FrancophonIA/ELRC3.0 huggingface dataset:
Polish: Należy okresowo kontrolować konieczność kontynuacji leczenia objawowego i odpowiedź na leczenie.
Icelandic: Endurmeta á reglulega þörf sjúklingsins fyrir meðferð til að lina einkenni og svörun hans við meðferðinni.
Polish: Aneks III Zmiany do odpowiednich punktów Charakterystyki Produktu Leczniczego oraz ulotki dla pacjenta
Icelandic: Viðauki III Breytingar á tilteknum köflum í samantekt á eiginleikum lyfs og fylgiseðli
Polish: 4.8 Działania niepożądane: [W punkcie tym należy wstawić poniższe sformułowania]
Icelandic: Kafli 4.8 Aukaverkanir:
Polish: TEVA Gyógyszergyár zRt.
Icelandic: Ungverjaland TEVA Gyógyszergyár zRt.
Polish: Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Icelandic: Šmarješka cesta 6 8501 Novo mesto Slovenia
Polish: Rua Prof. Sousa da Câmara,
Icelandic: Sousa da Câmara,
Polish: IBSA Pharma Információs és Szolgáltató Kft.
Icelandic: Ungverjaland IBSA Pharma Információs és Szolgáltató Kft.
Polish: 1074-803 Lisboa Portugal
Icelandic: 1074-803 Lisboa
Polish: No. 1 Croydon
Icelandic: 1 Croydon
Polish: Austria ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
Icelandic: Austurríki ratiopharm Arzneimittel VertriebsGmbH Albert-Schweitzer-Gasse 3 1140 Vienna
Polish: Via Cesarea, 11/10 Genova - 16121 Italy
Icelandic: Via Cesarea, 11/10 Genova - 16121
Polish: Wielka Brytania Crescent Pharma Limited Unit 3&4
Icelandic: Crescent Pharma Limited Unit 3&4
Polish: Finlandia ratiopharm Oy P.O.Box 67
Icelandic: Finnland ratiopharm Oy P.O.Box 67
Polish: Via Nocera Umbra 75 Roma - 00181
Icelandic: Angenerico S.p.a. Via Nocera Umbra 75 Roma - 00181
Polish: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon
Icelandic: ARROW GENERIQUES 26, avenue Tony Garnier 69007
Polish: Via Ragazzi del 99 5, Bologna - 40133 Italy
Icelandic: Via Ragazzi del 99 5, Bologna - 40133
Polish: Etienne Demunter 5, box 8 1090 Jette
Icelandic: Etienne Demunter 5, box 8 1090
Polish: A/S "Olainfarm" Rupnicu iela 5 Olaine, LV - 2114 Latvia
Icelandic: A/S "Olainfarm" Rupnicu iela 5 Olaine, LV - 2114
Polish: Pinewood Laboratories Ltd (T/A Pinewood Heathcare) Ballymacarbry Clonmel, Co. Tipperary Ireland
Icelandic: Pinewood Laboratories Ltd (T/A Pinewood Heathcare) Ballymacarbry Clonmel, Co.
Polish: Novartis Finland OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Icelandic: OY Metsänneidonkuja 10 FIN-02130 Espoo Finland
Polish: Niemcy hameln pharma plus gmbh Langes Feld 13
Icelandic: Þýskaland hameln pharma plus gmbh Langes Feld 13
Polish: Wielka Brytania Chelonia Healthcare Limited Boumpoulinas 11
Icelandic: Chelonia Healthcare Limited Boumpoulinas 11
Polish: Polígono Industrial Azque 28806 Alcalá de Henares (Madrid)
Icelandic: Industrial Azque 28806 Alcalá de Henares (Madrid)
Polish: Swansea Enterprise Park Swansea SA6 8QQ
Icelandic: Enterprise Park Swansea SA6 8QQ United Kingdom
Polish: Wielka Brytania Aptil Pharma limited 9th Floor
Icelandic: Aptil Pharma limited 9th Floor
Polish: Str. Stefan Mihaileanu nr.31, sector 2;
Icelandic: S.C. ARENA GROUP S.A. Str. Stefan Mihaileanu nr.31, sector 2;
Polish: SIA Briz Rasas iela 5 Riga, LV-1057 Latvia
Icelandic: SIA Briz Rasas iela 5 Riga, LV-1057
Polish: Pharmaswiss Eesti OÜ Tammsaare tee 47 11316 Tallinn Estonia
Icelandic: Pharmaswiss Eesti OÜ Tammsaare tee 47 11316
Polish: Laboratório B. A. Farma, Lda.
Icelandic: Laboratório B. A. Farma, Lda. Rua Prof.
Polish: Largo Donegani 4/a Novara - 28100 Italy
Icelandic: Largo Donegani 4/a Novara - 28100
Polish: Aneks I Wykaz nazw, postaci farmaceutycznych, mocy produktów leczniczych, dróg podania, podmiotów odpowiedzialnych posiadających pozwolenia na dopuszczenie do obrotu w Państwach Członkowskich
Icelandic: Viðauki I Listi yfir heiti, lyfjaform, styrkleika lyfjanna, íkomuleið(ir), markaðsleyfishafa í aðildarlöndunum
Polish: Sandoz Hungária Kft., ., Bartók Béla út 43.-47.
Icelandic: Ungverjaland Sandoz Hungária Kft., ., Bartók Béla út 43.-47.
Polish: Nie dotyczy wstrzyknięć dożylnych w bolusie.
Icelandic: Ekki ætlað til inndælingar í bláæð.
Polish: Leskoškova cesta 9D 1000 Ljubljana Slovenia
Icelandic: Leskoškova cesta 9D 1000
Polish: Pfizer AS Lilleakerveien 2B 1324 Lysaker Norway
Icelandic: Pfizer AS Lilleakerveien 2B 1324
Polish: 82041 Oberhaching Germany
Icelandic: 82041 Oberhaching
Polish: Pliva Ljubljana d.o.o.
Icelandic: Pliva Ljubljana d.o.o. pot k sejmišču
Polish: UAB „BERLIN CHEMIE MENARINI BALTIC" Jasinskio g. 16 a, 01112 Vilnius Lithuania
Icelandic: UAB „BERLIN CHEMIE MENARINI BALTIC" Jasinskio g. 16 a, 01112
Polish: Diclo-B „Lannacher"Kapseln
Icelandic: „Lannacher"Kapseln
Polish: Brianza, Milano, 20041 Italy
Icelandic: Brianza, Milano, 20041
Polish: 28290 Las Matas (Madrid) Spain
Icelandic: Oficina 203 28290 Las Matas (Madrid) Spain
Polish: Wielka Brytania Galen Limited Seagoe Industrial Estate Craigavon
Icelandic: Limited Seagoe Industrial Estate Craigavon
Polish: Str. Zugrav Nedelcu nr.3, Timişoara
Icelandic: STADA HEMOFARM S.R.L. Str. Zugrav Nedelcu nr.3, Timişoara
Polish: Str. Fabricii nr. 124 Cluj-Napoca 400 632 România
Icelandic: S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj-Napoca 400 632 România
Polish: Ciudad de Balaguer, 7-11 08022 Barcelona Spain
Icelandic: LABORATORIOS LLORENS, S.A. Ciudad de Balaguer, 7-11 08022 Barcelona Spain
Polish: Eurogenerics S.A Esplanade Heysel b 22
Icelandic: N.V. Eurogenerics S.A Esplanade Heysel b 22
Polish: Wielka Brytania Sandoz Limited Frimley Business Park Frimley
Icelandic: Sandoz Limited Frimley Business Park Frimley
Polish: Wielka Brytania Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Icelandic: Co-Pharma Limited Unit 4, Metro Centre Tolpits Lane, Watford Hertfordshire WD18 9SS United Kingdom
Polish: Luksemburg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Icelandic: Lúxemborg Daiichi Sankyo Belgium SA Rue Fond Jean Pâques 5
Polish: Genericon Pharma Gesellschaft m.b.H.
Icelandic: Pharma Gesellschaft m.b.H.
Polish: Pharmacia GmbH Linkstrasse 10 10785 Berlin Germany
Icelandic: GmbH Linkstrasse 10 10785 Berlin Germany
Polish: Wielka Brytania Actavis UK Limited Whiddon Valley
Icelandic: Actavis UK Limited Whiddon Valley Barnstaple
Polish: Majamil PPH
Icelandic: Díklófenaknatríum Majamil PPH
Polish: Olfen-75 SR Depotabs
Icelandic: Díklófenaknatríum Olfen-75 SR Depotabs
Polish: 110 B 20097 Hamburg Germany
Icelandic: Spaldingstr. 110 B 20097 Hamburg Germany
Polish: Voltarol Pain-Eze Extra Strength Tablets
Icelandic: Voltarol Pain-Eze Extra Strength
Polish: T & D Pharma GmbH Kleine Knopheide 4 32657 Lemgo Germany
Icelandic: GmbH Kleine Knopheide 4 32657 Lemgo Germany
Polish: EG LABO - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517 Boulogne Billancourt Cedex
Icelandic: - LABORATOIRES EUROGENERICS "Le Quintet" - bâtiment A 12, rue Danjou 92517
Polish: Via Enrico Fermi 1 Alanno (PE) 65020 Italy
Icelandic: Alfa Wassermann S.p.A. Via Enrico Fermi 1 Alanno (PE) 65020 Italy
Polish: Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium
Icelandic: N.V. Eurogenerics S.A Esplanade Heysel b 22 B-1020 Bruxelles Belgium
Polish: Chile, 8-2ª planta.
Icelandic: GERMED FARMACEUTICA, S.L. Chile, 8-2ª planta.
Polish: LABORATORIOS ALDOUNION, S.A.
Icelandic: LABORATORIOS ALDO-UNION, S.A.
Polish: Via Cantu, 11, Balsamo Milano, 20092
Icelandic: Germed Pharma S.p.a. Via Cantu, 11, Balsamo Milano, 20092
Polish: Wielka Brytania Chiesi Limited Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Icelandic: Cheadle Royal Business Park Highfield, Cheadle Cheshire SK8 3GY United Kingdom
Polish: Luksemburg Hexal AG Industriestraße 25
Icelandic: Lúxemborg Hexal AG Industriestraße 25
Polish: Wielka Brytania Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS
Icelandic: Ennogen Pharma Limited Unit G4, Riverside Way Dartford, DA1 5BS United Kingdom
Polish: Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain
Icelandic: LABORATORIOS NORMON, S.A. Ronda de Valdecarrizo, 6 28760 Tres Cantos (Madrid) Spain
Polish: B-dul Aurel Vlaicu nr. 82A Constanţa 900055
Icelandic: S.C. MAGISTRA C&C S.R.L. B-dul Aurel Vlaicu nr. 82A Constanţa 900055
Polish: Wielka Brytania Chatfield Pharmaceuticals Limited
Icelandic: Chatfield Pharmaceuticals Limited
Polish: Niemcy sigapharm GmbH Temmlerstr.
Icelandic: Þýskaland sigapharm GmbH Temmlerstr.
Polish: Via Sette Santi 3, Firenze 50131- Italy
Icelandic: Menarini Industrie Farmaceutiche Riunite S.r.l. Via Sette Santi 3, Firenze 50131- Italy
Polish: Luksemburg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium
Icelandic: Lúxemborg Socobom S.A Avenue Louise 149 b24 B-1050 Bruxelles Belgium
Polish: Louizalaan 149 box 24 1050 Ixelles Belgium
Icelandic: Louizalaan 149 box 24 1050
Polish: Zona Industrial do Lagedo 3465-157 Santiago de Besteiros
Icelandic: Zona Industrial do Lagedo 3465-157
Polish: Miles Gray Road Basildon, Essex SS14 3RF United Kingdom
Icelandic: Waymade Plc Regency House Miles Gray Road Basildon, Essex SS14 3RF United Kingdom
Polish: 97-107 Uxbridge Road London W5 5TL
Icelandic: Uxbridge Road London W5 5TL United Kingdom
Polish: Manston Pharma Limited 3 Montpelier Avenue, Bexley DA5 3AP Kent
Icelandic: 3 Montpelier Avenue, Bexley DA5 3AP Kent
Polish: Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
Icelandic: 7 Sopwith Way Drayton Fields Industrial Estate, Daventry Northamptonshire NN11 8PB United Kingdom
Polish: Gottlieb Daimler Strasse 19 D-89150 Laichingen Germany
Icelandic: Gottlieb Daimler Strasse 19 D-89150
Polish: Winthrop Arzneimittel GmbH Industriestrasse 26
Icelandic: Arzneimittel GmbH Industriestrasse 26
Polish: Wielka Brytania Actavis Group PTC ehf Reykjavikurvegi 76-78
Icelandic: Actavis Group PTC ehf Reykjavikurvegi 76-78 IS-220
Polish: Dolgit-Diclo 50
Icelandic: Díklófenaknatríum Dolgit-Diclo 50
Polish: de Europa, 20 B Parque Empresarial La Moraleja
Icelandic: Avda. de Europa, 20 B Parque Empresarial La Moraleja 28108 Alcobendas (Madrid) Spain
Polish: 92931 Paris La Défense Cedex
Icelandic: Paris La Défense Cedex France
Polish: Holandia ratiopharm Nederland B.V.
Icelandic: Holland ratiopharm Nederland B.V. Florapark 4
Polish: VOLTATABS 12,5 MG(EX:ZYMAMED)
Icelandic: VOLTATABS 12,5 MG(EX:
Polish: Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca 2705-906 Terrugem SNT Portugal
Icelandic: Estrada do Rio da Mo, 8, 8 A e 8 B - Fervenca
Polish: Olfen-100 SR Depocaps
Icelandic: Díklófenaknatríum Olfen-100 SR Depocaps
Polish: Rowex Ltd Bantry, Co. Cork Ireland
Icelandic: Rowex Ltd Bantry, Co.
Polish: FLECTOR 50 mg, granulés pour solution buvable en sachet-dose
Icelandic: Díklófenakepólamín FLECTOR 50 mg, granulés pour solution buvable en sachet-dose
Polish: 21ST Km National Highway Athens-Lamia, 14565 Greece
Icelandic: 21ST Km National Highway Athens-Lamia, 14565
Polish: Edíficio Arquiparque 1 R/C Esqº
Icelandic: 1 R/C Esqº
Polish: Eminocs 50 mg/ml, drank
Icelandic: Díklófenakkalíum Eminocs 50 mg/ml, drank
Polish: Wielka Brytania Therabel pharma UK Limited Compass House, vision Park Chivers, Histon
Icelandic: Therabel pharma UK Limited Compass House, vision Park Chivers, Histon Cambridge CB24 9AD United Kingdom
Polish: Wielka Brytania Mercury Pharma Group Limited
Icelandic: Mercury Pharma Group Limited
Polish: Actavis A/S Ornegardsvej 16 2820 Gentofte Denmark
Icelandic: Actavis A/S Ornegardsvej 16 2820
Polish: Wielka Brytania Mercury Pharma International Limited
Icelandic: Mercury Pharma International Limited
Polish: PANNONPHARMA Gyógyszergyártó Kft. PannonPharma út 1.
Icelandic: PannonPharma út 1.
Polish: 1 A Pharma Keltenring 1+3
Icelandic: Keltenring 1+3
Polish: FLECTOR 25 mg, granulés pour solution buvable en sachet-dose
Icelandic: Díklófenakepólamín FLECTOR 25 mg, granulés pour solution buvable en sachet-dose
Polish: Remedica Ltd Limassol Industrial Estate Aharnon Street PO Box 51706
Icelandic: Industrial Estate Aharnon Street PO Box 51706
Polish: Rivium Westlaan 142 2909 LD Capelle aan den IJssel
Icelandic: 2909 LD Capelle aan den IJssel The Netherlands
Polish: Tabletka
Icelandic: Tabletten
Polish: Novartis Hellas S.A.C.I.
Icelandic: Novartis Hellas S.A.C.I. 12th km
Polish: 8502 Lannach Austria
Icelandic: 8502 Lannach
Polish: Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Icelandic: S.p.A. Largo Umberto Boccioni, 1 Origgio - 21040 Varese Italy
Polish: London SW5 9JL
Icelandic: Kramer Mews London SW5 9JL United Kingdom
Polish: Astellas Pharma Co. Ltd 5 Waterside
Icelandic: Ltd 5 Waterside
Polish: Chephasaar ChemischPharmazeutische Fabrik GmbH
Icelandic: Chephasaar ChemischPharmazeutische Fabrik GmbH Muehlstr.
Polish: 12th Km National Highway No 1, Metamorfosi Attikis 144 51 Greece
Icelandic: No 1, Metamorfosi Attikis 144 51 Greece
Polish: Rua Félix Correia, 1-B 1500-271 Lisboa Portugal
Icelandic: Confar - Consórcio Farmacêutico, Lda. Rua Félix Correia, 1-B 1500-271 Lisboa
Polish: POLYFLAM EX RUFIMAX EX ALGIRHUMA 50 MG
Icelandic: POLYFLAM EX RUFIMAX EX
Polish: Naklofen SR 100 mg tablete s podaljšanim sproščanjem
Icelandic: SR 100 mg tablete s podaljšanim sproščanjem
Polish: Diklofenak potasowy
Icelandic: Diclofenac potassium
Polish: Diclofenac Mylan-75 Retard
Icelandic: Mylan-75 Retard
Polish: de Burgos, 16 D 5ª planta
Icelandic: RATIOPHARM ESPAÑA, S.A. Avda. de Burgos, 16 D 5ª planta
Polish: STADA Arzneimittel AG Stadastrasse 2-18 Bad Vilbel 61118
Icelandic: STADA Arzneimittel AG Stadastrasse 2-18
Polish: Jorge Comín (médico pediatra), 3-bajos 46015 Valencia Spain
Icelandic: Jorge Comín (médico pediatra), 3-bajos
Polish: Dania
Icelandic: Denmark
Polish: Kasułka dojelitowa, miękka
Icelandic: Magasýruþolið mjúkt hylki
Polish: 115 Narborough Road Leicester, LE3 0PA United Kingdom
Icelandic: Morningside Healthcare Limited 115 Narborough Road Leicester, LE3 0PA United Kingdom
Polish: Diclofenac- 1 A Pharma 100 mg Zäpfchen
Icelandic: Diclofenac- 1 A Pharma 100 mg
Polish: Actavis Deutschland GmbH & Co. KG
Icelandic: Actavis Deutschland GmbH & Co.
Polish: Diclofenac- 1 A Pharma 50 mg Zäpfchen
Icelandic: Diclofenac- 1 A Pharma 50 mg
Polish: Naklofen 50 mg svečke
Icelandic: 50 mg svečke
Polish: Olfen-50 Lactab 50mg
Icelandic: Díklófenaknatríum Olfen-50 Lactab 50mg
Polish: Budapest 1124, Hungary
Icelandic: Budapest 1124,
Polish: Kappler Pharma Consult GmbH
Icelandic: Kappler Pharma Consult GmbH Fonyoder Str. 18
Polish: 92300 Levallois-Perret France
Icelandic: 49, avenue Georges Pompidou 92300 Levallois-Perret France
Polish: 1 G. M. Dimitrov Blvd. Sofia 1172
Icelandic: 1 G. M. Dimitrov Blvd.
Polish: Gerot Pharmazeutika GmbH Arnethgasse 3
Icelandic: GmbH Arnethgasse 3
Polish: Diclofenac Temmler 25 mg Hartkapseln
Icelandic: Temmler 25 mg Hartkapseln
Polish: 1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria
Icelandic: 1A Pharma GmbH Stella-Klein-Löw-Weg 17 1020
Polish: Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020 Vienna Austria
Icelandic: Hexal Pharma GmbH Stella-Klein-Löw-Weg 17 1020
Polish: DICLOFENACO LLORENS 75 mg solución inyectable EFG
Icelandic: DICLOFENACO LLORENS 75 mg solución inyectable
Polish: Naklofen 50 mg gastrorezistentne tablete
Icelandic: 50 mg gastrorezistentne tablete
Polish: Via Dell'Industria Pietradefusi - 83030 Avellino Italy
Icelandic: Pietradefusi - 83030
Polish: Claudius Prinselaan 142 4818 CP Breda The Netherlands
Icelandic: 4818 CP Breda
Polish: Olfen-75 Ampoules 75mg/2ml
Icelandic: Díklófenaknatríum Olfen-75 Ampoules 75mg/2ml
Polish: Walter Ritter GmbH & Co. Spaldingstr.
Icelandic: Walter Ritter GmbH & Co.
Polish: Diclo-Klinge 75mg magensaftresistente Hartkapsel
Icelandic: Diclo-Klinge 75mg magensaftresistente
Polish: Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite 100 mg
Icelandic: Diclofenacnatrium Sandoz retard 100, tabletten met gereguleerde afgite
Polish: VOLTARENE 50 mg, comprimé enrobé gastro-résistant
Icelandic: Díklófenaknatríum VOLTARENE 50 mg, comprimé enrobé gastro-résistant
Polish: Diclofenac 1A Pharma retard 75 mg - Tabletten
Icelandic: 1A Pharma retard 75 mg - Tabletten
Polish: Diclofenac "BMM Pharma"
Icelandic: "BMM Pharma"
Polish: Voltaren 50 mg Pulver zur Herstellung einer Lösung zum Einnehmen
Icelandic: Voltaren 50 mg Pulver zur
Polish: Sandwich
Icelandic: Sodium
Polish: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Icelandic: Laboratórios Pfizer, Lda. Lagoas Park, Edifício 10 2740-271
Polish: Voltaren 100 mgZäpfchen für Erwachsene
Icelandic: Voltaren 100 mgZäpfchen für
Polish: Voltarol Retard 75 mg Film-coated Prolonged-release Tablets
Icelandic: Voltarol Retard 75 mg Film-coated
Polish: IS-220 Hafnarfjördur Iceæand
Icelandic: Hafnarfjördur Iceæand
Polish: Disphar International B.V.
Icelandic: Disphar International B.V. Winkelskamp 6
Polish: Olfen-100 Rectocaps 100mg
Icelandic: Díklófenaknatríum Olfen-100 Rectocaps 100mg
Polish: Voltaren Express 12,5mg Kapsułka, miękka Podanie doustne
Icelandic: Voltaren Express 12,5mg Mjúkt hylki
Polish: Wise Pharmaceuticals Ltd. Hamwells Business Park Unit No. 7, Hardicker Street M19 2RB Manchester United Kingdom
Icelandic: 7, Hardicker Street M19 2RB Manchester United Kingdom
Polish: Effekton 25 mg magensaftresistente Tabletten
Icelandic: Effekton 25 mg magensaftresistente
Polish: Teva Nederland B.V.
Icelandic: Teva Nederland B.V. Swensweg 5
Polish: Diclofenac 1A Pharma retard 150 mg - Tabletten
Icelandic: 1A Pharma retard 150 mg - Tabletten
Polish: Unit 5, Faraday court First Avenue,Centrum 100
Icelandic: Focus Pharmaceuticals Limited Unit 5, Faraday court First Avenue,Centrum 100 Burton upon trent Staffordshire, DE14 2WX United Kingdom
Polish: Bydło i psy
Icelandic: Nautgripir og hundar
Polish: 24 godziny
Icelandic: 46 dagar
Polish: 15 mg Tabletki
Icelandic: 50 ml
Polish: Opakowanie 6 butelek
Icelandic: Flaska (HDPE) 1.000 ml Pakkning með 6 flöskum
Polish: Psy: nie dotyczy
Icelandic: Á ekki við
Polish: [Nie wymagane na oznakowaniu opakowania bezpośredniego]
Icelandic: [Not required on the immediate label]
Polish: Masa ciała (kg)
Icelandic: Líkamsþungi (kg)
Polish: Psy: Nie dotyczy
Icelandic: Hundar: Á ekki við.
Polish: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Hiszpania
Icelandic: Camprodón, s/n°, Finca La Riba, Vall de Bianya, 17813 Girona Spánn
Polish: Podmiot odpowiedzialny Pfizer Limited Ramsgate Road Sandwich
Icelandic: Pfizer Limited Ramsgate Road Sandwich
Polish: Difloksacyna po podaniu doustnym u kurcząt jest prawie całkowicie wchłaniania z przewodu pokarmowego (w około 96%).
Icelandic: Hjá kjúklingum er dífloxacín nánast tekið upp að fullu eftir inntöku (u.þ.b. 96%).
Polish: Tabletki należy podawać jeszcze przez 2 dni po ustąpieniu objawów klinicznych schorzenia.
Icelandic: Gefa skal töflurnar í það minnsta í 2 daga eftir að klínísk einkenni eru horfin.
Polish: Indyki (młode indyki o masie ciała do 2 kg).
Icelandic: Kalkúnar (ungir kalkúnar upp í 2 kg líkamsþunga).
Polish: D. USTALENIE MAKSYMALNYCH LIMITÓW POZOSTAŁOŚCI (MRL) które zostały przyjęte zgodnie z rozporządzeniem Rady (EWG) nr 2377/90 i zgodnie z art.31 ust.3b zmienionego rozporządzenia Rady (EWG) nr 2309/93 z dnia 22 lipca 1993 r., w załączeniu.
Icelandic: DÝRALYFJALEIFA sem heimilað er samkvæmt reglugerð framkvæmdastjórnarinnar 2377/90 og í samræmi við 31. gr (3b) reglugerðar framkvæmdastjórnarinnar 2309/93 frá 22. júlí 1993, með breytingum.
Polish: ATC vet kod: QJ01MA94
Icelandic: QJ01MA94
Polish: Slovenská republika Pfizer Luxembourg SARL o.z.
Icelandic: Slovenská republika Pfizer Luxembourg SARL o.z. Tel:
Polish: 4.9 Dawkowanie i drogi podawania
Icelandic: 4.9 Skammtar og íkomuleið
Polish: ilość zwierząt w gospodarstwie (sztuk) x średnia masa ciała ptaka (kg) x 100
Icelandic: fjöldi dýra í húsinu X meðalþyngd hvers dýrs (kg) X 100
Polish: Okres trwałości po pierwszym otwarciu opakowania: 1 miesiąc.
Icelandic: Geymsluþol eftir að umbúðir hafa verið rofnar: 1 mánuður.
Polish: U obu gatunków difloksacyna może ulegać zmianom (glukuronizacji lub sulfhydrylacji), demetylacji do sarafloksacyny lub utlenieniu do N-oksy-difloksacyny.
Icelandic: Hjá báðum dýrategundum getur dífloxacín verið samokað (í glúkúróníð eða súlfat), afmetýlerað í sarafloxacín eða oxað í N-oxíð-dífloxacín.
Polish: Te reakcje niepożądane przemijały z reguły samoistnie w ciągu 1 - 2 dni, bez konieczności dodatkowego leczenia.
Icelandic: Aukaverkanirnar takmörkuðu sig sjálfar innan eins til tveggja daga og kröfðust ekki frekari meðferðar.
Polish: Difloksacyna u indyków wykazuje średnią biodostępność (około 58%).
Icelandic: Hjá kalkúnum hefur dífloxacín til inntöku meðalaðgengi (u.þ.b. 58%).
Polish: Wartości współczynnika dystrybucji osocze/tkanki wynoszą od 0.6 (tłuszcz brzuszny), 2.4 (płuca), 4.5 (mięśnie) do 14.1 (wątroba).
Icelandic: Hlutfallið milli vefja og plasma er á bilinu 0,6 (kviðfita), 2,4 (lungu), 4,5 (vöðvar) og 14,1 (lifur).
Polish: WIELKOŚĆ OPAKOWANIA 1 x 250 ml
Icelandic: PAKKNINGASTÆRÐ 1 x 250 ml
Polish: Większość difloksacyny (np. 68 - 82 %) jest wydalana wraz z kałem.
Icelandic: Meginhluti dífloxacíns (þ.e. 68 - 82%) skilst út í saur.
Polish: Szczegółowe informacje dotyczące powyższego produktu leczniczego weterynaryjnego są dostępne w witrynie internetowej Europejskiej Agencji Leków http://www.ema.europa.eu/
Icelandic: Ítarlegar upplýsingar um þetta dýralyf eru birtar á heimasíðu Evrópsku lyfjastofnunarinnar http://www.ema.europa.eu/
Polish: Wartości współczynnika dystrybucji osocze/tkanki wynoszą od 2.5 (tłuszcz brzuszny), 3.7 (mięśnie), 4.8 (płuca) do 36.5 (wątroba).
Icelandic: Hlutfallið milli vefja og plasma er á bilinu 2,5 (kviðfita), 3,7 (vöðvar), 4,8 (lungu) og 36,5 (lifur).
Polish: Ponieważ nie przeprowadzono badań na kulejących ptakach, nie stosować preparatu Dicural u ptaków z zaburzeniami aparatu ruchu lub ptaków cierpiących na osteoporozę.
Icelandic: Þar sem ekki hafa verið gerðar rannsóknir á höltum fuglum skal ekki nota Dicural til meðferðar fugla með fótamein eða fugla sem þjást af beinþynningu.
Polish: Świąd mijał po kilku minutach, zaś objawy miejscowego podrażnienia ustępowały w ciągu kilku dni.
Icelandic: Almennt hverfur kláðinn innan nokkurra mínútna og staðbundni þrotinn innan nokkurra daga.
Polish: Jeśli po trzech dniach leczenia nie doszło do zauważalnej poprawy stanu zwierzęcia, leczenie należy kontynuować jeszcze przez 2 kolejne dni.
Icelandic: Ef bati er ekki nægilegur eftir 3 daga má halda meðferðinni áfram í 2 daga í viðbót.
Polish: Czas jej połowicznej eliminacji wynosi na około 9,3 godziny.
Icelandic: Helmingunartími útskiljunar var að meðaltali 9,3 klst.
Polish: Podmiot posiadający niniejsze pozwolenie na dopuszczenie do obrotu musi powiadomić Komisję Europejską o planach związanych z obrotem produktem leczniczym posiadającym pozwolenie na mocy tej decyzji.
Icelandic: Markaðsleyfishafi skal upplýsa framkvæmdastjórn Evrópusambandsins um markaðssetningaráætlun fyrir þetta lyf.
Polish: Nie wszystkie wielkości opakowań muszą być wprowadzane do obrotu.
Icelandic: Ekki er víst að allar pakkningastærðir séu markaðssettar.
Polish: WIELKOŚĆ OPAKOWANIA 100 ml
Icelandic: PAKKNINGASTÆRÐ 100 ml
Polish: Psy.
Icelandic: Hundar.
Polish: Uwzględniając zawartość difloksacyny w roztworze doustnym (10%) zaleca się następujący sposób obliczania ilości roztworu (ml) potrzebnej do rozpuszczenia w 1000 l wody: ilość zwierząt w gospodarstwie (sztuk) x średnia masa ciała ptaka (kg) x 100 całkowite dzienne spożycie wody w gospodarstwie w poprzednim dniu (litry)
Icelandic: Með hliðsjón af því að dífloxacín er 10% af innihaldi flöskunnar, skal fylgja eftirfarandi reikningsaðferð til að ákvarða magn í ml sem bæta þarf í 1000 lítra af vatni: fjöldi dýra í húsinu X meðalþyngd hvers dýrs (kg) X 100 heildarvatnsneysla í húsinu síðastliðinn dag (lítrar)
Polish: 7 - 18 %) jest wydalana z moczem.
Icelandic: Örlítill hluti af dífloxacíni (þ.e. 7 - 18%) skilst út í þvagi.
Polish: Nie używać po upływie daty ważności podanej na blistrze po upływie „EXP"
Icelandic: Notið ekki eftir fyrningardagsetningu á merkimiða eftir "EXP"
Polish: 4.10 Przedawkowanie (objawy, postępowanie, odtrutki) Wyniki badań bezpieczeństwa prowadzone na kurczętach i indykach wykazały, że podawanie chlorowodorku difloksacyny w wodzie do picia w dawkach 30 mg/kg m.c.
Icelandic: 4.10 Ofskömmtun (einkenni, bráðameðferð, móteitur, ef þörf krefur) Rannsóknir á öryggi hjá kjúklingum og kalkúnum sýndu að dífloxacín hýdróklóríð virtist hættulaust fyrir fuglana þegar það var gefið í drykkjarvatni í skömmtunum 30 mg/kg (kjúklingar) eða 22 mg/kg (kalkúnar) í þrisvar sinnum lengri tíma en ráðlögð meðferðarlengd (15 daga í röð).