FrancophonIA/ELRC3.0 huggingface dataset:
English: INFORMATION IN BRAILLE SIFROL 0.35 mg
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.35 mg
English: SIFROL 0.088 mg tablets EU/1/97/050/001-002
Maltese: SIFROL 0.088 mg pilloli EU/1/97/050/001-002
English: If renal function declines during maintenance therapy the SIFROL daily dose should be reduced by the same percentage as the decline in creatinine clearance, i.e. if creatinine clearance declines by 30%, then the SIFROL daily dose should be reduced by 30%.
Maltese: Jekk il-funzjoni renali tonqos matul it-terapija ta' manteniment, id-doża ta' kuljum ta' SIFROL għandha titnaqqas bl-istess perċentwali bħat-tnaqqis fit-tneħħija tal-krejatinina, i.e. jekk it-tneħħija talkrejatinina tonqos bi 30%, allura d-doża ta' kuljum ta' SIFROL għandha titnaqqas bi 30%.
English: However, the potential influence of hepatic insufficiency on SIFROL pharmacokinetics has not been investigated.
Maltese: Madankollu, l-influwenza potenzjali ta' insuffiċjenza epatika fuq il-farmakokinetika ta' SIFROL ma kinitx investigata.
English: INFORMATION IN BRAILLE SIFROL 0.088 mg
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.088 mg
English: SIFROL has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Maltese: SIFROL kien assoċjat ma' ngħas u episodji ta' rqad li jiġi f'daqqa, partikularment f'pazjenti bil-marda ta' Parkinson.
English: SIFROL 0.18 mg tablets EU/1/97/050/003-004
Maltese: SIFROL 0.18 mg pilloli EU/1/97/050/003-004
English: SIFROL 0.7 mg tablets
Maltese: SIFROL 0.7 mg pilloli
English: 1 tablet SIFROL 0.35 mg OR
Maltese: 1 pillola ta' SIFROL 0.35 mg
English: 1 tablet SIFROL 0.35 mg and 1 tablet SIFROL 0.18 mg
Maltese: 1 pillola ta' SIFROL 0.35 mg u 1 pillola ta' SIFROL 0.18 mg JEW
English: INFORMATION IN BRAILLE SIFROL 0.18 mg
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.18 mg
English: SIFROL 0.18 mg tablets
Maltese: SIFROL 0.18 mg pilloli
English: SIFROL 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: SIFROL 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 4.2).
English: INFORMATION IN BRAILLE SIFROL 0.7 mg
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.7 mg
English: SIFROL 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg prolonged-release tablets are white to offwhite and of oval shape.
Maltese: SIFROL 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: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of SIFROL 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' SIFROL 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 SIFROL are available in aluminium blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Maltese: Il-qawwiet kollha ta' SIFROL huma disponibbli fi strixxi bil-folji tal-aluminju ta' 10 pilloli f'kull strixxa, f'kaxxi tal-kartun li fihom 1, 3 jew 10 strixxi bil-folji (10, 30 jew 100 pillola li jerħu lmediċina bil-mod).
English: SIFROL 2.62 mg prolonged-release tablets EU/1/97/050/031-033
Maltese: SIFROL 2.62 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/031-033
English: 1 tablet SIFROL 0.7 mg and 1 tablet SIFROL 0.35 mg three times a day
Maltese: 1 pillola ta' SIFROL 0.7 mg u 1 pillola ta' SIFROL 0.35 mg tliet darbiet kuljum
English: How to take SIFROL
Maltese: X'fih SIFROL
English: SIFROL 0.52 mg prolonged-release tablets EU/1/97/050/016-018
Maltese: SIFROL 0.52 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/016-018
English: SIFROL 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: SIFROL 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: Nausea and fatigue were more often reported in female patients treated with SIFROL (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: SIFROL is used to: - treat the symptoms of primary Parkinson's disease in adults.
Maltese: SIFROL jintuża biex: - jikkura s-sintomi tal-marda ta' Parkinson primarja fl-adulti.
English: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Hyperkinesia (increased movements and inability to keep still)* - Paranoia (e.g. excessive fear for one's own well-being)* - Delusion* - Amnesia (memory disturbance)* - Hallucinations (seeing, hearing or feeling things that are not there) - Confusion - Excessive daytime sleepiness and suddenly falling asleep - Weight increase - Hypotension (low blood pressure) - Excess of fluid, usually in the legs (peripheral oedema) - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Restlessness - Visual impairment - Weight loss including decreased appetite - 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: EU/1/97/050/012 [100 tablets]
Maltese: EU/1/97/050/012 [100 pillola]
English: 3 tablets SIFROL 0.18 mg OR
Maltese: 3 pilloli ta' SIFROL 0.18 mg
English: Patients being treated with SIFROL 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 SIFROL 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 l-magni), sakemm dawn l-episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4.4, 4.5 u 4.8).
English: SIFROL 2.1 mg prolonged-release tablets EU/1/97/050/022-024
Maltese: SIFROL 2.1 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/022-024
English: 2 tablets SIFROL 0.18 mg OR
Maltese: 2 pilloli ta' SIFROL 0.18 mg
English: SIFROL 1.05 mg prolonged-release tablets EU/1/97/050/019-021
Maltese: SIFROL 1.05 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/019-021
English: SIFROL 0.18 mg tablets and SIFROL 0.35 mg tablets are white, of oval shape, and flat.
Maltese: Il-pilloli SIFROL ta' 0.18 mg u l-pilloli SIFROL ta' 0.35 mg huma bojod, b'forma ovali, u ċatti.
English: INFORMATION IN BRAILLE SIFROL 2.62 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 2.62 mg pilloli li jerħu l-mediċina bil-mod
English: EU/1/97/050/004 [100 tablets]
Maltese: EU/1/97/050/004 [100 pillola]
English: When prescribing SIFROL 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 SIFROL lil pazjent bil-marda ta' Parkinson li jkollu indeboliment renali, hu ssuġġerit li tingħata doża mnaqqsa skont kif spjegat f'sezzjoni 4.2.
English: All strengths of SIFROL 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' SIFROL 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: 4 tablets SIFROL 0.088 mg
Maltese: 4 pilloli ta' SIFROL 0.088 mg
English: INFORMATION IN BRAILLE SIFROL 1.05 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 1.05 mg pilloli li jerħu l-mediċina bil-mod
English: The daily dose should not exceed 6 tablets SIFROL 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' SIFROL 0.088 mg jew doża ta' 0.54 mg (0.75 mg ta' melħ ta' pramipexole).
English: 2 tablets SIFROL 0.088 mg
Maltese: 2 pilloli ta' SIFROL 0.088 mg
English: INFORMATION IN BRAILLE SIFROL 0.52 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.52 mg pilloli li jerħu l-mediċina bil-mod
English: EU/1/97/050/002 [100 tablets]
Maltese: EU/1/97/050/002 [100 pillola]
English: INFORMATION IN BRAILLE SIFROL 1.57 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 1.57 mg pilloli li jerħu l-mediċina bil-mod
English: Dyspnoea Hiccups
Maltese: Fdalijiet fl-ippurgar
English: 6 tablets SIFROL 0.088 mg
Maltese: 6 pilloli ta' SIFROL 0.088 mg
English: SIFROL can reduce the production of breast milk.
Maltese: SIFROL jista' jnaqqas il-produzzjoni tal-ħalib tas-sider.
English: SIFROL 1.57 mg prolonged-release tablets EU/1/97/050/028-030
Maltese: SIFROL 1.57 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/028-030
English: 1 tablet SIFROL 0.18 mg OR
Maltese: 1 pillola ta' SIFROL 0.18 mg
English: INFORMATION IN BRAILLE SIFROL 0.26 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 0.26 mg pilloli li jerħu l-mediċina bil-mod
English: 1 tablet SIFROL 0.088 mg
Maltese: 1 pillola ta' SIFROL 0.088 mg
English: SIFROL 3.15 mg prolonged-release tablets EU/1/97/050/025-027
Maltese: SIFROL 3.15 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/025-027
English: INFORMATION IN BRAILLE SIFROL 3.15 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 3.15 mg pilloli li jerħu l-mediċina bil-mod
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.1 mg prolonged-release tablets Pramipexole
Maltese: IL-PRODOTT MEDIĊINALI SIFROL 2.1 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/016 [10 prolonged-release tablets] EU/1/97/050/017 [30 prolonged-release tablets] EU/1/97/050/018 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/016 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/017 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/018 [100 pillola li jerħu l-mediċina bil-mod]
English: Dose Schedule of SIFROL Titration Step Once Daily Evening Dose
Maltese: Skeda tad-Doża ta' SIFROL Pass tat
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.088 mg tablets Pramipexole
Maltese: SIFROL 0.088 mg pilloli Pramipexole
English: EU/1/97/050/006 [100 tablets]
Maltese: EU/1/97/050/006 [100 pillola]
English: There is no relevant use of SIFROL prolonged-release tablets in the paediatric population for the indication of Parkinson's Disease.
Maltese: M'hemm l-ebda użu rilevanti ta' SIFROL fil-popolazzjoni pedjatrika għal indikazzjoni tal-marda ta' Parkinson.
English: NAME OF THE MEDICINAL PRODUCT SIFROL 2.62 mg prolonged-release tablets Pramipexole
Maltese: SIFROL 2.62 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: INFORMATION IN BRAILLE SIFROL 2.1 mg prolonged-release tablets 17.
Maltese: INFORMAZZJONI BIL-BRAILLE SIFROL 2.1 mg pilloli li jerħu l-mediċina bil-mod
English: During the first week, the usual dose is 1 tablet SIFROL 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' SIFROL 0.088 mg tliet darbiet kuljum (ekwivalenti għal 0.264 mg kuljum):
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/025 [10 prolonged-release tablets] EU/1/97/050/026 [30 prolonged-release tablets] EU/1/97/050/027 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/025 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/026 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/027 [100 pillola li jerħu l-mediċina bil-mod]
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/031 [10 prolonged-release tablets] EU/1/97/050/032 [30 prolonged-release tablets] EU/1/97/050/033 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/031 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/032 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/033 [100 pillola li jerħu l-mediċina bil-mod]
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 SIFROL 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' SIFROL 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/1/97/050/028 [10 prolonged-release tablets] EU/1/97/050/029 [30 prolonged-release tablets] EU/1/97/050/030 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/028 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/029 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/030 [100 pillola li jerħu l-mediċina bil-mod]
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including SIFROL (see section 4.4).
Maltese: Is-sintomi jinkludu apatija, ansjetà, depressjoni, għeja, għaraq u wġigħ (ara sezzjoni 4.4).
English: SIFROL 0.7 mg tablets are white, of round shape, and flat.
Maltese: Il-pilloli SIFROL ta' 0.7 mg huma bojod, b'forma tonda, u ċatti.
English: Rare may affect up to1 in 1,000 people
Maltese: Rari jistgħu jaffettwaw sa persuna1 minn kull 1,000
English: NAME OF THE MEDICINAL PRODUCT SIFROL 1.57 mg prolonged-release tablets Pramipexole
Maltese: SIFROL 1.57 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/022 [10 prolonged-release tablets] EU/1/97/050/023 [30 prolonged-release tablets] EU/1/97/050/024 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/022 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/023 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/024 [100 pillola li jerħu l-mediċina bil-mod]
English: Gastrointestinal nausea constipation disorders vomiting
Maltese: Disturbi fissistema endokrinarja tnixxija mhux kif suppost talormon antidijuretiku
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/013 [10 prolonged-release tablets] EU/1/97/050/014 [30 prolonged-release tablets] EU/1/97/050/015 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/013 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/014 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/015 [100 pillola li jerħu l-mediċina bil-mod]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.35 mg tablets Pramipexole
Maltese: SIFROL 0.35 mg pilloli Pramipexole
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) SIFROL 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), SIFROL jista' jitwaqqaf f'daqqa mingħajr ma jkun hemm twaqqif gradwali.
English: SIFROL prolonged-release tablets are a once-a-day oral formulation of pramipexole.
Maltese: SIFROL pilloli li jerħu l-mediċina huma formulazzjoni orali ta' pramipexole li tittieħed darba kuljum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/97/050/019 [10 prolonged-release tablets] EU/1/97/050/020 [30 prolonged-release tablets] EU/1/97/050/021 [100 prolonged-release tablets]
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/97/050/019 [10 pilloli li jerħu l-mediċina bil-mod] EU/1/97/050/020 [30 pillola li jerħu l-mediċina bil-mod] EU/1/97/050/021 [100 pillola li jerħu l-mediċina bil-mod]
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.18 mg tablets Pramipexole
Maltese: SIFROL 0.18 mg pilloli Pramipexole
English: The following dose schedule is suggested:
Maltese: - Wara li twaqqaf jew tnaqqas it-trattament ta' SIFROL tiegħek:
English: NAME OF THE MEDICINAL PRODUCT SIFROL 3.15 mg prolonged-release tablets Pramipexole
Maltese: SIFROL 3.15 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: The European Medicines Agency has waived the obligation to submit the results of studies with SIFROL in all subsets of the paediatric population in Parkinson's Disease (see section 4.2 for information on paediatric use).
Maltese: Sindrome tat-twaqqif tat-trattament b'agonist ta' dopamine Biex jitwaqqaf it-trattament f'pazjenti bil-marda ta' Parkinson, pramipexole għandu jiġi mnaqqas bilmod (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.7 mg tablets Pramipexole
Maltese: SIFROL 0.7 mg pilloli Pramipexole
English: The treatment of patients with a creatinine clearance below 30 ml/min with SIFROL prolonged-release 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: The recommended starting dose of SIFROL 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' SIFROL hi ta' 0.088 mg ta' bażi (0.125 mg ta' melħ) li tittieħed darba kuljum 2-3 sigħat qabel ħin l-irqad.
English: During the first week, the usual dose is 1 tablet SIFROL 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' SIFROL 0.088 mg darba kuljum (ekwivalenti għal 0.088 mg kuljum):
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 SIFROL 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' SIFROL pilloli li jerħu l-mediċina bil-mod.
English: NAME OF THE MEDICINAL PRODUCT SIFROL 0.52 mg prolonged-release tablets Pramipexole
Maltese: SIFROL 0.52 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: NAME OF THE MEDICINAL PRODUCT SIFROL 1.05 mg prolonged-release tablets Pramipexole
Maltese: SIFROL 1.05 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: Not known: - After stopping or reducing your SIFROL treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
Maltese: Jistgħu jseħħu depressjoni, apatija, ansjetà, għeja kbira, għaraq jew uġigħ (imsejħa sindrome tat-twaqqif ta' agonist ta' dopamine jew DAWS [dopamine agonist withdrawal syndrome]).
English: If you stop taking SIFROL
Maltese: Skeda ta' doża li tiżdied ta' SIFROL
English: How to store SIFROL
Maltese: Kif gћandek tieћu SIFROL
English: MARKETING AUTHORISATION NUMBER(S) SIFROL 0.26 mg prolonged-release tablets EU/1/97/050/013-015
Maltese: SIFROL 0.26 mg pilloli li jerħu l-mediċina bil-mod EU/1/97/050/013-015
English: Nervous system disorders somnolence dizziness dyskinesia headache sudden onset of sleep amnesia hyperkinesia syncope
Maltese: Disturbi flgħajnejn indeboliment filvista inkluż vista doppja vista mċajpra tnaqqis fl-akutezza viżiva
English: It is available as capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg) and as an oral solution (2 mg/ml).
Maltese: Jiġi f'kapsuli (1.5 mg, 3 mg, 4.5 mg u 6 mg) u f'soluzzjoni orali (2 mg/ml).
English: The full EPAR for Rivastigmine Hexal can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 11-2012.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'11-2012.
English: EPAR summary for the public rivastigmine
Maltese: Sommarju tal-EPAR għall-pubbliku rivastigmine
English: Rivastigmine Hexal has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Maltese: Hexal ġie studjat fi tliet studji ewlenin li involvew 2,126 pazjent bil-marda ta' Alzheimer minn moderata għal gravi.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Hexal.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Rivastigmine Hexal.
English: The active substance in Rivastigmine Hexal, rivastigmine, is an antidementia medicine.
Maltese: Is-sustanza attiva f'Rivastigmine Hexal, ir-rivastigmina, hija mediċina kontra d-dimenzja.
English: For the global score, patients taking Rivastigmine Hexal had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Maltese: Kwantu għall-punteġġ globali, il-pazjenti ttrattati b'Rivastigmine Hexal kellhom żieda fis-sintomi ta' 4.1 punti apparagun ma' 4.4 punti rreġistrati fil-pazjenti ttrattati bi plaċebo.
English: Rivastigmine Hexal is a medicine containing the active substance rivastigmine.
Maltese: Rivastigmine 1 Hexal huwa mediċina li fiha s-sustanza attiva rivastigmina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Hexal on 11 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Rivastigmine Hexal fil-11 ta' Diċembru 2009.
English: An additional study in 27 patients was used to show that Rivastigmine Hexal capsules and oral solution produced similar levels of the active substance in the blood.
Maltese: Sar studju addizzjonali ieħor fuq 27 pazjent biex juri li l-kapsuli u s-soluzzjoni orali ta' Rivastigmine Hexal ipproduċew livelli simili tas-sustanza attiva fid-demm.