FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium laurilsulfate.
Maltese: Sodium laurisulfate.
English: Children aged < 5 years
Maltese: Tfal minn età < 5 snin
English: Tablet film-coating: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) and sodium laurilsulfate
Maltese: Kisja b'rita tal-pillola: polyvinyl alcohol, talc, titanium dioxyde (E171), glycerol monocaprylocaprate (Type I), iron oxide yellow (E172) u sodium laurisulfate
English: Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014 Paris
Maltese: Pépinière Paris Santé Cochin 27-29 rue du Faubourg Saint-Jacques 75014
English: Tablet core: mannitol, colloidal anhydrous silica and glycerol dibehenate.
Maltese: Qalba tal-pillola: mannitol, colloidal anhydrous silica u glycerol dibehenate.
English: Date of first authorisation: 5 September 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 5 ta' Settembru, 2017
English: Trientine is acetylated in two majors metabolites, N(1)-acetyltriethylenetetramine (MAT) and N(1),N(10)-diacetyltriethylenetetramine (DAT).
Maltese: Trientine huwa aċetilat f'żewġ metaboliti maġġuri, N(1)-aċetiltrietilenetetramina (N(1)acetyltriethylenetetramine, MAT) u N(1),N(10)-diaċetiltrietilenetetramina (N(1),N(10)diacetyltriethylenetetramine, DAT).
English: Frequencies are defined as: 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: Il-frekwenza hija ddefinita bħala: 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: Not known: duodenitis, colitis (including severe colitis).
Maltese: Mhux magħruf: duodenite, kollite (inkluż kollite severa).
English: In silico data predict that trientine displays irritating and sensitising properties.
Maltese: Data in silico tipprevedi li trientine juri karatteristiċi irritanti u ta' sensitizzazzjoni.
English: DELPHARM EVREUX 5 rue du Guesclin 27000 Evreux France
Maltese: Manifattur Delpharm Evreux 5 rue du Guesclin 27000 Evreux Franza
English: 27000 Evreux France
Maltese: Evreux Franza
English: In cases up to 20 g of trientine base there were no apparent adverse effects reported.
Maltese: F'każijiet sa 20 g ta' bażi ta' trientine, ma kien hemm l-ebda effetti avversi apparenti rrappurtati.
English: Cuprior is indicated for the treatment of Wilson's disease in adults, adolescents and children ≥ 5 years intolerant to D-penicillamine therapy.
Maltese: Cuprior huwa indikat għall-kura tal-marda ta' Wilson f'adulti, fl-adoloxxenti u fit-tfal ta' ≥ 5 snin intolleranti għal terapija b'peniċillamina-D.
English: The pharmacokinetic profile of Cuprior has been evaluated after a single oral dose of 450, 600 mg and 750 mg trientine in healthy male and female subjects.
Maltese: Ilprofil farmakokinetiku ta' Cuprior ġie evalwat wara doża orali waħda ta' 450, 600 mg u 750 mg trientine f'individwi rġiel u nisa b'saħħithom.
English: In adults of all ages, the recommended total daily dose is 3 to 6½ tablets per day (making a total of between 450 and 975 mg).
Maltese: Fl-adulti ta' kull età, id-doża totali rakkomandata ta' kuljum hija 3 sa 6½ pilloli kull jum (li jammontaw għat-total ta' bejn 450 u 975 mg).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX12.
Maltese: Prodotti oħra tal-apparat alimentari u tal-metaboliżmu, prodotti varji talapparat alimentari u tal-metaboliżmu, Kodiċi ATC:
English: Package leaflet online at QR code to be included http://www.cuprior.com Oral use.
Maltese: Fuljett ta' tagħrif online fuq għandu jiġi inkluż il-kodiċi QR http://www.cuprior.com Użu orali.
English: The NOAEL was established at approximately 92 mg/kg/day for males and 99 mg/kg/day for females.
Maltese: In-NOAEL ġie stabbilit b'madwar 92 mg/kg/jum għall-irġiel u 99 mg/kg/jum għan-nisa.
English: Common: nausea.
Maltese: Mhux magħruf: urtikarja.
English: OPA/Alu/PVC-Alu blisters, each blister contains 8 film-coated tablets.
Maltese: Folji OPA/Alu/PVC-Alu, kull folja fiha 8 pilloli miksijin b'rita.
English: The recommended dose is between 450 mg and 975 mg (3 to 6½ film-coated tablets) per day in 2 to 4 divided doses.
Maltese: Id-doża rakkomandata hija bejn 450 mg u 975 mg (3 sa 6½ pilloli miksijin b'rita) kull jum f'2 sa 4 dożi maqsumin.
English: What you need to know before you take Cuprior 3.
Maltese: X'għandek tkun taf qabel ma tieħu Cuprior 3.
English: In rats administered oral trientines doses, up to 600 mg/kg/day for 26 weeks, histopathology revealed a dose-related incidence and severity of focal chronic interstitial pneumonitis accompanied by fibrosis of the alveolar wall.
Maltese: F'firien li ngħataw dożi ta' trientine orali, sa 600 mg/kg/jum għal 26 ġimgħa, l-istopatoloġija wriet inċidenza relatata mad-doża u severità ta' pnewmonite interstizjali kronika fokali akkumpanjata minn fibrożi tal-ħajt alveolari.
English: Dogs receiving oral doses of trientine up to 300 mg/kg/day, showed neurological and/or musculo-skeletal clinical symptoms (abnormal gait, ataxia, weak limbs, body tremors) in repeat-dose toxicity studies, attributed to the copper-depleting activity of trientine.
Maltese: Il-klieb li rċivew dożi orali ta' trientine sa 300 mg/kg/jum, urew sintomi newroloġiċi u/jew muskoluskeletriċi (mixja anormali, dirgħajn dgħajfa, rogħda fil-ġisem) fi studji ta' effett tossiku minn dożi ripetuti, attribwiti lejn l-attività tat-tnaqqis tar-ram ta' trientine.
English: Distribution Little is known on the distribution of trientine in organs and tissues.
Maltese: Distribuzzjoni Hemm ftit informazzjoni dwar id-distribuzzjoni ta' trientine fl-organi u fit-tessuti.
English: This maximises the absorption of trientine and reduces the likelihood of the medicinal product binding to metals in the gastrointestinal tract.
Maltese: Dan jimassimizza l-assorbiment ta' trientine u jnaqqas il-probabbiltà li l-prodott mediċinali jeħel ma' metalli fl-apparat gastrointestinali.
English: Each film-coated tablet (tablet) contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Maltese: Kull pillola miksija b'rita (pillola) fiha trientine tetrahydrochloride ekwivalenti għal 150 mg trientine.
English: Cuprior 150 mg film-coated tablets trientine
Maltese: Cuprior 150 mg pilloli miksijin b'rita trientine
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta᾽ referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: The dose is usually between 225 mg and 600 mg per day (1½ to 4 film-coated tablets) in 2 to 4 divided doses.
Maltese: Id-doża normalment tkun bejn 225 mg u 600 mg kull jum (1½ sa 4 pilloli miksijin b'rita) f'2 sa 4 dożi maqsumin.
English: The usual total daily dose is between 225 and 600 mg (1½ to 4 tablets daily), which will be divided into 2 to 4 smaller doses to be taken during the day.
Maltese: Id-doża totali normali ta' kuljum hija bejn 225 u 600 mg (1½ sa 4 pilloli kuljum), li mbagħad tinqasam f'2 sa 4 dożi iżgħar li għandhom jittieħdu matul il-ġurnata.
English: The most reliable index for monitoring therapy is the determination of serum free copper which is calculated using the difference between the total copper and the ceruloplasmin-bound copper (normal level of free copper in the serum is usually 100 to 150 microgram/L).
Maltese: L-aktar indiċi affidabbli għal terapija ta' monitoraġġ huwa d-determinazzjoni tar-ram ħieles fis-seru li jiġi kkalkulat bl-użu tad-differenza bejn ir-ram totali u r-ram li jeħel ma' ċeruloplasmin (il-livell normali tar-ram ħieles fis-seru normalment huwa ta' 100 sa 150 mikrogramma/L).
English: MAT may also participate to the overall clinical activity of Cuprior, however the extent of MAT to the overall effect of Cuprior on copper levels remains to be determined.
Maltese: MAT jista' wkoll jipparteċipa għall-attività klinika globali ta' Curprior, madankollu, il-limitu ta' MAT għall-effett globali ta' Cuprior fuq il-livelli tar-ram għadu mhux determinat.
English: Not known: iron deficiency anaemia.
Maltese: Mhux magħruf: anemija ta' defiċjenza ta' ħadid.
English: Chronic over treatment can lead to copper deficiency and reversible sideroblastic anaemia.
Maltese: Kura żejda kronika tista' twassal għal defiċjenza tar-ram u anemija sideroblastika reversibbli.
English: Overall, trientine has shown positive effects in in vitro genotoxicity studies, including the Ames test and genotoxicity tests in mammalian cells.
Maltese: B'mod globali, trientine wera effetti pożittivi fi studji ta' effett tossiku fuq il-ġeni in vitro, inkluż ittest Ames u t-testijiet ta' effett tossiku fuq il-ġeni f'ċelluli tal-mammiferi.
English: Cuprior is a medicine used to treat Wilson's disease that contains the active substance trientine.
Maltese: Cuprior huwa mediċina li jintuża biex tikkura l-marda ta' Wilson li fih is-sustanza attiva trientine.
English: - stomach upsets and discomfort, including severe stomach pains (duodenitis)
Maltese: - taqlib u skumdità tal-istonku, inkluż uġigħ fl-istonku sever (duodenite)
English: Pack size: 72 or 96 film-coated tablets.
Maltese: Daqs tal-pakkett: 72 jew 96 pillola miksija b'rita.
English: You and your doctor should fully discuss the potential benefits of treatment whilst considering any possible risks that there may be.
Maltese: Inti u t-tabib tiegħek għandkom tiddiskutu b'mod sħiħ il-benefiċċji potenzjali tal-kura waqt li tikkunsidraw xi riskji possibbli li jista' jkun hemm.
English: Uncommon: skin rash, pruritus, erythema.
Maltese: Mhux komuni: raxx tal-ġilda, ħakk, eritema.
English: Cuprior is available in packs containing 72 or 96 film-coated tablets.
Maltese: Cuprior huwa disponibbli f'pakketti li jkun fihom Pakkett ta' 72 jew 96 pillola miksija b'rita.
English: Taking into account that trientine has irritating properties, it was estimated that the observed chronic interstitial pneumonitis was explained by a cytotoxic effect of trientine upon accumulation into bronchiolar epithelial cells and alveolar pneumocytes.
Maltese: Meta jiġi kkunsidrat li trientine għandu karatteristiċi irritanti, ġie stmat li l-pnewmonite interstizjali kronika osservata ġiet spjegata b'effett ċitotossiku ta' trientine fuq l-akkumulazzjoni fiċ-ċelluli epiteljali bronkjolari u fil-pnewmoċiti alveolari.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta᾽ farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: There is no antidote for trientine acute overdose.
Maltese: M'hemm l-ebda antidotu għal doża eċċessiva akuta bi trientine.
English: In vivo, trientine was however negative in the mouse micronucleus test.
Maltese: Madankollu, in vivo, trientine kien negattiv fit-test ta' mirkonukleu tal-ġurdien.
English: The rat NOAEL was considered 50 mg/kg/day for females, a NOAEL was not established for males.
Maltese: In-NOAEL tal-firien ġie kkunsidrat 50 mg/kg/jum għan-nisa, ma ġiex stabbilit NOAEL għall-irġiel.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains trientine tetrahydrochloride equivalent to 150 mg trientine.
Maltese: Kull pillola miksija b'rita fiha trientine tetrahydrochloride ekwivalenti għal 150 mg trientine.
English: The recommended doses of Cuprior are expressed as mg of trientine base (i.e. not in mg of the trientine tetrahydrochloride salt).
Maltese: Id-dożi rakkomandati ta' Cuprior huma espressi bħala mg ta' bażi ta' trientine (jiġifieri, mhux f'mg tal-melħ trientine tetrahydrochloride).
English: How to take Cuprior
Maltese: X'fih Cuprior
English: Cuprior is for oral use.
Maltese: Cuprior huwa għal użu orali.
English: Cuprior is given to adults, adolescents and children aged 5 years and over who cannot tolerate another medicine that is used to treat this disease, called penicillamine.
Maltese: Cuprior jingħata lill-adulti, l-adoloxxenti u t-tfal minn età 5 snin 'il fuq li ma jistgħux jittolleraw mediċina oħra li tintuża biex tikkura din il-marda, li tissejjaħ peniċillamina.
English: Genotoxicity
Maltese: FARMAĊEWTIKU
English: Linearity/non-linearity Plasma exposures in humans have shown a linear relationship with oral doses of trientine.
Maltese: Linearità/nuqqas ta' linearità L-esponimenti tal-plażma fil-bniedem urew relazzjoni lineari mad-dożi orali ta' trientine.
English: Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq is-sistema riproduttiva, li probabbli kien riżultat ta' defiċjenza tar-ram indotta minn trientine (ara sezzjoni 5.3).
English: Factors which need to be born in mind include the risks associated with the disease itself, the risk of those alternative treatments which are available and the possible teratogenic effects of trientine (see section 5.3).
Maltese: Il-fatturi li għandhom jiġu kkunsidrati jinkludu r-riskji assoċjati mal-marda nnifisha, ir-riskju ta' dawk il-kuri alternattivi li huma disponibbli u l-effetti teratoġeniċi possibbli ta' trientine (ara sezzjoni 5.3).
English: Lupus-like reactions (symptoms may include persistent rash, fever, joint pain, and tiredness) have been reported in some patients switched to trientine medicine after penicillamine medicine.
Maltese: Ġew irrappurtati reazzjonijiet bħal tal-lupus (is-sintomi jistgħu jinkludu raxx persistenti, deni, uġigħ fil-ġogi, u għeja) f'xi pazjenti li qelbu għal mediċina bi trientine wara mediċina b'peniċillamina.
English: NAME OF THE MEDICINAL PRODUCT Cuprior 150 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Cuprior 150 mg pilloli miksijin b'rita
English: Pregnancy There is a limited amount of data from the use of trientine in pregnant women.
Maltese: Tqala Hemm data limitata dwar l-użu ta'trientine f'nisa tqal.
English: This medicine is not recommended for children aged below 5 years of age.
Maltese: Din il-mediċina mhijiex rakkomandata fit-tfal minn età 5 snin jew inqas.
English: 96 film-coated tablets
Maltese: 96 pillola miksija b'rita
English: EXP
Maltese: DELPHARM
English: You can find the information also when flashing the QR code below with a smartphone or via the website QR code to be included http://www.cuprior.com
Maltese: Tista' wkoll issib l-informazzjoni meta turi l-kodiċi QR ta' hawn taħt bl-ismartphone jew permezz tassit elettoniku għandu jiġi inkluż il-kodiċi QR http://www.cuprior.com
English: Trientine and its metabolites are rapidly excreted in the urine, although low levels of trientine could still be detected in the plasma after 20 hours.
Maltese: Trientine u l-metaboliti tiegħu jiġu eliminati malajr fl-awrina, għalkemm xorta jistgħu jiġu identifikati livelli baxxi ta' trientine fil-plażma wara 20 siegħa.
English: Positive results for sensitization potential in Guinea pig maximization tests were reported.
Maltese: Ġew irrappurtati riżultati pożittivi għal potenzjal ta' sensitizzazzjoni f'testijiet ta' massimizzazzjoni fuq fniek tal-Indi.
English: Not known (frequency cannot be estimated from available data)
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: When switching a patient from another formulation trientine, caution is advised because doses expressed in trientine base may not be equivalent (see section 4.2).
Maltese: Meta teqleb pazjent minn formulazzjoni trientine oħra, hija rakkomandata l-kawtela għax id-dożi espressi f'bażi ta' trientine jistgħu ma jkunux ekwivalenti (ara sezzjoni 4.2).
English: Preclinical data obtained with trientine have shown adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use as follows:
Maltese: Tagħrif ta' qabel l-użu kliniku bi trientine wera effetti mhux mixtieqa li ma dehrux waqt studji kliniċi, iżda dehru f'annimali f'livelli ta' esponiment simili għal-livelli ta' esponiment kliniku u b'rilevanza possibbli għall-użu kliniku kif spjegat:
English: The microscopic changes in lung were considered indicative of a persistent inflammatory reaction or persistent toxic effect on alveolar cells.
Maltese: It-tibdil mirkoskopiku fil-pulmun ġie kkunsidrat indikattiv ta' reazzjoni infjammatorja persistenti jew effett tossiku persistenti fuq iċ-ċelluli alveolari.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista᾽ twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tarriskji).
English: - skin rashes - itching
Maltese: - raxx tal-ġilda - ħakk
English: Patients receiving Cuprior should remain under regular medical supervision and be monitored for appropriate control of symptoms and copper levels in order to optimise the dose (see section 4.2).
Maltese: Il-pazjenti li jirċievu Curprior għandhom jibqgħu taħt superviżjoni medika regolari u għandhom jiġu mmonitorjati għal kontroll xieraq ta' sintomi u livelli tar-ram sabiex tiġi ottimizzata d-doża (ara sezzjoni 4.2).
English: Yellow, 16 mm x 8 mm oblong film-coated tablet with a score line on each side.
Maltese: Pillola miksija b'rita safra, 16 mm x 8 mm rettangolari b'sinjal imnaqqax fuq kull naħa.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali soġġett għal riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Tablet film-coating:
Maltese: Grupp farmakoterapewtiku:
English: Trientine is a copper-chelating agent whose principal mechanism of action is to eliminate absorbed copper from the body by forming a stable complex that is then eliminated through urinary excretion.
Maltese: Trientine huwa aġent kelanti tar-ram li l-mekkaniżmu ta' azzjoni prinċipali tiegħu huwa li jelimina rram assorbit mill-ġisem bili jifforma kumpless stabbli li mbagħad jiġi eliminat permezz ta' eskrezzjoni fl-awrina.
English: Iron supplements may be necessary in case of iron deficiency anaemia and should be administered at a different time (see section 4.5).
Maltese: Is-supplimenti tal-ħadid jistgħu jkunu neċessarji f'każ ta' anemija ta' defiċjenza ta' ħadid u għandhom jingħataw f'ħin differenti (ara sezzjoni 4.5).
English: A large overdose of 40 g of trientine base resulted in selflimiting dizziness and vomiting with no other clinical sequelae or significant biochemical abnormalities reported.
Maltese: Doża eċċessiva kbira ta' 40 g ta' bażi ta' trientine, irriżultat fi sturdament u rimettar li jillimita lilu nnifsu mingħajr l-ebda sintomi kliniċi oħrajn jew anormalitajiet bijokimiċi sinifikanti rrappurtati.
English: 72 film-coated tablets
Maltese: 72 pillola miksija b'rita
English: Since chelation therapy leads to an increase in urinary copper levels, this may/will not give an accurate reflection of the excess copper load in the body but may be a useful measure of treatment compliance.
Maltese: Trientine nstab li jnaqqas il-livelli tal-ħadid fis-seru, possibbilment billi jnaqqas l-assorbiment tiegħu, u jistgħu jkunu meħtieġa supplimenti tal-ħadid.
English: The following adverse reactions have been reported with the use of trientine for Wilson's disease.
Maltese: Ġew irrappurtati r-reazzjonijiet avversi li ġejjin bl-użu ta' trientine għall-marda ta' Wilson.
English: 50 mg/kg/day resulting in safety margins of about 4 in males and 17 in females, towards human therapeutic exposures.
Maltese: In-NOAEL ġie stabbilit b'50 mg/kg/jum li jirriżulta f'marġini ta' sigurtà ta' madwar 4 fl-irġiel u 17 fin-nisa, lejn esponimenti terapewtiċi fil-bniedem.
English: Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size
Maltese: Għamla farmaċewtika
English: It is available as tablets (0.088, 0.18, 0.35, 0.7 and 1.1 mg).
Maltese: Jiġi bħala pilloli (0.088, 0.18, 0.35, 0.7 u 1.1 mg).
English: The full EPAR for Pramipexole Accord 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: The maximum daily dose is three 1.1 mg tablets.
Maltese: Id-doża massima ta' kuljum hi tliet pilloili ta' 1.1 mg.
English: Pramipexole Accord is a ‘generic medicine'.
Maltese: Pramipexole Accord huwa ‘mediċina ġenerika'.
English: The active substance in Pramipexole Accord, pramipexole, is a dopamine agonist (a substance that imitates the action of dopamine).
Maltese: Is-sustanza attiva fi Pramipexole Accord, il-pramipexole, hija agonista tad-dopamina (sustanza li timita l-azzjoni tad-dopamina).
English: The starting dose is one 0.088 mg tablet three times a day.
Maltese: Id-doża inizjali hija pillola waħda ta' 0.088 mg tliet darbiet kuljum.
English: Pramipexole Accord is used to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Maltese: Pramipexole Accord jintuża għall-kura tas-sintomi tal-marda ta' Parkinson, disturb mentali progressiv li jikkawża rogħda, dewmien fil-movimenti u ebusija muskolari.
English: Pramipexole Accord pramipexole
Maltese: Aktar tagħrif dwar Pramipexole Accord
English: The CHMP concluded that, in accordance with EU requirements, Pramipexole Accord has been shown to have comparable quality and to be bioequivalent to Mirapexin.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Pramipexole Accord għandu kwalità kumparabbli u li hu bijoekwivalenti għal Mirapexin.
English: This means that Pramipexole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Mirapexin.
Maltese: Dan ifisser li Pramipexole Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Mirapexin.
English: This is a summary of the European public assessment report (EPAR) for Pramipexole Accord.
Maltese: Dan huwa sommarju tar-rappport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pramipexole Accord.
English: Because Pramipexole Accord 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: Peress li Pramipexole Accord huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, tqies li l-benefiċċji u r-riskji huma l-istess bħal dawk tal-mediċina ta' referenza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pramipexole Accord on 30 September 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pramipexole Accord fit-30 ta' Settembru 2011.
English: Pramipexole Accord is a medicine that contains the active substance pramipexole.
Maltese: Pramipexole Accord huwa mediċina li fiha s-sustanza attiva pramipexole.