FrancophonIA/ELRC3.0 huggingface dataset:
English: Repeated dose toxicity studies showed that pramipexole exerted functional effects, mainly involving the CNS and female reproductive system, and probably resulting from an exaggerated pharmacodynamic effect of pramipexole.
Maltese: Studji dwar it-tossiċità ta' doża ripetuti wrew li pramipexole ħoloq effetti funzjonali, li primarjament kienu jinvolvu s-CNS u s-sistema riproduttiva fin-nisa, u probabbilment irriżultaw minn effett farmakodinamiku esaġerat ta' pramipexole.
English: INFORMATION IN BRAILLE Pramipexole Accord 1.1 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pramipexole Accord 1.1 mg
English: The frequency category is probably not greater than “uncommon”.
Maltese: Il-kategorija ta' frekwenza probabbilment mhijiex aktar minn “mhux komuni”.
English: 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 filkontroll talimpulsi u lkompulsjonijiet xiri kompulsiv logħob tal-azzard patoloġiku irrekwitezza ipersesswalità delużjoni disturbi fil-libido paranojja delirju teħid ta' ammonti kbar ta' ikel fi żmien qasir1 iperfaġija1
English: Neuroleptic malignant syndrome
Maltese: Sindromu malinn newroleptiku
English: Table 1: Parkinson's disease Body System Very common
Maltese: Tabella 1: Il-marda ta' Parkinson Sistema talĠisem
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Maltese: B'95% ċertezza, ilkategorija ta' frekwenza mhijiex ikbar minn mhux komuni, iżda tista' tkun iktar baxxa.
English: 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%, preżumibbilment permezz talinibizzjoni tas-sistema tat-trasport tat-tubuli renali li tnixxi l-katjoni.
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: L-effikaċja ta' pramipexole (0.0625-0.5 mg/kuljum) fuq pazjenti pedjatriċi li kellhom 6-17-il sena bid-Disturb ta' Tourette kienet evalwata fi studju li sar fuq doża flessibbli li kien double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali u kkontrollati bi plaċebo.
English: Endocrine disorders inappropriate antidiuretic hormone secretion1
Maltese: Disturbi fissistema endokrinarja tnixxija mhux kif suppost tal-ormon antidijuretiku1
English: In patients with a creatinine clearance between 20 and 50 ml/min, the initial daily dose of Pramipexole Accord 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' Pramipexole Accord 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: Very common:
Maltese: - Rari:
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 avanzat, dożi ta' pramipexole, ogħla minn 1.1 mg ta' bażi (1.5 mg ta' melħ) kuljum jistgħu jkunu utli f'pazjenti fejn it-tnaqqis tat-terapija ta' levodopa jkun intenzjonat.
English: Other medicines and Pramipexole Accord
Maltese: Mediċini oħra u Pramipexole Accord
English: If renal function declines during maintenance therapy the Pramipexole Accord 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 Pramipexole Accord daily dose should be reduced by 30%.
Maltese: Jekk il-funzjoni renali tonqos matul it-terapija ta' manteniment, id-doża ta' kuljum ta' Pramipexole Accord għandha titnaqqas bl-istess perċentwali bħat-tnaqqis fit-tneħħija tal-krejatinina, i.e. jekk ittneħħija tal-krejatinina tonqos bi 30%, allura d-doża ta' kuljum ta' Pramipexole Accord għandha titnaqqas bi 30%.
English: Patients being treated with Pramipexole Accord 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 Accord 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. jħaddmu lmagni), sakemm dawn l-episodji rikorrenti u ngħas ikunu ġew ikkurati (ara wkoll sezzjonijiet 4.4, 4.5 u 4.8).
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Accord Healthcare S.L.U.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u Manifattur Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Accord Healthcare S.L.U.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilprodotti mediċinali: http://www.ema.europa.eu.
English: Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy (see section 4.2).
Maltese: Sintomi li jissuġġerixxu sindromu malinn newroleptiku kienu rrappurtati mat-twaqqif f'daqqa tatterapija dopaminerġika (ara sezzjoni 4.2).
English: Do not worry.
Maltese: - Awmentazzjoni.
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 mhijiex possibbli għax l-effett sekondarju ma seħħx f'database tal-prova klinika ta' 2,762 pazjent bil-marda ta' Parkinson ikkurati bi pramipexole.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata i fissezzjoni 6.1.
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 talmediċina li kienet qed tiġi studjata fil-pazjenti li kienu qed jirċievu pramipexole kienu stat ta' konfużjoni, taħwid fid-diskors u kundizzjoni aggravata (ara sezzjoni 4.2).
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 other indication treated with pramipexole.
Maltese: Stima preċiża ta' frekwenza mhijiex possibbli għax l-effett sekondarju ma seħħx f'database tal-prova klinika ta' 1,395 pazjent b'indikazzjoni oħra kkurati bi pramipexole.
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: Pramipexole Accord 0.35 mg tablet
Maltese: Pramipexole Accord 0.35 mg pilloli
English: However, the potential influence of hepatic insufficiency on Pramipexole Accord pharmacokinetics has not been investigated.
Maltese: Madankollu, l-influwenza potenzjali ta' insuffiċjenza epatika fuq il-farmakokinetika ta' Pramipexole Accord ma kinitx investigata.
English: Pramipexole Accord 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: Pramipexole Accord hu indikat fl-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 listadji aħħarin fejn l-effett ta' levodopa jonqos ħafna jew isir inkonsistenti u jseħħu varjazzjonijiet taleffett terapewtiku (fl-aħħar tad-doża jew varjazzjonijiet “on off”).
English: Approximately 90% of 14C-labelled dose is excreted through the kidneys while less than 2% is found in the faeces.
Maltese: Madwar 90% tad-doża ttikkettata 14C titneħħa minn ġol-kliewi, filwaqt li inqas minn 2% tinstab fl-ippurgar.
English: behavioural symptoms of impulse control disorders and compulsions1
Maltese: Disturb fil-kontroll tal-impulsi u mġiba kompulsiva
English: Nausea and fatigue were more often reported in female patients treated with Pramipexole Accord (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 Accord 1.1 mg tablet EU/1/11/728/009-010 (30/100 tablets in alu/alu blister)
Maltese: Pramipexole Accord 1.1 mg pillola EU/1/11/728/009-010 (30/100 pillola alu / alu folja)
English: Pramipexole Accord 0.7 mg tablet
Maltese: Pramipexole Accord 0.7 mg pilloli
English: When prescribing Pramipexole Accord 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 Pramipexole Accord lil pazjent bil-marda ta' Parkinson li jkollu indeboliment renali, hu ssuġġerit li tingħata doża mnaqqsa skont kif spjegat f'sezzjoni 4.2.
English: Reports in the literature indicate that treatment of another indication with dopaminergic medicinal products can result in augmentation.
Maltese: Rapporti fil-letteratura jindikaw li l-kura ta' indikazzjoni oħra bi prodotti mediċinali dopaminerġiċi tista' tirriżulta f'awmentazzjoni.
English: During the first week, the usual dose is 1 tablet Pramipexole Accord 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' Pramipexole Accord 0.088 mg tliet darbiet kuljum (ekwivalenti għal 0.264 mg kuljum):
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 1.1 mg tablets Pramipexole
Maltese: Pramipexole Accord 1.1 mg pilloli Pramipexole
English: Pramipexole Accord 0.35 mg tablet EU/1/11/728/005-006 (30/100 tablets in alu/alu blister)
Maltese: Pramipexole Accord 0.35 mg pillola EU/1/11/728/005-006 (30/100 pillola alu / alu folja)
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 tossiċi fl-omm (ara sezzjoni 5.3).
English: Libido disorders
Maltese: Disturb fil-libido
English: Pramipexole Accord 0.18 mg tablet
Maltese: Pramipexole Accord 0.18 mg pilloli
English: Other indication, most common adverse reactions
Maltese: Indikazzjoni oħra, l-iktar reazzjonijiet avversi komuni
English: Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.1 mg pramipexole.
Maltese: Kull pillola fiha 1.5 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 1.1 mg pramipexole.
English: INFORMATION IN BRAILLE Pramipexole Accord 0.35 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pramipexole Accord 0.35 mg
English: INFORMATION IN BRAILLE Pramipexole Accord 0.088 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pramipexole Accord 0.088 mg
English: Pramipexole Accord 1.1 mg tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘5' on either side of the breakline on one side and breakline on other side.
Maltese: Pramipexole Accord 1.1 mg pilloli huma ta' lewn abjad għal offwajt, tondi, b'wiċċ ċatt, bit-tarf imżerżaq, bl-iskrizzjoni ‘I' u ‘5' fuq iż-żewġ naħat tal-linja tal-qsim fuq naħa waħda u linja tal-qsim fuq in-naħa l-oħra.
English: Kaplan-Meier analysis of time to augmentation showed no significant difference between pramipexole and placebo groups.
Maltese: Analiżi Kaplan-Meier tal-ħin talawmentazzjoni ma wriet l-ebda differenza sinifikanti bejn pramipexole u l-grupp tal-plaċebo.
English: Pramipexole Accord 0.088 mg tablet
Maltese: Pramipexole Accord 0.088 mg pillola
English: Pramipexole Accord 0.7 mg tablet EU/1/11/728/007-008 (30/100 tablets in alu/alu blister)
Maltese: Pramipexole Accord 0.7 mg pillola EU/1/11/728/007-008 (30/10 pillola alu / alu folja)
English: If you suffer from other indication, you may experience the following side effects:
Maltese: Jekk tbati minn indikazzjoni oħra, jista' jkollok l-effetti sekondarji li ġejjin:
English: Highest maintenance dose
Maltese: Kura ta' manteniment
English: 3rd week
Maltese: 2ni ġimgħa
English: • Dizziness
Maltese: - Distonja
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 kemm għall-punt aħħari primarju kif ukoll 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: Pramipexole Accord has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Maltese: Pramipexole Accord kien assoċjat ma' ngħas u episodji ta' rqad li jiġi f'daqqa, partikularment f'pazjenti bil-marda ta' Parkinson.
English: Parkinson's disease, most common adverse reactions
Maltese: Il-marda ta' Parkinson, l-iktar reazzjonijiet avversi komuni
English: • Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Maltese: - Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn).
English: INFORMATION IN BRAILLE Pramipexole Accord 0.7 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pramipexole Accord 0.7 mg
English: Nervous system disorders headache dizziness somnolance sudden onset of sleep syncope dyskinesia amnesia1 hyperkinesia1
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI Folja-alu/alu
English: Pregnancy
Maltese: Povidone
English: • rigid muscles
Maltese: .8 Effetti mhux mixtieqa
English: Ascending dose schedule of Pramipexole Accord
Maltese: Jekk tinsa tieħu Pramipexole Accord
English: Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate equivalent to 0.088 mg pramipexole.
Maltese: Kull pillola fiha 0.125 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.088 mg pramipexole.
English: INFORMATION IN BRAILLE Pramipexole Accord 0.18 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pramipexole Accord 0.18 mg
English: • Psychosis (e.g. comparable with symptoms of schizophrenia).
Maltese: - Irqad u episodji li torqod għal għarrieda - Psikosi, (eż. komparabbli ma' sintomi tal-iskiżofrenja).
English: Risk Management Plan (RMP) The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate equivalent to 0.18 mg pramipexole.
Maltese: Kull pillola fiha 0.25 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.18 mg pramipexole.
English: See section 4
Maltese: Ara sezzjoni 4.
English: You should avoid taking Pramipexole Accord together with antipsychotic medicines.
Maltese: Għandek tevita li tieħu Pramipexole Accord flimkien ma' mediċini antipsikotiċi.
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.088 mg tablets Pramipexole
Maltese: Pramipexole Accord 0.088 mg pilloli Pramipexole
English: Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate equivalent to 0.35 mg pramipexole.
Maltese: Kull pillola fiha 0.5 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.35 mg pramipexole.
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.35 mg tablets Pramipexole
Maltese: Pramipexole Accord 0.35 mg pilloli Pramipexole
English: Pramipexole Accord 0.35 mg tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘3' on either side of the breakline on one side and breakline on the other side.
Maltese: Pramipexole Accord 0.35 mg pilloli huma ta' lewn abjad għal offwajt, tondi, b'wiċċ ċatt, bit-tarf imżerżaq, bl-iskrizzjoni ‘I' u ‘3' fuq iż-żewġ naħat tal-linja tal-qsim fuq naħa waħda u linja tal-qsim fuq in-naħa l-oħra.
English: Frequency cannot be estimated from the available data
Maltese: Mhux magħruf ma tistax tittieħed stima tal-frekwenza mid-data disponibbli
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: Id-doża ta' kuljum tista' tingħata f'żewġ dożi maqsumin jekk it-tneħħija talkrejatinina tkun bejn 20 u 50 ml/min, u bħala doża waħda kuljum jekk it-tneħħija tal-krejatinina tkun inqas minn 20 ml/min.
English: Pramipexole Accord 0.7 mg tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘4' on either side of the breakline on one side and breakline on the other side..
Maltese: Pramipexole Accord 0.7 mg pilloli huma ta' lewn abjad għal offwajt, tondi, b'wiċċ ċatt, bit-tarf imżerżaq, bl-iskrizzjoni ‘I' u ‘4' fuq iż-żewġ naħat tal-linja tal-qsim fuq naħa waħda u linja tal-qsim fuq in-naħa l-oħra.
English: Very common: • Nausea (sickness)
Maltese: Komuni ħafna: - Nawseja (dardir)
English: • Sleeplessness (insomnia)
Maltese: TWISSIJA(IET) SPEĊJALI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/007-008 (30/100 tablets in alu/alu blister)
Maltese: FIS-SUQ EU/1/11/728/007-008 (30/100 pillola alu / alu folja)
English: The elimination half-life (t½) varies from 8 hours in the young to 12 hours in the elderly.
Maltese: Il-half-life (t½) tal-eliminazzjoni tvarja minn 8 sigħat fiż-żgħażagħ għal 12-il siegħa flanzjani.
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.18 mg tablets Pramipexole
Maltese: Pramipexole Accord 0.18 mg pilloli Pramipexole
English: NAME OF THE MEDICINAL PRODUCT Pramipexole Accord 0.7 mg tablets Pramipexole
Maltese: Pramipexole Accord 0.7 mg pilloli Pramipexole
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pramipexole Accord 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: When Pramipexole Accord is given in combination with levodopa, it is recommended that the dose of levodopa is reduced and the dose of other anti-parkinsonian medicinal products is kept constant while increasing the dose of Pramipexole Accord.
Maltese: Meta Pramipexole Accord jingħata flimkien ma' levodopa, hu rrakkomandat li d-doża ta' levodopa titnaqqas u li d-doża ta' prodotti mediċinali oħrajn kontra l-marda ta' Parkinson tinżamm kostanti, filwaqt li d-doża ta' Pramipexole Accord tiżdied.
English: Pramipexole Accord 0.18 mg tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘2' on either side of the breakline on one side and breakline on the other side.
Maltese: Pramipexole Accord 0.018 mg pilloli huma ta' lewn abjad għal offwajt, tondi, b'wiċċ ċatt, bit-tarf imżerżaq, bl-iskrizzjoni ‘I' u ‘2' fuq iż-żewġ naħat tal-linja tal-qsim fuq naħa waħda u linja tal-qsim fuq in-naħa l-oħra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/009-010 (30/100 tablets in alu/alu blister)
Maltese: FIS-SUQ EU/1/11/728/009-010 (30/100 pillola alu / alu folja)
English: Each tablet contains 1.0 mg pramipexole dihydrochloride monohydrate equivalent to 0.7 mg pramipexole.
Maltese: Kull pillola fiha 1.0 mg pramipexole dihydrochloride monohydrate ekwivalenti għal 0.7 mg pramipexole.
English: It can be used alone or in combination with levodopa (another medicine for Parkinson's disease).
Maltese: levodopa (mediċina oħra għall-marda ta' Parkinson).
English: Thereafter the dose should be reduced by 0.264 mg of base (0.375 mg of salt) per day (see section 4.4).
Maltese: Wara dak il-perijodu, id-doża għandha titnaqqas b'0.264 mg ta' bażi (0.375 mg ta' melħ) kuljum (ara sezzjoni 4.4).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/001-002 (30/100 tablets in alu/alu blister)
Maltese: FIS-SUQ EU/1/11/728/001-002 (30/100 pillola alu / alu folja)
English: Very rare may affect up to 1 in 10,000 people
Maltese: Rari ħafna jaffettwaw inqas minn utent 1 minn kull 10,000
English: The expected adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hyperkinesia, hallucinations, agitation and hypotension.
Maltese: Ir-reazzjonijiet avversi mistennija ser ikunu dawk relatati mal-profil farmakodinamiku ta' agonist ta' dopamine, li jinkludu nawseja, rimettar, iperkinesija, alluċinazzjonijiet, aġitazzjoni u pressjoni tad-demm baxxa.
English: Dyspnoea hiccups
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Maintenance treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: • Inappropriate antidiuretic hormone secretion*
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà
English: It is recommended that the dose of levodopa is reduced during both the dose escalation and the maintenance treatment with Pramipexole Accord, depending on reactions in individual patients (see section 4.5).
Maltese: Hu rrakkomandat li d-doża ta' levodopa titnaqqas kemm matul il-perijodu meta d-doża tkun qed tiżdied, kif ukoll matul il-kura ta' manteniment bi Pramipexole Accord, skont ir-reazzjonijiet fil-pazjenti individwali (ara sezzjoni 4.5).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/005-006 (30/100 tablets in alu/alu blister)
Maltese: EU/1/11/728/005-006 (30/100 pillola alu / alu folja)
English: However, it should be noted that the incidence of somnolence is increased at doses higher than 1.5 mg (of salt) per day (see section 4.8).
Maltese: Madankollu, wieħed għandu jinnota li l-inċidenza tan-ngħas tiżdied b'dożi ogħla minn 1.5 mg (ta' melħ) kuljum (ara sezzjoni 4.8).
English: In animal studies, pramipexole affected oestrous cycles and reduced female fertility as expected for a dopamine agonist.
Maltese: Fi studji fuq l-annimali, pramipexole affettwa ċċikli oestrous u naqqas il-fertilità fin-nisa kif mistenni minn agonist ta' dopamine.