FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking the effect of endothelin, Ambrisentan Mylan prevents the vessels becoming too narrow helping to lower the blood pressure and improving symptoms.
Maltese: Permezz tal-imblokkar tal-effett tal-endotelin, Ambrisentan Mylan jipprevjeni li l-vini jidjiequ, filwaqt li jgħinu sabiex il-pressjoni tad-demm titbaxxa u s-sintomi jitjiebu.
English: Treatment is started at a dose of 5 mg daily and the doctor may increase it to 10 mg daily depending on response and any side effects experienced by the patient.
Maltese: Il-kura tinbeda f'doża ta' 5 mg darba kuljum u t-tabib jista' jżidha għal 10 mg kuljum skont ir-rispons u kwalunkwe effetti sekondarji li jesperjenza l-pazjent.
English: Therefore, the Agency's view was that, as for Volibris, the benefit of Ambrisentan Mylan outweighs the identified risk and it can be authorised for use in the EU.
Maltese: Għaldaqstant, il-fehma tal-Aġenzija kienet li, bħal fil-każ ta' Volibris, il-benefiċċju ta' Ambrisentan Mylan huwa ikbar mir-riskju identifikat u li jista' jiġi awtorizzat għall-użu fl-UE.
English: Side effects reported with Ambrisentan Mylan are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Ambrisentan Mylan huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ambrisentan Mylan have also been included in the summary of product characteristics and the package leaflet.
Maltese: Ir-rakkomandazzjonijiet u l-prekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam talkura tas-saħħa u mill-pazjenti għal użu sigur u effettiv ta' Ambrisentan Mylan ġew inklużi wkoll fissommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/129)
Maltese: Eżitu ta' proċedura ta' referenza skont l-Artikolu 35 tad-Direttiva 2001/82/KE (EMEA/V/A/129)
English: What is paromomycin?
Maltese: X'inhu paromomycin?
English: On 25 September 2018, the Belgian medicines authority requested that the CVMP review all available data on paromomycin's effectiveness and residue depletion (how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body).
Maltese: Fil-25 ta' Settembru 2018, l-awtorità tal-mediċini Belġjana talbet li s-CVMP jirrieżamina d-data kollha disponibbli dwar l-effettività ta' paromomycin u t-tnaqqis ta' residwi (kemm tieħu żmien il-mediċina biex taqa' taħt il-limiti massimi ta' residwi (MRLs) fil-ġisem tal-annimal).
English: The Belgian authority noted that there were different approved uses, dose schedules and withdrawal periods across the EU.
Maltese: L-awtorità Belġjana nnutat li kien hemm użi approvati, skedi tad-dożi u perjodi ta' rtirar differenti fl-UE kollha.
English: Questions and answers on suspension of marketing authorisations for injectable veterinary medicines containing paromomycin given to pigs EMA/487471/2019
Maltese: 11 ta' Ottubru 2019 EMA/487471/2019
English: Why were veterinary medicines containing paromomycin reviewed?
Maltese: Għaliex ġew rieżaminati l- mediċini veterinarji li fihom paromomycin?
English: The European Commission issued a decision on 11 October 2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fil-11 ta' Ottubru 2019.
English: Paromomycin is an aminoglycoside antibiotic used to treat a wide range of bacterial infections and is given to pigs by injection into a muscle.
Maltese: Il-paromomycin huwa antibijotiku aminoglikosidu użat biex jikkura firxa wiesgħa ta' infezzjonijiet batteriċi u jingħata lill-ħnieżer permezz ta' injezzjoni fil-muskolu.
English: On 18 July 2019, the European Medicines Agency recommended suspending the marketing authorisations for paromomycin antibiotics given to pigs by injection into a muscle.
Maltese: Fit-18 ta' Lulju 2019, l-Aġenzija Ewropea għall-Mediċini rrakkomandat is-sospensjoni talawtorizzazzjonijiet għat-tqegħid fis-suq għall-antibijotiċi paromomycin mogħtija lill-ħnieżer permezz ta' injezzjoni fil-muskolu.
English: These included data from companies and published literature.
Maltese: Dawn kienu jinkludu data minn kumpaniji u mil-letteratura ppubblikata.
English: The CVMP reviewed available data on effectiveness and residue depletion.
Maltese: Is-CVMP irrieżamina d-data disponibbli dwar l-effettività u t-tnaqqis ta' residwi.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of veterinary medicines containing paromomycin given to pigs by injection into the muscle do not outweigh their risks.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCVMP ikkonkluda li l-benefiċċji tal-mediċini veterinarji li fihom paromomycin mogħtija lill-ħnieżer b'injezzjoni fil-muskolu ma jegħlbux ir-riskji tagħhom.
English: The Committee based its opinion on the lack of adequate data on how effective these medicines are and residue depletion data.
Maltese: Il-Kumitat ibbaża l-opinjoni tiegħu fuq in-nuqqas ta' data adegwata dwar kemm huma effettivi dawn il-mediċini u d-data dwar it-tnaqqis tar-residwi.
English: The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.
Maltese: Mistoqsijiet u tweġibiet dwar is-sospensjoni ta' awtorizzazzjonijiet għat-tqegħid fis-suq għal mediċini veterinarji injettabbli li fihom paromomycin mogħtija lillħnieżer
English: 08019 - Barcelona Spain
Maltese: 08019 - Barcelona Spanja
English: Empreendimento Lagoas Park Edifício 7 - 3º Piso 2740-244 Porto Salvo
Maltese: Empreendimento Lagoas Park Edifício 7 - 3º Piso 2740-244
English: Ireland sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, Ireland
Maltese: L-Irlanda sanofi-aventis Ireland Ltd., Citywest Business Campus, Dublin 24, L-Irlanda
English: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Cyprus
Maltese: Sanofi-aventis Cyprus Ltd, 14 Charalambou Mouskou street, 2015 - Nicosia, Ċipru
English: Estonia sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, Estonia
Maltese: L-Estonja sanofi-aventis Estonia OÜ, Pärnu mnt 139 E/2, 11317 Tallinn, L-Estonja
English: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014 Paris FRANCE
Maltese: Sanofi-aventis France 1-13 Boulevard Romain Rolland 75014
English: Greece sanofi-aventis AEBE 348 Syngrou avenueBuilding A
Maltese: Il-Greċja sanofi-aventis AEBE 348 Syngrou avenueBuilding A
English: Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Gebäude K703
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH, Industriepark Höchst, Gebäude K703
English: Sweden sanofi-aventis AB Box 141 42
Maltese: L-Isvezja sanofi-aventis AB Box 141 42
English: Netherlands sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, The Netherlands
Maltese: L-Olanda sanofi-aventis Netherlands B.V., Kampenringweg 45 DE, 2803 PE Gouda, L-Olanda
English: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom)
Maltese: Sanofi-aventis One Onslow Street, Guildford, Surrey, GU1 4YS, Ir-Renju Unit)
English: 65926 Frankfurt am Main, Deutschland
Maltese: 65926 Frankfurt am Main, Il-Ġermanja
English: United Kingdom Aventis Pharma Limited,
Maltese: Pharma Limited,
English: Slovenia sanofi-aventis d.o.o, Dunajska 151, 1000 Ljubljana, Slovenia
Maltese: Is-Slovenja sanofi-aventis d.o.o, Dunajska 151, 1000
English: Hungary sanofi-aventis Zrt.
Maltese: L-Ungerija sanofi-aventis Zrt.
English: Slovak Republic sanofi-aventis Slovakia s.r.o.,
Maltese: Is-Slovakkja sanofi-aventis Slovakia s.r.o.,
English: Italy sanofi-aventis S.p.A. Viale Luigi Bodio 37/B 20158 Milan Italy
Maltese: Viale Luigi Bodio 37/B 20158 Milan L-Italja
English: Belgium Sanofi-aventis Belgium
Maltese: Sanofi-aventis Belgium
English: Sanofi-Avenstis Bulgaria EOOD, Bulgaria, 1303 Sofia, 103 Alexander Stamboliiski Blvd, fl.8
Maltese: Il-Bulgarija Sanofi-Avenstis Bulgaria EOOD, IlBulgarija, 1303 Sofia, 103 Alexander
English: GR-Greece
Maltese: GR-Il-Greċja
English: UAB “SANOFIAVENTIS LIETUVA”, A.Juozapavičiaus g. 6/2, LT-09310 Vilnius, Lithuania
Maltese: 6/2, LT-09310 Vilnius, Il-Litwanja
English: Bratislava, Slovak Republic
Maltese: Ljubljana, Is-Slovenja
English: Luxembourg Sanofi-aventis Belgium
Maltese: Il-Lussumburgu Sanofi-aventis Belgium
English: 1045 Budapest, Hungary
Maltese: Budapest, L-Ungerija
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50 D-65 926 Frankfurt am Main, Germany
Maltese: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50
English: United Kingdom Aventis Pharma Limited, 50 Kings Hill Avenue
Maltese: Pharma Limited, 50
English: Finland sanofi-aventis Oy Huopalahdentie 24 00350 Helsinki, Finland
Maltese: Il-Finlandja sanofi-aventis Oy Huopalahdentie 24
English: Lithuania
Maltese: Is-Slovakkja
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: Anness I Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq flIstati Membri
English: EMA/3764/2016 EMEA/H/C/003932
Maltese: EMA/3764/2016 EMA/H/C/003932
English: The full EPAR and risk management plan summary for Zurampic can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zurampic is available as 200-mg tablets.
Maltese: Zurampic huwa disponibbli bħala pilloli ta' 200 mg.
English: Why is Zurampic approved?
Maltese: Għalfejn ġie approvat Zurampic?
English: This summary was last updated in 02-2016.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi XX-2016.
English: Zurampic contains the active substance lesinurad.
Maltese: Zurampic fih is-sustanza attiva lesinurad.
English: Overall, Zurampic 200 mg once daily was effective in 57% (60 of 106) patients.
Maltese: B'mod ġenerali, 200 mg ta' Zurampic darba kuljum kienet effettiva f'57% (60 minn 106) talpazjenti.
English: Adding Zurampic 200 mg once daily was effective in 55% (222 of 405) patients.
Maltese: Iż-żieda ta' 200 mg ta' Zurampic darba kuljum kienet effettiva f'55% (222 minn 405) tal-pazjenti.
English: This compared with 47% (51 of 109) patients given placebo.
Maltese: Dan tqabbel ma' 47% (51 minn 109) tal-pazjenti li ngħataw plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Zurampic.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zurampic.
English: This compared with 26% (104 of 407) in patients who took placebo in addition to allopurinol.
Maltese: Dan tqabbel ma' 26% (104 minn 407) tal-pazjenti li ħadu plaċebo flimkien ma' allopurinol.
English: A third main study involved 324 adults who had at least one measurable tophus (large deposit of uric acid in or around a joint or under the skin) and with high blood levels of uric acid (over 80 mg/litre without gout medicines or above 60 mg/litre despite treatment with allopurinol or febuxostat).
Maltese: It-tielet studju ewlieni involva 324 adult li kellhom għall-inqas tofus wieħed li seta' jitkejjel (depożitu kbir ta' aċidu uriku ġewwa jew madwar ġog jew taħt il-ġilda) u b'livelli ta' aċidu uriku fid-demm għoljin ('il fuq minn 80 mg/litru mingħajr mediċini għall-gotta jew 'il fuq minn 60 mg/litru minkejja l-kura b'allopurinol jew febuxostat).
English: The active substance in Zurampic, lesinurad, helps to remove uric acid from the body.
Maltese: Is-sustanza attiva f'Zurampic, il-lesinurad, tgħin fl-eliminazzjoni tal-aċidu uriku mill-ġisem.
English: Looking just at patients whose blood uric acid level did not fall sufficiently on treatment with febuxostat alone, the level dropped to less than 50 mg/litre in 44% (26 of 59) patients taking Zurampic compared to 24% (12 of 51) patients taking placebo.
Maltese: Meta wieħed iħares biss lejn pazjenti li l-livell tal-aċidu uriku fid-demm tagħhom ma niżilx biżżejjed bil-kura b'febuxostat waħdu, il-livell naqas għal anqas minn 50 mg/litru f'44% (26 minn 59) tal-pazjenti li kienu qed jieħdu Zurampic meta mqabbel ma' 24% (12 minn 51) tal-pazjenti li kienu qed jieħdu plaċebo.
English: It does this by blocking a protein called ‘uric acid transporter-1' (URAT1) in the kidneys.
Maltese: Dan tagħmlu billi tibblokka proteina li tissejjaħ 'trasportatur tal-aċidu uriku-1' (URAT1) fil-kliewi.
English: The most common side effects with Zurampic (which may affect up to 1 in 10 people) are flu, headache, heartburn and (gastro-oesophageal reflux disease) stomach acid coming back to the mouth, and blood tests showing increased blood creatinine levels (a marker of kidney function).
Maltese: L-effetti sekondarji l-aktar komuni b'Zurampic (li jistgħu jaffetwaw sa persuna 1 minn kull 10) huma influwenza, uġigħ ta' ras, ħruq ta' stonku (marda ta' rifluss gastroesofagali) u aċidu tal-istonku li jerġa' jitla' fil-ħalq, u testijiet tad-demm li juru żieda fil-livelli tal-krejatinina fid-demm (markatur tal-funzjoni tal-kliewi).
English: Zurampic was studied in two main studies involving over 1,200 adults with gout who were previously treated with allopurinol.
Maltese: Zurampic kien studjat f'żewġ studji ewlenin li involvew 'il fuq minn 1,200 adult bil-gotta li qabel kienu kkurati b'allopurinol.
English: The recommended dose is 200 mg once daily, taken in the morning at the same time as a xanthine oxidase inhibitor medicine such as allopurinol or febuxostat.
Maltese: Id-doża rakkomandata hija ta' 200 mg darba kuljum, meħuda filgħodu fl-istess ħin ta' mediċina tal-inibitur tal-ksantina ossidażi bħal allopurinol jew febuxostat.
English: What are the risks associated with Zurampic?
Maltese: X'inhuma r-riskji assoċjati ma' Zurampic?
English: The most serious adverse reactions were kidney failure, reduced kidney function, and kidney stones, which affected less than 1 patient in 100.
Maltese: Ir-reazzjonijiet avversi l-aktar serji kienu l-insuffiċjenza tal-kliewi, tnaqqis fil-funzjoni talkliewi, u ġebel fil-kliewi, li affetwaw anqas minn pazjent 1 minn kull 100.
English: Other information about Zurampic
Maltese: Kif jintuża Zurampic?
English: It is used in combination with a xanthine oxidase inhibitor, another type of gout medicine, when the xanthine oxidase inhibitor on its own is not able to control uric acid levels sufficiently.
Maltese: Dan jintuża f'kombinazzjoni ma' inibitur tal-ksantina ossidażi, tip ieħor ta' mediċina għall-gotta, meta l-inibitur tal-ksantina ossidażi waħdu mhuwiex kapaċi jikkontrolla biżżejjed il-livelli tal-aċidu uriku.
English: How does Zurampic work?
Maltese: Kif jaħdem Zurampic?
English: Risks such as kidney damage or heart problems are addressed in the product information.
Maltese: Riskji bħal ħsara fil-kliewi jew problemi tal-qalb huma indirizzati fl-informazzjoni tal-prodott.
English: Patients must not take Zurampic if they suffer from tumour lysis syndrome (a complication due to the rapid breakdown of cancer cells during cancer treatment) or a rare hereditary disease called LeschNyhan syndrome, both of which raise uric acid levels in the blood.
Maltese: Il-pazjenti ma għandhomx jieħdu Zurampic jekk ibatu minn sindrome tal-lysis tat-tumur (komplikazzjoni minħabba t-tkissir malajr ta' ċelluli tal-kanċer waqt il-kura tal-kanċer) jew marda ereditarja serja li tissejjaħ is-sindrome ta' Lesch-Nyhan, fejn it-tnejn li huma jgħollu l-livelli tal-aċidu uriku fid-demm.
English: Zurampic is used in combination with a xanthine oxidase inhibitor such as allopurinol or febuxostat.
Maltese: Jekk il-kura bl-inibitur tal-ksantina ossidażi tiġi interrotta, il-kura b'Zurampic għandha tiġi interrotta fl-istess ħin.
English: Xanthine oxidase inhibitors reduce the production of uric acid in the body.
Maltese: Linibituri tal-ksantina ossidażi jnaqqsu l-produzzjoni tal-aċidu uriku fil-ġisem.
English: Combined with a xanthine oxidase inhibitor, Zurampic reduced blood levels of uric acid in patients with gout whose high uric acid levels were not sufficiently controlled by a xanthine oxidase inhibitor.
Maltese: Zurampic huwa mediċina użata fl-adulti bil-gotta sabiex tnaqqas il-livelli għoljin tal-aċidu uriku fiddemm.
English: By blocking URAT1, more uric acid is passed out in the urine and less remains in the blood.
Maltese: Permezz talibblukkar tal-URAT1, jiġi eliminat aktar aċidu uriku fl-awrina u jibqa' anqas fid-demm.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 60 mg/litre after 6 months of treatment.
Maltese: Il-kejl ewlieni taleffikaċja kien in-numru tal-pazjenti li l-livell tal-aċidu uriku fid-demm tagħhom niżel taħt 60 mg/litru wara 6 xhur ta' kura.
English: The main measure of effectiveness was the number of patients whose blood level of uric acid dropped below 50 mg/litre after 6 months of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien innumru tal-pazjenti li l-livell tal-aċidu uriku fid-demm tagħhom niżel taħt 50 mg/litru wara 6 xhur ta' kura.
English: A risk management plan has been developed to ensure that Zurampic is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zurampic jintuża bl-aktar mod sigur possibbli.
English: 2 (2 x 1) vials + 2 (2 x 1) syringes +2 (2 x 1) needles + 2 (2 x 1) vial adapters + 4 (2 x 2) alcohol pads (multipack)
Maltese: 2 (2 × 1) kunjetti + 2 (2 × 1) siringi + 2 (2 × 1) labar + 2 (2 × 1) adatturi talkunjett + 4 (2 × 2) tajjariet bl-alkoħol (pakkett multiplu)
English: 1 vial + 1 syringe + 1 needle + 1 vial adapter + 2 alcohol pads
Maltese: 1 kunjett + 1 siringa + 1 labra + 1 adattur tal-kunjett + 2 tajjariet bl-alkoħol
English: 1 pre-filled syringe + 2 alcohol pads
Maltese: 1 siringa mimlija għal-lest + 2 tajjariet bl-alkoħol
English: Date of latest renewal: 15th July 2016
Maltese: Data tal-aħħar tiġdid: 15 Lul 2016
English: Silica, colloidal anhydrous Povidone
Maltese: Silica, colloidal anhydrous
English: North Harrow, Middx HA1 4HF United Kingdom
Maltese: North Harrow, Middx HA1 4HF Ir-Renju Unit
English: Store below 30°C.
Maltese: Aħżen f'temperatura inqas minn 30°C.
English: Manufacturer Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow
Maltese: Sage House, 319 Pinner road,
English: Cellulose, microcrystalline Maize starch
Maltese: Cellulose, microcrystalline
English: HA1 4HF, Middlesex, United Kingdom
Maltese: HA1 4HF, Middlesex, Ir-Renju Unit
English: Each blister strip contains 10 tablets.
Maltese: Kull strixxa tal-folji fiha 10 pilloli.
English: • Store below 30°C.
Maltese: • Aħżen f'temperatura inqas minn 30°C.
English: The other ingredients are mannitol, cellulose microcrystalline, maize starch, silica colloidal anhydrous, povidone K 30 and magnesium stearate.
Maltese: Is-sustanzi mhux attivi l-oħra huma mannitol, cellulose microcrystalline, maize starch, silica colloidal anhydrous, povidone K 30 u magnesium stearate.
English: • Allergic reactions (e.g. rash, itching, hypersensitivity)
Maltese: - Reazzjonijiet allerġiċi (eż. raxx, ħakk, sensittività eċċessiva)
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%), 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 tal-irqad (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: Pramipexole Accord 0.088 mg tablets Pramipexole Accord 0.18 mg tablets Pramipexole Accord 0.35 mg tablets Pramipexole Accord 0.7 mg tablets Pramipexole Accord 1.1 mg tablets
Maltese: Pramipexole Accord 0.088 mg pilloli Pramipexole Accord 0.18 mg pilloli Pramipexole Accord 0.35 mg pilloli Pramipexole Accord 0.7 mg pilloli Pramipexole Accord 1.1 mg pilloli
English: Inhibitors/competitors of active renal elimination pathway
Maltese: Inibituri/kompetituri tal-passaġġ tal-eliminazzjoni renali attiv
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 < 1/1,000); rari ħafna (< 1/10,000) ; mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Augmentation was specifically investigated in a controlled clinical trial over 26 weeks.
Maltese: L-awmentazzjoni kienet investigata speċifikament fi prova klinika kkontrollata fuq perijodu ta' 26 ġimgħa.
English: In human volunteers, a dose-dependent decrease in prolactin was observed.
Maltese: F'voluntiera umani, kien osservat tnaqqis fil-prolactin li jiddependi mid-doża.
English: The active ingredient is pramipexole.
Maltese: Is-sustanza attiva hi pramipexole.
English: All the strengths of Pramipexole Accord tablets are available in alu-alu blisters of 10 tablets per strip, in cartons containing 3 or 10 blister strips (30 or 100 tablets).
Maltese: Il-qawwiet kollha ta' Pramipexole Accord pilloli huma disponibbli fil-folji alu-alu ta' 10 pilloli kull strixxa, f'kartuniet li fihom 3 jew 10 strixxi ta' folji (30 jew 100 pillola).
English: The symptoms include:
Maltese: Mhux magħruf:
English: Date of first authorisation: 30 September 2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 30 ta' Settembru 2011
English: The leaflet was last revised in {MM/YYYY}.
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Clinical efficacy and safety in Parkinson's disease
Maltese: Effikaċja klinika u sigurtà fil-marda ta' Parkinson
English: Pack-sizes of 30 or 100 tablets
Maltese: Daqsijiet tal-pakkett ta' 30 jew 100 pillola
English: Pramipexole Accord 1.1 mg tablet
Maltese: Pramipexole Accord 1.1 mg pilloli
English: In a cross-sectional, retrospective screening and case-control study including 3,090 Parkinson's disease patients, 13.6% of all patients receiving dopaminergic or non-dopaminergic treatment had symptoms of an impulse control disorder during the past six months.
Maltese: Fi studju cross-sectional, screening retrospettiv u case-control li kien jinkludi 3,090 pazjent bil-marda ta' Parkinson, 13.6% tal-pazjenti kollha li kienu qed jingħataw kura dopaminerġika jew mhux dopaminerġika, kellhom sintomi ta' disturb fil-kontroll tal-impulsi matul l-aħħar sitt xhur.
English: Psychiatric disorders insomnia abnormal dreams restlessness confusion hallucinations libido disorder delusion1 hyperphagia1 paranoia1 mania1 delirium1
Maltese: Disturbi psikjatriċi insomnija ħolm mhux normali irrekwitezza konfużjoni alluċinazzjonijiet disturb fil-libido delużjoni1 iperfaġija1 paranojja1 manija1 delirju1
English: • Vision impairment.
Maltese: - Indeboliment fil-vista.