FrancophonIA/ELRC3.0 huggingface dataset:
Maltese: G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria
Icelandic: GmbH, Schlossplatz 1, 8502 Lannach, Austria
Maltese: Il-Litwanja Zentiva, k.s. U kabelovny 130
Icelandic: Ungverjaland Zentiva k.s. Dolny Mecholupy, U kabelovny 130
Maltese: Rowex Ltd, Bantry, Co. Cork, Ireland
Icelandic: Rowex Ltd, Bantry, Co.
Maltese: Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2
Icelandic: OÜ Pärnu mnt 139E/2
Maltese: Il-Ġermanja Juta Pharma GmbH Gutenbergstr.
Icelandic: Þýskaland Juta Pharma GmbH Gutenbergstr.
Maltese: Scarlatti, 31, Milano - 20124
Icelandic: Via Scarlatti, 31, Milano - 20124 Italy
Maltese: Id-Danimarka PharmaCoDane ApS, Marielundvej 46 A, DK-2730
Icelandic: PharmaCoDane ApS, Marielundvej 46 A, DK-2730 Herlev, Denmark
Maltese: Id-Danimarka HEXAL A/S, Kanalholmen 8-12, DK-2650
Icelandic: HEXAL A/S, Kanalholmen 8-12, DK2650 Hvodovre, Denmark
Maltese: FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid). 28108.SPAIN
Icelandic: FARMALIDER, S.A. Aragoneses, 2, Alcobendas (Madrid).
Maltese: Ir-Renju Unit Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET
Icelandic: Tillomed Laboratories Limited, 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET United Kingdom
Maltese: Kiron Pharmaceutica BV Groesbeekseweg 11 Nijmegen, 6524 CK The Netherlands
Icelandic: Frakkland Kiron Pharmaceutica BV Groesbeekseweg 11 Nijmegen, 6524 CK
Maltese: ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid. 28108.
Icelandic: RATIOPHARM ESPAÑA, S.A. C/ Anabel Segura 11, Edificio Albatros B 1ª Planta, Alcobendas , Madrid.
Maltese: Albany Gate, Darkes Lane, Potters bar Herts EN61AG
Icelandic: Ungverjaland Generics (UK) Ltd. Albany Gate, Darkes Lane, Potters bar Herts EN61AG United Kingdom
Maltese: Viale Fulvio Testi 330, 20126
Icelandic: Viale Fulvio Testi 330, 20126 Milano, Italia
Maltese: Il-Polonja Sandoz GmbH ul.
Icelandic: Sandoz GmbH ul.
Maltese: Reykjavikurvegur 76-78 IS-220 Hafnarfjördur Iceland
Icelandic: Reykjavikurvegur 76-78 IS-220
Maltese: Ir-Renju Unit Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
Icelandic: Winthrop Pharmaceuticals UK Limited, One Onslow Street, Guildford, Surrey GU1 4YS
Maltese: Stilnoct pillola
Icelandic: Stilnoct tafla
Maltese: Krka, d.d., Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Icelandic: Šmarješka cesta 6 8501 Novo mesto
Maltese: Tomás Ribeiro, 43 - Bloco 2, 3º FEdifício Neopark
Icelandic: Tomás Ribeiro, 43 - Bloco 2, 3º F - Edifício Neopark 2790-221 Carnaxide Portugal
Maltese: LEK Pharmaceuticals d.d. Verovskova Ljubljana
Icelandic: Ungverjaland LEK Pharmaceuticals d.d. Verovskova 57
Maltese: Vitabalans Oy Varastokatu 8
Icelandic: Þýskaland Vitabalans Oy Varastokatu 8
Maltese: Hexal Pharma GmbH, Stella-Klein-LöwWeg 17, 1020
Icelandic: Hexal Pharma GmbH, Stella-KleinLöw-Weg 17, 1020 Wien, Austria
Maltese: Id-Danimarka Meda AS, Solvang 8, DK-3450
Icelandic: Meda AS, Solvang 8, DK-3450 Allerød, Denmark
Maltese: Camí Real, 51-57 Palau-solita i Plegamans (Barcelona). 08184.
Icelandic: PHARMAGENUS, S.A. Avda. Camí Real, 51-57 Palau-solita i Plegamans (Barcelona).
Maltese: Il-Ġermanja Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Icelandic: Þýskaland Sandoz Pharmaceuticals GmbH Raiffeisenstr.
Maltese: TEVA GENERICOS ESPAÑOLA S.L.U. C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid). 28108.
Icelandic: C/ Anabel Segura, 11 Edificio Albatros B, 1 planta Alcobendas (Madrid).
Maltese: ITF Pharma
Icelandic: G.L. Pharma
Maltese: Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY United Kingdom
Icelandic: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey GU1 4SY
Maltese: Ir-Repubblika Slovakka sanofi-aventis Slovakia s.r.o.
Icelandic: Slóvakía sanofi-aventis Slovakia s.r.o.
Maltese: LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf 91140 Villebon Sur Yvette France
Icelandic: Frakkland LABORATOIRES ALTER 3, avenue de la Baltique ZI de Courtaboeuf
Maltese: Sanofi-Aventis Magyarország Zrt Tó u. 1-5
Icelandic: Ungverjaland Sanofi-Aventis Magyarország Zrt Tó u.
Maltese: Alkaloid d.o.o., Ulica grada Vukovara 226 F, Zagreb, Croatia
Icelandic: Vukovara 226 F, Zagreb, Croatia
Maltese: Sanofi Malta Ltd.
Icelandic: Sanofi Malta Ltd. St. Julian's Rd.
Maltese: Stilnoct, tabletten 10 mg pillola
Icelandic: Stilnoct, tabletten 10 mg tafla
Maltese: MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560
Icelandic: MYLAN BVBA/SPRL Terhulpsesteenweg
Maltese: SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014
Icelandic: Frakkland SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
Maltese: L-Awstrija ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140
Icelandic: Austurríki ratiopharm Arzneimittel VertriebsGmbH, Albert-Schweitzer-Gasse 3, 1140 Wien, Austria
Maltese: Il-Finlandja Sanofi Oy Huopalahdentie 24
Icelandic: Sanofi Oy Huopalahdentie 24 P.O.Box 22
Maltese: PHARMACHEMIE BV Swensweg 5 - Haarlem PO Box 552
Icelandic: 5 - Haarlem PO Box 552
Maltese: SVUS Pharma a.s., Smetanovo nábřeží 1238/20a
Icelandic: SVUS Pharma a.s., Smetanovo nábřeží 1238/20a 500 02 Hradec Králové Czech Republic
Maltese: EN6 1TL Hertfordshire - Potters Bar United Kingdom
Icelandic: EN6 1TL Hertfordshire
Maltese: LT-09310
Icelandic: LT-09310 Vilnius Lithuania
Maltese: Il-Polonja Pfizer Europe MA EEIG Ramsgate Road
Icelandic: Pfizer Europe MA EEIG Ramsgate Road Kent, Sandwich CT13 9 NJ
Maltese: Il-Polonja Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014
Icelandic: Sanofi-Aventis France 1-13 boulevard Romain Rolland 75014 Paris
Maltese: Ir-Repubblika Ċeka sanofi-aventis, s.r.o.
Icelandic: Tékkland sanofi-aventis, s.r.o.
Maltese: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten pillola li tfexfex
Icelandic: Zolpidem Eurogenerics bruis 10 mg bruistabletten, bruistabletten freyðitafla
Maltese: Il-Ġermanja Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 65926 Frankfurt am Main
Icelandic: Þýskaland Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703
Maltese: SANDOZ FARMACÉUTICA, S.A. Avda.
Icelandic: SANDOZ FARMACÉUTICA, S.A. Avda. Osa Mayor, 4
Maltese: Areos 103 and Ag.
Icelandic: ITF HELLAS S.A. Areos 103 and Ag.
Maltese: Zolpidem Sanofi-Aventis Belgium
Icelandic: Zolpidem Sanofi-Aventis Belgium 10 mg
Maltese: AVENTIS, S.A. Josep Plá, 2, Barcelona. 08019 SPAIN
Icelandic: SANOFI AVENTIS, S.A. Josep Plá, 2, Barcelona.
Maltese: ALKALOID-INT d.o.o. Šlandrova ulica 4 1231 Ljubljana-Črnuče Slovenia
Icelandic: Šlandrova ulica 4 1231
Maltese: João II, Lote 1.06.2.2 C - 7.3 e 7.4 1990-095 Lisboa
Icelandic: Parque Expo, Edifício Atlantis, Avenida D. João II, Lote 1.06.2.2 C - 7.3 e 7.4
Maltese: Lagoas Park, Edifício 5 A, Piso 2 2740245
Icelandic: Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. Lagoas Park, Edifício 5 A, Piso 2 2740-245
Maltese: - Viale Bodio 37/b, 20158 Milano Italy
Icelandic: ZENTIVA ITALIA S.R.L. - Viale Bodio 37/b, 20158 Milano Italy
Maltese: Genfarma B.V.
Icelandic: Frakkland Genfarma B.V.
Maltese: Route de la Ganne 36170 Saint Benoit du Sault France
Icelandic: Saint Benoit du Sault France
Maltese: 10 mg/ml qtar orali, soluzzjoni
Icelandic: 10 mg/ml dropar til inntöku, lausn
Maltese: KFT, BUDAPEST, HUNGAR
Icelandic: ITF PHARMA KERESKEDELMI ES SZOLGALTATO KFT, BUDAPEST, HUNGAR
Maltese: Synthon BV, Microweg 22, NL-6545 CM
Icelandic: Frakkland Synthon BV, Microweg 22, NL-6545 CM Nijmegen, The Netherlands
Maltese: NL 2333 CR Leiden The Netherlands
Icelandic: CR Leiden The Netherlands
Maltese: Il-Litwanja UAB „SANOFI-AVENTIS LIETUVA" A.
Icelandic: UAB „SANOFI-AVENTIS LIETUVA" A. Juozapavičiaus 6/2 g.
Maltese: ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA
Icelandic: ZOLPIDEM BEXALABS 10 mg COMPRIMIDOS CON CUBIERTOS CON PELICULA EFG
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl istati membri
Icelandic: Listi yfir heiti, lyfjaform, styrkleika lyfsins/lyfjanna, íkomuleið(ir), markaðsleyfishafa í aðildarlöndunum
Maltese: L-Islovenja ALKALOID-INT d.o.o. Šlandrova ulica 4
Icelandic: Alkaloid d.o.o., Ulica grada
Maltese: Sanofi-Aventis Netherlands B.V. Kampenringweg 45 D-E 2803 PE GOUDA The Netherlands
Icelandic: Sanofi-Aventis Netherlands B.V. Kampenringweg
Maltese: Il-Finlandja ratiopharm GmbH Graf Arco Strasse 3
Icelandic: Frakkland RATIOPHARM GMBH Graf Arco Strasse 3
Maltese: Ippakkjar Kontenut Daqs talpakkett
Icelandic: Lyfjaform Dýrategund Íkomuleið Umbúðir
Maltese: Mod ta' Amministra-zzjoni
Icelandic: Sérheiti Styrkleiki
Maltese: Doża, ml
Icelandic: Skammtur, ml
Maltese: Cooperia curticei C. onchophora
Icelandic: Cooperia curticei C. oncophora
Maltese: EU/2/09/101/006 EU/2/09/101/008 EU/2/09/101/010
Icelandic: EU/2/09/101/004 EU/2/09/101/006 EU/2/09/101/008 EU/2/09/101/010
Maltese: Elanco France S.A.S 26 Rue de la Chapelle F-68330 Huningue Franza
Icelandic: Elanco France S.A.S. 26 Rue de la Chapelle F-68330 Huningue Frakkland
Maltese: Nematodirus battus N. fillicollis
Icelandic: Nematodirus battus N. filicollis
Maltese: 2.5 l
Icelandic: 2,5 l 5 l
Maltese: Haemonchus contortus* Teladorsagia circumcincta* T. trifurcata*
Icelandic: Haemonchus contortus* Teladorsagia circumcincta*
Maltese: 700 µg/kg 7000 µg/k g
Icelandic: 700 µg/kg 7000 µg/kg 5000 µg/kg 2000 µg/kg
Maltese: Pakketti ta' 250 ml, 500 ml, 1 l, 2. 5 l, u 5 l.
Icelandic: Pakkningastærðir eru 250 ml, 500 ml, 1 l, 2,5 l, og 5 l.
Maltese: Dunsinane Industrial EstateDundee DD2 3XR
Icelandic: Dunsinane Industrial Estate Dundee, DD2 3XR
Maltese: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee
Icelandic: Argenta Dundee Limited Kinnoull Road Dunsinane Industrial Estate Dundee, DD2 3XR Bretland
Maltese: Żmien ta' tiżmim: 7 ijiem
Icelandic: BIÐTÍMI FYRIR AFURÐANÝTINGU Biðtími: 7 dagar
Maltese: EU/2/09/101/002 EU/2/09/101/004
Icelandic: MARKAÐSLEYFISNÚMER EU/2/09/101/002
Maltese: Argenta Dundee Limited Kinnoull Road
Icelandic: Argenta Dundee Limited
Maltese: Wara amministrazzjoni orali, monepantel jiġi assorbit minnufih u jiġi ossidat għal metabolit sulfone.
Icelandic: Eftir inntöku frásogast monepantel auðveldlega og oxast í sulfon umbrotsefni.
Maltese: Is-sustanza attiva f'ZOLVIX hija sustanza ammissibbli kif deskritt fit-tabella numru 1 fl-anness tarRegolament tal-Kummissjoni (UE) Nru 37/2010:
Icelandic: DÝRALYFJALEIFA Virka efnið í Zolvix er leyft innihaldsefni samkvæmt lýsingu í töflu 1 í viðaukanum við reglugerð framkvæmdastjórnarinnar (ESB) nr. 37/2010:
Maltese: HUWA INDIKAT IL-PRODOTT Nagħaġ
Icelandic: INNIHALDSLÝSING Virk innihaldsefni:
Maltese: Propylene glycol monocaprylate Propylene glycol dicaprylocaprate
Icelandic: RRR-α-tocopherol beta-caroten maísolía propylen glycol macrogolglycerol hydroxystearat polysorbat 80 propylen glycol monocaprylat propylen glycol dicaprylocaprat
Maltese: 1 ml għal kull 10 kg addizzjonali
Icelandic: 1 ml fyrir hver 10 kg umfram ofangreint
Maltese: Fliexken ta' polyethylene ta' densità għolja fluworinati (HDPE) b'tapp tal-polypropylene.
Icelandic: Flúortengd háþéttni polyethylen (HDPE) glös með polypropylen loki.
Maltese: Flixkun (HDPE): 3 snin.
Icelandic: Glas (HDPE):
Maltese: PERJODU TA' TIŻMIM 7 ijiem
Icelandic: BIÐTÍMI FYRIR AFURÐANÝTINGU 7 dagar.
Maltese: Elanco GmbH
Icelandic: Elanco France S.A.S 26
Maltese: Soluzzjoni orali.
Icelandic: Ormalyf.
Maltese: 4.11 Perjodu ta' tiżmim 7 ijiem.
Icelandic: 4.11 Biðtími fyrir afurðanýtingu
Maltese: Zolvix intwera li huwa effettiv kontra r-razez tal-parassiti elenkati fis-sezzjoni 4, reżistenti għal (pro)benzimidazoles, levamisole, morantel, macrocyclic lactones u razez ta' H. contortus reżistenti għas-salicylanilides.
Icelandic: Sýnt hefur verið fram á að ZOLVIX sé virkt gegn stofnum sníkjudýra í maga- og þörmum, sem talin eru upp í kafla 4, sem eru ónæmir fyrir (pro)benzimidazoli, levamisoli, moranteli, stórhringlaga laktónum og H. contortus stofnum sem eru ónæmir fyrir salicýlanilíðum.
Maltese: Soluzzjoni ċara oranġjo.
Icelandic: Tær, appelsínugul lausn.
Maltese: Aġenti kontra l parassiti/
Icelandic: Sníklalyf/ Lyf sem verka gegn innsníklum
Maltese: Monepantel huwa sustanza attiva kontra l-ħniex li jappartjeni għall-klassi molekolari tad-derivattiv amino-acetonitrile (AAD).
Icelandic: Monepantel er ormalyf sem tilheyrir flokki amínó-acetónítrílafleiðu (AAD) sameinda.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
Icelandic: Ítarlegar upplýsingar um dýralyfið eru birtar á vef Lyfjastofnunar Evrópu (http://www.ema.europa.eu/).
Maltese: DATA TA' SKADENZA Jiskadi {xahar / sena}
Icelandic: DAGSETNING ENDURSKOÐUNAR TEXTANS {MM/ÁÁÁÁ}
Maltese: Numru tal-MA (EU)
Icelandic: ESB markaðsleyfisnúmer (Sér)heiti Styrkleiki
Maltese: Zomarist ma' alkoħol
Icelandic: Notkun Zomarist með áfengi
Maltese: Zomarist 50 mg/1000 mg
Icelandic: 50 mg/1000 mg
Maltese: Zomarist 50 mg/850 mg
Icelandic: 50 mg/850 mg
Maltese: EU/1/08/483/007-012 EU/1/08/483/016-018 EU/1/08/483/025-030
Icelandic: EU/1/08/483/007-012 EU/1/08/483/016-018 EU/1/08/483/025-030 EU/1/08/483/034-036
Maltese: Tfal u adolexxenti L-użu ta' Zomarist fi tfal u adolexxenti ta' età ta' sa 18-il sena mhux rakkomandat.
Icelandic: Zomarist hjá börnum og unglingum yngri en 18 ára.
Maltese: Ir-rata u l-grad ta' assorbiment ta' metformin milZomarist 50 mg/1000 mg kienu mnaqqsa meta mogħtija ma' l-ikel bi tnaqqis fis-Cmax b'26%, AUC b'7% u Tmax ittardjat (2.0 sa 4.0 h).
Icelandic: Hraði og magn frásogs metformins úr Zomarist 50 mg/1000 mg minnkaði þegar það var gefið með mat eins og sést á því að Cmax minnkaði um 26%, AUC um 7% og Tmax seinkaði (2,0-4,0 klst.).
Maltese: Intweriet bioekwivalenza mejn Zomarist fi tlett qawwiet ta' dożi (50 mg/500 mg, 50 mg/850 mg u 50 mg/1000 mg), kontra kombinazzjoni ħielsa ta' pilloli ta' vildagliptin u metformin hydrochloride bid-dożi li jikkorrispondu għalihom.
Icelandic: Sýnt hefur verið fram á jafngildi aðgengis Zomarist í þremur skammtastyrkleikum (50 mg/500mg, 50 mg/850 mg og 50 mg/1000 mg) og samsetninga vildagliptins og metformin hýdróklóríðs taflna í samsvarandi skömmtum.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati ta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
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.
Maltese: Zomarist 50 mg/850 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
Icelandic: 50 mg/850 mg filmuhúðaðar töflur vildagliptin/metformin hýdróklóríð
Maltese: Madankollu, il-bioekwivalenza ta'Zomarist meta ngħata flimkien ma' vildagliptin u metformin ġiet murija (ara sezzjoni 5.2).
Icelandic: Hins vegar hefur verið sýnt fram á jafngildi aðgengis (bioequivalence) Zomarist og vildagliptins og metformins sem gefin eru samhliða (sjá kafla 5.2).
Maltese: 10 (10x1) kunjetti (pakkett multiplu)
Icelandic: 10 (10x 1) hettuglös (fjölpakkning)
Maltese: 10 (10x 1+1) kunjetti + ampoules (pakkett multiplu)
Icelandic: 10 (10x 1+1) hettuglös + lykjur (fjölpakkning)
Maltese: 4 kunjetti + 4 ampoules
Icelandic: + 4 lykjur
Maltese: Plaċebo Δ Zometa 
Icelandic: Lyfleysa Δ Zometa 
Maltese: * Id-dożi ġew ikkalkulati fuq mira tal-AUC ta' 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Icelandic: * Skammtar voru reiknaðir út með því að gera ráð fyrir AUC markgildinu 0,66 (mg•klst./l) (CLcr = 75 ml/mín.).
Maltese: Pakkett multiplu (5x1 flixkun)
Icelandic: Fjölpakkning (5x1 flaska)
Maltese: Pakkett multiplu (4x1 flixkun)
Icelandic: Fjölpakkning (4x1 flaska)
Maltese: Is-soluzzjoni rrikostitwita tibqa' stabbli għal 24 siegħa f'temperatura ta' bejn 2°C - 8°C.
Icelandic: Eftir blöndun er lausnin stöðug í 24 klst. við 2°C - 8°C.
Maltese: Pakketti multipli li fihom 4 (4x 1) jew 5 (5x 1) flixken.
Icelandic: Fjölpakkningar með 4 (4x 1) eða 5 (5x 1) flöskum.
Maltese: Komuni ħafna (1/10), komuni (1/100 sa <1/10), mhux komuni (1/1,000 sa <1/100), rari (1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima middejta disponibbli).
Icelandic: Mjög algengar (≥ 1/10), algengar (≥ 1/100 til < 1/10), sjaldgæfar (≥ 1/1.000 til < 1/100), mjög sjaldgæfar (≥ 1/10.000 til < 1/1.000), koma örsjaldan fyrir (< 1/10.000), tíðni ekki þekkt (ekki hægt að áætla tíðni út frá fyrirliggjandi gögnum).
Maltese: 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Id-dożi ġew ikkalkulati billi tqieset mira ta' AUC ta' 0.66 (mg•hr/l) (CLcr = 75 ml/min).
Icelandic: Zometa* 4,0 mg zoledronsýra 3,5 mg* zoledronsýra 3,3 mg* zoledronsýra 3,0 mg* zoledronsýra * Skammtar voru reiknaðir út með því að gera ráð fyrir AUC markgildinu 0,66 (mg·klst./l) (CLcr = 75 ml/mín).
Maltese: Ma jidhirx li zoledronic acid jeħel b'xi mod apprezzabbli mal-proteini fil-plażma u mhuwiex impeditur tal-enzima umana P450 in vitro (ara sezzjoni 5.2), iżda ma twettaq l-ebda studju kliniku formali ta' interazzjoni.
Icelandic: Zoledronsýra binst ekki að ráði við prótein í plasma og hamlar ekki P450-ensímum í mönnum in vitro (sjá kafla 5.2), en ekki hafa verið gerðar neinar formlegar klínískar rannsóknir á milliverkunum.
Maltese: EU/1/01/176/001 kunjett 1 u ampulla 1 EU/1/01/176/002 4 kunjetti u 4 ampulli
Icelandic: EU/1/01/176/001 1 hettuglas og 1 lykja EU/1/01/176/002 4 hettuglös og 4 lykjur
Maltese: Insuffiċjenza epatika
Icelandic: Ráðlagður skammtur
Maltese: L-effetti ta' zoledronic acid mogħti ġol-vina fil-kura ta' pazjenti pedjatriċi (mill-età ta' sena sa 17il sena) b'osteoġenesi imperfetta severa (tipi I,III u IV) tqabblu ma' pamidronate mogħti ġol-vina fi studju wieħed internazzjonali, multiċentriku, randomizzat, open label b'74 u 76 pazjent f'kull grupp ta' kura, rispettivament.
Icelandic: Verkun zoledronsýru, til notkunar í bláæð, við meðferð hjá börnum (1 árs til 17 ára) með alvarlegan beinstökkva (gerð I, III og IV) var borin saman við pamidronat, til notkunar í bláæð, í einni alþjóðlegri, fjölsetra, slembaðri, opinni rannsókn hjá 74 og 76 sjúklingum í hvorum meðferðarhópi fyrir sig.
Maltese: Pakketti multipli li fihom 10 (10 pakketti ta' 1) kunjetti.
Icelandic: Fjölpakkningar með 10 (10 pakkningar með 1) hettuglösum.
Maltese: Popolazzjoni pedjatrika
Icelandic: ASKJA - STAKPAKKNING
Maltese: Zometa jiġi f'pakketti individwali ta' 1 jew 4 kunjetti u 1 jew 4 ampulli, rispettivament, u bħala pakketti multipli li fihom 10 (10x 1+1) kunjetti u ampulli.
Icelandic: Zometa er fáanlegt í stakpakkningum með 1 eða 4 hettuglösum og 1 eða 4 lykjum, og í fjölpakkningum með 10 (10x 1+1) hettuglösum og lykjum.
Maltese: Doża ta' Zometa rrakkomandata*
Icelandic: Hvernig er Zometa gefið
Maltese: Millilitru 1 tal-konċentrat fih 0.8 mg zoledronic acid (bħala monohdyrate).
Icelandic: Einn ml af þykkni inniheldur 0,8 mg af zoledronsýru (sem einhýdrat).
Maltese: Għal pazjenti b'funzjoni renali normali (definita bħala CLcr >60 ml/min), zoledronic acid 4 mg/100 ml soluzzjoni għall-infużjoni tista' tingħata direttament mingħajr aktar preparazzjoni.
Icelandic: Sjúklingum með eðlilega nýrnastarfsemi (skilgreind sem CLcr > 60 ml/mín.) má gefa zoledronsýru 4 mg/100 ml innrennslislyf, lausn beint, án frekari undirbúnings.
Maltese: KUNJETTI BĦALA
Icelandic: B. FYLGISEÐILL
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KAXXA TINTLEWA - REĊIPJENT TA' BAXXA TA' PAKKETT MULTIPLU (B'KAXX BLU)
Icelandic: ASKJA - YTRI UMBÚÐIR FJÖLPAKKNINGA (MEÐ „BLUE BOX")
Maltese: Urtikarja.
Icelandic: Svefnhöfgi.
Maltese: EU/1/01/176/004 kunjett 1 EU/1/01/176/005 4 kunjetti
Icelandic: EU/1/01/176/004 1 hettuglas EU/1/01/176/005 4 hettuglös
Maltese: Doża aġġustata (mg ta' aċidu żoledroniku f'100 ml)
Icelandic: Aðlagaður skammtur (mg zoledronsýru í 100 ml)
Maltese: Disturb tal-funzjoni tal-kliewi msejjaħ sindrome Fanconi (normalment se jkun iddeterminat mittabib tiegħek permezz ta' ċerti testijiet tal-awrina).
Icelandic: Truflun á nýrnastarfsemi sem kallast Fanconis heilkenni (er venjulega greint af lækninum með ákveðnum þvagrannsóknum).
Maltese: Zometa jista' jingħata lill-persuni li għandhom 65 sena jew aktar.
Icelandic: Nota má Zometa handa sjúklingum 65 ára og eldri.
Maltese: M'għandekx tingħata Zometa jekk ħriġt tqila.
Icelandic: Til notkunar í bláæð.
Maltese: Inti se tingħata supplimenti adegwati ta' kalċju u vitamina D.
Icelandic: Sjúklingar skulu fá fullnægjandi kalsíumog D-vítamínuppbót.
Maltese: Pakketti individwali li fihom 1 jew 4 kunjetti.
Icelandic: Stakpakkningar með 1 eða 4 hettuglösum.
Maltese: Għall-pazjenti b'linja bażi anormali ta' kreatinina (>1.4 mg/dl jew >124 µmol/l), żieda ta' 1.0 mg/dl jew 88 µmol/l.
Icelandic: - Hjá sjúklingum með óeðlilegt upphafsgildi kreatíníns (> 1,4 mg/dl eða > 124 μmól/l), aukning um 1 mg/dl eða 88 μmól/l.
Maltese: Għall-kondizzjonijiet ta' ħażna tas-soluzzjoni rikostitwita għall-infużjoni, ara sezzjoni 6.3.
Icelandic: Geymsluskilyrði eftir blöndun innrennslislausnar, sjá kafla 6.3.
Maltese: Paġna 1 minn 1
Icelandic: Síða 1 af 1
Maltese: Farmaċewtika
Icelandic: Lyfjaform
Maltese: 1.2 Formola tal-Applikazzjoni - Anness A
Icelandic: 1.2 Umsóknareyðublað
Maltese: Zonisamide
Icelandic: Zonisamíð
Maltese: Mnejn għandu jingħata
Icelandic: - Viðauki A
Maltese: Numru tal-UE Isem Ivvintat Qawwa Għamla
Icelandic: ESB-númer Sérheiti
Maltese: Kunfidenzjali
Icelandic: Styrkleiki
Maltese: Eisai Manufacturing Ltd European Knowledge Centre Mosquito Way
Icelandic: Ltd European Knowledge Centre Mosquito Way
Maltese: Pożoloġija - Adulti
Icelandic: Skammtar - fullorðnir
Maltese: MedDRA verżjoni 13.1
Icelandic: MedDRA útgáfa 13.1
Maltese: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, Ir-Renju Unit.
Icelandic: Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, Bretland.
Maltese: Pazjenti li jiżnu > 55 kg
Icelandic: Sjúklingar sem vega > 55 kg
Maltese: CI95%
Icelandic: Mismunur Öryggisbil95%
Maltese: Naqqas f'intervalli ta' ġimgħa f'inkrementi ta': 20 - 28 kg 25 sa 50 mg/jum* 29 - 41 kg 50 sa 75 mg/jum* 42 - 55 kg 100 mg/jum* >55 kg
Icelandic: 20 - 28 kg 25 til 50 mg/sólarhring* 29 - 41 kg 50 til 75 mg/sólarhring* 42 - 55 kg 100 mg/sólarhring* >55 kg
Maltese: Hatfield, Hertfordshire, AL10
Icelandic: Hatfield, Hertfordshire, AL10 9SN Bretland
Maltese: Ġimgħa 3 sa 5
Icelandic: Vika 3 til 5
Maltese: Folji tal-PVC/PVDC/aluminju, pakketti ta' 14, 28, 56 u 84 kapsula iebsa.
Icelandic: Þynnupakkningar úr pólývinýlklóríði/PVDC/áli, pakkningar með 14, 28, 56 og 84 hörðum hylkjum.
Maltese: • aġitazzjoni, irrikwitezza, konfużjoni, depressjoni
Icelandic: æsingur, skapstyggð, ringlun, þunglyndi
Maltese: ≥ 1/10,000 sa < 1/1,000
Icelandic: ≥ 1/10.000 til < 1/1.000
Maltese: PP = Popolazzjoni Skont il-Protokoll; ITT = Popolazzjoni b'Intenzjoni li Tiġi Kkurata *Punt aħħari primarju
Icelandic: (Per Protocol); ITT = Hópur skv. meðferðarákvörðun (Intent To Treat) *Aðalendapunktur
Maltese: Folji tal-PVC/PVDC/aluminju, pakketti ta' 28, 56, 84, 98 u 196 kapsula iebsa.
Icelandic: Þynnupakkningar úr pólývinýlklóríði/PVDC/áli, pakkningar með 28, 56, 84, 98 og 196 hörðum hylkjum.
Maltese: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Il-Ġermanja
Icelandic: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Þýskaland
Maltese: 100 mg/jum*
Icelandic: 100 mg/sólarhring*
Maltese: Studji in vitro bl-użu ta' mikrożomi tal-fwied uman juru ftit jew xejn (<25%) inibizzjoni ta' cytochrome isozymes P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A4 f'livelli ta' zonisamide ta' madwar id-doppju jew iktar mill-konċentrazzjonijiet mhux imwaħħlin fis-serum li huma klinikament rilevanti.
Icelandic: Í in vitro rannsóknum á lifrarfrymisögnum (microsomes) úr mönnum hefur komið fram lítil sem engin (< 25%) hömlun á cýtókróm-P450-ísóensímunum 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 og 3A4 við þéttni óbundins zonisamíðs sem er u.þ.b. tvöföld klínískt mikilvæg sermisþéttni eða hærri.