FrancophonIA/ELRC3.0 huggingface dataset:
English: No particular studies are reported on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency, therefore Stalevo therapy should be administered cautiously to patients in severe renal impairment including those receiving dialysis therapy (see section 5.2).
Maltese: Ma ġew irrappurtati l-ebda studji partikolari dwar il-farmakokinetika ta' levodopa u carbidopa f'pazjenti b'insuffiċjenza renali, għalhekk terapija b'Stalevo għandha tingħata b'kawtela lill-pazjenti b'insuffiċjenza renali severa inkluż dawk li qed jirċievu terapija b'dijalisi (ara sezzjoni 5.2).
English: Film-coating of 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg and 200/50/200 mg: Glycerol (85 per cent) (E422)
Maltese: Kisja b'rita ta' 75/18.75/200 mg, 125/31.25/200 mg, 175/43.75/200 mg u 200/50/200 mg:
English: Management of acute overdose with Stalevo therapy is similar to acute overdose with levodopa.
Maltese: L-immaniġġjar ta' doża eċċessiva akuta b'terapija ta' Stalevo hija simili għal doża eċċessiva b'levodopa.
English: - Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg of levodopa, 43.75 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 175 mg/43.75 mg/200 mg fiha 175 mg ta' levodopa, 43.75 mg ta' carbidopa u 200 mg ta' entacapone.
English: Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Maltese: Entacapone f'doża għolja jista' jaffettwa l-assorbiment ta' carbidopa.
English: - Each Stalevo 100 mg/25 mg/200 mg tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 100 mg/25 mg/200 mg fiha 100 mg ta' levodopa, 25 mg ta'carbidopa u 200 mg ta' entacapone.
English: - Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola Stalevo 50 mg/12.5 mg/200 mg fiha 50 mg ta' levodopa, 12.5 mg ta'carbidopa u 200 mg ta' entacapone.
English: Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Stalevo (see section
Maltese: Jista' jkun hemm logħob tal-ażżard patoloġiku, żieda fil-libido, ipersesswalità, infiq jew xiri kompulsiv, ikel bl-addoċċ u b'mod kompulsiv f'pazjenti mogħtija agonisti ta' dopamine u/jew trattamenti dopaminerġiċi oħrajn li fihom levodopa inkluż Stalevo (ara sezzjoni 4.4).
English: Absorption/distribution: There are substantial inter- and intra-individual variations in the absorption of levodopa, carbidopa and entacapone.
Maltese: Hemm varjazzjonijiet inter- u intra-individwali sostanzjali fl-assorbiment ta' levodopa, carbidopa u entacapone.
English: Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Maltese: Stalevo fih tliet sustanzi attivi (levodopa, carbidopa u entacapone) f'pillola waħda miksija b'rita.
English: Serious events of gastrointestinal haemorrhage (uncommon) and angioedema (rare) have been identified from the clinical trials with Stalevo or entacapone combined with levodopa/DDC inhibitor.
Maltese: Avvenimenti serji ta' emorraġija gastro-intestinali (mhux komuni) u anġjoedima (rari) kienu identifikati mill-provi kliniċi b'Stalevo jew entacapone flimkien ma' levodopa/inibitur ta' DDC.
English: Stalevo 175 mg/43.75 mg/200 mg tablet comes in five different pack sizes (10, 30, 100, 130 or 175 tablets).
Maltese: Pilloli Stalevo 175 mg/43.75 mg/200 mg huma disponibbli f'ħames daqsijiet ta' pakketti differenti (10, 30, 100, 130 jew 175 pillola).
English: 50 mg/12.5 mg/200 mg EU/1/03/260/001-004 EU/1/03/260/013
Maltese: 50 mg/12.5 mg/200 mg EU/1/03/260/001-004
English: Other antiparkinsonian medicinal products: To date there has been no indication of interactions that would preclude concurrent use of standard antiparkinsonian medicinal products with Stalevo therapy.
Maltese: Prodotti mediċinali kontra l-marda ta' Parkinson oħra: S'issa ma kienx hemm indikazzjoni ta' interazzjonijiet li ma jippermettux l-użu flimkien ta' prodotti mediċinali standard kontra l-marda ta' Parkinson ma' terapija b'Stalevo.
English: Stalevo contains sucrose (1.2 mg/tablet).
Maltese: Stalevo fih sucrose (1.2 mg/pillola).
English: How to take Stalevo
Maltese: Mediċini oħra u Stalevo
English: Tel: + 34 91 599 86 01
Maltese: Orion Pharma S.L. Tel: + 34 91 599 86 01
English: Paediatric population: The safety and efficacy of Stalevo in children aged below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Stalevo fit-tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: Stalevo contains sucrose (1.6 mg/tablet).
Maltese: Stalevo fih sucrose (1.6 mg/pillola).
English: Stalevo contains sucrose (1.4 mg/tablet).
Maltese: Stalevo fih sucrose (1.4 mg/pillola).
English: Stalevo 75 mg/18.75 mg/200 mg: light brownish red, oval film-coated tablets marked with ‘LCE 75' on one side.
Maltese: Stalevo 75 mg/18.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, immarkati b'‘LCE 75' fuq naħa waħda.
English: Correspondingly, the daily OFF time decreased by 18% on entacapone and by 5% on placebo.
Maltese: B'hekk, il-perjodu OFF ta' kuljum naqas b'18% b'entacapone u b'5% bil-plaċebo.
English: b. When initiating Stalevo therapy for patients currently treated with entacapone and levodopa/carbidopa in doses not equal to Stalevo tablets (50 mg/12.5 mg/200 mg or 75 mg/18.75 mg/200 mg or 100 mg/25 mg/200 mg or 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg or 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg), Stalevo dosing should be carefully titrated for optimal clinical response.
Maltese: Meta tinbeda terapija b'Stalevo għall-pazjenti li bħalissa qed jiġu kkurati b'entacapone u b'levodopa/carbidopa f'dożi mhux ugwali għall-pilloli Stalevo (50 mg/12.5 mg/200 mg, jew 75 mg/18.75 mg/200 mg jew 100 mg/25 mg/200 mg jew 125 mg/31.25 mg/200 mg jew 150 mg/37.5 mg/200 mg jew 175 mg/43.75 mg/200 mg jew 200 mg/50 mg/200 mg), l-iddożar ta' Stalevo għandu jiġi ttitrat b'kawtela għal respons kliniku ottimali.
English: Stalevo 75 mg/18.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Stalevo 75 mg/18.75 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Therefore, Stalevo and iron preparations should be taken at least 2-3 hours apart (see section 4.8).
Maltese: Għalhekk, Stalevo u preparazzjonijiet li fihom il-ħadid għandhom jittieħdu tal-inqas 2-3 sigħat bogħod minn xulxin (ara sezzjoni 4.8).
English: How to transfer patients taking levodopa/DDC inhibitor (carbidopa or benserazide) preparations and entacapone tablets to Stalevo a. Patients who are currently treated with entacapone and with standard release levodopa/carbidopa in doses equal to Stalevo tablet strengths can be directly transferred to corresponding Stalevo tablets.
Maltese: Konvulżjonijiet seħħew b'mod rari b'levodopa/carbidopa; iżda relazzjoni kawżali ma' terapija b'levodopa/carbidopa ma ġietx stabbilita.
English: For example, a patient taking one tablet of 50 mg/12.5 mg of levodopa/carbidopa with one tablet of entacapone 200 mg four times daily can take one 50 mg/12.5 mg/200 mg Stalevo tablet four times daily in place of their usual levodopa/carbidopa and entacapone doses.
Maltese: Per eżempju, pazjent li qed jieħu pillola waħda ta' 50 mg/12.5 mg ta' levodopa/carbidopa ma' pillola waħda ta' entacapone 200 mg erba' darbiet kuljum jista' jieħu pillola waħda ta' 50 mg/12.5 mg/200 mg Stalevo erba' darbiet kuljum flok id-dożi tas-soltu ta' levodopa/carbidopa u entacapone.
English: Stalevo 175 mg/43.75 mg/200 mg: light brownish red, oval, unscored film-coated tablets marked with ‘LCE 175' on one side.
Maltese: Stalevo 175 mg/43.75 mg/200 mg: pilloli ovali, ta' lewn aħmar fil-kannella ċar, mingħajr sinjal imnaqqax, immarkati b'‘LCE 175' fuq naħa waħda.
English: However, a longer dosing interval of Stalevo may be considered for patients who are receiving dialysis therapy (see section 4.2).
Maltese: Madanakollu, jista' jiġi kkunsidrat intervall ta' dożaġġ ta' Stalevo itwal għall-pazjenti li qed jirċievu terapija b'dijalisi (ara sezzjoni 4.2).
English: - Each Stalevo 200 mg/50 mg/200 mg tablet contains 200 mg of levodopa, 50 mg of carbidopa and 200 mg of entacapone.
Maltese: - Kull pillola ta' Stalevo 200 mg/50 mg/200 mg fiha 200 mg ta' levodopa, 50 mg ta'carbidopa u 200 mg ta' entacapone.
English: Dopamine does not cross the blood-brain barrier.
Maltese: Dopamine ma jaqsamx il-barriera ta' bejn id-demm u l-moħħ.
English: - The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose and titanium dioxide (E171).
Maltese: - Is-sustanzi fil-kisja b'rita huma glycerol (85% fil-mija) (E422), hypromellose, magnesium stearate, polysorbate 80, iron oxide aħmar (E172), sucrose u titanium dioxide (E171).
English: Stalevo 175 mg/43.75 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Stalevo 175 mg/43.75 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Stalevo 175 mg/43.75 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Stalevo 175 mg/43.75 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: EU/1/03/260/034 10 film-coated tablets EU/1/03/260/035 30 film-coated tablets EU/1/03/260/036 100 film-coated tablets EU/1/03/260/037 130 film-coated tablets EU/1/03/260/038 175 film-coated tablets
Maltese: EU/1/03/260/034 10 pilloli miksija b'rita EU/1/03/260/035 30 pillola miksija b'rita EU/1/03/260/036 100 pillola miksija b'rita EU/1/03/260/037 130 pillola miksija b'rita EU/1/03/260/038 175 pillola miksija b'rita
English: Stalevo 125 mg/31.25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Stalevo 125 mg/31.25 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: EU/1/03/260/009 10 film-coated tablets EU/1/03/260/010 30 film-coated tablets EU/1/03/260/011 100 film-coated tablets EU/1/03/260/012 250 film-coated tablets EU/1/03/260/015 175 film-coated tablets EU/1/03/260/018 130 film-coated tablets
Maltese: EU/1/03/260/009 10 pilloli miksija b'rita EU/1/03/260/010 30 pillola miksija b'rita EU/1/03/260/011 100 pillola miksija b'rita EU/1/03/260/012 250 pillola miksija b'rita EU/1/03/260/015 175 pillola miksija b'rita EU/1/03/260/018 130 pillola miksija b'rita
English: EU/1/03/260/005 10 film-coated tablets EU/1/03/260/006 30 film-coated tablets EU/1/03/260/007 100 film-coated tablets EU/1/03/260/008 250 film-coated tablets EU/1/03/260/014 175 film-coated tablets EU/1/03/260/017 130 film-coated tablets
Maltese: EU/1/03/260/005 10 pilloli miksija b'rita EU/1/03/260/006 30 pillola miksija b'rita EU/1/03/260/007 100 pillola miksija b'rita EU/1/03/260/008 250 pillola miksija b'rita EU/1/03/260/014 175 pillola miksija b'rita EU/1/03/260/017 130 pillola miksija b'rita
English: Stalevo 50 mg/12.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Stalevo 50 mg/12.5 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: EU/1/03/260/029 10 film-coated tablets EU/1/03/260/030 30 film-coated tablets EU/1/03/260/031 100 film-coated tablets EU/1/03/260/032 130 film-coated tablets EU/1/03/260/033 175 film-coated tablets
Maltese: EU/1/03/260/029 10 pilloli miksija b'rita EU/1/03/260/030 30 pillola miksija b'rita EU/1/03/260/031 100 pillola miksija b'rita EU/1/03/260/032 130 pillola miksija b'rita EU/1/03/260/033 175 pillola miksija b'rita
English: Stalevo 150 mg/37.5 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Stalevo 150 mg/37.5 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: Stalevo 150 mg/37.5 mg/200 mg film-coated tablets levodopa/carbidopa/entacapone
Maltese: Stalevo 150 mg/37.5 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Stalevo 200 mg/50 mg/200 mg: dark brownish red, oval, unscored film-coated tablets marked with ‘LCE 200' on one side.
Maltese: Stalevo 200 mg/50 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ovali, ta' lewn aħmar skur fil-kannella immarkati b'‘LCE 200' fuq naħa waħda.
English: Stalevo 100 mg/25 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Stalevo 100 mg/25 mg/200 mg pilloli miksija b'rita Levodopa/carbidopa/entacapone
English: EU/1/03/260/024 10 film-coated tablets EU/1/03/260/025 30 film-coated tablets EU/1/03/260/026 100 film-coated tablets EU/1/03/260/027 130 film-coated tablets EU/1/03/260/028 175 film-coated tablets
Maltese: EU/1/03/260/024 10 pilloli miksija b'rita EU/1/03/260/025 30 pillola miksija b'rita EU/1/03/260/026 100 pillola miksija b'rita EU/1/03/260/027 130 pillola miksija b'rita EU/1/03/260/028 175 pillola miksija b'rita
English: Serious hepatitis with mainly cholestatic features, rhabdomyolysis and neuroleptic malignant syndrome may occur with Stalevo although no cases have been identified from the clinical trial data.
Maltese: B'Stalevo jistgħu jseħħu epatite serja l-aktar b'karatteristiċi kolestatiċi, rabdomijolisi u sindrome newrolettiku malinn għalkemm ma kienu identifikati l-ebda każijiet mid-data tal-prova klinika.
English: Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day.
Maltese: Għaxar pilloli ta' Stalevo 150 mg/37.5 mg/200 mg huma ekwivalenti għal
English: EU/1/03/260/001 10 film-coated tablets EU/1/03/260/002 30 film-coated tablets EU/1/03/260/003 100 film-coated tablets EU/1/03/260/004 250 film-coated tablets EU/1/03/260/013 175 film-coated tablets EU/1/03/260/016 130 film-coated tablets
Maltese: EU/1/03/260/001 10 pilloli miksija b'rita EU/1/03/260/002 30 pillola miksija b'rita EU/1/03/260/003 100 pillola miksija b'rita EU/1/03/260/004 250 pillola miksija b'rita EU/1/03/260/013 175 pillola miksija b'rita EU/1/03/260/016 130 pillola miksija b'rita
English: Stalevo 200 mg/50 mg/200 mg film-coated tablets Levodopa/carbidopa/entacapone
Maltese: Stalevo 200 mg/50 mg/200 mg pilloli miksija b'rita levodopa/carbidopa/entacapone
English: Experience with Stalevo in patients under 18 years is limited.
Maltese: Esperjenza b'Stalevo f'pazjenti taħt 18-il sena hija limitata.
English: Stalevo 100 mg/25 mg/200 mg: brownish or greyish red, oval, unscored film-coated tablets marked with ‘LCE 100' on one side.
Maltese: Stalevo 100 mg/25 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, ovali u mmarkati b'‘LCE 100' fuq naħa waħda.
English: EU/1/03/260/019 10 film-coated tablets EU/1/03/260/020 30 film-coated tablets EU/1/03/260/021 100 film-coated tablets EU/1/03/260/022 130 film-coated tablets EU/1/03/260/023 175 film-coated tablets
Maltese: EU/1/03/260/019 10 pilloli miksija b'rita EU/1/03/260/020 30 pillola miksija b'rita EU/1/03/260/021 100 pillola miksija b'rita EU/1/03/260/022 130 pillola miksija b'rita EU/1/03/260/023 175 pillola miksija b'rita
English: If you get any side effects, talk to your doctor or pharmacist.
Maltese: L-effetti ta' Stalevo jistgħu jiġu mdgħajjfa minn ċertu mediċini.
English: - Periodic evaluation of hepatic, haematopoietic, cardiovascular and renal function is recommended during extended therapy with Stalevo.
Maltese: - Hija rrakkomandata evalwazzjoni perjodika tal-funzjoni epatika, emopoetika, kardjovaskulari u renali waqt terapija mtawwla b'Stalevo.
English: However, caution should be exercised when these medicinal products are used concomitantly with Stalevo (see sections 4.3 and 4.4).
Maltese: Iżda, għandha tintuża kawtela meta dawn il-prodotti mediċinali jintużaw flimkien ma' Stalevo (ara sezzjonijiet 4.3 u 4.4).
English: Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50' on one side.
Maltese: Stalevo 50 mg/12.5 mg/200 mg: pilloli miskija b'rita, bla sinjal imnaqqax, ta' lewn aħmar fil-kannella jew fil-griż, tondi, ibbuzzati u mmarkati b'‘LCE 50' fuq naħa waħda.
English: Taking into account the PRAC Assessment Report on the PSURs for carbidopa/entacapone/levodopa, the scientific conclusions of the CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal carbidopa/entacapone/levodopa, il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Orion Pharma d.o.o.
Maltese: Orion Pharma AB
English: London, 11 July 2007 EMEA/CHMP/75066/2007
Maltese: Londra, 11 ta' Lulju 2007 EMEA/CHMP/75066/2007
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Bengt Ljungberg.
Maltese: IrRapporteur kien Dr Ian Hudson l-ko-Rapporteur kien Dr Bengt Ljungberg.
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Maltese: 1 Artikolu 29(4) tad-Directtiva 2001/83/KE, kif emendata.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Ciprofloxacin Hikma and associated names International Non-Proprietary Name (INN): Ciprofloxacin BACKGROUND INFORMATION Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion, is an antibiotic belonging to the quinolone family, effective in vitro against a large number of Gram-negative aerobic bacteria as well as against some Gram-positive organisms.
Maltese: Ciprofloxacin Hikma u l-ismijiet assoċjati li jiġi bħala soluzzjoni għall-infużjoni ta' 2 mg/ml, hu antibijotiku li jagħmel parti mill-familja tal-quinolone li in vitro huwa effettiv kontra numru kbir ta' batterji aerobiċi Gram-negative aerobic bacteria kif ukoll kontra xi organiżmi Gram-positive.
English: The Reference Member State was the Netherlands and the Concerned Member States were Austria, Germany, Ireland, Italy, and United Kingdom.
Maltese: L-Istat Membru ta' Referenza kien l-Olanda u lIstati Membri konċernati kienu l-Awstrija, il-Ġermanja, l-Irlanda, l-Italja, u r-Renju Unit.
English: Significant differences have been identified with regard to dose in urinary tract infections and of the maximum adult daily dose.
Maltese: Ġew identifikati differenzi sinjifikanti dwar id-doża fl-infezzjonijiet fil-pajp ta' l-awrina u dwar id-doża massima ta' kuljum fl-adulti.
English: In addition, it was considered that the applicant should include in the Summary of Product Characteristics (point 5.1) the organisms listed in the breakpoints and susceptibility table relevant to the indications, as per the Note for Guidance on Evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev.1).
Maltese: Barra minn hekk, ġie kkunsidrat li fis-Sommarju tal-Karatteristiċi tal-Prodott (punt 5.1), l-applikant irid jinkludi l-organiżmi elenkati fil-breakpoints u t-tabella dwar is-suxxettibilità li tkun relevanti għall-indikazzjonijiet, kif indikat fin-Nota għall-Gwida fuq l-Evalwazzjoni tal-prodotti mediċinali indikati għat-trattament ta' infezzjonijiet minn batterji (CPMP/EWP/558/95 rev.1).
English: Hikma Farmaceutica Lda.
Maltese: Ciprofloxacin Hikma u ismijiet assoċjati.
English: The arbitration procedure started on 27 July 2006 with the adoption of a list of questions.
Maltese: Il-proċedura ta' l-arbitraġġ inbdiet fis-27 ta' Lulju ta' l-2006 bl-adozzjoni ta' lista ta' mistoqsijiet.
English: The Marketing Authorisation Holder provided written explanations on 20 October 2006.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq ta spjegazzjoni bil-miktub fil-20 ta' Ottubru ta' l-2006.
English: The Netherlands referred the reasons for disagreement to the EMEA on 7 July 2006.
Maltese: L-Olanda rreferiet ir-raġunijiet għan-nuqqas ta' qbil lill-EMEA fis-7 ta' Lulju ta' l-2006.
English: During their January 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Ciprofloxacin Hikma and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Maltese: Waqt il-laqgħa tiegħu ta' Jannar ta' l-2007, il-CHMP, fid-dawl tat-tagħrif sottomess kollu u fid-dawl taddiskussjoni xjentifika fi ħdan il-Kumitat, kien tal-fehma li l-bilanċ bejn il-benefiċċji u r-riskji kien favorevoli għal Ciprofloxacin Hikma u ismijiet assoċjati, li l-objezzjonijiet imqajma ma għandhomx jimpedixxu l-għoti ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq u li s-Sommarju tal-Karatteristiċi tal-Prodott, it-tikketta u l-fuljett ta' tagħrif ta' l-Istat Membru ta' Referenza għandhom jiġu emendati.
English: submitted applications for mutual recognition of Ciprofloxacin Hikma and associated names, 2 mg/ml solution for infusion on the basis of the marketing authorisation granted by the Netherlands on 12 April 2005.
Maltese: Hikma Farmaceutica Lda. issottomettew żewġ applikazzjonijiet għal rikonoxximent reċiproku Isem Komuni Internazzjonali ta' Ciprofloxacin Hikma u ismijiet assoċjati, f'soluzzjoni għall-injezzjoni ta' 2 mg/ml abbażi ta' l-awtorizzazzjoni għat-tqegħid fis-suq mogħtija lill-Olanda fit-12 ta' April ta' l-2005.
English: The full EPAR for Januvia 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 active substance in Januvia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: Is-sustanza attiva f'Januvia, is-sitagliptina, hija inibitur tad-dipeptidil-peptidażi-4 (DPP 4).
English: Januvia is a medicine that contains the active substance sitagliptin.
Maltese: Januvia huwa mediċina li fiha s-sustanza attiva sitagliptina.
English: Serious side effects reported with Januvia include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Maltese: L-effetti sekondarji serji li ġew irrapportarti bl-użu ta' Januvia inkludew pankreatite (infjamazzjoni talfrixa) u ipersensittività (reazzjonijiet allerġiċi).
English: This is a summary of the European public assessment report (EPAR) for Januvia.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Januvia.
English: Januvia is taken at a dose of 100 mg once a day.
Maltese: Januvia jittieħed f'doża ta' 100 mg darba kuljum.
English: • three additional studies compared Januvia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Maltese: • tliet studji oħra qabblu lil Januvia ma' plaċebo meta żdiedu ma' mediċini oħrajn kontra d-dijabete: il-glimepiride (sulfonilurea oħra), bil-metformina jew mingħajrha, fuq 441 pazjent; it-taħlita talmetformina u r-rosiglitażonu (agonista PPAR gamma) fuq 278 pazjent; u doża stabbli ta' insulina, bil-metformina jew mingħajrha, fuq 641 pazjent.
English: What is Januvia?
Maltese: X'inhu Januvia?
English: Why has Januvia been approved?
Maltese: Għaliex ġie approvat Januvia?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Januvia on 21 March 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Januvia valida fl-Unjoni Ewropea kollha fil-21 ta' Marzu 2007.
English: Januvia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Maltese: Januvia jew plaċebo ntużaw waħedhom f'żewġ studji fuq 1,262 pazjent, bħala żieda mal-metformina fi studju wieħed fuq 701 pazjent, u bħala żieda mal-pijoglitażonu (agonista PPAR-gamma) fi studju fuq 353 pazjent;
English: 0.12% and 0.18%, respectively, in the patients taking placebo.
Maltese: Min-naħa l-oħra għolew b'0.12% u b'0.18% rispettivament f'pazjenti li ħadu l-plaċebo.
English: What is the risk associated with Januvia?
Maltese: X'inhu r-riskju assoċjat ma' Januvia?