FrancophonIA/ELRC3.0 huggingface dataset:
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Maltese: Konklużżjonijiet dwar ir-rilevanza ta' mutazzjonijiet partikolari jew ta'disinni ta' mutazzjonijiet jistgħu jiżdiedu b'aktar data, u hu rrakkomandat li dejjem tikkonsulta sistemi ta' interpretazzjoni kurrenti biex tanaliżża riżultati fuq testijiet ta' reżistenza.
English: Anticonvulsant active substances: concomitant administration of anticonvulsant active substances known as enzymatic inductors (phenytoin, phenobarbital, carbamazepine) with amprenavir may lead to a decrease in the plasma concentrations of amprenavir.
Maltese: Sustanzi attivi kontra l-konvulżjonijiet: l-għoti flimkien ta' sustanzi attivi kontra l-konvulżjonijiet magħrufa bħala inductors ta' l-enżimi (phenytoin, phenobarbital, carbamazepine) ma' amprenavir jistgħu iwasslu għal tnaqqis fil-konċentrazzjoni tal-plażma ta' amprenavir.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, 4.2).
Maltese: IMPOSTI FUQ ID-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FISProdott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I : Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Hepatic impairment: the pharmacokinetics of amprenavir are significantly altered in patients with moderate to severe hepatic impairment.
Maltese: Indeboliment tal-Fwied: ħsara moderata jew serja fil-fwied iġġib bidla sinjifikanti fil-proprjetajiet farmakokinetiċi ta' amprenavir.
English: Hyperbilirubinaemia
Maltese: KIF TAĦŻEN AGENERASE
English: There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Maltese: Ġew irrapurtati każi ta' uġigħ jew indebboliment fil-muskoli, l-aktar f'kura antiretrovirali permezz ta' inibituri protease u analogi tan-nuklejosajd.
English: MARKETING AUTHORISATION NUMBER EU/1/00/148/001
Maltese: FIS-SUQ EU/1/00/148/001
English: Based on data for other CYP3A4 inhibitors, plasma concentrations of midazolam are expected to be significantly higher when midazolam is given orally.
Maltese: Skond informazzjoni minn inibituri oħra ta' CYP3A4, konċentrazzjonijiet ta' midazolam fil-plażma huma mistennija li jkunu ħafna aktar ogħla meta midazolam jingħata mill-ħalq.
English: Immunosuppressants: frequent therapeutic concentration monitoring of immunosuppresant levels is recommended until levels have stabilised as plasma concentrations of cyclosporin, rapamycin and tacrolimus may be increased when co-administered with amprenavir (see section 4.4).
Maltese: Immunosuppressanti: monitoraġġ ta' spiss ta' konċentrazzjonijiet terapewtiċi ta' livelli ta' immunosuppressanti hu rakkomandat sakemm il-livelli jistabbilizzaw ruħhom għaliex konċentrazzjonijiet ta' cyclosporin, rapamycin u tacrolimus fil-plażma jistgħu jiżdiedu meta jingħataw flimkien ma' ampenavir (ara sezzjoni 4.4).
English: Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Maltese: Jerozoimskie 146A 02-305 Warsaw, Poland
English: Nycomed Pharma Sp. z o.o.
Maltese: Nycomed Pharma Sp. z o.o. Al.
English: Albert-Schweitzer Gasse 3 1140 Wien
Maltese: Albert-Schweitzer Gasse 3 1140
English: Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR United Kingdom
Maltese: Sovereign House, Miles Gray Road, Basildon, Essex SS14
English: SI - Slovenia
Maltese: SI - Slovenja
English: S.p.A. Viale Amelia 70 00181 Roma Italy
Maltese: Viale Amelia 70 00181 Roma
English: H-2045 Törökbálint, Tó Park Hungary
Maltese: Törökbálint, Tó Park Hungary
English: m .
Maltese: G.
English: Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020 Wien
Maltese: Janssen - Cilag Pharma GmbH Vorgartenstraße 206b 1020
English: GlaxoSmithKline Pharma GmbH Albert-Schweitzer-Gasse 6 1140 Wien
Maltese: GlaxoSmithKline Pharma GmbH Albert-Schweitzer-Gasse 6 1140
English: Box 552 2003 RN Haarlem Netherlands
Maltese: Swensweg 5, P.O. Box 552 2003 RN Haarlem Netherlands
English: Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Maltese: Mundipharma Oy Rajatorpantie 41 B 01640
English: Praça Duque de Saldanha, 1 - 6ºEdifício Atrium Saldanha, 1050-094 São Jorge de Arroios - Lisboa Portugal
Maltese: Praça Duque de Saldanha, 1 - 6ºEdifício Atrium Saldanha, 1050-094
English: JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 Cologno Monzese (MI) Italy
Maltese: Buonarroti, 23 20093 Cologno Monzese (MI) Italy
English: Plynárenská 7/B Bratislava 82478
Maltese: Johnson & Johnson s.r.o. Plynárenská 7/B Bratislava 82478
English: LV - Latvia
Maltese: LV - Il-Latvja
English: 17-21, rue St. Mathieu (Z.I.)
Maltese: 17-21, rue St.
English: Ethypharm21, rue St. Mathieu (Z.I.)
Maltese: Ethypharm21, rue St.
English: NO - Norway
Maltese: NO - InNorveġja
English: UK - United Kingdom
Maltese: 3FR United Kingdom
English: NL-1507 CC Zaandam Florapark 4 2012 HK Haarlem The Netherlands
Maltese: Zaandam Florapark 4 2012 HK Haarlem The Netherlands
English: IS - Iceland
Maltese: IS - L-islanda
English: LT - Lithuania
Maltese: LT - Il-Litwanja
English: PALLADONE IMMEDIATE RELEASE 1,3 MG
Maltese: IMMEDIATE RELEASE 1,3 MG
English: BG - Bulgaria
Maltese: BG - Il-Bulgarija
English: Capsule, hard
Maltese: Kapsula, iebsa
English: PALLADONE IMMEDIATE RELEASE 2,6 MG
Maltese: IMMEDIATE RELEASE 2,6 MG
English: Molteni Farmaceutici Polska Sp. z o.o.
Maltese: Molteni Farmaceutici Polska Sp. z o.o. 3 Obroncow Modlina St.
English: FI - Finland
Maltese: FI - Il-Finlandja
English: GlaxoSmithKline B.V. Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
Maltese: Huis ter Heideweg 62 NL-3705 LZ Zeist The Netherlands
English: Schalienhoevedreef 20H B- 2800 Mechelen Belgium
Maltese: B- 2800 Mechelen Belgium
English: Mundipharma Pharmaceuticals Srl Via G. Serbelloni, 4
Maltese: Mundipharma Pharmaceuticals Srl Via G.
English: F- 78550 Houdan
Maltese: Mathieu (Z.I.) F- 78550 Houdan
English: Johnson & Johnson d.o.o.
Maltese: Johnson & Johnson d.o.o. Šmartinska 53
English: MUNDIPHARMA 2, rue du Docteur Lombard 92130 Issy-les-Moulineaux France
Maltese: MUNDIPHARMA 2, rue du Docteur Lombard 92130
English: PT - Portugal
Maltese: PT - Il-Portugall
English: BRUNO FARMACEUTICI S.P.A.
Maltese: BRUNO FARMACEUTICI
English: C. F. Tietgens Boulevard 40 5220 ODENSE SØ Denmark
Maltese: C. F. Tietgens Boulevard 40 5220
English: ACINO AG Am Windfeld 35 D-83714 Miesbach Germany
Maltese: Windfeld 35 D-83714 Miesbach Germany
English: SK - Slovakia
Maltese: SK - IsSlovakkja
English: RO - Romania
Maltese: RO - IrRumanija
English: G. L. Pharma GmbH Schloßplatz 1
Maltese: L. Pharma GmbH Schloßplatz 1
English: FR-92500 Rueil Malmaison France
Maltese: Rueil Malmaison France
English: HU - Hungary
Maltese: HU - L-Ungerija
English: TEVA PHARMA BELGIUM Laarstraat 16
Maltese: Laarstraat 16
English: DK - Denmark
Maltese: Hvidovre Denmark
English: Strength Pharmaceutical form Route of administration medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
Maltese: Route of administration medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
English: PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Maltese: PS Pharma Service GmbH Lise-Meitner-Str. 10
English: MORFINA LANNACHER 200 MG Comprimidos
Maltese: MORFINA LANNACHER 200
English: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Prolonged-release capsule, hard Oral use
Maltese: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Kapsula li terħi l-mediċina bilmod, iebsa
English: Norpharma A/S Slotsmarken 15 2970 Hørsholm Denmark
Maltese: Norpharma A/S Slotsmarken 15 2970
English: Mundipharma GmbH Apollogasse 16-18 1070 Wien Austria
Maltese: Mundipharma GmbH Apollogasse 16-18 1070
English: Targinact 20 mg/ 10 mg, tabletten met verlengde afgifte 20 and 10 mg Prolonged release tablet
Maltese: Targinact 20 mg/ 10 mg, tabletten met verlengde afgifte 20 and 10 mg
English: MXL 120 MG
Maltese: MXL 120
English: AT - Austria
Maltese: Wien Austria
English: LAVIPHARM HELLAS AE Agias Marinas Str. Paiania Attikis 19002 Greece
Maltese: HELLAS AE Agias Marinas Str.
English: MORFINA LANNACHER 100 MG 100mg coated tablet
Maltese: MORFINA LANNACHER 100 MG 100mg
English: ARCHIMEDES PHARMA IBERICA S.L.
Maltese: ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139
English: Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Maltese: Norpharma Slotsmarken 15 2970
English: HEXAL A/S Kanalholmen 8-12 DK 2650 Hvidovre Denmark
Maltese: HEXAL A/S Kanalholmen 8-12 DK 2650
English: Targinact 10 mg/ 5 mg, tabletten met verlengde afgifte 10 and 5 mg Prolonged release tablet
Maltese: Targinact 10 mg/ 5 mg, tabletten met verlengde afgifte 10 and 5 mg
English: TARGINACT 20 MG/10 MG 21 mg
Maltese: MG/10 MG 21 mg
English: LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE TABLETS
Maltese: LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE
English: Hexal A/S Kanalholmen 8-12 2650 HVIDOVRE Denmark
Maltese: Hexal A/S Kanalholmen 8-12 2650
English: Pharma GmbH Schloβplatz 1
Maltese: G.L. Pharma GmbH Schloβplatz 1
English: EL-Greece
Maltese: EL - Il-Greċja
English: LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS 5 mg
Maltese: MG FILM-COATED, PROLONGED RELEASE TABLETS 5 mg
English: RATIOPHARM GMBH Graf-Arco Strasse 3 Ulm, D-89079
Maltese: GMBH Graf-Arco Strasse 3 Ulm, D-89079
English: MST 200 mg Mundipharma 200 mg Prolonged-release tablet
Maltese: MST 200 mg Mundipharma 200 mg Pillola li terħi il-mediċina bilmod
English: Relimal 200 mg Retardtabletten 200 mg Prolonged-release tablet
Maltese: Relimal 200 mg Retardtabletten 200 mg Pillola li terħi il-mediċina bilmod
English: MORFINA LANNACHER 10 MG 10 mg coated tablet
Maltese: MORFINA LANNACHER 10 MG 10 mg
English: OXYCONTIN 5MG FILMCOATED, PROLONGED RELEASE TABLETS
Maltese: OXYCONTIN 5MG FILMCOATED, PROLONGED RELEASE
English: FI - Finland ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM Germany
Maltese: FI - Il-Finlandja ratiopharm GmbH Graf-Arco-Strasse 3 89079 ULM
English: 100 mg Modified-release granules for oral suspension
Maltese: 100 mg Granuli b'rilaxx modifikat għal sospensjoni orali
English: AT - Austria betapharm Arzneimittel GmbH Kobelweg 95
Maltese: AT - L-Awstrija betapharm Arzneimittel GmbH Kobelweg 95
English: Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten 200 mg Prolonged-release tablet
Maltese: Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten 200 mg
English: FILNARINE SR 200MG PROLONGED RELEASE TABLETS 200 mg Prolonged-release tablet
Maltese: FILNARINE SR 200MG PROLONGED RELEASE TABLETS 200 mg
English: MORFINA LANNACHER 30 MG 30 mg coated tablet
Maltese: MORFINA LANNACHER 30 MG 30 mg
English: Morphin ZWEI PS Pharma 60 mg retard ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Morphin ZWEI PS Pharma 60 mg retard ratiopharm GmbH Graf-Arco-Str.
English: OXYCONTIN 80MG FILMCOATED, PROLONGED RELEASE TABLETS
Maltese: OXYCONTIN 80MG FILMCOATED, PROLONGED RELEASE
English: CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS 5 mg
Maltese: MG PROLONGED-RELEASE TABLETS 5 mg
English: OXYCONTIN 10MG FILMCOATED, PROLONGED RELEASE TABLETS
Maltese: OXYCONTIN 10MG FILMCOATED, PROLONGED RELEASE
English: MSTW 200 mg Krugmann 200 mg Prolonged-release tablet
Maltese: MSTW 200 mg Krugmann 200 mg
English: OXYCONTIN 20MG FILMCOATED, PROLONGED RELEASE TABLETS
Maltese: OXYCONTIN 20MG FILMCOATED, PROLONGED RELEASE
English: SE - Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Maltese: SE - L-Isvezja ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: OXYCONTIN 40MG FILMCOATED, PROLONGED RELEASE TABLETS
Maltese: OXYCONTIN 40MG FILMCOATED, PROLONGED RELEASE
English: Kapanol 100, capsules met gereguleerde afgifte 20 mg 100 mg Prolonged-release capsule Oral use
Maltese: Kapanol 100, capsules met gereguleerde afgifte 20 mg 100 mg
English: 200 mg coated tablet
Maltese: 200 mg Pillola miksija
English: Strength
Maltese: Vantaa
English: 100 mg Prolonged-release tablet betapharm Arzneimittel GmbH Kobelweg 95
Maltese: 100 mg Pillola li terħi il-mediċina bilmod betapharm Arzneimittel GmbH Kobelweg 95
English: G.L.
Maltese: C.F.
English: 2000 mg Modified-release tablet
Maltese: 2000 mg Pillola li terħi il-mediċina b'mod modifikat
English: 100 mg Prolonged-release granules, for oral suspension
Maltese: 100 mg Granuli b'rilaxx prolongat għal sospensjoni orali
English: 100 mg Controlled release granules for oral suspension
Maltese: 100 mg Granuli b'rilaxx ikkontrollat għal sospensjoni orali
English: 13 D-24941 Flensburg Germany
Maltese: Juta Pharma GmbH Gutenbergstr. 13 D-24941 Flensburg Germany
English: Morphin 100 retard Heumann 100 mg Prolonged-release tablet
Maltese: Morphin 100 retard Heumann 100 mg Pillola li terħi il-mediċina bilmod
English: 20 mg/10 mg Prolonged-release tablet
Maltese: MG/10 MG PROLONGED-RELEASE TABLETS
English: 1106, Budapest Hungary
Maltese: Keresztúri út 30-38. 1106, Budapest Hungary
English: GlaxoSmithKline GmbH & Co. KG Theresienhöhe 11
Maltese: GlaxoSmithKline GmbH & Co.
English: Oxycodonhydrochloridratiopharm 5 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodonhydrochloridratiopharm 5 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: TARGINACT 5MG/2,5MG 5.25 mg Prolonged-release tablet
Maltese: TARGINACT 5MG/2,5MG 5.25 mg
English: 20 mg/dose Prolonged-release granules for oral suspension
Maltese: 20 mg/dose Granuli b'rilaxx modifikat għal sospensjoni orali
English: ETHYPHARM MORPHINE SULPHATE 100 MG
Maltese: ETHYPHARM MORPHINE SULPHATE 100
English: Oxycodonhydrochloridratiopharm 20 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodonhydrochloridratiopharm 20 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Maltese: AbZ-Pharma GmbH Dr. Georg-Spohn-Str.
English: 100 mg Prolonged-release tablet
Maltese: MG PROLONGED-RELEASE TABLETS 100 mg
English: ETHYPHARM MORPHINE SULPHATE 60 MG
Maltese: ETHYPHARM MORPHINE SULPHATE 60
English: ZOMORPH10 MG Cápsulas 10mg
Maltese: MG Cápsulas 10mg
English: CZ - Czech Republic
Maltese: CZ - IrRepubblika Ċeka
English: MSTW 100 mg Krugmann 100 mg Prolonged-release tablet
Maltese: MSTW 100 mg Krugmann 100 mg Pillola li terħi il-mediċina bilmod
English: MORPHGESIC SR 100MG TABLETS
Maltese: SR 100MG TABLETS
English: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Maltese: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem
English: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Maltese: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem
English: Hydromorphon-ratiopharm 8 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Hydromorphon-ratiopharm 8 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Oxycodon-HCl-ratiopharm 80 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodon-HCl-ratiopharm 80 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Oxycodonhydrochloridratiopharm 10 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodonhydrochloridratiopharm 10 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Hydromorphon-ratiopharm 24 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Hydromorphon-ratiopharm 24 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Oxycodonhydrochloridratiopharm 40 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodonhydrochloridratiopharm 40 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Šmartinska 53
Maltese: LONGTEC 5
English: MORPHGESIC SR 60MG TABLETS
Maltese: SR 60MG TABLETS
English: Oxycodon-HCl-ratiopharm 20 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodon-HCl-ratiopharm 20 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: LEK farmacevtska družba d.d.
Maltese: LEK farmacevtska družba d.d. Verovškova 57
English: F- 78550 Houdan France
Maltese: Mathieu (Z.I.) F- 78550
English: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Maltese: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem
English: Morphin AWD 100 mg retard 100 mg Prolonged-release tablet
Maltese: Morphin AWD 100 mg retard 100 mg
English: Oxycodon-HCl-ratiopharm 5 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Maltese: Oxycodon-HCl-ratiopharm 5 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str.
English: Vancomycin capsules
Maltese: Kapsuli ta' vankomiċina
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2017 EMA/645879/2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 ta' Settembru 2017 EMA/645879/2017
English: The review of vancomycin-containing medicines was initiated on 1 April 2016 at the request of the Spanish medicines agency (AEMPS), under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' mediċini li fihom vankomiċina inbdiet fl-1 ta' April 2016 fuq talba tal-aġenzija talmediċini Spanjola (AEMPS), skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Information for patients
Maltese: Informazzjoni għall-pazjenti
English: • Vancomycin solution for infusion can be used in patients of all ages for the treatment of complicated soft-tissue infections, bone and joint infections, community- and hospital-acquired pneumonia (including ventilator-associated pneumonia), infective endocarditis, acute bacterial meningitis, and bacteraemia associated with the above infections.
Maltese: • Is-soluzzjoni ta' vankomiċina għall-infużjoni tista' tintuża fuq pazjenti ta' kull età għall-kura ta' infezzjonijiet ikkumplikati tat-tessut artab, infezzjonijiet fl-għadam u fil-ġogi, pulmonite akkwiżita f'komunità u mill-isptar (inkluża pulmonite assoċjata ma' ventilazzjoni mekkanika), endokardite infettiva, meninġite batterika akuta, u batteremija assoċjata mal-infezzjonijiet ta' hawn fuq.
English: • The maximum dose should not exceed 2 g per day.
Maltese: • Id-doża massima ma għandhiex taqbeż iż-2 g kuljum.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 21/09/2017.
Maltese: L-opinjoni tasCHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli flIstati Membri kollha tal-UE fil-21/09/2017.
English: • Vancomycin parenteral formulations authorised for oral use can be used by mouth in patients of all ages for the treatment of Clostridium difficile infection (CDI).
Maltese: • Formulazzjonijiet parenterali ta' vankomiċina awtorizzati għall-użu orali jistgħu jintużaw mill-ħalq f'pazjenti ta' kull età għall-kura ta' infezzjoni bi Clostridium difficile (CDI).
English: Vancomycin is one of a group of antibiotics known as glycopeptides.
Maltese: Il-vankomiċina hija waħda minn grupp ta' antibijotiċi magħrufa bħala glikopeptidi.
English: Information for healthcare professionals The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin.
Maltese: Ir-rakkomandazzjonijiet tal-Aġenzija huma bbażati fuq reviżjoni tad-data farmakoloġika u klinika disponibbli għall-vankomiċina.
English: It is given as an infusion (drip) into a vein or by injection in the abdomen (belly).
Maltese: Tingħata bħala infużjoni (dripp) ġo vina jew b'injezzjoni fl-addome (żaqq).
English: It is given by infusion (drip) into a vein to treat serious infections due to Gram-positive bacteria such as meticillin-resistant Staphylococcus aureus (MRSA) that are resistant to other antibiotics, or in patients in whom other antibiotics cannot be used.
Maltese: Tingħata permezz ta' infużjoni (dripp) ġo vina għall-kura ta' infezzjonijiet serji minħabba batterji Gram-pożittivi bħal Staphylococcus aureus reżistenti għall-metiċillina (MRSA) li huma reżistenti għal antibijotiċi oħra, jew fuq pazjenti li fuqhom ma jistgħux jintużaw antibijotiċi oħra.
English: EMA recommends changes to prescribing information for vancomycin antibiotics
Maltese: L-EMA tirrakkomanda tibdil fl-informazzjoni dwar il preskrizzjoni ta' antibijotiċi li fihom il-vankomiċina
English: • Vancomycin parenteral formulations authorised for intraperitoneal use can be used in patients of all ages for the treatment of peritoneal dialysis-associated peritonitis.
Maltese: • Formulazzjonijiet parenterali ta' vankomiċina awtorizzati għall-użu intraperitoneali jistgħu jintużaw f'pazjenti ta' kull età għall-kura ta' peritonite assoċjata ma' dijaliżi periteonali.
English: Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.
Maltese: Mediċini li fihom il-vankomiċina ilhom għal diversi snin awtorizzati nazzjonalment fl-UE, bħala Vancocin u varjetà ta' ismijiet oħra.
English: On 19 May 2017, the European Medicines Agency (EMA) recommended changes to prescribing information for the antibiotic vancomycin to ensure appropriate use in the treatment of serious infections caused by Gram-positive bacteria.
Maltese: Fid-19 ta' Mejju 2017, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat tibdil fl-informazzjoni dwar il-preskrizzjoni għall-antibijotiku msejjaħ vankomiċina biex jiġi żgurat użu xieraq fil-kura ta' infezzjonijiet serji kkawżati minn batterji Gram-pożittivi.
English: It can also be used for perioperative prophylaxis in patients at risk of developing bacterial endocarditis and for the treatment of peritoneal dialysis-associated peritonitis.
Maltese: Tista' tintuża wkoll għal profilassi perioperattiva f'pazjenti f'riskju li jiżviluppaw endokardite batterika u għall-kura ta' peritonite assoċjata ma' dijaliżi periteonali.
English: Vancomycin has been used since the 1950s and to this day it remains an important therapeutic option for the treatment of serious infections.The Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the available data on vancomycin medicines given by infusion (drip) and injection and taken by mouth as part of its strategy to update the product information of old antibacterial agents in the context of the fight against antimicrobial resistance1.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija rreveda d-data disponibbli dwar il-mediċini li fihom il-vankomiċina li jingħataw permezz ta' infużjoni (dripp) u ta' injezzjoni u li jittieħdu mill-ħalq bħala parti mill-istrateġija tiegħu sabiex tiġi aġġornata linformazzjoni dwar il-prodott ta' aġenti antibatteriċi antiki fil-kuntest tal-ġlieda kontra r-reżistenza għall-antimikrobiċi1.
English: • The available data do not adequately support the use of oral vancomycin in the treatment of staphylococcal enterocolitis and for the decontamination of the GI tract in immunocompromised patients.
Maltese: • Id-data disponibbli ma tappoġġjax b'mod adegwat l-użu ta' vankomiċina mill-ħalq għall-kura ta' enterokolite stafilokokkali u għad-dekontaminazzjoni tal-passaġġ gastrointestinali f'pazjenti immunokompromessi.
English: When taken by mouth, use should be limited to the treatment of Clostridium difficile infections (CDI).
Maltese: Meta tittieħed mill-ħalq, l-użu għandu jkun limitat għallkura ta' infezzjonijiet bi Clostridium difficile (CDI).
English: Because the available data do not adequately support the use of vancomycin in the treatment of staphylococcal enterocolitis (inflammation of the gut caused by S. aureus) and its use to clear the gut of bacteria in patients with a weakened immune (defence) system, the CHMP concluded that vancomycin should no longer be used for these indications.
Maltese: Data disponibbli wriet li d-doża ta' kuljum preċedentement rakkomandata ħafna drabi kienet qed twassal għal konċentrazzjonijiet subottimali ta' vankomiċina fis-serum.