FrancophonIA/ELRC3.0 huggingface dataset:
English: Special warnings and precautions for use: [For products indicated in neonates (age up to 28 days)] Light exposure of solutions for intravenous parenteral nutrition, especially after admixture with trace elements and/or vitamins, may have adverse effects on clinical outcome in neonates, due to generation of peroxides and other degradation products.
Maltese: [Għall-prodotti indikati fit-trabi tat-twelid (li għandhom sa 28 jum)] L-esponiment għad-dawl ta' soluzzjonijiet għal nutrizzjoni parenterali ġol-vina, speċjalment wara taħlita ma' elementi ta' traċċa u/jew vitamini, jista' jkollu effetti negattivi fuq l-eżitu kliniku fi trabi tattwelid, minħabba l-ġenerazzjoni ta' perossidi u prodotti oħra ta' degradazzjoni.
English: Bleeding.
Maltese: Fsada.
English: If you are a woman of childbearing potential you may be advised to use effective contraception.
Maltese: Jekk int mara li tista' toħroġ tqila tista' tiġi avżata biex tuża kontraċezzjoni effettiva.
English: Summary of product characteristics (* include neonates and if product is indicated in such population) 4.2.
Maltese: Sommarju tal-karatteristiċi tal-prodott (* inkludi trabi tat-twelid u jekk il-prodott huwa indikat f'popolazzjoni bħal din) 4.2.
English: Frequency not known: nephrolithiasis* * See section 4.4 for further information
Maltese: .8. Effetti mhux mixtieqa Disturbi fil-kliewi u fis-sistema urinarja Frekwenza mhux magħrufa: nefrolitjażi* * Ara s-sezzjoni 4.4 għal aktar informazzjoni
English: Shelf life
Maltese: "Mhux magħrufa"
English: Talk to your doctor or nurse before taking <product name>:
Maltese: Mhux magħruf jekk <isem tal-prodott> huwiex sikur waqt it-tqala.
English: • kidney stones and associated kidney pain (see also section 2)
Maltese: • ġebel fil-kliewi u uġigħ tal-kliewi assoċjat (ara wkoll sezzjoni 2)
English: Nitisinone MDK is available as capsules (2 mg, 5 mg and 10 mg).
Maltese: Nitisinone MDK jiġi f'kapsuli (2 mg, 5 mg u 10 mg).
English: The full EPAR for Nitisinone MDK 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: Nitisinone MDK is a ‘generic medicine'.
Maltese: Nitisinone MDK huwa "mediċina ġenerika".
English: Nitisinone MDK is a medicine used to treat hereditary tyrosinaemia type 1 (HT-1).
Maltese: Nitisinone MDK huwa mediċina li tintuża biex tikkura tirożinemja tat-tip 1 ereditarja (HT-1).
English: The active substance in Nitisinone MDK, nitisinone, blocks an enzyme that converts tyrosine into harmful substances.
Maltese: Is-sustanza attiva f'Nitisinone MDK, in-nitisinone, timblokka enzima li tikkonverti t-tirożina f'sustanzi perikolużi.
English: Nitisinone MDK contains the active substance nitisinone.
Maltese: Nitisinone MDK fih is-sustanza attiva nitisinone.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nitisinone MendeliKABS on 24 August 2017.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nitisinone MendeliKABS fl-24 ta' Awwissu 2017.
English: Because Nitisinone MDK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Nitisinone MDK huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Nitisinone MDK is used together with a diet that restricts the intake of the amino acids tyrosine and phenylalanine.
Maltese: Nitisinone MDK jintuża flimkien ma' dieta li tillimita l-konsum tal-amminoaċidi tirożina u fenilalanina.
English: Nitisinone MDK
Maltese: Informazzjoni oħra dwar Nitisinone MDK
English: The recommended starting dose is 1 mg per kilogram body weight per day.
Maltese: Id-doża tal-bidu rrakkomandata hija 1 mg għal kull kilogramma tal-piż tal-ġisem kuljum.
English: Why is Nitisinone MDK approved?
Maltese: Għaliex ġie approvat Nitisinone MDK?
English: What are the benefits and risks of Nitisinone MDK?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Nitisinone MDK?
English: The name of the medicine was changed to Nitisinone MDK on 3 October 2017.
Maltese: L-isem tal-prodott inbidel għal Nitisinone MDK fit-3 ta' Ottubru 2017.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Nitisinone MDK has been shown to have comparable quality and to be bioequivalent to Orfadin.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, f'konformità mar-rekwiżiti tal-UE, Nitisinone MDK wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Orfadin.
English: This means that Nitisinone MDK contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Orfadin.
Maltese: Dan ifisser li Nitisinone MDK fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Orfadin.
English: The capsules are usually swallowed whole, but they may be opened and their contents mixed into a small amount of water or formula just before swallowing.
Maltese: Normalment il-kapsuli jinbelgħu sħaħ, iżda jistgħu jinfetħu u lkontenut tagħhom jitħallat ma' ammont żgħir ta' ilma jew formula qabel ma jinbelgħu.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku nitisinone
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Orfadin, and do not need to be repeated for Nitisinone MDK.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Orfadin, u ma għandhomx għalfejn jiġu ripetuti għal Nitisinone MDK. Bħal kull mediċina oħra, il-kumpanija pprovdiet studji fuq il-kwalità ta' Nitisinone MDK. Il-kumpanija għamlet ukoll studju li wera li hu "bijoekwivalenti" għall-mediċina ta' referenza.
English: The Agency recommended that Nitisinone MDK be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Nitisinone MDK ikun approvat għall-użu fl-UE.
English: Nitisinone MDK can only be obtained with a prescription and treatment should be started and monitored by doctors who have experience in the treatment of patients with HT-1.
Maltese: Nitisinone MDK jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda u tkun taħt is-sorveljanza ta' tabib li jkollu esperjenza fil-kura ta' HT-1.
English: These amino acids are normally found in proteins in foods and drinks.
Maltese: Dawn l-amminoaċidi normalment jinsabu fil-proteini fl-ikel u fix-xorb.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nitisinone MDK have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u millpazjenti għall-użu sigur u effettiv ta' Nitisinone MDK.
English: November 20172019
Maltese: Novembru 20172019
English: Final study report by:
Maltese: Rapport finali ta' studju sa:
English: 07 April 2018
Maltese: 07 ta' April 2018
English: The PASS final study report submitted by the MAHs complies with their obligation to perform a survey among health care professionals to evaluate their knowledge and attitudes on prescribing conditions of thiocolchicoside containing medicinal products, as imposed during the Article 31 procedure EMEA/H/A
Maltese: Ir-rapport ta' studju finali ta' PASS ippreżentat mill-MAHs jikkonforma mal-obbligu tagħhom li jwettqu stħarriġ fost il-professjonisti tal-kura tas-saħħa sabiex jevalwa l-għarfien u l-attitudnijiet tagħhom dwar il-preskrizzjoni ta' kondizzjonijiet ta' prodotti mediċinali li fihom thiocolchicoside, kif impost waqt ilproċedura tal-Artikolu 31 EMEA/H/A-1361.
English: February 2018 CMDh meeting
Maltese: Laqgħa tas-CMDh Frar 2018
English: 06 June 2018
Maltese: 06 ta' Ġunju 2018
English: The final results of the complementary drug utilization study using databases, which allows a dual approach to assessing the effectiveness of the risk minimisation measures imposed on thiocolchicoside containing medicinal products, are expected in 2019, and this new due date should be reflected in the conditions of the Marketing Authorisation.
Maltese: Ir-riżultati finali tal-istudju dwar l-użu kumplimentari tal-mediċina permezz tal-bażijiet tad-data, li jippermetti approċċ doppju għall-valutazzjoni tal-effettività ta' miżuri tal-imminimizzar tar-riskju imposti fuq prodotti mediċinali li fihom thiocolchicoside, huma mistennija fl-2019, u din id-data ta' maturità ġdida għandha tiġi riflessa fil-kundizzjonijiet tal-Awtorizzazzjoni għat-Tqegħid fis-Suq.
English: On the basis of the scientific conclusions for the results of the study for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the CMDh is of the opinion that the benefit-risk balance of the medicinal product(s) mentioned above is unchanged subject to the proposed changes to the product information.
Maltese: Abbażi tal-konklużjonijiet xjentifiċi għar-riżultati tal-istudju għall-prodott(i) mediċinali li fih(om) issustanza attiva thiocolchicoside u li hu(w)ma kkonċernat(i) mir-rapport finali ta' PASS, is-CMDh huwa tal-fehma li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodott(i) mediċinali msemmi(ja) hawn fuq mhuwiex mibdul suġġett għall-bidliet proposti għall-informazzjoni tal-prodott.
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance thiocolchicoside concerned by the noninterventional imposed PASS final report
Maltese: Tibdil li għandu jsir fil-kundizzjonijiet tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq ta' prodott(i) mediċinali li fih(om) is-sustanza attiva thiocolchicoside li hu(w)ma kkonċernat(i) mir-rapport finali ta' PASS impost mingħajr intervent
English: The MAH(s) should provide within the risk management plan submission, a protocol for results of the drug utilisation study to characterise prescribing practices for the medicinal products during typical clinical use in representative groups of prescribers and to assess main reasons for prescription.
Maltese: L-MAH(s) għandu(hom) jipprovdi(u) fi ħdan issottomissjoni tal-pjan ta' ġestjoni tar-riskji, protokoll għal riżultati tal-istudju dwar l-użu magħmul mill-mediċina sabiex jiġu kkaratterizzati l-prattiki tal-preskrizzjoni għallprodotti mediċinali matul użu kliniku tipiku fi gruppi rappreżentattivi ta' dawk li jippreskrivu u sabiex jiġu vvalutati r-raġunijiet ewlenin għallpreskrizzjoni.
English: The following changes to the conditions of the marketing authorisation(s) of medicinal products containing the active substance thiocolchicoside concerned by the PASS final report are recommended:
Maltese: Huwa rakkomandat it-tibdil li ġej fil-kundizzjonijiet tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq ta' prodotti mediċinali li fihom is-sustanza attiva thiocolchicoside li huma kkonċernati mir-rapport finali ta' PASS:
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance thiocolchicoside and concerned by the PASS final report , the scientific conclusions are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC għar-rappport finali ta' studju dwar issikurezza wara l-awtorizzazzjoni (PASS) impost mingħajr intervent għall-prodott(i) mediċinali li fih(om) is-sustanza attiva thiocolchicoside u li huma kkonċernati mir-rapport finali ta' PASS, il-konklużjonijiet xjentifiċi huma kif ġej:
English: The marketing authorisation holder(s) shall change the following condition(s) (new text underlined and in bold, deleted text strike through)
Maltese: Id-detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq għandu(hom) jibdel (jibdlu) l-kundizzjoni(jiet) li ġejja (ġejjin) (test ġdid sottolinjati u b'tipa grassa, it-test imħassar huwa ingassat)
English: 100 tablets
Maltese: 100 pillola
English: Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Germany
Maltese: Rottendorf Pharma GmbH Ostenfelder Strasse 51 - 61 59320 Ennigerloh Il-Ġermanja
English: The other ingredients are hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.
Maltese: Is-sustanzi mhux attivi l-oħra huma hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate.
English: PHARMACEUTICAL FORM AND CONTENTS 30 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola
English: Tablet
Maltese: Pillola.
English: D-55216 Ingelheim am Rhein
Maltese: D-55216 Ingelheim am Rhein Il-Ġermanja
English: 6.5 Nature and contents of container OPA/aluminium/PVC-aluminium blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Folji OPA/aluminju/PVC-aluminju.
English: Each blister strip contains 10 tablets.
Maltese: Kull strixxa bil-folji fiha 10 pilloli.
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: The other ingredients are mannitol, maize starch, anhydrous colloidal silica, povidone K 25 and magnesium stearate.
Maltese: Is-sustanzi mhux attivi l-oħra huma mannitol, maize starch, anhydrous colloidal silica, povidone K 25 u magnesium stearate.
English: s r.o.
Maltese: U L-UŻU.
English: Each tablet contains 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, or 3.15 mg pramipexole as 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, or 4.5 mg pramipexole dihydrochloride monohydrate, respectively.
Maltese: Kull pillola fiha 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, jew 3.15 mg ta' pramipexole bħala 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, jew 4.5 mg ta' pramipexole dihydrochloride monohydrate, rispettivament.
English: Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucureşti Tel: +40 21 302 28 00
Maltese: KG Viena - Sucursala Bucureşti Tel: +40 21 302 28 00
English: However, the potential influence of hepatic insufficiency on MIRAPEXIN pharmacokinetics has not been investigated.
Maltese: Madankollu, l-influwenza potenzjali ta' insuffiċjenza epatika fuq il-farmakokinetika ta' MIRAPEXIN ma kinitx investigata.
English: All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P1, P2, P3, P12, P4, P13, or P5 on the other side, representing the tablet strengths 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg and 3.15 mg, respectively.
Maltese: Il-pilloli kollha għandhom is-simbolu tal-kumpanija ta' Boehringer Ingelheim imnaqqax fuq naħa waħda u l-kodiċi P1, P2, P3, P12, P4, P13, jew P5 fuq in-naħa l-oħra, li tirrappreżenta l-qawwa talpillola ta' 0.26 mg, 0.52 mg, 1.05 mg, 1.57 mg, 2.1 mg, 2.62 mg, u 3.15 mg, rispettivament.
English: Boehringer Ingelheim International GmbH D-55216 Ingelheim am Rhein Germany
Maltese: Boehringer Ingelheim International GmbH D-55216
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, jew 0.7 mg ta' pramipexole bħala 0.125 mg, 0.25 mg, 0.5 mg, jew 1 mg ta' pramipexole dihydrochloride monohydrate, rispettivament.
English: Lot {number}
Maltese: TA' EĊĊIPJENTI
English: MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets
Maltese: MIRAPEXIN 0.088 mg pilloli MIRAPEXIN 0.18 mg pilloli MIRAPEXIN 0.35 mg pilloli MIRAPEXIN 0.7 mg pilloli
English: All tablets have the Boehringer Ingelheim company symbol embossed on one side and the codes P6, P7, P8, or P9 on the other side, representing the tablet strengths 0.088 mg, 0.18 mg, 0.35 mg, and 0.7 mg, respectively.
Maltese: Il-pilloli kollha għandhom is-simbolu tal-kumpanija Boehringer Ingelheim imnaqqax fuq naħa waħda u l-kodiċi P6, P7, P8, jew P9 fuq in-naħa l-oħra, li tirrappreżenta l-qawwiet tal-pilloli ta' 0.088 mg, 0.18 mg, 0.35 mg, u 0.7 mg, rispettivamant.
English: MIRAPEXIN 0.088 mg tablets MIRAPEXIN 0.18 mg tablets MIRAPEXIN 0.35 mg tablets MIRAPEXIN 0.7 mg tablets Pramipexole
Maltese: MIRAPEXIN 0.088 mg pilloli MIRAPEXIN 0.18 mg pilloli MIRAPEXIN 0.35 mg pilloli MIRAPEXIN 0.7 mg pilloli Pramipexole
English: MIRAPEXIN is indicated in adults for treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without levodopa) or in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Maltese: MIRAPEXIN huwa indikat f'adulti għall-kura tas-sinjali u tas-sintomi tal-marda idjopatika ta' Parkinson, waħdu (mingħajr levodopa) jew flimkien ma' levodopa, i.e. matul il-kors tal-marda, sa listadji aħħarin fejn l-effett ta' levodopa jonqos ħafna jew isir inkonsistenti u jseħħu fluttwazzjonijiet tal-effett terapewtiku (fl-aħħar tad-doża jew fluttwazzjonijiet “on off”).
English: MIRAPEXIN has been associated with sleepiness and episodes of suddenly falling asleep, particularly in patients with Parkinson's disease.
Maltese: MIRAPEXIN kien assoċjat ma' ngħas u episodji ta' rqad li jiġi f'daqqa, partikularment f'pazjenti bilmarda ta' Parkinson.
English: - You may experience vomiting, restlessness, or any of the side effects as described in section 4 “Possible side effects”.
Maltese: - Jista' jkollok rimettar, nuqqas ta' kwiet f'ġismek, jew kwalunkwe mill-effetti sekondarji deskritti f'sezzjoni 4 “Effetti sekondarji possibbli”.
English: MIRAPEXIN 0.26 mg prolonged-release tablets MIRAPEXIN 0.52 mg prolonged-release tablets MIRAPEXIN 1.05 mg prolonged-release tablets MIRAPEXIN 1.57 mg prolonged-release tablets MIRAPEXIN 2.1 mg prolonged-release tablets MIRAPEXIN 2.62 mg prolonged-release tablets MIRAPEXIN 3.15 mg prolonged-release tablets
Maltese: MIRAPEXIN 0.26 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 0.52 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 1.05 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 1.57 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 2.1 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 2.62 mg pilloli li jerħu l-mediċina bil-mod MIRAPEXIN 3.15 mg pilloli li jerħu l-mediċina bil-mod
English: MIRAPEXIN 0.35 mg tablets EU/1/97/051/011-012
Maltese: MIRAPEXIN 0.35 mg pilloli EU/1/97/051/011-012
English: Other medicines and MIRAPEXIN
Maltese: Mediċini oħra u MIRAPEXIN
English: Uncommon: - Urge to behave in an unusual way* - Cardiac failure (heart problems which can cause shortness of breath or ankle swelling)* - Inappropriate antidiuretic hormone secretion* - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs) - Hyperkinesia (increased movements and inability to keep still)* - Paranoia (e.g. excessive fear for one's own well-being)* - Delusion* - Amnesia (memory disturbance)* - Hallucinations (seeing, hearing or feeling things that are not there) - Confusion - Excessive daytime sleepiness and suddenly falling asleep - Weight increase - Hypotension (low blood pressure) - Excess of fluid, usually in the legs (peripheral oedema) - Allergic reactions (e.g. rash, itching, hypersensitivity) - Fainting - Restlessness - Visual impairment - Weight loss including decreased appetite - Dyspnoea (difficulties to breathe) - Hiccups - Pneumonia (infection of the lungs)* - Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
Maltese: Mhux komuni: - Xewqa kbira li ġġib ruħek b'mod mhux tas-soltu* - Insuffiċjenza kardijaka (problemi tal-qalb li jistgħu jikkawża qtugħ ta' nifs jew nefħa fl-għekiesi)* - Tnixxija mhux kif suppost ta' ormon antidijuretiku* - Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn) - Iperkinesija (żieda fil-movimenti tal-ġisem u ma tkunx kapaċi twaqqafhom)* - Paranojja (eż. biża' eċċessiv għall-benesseri tiegħek)* - Delużjoni* - Amnesija (disturb fil-memorja)* - Alluċinazzjonijiet (tara, tisma' jew tħoss affarijiet li ma jkunux hemm) - Konfużjoni - Irqad eċċessiv matul il-ġurnata u li torqod għal għarrieda - Żieda fil-piż - Ipotensjoni (pressjoni tad-demm baxxa) - Fluwidu eċċessiv, normalment fir-riġlejn (edema periferali)
English: You should avoid taking MIRAPEXIN together with antipsychotic medicines.
Maltese: Għandek tevita li tieħu MIRAPEXIN flimkien ma' mediċini antipsikotiċi.
English: - Dyskinesia (e.g. abnormal, uncontrolled movements of the limbs).
Maltese: - Diskinesija (eż. movimenti anormali, mingħajr kontroll tad-dirgħajn/riġlejn).
English: Date of latest renewal: 23 February 2008
Maltese: Data tal-aħħar tiġdid: 23 ta' Frar, 2008
English: Axial dystonia including antecollis, camptocormia and pleurothotonus (Pisa Syndrome) has occasionally been reported in patients with Parkinson's disease following initiation or incremental dose increase of pramipexole.
Maltese: Distonja axjali, inkluż l-antecollis, il-camptocormia u l-pleurothotonus (il-Marda ta' Pisa) xi kultant ġiet irrappurtata f'pazjenti bil-marda tal-Parkinson, wara inizjazzjoni jew żieda fid-doża inkrimentali ta' pramipexole.
English: 1 tablet MIRAPEXIN 0.35 mg and 1 tablet MIRAPEXIN 0.18 mg OR
Maltese: 1 pillola ta' MIRAPEXIN 0.35 mg u 1 pillola ta' MIRAPEXIN 0.18 mg JEW
English: MIRAPEXIN 0.7 mg tablets EU/1/97/051/005-006
Maltese: MIRAPEXIN 0.7 mg pilloli EU/1/97/051/005-006
English: MIRAPEXIN 0.088 mg tablets EU/1/97/051/001-002
Maltese: MIRAPEXIN 0.088 mg pilloli EU/1/97/051/001-002
English: If renal function declines during maintenance therapy the MIRAPEXIN 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 MIRAPEXIN daily dose should be reduced by 30%.
Maltese: Jekk il-funzjoni renali tonqos matul it-terapija ta' manteniment, id-doża ta' kuljum ta' MIRAPEXIN għandha titnaqqas bl-istess perċentwali bħat-tnaqqis fit-tneħħija tal-krejatinina, i.e. jekk it-tneħħija talkrejatinina tonqos bi 30%, allura d-doża ta' kuljum ta' MIRAPEXIN għandha titnaqqas bi 30%.
English: MIRAPEXIN 0.18 mg tablets EU/1/97/051/003-004
Maltese: MIRAPEXIN 0.18 mg pilloli EU/1/97/051/003-004
English: Nausea and fatigue were more often reported in female patients treated with MIRAPEXIN (20.8% and 10.5%, respectively) compared to males (6.7% and 7.3%, respectively).
Maltese: 5%, rispettivament) meta mqabbla ma' pazjenti rġiel (6.7% u 7.3% rispettivament).
English: All strengths of MIRAPEXIN are available in aluminium blister strips of 10 tablets per strip, in cartons containing 1, 3 or 10 blister strips (10, 30 or 100 prolonged-release tablets).
Maltese: Il-qawwiet kollha ta' MIRAPEXIN huma disponibbli fi strixxi bil-folji tal-aluminju ta' 10 pilloli f'kull strixxa, f'kaxxi tal-kartun li fihom 1, 3 jew 10 strixxi bil-folji (10, 30 jew 100 pillola li jerħu lmediċina bil-mod).
English: 1 tablet MIRAPEXIN 0.35 mg
Maltese: 1 pillola ta' MIRAPEXIN 0.35 mg
English: Reports in the literature indicate that treatment of Restless Legs Syndrome with dopaminergic medicinal products can result in augmentation.
Maltese: Rapporti fil-letteratura jindikaw li l-kura tas-Sindrome tar-Riġlejn Irrekwieti bi prodotti mediċinali dopaminerġiċi tista' tirriżulta f'awmentazzjoni.