FrancophonIA/ELRC3.0 huggingface dataset:
English: PACKAGE LEAFLET: Meloxoral 0.5 mg/ml oral suspension for cats
Icelandic: FYLGISEÐILL Meloxoral 0,5 mg/ml mixtúra, dreifa handa köttum
English: Shelf life after first opening the immediate packaging: 6 months.
Icelandic: Rofna pakkningu skal nota innan 6 mánaða.
English: In cats, Meloxoral 0.5 mg/ml oral suspension for cats should be used.
Icelandic: Nota skal Meloxoral 0,5 mg/ml mixtúru, dreifu handa köttum.
English: Absorption
Icelandic: AUKAVERKANIR
English: Produlab Pharma B.V. Forellenweg 16
Icelandic: Pharma B.V.
English: Glycerol
Icelandic: Kalinovica
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Icelandic: Ennfremur hemur það í takmörkuðum mæli samsöfnun blóðflagna vegna áhrifa frá kollageni.
English: Avoid introduction of contamination during use.
Icelandic: Þess skal gætt að lyfið mengist ekki við notkun.
English: Strength Pharmaceutical form
Icelandic: Sérheiti Styrkleiki
English: Invented name
Icelandic: Innihald
English: MA (EU) Number (Invented) name
Icelandic: ESB markaðsleyfisnúmer (Sér) heiti
English: Concentrate for solution for infusion
Icelandic: Innrennslisþykkni, lausn í bláæð
English: Solution for injection
Icelandic: Lyfjaform Íkomuleið Innri umbúðir
English: GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.
Icelandic: P.N.G. GEROLYMATOS ΑΕΒΕ 13 Asklipiou Str.
English: Al. Jerozoimskie 146A 02-305 Warsaw, Poland
Icelandic: Jerozoimskie 146A 02-305 Warsaw, Poland
English: Mundipharma Oy Rajatorpantie 41 B 01640 Vantaa Finland
Icelandic: Oy Rajatorpantie 41 B 01640 Vantaa Finland
English: EL-Greece
Icelandic: EL-Grikkland
English: LV - Latvia
Icelandic: LV - Lettland
English: Praça Duque de Saldanha, 1 - 6ºEdifício Atrium Saldanha, 1050-094 São Jorge de Arroios - Lisboa Portugal
Icelandic: Mundipharma Farmacêutica, Lda. Praça Duque de Saldanha, 1 - 6ºEdifício Atrium Saldanha, 1050-094 São Jorge de Arroios - Lisboa Portugal
English: Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
Icelandic: Janssen-Cilag Farmacêutica, Lda. Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugal
English: BG - Bulgaria
Icelandic: BG - Búlgaría
English: Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
Icelandic: Teva Uk Limited Brampton Road, Hampden Park, Eastbourne, E Sussex BN22 9AG United Kingdom
English: Box 552 2003 RN Haarlem Netherlands
Icelandic: Swensweg 5, P.O. Box 552 2003 RN Haarlem Netherlands
English: UK - United Kingdom
Icelandic: UK - Bretland
English: LT - Lithuania
Icelandic: LT - Litháen
English: RO - Romania
Icelandic: RO - Rúmenía
English: Schlossplatz 1
Icelandic: H Schlossplatz 1
English: FR - France
Icelandic: FR - Frakkland
English: BE - Belgium
Icelandic: BE - Belgía
English: Mundipharma As Vollsveien 13c 1366 Lysaker Norway
Icelandic: Mundipharma As Vollsveien 13c 1366
English: Prolonged release capsule
Icelandic: PROLONGED-RELEASE CAPSULES
English: Lannacher Heilmittel Ges.m.b.H.
Icelandic: Lannacher Heilmittel Ges.m.b.
English: LANNACHER HEILMITTEL GES.M.G.H.Schlobplatz, 1 Lannach A-9502
Icelandic: GES.M.G.H.Schlobplatz, 1 Lannach A-9502
English: Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163 Marly-le-Roi Cedex France
Icelandic: Laboratoire GLAXOSMITHKLINE 100, route de Versailles 78163
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states (EU/EEA)
Icelandic: VIÐAUKI I LISTI YFIR HEITI, LYFJAFORM, STYRKLEIKA LYFSINS, ÍKOMULEIÐ(IR), MARKAÐSLEYFISHAFA Í AÐILDARLÖNDUNUM
English: (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw C Laarstraat 16
Icelandic: I.P.S. (INTERN.PHARMAC.SERVICES)NV Garden Square, Gebouw
English: PALLADONE IMMEDIATE RELEASE 1,3 MG
Icelandic: IMMEDIATE RELEASE 1,3 MG
English: DOCPHARMA N.V. Ambachtenlaan 13H 3001 Leuven Belgium
Icelandic: Ambachtenlaan 13H 3001 Leuven Belgium
English: PALLADONE IMMEDIATE RELEASE 2,6 MG
Icelandic: IMMEDIATE RELEASE 2,6 MG
English: Modified-release tablet
Icelandic: RELEASE TABLETS
English: SE - Sweden
Icelandic: SE - Svíþjóð
English: AT - Austria betapharm Arzneimittel GmbH Kobelweg 95
Icelandic: AT - Austurríki betapharm Arzneimittel GmbH Kobelweg 95
English: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F.
Icelandic: Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Viale Amelia 70 00181
English: Morphine Sulfate LP Ethypharm 200mg
Icelandic: Sulfate LP Ethypharm 200mg
English: Limbirg D-6270
Icelandic: D-6270
English: Johnson & Johnson UAB Gelezinio Vilko g. 18A LT-08104 Vilnius Lithuania
Icelandic: 18A LT-08104 Vilnius Lithuania
English: Modified-release capsule
Icelandic: RELEASE CAPSULES
English: Schlossplatz 1 8502 Lannach Austria
Icelandic: H., Schlossplatz 1 8502 Lannach Austria
English: Kapanol 50, capsules met gereguleerde afgifte 20 mg 50 mg
Icelandic: Kapanol 50, capsules met gereguleerde afgifte 20 mg
English: Strength
Icelandic: Forðakyrni
English: Capsule, hard
Icelandic: Hylki, hart
English: YES Pharmaceutical Devel.
Icelandic: YES Pharmaceutical
English: Norpharma Slotsmarken 15 2970 Hørsholm Denmark
Icelandic: Slotsmarken 15 2970 Hørsholm Denmark
English: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Prolonged-release capsule, hard Oral use
Icelandic: SUBSTITOL 200 mg trde kapsule s podaljšanim sproščanjem200 mg Forðahylki, hart
English: Apollogasse 16-18, Postfach 83 1072 Vienna
Icelandic: Mundipharma Ges.m.b.H. Apollogasse 16-18, Postfach 83 1072 Vienna
English: Johnson & Johnson d.o.o.
Icelandic: Johnson & Johnson d.o.o. Šmartinska 53
English: GlaxoSmithKline B.V.
Icelandic: GlaxoSmithKline GmbH & Co.
English: 200 mg coated tablet
Icelandic: 200 mg Húðuð tafla
English: Relimal 200 mg Retardtabletten 200 mg Prolonged-release tablet
Icelandic: Relimal 200 mg Retardtabletten 200 mg Forðatafla
English: The Netherlands
Icelandic: NL - Holland
English: 17-21, rue St. Mathieu (Z.I.)
Icelandic: 17-21, rue St. Mathieu (Z.I.) F- 78550 Houdan
English: Ethypharm21, rue St. Mathieu (Z.I.)
Icelandic: Ethypharm21, rue St. Mathieu (Z.I.) F- 78550 Houdan
English: SI - Slovenia
Icelandic: SI - Slóvenía
English: MSTW 200 mg Krugmann 200 mg Prolonged-release tablet
Icelandic: MSTW 200 mg Krugmann 200 mg Forðatafla
English: ARCHIMEDES PHARMA IBERICA S.L.
Icelandic: ARCHIMEDES PHARMA IBERICA S.L. C/ Jorge Juan 139
English: 100 mg Prolonged-release tablet betapharm Arzneimittel GmbH Kobelweg 95
Icelandic: 100 mg Forðatafla betapharm Arzneimittel GmbH Kobelweg 95
English: Mundipharma Pharmaceuticals B.V. De Weil 20
Icelandic: Mundipharma Pharmaceuticals B.V.
English: Actavis Deutschland GmbH & Co. KG Elisabeth-Selbert-Str. 1
Icelandic: KG Elisabeth-Selbert-Str.
English: MORFINA LANNACHER 100 MG 100mg coated tablet
Icelandic: MORFINA LANNACHER 100 MG 100mg
English: Heumann Pharma GmbH & Co. Generica KG
Icelandic: Heumann Pharma GmbH & Co.
English: AbZ-Pharma GmbH Dr.Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Icelandic: AbZ-Pharma GmbH Dr.Georg-Spohn-Str.
English: Morphin AWD 30 mg retard 30 mg
Icelandic: Morphin AWD 30 mg retard
English: Pharma GmbH Schloβplatz 1
Icelandic: GmbH Schloβplatz
English: Palladone SR Capsules 16 mg 16 mg
Icelandic: SR Capsules 16 mg 16 mg
English: PS Pharma Service GmbH Lise-Meitner-Str. 10 D-40670 Meerbusch Germany
Icelandic: PS Pharma Service GmbH Lise-Meitner-Str.
English: LONGTEC 40 MG FILM-COATED, PROLONGED RELEASE TABLETS
Icelandic: LONGTEC 40 MG FILM-COATED, PROLONGED
English: LONGTEC 20 MG FILM-COATED, PROLONGED RELEASE TABLETS
Icelandic: LONGTEC 20 MG FILM-COATED, PROLONGED
English: FILNARINE SR 30MG PROLONGED RELEASE TABLETS
Icelandic: FILNARINE SR 30MG PROLONGED
English: MORPHIN-PUREN 30 mg retard 30 mg
Icelandic: MORPHIN-PUREN 30 mg retard
English: Kapanol CSR 100 mg - Kapseln 100 mg Prolonged-release capsule, hard Oral use
Icelandic: Kapanol CSR 100 mg - Kapseln 100 mg Forðahylki, hart
English: Apollogasse 16-18., A-1072 Vienna Austria
Icelandic: Mundipharma Ges.m.b.H. Apollogasse 16-18., A-1072 Vienna Austria
English: SE - Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
Icelandic: SE - Svíþjóð ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Germany
English: Palladone SR Capsules 24 mg 24 mg
Icelandic: SR Capsules 24 mg 24 mg
English: ZOMORPH CAPSULES XL 120MG PROLONGED-RELEASE CAPSULES
Icelandic: ZOMORPH CAPSULES XL 120MG
English: FILNARINE SR 100MG PROLONGED RELEASE TABLETS
Icelandic: FILNARINE SR 100MG PROLONGED
English: MST 200 mg Mundipharma 200 mg Prolonged-release tablet
Icelandic: MST 200 mg Mundipharma 200 mg Forðatafla
English: MORFINA LANNACHER 10 MG 10 mg coated tablet
Icelandic: MORFINA LANNACHER 10 MG 10 mg
English: Jurnista 32 mg tablety s predĺženým uvoľňovaním 32 mg
Icelandic: Jurnista 32 mg tablety s predĺženým uvoľňovaním
English: MSTW 100 mg Krugmann 100 mg Prolonged-release tablet
Icelandic: MSTW 100 mg Krugmann 100 mg Forðatafla
English: PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem 8 mg
Icelandic: PALLADONE 8 mg trde kapsule s podaljšanim sproščanjem
English: LONGTEC 5 MG FILM-COATED, PROLONGED RELEASE TABLETS 5 mg
Icelandic: LONGTEC 5 MG FILM-COATED, PROLONGED
English: DK - Denmark
Icelandic: CZ - Tékkland
English: OXYCONTIN 5MG FILMCOATED, PROLONGED RELEASE TABLETS
Icelandic: OXYCONTIN 5MG FILMCOATED, PROLONGED
English: Carexil 10 mg tablete s podaljšanim sproščanjem 10 mg
Icelandic: Carexil 10 mg tablete s podaljšanim sproščanjem
English: ZOMORPH CAPSULES XL 200MG PROLONGED-RELEASE CAPSULES
Icelandic: ZOMORPH CAPSULES XL 200MG
English: M-eslon 60 mg trde kapsule s podaljšanim sproščanjem 60 mg
Icelandic: M-eslon 60 mg trde kapsule s podaljšanim sproščanjem
English: 4.5 mg + 2.25 mg
Icelandic: 4.5 mg +
English: M-eslon 10 mg trde kapsule s podaljšanim sproščanjem 10 mg
Icelandic: M-eslon 10 mg trde kapsule s podaljšanim sproščanjem
English: MORFINA LANNACHER 30 MG 30 mg coated tablet
Icelandic: MORFINA LANNACHER 30 MG 30 mg
English: MORFINA LANNACHER 60 MG 60 mg coated tablet
Icelandic: MORFINA LANNACHER 60 MG 60 mg
English: Palladon-SR capsule 16 mg, capsules met verlengde afgifte 16 mg
Icelandic: Palladon-SR capsule 16 mg, capsules met verlengde afgifte
English: Oksikodon Lek 80 mg tablete s podaljšanim sproščanjem
Icelandic: Lek 80 mg tablete s podaljšanim sproščanjem
English: AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany
Icelandic: AbZ-Pharma GmbH Dr. Georg-Spohn-Str.
English: PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem 16 mg
Icelandic: PALLADONE 16 mg trde kapsule s podaljšanim sproščanjem
English: SKENAN L.P. 60 mg, microgranules à libération prolongée en gélule
Icelandic: 60 mg, microgranules à libération prolongée en gélule
English: SKENAN L.P. 200 mg, microgranules à libération prolongée en gélule
Icelandic: 200 mg, microgranules à libération prolongée en gélule
English: Mundipharma Ges.m.b.H Apollogase 16-18
Icelandic: Ges.m.b.H Apollogase 16-18
English: LONGTEC 10 MG FILM-COATED, PROLONGED RELEASE TABLETS 10 mg
Icelandic: LONGTEC 10 MG FILM-COATED, PROLONGED
English: Jurnista 64 mg tablety s predĺženým uvoľňovaním 64 mg
Icelandic: Jurnista 64 mg tablety s predĺženým uvoľňovaním
English: SKENAN L.P. 30 mg, microgranules à libération prolongée en gélule
Icelandic: 30 mg, microgranules à libération prolongée en gélule
English: OXYCONTIN 80MG FILMCOATED, PROLONGED RELEASE TABLETS
Icelandic: OXYCONTIN 80MG FILMCOATED, PROLONGED
English: SKENAN L.P. 100 mg, microgranules à libération prolongée en gélule
Icelandic: 100 mg, microgranules à libération prolongée en gélule
English: MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS 5 mg
Icelandic: MST CONTINUS 5 MG PROLONGED-RELEASE TABLETS
English: LONGTEC 80 MG FILM-COATED, PROLONGED RELEASE TABLETS 80 mg
Icelandic: LONGTEC 80 MG FILM-COATED, PROLONGED
English: Strength Pharmaceutical form Route of administration medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
Icelandic: Forðahylki, hart medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
English: Capros 10mg medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
Icelandic: 100 mg Forðahylki, hart medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
English: Palladon-SR capsule 24 mg, capsules met verlengde afgifte 24 mg
Icelandic: Palladon-SR capsule 24 mg, capsules met verlengde afgifte
English: Oxypro 40 mg tablety s predĺženým uvoľňovaním 40 mg
Icelandic: Oxypro 40 mg tablety s predĺženým uvoľňovaním
English: SKENAN L.P. 10 mg, microgranules à libération prolongée en gélule
Icelandic: 10 mg, microgranules à libération prolongée en gélule
English: Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním 20 mg
Icelandic: Oxykodón YES 20 mg tablety s predĺženým uvoľňovaním
English: CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS 40 mg
Icelandic: CONTIROXIN 40 MG PROLONGED-RELEASE TABLETS
English: SK - Slovakia
Icelandic: SK - Slóvakía
English: 100 mg Prolonged-release tablet ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
Icelandic: 100 mg Forðatafla ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Germany
English: AWD.pharma GmbH & Co. KG Wasastr.
Icelandic: AWD.pharma GmbH & Co.
English: MOSCONTIN 10 mg, comprimé enrobé à libération prolongée 10 mg
Icelandic: MOSCONTIN 10 mg, comprimé enrobé à libération prolongée
English: TARGINACT 5MG/2,5MG 5.25 mg Prolonged-release tablet
Icelandic: TARGINACT 5MG/2,5MG 5.25 mg Forðatafla
English: Oxypro 20 mg tablety s predĺženým uvoľňovaním 20 mg
Icelandic: Oxypro 20 mg tablety s predĺženým uvoľňovaním
English: Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním 80 mg
Icelandic: Oxykodón YES 80 mg tablety s predĺženým uvoľňovaním
English: OXYCONTIN 10MG FILMCOATED, PROLONGED RELEASE TABLETS
Icelandic: OXYCONTIN 10MG FILMCOATED, PROLONGED
English: ZOMORPH CAPSULES XL 20MG PROLONGED-RELEASE CAPSULES
Icelandic: ZOMORPH CAPSULES XL 20MG
English: Morphin AWD 100 mg retard 100 mg Prolonged-release tablet
Icelandic: Morphin AWD 100 mg retard 100 mg Forðatafla
English: OXYCONTIN 20MG FILMCOATED, PROLONGED RELEASE TABLETS
Icelandic: OXYCONTIN 20MG FILMCOATED, PROLONGED
English: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS 10 mg
Icelandic: MST CONTINUS 10 MG PROLONGED-RELEASE TABLETS
English: JURNISTA 32 mg tablete s podaljšanim sproščanjem 32 mg
Icelandic: JURNISTA 32 mg tablete s podaljšanim sproščanjem
English: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte 5 mg
Icelandic: Oxycodon HCl Sandoz 5 mg, tabletten met verlengde afgifte
English: 10 + 5 mg Prolonged-release tablet
Icelandic: 5 MG PROLONGED-RELEASE TABLETS
English: Jurnista 16 mg tablety s predĺženým uvoľňovaním 16 mg
Icelandic: Jurnista 16 mg tablety s predĺženým uvoľňovaním
English: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée 30 mg
Icelandic: MOSCONTIN 30 mg, comprimé enrobé à libération prolongée
English: Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten 30 mg
Icelandic: Morphinhydrochlorid Lannacher retard 30 mg - Filmtabletten
English: OXYCONTIN 40MG FILMCOATED, PROLONGED RELEASE TABLETS
Icelandic: OXYCONTIN 40MG FILMCOATED, PROLONGED
English: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem 4 mg
Icelandic: PALLADONE 4 mg trde kapsule s podaljšanim sproščanjem
English: 300 mg Prolonged-release tablet
Icelandic: 30 mg prolonged-release tablets
English: Huis ter Heideweg 62
Icelandic: C Laarstraat 16
English: ET - Estonia
Icelandic: ET - Eistland
English: ZOMORPH CAPSULES XL 60MG PROLONGED-RELEASE CAPSULES
Icelandic: ZOMORPH CAPSULES XL 60MG
English: JURNISTA 8 mg tablete s podaljšanim sproščanjem 8 mg
Icelandic: JURNISTA 8 mg tablete s podaljšanim sproščanjem
English: ZOMORPH CAPSULES XL 40MG PROLONGED-RELEASE CAPSULES
Icelandic: ZOMORPH CAPSULES XL 40MG
English: FILNARINE SR 10MG PROLONGED RELEASE TABLETS 10 mg
Icelandic: FILNARINE SR 10MG PROLONGED
English: MST 100 mg Mundipharma 100 mg Prolonged-release tablet
Icelandic: MST 100 mg Mundipharma 100 mg Forðatafla
English: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte 10 mg
Icelandic: Oxycodon HCl Sandoz 10 mg, tabletten met verlengde afgifte
English: Kapanol 100, capsules met gereguleerde afgifte 20 mg 100 mg Prolonged-release capsule Oral use
Icelandic: Kapanol 100, capsules met gereguleerde afgifte 20 mg
English: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS 100 mg Prolonged-release tablet
Icelandic: MST CONTINUS 100 MG PROLONGED-RELEASE TABLETS
English: Morphin Grünenthal 100 mg 100 mg Prolonged-release tablet
Icelandic: Morphin Grünenthal 100 mg 100 mg Forðatafla
English: 200 mg Prolonged-release capsule, hard Oral use medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
Icelandic: 200 mg Forðahylki, hart medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstr.
English: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte 20 mg
Icelandic: Oxycodon HCl Sandoz 20 mg, tabletten met verlengde afgifte
English: Oksikodon Lek 40 mg tablete s podaljšanim sproščanjem
Icelandic: Lek 40 mg tablete s podaljšanim sproščanjem
English: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS 30 mg
Icelandic: MST CONTINUS 30 MG PROLONGED-RELEASE TABLETS
English: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Icelandic: MST Continus 100 mg filmsko obložene tablete s podaljšanim sproščanjem
English: Palladone SR Capsules 2 mg 2 mg
Icelandic: SR Capsules 2 mg 2 mg
English: PALLADONE - SR capsules 8 mg 8 mg
Icelandic: - SR capsules 8 mg 8 mg
English: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Icelandic: MST Continus 30 mg filmsko obložene tablete s podaljšanim sproščanjem
English: Hydal retard 2 mg - Kapseln 2 mg
Icelandic: 2 mg - Kapseln 2 mg
English: 100 mg Modified-release capsule
Icelandic: 100 mg Mixtúruforðakyrni
English: TARGINACT 10 MG/5 MG 10.5 mg Prolonged-release tablet
Icelandic: TARGINACT 10 MG/5 MG 10.5 mg Forðatafla
English: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem film-coated prolonged-release capsule, hard
Icelandic: MST Continus 10 mg filmsko obložene tablete s podaljšanim sproščanjem
English: P.N.G.
Icelandic: Generica KG
English: Palladone SR Capsules 4 mg 4 mg
Icelandic: SR Capsules 4 mg 4 mg
English: PALLADONE - SR capsules 16 mg
Icelandic: - SR capsules 16 mg
English: Do not use solutions that
Icelandic: Notið ekki lausnir sem
English: Mississauga, Ontario, Canada L5N 8H9
Icelandic: Mississauga, Ontario, Kanada L5N 8H9
English: Please discuss possibility of stopping the treatment with your doctor.
Icelandic: Vinsamlegast ræðið möguleikann á að hætta meðferð við lækninn.
English: This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Icelandic: Þetta eftirlit eftir markaðssetningu mun gilda þar til 40 sjúklingar hafa
English: The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Icelandic: Öryggi og verkun ATryn fyrir börn og unglinga (<18 ára) hefur ekki verið staðfest.
English: What ATryn is and what it is used for
Icelandic: Upplýsingar um ATryn og við hverju það er notað
English: This leaflet was last revised in
Icelandic: Þessi fylgiseðill var síðast samþykktur í
English: The doctor will treat you, as appropriate, if you have any particular side effects.
Icelandic: Læknirinn mun meðhöndla þig eins og við á ef þú færð einhverja sérstaka aukaverkun.
English: The experience from repeated treatment with this medicine is very limited.
Icelandic: Reynsla af endurtekinni meðferð með þessu lyfi er mjög takmörkuð.
English: • bleeding (at site of infusion or after surgery)
Icelandic: • blæðingar (við stungustað eða eftir skurðaðgerð)
English: Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Icelandic: Nýjasta dagsetning endurnýjunar markaðsleyfis: 15. júlí 2016.
English: Available data do not suggest harmful effects to the mother or infant.
Icelandic: Fyrirliggjandi gögn benda hvorki til skaðlegra áhrifa á móður né ungbarn.
English: Close surveillance with regard to immunological reactions is especially important in such situations.
Icelandic: Mjög mikilvægt er að fylgst sé með ónæmisviðbrögðum í slíkum tilvikum.
English: • Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
Icelandic: Úthreinsun: 0,665 ± 0,0493 l/klst. (meðaltal ± staðalfrávik)
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.
Icelandic: Skilyrði um hvernig leggja skal fram samantektir um öryggi lyfsins koma fram í lista yfir viðmiðunardagsetningar Evrópusambandsins (EURD-lista) sem gerð er krafa um í grein 107c(7) í tilskipun 2001/83/EB og öllum síðari uppfærslum sem birtar eru í evrópsku lyfjavefgáttinni.
English: It is one of the most important natural inhibitors of blood coagulation.
Icelandic: Það er einn mikilvægasti náttúrulegi hemillinn gegn blóðstorknun.
English: A risk to the suckling child cannot be excluded.
Icelandic: Ekki er hægt að útiloka áhættu þegar börn á brjósti eiga í hlut.
English: The solution should be slightly yellow, clear to slightly opalescent.
Icelandic: Lausnin á að vera örlítið gulleit, tær til örlítið ópallýsandi.
English: To protect you from developing blood clots the medicine will continue to be administered to you until your doctor determines it safe to stop treatment.
Icelandic: Til að koma í veg fyrir blóðtappamyndun verður þér gefið inn lyfið þar til læknirinn þinn hefur ákvarðað að öruggt sé að hætta meðferð.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Icelandic: Þetta lyf hefur verið samþykkt samkvæmt ferli um undantekningartilvik og í samræmi við grein 14(8) í reglugerð (EB) nr. 726/2004 skal markaðsleyfishafi framkvæma eftirfarandi innan tilgreindra
English: No information is available on the possible effects of antithrombin alfa on male and female fertility.
Icelandic: Engar upplýsingar liggja fyrir um möguleg áhrif antithrombin alfa á frjósemi karla og kvenna.
English: It is unknown whether it is present in breast milk.
Icelandic: Ekki er vitað hvort það skilst út í brjóstamjólk.
English: Name and address of the manufacturer(s) of the biological active substance(s) Therapure Biopharma Inc.
Icelandic: Heiti og heimilisfang framleiðanda líffræðilegra virka efna Therapure Biopharma Inc.
English: Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Icelandic: Algengar (≥ 1/100 til < 1/10) og sjaldgæfar (≥1/1.000 til <1/100).
English: Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Icelandic: Athuga ber AT-virkni 30 mínútum eftir allar breytingar á innrennslishraða, eða fjórum klst.
English: This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Icelandic: Þetta þýðir að vegna þess hve sjaldgæfur sjúkdómurinn er hefur ekki reynst mögulegt að afla allra tilskilinna upplýsinga um lyfið.
English: Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Icelandic: Því er mikilvægt að andtrombíngildi í blóði sé haldið nægilega háu við slíkar
English: If you use more ATryn than you should
Icelandic: Ef notaður er stærri skammtur af ATryn en mælt er fyrir um
English: The required loading dose is determined using the following formula:
Icelandic: Hleðsluskammturinn sem nota þarf er ákvarðaður með því að nota eftirfarandi formúlu:
English: ATryn is not indicated for use in pregnant women.
Icelandic: ATryn er ekki ætlað til nota fyrir þungaðar konur.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1, 10 OR 25 VIALS)
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á YTRI UMBÚÐUM YTRI ASKJA (1, 10 EÐA 25 HETTUGLÖS)
English: Read all of this leaflet carefully before you start using this medicine because it contains important
Icelandic: Lesið allan fylgiseðilinn vandlega áður en byrjað er að nota lyfið.