FrancophonIA/ELRC3.0 huggingface dataset:
English: AST, ALT, GGT), weight increasede, heart rate increasede, CPK increasedd,e
Maltese: AST, ALT, GGT), żieda filpiże, żieda firrata tal qalbe, żieda fis-CPKd,e
English: How to store Neupro
Maltese: X'fih Neupro
English: hallucination, hallucination visual, hallucination auditory, illusion), nightmaree, paranoia e, confusional state e, psychotic disorder e, delusion e, delirium e
Maltese: (inkl. alluċinazzjoni, alluċinazzjoni viżwali, alluċinazzjoni awditorja, illużjoni), ħmar il-lejle, paranojjae, stat konfużjonalie, mard psikotikue, delużjonie, delirju
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1,307 Neuproand 607 placebo-treated patients, 72.5% of the patients on Neupro and 58.0% of patients on placebo reported at least one adverse reaction.
Maltese: Ibbażat fuq l-analiżi miġbura minn ġabra ta' provi kliniċi kkontrollati bil-plaċebo li kienu jinkludu total ta' 1,307 pazjenti li kienu ikkurati b'Neupro u 607 pazjenti kkurati bil-plaċebo, 72.5% talpazjenti fuq Neupro u 58.0% ta' pazjenti fuq il-plaċebo irrappurtaw mill-inqas reazzjoni avversa waħda.
English: With rotigotine, the mean improvement in the UPDRS score (Parts II + III) was -3.98 points (baseline 29.9 points) whereas in the placebo-treated arm a worsening of 1.31 points was observed (baseline 30.0 points).
Maltese: kienet ta' -3.98 punti (linja bażi 29.9 punti) filwaqt li fil-parti ta' l-istudju fejn il-pazjenti kienu kkurati bil-plaċebo, kien osservat li dawn marru għall-agħar b'1.31 punti (linja bażi 30.0 punt).
English: Adverse drug reactions (ADRs) reported in more than 10% of patients treated with Neupro transdermal patch are nausea, vomiting, application site reactions, somnolence, dizziness and headache.
Maltese: Reazzjonijiet avversi tal-mediċina (Adverse Drug Reactions - ADRs) irrappurtati f'iktar minn 10% talpazjenti kkurati bil-garża transdermali Neupro huma dardir, rimettar, reazzjonijiet fis-sit tat-teħid, nagħas tqil, sturdament u uġigħ ta' ras.
English: Disturbances in consciousness NEC
Maltese: Disturbi filkoxjenza NECa
English: The majority of application site reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of Neupro in 7.2% of subjects.
Maltese: Il-maġġoranza tar-reazzjonijiet fis-sit ta' applikazzjoni kienu ħfief jew moderati fl-intensità, limitati għal-post mnejn jittieħed u rriżultaw fit-twaqqif tal-kura b'Neupro f'7.2% tal-pazjenti.
English: Obsessivecompulsive disorder, agitationd
Maltese: Mard kompulsiv ossessiv, aġitazzjonid
English: At the end of the maintenance treatment an improvement of at least 30% was seen in 57% and 55% of the subjects receiving rotigotine 8 mg/24 h and 12 mg/24 h, respectively and in 34% of the subjects receiving placebo (Differences 22% and 21%, respectively, CI95% 10%; 35% and 8%; 33%, respectively, p<0.001 for both rotigotine groups).
Maltese: Fit-tmiem tat-trattament tal-manteniment, titjib ta' mill-inqas 30% kien osservat f'57% u f'55% tal-pazjenti li kienu qed jirċievu rotigotine 8 mg/24 siegħa u 12 mg/24 siegħa, rispettivament u f'34% tal-pazjenti li kienu qed jirċievu l-plaċebo (differenza ta' 22% u 21%, rispettivament CI95% 10%; 35% u 8%; 33%, rispettivament, p<0.001 għaż żewġ gruppi ta' rotigotine).
English: The strengths are 2 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h for the treatment of Parkinson's disease.
Maltese: Id-dożi huma ta 2 mg/24 h, 4 mg/24 h, 6 mg/24 h u 8 mg/24 h għat-trattament tal-Marda ta' Parkinson's.
English: Erythemae, hyperhidrosise, pruritus generalisede, skin irritatione, dermatitis contacte, rash generalisede
Maltese: Eritemae, iperidrożie, pruritus ġeneraliżżatae, irritazzjoni talġildae, dermatite talkuntatte, raxx ġeneralizzate,
English: Neupro is indicated for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease as monotherapy (i.e. 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: Neupro hu indikat għat-trattament tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson fl-istadju bikri bħala monoterapija (i.e. mingħajr levodopa) jew flimkien ma' levodopa, i.e. matul il-kors talmarda, sa l-istadji aħħarin fejn l-effett ta' levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet ta' l-effett terapewtiku (fluttwazzjonijiet fl-aħħar tad-dożaġġ jew ‘on-off').
English: At the end of maintenance, the mean UPDRS part III score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the placebo group (baseline 32.0).
Maltese: III kienet tjiebet b'7.0 punti filpazjenti ttrattati b'rotigotine (linja bażi 29.6), u b'3.9 punti fil-grupp tal-plaċebo (linja bażi
English: (incl.
Maltese: (sigħat).
English: Pruritus generalised, skin irritation, dermatitis contact
Maltese: Ħakk ġeneralizzat, irritazzjoni talġilda, dermatite talkuntatt
English: Multipack: 84 (3 packs of 28) transdermal patches
Maltese: U KONTENUT Pakkett multiplu: 84 ( 3 pakketti ta' 28) garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda
English: pathological gambling, stereotypy/ punding, binge eating/eating disorderb, compulsive shoppingc)
Maltese: Mhux magħruf stereotypy/ punding, iffangar/ disturbi ta' kif tiekolb, xiri kompulsiv),
English: Transdermal patch rotigotine
Maltese: Mediċini newroleptiċi
English: • 8 mg/24 h: Each patch releases 8 mg of rotigotine per 24 hours.
Maltese: • 8 mg/24 h: Kull impjastru jerħi 8 mg ta' rotigotine kull 24 siegħa.
English: syncope, syncope vasovagal, loss of consciousness), dyskinesiae, dizziness posturale, lethargye, convulsione
Maltese: sinkope, sinkope vażovagali, telf ta' koxxjenza), diskinesjae, sturdament posturalie, letarġijae, konvulżjonie
English: The primary outcome assessment was the score for the Activities of Daily Living (ADL) component (Part II) plus the Motor Examination component (Part III) of the Unified Parkinson's Disease Rating Scale (UPDRS).
Maltese: L-evalwazzjoni tar-riżultat primarju kien il-punteġġ għallkomponent Activities of Daily Living (ADL) (Parti II) flimkien mal-komponent Motor Examination (Parti
English: The strengths are 1 mg/24 h, 2 mg/24 h, 3 mg/24 h, 4 mg/24 h, 6 mg/24 h and 8 mg/24 h. The patches of 1 mg/24 h and 3 mg/24 h are used for the treatment of Restless Leg Syndrome, while the patches of 4 mg/24 h, 6 mg/24 h and 8 mg/24 h are used for the treatment of Parkinson's disease.
Maltese: L-impjastri ta' 1 mg/24h u 3 mg/24 h jintużaw għat-trattament ta Restless Leg Syndrome, waqt li limpjastri ta' 4 mg/24 h, 6mg/24 h u 8 mg/24 h jintużaw għat-trattament tal-Marda ta' Parkinson's.
English: The effectiveness of rotigotine in the treatment of the signs and symptoms of idiopathic Parkinson's disease was evaluated in a multinational drug development program consisting of four pivotal, parallel, randomized, double-blind placebo controlled studies and three studies investigating specific aspects of Parkinson's disease.
Maltese: L-effettività ta' rotigotine fit-trattament tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson kienet evalwata fi programm multinazzjonali dwar l-iżvilupp tal-mediċina li kien jikkonsisti f'erba' studji importanti ħafna, paralleli, randomized, double-blind, ikkontrollati bil-plaċebo u tlett studji li jinvestigaw aspetti differenti tal-Marda ta' Parkinson
English: Atrial fibrillation Supraventricular tachycardia
Maltese: Takikardja supraventri kulari
English: Neupro 1 mg/24 h transdermal patch EU/1/05/331/038
Maltese: Neupro 1 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda EU/1/05/331/038
English: Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-group after 4 weeks of maintenance.
Maltese: Iż-żewġ studji wrew titjib fil-funzjoni tal-muskoli kmieni filgħodu, Sintomi motorili (UPDRS Part III) tjiebu b'6.3 ± 1.3 punti u b' 5.9 ± 1.3 punti fil-grupp ta' ropinirole wara 4 ġimgħat ta' manteniment.
English: Each patch of 30 cm2 contains 13.5 mg of rotigotine.
Maltese: Kull impjastru ta' 30 cm2 fih 13.5 mg ta'
English: Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.5% of the patients on Neupro and 33.2% of patients on placebo reported at least one adverse reaction.
Maltese: Ibbażat fuq l-analiżi miġbura minn ġabra ta' provi kliniċi kkontrollati bil-plaċebo li kienu jinkludu total ta' 748 pazjent li kienu ikkurati b'Neupro u 214 pazjent kkurati bil-plaċebo, 65. 5% tal-pazjenti fuq Neupro u 33.2% ta' pazjenti fuq il-plaċebo irrappurtaw mill-inqas reazzjoni avversa waħda.
English: Each patch of 20 cm2 contains 9.0 mg of rotigotine.
Maltese: Kull impjastru ta' 20 cm2 fih 9.0 mg ta'
English: Diarrhoeac
Maltese: FARMAĊEWTIKU
English: Neupro 6 mg/24 h
Maltese: Neupro 6 mg/24 siegħa
English: Erectile dysfunction e
Maltese: Konvulżjon i,
English: Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Neupro, and co-administration should be avoided.
Maltese: Minħabba li rotigotine hu agonist ta' dopamine, hu ssoponut li l-antagonisti ta' dopamine, bħal newroleptiċi (eż. phenothiazines, butyrophenones, thioxanthenes) jew metoclopramide, jistgħu jnaqqsu l-effettività ta' Neupro, u l-għoti flimkien għandu jiġi evitat.
English: Neupro contains sodium metabisulphite, a sulphite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
Maltese: Neupro fih sodium metabisulphite, sulphite li jista' jikkawża reazzjonijiet tat-tip allerġiċi inklużi sintomi anafilattiċi u episodji fejn ikun hemm periklu tal-mewt, jew episodji ażżmatiċi anqas severi, f'persuni suxxettibbli.
English: Each patch of 40 cm2 contains 18.0 mg of rotigotine.
Maltese: Kull impjastru ta' 40 cm2 fih 18.0 mg ta'
English: Each patch of 15 cm2 contains 6.75 mg of rotigotine.
Maltese: Kull impjastru ta' 15 cm2 fih 6.75 mg ta'
English: Neupro 8 mg/24 h
Maltese: Neupro 8 mg/24 siegħa
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Maltese: (inkluż sinkope, sinkope vasovagali, tintilef minn sensik), diskinesija, sturdament li jiddependi millqagħda, letarġija
English: Biotransformation
Maltese: Fibrillazzjoni
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 mediċinali tinsab fuq is-sit elettroniku ta' lAġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/.
English: Neupro 2 mg/24 h
Maltese: Neupro 2 mg/24 siegħa
English: Neupro 8 mg/24 h transdermal patch EU/1/05/331/010
Maltese: Neupro 8 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/05/331/010
English: Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is expected.
Maltese: Din tiġri speċjalment meta tibda tuża Neupro jew meta tiżdiedlek id-doża.
English: Neupro 3 mg/24 h transdermal patch EU/1/05/331/047
Maltese: Neupro 3 mg/24 siegħa garża li tipprovdi mediċina li tgħaddi minn ġol-ġilda EU/1/05/331/047
English: Neupro 6 mg/24 h transdermal patch EU/1/05/331/007
Maltese: Neupro 6 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/05/331/007
English: Neupro is for transdermal use.
Maltese: Neupro jiġi applikat darba kuljum.
English: Neupro is available in different strength patches which release the medicine over 24 hours.
Maltese: Neupro issibu bħala impjastri ta' qawwiet differenti li jirrilaxxaw il-mediċina f' 24 siegħa.
English: EU/1/05/331/047 [7 transdermal patches] EU/1/05/331/049 [28 transdermal patches] EU/1/05/331/050 [30 transdermal patches] EU/1/05/331/058 [14 transdermal patches]
Maltese: EU/1/05/331/047 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/049 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/050 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/058 [14 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: Neupro 2 mg/24 h 4 mg/24 h 6 mg/24 h 8 mg/24 h
Maltese: 2 mg/24 siegħa 4 mg/24 siegħa 6 mg/24 siegħa 8 mg/24 siegħa
English: Ophthalmologic monitoring is recommended at regular intervals or if vision abnormalities occur.
Maltese: Neupro jista' jikkawża aġir u ħsibijiet abnormali oħra.
English: EU/1/05/331/010 [7 transdermal patches] EU/1/05/331/011 [28 transdermal patches] EU/1/05/331/033 [30 transdermal patches] EU/1/05/331/061 [14 transdermal patches]
Maltese: EU/1/05/331/010 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/011 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/033 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/061 [14 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion.
Maltese: Fl-istudji ta' doża ripetuta u dwar it-tossiċità fit-tul, l-effetti prinċipali kienu assoċjati ma' l-agonist ta' dopamine marbuta ma' l-effetti farmakodinamiċi u t-tnaqqis konsegwenti tat-tnixxija ta' prolactin.
English: Each patch of 10 cm2 contains 4.5 mg of rotigotine.
Maltese: Kull impjastru ta' 10 cm2 fih 4.5 mg ta'
English: neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE neupro 2 mg/24 siegħa, 4 mg/24 siegħa, 6 mg/24 siegħa, 8 mg/24 siegħa.
English: neupro 4 mg/24 h
Maltese: Neupro 4 mg/24 siegħa
English: The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h'.
Maltese: In-naħa ta' barra hi ta' kulur kannella ċar u għandha l-kliem Neupro 2 mg/24 h, 4 mg/24 h, 6 mg/24 h, 8 mg/24 h stampat fuqha.
English: EU/1/05/331/007 [7 transdermal patches] EU/1/05/331/008 [28 transdermal patches] EU/1/05/331/027 [30 transdermal patches] EU/1/05/331/060 [14 transdermal patches]
Maltese: EU/1/05/331/007 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/008 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/027 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/060 [14 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: 7 transdermal patches of Neupro 8 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE neupro 8 mg/24 siegħa
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jista' jaffettwa sa 1 minn kull 100 persuna
English: Rash generalised
Maltese: Raxx ġeneralizzat
English: Neupro 4 mg/24 h transdermal patch EU/1/05/331/004
Maltese: Neupro 4 mg/24 h impjastra li tipprovdi mediċina li tgħaddi minn taħt il-ġilda EU/1/05/331/004
English: What Neupro is Neupro contains the active substance rotigotine.
Maltese: X'inhu Neupro Neupro fih is-sustanza attiva rotigotine.
English: EU/1/05/331/038 [7 transdermal patches] EU/1/05/331/040 [28 transdermal patches] EU/1/05/331/041 [30 transdermal patches] EU/1/05/331/056 [14 transdermal patches]
Maltese: EU/1/05/331/038 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/040 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/041 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: EU/1/05/331/004 [7 transdermal patches] EU/1/05/331/005 [28 transdermal patches] EU/1/05/331/021 [30 transdermal patches] EU/1/05/331/059 [14 transdermal patches]
Maltese: EU/1/05/331/004 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/059 [14 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/005 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/021 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: 7 transdermal patches of Neupro 6 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE neupro 6 mg/24 siegħa
English: (see Special populations)
Maltese: Popolazzjonijiet speċjali)
English: EU/1/05/331/053 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/053 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disorders a,d
Maltese: ħolm anormali, disturbi filkontrol talimpulsia,d (li jinkludi logħob ta' l-ażżard patoloġiku,
English: Neupro 4 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 4 mg/24 h'.
Maltese: Fil-bidu tat-tieni ġimgħa, inti għandek tieħu Neupro 4 mg (pakkett immarkat “Ġimgħa 2”).
English: UCB Pharma GmbH Tel: +49-(0) 2173 48 48 48
Maltese: Tel: + 49 / (0) 2173 48 48 48
English: EU/1/05/331/001 [7 transdermal patches] EU/1/05/331/002 [28 transdermal patches] EU/1/05/331/015 [30 transdermal patches] EU/1/05/331/057 [14 transdermal patches]
Maltese: EU/1/05/331/001 [7 garżi li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/002 [28 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda] EU/1/05/331/015 [30 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda]
English: EU/1/05/331/036 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/036 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: EU/1/05/331/044 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/044 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: EU/1/05/331/018 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/018 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: Neupro 2 mg/24 h Neupro 4 mg/24 h Neupro 6 mg/24 h Neupro 8 mg/24 h Transdermal patch
Maltese: Il-qawwiet huma 2 mg/24 siegħa, 4 mg/24 siegħa, 6 mg/24 siegħa u 8 mg/24 siegħa għat-trattament tal-Marda ta' Parkinson's.
English: The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Maltese: Id-doża ta' kuljum għandha titnaqqas f'inkrementi ta' 2 mg/24 siegħa bi tnaqqis tad-doża preferibbilment darba kull jumejn, sakemm Neupro jitwaqqaf għal kollox (ara sezzjoni 4.4).
English: Neupro 6 mg/24 h transdermal patch The outside of the backing layer is tan-coloured and imprinted with ‘Neupro 6 mg/24 h'.
Maltese: Fil-bidu tat -tielet ġimgħa, inti għandek tieħu Neupro 6 mg (pakkett immarkat “Ġimgħa 3).
English: EU/1/05/331/024 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/024 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda ( 3 pakketti ta' 28)]
English: This is known as ‘dopamine dysregulation syndrome' and can lead to use of too much Neupro
Maltese: Dan huwa magħruf bħala ‘sindromu ra' disregulazzjoni ta' dopamine' u jista' jwassal tal-użu żejjed ta' Neupro
English: Neupro 4 mg/24 h transdermal patch Neupro 6 mg/24 h transdermal patch Neupro 8 mg/24 h transdermal patch
Maltese: Matul it-tielet ġimgħa, hu jew hi jieħu/tieħu Neupro 6 mg/24 siegħa u matul ir-raba' ġimgħa Neupro 8 mg/24 siegħa.
English: Constipatione, dry mouthe, abdominal paine, diarrhoeac
Maltese: • konstipazzjoni, ħalq niexef, ħruq ta stonku
English: EU/1/05/331/030 [84 transdermal patches (3 packs of 28)]
Maltese: FIS-SUQ EU/1/05/331/030 [84 garża li jipprovdu mediċina li tgħaddi minn ġol-ġilda (3 pakketti ta' 28)]
English: 7 transdermal patches 14 transdermal patches 28 transdermal patches 30 transdermal patches
Maltese: • impuls qawwi biex tilgħab wisq flus -anke jekk din taffettwa serjament lileku lill-familja tiegħek
English: Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.
Maltese: Wara din il-proċedura, ma ġiex osservat l-effett rebound ( meta s-sintomi jiggravaw wara l'intensita` inizjali wara li jitwaqqaf it-trattament).
English: The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Maltese: Il-qawwiet huma ta' 1 mg/24 siegħa, 2 mg/24 siegħa, u 3 mg/24 siegħa għat-trattament ta' Restless Leg Synrome.
English: Neupro 1 mg/24 h transdermal patch Neupro 3 mg/24 h transdermal patch
Maltese: INFORMAZZJONI BIL-BRAILLE neupro 3 mg/24 siegħa
English: In clinical studies with rotigotine, syncope has been observed at a rate that was similar to that observed in patients treated with placebo.
Maltese: F'studji kliniċi b' rotigotine, sinkope kien osservat b' rata li kienet simili ta' dik osservata f'pazjenti li kienu kkurati bil-plaċebo.
English: 7 transdermal patches of Neupro 4 mg/24 h
Maltese: INFORMAZZJONI BIL-BRAILLE neupro 4 mg/24 siegħa
English: In trials where the application sites were rotated as reflected in the instructions provided in SmPC and package leaflet, 35.7% of 830 patients using the Neupro transdermal patch, experienced application site reactions.
Maltese: Fi provi fejn iż-zoni ta' l-applikazzjoni nbidlu kif indikat fl-istruzzjonijiet ipprovduti fl-SmPC u filfuljett ta' tagħrif, 35.7% tat-830 pazjent li kienu jużaw il-garża Neupro li tipprovdi mediċina li tgħaddi minn ġol-ġilda, ġarrbu reazzjonijiet fiż-żona ta' l-applikazzjoni.
English: However, there is no indication of a relevant impact on the clinical outcome.
Maltese: Madankollu, m'hemm l-ebda indikazzjoni ta' impatt rilevanti fuq ir-riżultat kliniku.
English: Neupro treatment initiation pack contains 4 different packages (one for each strength) with 7 patches each, for the first four weeks of therapy.
Maltese: Il-pakkett tal-bidu tal-kura ta' Neupro fih 4 pakketti differenti (wieħed għal kull qawwa) b'7 impjastri kull wieħed, għall-ewwel erba' ġimgħat tat-terapija.
English: The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see section 4.4).
Maltese: Id-doża ta' kuljum għandha titnaqqas f'inkrementi ta' 1 mg/24 siegħa bi tnaqqis tad-doża preferibbilment darba kull jumejn, sakemm Neupro jitwaqqaf għal kollox (ara sezzjoni 4.4).
English: Ref.: EMEA/356088/2009 EMEA/H/C/1053
Maltese: Dok. ta' ref.:EMEA/484222/2009 EMEA/H/C/1053
English: It is available as pink tablets (75 mg).
Maltese: Huwa disponibbli bħala pilloli roża (75 mg).
English: Clopidogrel Teva clopidogrel EPAR summary for the public
Maltese: Clopidogrel Teva clopidogrel Sommarju tal-EPAR għall-pubbliku
English: The active substance in Clopidogrel Teva, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva ta' Clopidogrel Teva, clopidogrel, hu inibitur tal-aggregazzjoni tal-platelets.
English: Clopidogrel Teva is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Teva huwa mediċina li fiha s-sustanza attiva clopidogrel.
English: Clopidogrel Teva can be used in patients who are having myocardial infarction with ‘ST segment elevation' (an abnormal reading on the ECG or electrocardiogram) when the doctor thinks that they would benefit from the treatment.
Maltese: Clopidogrel Teva jista' jintuża f'pazjenti li jkollhom infart mijokardiku flimkien ma' ‘elevazzjoni fis-segment ST' (riżultat anomalu tal-elettrokardjogramma jew ECG) meta t-tabib ikun ikkunsidra li jkunu se jibbenefikaw mit-trattament.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Teva to Teva Pharma B.V. on 28 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Clopidogrel Teva lil Teva Pharma B.V. fi 28 ta' Lulju 2009.
English: In acute coronary syndrome, Clopidogrel Teva is used together with aspirin and treatment generally starts with a loading dose of four 75 mg tablets.
Maltese: Fis-sindromu koronarju akut, Clopidogrel Teva jintuża mal-aspirina u t-trattament ġeneralment jibda b'doża ta' tagħbija (loading dose) ta' erba' pilloli ta' 75 mg.