excessive daytime sleepiness) u rqad f'daqqa (SOS - sudden sleep onset)
English: In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular adverse 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 avversi (inklużi pressjoni għolja u pressjoni posturali baxxa) li għaddew kif twaqqaf it-trattament.
English: Arthralgia, Neck pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Cases of patients, treated with rasagiline and other dopaminergic medicinal products, falling asleep while engaged in activities of daily living have been reported.
Maltese: Kienu rrappurtati każijiet ta' pazjenti, ittrattati b'rasagiline u prodotti mediċinali dopaminerġiċi oħra, li jorqdu waqt li jkunu impenjati fl-attivitajiet ta' kuljum.
English: INFORMATION IN BRAILLE Rasagiline ratiopharm
Maltese: Kif taħżen Rasagiline ratiopharm
English: - Abdominal pain - Fall - Allergy - Fever - Flu (influenza) - General feeling of being unwell (malaise) - Neck pain - Chest pain (angina pectoris) - Low blood pressure when rising to a standing position with symptoms like dizziness/light headedness (orthostatic hypotension) - Decreased appetite - Constipation - Dry mouth - Nausea and vomiting - Flatulence
Maltese: - Uġigħ addominali - Waqgħat - Allerġija - Deni - Influwenza - Sensazzjoni ġenerali li ma tħossokx f'sikktek (telqa ġenerali) - Uġigħ fl-għonq - Uġigħ fis-sider (anġina pektoris) - Pressjoni titbaxxa meta tqum bil-wieqfa b'sintomi bħal sturdament/ jew li ma tħossokx f'sikktek
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/977/001-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/977/001-010
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Maltese: excessive daytime sleepiness) u ta'
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies, in patients receiving 1 mg/day rasagiline.
Maltese: Il-lista f'tabella 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.
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep
Maltese: (EDS - excessive daytime sleepiness) u ta'
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with Rasagiline ratiopharm may influence your ability to do so. Rasagiline ratiopharm can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Maltese: Għandek tevita li tieħu Rasagiline ratiopharm jekk inti tqila, peress li l-effetti ta' Rasagiline ratiopharm fuq it-tqala u t-tarbija mhux imwielda mhumiex magħrufa.
English: Dyskinesia
Maltese: Influwenza
English: Fall *See section description of selected adverse reactions Description of selected adverse reactions
Maltese: Telqa ġenerali * Ara s-sezzjoni deskrizzjoni ta' reazzjonijiet avversi magħżula
English: Rasagiline ratiopharm is indicated in adults for the treatment of idiopathic Parkinson's disease as monotherapy (without levodopa) or as adjunct therapy (with levodopa) in patients with end of dose fluctuations.
Maltese: Rasagiline ratiopharm huwa indikat f'adulti għat-trattament tal-marda ta' Parkinson idjopatika, bħala monoterapija (mingħajr levodopa) jew bħala terapija miżjuda (ma' levodopa) f'pazjenti b'tibdil filkundizzjoni tagħhom fl-aħħar tad-doża.
English: With MAO inhibitors there have been reports of medicinal product interactions with the concomitant use of sympathomimetic medicinal products.
Maltese: Kien hemm rapporti li impedituri ta' MAO ma' jaqblux ma' prodotti mediċinali simpatomimetiċi meta jittieħdu flimkien.
English: Rasagiline is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Rasagiline huwa kontraindikat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.3).
English: In the post-marketing period, cases of potentially life-threating serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants, meperidine, tramadol, methadone, or propoxyphene concomitantly with rasagiline.
Maltese: Fil-perjodu ta' wara t-tqegħid fis-suq, ġew irrappurtati każijiet ta' sindrome ta' serotonin b'potenzjal ta' periklu għall-ħajja assoċjati ma' aġitazzjoni, konfużjoni, riġidità, deni u mijoklonus minn pazjenti ttrattati b'antidepressanti, meperidine, tramadol, methadone, jew propoxyphene flimkien ma' rasagiline.
English: Hallucinations
Maltese: Allerġija
English: Adverse reactions were mild or moderate and not related to rasagiline treatment.
Maltese: Reazzjonijiet avversi kienu ħfief jew moderati u ma kienux relatati ma' trattament b' rasagiline.
English: Neoplasms benign, malignant and unspecified
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati
English: The robustness of the results for the primary efficacy endpoint, 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: MM/YYYY
Maltese: OĦRAJN
English: Especially tell your doctor if you are taking any of the following medicines: - 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: There is no relevant use of Rasagiline ratiopharm in children and adolescents.
Maltese: M'hemm l-ebda użu rilevanti ta' Rasagiline ratiopharm fi tfal u adolexxenti.
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l. Plasma protein binding following a single oral dose of 14C-labelled rasagiline is approximately 60 to 70%.
Maltese: L-ammont li jeħel ma' l-proteini tal-plażma wara doża waħda mill-ħalq ta' rasagiline bit-tikketta 14C kien ta' bejn wieħed u ieħor 60% sa 70%.
English: What Rasagiline ratiopharm looks like and contents of the pack Rasagiline ratiopharm tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Maltese: Kif jidher Rasagiline ratiopharm u l-kontenut tal-pakkett Il-pilloli Rasagiline ratiopharm huma bojod għal offwajt, tondi, ċatti, b'xifer imżerżaq, mnaqqxa b' “GIL” u “1” minn taħt fuq naħa waħda u mingħajr ebda marka speċjali in-naħa l-oħra.