FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.35 mg tablets Pramipexole
Maltese: MIRAPEXIN 0.35 mg pilloli Pramipexole
English: MIRAPEXIN 0.7 mg tablets are white, of round shape, and flat.
Maltese: Il-pilloli MIRAPEXIN ta' 0.7 mg huma bojod, b'forma tonda, u ċatti.
English: EXPIRY DATE EXP {MM/YYYY}
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 3.15 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 3.15 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.7 mg tablets Pramipexole
Maltese: MIRAPEXIN 0.7 mg pilloli Pramipexole
English: Nervous system disorders headache dizziness somnolance sudden onset of sleep syncope dyskinesia amnesia hyperkinesia
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa.
Maltese: L-alluċinazzjonijiet huma effett sekondarju magħruf tal-kura b'agonisti ta' dopamine u levodopa.
English: In a Phase I trial, where pramipexole immediate release and prolonged-release tablets were assessed in fasted state, the minimum and peak plasma concentration (Cmin, Cmax) and exposure (AUC) of the same daily dose of MIRAPEXIN prolonged-release tablets given once daily and MIRAPEXIN tablets given three times a day were equivalent.
Maltese: Fi prova ta' Fażi I, fejn pramipexole pilloli li jerħu b'mod immedjat u pilloli li jerħu l-mediċina bilmod kienu evalwati fl-istat sajjem, il-konċentrazzjoni minima u massima fil-plażma (Cmin, Cmax) u espożizzjoni (AUC) tal-istess doża ta' kuljum ta' MIRAPEXIN pilloli li jerħu l-mediċina bil-mod mogħtija darba kuljum u MIRAPEXIN pilloli mogħtija tliet darbiet kuljum, kienu ekwivalenti.
English: - Psychosis (e.g. comparable with symptoms of schizophrenia) - Vision impairment.
Maltese: - Reazzjonijiet allerġiċi (eż. raxx, ħakk, sensittività eċċessiva)
English: In patients pramipexole alleviates signs and symptoms of idiopathic Parkinson's disease.
Maltese: Fil-pazjenti, pramipexole itaffi s-sinjali u s-sintomi tal-marda idjopatika ta' Parkinson.
English: NAME OF THE MEDICINAL PRODUCT MIRAPEXIN 0.52 mg prolonged-release tablets Pramipexole
Maltese: MIRAPEXIN 0.52 mg pilloli li jerħu l-mediċina bil-mod Pramipexole
English: The tablets are white to off-white, of round shape, with bevelled edges, and have a code embossed (one side with the code P2, and one side with the Boehringer Ingelheim company symbol).
Maltese: Il-pilloli huma ta' lewn abjad, ċatti, għandhom forma ovali, fihom ferq fuq iż-żewġ naħat, u għandhom kodiċi bbuzzata (naħa minnhom bil-kodiċi P7, u n-naħa l-oħra bis-simbolu tal-kumpanija Boehringer Ingelheim).
English: 40 (1 cartridge x 40) tablets
Maltese: 40 (1 skartoċċ x 40) pillola
English: (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-MA (UE) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Immediate Packaging Pack size
Maltese: Daqs talpakkett
English: Whereas
Maltese: III.
English: 2 - CMDh revised position
Maltese: 2 - Pożizzjoni riveduta tas-CMDh
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for ambroxol- and bromhexine-containing medicinal products.
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta middata tal-farmakoviġilanza għal prodotti mediċinali li fihom ambroxol u bromeksin.
English: The PRAC also considered the available data in the paediatric population.
Maltese: Il-PRAC ikkunsidra wkoll id-data disponibbli fil-popolazzjoni pedjatrika.
English: On 25 February 2015, the CMDh, having considered the PRAC recommendation, dated 9 January 2015, reached by majority the position that the marketing authorisations for the concerned medicinal products should be varied.
Maltese: Fil-25 ta' Frar 2015, is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC, datata 9 ta' Jannar 2015, laħaq b'maġġoranza l-pożizzjoni li l-awtorizzazzjonijiet għat-tqegħid fis-suq għallprodotti mediċinali kkonċernati għandhom jiġu varjati.
English: An increase was observed in the reporting frequency of anaphylactic reactions over 2012-2014 linked to ambroxol.
Maltese: Kienet osservata żieda fil-frekwenza ta' rapportar ta' reazzjonijiet anafilattiċi matul l-2012-2014 marbuta ma' ambroxol.
English: Four cases of SCARs retrieved from Eudravigilance and 3 others from the literature have been assessed as related to ambroxol.
Maltese: Erba' każijiet ta' SCARs irkuprati minn Eudravigilance u 3 oħra middokumentazzjoni ġew ivvalutati bħala relatati ma' ambroxol.
English: Further to the evaluation of a Worksharing PSUR of ambroxol-containing medicinal products started in January 2012 and of follow-up submissions as well as signal detection activities, the Belgian national competent authority (FAMHP) identified an increase in reporting of hypersensitivity reactions over the years 2012-2014, reports of severe cutaneous adverse reactions (SCARs) and a benefit-risk evaluation in children below 6 years of age concluded that while there was no indication of a different safety profile, insufficient evidence of efficacy was available in secretolytic therapy in this age group, leading to a negative benefit-risk balance.
Maltese: B'referenza għall-evalwazzjoni ta' PSUR b'Kondiviżjoni tax-Xogħol ta' prodotti mediċinali li fihom ambroxol li bdiet f'Jannar 2012 u ta' sottomissjonijiet ta' segwitu kif ukoll attivitajiet ta' detezzjoni tassinjal, l-awtorità kompetenti nazzjonali Belġjana (FAMHP) identifikat żieda fir-rapportar ta' reazzjonijiet ta' sensittività eċċessiva matul is-snin 2012-2014, rapporti ta' reazzjonijiet avversi severi tal-ġilda (SCARs) u evalwazzjoni bejn il-benefiċċju u r-riskju fit-tfal li għandhom inqas minn 6 snin, u kkonkludiet li filwaqt li ma kien hemm ebda indikazzjoni ta' profil ta' sigurtà differenti, ma kienx hemm disponibbli biżżejjed evidenza tal-effikaċja fit-terapija sekretolitika f'dan il-grupp ta' etajiet, li twassal għal bilanċ negattiv bejn il-benefiċċju u r-riskju.
English: Further, the definition of the relevant clinical endpoints and the measurement of symptoms in these conditions are challenging (Rubin, 2007).
Maltese: Barra minn hekk, id-definizzjoni tal-punti ta' tmiem kliniċi rilevanti u l-kejl tas-sintomi f'dawn il-kundizzjonijiet huma ta' sfida (Rubin, 2007).
English: The PRAC noted that the worldwide estimated exposure of the originator's products alone is over 50 million patient-years and, in the EU over the last decade, around 6.8 million patient-years.
Maltese: Il-PRAC innota li l-espożizzjoni stmata madwar id-dinja tal-prodotti tal-oriġinatur waħedhom hija ta' iktar minn 50 miljun sena ta' pazjent u, fl-UE matul dan l-aħħar deċennju, madwar 6.8 miljun sena ta' pazjent.
English: Moreover SCARs cases should be analysed in details in future PSURs.
Maltese: Barra minn hekk, il-każijiet ta' SCARs għandhom jiġu analizzati fid-dettall fi PSURs futuri.
English: 1 - Overall summary of the scientific evaluation by the PRAC Safety issues
Maltese: 1 - Sommarju ġenerali tal-valutazzjoni xjentifika mill-PRAC
English: Ambroxol- and bromhexine-containing medicines are available as over-the-counter (OTC) as well as prescription-only medicines (POM).
Maltese: Il-mediċini li fihom ambroxol u bromeksin huma disponibbli mingħajr riċetta (OTC) kif ukoll bħala mediċini b'riċetta biss (POM).
English: When considering data in support of the safety issues, the PRAC was of the view that ambroxol- and bromhexine-containing products are associated with case reports of immediate and delayed hypersensitivity including hypersensitivity reactions, anaphylactic reactions including anaphylactic shock, angioedema, pruritus, rash and urticaria.
Maltese: Meta kkunsidra d-data li tappoġġja l-kwistjonijiet ta' sigurtà, il-PRAC kien tal-fehma li l-prodotti mediċinali li fihom ambroxol u bromeksin huma assoċjati ma' rapporti tal-każ ta' sensittività eċċessiva immedjata u mdewma inkluż reazzjonijiet ta' sensittività eċċessiva, reazzjonijiet anafilattiċi inkluż xokk anafilattiku, anġjoedema, ħakk, raxx u urtikarja.
English: The authorised indications of ambroxol, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, prophylaxis and treatment of Infant Respiratory Distress Syndrome (IRDS), prophylaxis and treatment of post-operative bronchopulmonary complications (PPC) and pain relief in acute sore throat.
Maltese: L-indikazzjonijiet awtorizzati ta' ambroxol, kif elenkati fl-Iskeda ta' Data Ewlenija tal-Kumpanija tal-oriġinatur, huma terapija sekretolitika, profilassi u l-kura ta' Sindrome ta' Diffikultà Respiratorja fit-Trabi (IRDS), profilassi u lkura ta' kumplikazzjonijiet wara operazzjoni bronkopulmonari (PPC) u serħan minn uġigħ akut filgriżmejn.
English: • The PRAC considered that there is a reasonable possibility of a risk of SCARs associated with ambroxol and bromhexine.
Maltese: • Il-PRAC ikkunsidra li hemm possibbiltà raġonevoli ta' riskju ta' SCARs assoċjati ma' ambroxol u bromeksin.
English: Of note, drugs started less than 4 days or more than 8 weeks before the onset of the reaction are unlikely to be responsible.
Maltese: Ta' min jinnota, li l-mediċini li jinbdew inqas minn 4 ijiem jew iktar minn 8 ġimgħat qabel il-bidu tar-reazzjoni huwa improbabbli li jkunu responsabbli għal dan.
English: These products are contra-indicated in different subsets of the paediatric population in the EU MS. Ambroxol and bromhexine are marketed in several formulations for oral, nasal, oromucosal, intravenous or rectal administration under various invented names.
Maltese: Dawn il-prodotti huma kontraindikati f'sottosettijiet differenti tal-popolazzjoni pedjatrika fl-Istati Membri tal-UE. Ambroxol u bromeksin huma kkummerċjalizzati b'diversi formulazzjonijiet għal għoti orali, nażali, lill-membrana mukuża tal-ħalq, ġol-vina jew fir-rektum taħt diversi ismijiet ivvintati.
English: Ambroxol- and bromhexine-containing medicinal products have first been registered in a European Union (EU) Member State (MS) in 1978 and 1963, respectively, and are currently authorised in all EU MSs (as well as in Norway and Iceland) except the United Kingdom.
Maltese: Il-prodotti mediċinali li fihom ambroxol u bromeksin ġew irreġistrati l-ewwel darba fi Stat Membru (MS) tal-Unjoni Ewropea (UE) fl-1978 u l-1963, rispettivament, u bħalissa huma awtorizzati fl-Istati Membri tal-UE kollha (kif ukoll fin-Norveġja u l-Iżlanda) ħlief fir-Renju Unit.
English: The authorised indications of bromhexine, as listed in the Company Core Data Sheet of the originator, are secretolytic therapy, alteration in the production or elimination of mucus (acute and chronic sinusitis) and Sjögren's syndrome.
Maltese: L-indikazzjonijiet awtorizzati ta' bromeksin, kif elenkati fl-Iskeda ta' Data Ewlenija talKumpanija tal-oriġinatur, huma terapija sekretolitika, tibdil fil-produzzjoni jew l-eliminazzjoni talmukus (sinusite akuta jew kronika) u sindromu ta' Sjögren.
English: Hypersensitivity reactions are dose and formulation independent, therefore the possible risk of developing hypersensitivity reactions including SCARs is inherent to all ambroxol- and bromhexinecontaining products.
Maltese: Ir-reazzjonijiet ta' sensittività eċċessiva huma indipendenti mid-doża u l-formulazzjoni, u għalhekk ir-riskju possibbli li jiġu żviluppati reazzjonijiet ta' sensittività eċċessiva li jinkludu SCARs huwa inerenti għall-prodotti kollha li fihom ambroxol u bromeksin.
English: • The PRAC considered that ambroxol and bromhexine are associated with an increased risk of hypersensitivity reactions.
Maltese: • Il-PRAC ikkunsidra li ambroxol u bromeksin huma assoċjati ma' riskju ikbar ta' reazzjonijiet ta' sensittività eċċessiva.
English: Analysis of the safety information submitted by the MAH, from Eudravigilance and from the literature, demonstrates that ambroxol and bromhexine formulations in their different indications have been associated with reports of serious immediate hypersensitivity reactions.
Maltese: L-analiżi tal-informazzjoni dwar is-sigurtà sottomessa mill-MAH, minn Eudravigilance u middokumentazzjoni, turi li l-formulazzjonijiet ta' ambroxol u bromeksin fl-indikazzjonijiet differenti tagħhom ġew assoċjati ma' rapporti ta' reazzjonijiet ta' sensittività eċċessiva immedjata serja.
English: Nevertheless, modest but positive results were reported for ambroxol and bromhexine.
Maltese: Madankollu, ġew irrapportati riżultati modesti iżda pożittivi għal ambroxol u bromeksin.
English: Based on these data it is considered that the susceptibility of all age groups (paediatric, adults and elderly) to putative hypersensitivity-related undesirable effects of ambroxol or bromhexine is likely similar.
Maltese: Abbażi ta' din id-data, huwa kkunsidrat li s-suxxettibbiltà tal-gruppi ta' l-etajiet kollha (pedjatriċi, adulti u anzjani) sal-effetti putattivi mhux mixtieqa relatati ma' sensittività eċċessiva ta' ambroxol jew bromeksin hija probabbilment simili.
English: The PDCO was also of the view that these products are no longer the preferred treatment option in IRDS.
Maltese: Il-PDCO kien ukoll tal-fehma li dawn il-prodotti ma għadhomx għażla ta' kura ppreferuta fl-IRDS.
English: Benefit-risk assessment
Maltese: Valutazzjoni bejn il-benefiċċju u r-riskju
English: In light of the above, on 4 April 2014, the FAMHP informed the European Medicines Agency, of their decision to notify a referral procedure to ask for the PRAC's recommendation pursuant to Article 31 of Directive 2001/83/EC, on whether the balance of benefits and risks for these products is still positive in the approved indications, and whether the marketing authorisations for ambroxol- and bromhexinecontaining medicinal products should be maintained, varied, suspended or withdrawn.
Maltese: Fid-dawl ta' dak li ntqal hawn fuq, fl-4 ta' April 2014, il-FAMHP infurmat lill-Aġenzija Ewropea għallMediċini, dwar id-deċiżjoni tagħha li tinnotifika proċedura ta' riferiment biex titlob għarrakkomandazzjoni tal-PRAC skont l-Artikolu 31 tad-Direttiva 2001/83/KE, dwar jekk il-bilanċ bejn ilbenefiċċju u r-riskju ta' dawn il-prodotti għadux pożittiv fl-indikazzjonijiet approvati, u jekk lawtorizzazzjonijiet għat-tqegħid fis-suq għal prodotti mediċinali li fihom ambroxol u bromhexine għandhomx jinżammu, jiġu varjati, sospiżi jew irtirati.
English: • The PRAC reviewed the totality of the data submitted in support of the safety and efficacy of ambroxol- and bromhexine-containing products, including submissions from the marketing authorisation holders and expert input.
Maltese: • Il-PRAC irreveda d-data kollha li tappoġġja s-sigurtà u l-effikaċja tal-prodotti mediċinali li fihom ambroxol u bromeksin, inkluż is-sottomissjonijiet mid-detenturi tal-awtorizzazzjonijiet għattqegħid fis-suq u l-kontribut tal-esperti.
English: In addition, ambroxol and bromhexine have been approved in some EU MS in airway diseases indications in fixed dose combinations with various active substances.
Maltese: Barra minn hekk, ambroxol u bromeksin ġew approvati f'xi Stat Membru tal-UE f'indikazzjonijiet ta' mard tal-passaġġ respiratorju f'kombinazzjonijiet ta' doża fissa b'diversi sustanzi attivi.
English: The clinical studies performed during the development of bromhexine- and ambroxol-containing products between the 1950ies and 1980ies were considerably less standardised than would be necessary today, and would not completely fulfil contemporary requirements with regard to validated endpoints, statistical confirmation, or Good Clinical Practice (GCP).
Maltese: L-istudji kliniċi mwettqa matul l-iżvilupp ta' prodotti li fihom bromeksin u ambroxol bejn il-ħamsinijiet u t-tmeninijiet kienu ferm inqas standardizzati milli meħtieġ illum, u ma kinux jissodisfaw kompletament ir-rekwiżiti kontemporanji fir-rigward ta' punti ta' tmiem ivvalidati, il-konferma statistika, jew il-Prassi Klinika Tajba (PKT).
English: The PRAC considered that there was a reasonable possibility that ambroxol and bromhexine are associated with serious delayed-type hypersensitivity reactions associated with SCARs.
Maltese: Il-PRAC ikkunsidra li kien hemm possibbiltà raġonevoli li ambroxol u bromeksin huma assoċjati ma' reazzjonijiet ta' sensittività eċċessiva serji mdewma assoċjati ma' SCARs.
English: However, when looking at the date of the reports, 40 reports, out of the 119 reported in total for the originator since the first marketing authorisation, appear to have been sent in two batches by the Chinese health authority to the MAH of the originator of these products.
Maltese: Madankollu, meta wieħed jeżamina d-data tar-rapporti, 40 rapport, minn total ta' 119-il rapport għall-oriġinatur mill-ewwel awtorizzazzjoni għat-tqegħid fis-suq, jidher li ntbagħtu f'żewġ lottijiet mill-awtorità tas-saħħa Ċiniża lill-MAH tal-oriġinatur ta' dawn il-prodotti.
English: The safety information submitted by the MAHs, from Eudravigilance and from the literature, comprises in total around 300 case reports of suspected SCARs, many of which have possible confounders.
Maltese: L-informazzjoni dwar is-sigurtà sottomessa mill-MAHs, minn Eudravigilance u mid-dokumentazzjoni, tinkludi b'kollox madwar 300 rapport tal-każ ta' SCARs suspettati, li ħafna minnhom jaf għandhom fatturi ta' konfużjoni.
English: In addition, ambroxol formulations indicated in secretolytic therapy and prophylaxis or treatment of IRDS and PPC have been associated with delayed-onset hypersensitivity reactions without severe skin injury.
Maltese: Barra minn hekk, il-formulazzjonijiet ta' ambroxol indikati f'terapija sekretolitka u profilassi jew kura ta' IRDS u PPC ġew assoċjati ma' reazzjonijiet ta' sensittività eċċessiva b'bidu mdewwem mingħajr ġrieħi gravi fil-ġilda.
English: The CMDh considered the PRAC recommendation that the evidence available did not provide sufficient grounds to demonstrate a change to the established benefit-risk balance, provided the recommended amendments to sections 4.4 and 4.8 of the product information, detailed in annex III, are implemented.
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni talPRAC li l-evidenza disponibbli ma pprovdiet ebda raġunijiet suffiċjenti biex turi bidla fil-bilanċ stabbilit bejn il-benefiċċju u r-riskju, sakemm jiġu implimentati l-emendi rakkomandati fis-sezzjonijiet 4.4 u 4.8 tal-informazzjoni tal-prodott, li huma indikati fl-Anness
English: Taking all of the above into consideration, the PRAC concluded that the data reviewed supported amendments of the product information to reflect the risk of severe cutaneous adverse reactions, and that further age restrictions to reflect the concerns about the benefit-risk balance of ambroxol- and bromhexine-containing products are not justified on the basis of the data available.
Maltese: Filwaqt li jikkunsidra dak kollu li ntqal hawn fuq, il-PRAC ikkonkluda li d-data riveduta appoġġjat lemendi tal-informazzjoni tal-prodott biex tirrifletti r-riskju ta' reazzjonijiet avversi severi tal-ġilda, u li iktar restrizzjonijiet skont l-età biex jiġi rifless it-tħassib dwar il-bilanċ bejn il-benefiċċju u r-riskju talprodotti li fihom ambroxol u bromeksin mhumiex iġġustifikati abbażi tad-data disponibbli.
English: As ambroxol is a metabolite of bromhexine and hypersensitivity reactions are not dependent on the dose of the allergenic substance absorbed, the FAMHP considered that any confirmed risk with ambroxol could also be found in bromhexine-containing medicinal products with regards to these reactions.
Maltese: Peress li ambroxol huwa metabolit ta' bromeksin u rreazzjonijiet ta' sensittività eċċessiva ma jiddependux fuq id-doża tas-sustanza allerġenika assorbita, il-FAMHP ikkunsidrat li kwalunkwe riskju kkonfermat b'ambroxol jista' jinstab ukoll fi prodotti mediċinali li fihom bromeksin fir-rigward ta' dawn ir-reazzjonijiet avversi.
English: The PRAC took note of the advice of the paediatric committee (PDCO) that the use of ambroxol and bromhexine varies significantly in paediatric clinical practice across the EU.
Maltese: Il-PRAC ħa l-parir tal-kumitat pedjatriku (PDCO) li l-użu ta' ambroxol u bromeksin ivarja b'mod sinifikanti fil-prattika klinika pedjatrika fl-UE kollha.
English: The PRAC was of the view that the possible risk of SCARs can be adequately addressed by the proposed amendments to the PI to inform caregivers and patients of the risk and allow early identification of signs of SCARs and immediate discontinuation of treatment should they occur.
Maltese: Il-PRAC kien tal-fehma li r-riskju possibbli ta' SCARs jista' jiġi indirizzat b'mod adegwat bl-emendi proposti fil-PI biex il-pazjenti u dawk li jieħdu ħsiebhom jiġu infurmati dwar ir-riskju u jippermettu identifikazzjoni bikrija ta' sinjali ta' SCARs u t-twaqqif immedjat tal-kura jekk dawn iseħħu.
English: The PRAC considered all these elements in its review of the available data on the efficacy of ambroxol- and bromhexine-containing products.
Maltese: Il-PRAC ikkunsidra dawn l-elementi kollha fir-reviżjoni tiegħu tad-data disponibbli dwar l-effikaċja tal-prodotti mediċinali li fihom ambroxol u bromeksin.
English: Magnetic resonance imaging and cardioversion
Maltese: Magnetic resonance imaging u cardioversion
English: It may harm them,
Maltese: Konvulżjo ni,
English: Allée de la Recherche 60 B-1070 Bruxelles Belgium
Maltese: B-1070 Bruxelles Belgium
English: • paranoia
Maltese: • paranoja
English: The differences were statistically significant (p<0.001 and p=0.003, respectively).
Maltese: Id-differenzi kienu statistikament sinifikanti (p<0.001 u p=0.003, rispettivament).
English: 30 seconds.
Maltese: 30 xahar.
English: • vertigo (sensation of whirling motion)
Maltese: • vertigo (sensazzjoni ta' mozzjoni idur)
English: Irritability, oedema peripheral
Maltese: Irritabilità, edima periferali
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' eċċipjenti, ara sezzjoni 6.1.
English: Summary of the safety profile
Maltese: Sommarju tal-profil ta' sigurta`
English: EU/1/11/695/010 EU/1/11/695/012 EU/1/11/695/013 EU/1/11/695/016
Maltese: EU/1/11/695/012 EU/1/11/695/013 EU/1/11/695/016
English: The active substance is rotigotine.
Maltese: Is-sustanza attiva hi rotigotine.
English: Dizziness e, disturbances in consciousness NECe (incl.
Maltese: Nagħas sturdamente, disturbi filkoxxjenza NECe (inkl.
English: • diarrhoea
Maltese: • diareja
English: • feeling irritable
Maltese: • irritabbilta`
English: Constipation e,
Maltese: Konvulżjon i,
English: • Restless Legs Syndrome - lowered by 1 mg every other day.
Maltese: • Sindromu ta' Restless Legs - titnaqqas b' 1 mg kull jumejn.
English: Other ingredients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolymer, polyester, silicone, aluminium, pigments (yellow95, red166, red144, black7)
Maltese: Sustanzi oħra: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidoneK90, E171, E223, E304, E307, fluoropolimer, poliester, silikon, aluminju, pigmenti (isfar95, aħmar166, aħmar144, iswed7)
English: Date of first authorisation: 16 June 2011 Date of latest renewal: 14 January 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 16 Gunju 2011 Data tal-aħħar awtorizzazzjoni: 14 Jannar 2016
English: Investigations
Maltese: Investigazzjonijet
English: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents.
Maltese: Każijiet ta' fibrożi retroperitonali, infiltrati pulmonari, effużjonijiet mill-plewra, plewra li teħxien, perikardite u valvulopatija kardijaka kienu rrappurtati f'xi pazjenti kkurati b'sustanzi dopaminerġiċi li ġejjin mill-ergot.
English: The patches of 2 mg/24 h are used for the treatment of Parkinson´s disease and Restless Leg Syndrome.
Maltese: Limpjastri ta' 2 mg/24 h jintużaw għat-trattament tal-marda ta' Parkinson's u Restless Leg Syndrome.
English: System/organ classes acc. to MedDRA
Maltese: Sistema talklassifika/talorgani SKONT MedDRA