FrancophonIA/ELRC3.0 huggingface dataset:
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
Swedish: D-53773 Hennef mirtazepin-biomo 30 mg Filmtabletten
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
Swedish: Luxemburg SANDOZ S.A., Telecom Gardens, Medialaan 40, B-1800 Vilvoorde, Belgium
English: WYETH-LEDERLE PHARMA GMBH, Vienna, Storchengasse 1, 1150 Wien, Austria
Swedish: Tjeckien WYETH-LEDERLE PHARMA GMBH, Vienna, Storchengasse 1, 1150 Wien, Austria
English: Medochemie Ltd, P.O.Box 51409 CY - 3505 Limassol CYPRUS
Swedish: Lettland Medochemie Ltd, P.O.Box 51409 CY - 3505 Limassol
English: Denmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
Swedish: Danmark Laboratoires IREX, 22 Avenue Galilée, 92350 Le Plessis Robinson, France
English: Denmark N.V. Organon, P.O.
Swedish: Danmark N.V.
English: Netherlands Alpharma B.V. Postbus 313
Swedish: Nederländerna Alpharma B.V.
English: Dispersable tablet
Swedish: Dispergerbar tablett
English: Luxembourg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
Swedish: Luxemburg SANDOZ S.A., Telecom Gardens, Medialaan 40 B-1800 VILVOORDE, Belgium
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
Swedish: Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre
English: Belgium EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
Swedish: EUROGENERICS N.V.Heizel Esplanade B 22 1020 BRUSSEL, Belgium
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
Swedish: D-53773 Hennef mirtazapin-biomo 45 mg Filmtabletten
English: Member State Marketing Authorisation Holder Invented Name
Swedish: Medlems stat Innehavare av godkännande för försäljning
English: Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Swedish: Nederländerna Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
English: H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
Swedish: Storbritannien H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
English: PAROXETINE,
Swedish: Holczkirhen,
English: Netherlands Apothecon B.V. Postbus 324
Swedish: Nederländerna Apothecon B.V.
English: REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller REBOXETIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: SOLVAY PHARMACEUTICALS BV, WEESP, C.J. van Houtenlaan 36, 1381 CP Weesp, Netherlands
Swedish: Tjeckien SOLVAY PHARMACEUTICALS BV, WEESP, C.J. van Houtenlaan 36, 1381 CP Weesp, Netherlands
English: Denmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
Swedish: Danmark Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vibel, Germany
English: Luxembourg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Swedish: Luxemburg MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
English: Coated tablets
Swedish: Dragerad tabletts
English: Ranbaxy (UK) Ltd, C.P.House, 97-107 Uxbridge Road, Eabing, London, W5 5TL, U.K.
Swedish: Slovakien Ranbaxy (UK) Ltd, C.P.House, 97-107 Uxbridge Road, Eabing, London, W5 5TL, U.K.
English: Fluoxetin „1A Pharma“ 20mg-Tabletten
Swedish: Fluoxetin „1A Pharma“ 20mg-Tablettten
English: Lithuania Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
Swedish: Solvay Pharmaceuticals B.V., C.J. van Houtenlaan 36, 1381 CP, Weesp, The Nethrelands
English: Denmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
Swedish: Danmark H. Lundbeck A/S, Ottiliavej 7-9, DK2500 Valby, Denmark
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
Swedish: D-53773 Hennef mirtazapin-biomo 15 mg Filmtabletten
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln
Swedish: D-53773 Hennef fluoxetin-biomo 20mg Kapseln
English: KRKA, D.D., NOVO MĚSTO, Šmajješka cesta 6, 8501 Novo Město, Slovenia
Swedish: Tjeckien KRKA, D.D., NOVO MĚSTO, Šmajješka cesta 6, 8501 Novo Město, Slovenia
English: APOTEX EUROPE LTD., READING, Rowan House 41 London Street, Reading, Berkshire, RG1 4PS, UK
Swedish: Tjeckien APOTEX EUROPE LTD., READING, Rowan House 41 London Street, Reading, Berkshire, RG1 4PS, UK
English: Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten
Swedish: D-53773 Hennef fluoxetin-biomo 20mg Tabletten
English: Ratiopharm GmbH, Graf-Arco-Str. 3, D - 890 79 Ulm, Germany
Swedish: Slovakien Ratiopharm GmbH, Graf-Arco-Str. 3, D - 890 79 Ulm, Germany
English: Belgium RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
Swedish: RATIOPHARM S.A. Rue St, Lambert 141 1200 BRUXELLES, Belgium
English: Luxembourg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
Swedish: Luxemburg HEXAL AG, Industriestrasse 25, D8367 Holzkirchen, Germany
English: Belgium RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium
Swedish: RATIOPHARM S.A. Rue St. Lambert 141, 1200 Bruxelles, Belgium
English: MILNACIPRAN containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller MILNACIPRAN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: RATIOPHARM GMBH, ULM, GrafArco-Strasse 3, 890 79 Ulm, Germany
Swedish: Tjeckien RATIOPHARM GMBH, ULM, GrafArco-Strasse 3, 890 79 Ulm, Germany
English: Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
Swedish: Danmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
English: Denmark Copyfarm A/S, Energivej 15, DK-5260 Odense s, Denmark
Swedish: Danmark Copyfarm A/S, Energivej 15, DK-5260 Odense S, Denmark
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
Swedish: D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten
English: Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef
Swedish: Tyskland Biomo pharma GmbH Josef-Dietzgen-Str. 3
English: CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller CITALOPRAM med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Denmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
Swedish: Danmark Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria
English: H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
Swedish: Grekland H. LUNDBECK A/S DENMARK, Ottiliave 9, DK-2500, VALBY COPENHAGEN, DENMARK
English: Belgium MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
Swedish: MERCK N.V., Brusselsesteenweg 288, B-3090 Overijse, Belgium
English: SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
Swedish: Grekland SANDOZ AUSTRIA Biochemiestrasse 10, A-6250 Kundl, Austria
English: Netherlands Hexal B.V. Postbus 251
Swedish: Nederländerna Hexal B.V.
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
Swedish: KRKA, d.d., Novo mesto, Smarjeska c. 6, 8501 Novo mesto, Slovenia
English: Netherlands Pharmachemie B.V. Postbus 552
Swedish: Nederländerna Pharmachemie B.V.
English: FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller FLUVOXAMIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller SERTRALIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Luxembourg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
Swedish: Luxemburg Hexal AG, Industriestrasse 25, 83607 HOLZKIRCHEN, Germany
English: ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller ESCITALOPRAM med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller MIRTAZAPIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Lithuania KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
Swedish: KRKA, d.d., Novo mesto, Smarjeska c.6, 8501 Novo mesto, Slovenia
English: Alfred E Tiefenbacher (GmbH & Co. KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
Swedish: KG) Van-der-Smissen Strasse 1 DE22767 Hamburg Tyskland (DEU)
English: LICHTENSTEIN
Swedish: Bratislava
English: Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
Swedish: Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, UK
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
Swedish: D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten
English: Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Swedish: Storbritannien Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
English: 1050 Bruxelles, Belgium
Swedish: B-1080 Bruxelles
English: PAROXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller PAROXETINE med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Denmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
Swedish: Danmark HEXAL A/S, Kanalholmen 8-12, DK2650 Hvidovre, Denmark
English: Denmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
Swedish: Danmark Actavis Nordic A/S, Hammervej 7, DK-2970 Hørsholm, Denmark
English: H.Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen Valby
Swedish: Slovakien H.Lundbeck A/S, Ottiliavej 9, DK2500 Copenhagen Valby
English: SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
Swedish: Grekland SANDOZ AUSTRIA, Biochemiestrasse 10, A-6250 Kundl, Austria
English: Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
Swedish: D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten
English: Basics GmbH Hemmelrather Weg 201 D-51377 Leverkusen
Swedish: D-51377 Leverkusen
English: Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
Swedish: Storbritannien Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
English: Constantinoupoleos Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus
Swedish: Slovakien Medochemie Ltd., 1-10 Constantinoupoleos Str., P.O.Box 51409 Limassol, CY - 3505 Cyprus
English: MIANSERINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller MIANSERIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Denmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
Swedish: Danmark Ratiopharm GmbH, Grat-Arco-Strasse 3, D-89079 Ulm, Germany
English: FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller FLUOXETIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Denmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
Swedish: Danmark Actavis Nordic A/S, Hammervej 7, DK- 2970 Hørsholm, Denmark
English: Strength Pharmaceutical form Route of administration
Swedish: Läkemedlets namn Styrka
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 Overijse
Swedish: Brusselsesteenweg 288 3090 Overijse
English: Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France
Swedish: Frankrike Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08 - France
English: DOBUPAL RETARD 75 mg hard Capsules
Swedish: DOBUPAL RETARD 75 mg
English: Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
Swedish: Storbritannien Stada Arzneimittel AG, Stadastrasse 218, D-61118 Bad Vilbel, Germany
English: Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France
Swedish: Frankrike Merck Generiques 34 rue saint Romain 69 359 lyon cedex 08- France
English: Lithuania Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Swedish: Slovenien Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
English: Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
Swedish: Storbritannien Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, UK
English: Denmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
Swedish: Danmark Ratiopharm GmbH, Graft-Arco-Strasse 3, D-89079 Ulm, Germany
English: Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
Swedish: Storbritannien Hexal A/S, Kanalholmen 8-12, Hvidovre, DK-2650, Denmark
English: Sandoz GmbH, Biochemiestrasse 10, A - 6250 Kundl
Swedish: Slovakien Sandoz GmbH, Biochemiestrasse 10, A - 6250 Kundl
English: Belgium EUROGENERICS N.V. Heizel Esplanade B 22 1020 Brussel
Swedish: Heizel Esplanade B 22 1020 Brussel
English: Denmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
Swedish: Danmark Ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany
English: Belgium TEVA PHARMA BELGIUM N.V. Laarstraat 16, 2610 WILRIJK, Belgium
Swedish: Laarstraat 16, 2610 WILRIJK, Belgium
English: NL - 1380 DA Weesp] C.J. van Houtenlaan 36
Swedish: C.J. van Houtenlaan 36
English: LEK PHARMACEUTICALS D.D., LJUBLJANA, Verovškova 57, 1526 Ljubljana, Slovenia
Swedish: Tjeckien LEK PHARMACEUTICALS D.D., LJUBLJANA, Verovškova 57, 1526
English: Felicium 20mg-Tabletten 20mg
Swedish: Felicium 20mgTablettten
English: Belgium MERCK N.V. Brusselsesteenweg 288 3090 OVERIJSE, Belgium
Swedish: Brusselsesteenweg 288 3090 OVERIJSE, Belgium
English: Belgium AKTUAPHARMA N.V. Ambachtenlaan 13, 3001 Heverlee, Belgium
Swedish: Ambachtenlaan 13, 3001 Heverlee, Belgium
English: Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08 France
Swedish: Frankrike Merck generiques 34 rue Saint Romain 69359 Lyon cedex 08
English: Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08 France
Swedish: Frankrike Merk Generiques 34 rue Saint Romain 69359 Lyon cedex 08
English: Luxembourg EUROGENERICS N.V. Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
Swedish: Heizel Esplanade B 22 B-1020 BRUSSEL, Belgium
English: VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name
Swedish: Läkemedel som innehåller VENLAFAXIN med godkännande för försäljning i den Europeiska Unionen Medlems stat Innehavare av godkännande för försäljning
English: Alfred E. Tiefenbacher GmbH & Co. KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
Swedish: KG, Van-der-Smissen-Strasse 1, 22767 HAMBURG, Germany
English: Limassol, Cyprus
Swedish: Ljubljana, Slovenia
English: G GAM
Swedish: KG)
English: Lithuania Hexal AG,Industriestrasse 25, D-8367 Holzkirchen, Germany
Swedish: Hexal AG,Industriestrasse 25, D-8367 Holzkirchen, Germany
English: Europarc
Swedish: Frankrike G GAM Europarc
English: Alfred E. Tiefenbacher (GmbH & Co. KG), Van-der Smissen-Str. 1, DE22767 Hamburg, Germany
Swedish: KG), Van-der Smissen-Str. 1, DE22767 Hamburg, Germany
English: QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08 France paroxetine Qualimed 20 mg
Swedish: Frankrike QUALIMED 34 rue Saint Romain 69359 Lyon cedex 08
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Swedish: EMA:s procedurnummer (Läkemedlets) namn
English: Meat and offal: cattle: 22 days.
Swedish: Kött och slaktbiprodukter: nötkreatur: 22 dagar
English: Cattle
Swedish: Karenstid
English: Target species
Swedish: Nötkreatur Subkutan användning
English: This summary was last updated on 14/03/2011.
Swedish: Denna sammanfattning aktualiserades senast 14/03/2011.
English: These reactions resolve spontaneously within two days to two weeks.
Swedish: Dessa reaktioner försvinner spontant inom två dagar till två veckor.
English: E-mail info@ema.europa.eu Website www.ema.europa.eu
Swedish: E-mail info@ema.europa.eu Website www.ema.europa.u
English: It is widespread in countries bordering the Mediterranean Sea.
Swedish: Den är vanlig i Medelhavsländerna.
English: Afterward a single ‘booster' should be given every year to maintain the vaccine's effect.
Swedish: Därefter ska en enda boosterdos ges årligen för att upprätthålla vaccinets effekt.
English: The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended.
Swedish: Effekten av vaccinering hos redan infekterade hundar har inte undersökts och kan därför inte rekommenderas.
English: CaniLeish is a vaccine.
Swedish: CaniLeish är ett vaccin.
English: The first injection can be given from six months of age, the second injection is given three weeks later and the third three weeks from the second one.
Swedish: Den första injektionen kan ges från sex månaders ålder, den andra ges tre veckor senare och den tredje tre veckor efter den andra injektionen.
English: The risk of vaccine-induced infection can be excluded since the vaccine does not contain parasites.
Swedish: Risken för vaccinutlöst infektion kan uteslutas eftersom vaccinet inte innehåller parasiter.
English: Infected dogs play a central role in the accidental transmission of parasites to humans.
Swedish: Infekterade hundar spelar en central roll vid oavsiktlig överföring av parasiter till människor.
English: A number of laboratory trials where dogs were submitted to experimental infection were also presented.
Swedish: Dessutom presenterades en rad laboratoriestudier där hundar utsattes för experimentell infektion.
English: The number of dogs developing an active infection and a symptomatic disease was significantly reduced in the vaccinated group.
Swedish: Antalet hundar som utvecklade en aktiv infektion och en symtomatisk sjukdom minskade signifikant i den vaccinerade gruppen.
English: The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies.
Swedish: Parasiten överförs från en infekterad hund till en icke-infekterad genom sandflugebett.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Swedish: Nytta-/riskförhållandet behandlas i modulen med den vetenskapliga diskussionen i detta EPAR.
English: It contains Leishmania infantum excreted secreted proteins (ESP).
Swedish: Det innehåller Leishmania infantum utsöndrat/avsöndrat protein (Excreted Secreted Protein, ESP).
English: Leishmania infantum is a parasite that causes leishmaniosis.
Swedish: Leishmania infantum är en parasit som orsakar leishmaniasis.
English: The vaccine is given to dogs as three injections, three weeks apart, under the skin.
Swedish: Vaccinet ges till hundar som tre injektioner under huden med tre veckors mellanrum.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011.
Swedish: Den 14/03/2011 beviljade Europeiska kommissionen Virbac S.A. ett godkännande för försäljning av CaniLeish som gäller i hela Europeiska unionen.
English: CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response.
Swedish: CaniLeish innehåller ett adjuvans (en högrenad fraktion av Quillaja saponaria) för att öka immunsvaret.
English: In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Swedish: Hos hundar som utvecklar leishmaniasis (aktiv infektion eller sjukdom) trots vaccination är fortsatta vaccininjektioner inte till någon nytta.
English: Dogs that have been infected may show no signs of infection, but some do (fever, hair and weight loss, skin sores) and in the latter case the outcome of active infection can be fatal.
Swedish: Hundar som infekterats uppvisar inte alltid några tecken på infektion, men vissa gör det (feber, hårförlust, viktminskning, hudsår) och då kan den aktiva infektionen vara livshotande.
English: The efficacy of the vaccine was studied in one main field trial that lasted for two years involving vaccinated and control dogs submitted to natural exposure to infection in zones where there is a high risk of infection.
Swedish: Vaccinets effekt undersöktes i ett huvudsakligt fältförsök som pågick i två år och omfattade vaccinerade hundar och kontrollhundar som utsattes för naturlig exponering för infektionen i områden med hög infektionsrisk.
English: Why has CaniLeish been approved?
Swedish: Varför har CaniLeish godkänts?
English: Other temporary signs commonly seen following vaccination can also occur such as hyperthermia (raised body temperature), apathy (lack of vitality) and digestive disorders lasting one to six days.
Swedish: Andra övergående symtom som normalt ses efter vaccination kan också uppträda, t.ex. förhöjd kroppstemperatur, apati (håglöshet) och matsmältningsstörningar som varar i en till sex dagar.
English: The safety of the vaccine was studied in two main laboratory safety studies carried out in leishmania-free dogs (overdose and single and repeated administration) and one field trial.
Swedish: Vaccinets säkerhet har undersökts i två huvudsakliga säkerhetsstudier på laboratorier som gjordes på leishmaniafria hundar (överdoser, enkeldoser och upprepade doser) och i ett fältförsök.
English: CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth.
Swedish: CaniLeish är ett vaccin som innehåller en rad proteiner som frisätts av parasiten Leishmania infantum under dess tillväxt.
English: What benefit has CaniLeish shown during the studies?
Swedish: Vilken nytta har CaniLeish visat vid studierna?
English: The studies showed that the vaccine is safe for both leishmania-negative and leishmania-infected dogs.
Swedish: Studierna visade att vaccinet är säkert för både leishmanianegativa och leishmaniainfekterade hundar.
English: Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment.
Swedish: Hundar som visar symtom på en allergisk reaktion bör ges lämplig symtomatisk behandling.
English: Veterinarians should assess the benefit-risk balance before vaccinating dogs in areas with little or no Leishmania infantum.
Swedish: Veterinärer bör göra en nytta-/riskbedömning före vaccinering av hundar i områden med liten eller ingen förekomst av Leishmania infantum.
English: Other information about CaniLeish:
Swedish: Mer information om CaniLeish
English: The detection of Leishmania infection using a rapid diagnostic test is recommended before vaccination.
Swedish: Ett snabbt diagnostiskt test för att upptäcka leishmaniainfektion rekommenderas före vaccinationen.
English: What is CaniLeish?
Swedish: Vad är CaniLeish?
English: After vaccination transient antibodies against leishmania detected by immunofluorescence antibody test (IFAT) may appear but do not reflect an active infection.
Swedish: Efter vaccinering kan övergående antikroppar mot leishmania som påvisas med immunofluorescens antikroppstest (IFAT) förekomma, men det innebär inte att en aktiv infektion har utvecklats.
English: In case of accidental self-injection, the advice of a doctor should be sought immediately.
Swedish: Om du råkar injicera dig själv ska du genast uppsöka läkare.