FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of naldemedine after administration of a single 200 microgram dose of naldemedine was studied in subjects with mild, moderate or severe renal impairment, or with endstage renal disease (ESRD) requiring haemodialysis, and compared with healthy subjects with normal renal function.
Maltese: Il-farmakokinetika ta' naldemedine wara l-għoti ta' doża waħda ta' 200 mikrogramma ta' naldemedine kienet studjata f'individwi b'indeboliment renali ħafif, moderat jew sever, jew b'mard renali tal-aħħar stadju (ESRD, end-stage renal disease) li jkunu jeħtieġu emodijalisi, u mqabbla ma' individwi f'saħħithom b'funzjoni renali normali.
English: Change in frequency of SBMs per week (LS Mean)
Maltese: Bidla fil-frekwenza ta' SBMs fil-ġimgħa (Medja tal-LS)
English: Taking into account the PRAC Assessment Report on the PSUR(s) for naldemedine, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal naldemedine, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Abdominal adverse reactions (e.g. abdominal pain, vomiting and diarrhoea) have been reported with Rizmoic.
Maltese: Reazzjonijiet avversi addominali (eż. uġigħ addominali, rimettar u dijarea) ġew irrappurtati b'Rizmoic.
English: Concomitant use of naldemedine with moderate inducers (e.g. efavirenz) has not been established, and patients should be monitored (see section 4.4).
Maltese: L-użu fl-istess ħin ta' naldemedine ma' indutturi moderati (eż. efavirenz) ma ġiex stabbilit u l-pazjenti għandhom jiġu mmonitorjati (ara sezzjoni 4.4).
English: Change in the frequency of BMs per week from baseline to each visit (LS Mean) ITT population in study V9235
Maltese: Bidla fil-frekwenza ta' BMs kull ġimgħa mil-linja bażi sa kull ITT popolazzjoni żjara (Medja tal-LS) fi studju V9235.
English: • watery eyes or runny nose
Maltese: • nawseja (tħossok imdardar)
English: These patients should be clinically monitored when taking Rizmoic.
Maltese: Dawn il-pazjenti għandhom jiġu mmonitorjati klinikament meta jieħdu Rizmoic.
English: [Carbonyl-14C]-naldemedine-derived radioactivity was excreted into milk in lactating rats.
Maltese: Radjuattività derivata minn [carbonyl-14C]-naldemedine kienet eliminata fil-ħalib ta'
English: The recommended dose of naldemedine is 200 micrograms (one tablet) daily.
Maltese: Id-doża rakkomandata ta' naldemedine hija ta' 200 mikrogramma (pillola waħda) kuljum.
English: Three-day earlier vaginal opening indicative of an early onset of sexual maturity was also observed, but only at high exposures considered sufficiently in excess of the maximum human exposure at an oral dose of 200 micrograms.
Maltese: Ftuħ vaġinali tliet jiem qabel, li kien jindika bidu bikri ta' maturità sesswali, ġie osservat ukoll, iżda biss f'esponimenti meqjusa ferm aktar għolja mill-massimu ta' esponiment fil-bniedem f'doża orali ta' 200 mikrogramma.
English: If naldemedine is used with strong P-gp inhibitors, monitor for adverse reactions.
Maltese: Jekk naldemedine jintuża ma' inibituri qawwija ta' P-gp, immonitorja għal reazzjonijiet avversi.
English: There is no specific antidote for naldemedine.
Maltese: M'hemm l-ebda antidotu speċifiku għal naldemedine.
English: - if you are taking certain medicines such as itraconazole to treat fungal infections, or an antibiotic called rifampicin to treat tuberculosis and other infections.
Maltese: - jekk qed tieħu ċertu mediċini bħal itraconazole biex tikkura infezzjonijiet fungali, jew antibijotiku msejjaħ rifampicin li jikkura t-tuberkulożi u infezzjonijiet oħra.
English: - if you suffer from symptoms of opioid withdrawal syndrome (see section 4 Possible side effects) which can develop within minutes to several days after taking a medicine such as Rizmoic.
Maltese: - jekk inti tbati minn sintomi kkawżati meta wieħed jieqaf jieħu l-opjojdi (ara sezzjoni 4 Effetti sekondarji possibbli) li jistgħu jiżviluppaw fi ftit minuti sa diversi jiem wara li tieħu mediċina bħal Rizmoic.
English: The patients who participated in Studies V9231, V9232 and V9235 were taking a wide range of opioids.
Maltese: Ilpazjenti li pparteċipaw fi Studji V9231, V9232 u V9235 kienu qed jieħdu varjetà kbira ta' opjojdi.
English: - if you have cancer of the brain or central nervous system, multiple sclerosis, or Alzheimer's disease.
Maltese: - jekk għandek kanċer tal-moħħ jew tas-sistema nervuża ċentrali, sklerożi multipla jew il-marda ta' Alzheimer.
English: Tablet core
Maltese: Madankollu,
English: Placebo (N=56)
Maltese: (N = 56)
English: Placebo (N=96)
Maltese: (N = 96)
English: Concomitant use of strong CYP3A inhibitors such as grapefruit juice, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin and clarithromycin should be avoided.
Maltese: L-użu fl-istess ħin ta' inibituri qawwija ta' CYP3A bħal meraq tal-grejpfrut, itraconazole, ketoconazole, ritonavir, indinavir, saquinavir, telithromycin u clarithromycin għandu jiġi evitat.
English: Vomiting
Maltese: Manifattur
English: Rizmoic 200 micrograms film-coated tablets naldemedine
Maltese: Informazzjoni għall-pazjent Rizmoic 200 mikrogramma pilloli miksija b'rita naldemedine
English: You will be monitored for opioid withdrawal symptoms (see section 2, under ‘Warnings and Precautions', and section 4).
Maltese: Inti se tkun immonitorjat għal sintomi ta' meta wieħed jieqaf jieħu l-opjojdi (ara sezzjoni 2, taħt ‘Twissijiet u Prekawzjonijiet', u sezzjoni 4).
English: Film coating
Maltese: Mhux komuni
English: Unknown
Maltese: Rari
English: Naldemedine was not studied in the clinical trial programme in patients who had a recent history of myocardial infarction, stroke or transient ischaemic attack within 3 months of screening.
Maltese: Naldemedine ma kienx studjat fil-programm ta' provi kliniċi f'pazjenti li kellhom storja medika riċenti ta' infart mijokardijaku, puplesija jew attakk iskemiku temporanju fi żmien 3 xhur mill-iscreening.
English: Rizmoic
Maltese: rimettar
English: Patients with known or suspected gastrointestinal obstruction or perforation or patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation (see section 4.4).
Maltese: Pazjenti b'ostruzzjoni jew perforazzjoni gastrointestinali magħrufa jew issuspettata jew pazjenti f'riskju akbar ta' ostruzzjoni rikorrenti, minħabba l-potenzjal għal perforazzjoni gastrointestinali (ara sezzjoni 4.4).
English: Each film-coated tablet contains 200 micrograms naldemedine (as tosylate).
Maltese: Kull pillola miksija b'rita fiha 200 mikrogramma naldemedine (bħala tosylate).
English: Due to the limited therapeutic experience, patients with severe renal impairment should be clinically monitored when initiating therapy with naldemedine.
Maltese: Minħabba l-esperjenza terapewtika limitata, pazjenti b'indeboliment sever renali għandhom ikunu mmonitorjati klinikament meta tinbeda t-terapija b'naldemedine.
English: Naldemedine is an antagonist of opioid binding at the mu-, delta-, and kappa-opioid receptors.
Maltese: Naldemedine huwa antagonist tal-opjojdi li jeħel fuq ir-riċetturi tal-opjojdi mu, delta u kappa.
English: In Studies V9231 and V9232, patients who, based on concomitant medication records, were on laxative therapy prior to entering the study and who stopped its use within 30 days prior to Screening, and had self-reported OIC, were considered to be a LIR.
Maltese: Fi Studji V9231 u V9232, pazjenti li, skont rekords ta' medikazzjoni fl-istess ħin, kienu fuq terapija ta' lassattivi qabel ma daħlu fl-istudju u li waqfu l-użu tiegħu fi żmien 30 jum qabel l-iScreening, u kienu huma stess li rrappurtaw OIC, kienu kkunsidrati bħala LIR.
English: If you stop taking your opioid medicine
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: • a disease causing severe inflammation of the digestive tract such as Crohn's disease .
Maltese: • marda li tikkawża infjammazzjoni severa tal-passaġġ diġestiv bħal l-marda ta' Crohn.
English: The pharmacokinetics of naldemedine between subjects with mild, moderate or severe renal impairment, or subjects with ESRD requiring hemodialysis and healthy subjects with normal renal function were similar.
Maltese: Il-farmakokinetika ta' naldemedine bejn individwi b'indeboliment renali ħafif, moderat jew sever, jew individwi b'ESRD li jkunu jeħtieġu emodijalisi, u individwi f'saħħithom b'funzjoni renali normali kienet simili.
English: Concomitant use of moderate CYP3A inhibitors such as fluconazole, may increase the plasma concentration of naldemedine.
Maltese: L-użu fl-istess ħin ma' inibituri moderati ta' CYP3A bħal fluconazole, jista' jżid il-konċentrazzjoni ta' naldemedine fil-plażma.
English: 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 ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of naldemedine was not evaluated.
Maltese: L-effett ta' indeboliment sever epatiku (Child-Pugh Klassi Ċ) fuq il-farmakokinetika ta' naldemedine ma ġiex evalwat.
English: For Study V9235, long term efficacy data defined as the change in frequency of BMs at week 52 from baseline, assessed as a secondary endpoint, showed that subjects in the naldemedine group had improvements in the frequency of BMs compared with subjects in the placebo group in both LIR (3.10 vs 1.90, p=0.0210) and non-LIR (4.26 vs 3.39, p=0.1349) subgroups.
Maltese: LIR (3.10 vs 1.90, p=0.0210) u mhux LIR (4.26 vs 3.39, p=0.1349).
English: Therefore, treatment with naldemedine is not expected to alter the pharmacokinetics of co-administered medicines that are substrates of these enzymes and transporters.
Maltese: Għalhekk, it-trattament b'naldemedine mhux mistenni li jibdel il-farmakokinetika ta' mediċini li jingħataw flimkien li huma sottostrati ta' dawn l-enzimi u trasportaturi.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tarriskji).
English: Opioid withdrawal syndrome is a cluster of three or more of the following signs or symptoms: dysphoric mood, nausea or vomiting, muscle aches, lacrimation or rhinorrhea, pupillary dilation or piloerection or sweating, diarrhoea, yawning, fever or insomnia.
Maltese: Is-sindromu ta' meta wieħed jieqaf jieħu l-opjojdi huwa ġabra ta' tlieta jew aktar minn dawn is-sinjali jew sintomi li ġejjin: burdata disforika, dardir jew rimettar, uġigħ fil-muskoli, lakrimazzjoni jew rinorrea, dilatazzjoni pupillarja jew erezzjoni tax-xagħar jew ħruġ ta' għaraq, dijarea, titwib, deni jew nuqqas ta' rqad.
English: How to take Rizmoic
Maltese: Jekk tieqaf tieħu Rizmoic
English: The primary endpoint for Study V9236 and the secondary endpoint, without multiplicity adjustment, for Study V9222 were the proportion of SBM responders during the 2-week Treatment Period.
Maltese: Il-punt aħħari primarju għal Studju V9236 u l-punt aħħari sekondarju, mingħajr aġġustament għallmultipliċità, għal Studju V9222 kienu l-proporzjon tal-pazjenti b'SBM li kellhom rispons matul itTrattament ta' Perjodu ta' ġimagħtejn.
English: The majority of these gastrointestinal adverse reactions were of mild to moderate severity and resolved with treatment.
Maltese: Il-biċċa l-kbira ta' dawn ir-reazzjonijiet avversi gastrointestinali kienu ta' severità ħafifa sa moderata u fiequ bit-trattament.
English: The peak plasma concentration and area under the plasma concentration-time curve increased in an almost dose-proportional manner within the dose range of 0.1 to 100 mg. A slight accumulation
Maltese: L-ogħla konċentrazzjoni tal-plażma u ż-żona taħt il-kurva ta' konċentrazzjoni fil-plażma-ħin żdiedu b'mod kważi proporzjonali għad-doża fil-medda tad-doża ta' 0.1 sa 100 mg.
English: The peak plasma concentration was reduced by 35% and time to achieve peak plasma concentration was delayed from 0.75 hours in the fasted state to 2.5 hours in the fed state, whereas no significant difference was observed in the area under the plasma concentration-time curve by food intake.
Maltese: L-ogħla konċentrazzjoni fil-plażma tnaqqset b'35% u kien hemm dewmien fil-ħin biex tintlaħaq l-ogħla konċentrazzjoni fil-plażma minn 0.75 siegħa fl-istat sajjem sa 2.5 sigħat wara l-ikel, filwaqt li ma ġiet osservata l-ebda differenza sinifikanti fiż-żona taħt il-kurva ta' konċentrazzjoni fil-plażma-ħin meta ttieħed l-ikel.
English: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria
Maltese: Balkanpharma Dupnitsa AD 3 Samokovsko Shosse Str., Dupnitsa 2600,
English: GALIEN LPS 98 rue Bellocier 89100 Sens France
Maltese: GALIEN LPS 98 rue Bellocier 89100 Sens Franza
English: Pliva Hrvatska d.o.o.
Maltese: Hrvatska Pliva Hrvatska d.o.o.
English: Pharmachemie B.V. Swensweg 5, Postbus 552, 2003 RN Haarlem The Netherlands
Maltese: Pharmachemie B.V. Swensweg 5, Postbus 552, 2003 RN Haarlem
English: Táncsics Mihály út 82 Hungary
Maltese: Táncsics Mihály út 82
English: Date of latest renewal: 26 August 2013
Maltese: Data tal-aħħar tiġdid: 26 ta' Awwissu 2013
English: TEVA Pharmaceutical Works Private Limited Company
Maltese: Manifattur TEVA Pharmaceutical Works Private Limited Company
English: Teva Pharmaceuticals Ireland L-Irlanda
Maltese: Malta Teva Pharmaceuticals Ireland
English: Antipsychotic medicinal products
Maltese: Prodotti mediċinali antipsikotiċi
English: The adjusted mean difference was -4.3 points (CI 95% -6.4; -2.1 points, p-value <0.0001).
Maltese: Id-differenza medja aġġustata kienet -4.3 punti (CI ta' 95% -6.4; -2.1 punti, valur p < 0.0001).
English: Teva Pharma, S.L.U.
Maltese: España Teva Pharma, S.L.U.
English: The other ingredients are mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
Maltese: Is-sustanzi l-oħra huma mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, sodium stearyl fumarate, colloidal silicon dioxide.
English: The active substance is pramipexole.
Maltese: Is-sustanza attiva hi pramipexole.
English: Microcrystalline cellulose Sodium starch glycolate Povidone K25
Maltese: Microcrystalline cellulose Sodium starch glycolate
English: • Delusion*
Maltese: • Delużjoni*
English: mania
Maltese: manija
English: Teva Santé Tél: +33 155917800
Maltese: Tél: +33 155917800
English: • Amnesia (memory disturbance)*
Maltese: • Amnesija (disturb fil-memorja)*
English: Pramipexole Teva contains sodium
Maltese: Pramipexole Teva fih sodium
English: Ελλάδα
Maltese: Ελλάδα Teva
English: Rare to
Maltese: Rari sa
English: TEVA UK Ltd Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Maltese: Eastbourne, East Sussex, BN22 9AG
English: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: Teva Ελλάς Α.Ε. Ελλάδα
English: • Visual impairment
Maltese: • Indeboliment tal-vista
English: Pharmacotherapeutic group: anti-Parkinson drugs, dopamine agonists, ATC code: N04BC05
Maltese: Kategorija farmakoterapewtika: mediċini kontra l-marda ta' Parkinson, agonisti ta' dopamine, Kodiċi ATC:
English: Adverse events occurring in at least 5% of patients in the pramipexole group and more common in the pramipexole-treated patients than in patients on placebo were: headache (27.9%, placebo 25.0%), somnolence (7.0%, placebo 5.0%), nausea (18.6%, placebo 10.0%), vomiting (11.6%, placebo 0.0%), upper abdominal pain (7.0%, placebo 5.0%), orthostatic hypotension (9.3%, placebo 5.0%), myalgia (9.3%, placebo 5.0%), sleep disorder (7.0%, placebo 0.0%), dyspnoea (7.0%, placebo 0.0%) and upper respiratory tract infection (7.0%, placebo 5.0%).
Maltese: 0%), ngħas (7.0%, plaċebo 5.0%), nawseja (18.6%, plaċebo 10.0%), rimettar (11.6%, plaċebo 0.0%), uġigħ fin-naħa ta' fuq taż-żaqq (7.0%, plaċebo 5.0%), pressjoni tad-demm baxxa meta wieħed iqum bilwieqfa (9.3%, plaċebo 5.0%), majalġja (9.3%, plaċebo 5.0%), problemi biex torqod (7.0%, plaċebo 0.0%), qtugħ ta' nifs (7.0%, plaċebo 0.0%) u infezzjoni fil-parti ta' fuq tal-apparat respiratorju (7.0%, plaċebo 5.0%).
English: Impulse control disorders
Maltese: Disturb fil-kontroll tal-impulsi
English: Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: Fil-kategoriji tas-sistemi tal-organi, ir-reazzjonijiet avversi huma elenkati taħt titli ta' frekwenza (numru ta' pazjenti li huma mistennija li jkollhom ir-reazzjoni), bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < /1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Allergic reactions (e.g. rash, itching, hypersensitivity)
Maltese: • Reazzjonijiet allerġiċi (eż. raxx, ħakk, sensittività eċċessiva)
English: • Excess of fluid, usually in the legs (peripheral oedema)
Maltese: • Fluwidu eċċessiv, normalment fir-riġlejn (edema periferali)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Ewropea għall-Mediċini http://www.ema.europa.eu/
English: 30 tablets 50 x 1 tablets 100 tablets 30 x 1 tablets 100 x 1 tablets
Maltese: 30 pillola 50 x 1 pillola 100 pillola 30 x 1 pillola 100 x 1 pillola
English: Pack sizes: 90 tablets.
Maltese: Daqs tal-pakkett: 90 pillola,.
English: Pramipexole Teva 0.088 mg tablets Pramipexole Teva 0.18 mg tablets Pramipexole Teva 0.35 mg tablets Pramipexole Teva 0.7 mg tablets
Maltese: Pramipexole Teva 0.088 mg pilloli Pramipexole Teva 0.18 mg pilloli Pramipexole Teva 0.35 mg pilloli Pramipexole Teva 0.7 mg pilloli
English: The absolute bioavailability is greater than 90 % and the maximum plasma concentrations occur between 1 and 3 hours.
Maltese: Il-bijodisponibilità assoluta hi aktar minn 90% u l-konċentrazzjonijiet massimi fil-plażma jseħħu wara bejn 1 u 3 sigħat.
English: (mg of base)
Maltese: (mg ta' bażi)
English: H-4042 Debrecen
Maltese: Debrecen H-4142
English: Table 1: Parkinson's disease
Maltese: Tabella 1: Marda ta' Parkinson
English: In human volunteers, a dose-dependent decrease in prolactin was observed.
Maltese: F'voluntiera umani, kien osservat tnaqqis li jiddependi mid-doża fil-prolactin.
English: Augmentation was observed in 11.8% of patients in the pramipexole group (N = 152) and 9.4% of patients in the placebo group (N = 149).
Maltese: L-awmentazzjoni kienet osservata fi 11.8% tal-pazjenti fil-grupp ta' pramipexole (N = 152) u f'9.4% tal-pazjenti fil-grupp tal-plaċebo (N = 149).
English: Mania and delirium
Maltese: Manija u delirju
English: • Amnesia (memory disturbance)
Maltese: • Amnesija (disturb fil-memorja)
English: 30 tablets 50 x 1 tablets 100 tablets 30 x 1
Maltese: 30 pillola 50 X 1 pillola 100 pillola
English: Teva Pharmaceuticals S.R.L.
Maltese: România Teva Pharmaceuticals S.R.L.
English: Teva Pharma - Produtos Farmacêuticos, Lda.
Maltese: Portugal Teva Pharma - Produtos Farmacêuticos,
English: The Netherlands
Maltese: Nederland Teva
English: • Pneumonia (infection of the lungs)*
Maltese: • Pnewmonja (infezzjoni tal-pulmun)*
English: TEVA Pharmaceuticals Slovakia s.r.o.
Maltese: Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o.
English: Each tablet contains 0.088 mg, 0.18 mg, 0.35 mg, or 0.7 mg pramipexole as 0.125 mg, 0.25 mg, 0.5 mg, or 1 mg pramipexole dihydrochloride monohydrate, respectively.
Maltese: Kull pillola fiha 0.088 mg, 0.18 mg, 0.35 mg, 0.7 mg, jew 1.1 mg ta' pramipexole bħala 0.125 mg, 0.25 mg, 0.5 mg, 1 mg jew 1.5 mg ta' pramipexole dihydrochloride monohydrate, rispettivament.
English: A total of 63 patients were randomised (43 on pramipexole, 20 on placebo).
Maltese: Total ta' 63 pazjent intgħażlu b'mod każwali (43 ħadu pramipexole, 20 ħadu plaċebo).
English: There is no pharmacokinetic interaction with selegiline and levodopa.
Maltese: M'hemm l-ebda interazzjoni farmakokinetika b'selegiline u b'levodopa.
English: Tablet container: 90 tablets
Maltese: Kontenitur tal-pilloli: 90 pillola
English: TEVA Pharmaceutical Works Private Limited Company Pallagi út 13,
Maltese: TEVA Pharmaceutical Works Private Limited Company H-2100 Gödöllő,
English: 72.0% for placebo and pramipexole, respectively (difference 20% CI 95%: 8.1%; 31.8%, p<0.0005).
Maltese: Ir-rati tas-CGI-I ta' dawk li rrispondew (imtejba, imtejba ħafna) kienu 51.2% u 72.0% għall-plaċebo u pramipexole, rispettivament (differenza ta' 20% CI 95%: 8.1%; 31.8%, p < 0.0005).
English: • Psychosis (e.g. comparable with symptoms of schizophrenia).
Maltese: • Psikosi, (eż. komparabbli ma' sintomi tal-iskiżofrenja).
English: • Vision impairment.
Maltese: • Indeboliment fil-vista.
English: In a pharmacoepidemiological study pramipexole use was associated with an increased risk of cardiac failure compared with non-use of pramipexole (observed risk ratio 1.86; 95% CI, 1.21
Maltese: Fi studju farmakoepidemijoloġiku, l-użu ta' pramipexole kien assoċjat ma' żieda fir-riskju ta' insuffiċjenza kardijaka meta mqabbel ma' meta pramipexole ma jintużax (proporzjon ta' riskju osservat 1.86; 95% CI, 1.21-2.85).
English: The elimination of pramipexole is dependent on renal function.
Maltese: L-eliminazzjoni ta' pramipexole tiddependi fuq il-funzjoni renali.
English: Dystonia
Maltese: Diskensija
English: Infections and infestations pneumonia1
Maltese: Infezzjonijiet u infestazzjonijiet pnewmonja1
English: • Pneumonia (infection of the lungs)
Maltese: • Pnewmonja (infezzjoni tal-pulmun)
English: Tel: +353 51321740
Maltese: L-Irlanda Tel: +353 51321740
English: Do not take Pramipexole Teva:
Maltese: Tiħux Pramipexole Teva:
English: If renal function declines during maintenance therapy, the Pramipexole Teva 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 Teva daily dose should be reduced by 30 %.
Maltese: Jekk il-funzjoni renali tonqos matul it-terapija ta' manteniment, id-doża ta' kuljum ta' Pramipexole Teva għandha titnaqqas bl-istess perċentwali bħat-tnaqqis fit-tneħħija tal-kreatinina, i.e. jekk it-tneħħija tal-kreatinina tonqos bi 30%, allura d-doża ta' kuljum ta' Pramipexole Teva għandha titnaqqas bi 30%.
English: Clinical efficacy and safety in Parkinson's disease
Maltese: Effikaċja klinika u sigurtà bil-marda ta' Parkinson
English: Dose (mg of base)
Maltese: Doża (mg ta' bażi)
English: (≥1/100 to
Maltese: Komuni (≥1/100 sa
English: With 95 % certainty, the frequency category is not greater than uncommon, but might be lower.
Maltese: B'ċertezza ta' 95%, il-kategorija ta' frekwenza mhix aktar minn mhux komuni, iżda tista' tkun aktar baxxa.
English: Neuropharmacological evidence suggests primary dopaminergic system involvement.
Maltese: Evidenza newrofarmakoloġika tissuġġerixxi l-involviment tas-sistema dopaminerġika primarja.
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: • treat the symptoms of primary Parkinson's disease in adults.
Maltese: • jikkura s-sintomi tal-marda ta' Parkinson primarja fl-adulti.