FrancophonIA/ELRC3.0 huggingface dataset:
English: Oprymea 0.088 mg tablets White, round, with bevelled edges and imprint "P6" on one side of the tablet.
Maltese: Oprymea 0.088 mg pilloli huma bojod, tondi, bi truf iċċanfrati u b'intaljar ta'"P6" fuq naħa waħda talpillola.
English: If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Maltese: Jekk ikun hemm sinjali ta' stimulazzjoni tas-sistema nervuża ċentrali, jista' jkun hemm bżonn ta' mediċina newroleptika.
English: Oprymea 0.18 mg tablets Pramipexole
Maltese: Oprymea 0.18 mg pilloli Pramipexole
English: How to take Oprymea
Maltese: X'fih Oprymea
English: The total clearance of pramipexole is approximately 500 ml/min and the renal clearance is approximately 400 ml/min.
Maltese: It-tneħħija totali ta' pramipexole hi ta' madwar 500 ml/min u t-tneħħija renali hi ta' madwar 400 ml/min.
English: Nausea and fatigue were more often reported in female patients (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Maltese: 5%, rispettivament) meta mqabbla ma' pazjenti rġiel (6.7% u 7.3%, rispettivament).
English: 10 prolonged-release tablets 30 prolonged-release tablets 90 prolonged-release tablets 100 prolonged-release tablets
Maltese: 10 pilloli li jerħu l-mediċina bil-mod 30 pillola li jerħu l-mediċina bil-mod 90 pillola li jerħu l-mediċina bil-mod 100 pillola li jerħu l-mediċina bil-mod
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 ta' 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: Dyspnoea hiccups
Maltese: Fdalijiet fl-ippurgar
English: A precise frequency estimation is not possible as the side effect did not occur in a clinical trial database of 2,762 patients with Parkinson's Disease treated with pramipexole.
Maltese: Stima preċiża ta-frekwenza mhix possibbli għax l-effett sekondarju ma seħħx f'database ta' prova klinika ta' 2,762 pazjent bil-Marda ta' Parkinson ittrattati bi pramipexole.
English: 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: 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: Oprymea 1.05 mg: Each prolonged-release tablet contains 1.05 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 1.05 mg: Kull pillola li terħi l-mediċina bil-mod fiha 1.05 mg ta'pramipexole (bħala 1.5 mg pramipexole dihydrochloride monohydrate).
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: The increase in Cmax is not considered clinically relevant.
Maltese: Iż-żieda fis-Cmax mhix ikkunsidrata li hi klinikament rilevanti.
English: This reduces the risk of worsening symptoms.
Maltese: Dan inaqqas ir-riskju li s-sintomi jmorru għall-agħar.
English: 4 tablets Oprymea 0.088 mg
Maltese: 4 pilloli ta' Oprymea 0.088 mg
English: Oprymea 1.1 mg tablets Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 1.1 mg pilloli Kull pillola fiha 1.1 mg ta' pramipexole (bħala 1.5 mg pramipexole dihydrochloride monohydrate).
English: Oprymea 0.18 mg tablets Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 0.18 mg pilloli Kull pillola fiha 0.18 mg ta' pramipexole (bħala 0.25 mg pramipexole dihydrochloride monohydrate).
English: Oprymea 0.7 mg tablets Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 0.7 mg pilloli Kull pillola fiha 0.7 mg ta' pramipexole (bħala 1 mg pramipexole dihydrochloride monohydrate).
English: 6 tablets Oprymea 0.088 mg
Maltese: 6 pilloli ta' Oprymea 0.088 mg
English: MARKETING AUTHORISATION HOLDER
Maltese: Kura ta' manteniment
English: Oprymea is used to treat the symptoms of primary Parkinson's disease in adults.
Maltese: Oprymea jintuża biex jikkura s-sintomi tal-marda ta' Parkinson primarja fl-adulti.
English: 2 tablets Oprymea 0.088 mg
Maltese: 2 pilloli ta' Oprymea 0.088 mg
English: 3 tablets Oprymea 0.18 mg OR
Maltese: 3 pilloli ta' Oprymea 0.18 mg
English: Each tablet contains 1.1 mg pramipexole (as 1.5 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola fiha 1.1 mg ta' pramipexole (bħala 1.5 mg pramipexole dihydrochloride monohydrate).
English: Each prolonged-release tablet contains 0.26 mg, 0.52 mg or 1.05 mg pramipexole as 0.375 mg, 0.75 mg or 1.5 mg pramipexole dihydrochloride monohydrate, respectively.
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 0.26 mg, 0.52 mg jew 1.05 mg ta' pramipexole bħala 0.375 mg, 0.75 mg jew 1.5 mg ta' pramipexole dihydrochloride monohydrate, rispettivament.
English: Patients being treated with Oprymea 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 Oprymea 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: Prolonged-release tablet
Maltese: TAL-PRODOTT MEDIĊINALI
English: Oprymea 2.62 mg prolonged-release tablets Pramipexole
Maltese: Oprymea 2.62 mg pilloli li jerħu l-mediċina bil-mod 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: Mhux komuni: - Xewqa kbira li ġġib ruħek b'mod mhux tas-soltu* - Insuffiċjenza kardijaka (problemi tal-qalb li jistgħu jikkawża qtugħ ta' nifs jew nefħa fl għekiesi)* - Tnixxija mhux kif suppost ta' ormon antidijuretiku* - Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn) - Iperkinesija (żieda fil-movimenti tal-ġisem u ma tkunx kapaċi twaqqafhom)* - Paranojja (eż. biża' eċċessiv għall-benesseri tiegħek)* - Delużjoni* - Amnesija (disturb fil-memorja)* - Alluċinazzjonijiet (tara, tisma' jew tħoss affarijiet li ma jkunux hemm) - Konfużjoni - Irqad eċċessiv matul il-ġurnata u li torqod għal għarrieda - Żieda fil-piż - Ipotensjoni (pressjoni tad-demm baxxa) - Fluwidu eċċessiv, normalment fir-riġlejn (edema periferali)
English: Total Daily Dose (mg of base)
Maltese: Doża Totali ta' Kuljum (mg ta' bażi)
English: Oprymea 0.26 mg: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 0.26 mg :Kull pillola li terħi l-mediċina bil-mod fiha 0.26 mg ta' pramipexole (bħala 0.375 mg pramipexole dihydrochloride monohydrate).
English: Oprymea 0.52 mg: Each prolonged-release tablet contains 0.52 mg pramipexole (as 0.75 mg pramipexole dihydrochloride monohydrate).
Maltese: Oprymea 0.52 mg: Kull pillola li terħi l-mediċina bil-mod fiha 0.52 mg ta'pramipexole (bħala 0.75 mg pramipexole dihydrochloride monohydrate).
English: Each tablet contains 0.35 mg pramipexole (as 0.5 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola fiha 0.35 mg ta' pramipexole (bħala 0.5 mg pramipexole dihydrochloride monohydrate).
English: Other significant adverse events leading to discontinuation of study medication for patients receiving pramipexole were confusional state, speech disorder and aggravated condition (see section 4.2).
Maltese: Avvenimenti avversi sinifikanti oħrajn li wasslu għat-twaqqif tal-mediċina li kienet qed tiġi studjata għal pazjenti li kienu qed jirċievu pramipexole kienu stat ta' konfużjoni, taħwid fiddiskors u kundizzjoni aggravata (ara sezzjoni 4.2).
English: Blister (OPA/Alu/desiccant/PE-Alu foil): 10, 30, 90 or 100 prolonged-release tablets, in a box.
Maltese: Folja (OPA/fojl tal-Alu/dessikant/PE-Alu): 10, 30, 90 jew 100 pillola li jerħu l-mediċina bil-mod f'kaxxa.
English: During the first week, the usual dose is 1 tablet Oprymea 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' Oprymea 0.088 mg tliet darbiet kuljum (ekwivalenti għal 0.264 mg kuljum):
English: The individual dose of pramipexole should be in the range of 0.26 mg of base (0.375 mg of salt) to a maximum of 3.15 mg of base (4.5 mg of salt) per day.
Maltese: Id-doża individwali ta' pramipexole għandha tkun fil-medda ta' 0.26 mg ta' bażi (0.375 mg ta' melħ) sa massimu ta' 3.15 mg ta' bażi (4.5 mg ta' melħ) kuljum.
English: Blister (week 2)
Maltese: Folja (ġimgħa 2)
English: No difference was observed for pramipexole as compared to placebo for either the primary endpoint or for any of the secondary efficacy endpoints including YGTSS total score, Patient Global Impression of Improvement (PGI-I), Clinical Global Impression of Improvement (CGI-I), or Clinical Global Impressions of Severity of Illness (CGI-S).
Maltese: Ma kienet osservata l-ebda differenza għal pramipexole meta mqabbel ma' plaċebo għal jew il-punt aħħari primarju jew għal kwalunkwe punti aħħarin tal-effikaċja sekondarja li jinkludu l-punteġġ totali YGTSS, Impressjoni Globali tal-Pazjent dwar it-Titjib (PGI-I), Impressjoni Globali Klinika dwar it-Titjib (CGI-I), jew Impressjonijiet Globali
English: 1 tablet Oprymea 0.088 mg
Maltese: 1 pillola ta' Oprymea 0.088 mg
English: Each tablet contains 0.18 mg pramipexole (as 0.25 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola fiha 0.18 mg ta' pramipexole (bħala 0.25 mg pramipexole dihydrochloride monohydrate).
English: EU/1/08/469/011 [20 tablets] EU/1/08/469/012 [30 tablets] EU/1/08/469/013 [60 tablets] EU/1/08/469/014 [90 tablets] EU/1/08/469/015 [100 tablets]
Maltese: EU/1/08/469/011 [20 pillola] EU/1/08/469/012 [30 pillola] EU/1/08/469/013 [60 pillola] EU/1/08/469/014 [90 pillola] EU/1/08/469/015 [100 pillola]
English: Oprymea is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Maltese: Oprymea huwa indikat f'adulti għall-kura tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson, waħdu (mingħajr levodopa) jew flimkien ma' levodopa, i.e. matul il-kors tal-marda, sa l-istadji aħħarin fejn l-effett ta' levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet tal-effett terapewtiku (fl-aħħar tad-doża jew fluttwazzjonijiet “on off”).
English: Each prolonged-release tablet contains 2.1 mg pramipexole (as 3 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 2.1 mg ta' pramipexole (bħala 3 mg pramipexole dihydrochloride monohydrate).
English: B. PACKAGE LEAFLET
Maltese: Analiżi Kaplan
English: During the first week, the usual dose is 1 tablet Oprymea 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' Oprymea 0.088 mg darba kuljum (ekwivalenti għal 0.088 mg kuljum):
English: EU/1/08/469/021 [20 tablets] EU/1/08/469/022 [30 tablets] EU/1/08/469/023 [60 tablets] EU/1/08/469/024 [90 tablets] EU/1/08/469/025 [100 tablets]
Maltese: EU/1/08/469/021 [20 pillola] EU/1/08/469/022 [30 pillola] EU/1/08/469/023 [60 pillola] EU/1/08/469/024 [90 pillola] EU/1/08/469/025 [100 pillola]
English: EU/1/08/469/016 [20 tablets] EU/1/08/469/017 [30 tablets] EU/1/08/469/018 [60 tablets] EU/1/08/469/019 [90 tablets] EU/1/08/469/020 [100 tablets]
Maltese: EU/1/08/469/016 [20 pillola] EU/1/08/469/017 [30 pillola] EU/1/08/469/018 [60 pillola] EU/1/08/469/019 [90 pillola] EU/1/08/469/020 [100 pillola]
English: EU/1/08/469/001[20 tablets] EU/1/08/469/002 [30 tablets] EU/1/08/469/003 [60 tablets] EU/1/08/469/004 [90 tablets] EU/1/08/469/005 [100 tablets]
Maltese: EU/1/08/469/001 [20 pillola] EU/1/08/469/002 [30 pillola] EU/1/08/469/003 [60 pillola] EU/1/08/469/004 [90 pillola] EU/1/08/469/005 [100 pillola]
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 pramipexole 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' pramipexole 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: 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: Blister (week 1)
Maltese: Folja (ġimgħa 1)
English: Each tablet contains 0.7 mg pramipexole (as 1 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola fiha 0.7 mg ta' pramipexole (bħala 1 mg pramipexole dihydrochloride monohydrate).
English: Pramipexole is completely absorbed following oral administration.
Maltese: Pramipexole jiġi assorbit kompletament wara l-għoti mill-ħalq.
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: Gastrointestinal disorders nausea constipation vomiting
Maltese: Disturbi gastrointestinali dardir stitikezza rimettar
English: Each prolonged-release tablet contains 3.15 mg pramipexole (as 4.5 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 3.15 mg ta' pramipexole (bħala 4.5 mg pramipexole dihydrochloride monohydrate).
English: Out of these 87 patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
Maltese: Minn dawn is-87 pazjent, 82.8% ma bidlux id-doża tagħhom, 13.8% żiedu u 3.4% naqqsu ddoża tagħhom.
English: EU/1/08/469/006 [20 tablets] EU/1/08/469/007 [30 tablets] EU/1/08/469/008 [60 tablets] EU/1/08/469/009 [90 tablets] EU/1/08/469/010 [100 tablets]
Maltese: EU/1/08/469/006 [20 pillola] EU/1/08/469/007 [30 pillola] EU/1/08/469/008 [60 pillola] EU/1/08/469/009 [90 pillola] EU/1/08/469/010 [100 pillola]
English: 3-week treatment initiation pack contains 21 prolonged-release tablets in 3 packages: - the package marked "Week 1" contains 1 blister of 7 tablets of 0.26 mg, - the package marked "Week 2" contains 1 blister of 7 tablets of 0.52 mg, - the package marked "Week 3" contains 1 blister of 7 tablets of 1.05 mg.
Maltese: Pakkett tal-bidu ta' 3 ġimgħat fih 21 pillola li terħi l-pillola bil-mod fi 3 pakketti: - il-pakkett immarkat "Ġimgħa 1" fih folja ta' 7 pilloli ta' 0.26 mg,
English: Endocrine inappropriate disorders antidiuretic hormone secretion
Maltese: Infezzjonijiet u pnewmonja infestazzjonijiet Disturbi fissistema endokrinarja tnixxija mhux kif suppost talormon antidijuretiku
English: Each prolonged-release tablet contains 1.57 mg pramipexole (as 2.25 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 1.57 mg ta'pramipexole (bħala 2.25 mg pramipexole dihydrochloride monohydrate).
English: When prescribing Oprymea 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 Oprymea lil pazjent bil-marda ta' Parkinson li jkollu indeboliment renali, hu ssuġġerit li tingħata doża mnaqqsa skont kif spjegat f'sezzjoni 4.2.
English: Blister (week 3)
Maltese: Folja (ġimgħa 3)
English: 0.26 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P1 on one side, with bevelled edges and possible spots.
Maltese: 0.26 mg: Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P1 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: 1 tablet Oprymea 0.18 mg OR
Maltese: 1 pillola ta' Oprymea 0.18 mg
English: Oprymea 2.1 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/042 30 prolonged-release tablets: EU/1/08/469/043 90 prolonged-release tablets: EU/1/08/469/044 100 prolonged-release tablets: EU/1/08/469/045
Maltese: Oprymea 2.1 mg pilloli li jerħu l-mediċina bil-mod 10 pilloli li jerħu l-mediċina bil-mod: EU/1/08/469/042 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/043 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/044 100 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/045
English: Superiority of pramipexole 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: Pramipexole is commonly associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes (see also section 4.4).
Maltese: Pramipexole hu assoċjat b'mod komuni man-ngħas u kien assoċjat b'mod mhux komuni ma' ngħas eċċessiv matul il-jum u episodji ta' rqad li jiġi f'daqqa (ara wkoll sezzjoni 4.4).
English: Method of administration
Maltese: Sistema talĠisem
English: Do not use this medicine after the expiry date which is stated on the packaging after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-pakkett wara EXP.
English: Oprymea 0.26 mg prolonged-release tablets Oprymea 0.52 mg prolonged-release tablets Oprymea 1.05 mg prolonged-release tablets
Maltese: Oprymea 0.26 mg pilloli li jerħu l-mediċina bil-mod Oprymea 0.52 mg pilloli li jerħu l-mediċina bil-mod Oprymea 1.05 mg pilloli li jerħu l-mediċina bil-mod
English: The following dose schedule is suggested:
Maltese: - Wara li twaqqaf jew tnaqqas it-trattament ta' Oprymea tiegħek:
English: However, the potential influence of hepatic insufficiency on Oprymea pharmacokinetics has not been investigated.
Maltese: Madankollu, l-influwenza potenzjali ta' insuffiċjenza epatika fuq il-farmakokinetika ta' Oprymea ma kinitx investigata.
English: Psychiatric disorders
Maltese: Diskinesija
English: 1.05 mg: White or almost white, round (diameter 10 mm), slightly biconvex tablets engraved with P3 on one side, with bevelled edges and possible spots.
Maltese: 1.05 mg: Pilloli ta' lewn abjad jew kważi abjad, tondi (dijametru ta' 10 mm), u huma kemxejn bikunvessi bi P3 imnaqqax fuq naħa waħda, bi xfar mċanfrin u possibiltà ta' dbabar.
English: One Oprymea 1.05 mg prolonged-release tablet on blister "Week 3".
Maltese: Pillola li terħi l-mediċina bil-mod ta' Oprymea 1.05 mg fuq il-folja ta' “Ġimgħa 3”.
English: Oprymea 1.05 mg prolonged-release tablets 10 prolonged-release tablets: EU/1/08/469/034 30 prolonged-release tablets: EU/1/08/469/035 90 prolonged-release tablets: EU/1/08/469/036 100 prolonged-release tablets: EU/1/08/469/037
Maltese: Oprymea 1.05 mg pilloli li jerħu l-mediċina bil-mod 10 pilloli li jerħu l-mediċina bil-mod: EU/1/08/469/034 30 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/035 90 pillola li jerħu l-mediċina bil-mod: EU/1/08/469/036 100 pillola li jerħu l-mediċina bil-mod:
English: Week 2
Maltese: Ġimgħa 2
English: Common: - Urge to behave in an unusual way - Hallucinations (seeing, hearing or feeling things that are not there) - Confusion - Tiredness (fatigue) - Sleeplessness (insomnia) - Excess of fluid, usually in the legs (peripheral oedema) - Headache - Hypotension (low blood pressure) - Abnormal dreams - Constipation - Visual impairment - Vomiting (being sick) - Weight loss including decreased appetite
Maltese: Komuni: - Xewqa kbira li ġġib ruħek b'mod mhux tas-soltu - Alluċinazzjonijiet (tara, tisma' jew tħoss affarijiet li ma jkunux hemm) - Konfużjoni - Għeja - Ma tkunx tista' torqod (insomnja) - Fluwidu eċċessiv, normalment fir-riġlejn (edema periferali) - Uġigħ ta' ras - Ipotensjoni (pressjoni tad-demm baxxa) - Ħolm anormali - Stitikezza - Indeboliment tal-vista - Rimettar - Tnaqqis fil-piż li jinkludi telf fil-piż
English: Each prolonged-release tablet contains 0.26 mg pramipexole (as 0.375 mg pramipexole dihydrochloride monohydrate).
Maltese: Kull pillola li terħi l-mediċina bil-mod fiha 0.26 mg ta' pramipexole (bħala 0.375 mg pramipexole dihydrochloride monohydrate).
English: Dystonia
Maltese: Distonja
English: EU/1/08/469/034 [10 prolonged-release tablets] EU/1/08/469/035 [30 prolonged-release tablets] EU/1/08/469/036 [90 prolonged-release tablets] EU/1/08/469/037 [100 prolonged-release tablets]
Maltese: EU/1/08/469/034 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/08/469/035 [30 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/036 [90 pillola li jerħu l-mediċina bil-mod] EU/1/08/469/037 [100 pillola li jerħu l-mediċina bil-mod]
English: Dose adjustment in patients with hepatic failure is probably not necessary, as approx. 90% of absorbed active substance is excreted through the kidneys.
Maltese: Aġġustament fid-doża f'pazjenti b'insuffiċjenza epatika probabbilment ma jkunx meħtieġ, għax madwar 90% tas-sustanza attiva assorbita titneħħa minn ġol-kliewi.
English: One Oprymea 0.26 mg prolonged-release tablet on blister "Week 1".
Maltese: Pillola li terħi l-mediċina bil-mod ta' Oprymea 0.26 mg fuq il-folja ta' “Ġimgħa 1”.