FrancophonIA/ELRC3.0 huggingface dataset:
English: PALLADONE - SR capsules 8 mg 8 mg
Polish: PALLADONE - SR capsules 8 mg
English: ZOMORPH CAPSULES XL 120MG PROLONGED-RELEASE CAPSULES
Polish: ZOMORPH CAPSULES XL 120MG PROLONGEDRELEASE CAPSULES
English: PALLADONE - SR capsules 2 mg 2 mg
Polish: PALLADONE - SR capsules 2 mg
English: PALLADONE - SR capsules 4 mg 4 mg
Polish: PALLADONE - SR capsules 4 mg
English: Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten 5 mg
Polish: Oxycodonhydrochlorid - 1 A Pharma 5 mg Retardtabletten
English: LONGTEC 20 MG FILM-COATED, PROLONGED RELEASE TABLETS
Polish: LONGTEC 20 MG FILMCOATED, PROLONGED RELEASE TABLETS
English: Palladone SR Capsules 24 mg 24 mg
Polish: Palladone SR Capsules 24 mg
English: MORPHIN-PUREN 30 mg retard 30 mg
Polish: MORPHIN-PUREN 30 mg retard
English: MORPHIN-PUREN 10 mg retard 10 mg
Polish: MORPHIN-PUREN 10 mg retard
English: Morphinhydrochlorid Lannacher retard 10 mg - Filmtabletten
Polish: Morphinhydrochlorid Lannacher retard 10 mgFilmtabletten
English: MST Continus 100 mg
Polish: MST Continus 100 mg 100 mg
English: JURNISTA 8 mg Retardtabletten 8 mg
Polish: JURNISTA 8 mg Retardtabletten
English: OxyContin 5 mg, tabletten met gereguleerde afgifte
Polish: OxyContin 5 mg, tabletten met gereguleerde afgifte 5 mg
English: Mundidol Uno retard 200 mgKapseln
Polish: Mundidol Uno retard 200 mg - Kapseln
English: OXYCONTIN 15 MG
Polish: OXYCONTIN 15 MG 15 mg
English: 40 and 20 mg Prolonged release tablet
Polish: 40 and 20 mg Tabletka o przedłużonym uwalnianiu
English: Morphinhydrochlorid Lannacher retard 100 mg - Filmtabletten
Polish: Morphinhydrochlorid Lannacher retard 100 mgFilmtabletten
English: M-Stada 10 mg Retardtabletten 10 mg
Polish: M-Stada 10 mg Retardtabletten
English: ETHIRFIN 120 mg prolongedrelease capsules, hard
Polish: ETHIRFIN 120 mg prolonged-release capsules, hard
English: Oxycodonhydrochlorid "Hexal" 20 mg
Polish: Oxycodonhydrochlorid "Hexal"
English: MORFINA LANNACHER 10 MG 10 mg coated tablet
Polish: MORFINA LANNACHER 10 MG
English: ETHIRFIN 200 mg prolongedrelease capsules, hard
Polish: ETHIRFIN 200 mg prolonged-release capsules, hard
English: LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS 5 mg
Polish: LONGTEC 5 MG FILMCOATED, PROLONGED RELEASE TABLETS
English: MST CONTINUS SUSPENSION 200MG
Polish: MST CONTINUS SUSPENSION 200MG 200 mg
English: JURNISTA 4 mg Retardtabletten 4 mg
Polish: JURNISTA 4 mg Retardtabletten
English: ETHIRFIN 20 mg prolongedrelease capsules, hard
Polish: ETHIRFIN 20 mg prolonged-release capsules, hard
English: PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem 8 mg
Polish: PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem
English: CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS 40 mg
Polish: Oxycontin 40 mg Prolonged-release tablets 40 mg
English: OXYCONTIN 30 MG
Polish: OXYCONTIN 30 MG 30 mg
English: Palladone SR Capsules 16 mg 16 mg
Polish: Palladone SR Capsules 16 mg
English: M-Stada 30 mg Retardtabletten 30 mg
Polish: M-Stada 30 mg Retardtabletten
English: MST CONTINUS 30 mg tablets 30mg
Polish: MST CONTINUS 30 mg tablets
English: MST CONTINUS TABLETS 10MG 10 mg
Polish: MST CONTINUS TABLETS 10MG
English: M-eslon 60 mg trde kapsule s podaljšanim sproščanjem 60 mg
Polish: M-eslon 60 mg trde kapsule s podaljšanim sproščanjem
English: M-eslon 10 mg trde kapsule s podaljšanim sproščanjem 10 mg
Polish: M-eslon 10 mg trde kapsule s podaljšanim sproščanjem
English: OXYCONTIN 60 MG
Polish: OXYCONTIN 60 MG 60 mg
English: SKENAN L.P. 200 mg, microgranules à libération prolongée en gélule
Polish: 200 mg, microgranules à libération prolongée en gélule
English: Palladone SR Capsules 2 mg 2 mg
Polish: Palladone SR Capsules 2 mg
English: MORFINA LANNACHER 30 MG 30 mg coated tablet
Polish: MORFINA LANNACHER 30 MG
English: Oksikodon Lek 5 mg tablete s podaljšanim sproščanjem 5 mg
Polish: Oksikodon Lek 5 mg tablete s podaljšanim sproščanjem
English: ZOMORPH CAPSULES XL 60MG PROLONGED-RELEASE CAPSULES
Polish: ZOMORPH CAPSULES XL 60MG PROLONGEDRELEASE CAPSULES
English: Palladon-SR capsule 16 mg, capsules met verlengde afgifte 16 mg
Polish: Palladon-SR capsule 16 mg, capsules met verlengde afgifte
English: JURNISTA 64 mg tablete s podaljšanim sproščanjem
Polish: Jurnista 64 mg tablety s predĺženým uvoľňovaním
English: MS Contin 5 mg, tabletten met gereguleerde afgifte
Polish: MS Contin 5 mg, tabletten met gereguleerde afgifte 5 mg
English: Palladone SR Capsules 4 mg 4 mg
Polish: Palladone SR Capsules 4 mg
English: Hydromorphon ratiopharm 24 mg Retardtabletten
Polish: Hydromorphon ratiopharm 24 mg Retardtabletten 24 mg
English: ZOMORPH CAPSULES XL 20MG PROLONGED-RELEASE CAPSULES
Polish: ZOMORPH CAPSULES XL 20MG PROLONGEDRELEASE CAPSULES
English: Oxycodonhydrochlorid "Acino" 5 mg
Polish: Oxycodonhydrochlorid "Acino"
English: SKENAN L.P. 60 mg, microgranules à libération prolongée en gélule
Polish: 60 mg, microgranules à libération prolongée en gélule
English: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Prolonged-release capsule, hard Oral use
Polish: MST Continus 200mg 200 mg Kapsułka o przedłużonym uwalnianiu, twarda
English: MST CONTINUS 60mg tablets 60mg
Polish: MST CONTINUS 60mg tablets
English: ETHIRFIN 60 mg prolongedrelease capsules, hard
Polish: ETHIRFIN 60 mg prolonged-release capsules, hard
English: ZOMORPH CAPSULES XL 40MG PROLONGED-RELEASE CAPSULES
Polish: ZOMORPH CAPSULES XL 40MG PROLONGEDRELEASE CAPSULES
English: MORFINA LANNACHER 60 MG 60 mg coated tablet
Polish: MORFINA LANNACHER 60 MG
English: CAREXIL 5MG PROLONGEDRELEASE TABLETS
Polish: CAREXIL 5MG PROLONGED-RELEASE TABLETS
English: ZOMORPH L.P. 200 mg, gélule à libération prolongée
Polish: 200 mg, gélule à libération prolongée
English: MST CONTINUS TABLETS 60MG 60 mg
Polish: MST CONTINUS TABLETS 60MG
English: CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS 5 mg
Polish: CONTIROXIN 5 MG PROLONGED-RELEASE TABLETS
English: PALLADONE SR CAPSULES 4MG 4 mg
Polish: PALLADONE SR CAPSULES 4MG
English: PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem 16 mg
Polish: PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem
English: Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten 30 mg
Polish: Morphinhydrochlorid Lannacher retard 30 mgFilmtabletten
English: ETHIRFIN 40 mg prolongedrelease capsules, hard
Polish: ETHIRFIN 40 mg prolonged-release capsules, hard
English: SKENAN L.P. 30 mg, microgranules à libération prolongée en gélule
Polish: 30 mg, microgranules à libération prolongée en gélule
English: PALLADONE SR CAPSULES 2MG 2 mg
Polish: PALLADONE SR CAPSULES 2MG
English: SKENAN L.P. 100 mg, microgranules à libération prolongée en gélule
Polish: 100 mg, microgranules à libération prolongée en gélule
English: Oxycodonhydrochlorid Acino 5 mg Retardtabletten
Polish: Oxycodonhydrochlorid Acino 5 mg Retardtabletten 5 mg
English: Morphinsulfat "Ethypharm"
Polish: Morphinsulfat "Ethypharm" 40 mg
English: MORFINA LANNACHER 100 MG 100mg coated tablet
Polish: MORFINA LANNACHER 100 MG
English: Palladon-SR capsule 24 mg, capsules met verlengde afgifte 24 mg
Polish: Palladon-SR capsule 24 mg, capsules met verlengde afgifte
English: LONGTEC 80 MG FILM-COATED, PROLONGED RELEASE TABLETS 80 mg
Polish: LONGTEC 80 MG FILMCOATED, PROLONGED RELEASE TABLETS
English: MORPHIN-PUREN 60 mg retard 60 mg
Polish: Morphin AL 60 retard 60 mg
English: Jurnista 32 mg tablety s predĺženým uvoľňovaním 32 mg
Polish: Jurnista 32 mg tablety s predĺženým uvoľňovaním
English: Targin 40mg/20 mg Prolongedrelease tablets
Polish: Targin 40mg/20 mg Prolonged-release tablets
English: LONGTEC 10 MG FILM-COATED, PROLONGED RELEASE TABLETS 10 mg
Polish: LONGTEC 10 MG FILMCOATED, PROLONGED RELEASE TABLETS
English: SKENAN L.P. 10 mg, microgranules à libération prolongée en gélule
Polish: 10 mg, microgranules à libération prolongée en gélule
English: MST CONTINUS TABLETS 30MG 30 mg
Polish: MST CONTINUS TABLETS 30MG
English: MST Continus 60 mg
Polish: MST Continus 60 mg 60 mg
English: Vendal retard 60 mg prolonged-release tablets
Polish: Vendal retard 60 mg prolonged-release tablets 60 mg
English: MOSCONTIN 10 mg, comprimé enrobé à libération prolongée 10 mg
Polish: MOSCONTIN 10 mg, comprimé enrobé à libération prolongée
English: Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním 20 mg
Polish: Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním
English: MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS 5 mg
Polish: MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS
English: 100 mg Prolonged-release tablet ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Polish: 100 mg Tabletka o przedłużonym uwalnianiu ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: Oxycodon-HCl-ratiopharm 5 mg Retardtabletten
Polish: Oxycodon-HCl-ratiopharm 5 mg Retardtabletten 5 mg
English: CANDOX 10MG PROLONGEDRELEASE TABLETS
Polish: CANDOX 10MG PROLONGED-RELEASE TABLETS
English: PALLADONE L.P. 24 mg, gélule à libération prolongée
Polish: 24 mg, gélule à libération prolongée
English: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS 10 mg
Polish: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS
English: Targin 20mg/10 mg Prolongedrelease tablets
Polish: Targin 20mg/10 mg Prolonged-release tablets
English: Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním 80 mg
Polish: Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním
English: FILNARINE SR 60MG PROLONGED RELEASE TABLETS 60 mg
Polish: FILNARINE SR 60MG PROLONGED RELEASE TABLETS
English: PALLADONE L.P. 4 mg, gélule à libération prolongée
Polish: 4 mg, gélule à libération prolongée
English: CANDOX 40 MG PROLONGEDRELEASE TABLETS
Polish: CANDOX 40 MG PROLONGED-RELEASE TABLETS
English: FILNARINE SR 10MG PROLONGED RELEASE TABLETS 10 mg
Polish: FILNARINE SR 10MG PROLONGED RELEASE TABLETS
English: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte 5 mg
Polish: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte
English: MS Contin 10 mg, tabletten met gereguleerde afgifte
Polish: MS Contin 10 mg, tabletten met gereguleerde afgifte 10 mg
English: Compensan retard 200 mgFilmtabletten
Polish: Compensan retard 200 mg - Filmtabletten
English: OxyContin 160 mg prolonged release tablets
Polish: OxyContin 160 mg prolonged release tablets 160mg
English: 150 mg Prolonged-release capsule, hard Oral use
Polish: 150 mg Kapsułka o przedłużonym uwalnianiu, twarda
English: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée 30 mg
Polish: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée
English: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem 4 mg
Polish: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem
English: Oxydon 5 mg Prolonged-release tablets
Polish: CANDOX 5MG PROLONGED-RELEASE TABLETS
English: ZOMORPH L.P. 40 mg, gélule à libération prolongée
Polish: 40 mg, gélule à libération prolongée
English: Oxycodon-HCl-ratiopharm 40 mg Retardtabletten
Polish: Oxycodon-HCl-ratiopharm 40 mg Retardtabletten 40 mg
English: OxyContin 40 mg prolonged release tablets
Polish: OxyContin 40 mg prolonged release tablets 40 mg
English: Hydromorphon-ratiopharm 8 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Polish: Hydromorphon-ratiopharm 8 mg Retardtabletten 8 mg ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: PALLADONE L.P. 16 mg, gélule à libération prolongée
Polish: 16 mg, gélule à libération prolongée
English: M-eslon 100 mg trde kapsule s podaljšanim sproščanjem 100 mg Prolonged-release capsule, hard Oral use
Polish: MST Continus 100mg 100 mg Kapsułka o przedłużonym uwalnianiu, twarda
English: ZOMORPH L.P. 120 mg, gélule à libération prolongée
Polish: 120 mg, gélule à libération prolongée
English: OxyContin 80 mg prolonged release tablets
Polish: OxyContin 80 mg prolonged release tablets 80 mg
English: Vendal retard 30 mg prolonged-release tablets
Polish: Vendal retard 30 mg prolonged-release tablets 30 mg
English: DANCEX SR 20 mg Prolongedrelease tablets
Polish: DANCEX SR 20 mg Prolonged-release tablets 20 mg
English: Morphinhydrochlorid Lannacher retard 200 mg - Filmtabletten 200 mg Prolonged-release tablet
Polish: Morphinhydrochlorid Lannacher retard 200 mgFilmtabletten
English: CAREXIL 20MG PROLONGEDRELEASE TABLETS
Polish: CAREXIL 20MG PROLONGED-RELEASE TABLETS
English: OxyContin 60 mg prolonged release tablets
Polish: OxyContin 60 mg prolonged release tablets 60mg
English: M-Stada 60 mg Retardtabletten 60 mg
Polish: M-Stada 60 mg Retardtabletten
English: Oksikodon Lek 10 mg tablete s podaljšanim sproščanjem 10 mg
Polish: Oksikodon Lek 10 mg tablete s podaljšanim sproščanjem
English: MST CONTINUS 30 MG
Polish: MST Continus 30 mg 30 mg
English: TARGINACT 10 MG/5 MG 10.5 mg Prolonged-release tablet
Polish: TARGINACT 10 MG/5 MG 10.5 mg Tabletka o przedłużonym uwalnianiu
English: Compensan retard 100 mgFilmtabletten
Polish: Compensan retard 100 mg - Filmtabletten
English: FILNARINE SR 200MG PROLONGED RELEASE TABLETS 200 mg Prolonged-release tablet
Polish: FILNARINE SR 200MG PROLONGED RELEASE TABLETS
English: Morphin AL 10 retard
Polish: Morphin AL 10 retard 10 mg
English: Prolonges release capsule, hard Oral use
Polish: Kapsułka powlekana o przedłużonym uwalnianiu, twarda
English: Oxycodon-HCl-ratiopharm 80 mg Retardtabletten
Polish: Oxycodon-HCl-ratiopharm 80 mg Retardtabletten 80 mg
English: MS Contin 30 mg, tabletten met gereguleerde afgifte
Polish: MS Contin 30 mg, tabletten met gereguleerde afgifte 30 mg
English: Oksikodon Lek 20 mg tablete s podaljšanim sproščanjem 20 mg
Polish: Oksikodon Lek 20 mg tablete s podaljšanim sproščanjem
English: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte 10 mg
Polish: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte
English: 5/2.5 mg Prolonged-release tablet
Polish: 5/2.5 mg Tabletka o przedłużonym uwalnianiu
English: Jurnista 4 mg tablety s predĺženým uvoľňovaním
Polish: Jurnista 4 mg tablety s predĺženým uvoľňovaním 4 mg
English: CAREXIL 10MG PROLONGEDRELEASE TABLETS
Polish: CAREXIL 10MG PROLONGED-RELEASE TABLETS
English: OxyContin 30 mg prolonged release tablets
Polish: OxyContin 30 mg prolonged release tablets 30mg
English: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS 100 mg Prolonged-release tablet
Polish: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS
English: CANDOX 20 MG PROLONGEDRELEASE TABLETS
Polish: CANDOX 20 MG PROLONGED-RELEASE TABLETS
English: Oxypro 10 mg tablety s predĺženým uvoľňovaním
Polish: Oxypro 10 mg tablety s predĺženým uvoľňovaním 10 mg
English: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte 20 mg
Polish: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte
English: PALLADONE L.P. 8 mg, gélule à libération prolongée
Polish: 8 mg, gélule à libération prolongée
English: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Polish: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem
English: ZOMORPH L.P. 20 mg, gélule à libération prolongée
Polish: 20 mg, gélule à libération prolongée
English: MST Continus 30 mg
Polish: MST CONTINUS 30 MG 30mg
English: Oxycodon-HCl-ratiopharm 10 mg Retardtabletten ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Polish: Oxycodon-HCl-ratiopharm 10 mg Retardtabletten 10 mg ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: 10 mg + 5mg Prolonged-release tablet
Polish: 10 mg + 5mg Tabletka o przedłużonym uwalnianiu
English: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Polish: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem
English: Morphin AL 100 retard
Polish: Morphin AL 100 retard 100 mg
English: ZOMORPH L.P. 60 mg, gélule à libération prolongée
Polish: 60 mg, gélule à libération prolongée
English: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS 30 mg
Polish: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS
English: Hydal retard 8 mg - Kapseln 8 mg
Polish: Hydal retard 8 mgKapseln
English: 5 mg/2,5 mg prolonged-release tablet
Polish: 5 mg/2,5 mg Tabletka o przedłużonym uwalnianiu
English: 5 mg/ 2,5 mg Prolonged-release tablet
Polish: 5 mg/ 2,5 mg Tabletka o przedłużonym uwalnianiu
English: CANDOX 80 MG PROLONGEDRELEASE TABLETS
Polish: CANDOX 80 MG PROLONGED-RELEASE TABLETS
English: Kapanol 100, capsules met gereguleerde afgifte 20 mg 100 mg Prolonged-release capsule Oral use
Polish: Kapanol 100, capsules met gereguleerde afgifte 20 mg
English: KAPANOL L.P. 100 mg, gélule à libération prolongée
Polish: 100 mg, gélule à libération prolongée
English: KAPANOL L.P. 50 mg, gélule à libération prolongée
Polish: 50 mg, gélule à libération prolongée
English: Prolonged-release capsule, soft Oral use
Polish: Kapsułka o przedłużonym uwalnianiu, miękka
English: Relimal 200 mg Retardtabletten 200 mg Prolonged-release tablet
Polish: Relimal 200 mg Retardtabletten
English: 20 + 10 mg Prolonged-release tablet
Polish: 20 + 10 mg Tabletka o przedłużonym uwalnianiu
English: TARGINACT 5MG/2,5MG 5.25 mg Prolonged-release tablet
Polish: Targin 5mg/2.5 mg Prolonged-release tablets 5mg/2.5 mg
English: 100 mg Prolonged-release granules, for oral suspension
Polish: 100 mg Granulat o przedłużonym uwalnianiu
English: 40/20 mg Prolonged-release tablet
Polish: 40/20 mg Tabletka o przedłużonym uwalnianiu
English: Oxykosan 10 mg tablety s predĺženým uvoľňovaním
Polish: Oxykosan 10 mg tablety s predĺženým uvoľňovaním 10 mg
English: MST 200 mg Mundipharma 200 mg Prolonged-release tablet
Polish: MST 200 mg Mundipharma 200 mg
English: Morphin AL 30 retard
Polish: Morphin AL 30 retard 30 mg
English: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Polish: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem
English: MORPHINE STADA L.P. 200 mg, comprimé pelliculé à libération prolongée
Polish: 200 mg, comprimé pelliculé à libération prolongée
English: 200 mg Prolonged-release capsule, hard Oral use
Polish: 200 mg Kapsułka o przedłużonym uwalnianiu, twarda
English: 10 + 5 mg Prolonged-release tablet
Polish: 10 + 5 mg Tabletka o przedłużonym uwalnianiu
English: 100 mg Modified-release capsule
Polish: 100 mg Kapsułka o przedłużonym uwalnianiu
English: • The maximum dose should not exceed 2 g per day.
Polish: • Maksymalna dawka nie powinna przekraczać 2 g na dobę.
English: • Patients who have any questions about their treatment should talk to their doctor or pharmacist.
Polish: • W przypadku pytań dotyczących leczenia pacjenci powinni porozmawiać ze swoim lekarzem lub farmaceutą.
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.
Polish: Opinia CHMP została przekazana do Komisji Europejskiej, która w dniu 21 września 2017 r. wydała ostateczną, prawnie wiążącą decyzję obowiązującą we wszystkich państwach członkowskich UE.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2017 EMA/645879/2017
Polish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 września 2017 r.
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.
Polish: Procedurę ponownej oceny leków zawierających wankomycynę wszczęto w dniu 1 kwietnia 2016 r. na wniosek hiszpańskiej Agencji Leków (AEMPS) zgodnie z art. 31 dyrektywy 2001/83/WE.
English: For younger children, the use of age-appropriate formulations is recommended.
Polish: U młodszych dzieci zaleca się stosowanie leku w postaci odpowiedniej dla wieku.
English: Changes aim to ensure appropriate use in context of fight against antimicrobial resistance
Polish: Zmiany mają na celu zapewnienie właściwego stosowania leku w kontekście walki z opornością na środki przeciwdrobnoustrojowe.
English: • The available information on vancomycin has been reviewed and recommendations have been made on its safe use and appropriate dosage.
Polish: • Dostępne informacje na temat wankomycyny poddano ponownej ocenie i wydano zalecenia dotyczące jej bezpiecznego stosowania i właściwego dawkowania.
English: Vancomycin capsules
Polish: Wankomycyna w kapsułkach
English: EMA recommends changes to prescribing information for vancomycin antibiotics
Polish: EMA zaleca wprowadzenie zmian w informacjach dotyczących przepisywania antybiotyków z wankomycyną
English: Vancomycin-containing medicines have been authorised nationally in the EU for many years, as Vancocin and a variety of other names.
Polish: Leki zawierające wankomycynę są od wielu lat dopuszczone do obrotu w UE w drodze procedur krajowych, pod nazwą Vancocin i pod wieloma innymi nazwami.
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.
Polish: W dniu 19 maja 2017 r. Europejska Agencja Leków (EMA) zaleciła wprowadzenie zmian w informacjach dotyczących przepisywania antybiotyku wankomycyny w celu zapewnienia jej właściwego stosowania w leczeniu poważnych zakażeń powodowanych przez bakterie Gram-dodatnie.
English: • The product information for medicines containing vancomycin will be updated to take these recommendations into account.
Polish: • Druki informacyjne dotyczące leków zawierających wankomycynę zostaną uaktualnione w celu uwzględnienia tych zaleceń.
English: Vancomycin is one of a group of antibiotics known as glycopeptides.
Polish: Wankomycyna należy do grupy antybiotyków zwanych glikopeptydami.
English: In addition, the Committee reviewed the recommended dosage for vancomycin for the various indications and patient groups, and concluded that the starting dose of vancomycin by infusion should be calculated according to the age and weight of the patient.
Polish: Ponadto Komitet poddał ponownej ocenie zalecany sposób dawkowania wankomycyny w różnych wskazaniach i w różnych grupach pacjentów, i uznał, że dawkę początkową wankomycyny podawanej w postaci wlewu należy obliczać w zależności od wieku i masy ciała pacjenta.
English: Information for healthcare professionals The Agency's recommendations are based on a review of the available pharmacological and clinical data for vancomycin.
Polish: Zalecenia Agencji są oparte na wynikach ponownej oceny dostępnych danych farmakologicznych i klinicznych dotyczących wankomycyny.
English: • Vancomycin is an antibiotic used for serious infections, often caused by bacteria that have become resistant to other treatments.
Polish: • Wankomycyna jest antybiotykiem stosowanym w leczeniu poważnych zakażeń, często powodowanych przez bakterie, które stały się oporne na inne sposoby leczenia.
English: It can also be taken by mouth (as capsules or liquid) to treat an infection of the lining of the gut caused by bacteria called Clostridium difficile.
Polish: Można ją także przyjmować doustnie (w postaci kapsułek lub cieczy) w leczeniu zakażenia wyściółki jelita powodowanego przez bakterie o nazwie Clostridium difficile.
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.
Polish: Ponieważ dostępne dane nie uzasadniają w wystarczającym stopniu stosowania wankomycyny w leczeniu gronkowcowego zapalenia jelita cienkiego i okrężnicy (zapalenie jelit powodowane przez S. aureus), a także stosowania jej w celu wyeliminowania bakterii z jelita u pacjentów z osłabionym układem odpornościowym (obronnym), CHMP uznał, że wankomycyna nie powinna być nadal stosowana w tych wskazaniach.