FrancophonIA/ELRC3.0 huggingface dataset:
English: MIRAPEXIN 0.35 mg tablets
Maltese: MIRAPEXIN 0.35 mg pilloli
English: MIRAPEXIN is indicated in adults for symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in doses up to 0.54 mg of base (0.75 mg of salt) (see section 4.2).
Maltese: MIRAPEXIN hu indikat fl-adulti għall-kura sintomatika tas-Sindrome tar-Riġlejn Irrekwieti idjopatiku li jkun minn moderat sa sever f'dożi sa 0.54 mg ta' bażi (0.75 mg ta' melħ) (ara sezzjoni
English: MIRAPEXIN 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to off-white and of oval shape.
Maltese: MIRAPEXIN 1.05 mg, 1.57 mg u 2.1 mg, 2.62 mg u 3.15 mg pilloli li jerħu l-mediċina bil-mod huma ta' lewn abjad jew abjad jagħti fil-griż, u b'forma ovali.
English: Parkinson's disease, most common adverse reactions The most commonly (≥ 5%) reported adverse drug reactions in patients with Parkinson's disease more frequent with pramipexole treatment than with placebo were nausea, dyskinesia, hypotension, dizziness, somnolence, insomnia, constipation, hallucination, headache and fatigue.
Maltese: Il-marda ta' Parkinson, l-iktar reazzjonijiet avversi komuni L-aktar reazzjonijiet avversi għall-mediċina (≥ 5%) irrappurtati b'mod komuni f'pazjenti bil-marda ta' Parkinson li kienu aktar frekwenti bil-kura bi pramipexole milli bil-plaċebo kienu nawseja, diskinesija, pressjoni tad-demm baxxa, sturdament, ngħas, nuqqas ta' rqad, stitikezza, alluċinazzjonijiet, uġigħ ta' ras u għeja kbira.
English: MIRAPEXIN 0.088 mg tablets
Maltese: MIRAPEXIN 0.088 mg pilloli
English: MIRAPEXIN 2.62 mg prolonged-release tablets EU/1/97/051/031-033
Maltese: MIRAPEXIN 2.62 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/031-033
English: Patients being treated with MIRAPEXIN and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved (see also sections 4.4, 4.5 and 4.8).
Maltese: Pazjenti li qed jiġu kkurati bi MIRAPEXIN u li jkollhom ngħas u/jew episjodi ta' rqad li jiġi għal għarrieda, għandhom ikunu infurmati biex ma jsuqux jew jagħmlu attivitajiet fejn in-nuqqas ta' attenzjoni jista' jpoġġi lilhom jew lill-oħrajn f'riskju ta' korriment serju jew mewt (eż. jħaddmu lmagni), sakemm dawn l-episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4.4, 4.5 u 4.8).
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of MIRAPEXIN should be administered in two divided doses, starting at 0.088 mg of base (0.125 mg of salt) twice a day (0.176 mg of base/0.25 mg of salt daily).
Maltese: F'pazjenti bi tneħħija tal-krejatinina bejn 20 u 50 ml/min, id-doża inizjali ta' kuljum ta' MIRAPEXIN għandha tingħata f'żewġ dożi maqsumin, li jibdew minn 0.088 mg ta' bażi (0.125 mg ta' melħ) darbtejn kuljum (0.176 mg ta' bażi/0.25 mg ta' melħ kuljum).
English: All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Maltese: Il-qawwiet kollha ta' MIRAPEXIN huma disponibbli fi strixxi bil-folji tal-aluminju ta' 10 pilloli f'kull strixxa, f'kaxxi tal-kartun li fihom 3 jew 10 strixxi bil-folji (30 jew 100 pillola).
English: MIRAPEXIN 0.7 mg tablets
Maltese: MIRAPEXIN 0.7 mg pilloli
English: MIRAPEXIN is used to: - treat the symptoms of primary Parkinson's disease in adults.
Maltese: MIRAPEXIN jintuża biex: - jikkura s-sintomi tal-marda ta' Parkinson primarja fl-adulti.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 1998
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 23 ta' Frar, 1998
English: Possible independent risk factors for impulse control disorders included dopaminergic treatments and higher doses of dopaminergic treatment, younger age ( ≤ 65 years), not being married and self-reported family history of gambling behaviours.
Maltese: Fatturi ta' riskju indipendenti possibbli għal disturbi fil-kontroll tal-impulsi kienu jinkludu kuri dopaminerġiċi u dożi ogħla ta' kura dopaminerġika, età iżgħar (≤ 65 sena), li ma tkunx miżżewweġ/miżżewġa u storja fil-famija ta' logħob tal-azzard irrappurtata minn dak li jkun.
English: INFORMATION IN BRAILLE MIRAPEXIN 0.088 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.088 mg
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 1,395 patients with Restless Legs Syndrome treated with pramipexole
Maltese: Stima preċiża tal-frekwenza mhix possibbli għax l-effett sekondarju ma seħħx f'database ta' prova klinika ta' 1,395 pazjent bis-Sindrome tar-Riġlejn Irrekwieti ttrattati bi pramipexole.
English: MIRAPEXIN 0.18 mg tablets
Maltese: MIRAPEXIN 0.18 mg pilloli
English: When prescribing MIRAPEXIN in a patient with Parkinson's disease with renal impairment a reduced dose is suggested in line with section 4.2.
Maltese: Meta tingħata riċetta għal MIRAPEXIN lil pazjent bil-marda ta' Parkinson li jkollu indeboliment renali, hu ssuġġerit li tingħata doża mnaqqsa skont kif spjegat f'sezzjoni 4.2.
English: INFORMATION IN BRAILLE MIRAPEXIN 0.35 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.35 mg
English: MIRAPEXIN 0.26 mg prolonged-release tablets Each prolonged-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.26 mg pramipexole.
Maltese: MIRAPEXIN 0.26 mg pilloli li jerħu l-mediċina bil-mod Kull pillola li terħi l-mediċina bil-mod fiha 0.375 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.26 mg ta' pramipexole.
English: 1 tablet MIRAPEXIN 0.7 mg and 1 tablet MIRAPEXIN 0.35 mg three times a day
Maltese: 1 pillola ta' MIRAPEXIN 0.7 mg u 1 pillola ta' MIRAPEXIN 0.35 mg tliet darbiet kuljum
English: INFORMATION IN BRAILLE MIRAPEXIN 0.18 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.18 mg
English: Cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Maltese: Kaxxi tal-kartun li fihom 1, 3 jew 10 strixxi bil-folja (10, 30 jew 100 pillola li jerħu l-mediċina bilmod).
English: EU/1/97/051/012 [100 tablets]
Maltese: EU/1/97/051/012 [100 pillola]
English: INFORMATION IN BRAILLE MIRAPEXIN 2.62 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 2.62 mg pilloli li jerħu l-mediċina bil-mod
English: 3 tablets MIRAPEXIN 0.18 mg
Maltese: 3 pilloli ta' MIRAPEXIN 0.18 mg
English: INFORMATION IN BRAILLE MIRAPEXIN 0.7 mg
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.7 mg
English: MIRAPEXIN can reduce the production of breast milk.
Maltese: MIRAPEXIN jista' jnaqqas il-produzzjoni tal-ħalib tas-sider.
English: Each prolonged-release tablet contains 3.75 mg pramipexole dihydrochloride monohydrate equivalent to 2.62 mg pramipexole.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 3.75 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 2.62 mg ta' pramipexole.
English: MIRAPEXIN 2.1 mg prolonged-release tablets EU/1/97/051/022-024
Maltese: MIRAPEXIN 2.1 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/022-024
English: The daily dose should not exceed 6 tablets MIRAPEXIN 0.088 mg or a dose of 0.54 mg (0.75 mg pramipexole salt).
Maltese: Id-doża ta' kuljum m'għandhiex taqbeż 6 pilloli ta' MIRAPEXIN 0.088 mg jew doża ta' 0.54 mg (0.75 mg ta' melħ ta' pramipexole).
English: Uncommon: - Paranoia (e.g. excessive fear for one's own well-being) - Delusion - Excessive daytime sleepiness and suddenly falling asleep - Amnesia (memory disturbance) - Hyperkinesia (increased movements and inability to keep still) - Weight increase - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Restlessness - Dyspnoea (difficulties to breathe) - Hiccups - Pneumonia (infection of the lungs) - Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Maltese: - Iħossok ħażin - Insuffiċjenza kardijaka (problemi tal-qalb li jistgħu jikkawża qtugħ ta' nifs jew nefħa fl-għekiesi)* - Tnixxija mhux kif suppost ta' ormon antidijuretiku* - Nuqqas ta' kwiet f'ġismek - Dispnea (diffikultajiet biex tieħu n-nifs) - Sulluzzu - Pnewmonja (infezzjoni tal-pulmun) - Ma tkunx kapaċi tirreżisti l-impuls, ix-xewqa jew it-tentazzjoni li twettaq azzjoni li tista' tkun ta'
English: 2 tablets MIRAPEXIN 0.18 mg
Maltese: 2 pilloli ta' MIRAPEXIN 0.18 mg
English: Since the daily dose for the treatment of Restless Legs Syndrome will not exceed 0.54 mg of base (0.75 mg of salt) MIRAPEXIN can be discontinued without tapering off.
Maltese: Minħabba li d-doża ta' kuljum għall-kura tas-Sindrome tar-Riġlejn Irrekwieti ma taqbiżx 0.54 mg ta' bażi (0.75 mg ta' melħ), MIRAPEXIN jista' jitwaqqaf f'daqqa mingħajr ma jkun hemm twaqqif gradwali.
English: MIRAPEXIN prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Maltese: MIRAPEXIN pilloli li jerħu l-mediċina huma formulazzjoni orali ta' pramipexole li tittieħed darba kuljum.
English: MIRAPEXIN 0.52 mg prolonged-release tablets EU/1/97/051/016-018
Maltese: MIRAPEXIN 0.52 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/016-018
English: EU/1/97/051/004 [100 tablets]
Maltese: EU/1/97/051/004 [100 pillola]
English: Each prolonged-release tablet contains 2.25 mg pramipexole dihydrochloride monohydrate equivalent to 1.57 mg pramipexole.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 2.25 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 1.57 mg ta' pramipexole.
English: 4 tablets MIRAPEXIN 0.088 mg
Maltese: 4 pilloli ta' MIRAPEXIN 0.088 mg
English: 6.4 Special precautions for storage Do not store above 30°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Taħżinx f'temperatura 'l fuq minn 30°C.
English: INFORMATION IN BRAILLE MIRAPEXIN 0.52 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.52 mg pilloli li jerħu l-mediċina bil-mod
English: Do not take MIRAPEXIN: - if you are allergic to pramipexole or to any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux MIRAPEXIN - jekk inti allerġiku għal pramipexole jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis sezzjoni 6).
English: 6 tablets MIRAPEXIN 0.088 mg
Maltese: 6 pilloli ta' MIRAPEXIN 0.088 mg
English: MIRAPEXIN 1.05 mg prolonged-release tablets EU/1/97/051/019-021
Maltese: MIRAPEXIN 1.05 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/019-021
English: 1 tablet MIRAPEXIN 0.18 mg
Maltese: 1 pillola ta' MIRAPEXIN 0.18 mg
English: 2 tablets MIRAPEXIN 0.088 mg
Maltese: 2 pilloli ta' MIRAPEXIN 0.088 mg
English: INFORMATION IN BRAILLE MIRAPEXIN 1.05 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 1.05 mg pilloli li jerħu l-mediċina bil-mod
English: Marketing Authorisation Holder
Maltese: Kura ta' manteniment
English: INFORMATION IN BRAILLE MIRAPEXIN 3.15 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 3.15 mg pilloli li jerħu l-mediċina bil-mod
English: EU/1/97/051/002 [100 tablets]
Maltese: EU/1/97/051/002 [100 pillola]
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Maltese: Kull pillola fiha 0.25 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.18 mg ta' pramipexole
English: Gastrointestinal disorders nausea constipation vomiting
Maltese: Disturbi fissistema endokrinarja tnixxija mhux kif suppost talormon antidijuretiku
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Maltese: Kull pillola fiha 0.5 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.35 mg ta' pramipexole.
English: MIRAPEXIN 1.57 mg prolonged-release tablets EU/1/97/051/028-030
Maltese: MIRAPEXIN 1.57 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/028-030
English: EU/1/97/051/006 [100 tablets]
Maltese: EU/1/97/051/006 [100 pillola]
English: INFORMATION IN BRAILLE MIRAPEXIN 0.26 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 0.26 mg pilloli li jerħu l-mediċina bil-mod
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.62 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 2.62 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: 1 tablet MIRAPEXIN 0.088 mg
Maltese: 1 pillola ta' MIRAPEXIN 0.088 mg
English: Symptoms include apathy, anxiety, depression, fatigue, sweating and pain (see section
Maltese: Is-sintomi jinkludu apatija, ansjetà, depressjoni, għeja, għaraq u wġigħ (ara sezzjoni
English: Each prolonged-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.05 mg pramipexole.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 1.5 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 1.05 mg ta' pramipexole.
English: INFORMATION IN BRAILLE MIRAPEXIN 1.57 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 1.57 mg pilloli li jerħu l-mediċina bil-mod
English: Superiority of MIRAPEXIN prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints in a double-blind placebo-controlled trial including a total of 539 patients with early Parkinson's disease.
Maltese: Għall-effetti sekondarji mmarkati b'asterisk (*), stima preċiża ta' frekwenza mhijiex possibbli, għax dawn l-effetti sekondarji ma kinux osservati fi studji kliniċi fost 2,762 pazjent ikkurati bi pramipexole.
English: Each prolonged-release tablet contains 3 mg pramipexole dihydrochloride monohydrate equivalent to 2.1 mg pramipexole.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 3 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 2.1 mg ta' pramipexole.
English: INFORMATION IN BRAILLE MIRAPEXIN 2.1 mg prolonged-release tablets
Maltese: INFORMAZZJONI BIL-BRAILLE MIRAPEXIN 2.1 mg pilloli li jerħu l-mediċina bil-mod
English: The daily dose can be administered in two divided doses if creatinine clearance is between 20 and 50 ml/min and as a single daily dose if creatinine clearance is less than 20 ml/min.
Maltese: Pazjenti bi tneħħija tal-krejatinina ta' iktar minn 20 ml/min ma jeħtieġu l-ebda tnaqqis fid-doża ta' kuljum.
English: In a double-blind placebo-controlled trial including a total of 517 patients with advanced Parkinson's disease who were on concomitant levodopa therapy superiority of MIRAPEXIN prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Maltese: Fi prova double-blind ikkontrollata bil-plaċebo li kienet tinkludi total ta' 517-il pazjent bil-marda ta' Parkinson fl-istadju avvanzat, li kienu qed jingħataw terapija b'levodopa fl-istess ħin, is-superjorità ta' MIRAPEXIN pilloli li jerħu l-mediċina bil-mod fuq il-plaċebo, intweriet wara 18-il ġimgħa ta' kura kemm fuq l-endpoint tal-effikaċja primarja (punteġġ UPDRS Partijiet II+III) kif ukoll fuq dak sekondarju importanti ħafna (off-time).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/016 [10 prolonged-release tablets] EU/1/97/051/017 [30 prolonged-release tablets] EU/1/97/051/018 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/016 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/017 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/018 [100 pillola li jerħu l-mediċina bil-mod]
English: There is no relevant use of MIRAPEXIN prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Maltese: M'hemm l-ebda użu rilevanti ta' MIRAPEXIN fil-popolazzjoni pedjatrika għal indikazzjoni tal-marda ta' Parkinson.
English: MIRAPEXIN 0.18 mg tablets and MIRAPEXIN 0.35 mg tablets are white, of oval shape, and flat.
Maltese: Il-pilloli MIRAPEXIN ta' 0.18 mg u l-pilloli MIRAPEXIN ta' 0.35 mg huma bojod, b'forma ovali, u ċatti.
English: MARKETING AUTHORISATION NUMBER(S) MIRAPEXIN 0.26 mg prolonged-release tablets EU/1/97/051/013-015
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ MIRAPEXIN 0.26 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/013-015
English: Pramipexole should be tapered off at a rate of 0.52 mg of base (0.75 mg of salt) per day until the daily dose has been reduced to 0.52 mg of base (0.75 mg of salt).
Maltese: Pramipexole għandu jitwaqqaf gradwalment b'rata ta' 0.52 mg ta' bażi (0.75 mg ta' melħ) kuljum sakemm id-doża ta' kuljum tkun tnaqqset għal 0.52 mg ta' bażi (0.75 mg ta' melħ).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/025 [10 prolonged-release tablets] EU/1/97/051/026 [30 prolonged-release tablets] EU/1/97/051/027 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/025 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/026 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/027 [100 pillola li jerħu l-mediċina bil-mod]
English: Boehringer Ingelheim b.v. Tel: +31 (0) 800 22 55 889
Maltese: Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/031 [10 prolonged-release tablets] EU/1/97/051/032 [30 prolonged-release tablets] EU/1/97/051/033 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/031 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/032 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/033 [100 pillola li jerħu l-mediċina bil-mod]
English: MIRAPEXIN 3.15 mg prolonged-release tablets EU/1/97/051/025-027
Maltese: MIRAPEXIN 3.15 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/051/025-027
English: MIRAPEXIN is used to treat the symptoms of primary Parkinson's disease in adults.
Maltese: MIRAPEXIN jintuża biex jikkura s-sintomi tal-marda ta' Parkinson primarja fl-adulti.
English: Ascending dose schedule of MIRAPEXIN Week
Maltese: Jekk tieqaf tieħu MIRAPEXIN
English: The recommended starting dose of MIRAPEXIN is 0.088 mg of base (0.125 mg of salt) taken once daily 2-3 hours before bedtime.
Maltese: Id-doża tal-bidu rakkomandata ta' MIRAPEXIN hi ta' 0.088 mg ta' bażi (0.125 mg ta' melħ) li tittieħed darba kuljum 2-3 sigħat qabel ħin l-irqad.
English: The symptoms include: - akinesia (loss of muscle movement) - rigid muscles - fever - unstable blood pressure - tachycardia (increased heart rate) - confusion - depressed level of consciousness (e.g. coma)
Maltese: Is-sintomi jinkludu: - akinesija (telf ta' moviment tal-muskoli) - muskoli ibsin - deni - pressjoni tad-demm instabbli - takikardija (żieda fir-rata ta' taħbit tal-qalb) - konfużjoni - livell baxx ta' koxjenza (eż. koma)
English: How to store MIRAPEXIN
Maltese: Kif gћandek tieћu MIRAPEXIN
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/028 [10 prolonged-release tablets] EU/1/97/051/029 [30 prolonged-release tablets] EU/1/97/051/030 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/028 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/029 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/030 [100 pillola li jerħu l-mediċina bil-mod]
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 2.1 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 2.1 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Maltese: Kull pillola fiha 1.0 mg ta' pramipexole dihydrochloride monohydrate ekwivalenti għal 0.7 mg ta' pramipexole.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.088 mg tablets Pramipexole
Maltese: MIRAPEXIN 0.088 mg pilloli Pramipexole
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg three times a day (equivalent to 0.264 mg daily):
Maltese: Matul l-ewwel ġimgħa, id-doża normali hi ta' pillola waħda ta' MIRAPEXIN 0.088 mg tliet darbiet kuljum (ekwivalenti għal 0.264 mg kuljum):
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/022 [10 prolonged-release tablets] EU/1/97/051/023 [30 prolonged-release tablets] EU/1/97/051/024 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/022 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/023 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/024 [100 pillola li jerħu l-mediċina bil-mod]
English: However, in Phase III trials in Parkinson's disease patients no clinically meaningful influence of body weight on the therapeutic effect and tolerability of MIRAPEXIN prolonged-release tablets was detected.
Maltese: III f'pazjenti bilmarda ta' Parkinson, ma nstabet l-ebda influwenza klinikament sinifikanti tal-piż tal-ġisem fuq l-effett terapewtiku u t-tollerabilità ta' MIRAPEXIN pilloli li jerħu l-mediċina bil-mod.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.57 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 1.57 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/013 [10 prolonged-release tablets] EU/1/97/051/014 [30 prolonged-release tablets] EU/1/97/051/015 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/013 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/014 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/015 [100 pillola li jerħu l-mediċina bil-mod]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/051/019 [10 prolonged-release tablets] EU/1/97/051/020 [30 prolonged-release tablets] EU/1/97/051/021 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/051/019 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/051/020 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/051/021 [100 pillola li jerħu l-mediċina bil-mod]
English: MIRAPEXIN with food, drink and alcohol You should be cautious while drinking alcohol during treatment with MIRAPEXIN.
Maltese: MIRAPEXIN ma' ikel, xorb u alkoħol Għandek toqgħod attent/a meta tixrob l-alkoħol matul il-kura bi MIRAPEXIN.
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including MIRAPEXIN (see section 4.4).
Maltese: Is-sintomi jinkludu apatija, ansjetà, depressjoni, għeja, għaraq u wġigħ (ara sezzjoni 4.4).
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux ilpakketti tad-daqsijiet kollha jkunu fis-suq.
English: During the first week, the usual dose is 1 tablet MIRAPEXIN 0.088 mg once a day (equivalent to 0.088 mg daily):
Maltese: Matul l-ewwel ġimgħa, id-doża normali hi ta' pillola waħda ta' MIRAPEXIN 0.088 mg darba kuljum (ekwivalenti għal 0.088 mg kuljum):
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 1.05 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 1.05 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including MIRAPEXIN.
Maltese: Għid lit-tabib tiegħek jekk ikollok sintomi bħal depressjoni, apatija, ansjetà, għeja kbira, għaraq jew uġigħ wara li tnaqqas jew twaqqaf it-trattament ta' MIRAPEXIN tiegħek.
English: What MIRAPEXIN looks like and contents of the pack MIRAPEXIN 0.088 mg tablets are white, of round shape, flat, and without scoring.
Maltese: Il-pilloli MIRAPEXIN 0.088 mg huma bojod, b'forma tonda, ċatti, u mingħajr ferq.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.18 mg tablets Pramipexole
Maltese: MIRAPEXIN 0.18 mg pilloli Pramipexole
English: The treatment of patients with a creatinine clearance below 30 ml/min with MIRAPEXIN prolongedrelease tablets is not recommended as no data are available for this patient population.
Maltese: Reazzjoni avversa aktar frekwenti għall-mediċina fil-kura flimkien ma' levodopa kienet id-diskinesija.
English: BATCH NUMBER Lot {number} OTHER
Maltese: Meta tinsa tieħu doża