FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pramipexole Teva 0.35 mg tablets are white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side.
Maltese: • Il-pilloli Pramipexole Teva ta' 0.35 mg huma bojod u ovali, imbuzzati fuq żewġ naħat u li fuqhom hemm intaljat 9 b'mod vertikali mal-linja tal-ferq u 3 fuq in-naħa mnaqqxa u 8023 fuq in-naħa l-oħra.
English: In a 26 week placebo controlled trial, rebound of RLS symptoms (worsening of symptom severity as compared to baseline) was observed in 10% of patients (14 out of 135) after abrupt discontinuation of treatment.
Maltese: Fi prova li damet 26 ġimgħa, ikkontrollata bi plaċebo, kien osservat rebound ta' sintomi RLS (aggravar fis-severità tas-sintomi meta mqabbel mal-linja bażi) f'10% tal-pazjenti (14 minn 135) wara t-twaqqif f'daqqa tal-kura.
English: Maintenance treatment
Maltese: manteniment
English: The primary endpoint was change from baseline on the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS).
Maltese: Il-punt aħħari primarju kien bidla mil-linja bażi fuq il-Punteġġ Totali Tic (TTS) tal-Yale Global Tic Severity Scale (YGTSS).
English: BATCH NUMBER
Maltese: Numru ta'
English: Pramipexole Teva is used to:
Maltese: Pramipexole Teva jintuża biex:
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 nawsja, diskinesija, pressjoni tad-demm baxxa, sturdament, ngħas, nuqqas ta' rqad, stitikezza, alluċinazzjonijiet, uġigħ ta' ras u għeja kbira.
English: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Maltese: Ludwig-Merckle-Straße 3
English: CGI-I responder rates (much improved, very much improved) were 50.3% (80/159) and 68.5% (111/162) for placebo and pramipexole, respectively (p = 0.001), corresponding to a number needed to treat (NNT) of 6 patients (95%CI: 3.5, 13.4).
Maltese: Ir-rati ta' dawk li rrispondew għal CGI-I (titjib kbir, titjib kbir ħafna) kienu ta' 50.3% (80/159) u 68.5% (111/162) għal plaċebo u pramipexole, rispettivament (p = 0.001), li jikkorrispondu għal numru meħtieġ għal kura (NNTneeded to treat) ta' 6 pazjenti (CI ta' 95%: 3.5, 13.4).
English: • Delirium (decreased awareness, confusion, loss of reality)*
Maltese: • Delirju (tnaqqis fl-għarfien, konfużjoni, telf tar-realtà)*
English: Colloidal silicon dioxide.
Maltese: Sodium monostearyl fumarate Colloidal silicon dioxide.
English: Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Maltese: L-awmentazzjoni kienet investigata speċifikament fi prova klinika kkontrollata fuq perjodu ta' 26 ġimgħa.
English: In a cross-sectional, retrospective screening and case-control study including 3,090 Parkinson's disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had symptoms of an impulse control disorder during the past six months.
Maltese: Fi studju cross-sectional, screening retrospettiv u case-control li kine jinkludi 3,090 pazjent bil-marda ta' Parkinson, 13.6% tal-pazjenti kollha li kienu qed jirċievu kura dopaminerġika jew mhux dopominerġika, kellhom sintomi ta' disturb fil-kontroll tal-impulsi matul l-aħħar sitt xhur.
English: Co-administration of antipsychotic medicinal products with pramipexole should be avoided (see section 4.4), e.g. if antagonistic effects can be expected.
Maltese: L-għoti flimkien ta' prodotti mediċinali antipsikotiċi ma' pramipexole għandu jkun evitat (ara sezzjoni 4.4), eż. jekk ikunu mistennija effetti antagonistiċi.
English: • Pramipexole Teva tablets are available in blister packs of 30, 30 x 1, 50 x 1, 100 x 1 and 100 tablets and bottles containing 90 tablets.
Maltese: • Il-pilloli Pramipexole Teva jiġu f'pakketti ta' folji ta' 30, 30 x 1, 50 x 1, u 100 x 1 u 100 pillola u fi flieken li fihom 90 pillola.
English: Table 2: Restless Legs Syndrome Body System Very common
Maltese: Tabella 2: Sindrome tar-Riġlejn Irrekwieti Sistema talĠisem
English: Pramipexole is bound to plasma proteins to a very low (< 20 %) extent, and little biotransformation is seen in man.
Maltese: Pramipexole jeħel ftit ħafna mal-proteini fil-plażma (< 20 %), u ftit bijotrasformazzjoni tiġi osservata fil-bniedem.
English: Total daily dose (mg)
Maltese: Doża totali ta' kuljum (mg)
English: White, round, flat face bevel edge tablet, 8.82 mm diameter, embossed with "8024" over "8024" on the scored side and "93" on the other side.
Maltese: Pillola bajda, tonda, b'wiċċ ċatt b'xifer imżerżaq, b'dijametru ta' 8.82 mm, intaljata b'"8024" fuq "8024" fuq in-naħa b'sinjal imnaqqax u "93" fuq in-naħa l-oħra.
English: • Tiredness (fatigue)
Maltese: • Rimettar (tkun imdardar)
English: Neuroleptic malignant syndrome
Maltese: Sindrome tar-Riġlejn Irrekwieti
English: However, the marketing authorisation holder shall submit periodic safety update reports for this medicinal product if the product is included in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Madankollu d-detentur tal-awtorizzazzjoni għattqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott jekk il-prodott ikun inkluż fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: For both primary endpoints statistically significant differences have been observed for the pramipexole dose groups 0.25 mg, 0.5 mg and 0.75 mg pramipexole salt in comparison to placebo.
Maltese: Għaż-żewġ endpoints primarji, kienu osservati differenzi statistikament sinifikanti għall-gruppi tad-doża ta' 0.25 mg, 0.5 mg u 0.75 mg ta' melħ ta' pramipexole, meta mqabbla mal-plaċebo.
English: Placebocontrolled clinical trials included approximately 1,800 patients of Hoehn and Yahr stages I - V treated with pramipexole.
Maltese: Provi kliniċi kkontrollati bil-plaċebo kienu jinkludu madwar 1,800 pazjent li kienu fi stadji I - V ta' Hoehn u Yahr ikkurati bi pramipexole.
English: Patients with psychotic disorders
Maltese: Pazjenti b'disturbi psikotiċi
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Maltese: Rapporti fil-letteratura jindikaw li trattament tas-Sindrome tar-Riġlejn Irrekwieti bi prodotti mediċinali dopaminerġiċi tista' tirriżulta f'awmentazzjoni.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Combination with levodopa
Maltese: Kumbinazzjoni ma' levodopa
English: • Fainting
Maltese: • Sturdament
English: • treat the symptoms of moderate to severe primary Restless Legs Syndrome in adults.
Maltese: • jikkura s-sintomi tas-Sindrome tar-Riġlejn Irrekwieti (Restless Legs Syndrome - RLS) primarju fl-adulti li jkun minn moderat sa sever.
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-familja ta'
English: Number of tablets
Maltese: Numru ta' pilloli
English: Pramipexole Teva 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: Pramipexole Teva 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: Dose (mg of salt)
Maltese: Doża (mg ta' melħ)
English: The potential effects of pramipexole on reproductive function have been investigated in rats and rabbits.
Maltese: L-effetti potenzjali ta' pramipexole fuq il-funzjoni riproduttiva kienu investigati fil-firien u fil-fniek.
English: Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson's disease following initiation or incremental dose increase of pramipexole.
Maltese: Distonja axjali, inkluż l-antecollis, il-camptocormia u l-pleurothotonus (il-Marda ta' Pisa) xi kultant ġiet irrappurtata f'pazjenti bil-marda tal-Parkinson, wara inizjazzjoni jew żieda inkrementali fid-doża ta' pramipexole.
English: White, round, flat face bevel edge tablet, 5.55 mm diameter, embossed with “93” on one side and “P1” on the other side.
Maltese: Pillola tonda, wiċċ ċatt b'xifer imżerżaq, b'dijametru ta' 5.55 mm, intaljat b'"93" fuq naħa waħda u "P1" fuq in-naħa l-oħra .
English: Endocrine disorders inappropriate antidiuretic hormone secretion1
Maltese: Disturbi fissistema endokrinarja tnixxija mhux kif suppost tal ormon antidijuretiku1
English: The usual maintenance dose is 1.1 mg per day.
Maltese: Doża totali ta' kuljum (mg) Id-doża normali ta' manteniment hi ta' 1.1 mg kuljum.
English: PHARMACEUTICAL FORM AND CONTENTS Tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Talk to your doctor before taking Pramipexole Teva.
Maltese: Mediċini oħra u Pramipexole Teva
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 tal-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: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tél/Tel: +49 73140202
Maltese: Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland
English: The mean change from baseline in the Restless Legs Syndrome Rating Scale (IRLS) and the Clinical Global Impression-Improvement (CGI-I) were the primary efficacy outcome measures.
Maltese: Il-bidla medja mil-linja bażi fir-Restless Legs Syndrome Rating Scale (IRLS) u l-Clinical Global Impression-Improvement (CGI-I) kienu l-miżuri tar-riżultat tal-effikaċja primarja.
English: White, round, flat face bevel edge tablet, 7.00 mm diameter, embossed with "P2" over "P2" on the scored side and "93" on the other side.
Maltese: Pillola bajda, tonda, b'wiċċ ċatt b'xifer imżerżaq, b'dijametru ta' 7.00 mm, intaljata b'"P2" fuq "P2" fuq in-naħa b'sinjal imnaqqax u "93" fuq in-naħa l-oħra.
English: Very rare may affect up to 1 in 10,000 people
Maltese: Rari ħafna jistgħu jaffettwaw sa persuna 1 minn kull 10,000
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Pramipexole Teva 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-kreatinina ta' bejn 20 u 50 ml/min, id-doża inizjali ta' kuljum ta' Pramipexole Teva 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: Clinical efficacy and safety in Restless Legs Syndrome The efficacy of pramipexole was evaluated in four placebo-controlled clinical trials in approximately 1,000 patients with moderate to very severe idiopathic Restless Legs Syndrome.
Maltese: Effikaċja klinika u sigurtà bis-Sindrome tar-Riġlejn Irrekwieti L-effikaċja ta' pramipexole kienet evalwata f'erba' provi kliniċi kkontrollati bil-plaċebo f'madwar 1,000 pazjent li kellhom Sindrome tar-Riġlejn Irrekwieti idjopatiku li kien minn moderat sa sever ħafna.
English: Patients being treated with Pramipexole Teva 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 Pramipexole Teva u li jkollhom ngħas u/jew episodji 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. iħaddmu lmagni), sakemm dawn l-episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4.4, 4.5, u 4.8).
English: Inhibitors/competitors of active renal elimination pathway Cimetidine reduced the renal clearance of pramipexole by approximately 34 %, presumably by inhibition of the cationic secretory transport system of the renal tubules.
Maltese: Cimetidine naqqas it-tneħħija renali ta' pramipexole b'madwar 34 %, preżumibilment permezz tal-inibizzjoni tas-sistema tat-trasport li tnixxi l-ketajins tat-tubuli renali.
English: Eye disorders visual impairment including diplopia vision blurred visual acuity reduced
Maltese: Disturbi flgħajnejn indeboliment filvista inkluż vista doppja vista mċajpra tnaqqis flakutezza viżiva
English: • Hypotension (low blood pressure)
Maltese: • Ipotensjoni (pressjoni tad-demm baxxa)
English: The individual dose of pramipexole should be in the range of 0.264 mg of base (0.375 mg of salt) to a maximum of 3.3 mg of base (4.5 mg of salt) per day.
Maltese: Id-doża individwali ta' pramipexole għandha tkun fil-medda ta' 0.264 mg ta' bażi (0.375 mg ta' melħ) sa massimu ta' 3.3 mg ta' bażi (4.5 mg ta' melħ) kuljum.
English: • Delirium (decreased awareness, confusion, loss of reality)
Maltese: • Delirju (tnaqqis fl-għarfien, konfużjoni, telf tar-realtà)
English: Psychiatric disorders insomnia hallucinations abnormal dreams confusion behavioural symptoms of impulse control disorders and compulsions compulsive shopping pathological gambling restlessness hypersexuality delusion libido disorder paranoia delirium binge eating1 hyperphagia1
Maltese: Disturbi psikjatriċi insomnija alluċinazzjonijiet ħolm mhux normali konfużjoni sintomi fl-imġiba ta' disturbi fil kontroll tal impulsi u lkompulsjonijiet xiri kompulsiv logħob talazzard patoloġiku irrekwitezza ipersesswalità delużjoni disturbi fillibido paranojja delirju teħid ta' ammonti kbar ta' ikel fi żmien qasir1 iperfaġija1
English: White to off-white, oval, biconvex tablets, engraved with 9 vertical scoreline 3 on the scored side, and 8023 on the other side.
Maltese: Pilloli bojod għal ofwajt, ovali, imbuzzati fuq iż-żewġ naħat li fuqhom hemm intaljat 9 b'mod vertikali mal-linja tas-sinjal imnaqqax u 3 fuq in-naħa mnaqqxa u 8023 fuq in-naħa l-oħra.
English: • Paranoia (e.g. excessive fear for one's own well-being)*
Maltese: • Paranojja (eż. biża' eċċessiv għall-benesseri tiegħek)*
English: Nausea and fatigue were more often reported in female patients treated with pramipexole (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: Pramipexole Teva 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: Parkinson, waħdu (mingħajr levodopa) jew flimkien ma' levodopa, i.e. matul il-kors tal-marda, salistadji 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: Patients should be regularly monitored for the development of impulse control disorders.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati regolarment għall-iżvilupp ta' disturbi fil-kontroll tal-impulsi.
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 ittrattati bi pramipexole.
English: After 12 weeks of treatment the baseline IRLS score improved from 23.5 to 14.1 points for placebo and from 23.4 to 9.4 points for pramipexole (doses combined).
Maltese: Wara 12-il ġimgħa ta' kura, il-punteġġ IRLS tal-linja bażi tjieb minn 23.5 għal 14.1 punti għall-plaċebo, u minn 23.4 għal 9.4 punti għal pramipexole (dożi kombinati).
English: • Dizziness
Maltese: • Awmentazzjoni.
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 4.4).
English: Pramipexole Teva 0.35 mg tablets
Maltese: Pramipexole Teva 0.35 mg pilloli
English: In advanced Parkinson's disease, pramipexole doses higher than 1.1 mg of base (1.5 mg of salt) per day can be useful in patients where a reduction of the levodopa therapy is intended.
Maltese: Fil-marda ta' Parkinson fl-istadju avvanzat, dożi ta' pramipexole, ogħla minn 1.1 mg tal-bażi (1.5 mg ta' melħ) kuljum jistgħu jkunu utli f'pazjenti fejn it-tnaqqis tat-terapija ta' levodopa jkun intenzjonat.
English: The efficacy of pramipexole (0.0625-0.5 mg/day) with paediatric patients aged 6-17 years with Tourette Disorder was evaluated in a 6-week, double-blind, randomised, placebo-controlled flexible dose study.
Maltese: Effikaċja klinika u sigurtà fuq id-Disturb ta' Tourette L-effikaċja ta' pramipexole (0.0625-0.5 mg/kuljum) fuq pazjenti pedjatriċi li kellhom 6-17-il sena bidDisturb ta' Tourette kienet evalwata fi studju li sar fuq doża flessibbli li kien double-blind, li fih ilparteċipanti ntgħażlu b'mod każwali u kkontrollati bi plaċebo.
English: Pramipexole Teva 0.7 mg tablets
Maltese: Pramipexole Teva 0.7 mg pilloli
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 fid-diskors u kundizzjoni aggravata (ara sezzjoni 4.2).
English: If signs of central nervous system stimulation are present, a neuroleptic agent may be indicated.
Maltese: Jekk ikun hemm sinjali ta' stimulazzjoni tassistema nervuża ċentrali, jista' jkun hemm bżonn ta' mediċina newroleptika.
English: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Maltese: Sindromu malinn newroleptiku Sintomi li jissuġerixxu sindrome mallin newroleptiku kienu rappurtati mat-twaqqif f'daqqa tat-terapija dopaminerġika (ara sezzjoni 4.2).
English: 6 tablets Pramipexole Teva 0.088 mg
Maltese: 6 pilloli ta' Pramipexole Teva 0.088 mg
English: There is no clinical experience with massive overdose.
Maltese: M'hemm l-ebda esperjenza klinika b'doża eċċessiva massiva.
English: Pramipexole Teva 0.18 mg tablets
Maltese: Pramipexole Teva 0.18 mg pilloli
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Other medicines and Pramipexole Teva
Maltese: 1 pillola ta' Pramipexole
English: Pramipexole Teva 0.088 mg tablets
Maltese: Pramipexole Teva 0.088 mg pilloli
English: EXPIRY DATE
Maltese: DATA TA' REVIJONI TAT-TEST
English: Date of first authorisation: 18 December 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Diċembru 2008
English: 2 tablets Pramipexole Teva 0.18 mg
Maltese: 2 pilloli ta' Pramipexole Teva 0.18 mg
English: In clinical trials approximately 5 % of patients were treated at doses below 1.1 mg of base (1.5 mg of salt).
Maltese: Fil-provi kliniċi, madwar 5% tal-pazjenti kienu kkurati b'dożi li kienu taħt 1.1 mg tal-bażi (1.5 mg ta' melħ).
English: Pramipexole was not teratogenic in rats and rabbits, but was embryotoxic in the rat at maternotoxic doses (see section 5.3).
Maltese: Pramipexole ma kienx teratoġeniku fil-firien u fil-fniek, iżda kien embrijotossiku fil-firien f'dożi maternotossiċi (ara sezzjoni 5.3).
English: In a controlled double blind clinical trial of 2 year duration, initial treatment with pramipexole significantly delayed the onset of motor complications, and reduced their occurrence compared to initial treatment with levodopa.
Maltese: Fi prova klinika kkontrollata double blind li damet sentejn, il-kura inizjali bi pramipexole, ittardjat b'mod sinifikanti l-bidu ta' kumplikazzjonijiet tal-moviment, u naqqset l-okkorrenza tagħhom meta mqabbla mal-kura inizjali b'levodopa.
English: You should avoid taking Pramipexole Teva together with antipsychotic medicines.
Maltese: Għandek tevita li tieħu Pramixpexole Teva flimkien ma' mediċini antipsikotiċi.
English: 3 tablets Pramipexole Teva 0.18 mg
Maltese: 3 pilloli ta' Pramipexole Teva 0.18 mg
English: • Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs)
Maltese: • Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn)
English: Blisters:
Maltese: Folji:
English: Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.4, 4.7 and 4.8).
Maltese: Minħabba l-possibbiltà ta' effetti addittivi, għandha tingħata attenzjoni meta l-pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma' pramipexole (ara sezzjonijiet 4.4, 4.7 u 4.8).
English: For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 1,395 patients treated with pramipexole.
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 1,395 pazjent ikkurati bi pramipexole.
English: For the side effects marked with * a precise frequency estimation is not possible, since these side effects were not observed in clinical studies among 2,762 patients treated with pramipexole.
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: • Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Maltese: • Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn).
English: EU/1/08/490/001 EU/1/08/490/002 EU/1/08/490/003 EU/1/08/490/004 EU/1/08/490/017 EU/1/08/490/018
Maltese: EU/1/08/490/001 EU/1/08/490/002 EU/1/08/490/003 EU/1/08/490/004
English: Because of possible additive effects, caution should be advised when patients are taking other sedating medicinal products or alcohol in combination with pramipexole (see sections 4.5, 4.7 and section 4.8).
Maltese: Minħabba l-possibbiltà ta' effetti addittivi, għandha tingħata attenzjoni meta l-pazjenti jkunu qed jieħdu prodotti mediċinali sedattivi oħrajn jew alkoħol flimkien ma' pramipexole (ara sezzjonijiet 4.5, 4.7 u sezzjoni 4.8).
English: Pramipexole Teva can have a major influence on the ability to drive and use machines.
Maltese: Madankollu, l-influwenza potenzjali ta'
English: 3rd week
Maltese: ANNESS III