natgillin/translations-raw huggingface dataset:
Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park; Caldecotte; Milton Keynes; Bucks; MK7 8LF; UK 
Velika Britanija Lundbeck Limited; Lundbeck House; Caldecotte Lake Business Park;
Mirtabene „ratiopharm“ 30mg-Filmtabletten 
Mirtabene „ratiopharm“ 30mgFilmtabletten
Felixsan 50mgFilmtabletten 
Felixsan 50mg-Filmtabletten 50mg
Luxembourg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium 
Luksemburg RATIOPHARM S.A. Rue St, Lambert 141 B-1200 BRUXELLES, Belgium
Netherlands GlaxoSmithKline B.V. Postbus 780 
Nizozemska GlaxoSmithKline B.V.
VELAXIN 37,5 mg tabletta 
VELAXIN 37,5 mg tabletta 37,5mg
MOTIVAN 20 mg, Comprimidos 
MOTIVAN 20 mg, Comprimidos 20 mg
REMOOD 30 MG 30 mg 
REMOOD 30 MG
AlenFarma - Especialidades Farmacêuticas, Lda., Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131 Algés Portugal 
Portugalska AlenFarma - Especialidades Farmacêuticas, Lda., Rua Dr. António Loureiro Borges, 3, ArquiparqueMiraflores 1495-131 Algés Portugal
Loxozapin 30 mg Filmtabletten 
Loxozapin 30 mg Filmtabletten 30 mg
Fluoxetin Stada 20 mg 20 mg 
Fluoxetin Stada 20 mg
Paroxetine 20, tabletten 20 mg 
Paroxetine 20, tabletten 20 mg 20 mg
Mianserine HCl Gf 30 mg, tablets 
Mianserine HCl Gf 30 mg, tablets 30 mg
Fluoxetina Ratiopharm GmbH 
Fluoxetina Ratiopharm GmbH 20 mg
Apotex Europe Ltd., Rowan House, 41 London Street, Reading Berkshire UKRG14PS 
Madžarska Apotex Europe Ltd., Rowan House, 41 London Street, Reading Berkshire UKRG14PS
Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK 
Madžarska Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG, UK
Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG, UK 
Madžarska Merck Generics Albany Gates, Darkes Lane Potters Bar, Herts, EN6 1AG,UK
Sweden ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU) 
Švedska ratiopharm GmbH Graf-Arco-Strasse 3 DE-89079 Ulm Tyskland (DEU)
Mianserine HCl Gf 10 mg, tablets 
Mianserine HCl Gf 10 mg, tablets 10 mg
Fluctine 20mg-lösliche Tabletten 
Fluctine 20mg-lösliche Tabletten 20mg
Fluoxetina Bexal 20 mg Cápsulas 
Fluoxetina Bexal 20 mg Cápsulas 20 mg
Therefore the CHMP concluded that a warning to reflect that hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among children and adolescents treated with atomoxetine compared to those treated with placebo and a warning indicating the lack of efficacy in depression should be included in the Summaries of Product Characteristics and the relevant section of the Package Leaflets of atomoxetine containing medicinal products. 
Zato je Odbor za zdravila za uporabo v humani medicini zaključil, da je treba v Povzetke glavnih značilnosti zdravila in zadevno poglavje Navodil za uporabo zdravil, ki vsebujejo atomoksetin, vključiti opozorilo, ki bo odražalo pogostejše opažanje sovražnosti (večinoma nasilnega vedenja, nasprotovalnega vedenja in jeze) ter čustvene labilnosti v kliničnih preskušanjih pri otrocih in mladostnikih, ki so bili zdravljeni z atomoksetinom, v primerjavi s tistimi, ki so prejemali placebo, ter opozorilo, ki nakazuje neučinkovitost pri zdravljenju depresije.
Loxozapin 15 mg Filmtabletten 
Loxozapin 15 mg Filmtabletten 15 mg
Prolonged release capsule Oral use 
Peroralna raztopina Peroralna uporaba
MIRZATEN 15 mg filmtabletta 
MIRZATEN 15 mg filmtabletta 15mg
Paroxetin-ratiopharm® 20mg 
Paroxetin-ratiopharm® 20mg 20mg
H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark 
Velika Britanija H Lundbeck A/S; Ottliliavej 9; DK 2500 Valby; Copenhagen; Denmark
- The Committee, as a consequence, concluded that a warning to reflect that suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products. 
- je Odbor posledično zaključil, da je treba v Povzetke glavnih značilnosti zdravila in zadevno poglavje Navodil za uporabo zdravil, ki vsebujejo citalopram, escitalopram, fluoksetin, fluvoksamin, mianserin, milnacipran, mirtazapin, paroksetin, reboksetin, sertralin in venlafaksin, vključiti opozorilo, ki bo odražalo pogostejše opažanje s samomori povezanih vedenj (poskusov samomora in samomorilnih misli) in sovražnosti (večinoma nasilnega vedenja, nasprotovalnega vedenja in jeze) v kliničnih preskušanjih pri otrocih in mladostnikih, ki so bili zdravljeni z antidepresivnimi zdravili, v primerjavi s tistimi, ki so prejemali placebo.
MIZAPIN 45 mg filmtabletta 
MIZAPIN 45 mg filmtabletta 45mg
Fluoxetin-ratiopharm Loesung 
Fluoxetin-Ratiopharm
MIZAPIN 15 mg filmtabletta 
MIZAPIN 15 mg filmtabletta 15mg
Netherlands Apothecon B.V. Postbus 324 
Nizozemska Apothecon B.V.
EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary. 
Madžarska EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary.
Fluvoxamin STADA 100 mg 
Fluvoxamin STADA 100 mg 100 mg
Fluoxetin-CT 20mg Hartkapseln 
Fluoxetin-CT 20mg Hartkapseln 20 mg
Krka d.d., Smarjeska cesta 6, 8501 Novo mesto, Slovenia 
Madžarska Krka d.d., Smarjeska cesta 6, 8501 Novo mesto, Slovenia
EFECTIN 50 MG 50 mg 
EFECTIN 50 MG
Denmark N.V. Organon, P.O. 
Luksemburg ORGANON EUROPE N.V.
Lek Pharmaceuticals d.d., Verevskova 57, Ljubljana, 1526, Slovenia 
Madžarska Lek Pharmaceuticals d.d., Verevskova 57, Ljubljana, 1526, Slovenia
Netherlands Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl 
Nizozemska Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl
Mianserine HCl 10 PCH, tablets 
Mianserine HCl 10 PCH, tablets 10 mg
Mianserine HCl 30 PCH, tablets 
Mianserine HCl 30 PCH, tablets 30 mg
FLUOX BASICS 20 mg Kapseln 
FLUOX BASICS 20 mg Kapseln 20 mg
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg 20 mg 
Biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef paroxetin-biomo 20mg
The CHMP concluded that a warning to reflect that suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo, should be included in the Summaries of Product Characteristics and relevant section of the Package Leaflets of citalopram, escitalopram, fluoxetine, fluvoxamine, mianserine, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline and venlafaxine containing medicinal products. 
Odbor za zdravila za uporabo v humani medicini je zaključil, da je treba v Povzetke glavnih značilnosti zdravila in zadevno poglavje Navodil za uporabo zdravil, ki vsebujejo citalopram, escitalopram, fluoksetin, fluvoksamin, mianserin, milnacipran, mirtazapin, paroksetin, reboksetin, sertralin in venlafaksin, vključiti opozorilo, ki bo odražalo pogostejše opažanje s samomori povezanih vedenj (poskusov samomora in samomorilnih misli) in sovražnosti (večinoma nasilnega vedenja, nasprotovalnega vedenja in jeze) v kliničnih preskušanjih pri otrocih in mladostnikih, ki so bili zdravljeni z antidepresivnimi zdravili, v primerjavi s tistimi, ki so prejemali placebo.
Netherlands Alpharma B.V. Postbus 313 
Nizozemska Alpharma B.V.
Mirta TAD 30 mg Filmtabletten 
Mirta TAD 30 mg Filmtabletten 30 mg
REMERON Soltab 15mg 15mg 
Remeron Soltab 15mg
Fluoxetin Sandoz 20 mg Tabletten 
Fluoxetin Sandoz 20 mg Tabletten 20 mg
DEPESERT 100 mg tablets 
DEPESERT 100 mg tablets 100 mg
MIRZATEN 45 mg filmtabletta 
MIRZATEN 45 mg filmtabletta 45mg
Mirtazapin Ratiopharm 15 mg 
MIRTAZAPINA RATIOPHARM 15 mg
Mirta TAD 15 mg Filmtabletten 
Mirta TAD 15 mg Filmtabletten 15 mg
Mirta TAD 45 mg Filmtabletten 
Mirta TAD 45 mg Filmtabletten 45 mg
MIZAPIN 30 mg filmtabletta 
MIZAPIN 30 mg filmtabletta 30mg
Remergil 45 mg Filmtabletten 
Remergil 45 mg Filmtabletten 45 mg
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln 
Nemčija biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Kapseln 20 mg
Remergil 15mg Filmtabletten 
Remergil 15mg Filmtabletten 15 mg
EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary 
Madžarska EGIS Gyógyszergyár Rt., Keresztúri út 30-38, 1106 Budapest, Hungary
Germany biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten 
Nemčija biomo pharma GmbH Josef-Dietzgen-Str. 3 D-53773 Hennef fluoxetin-biomo 20mg Tabletten 20 mg
Fluoxetin „Kwizda“ 20mg-Kapseln 
Fluoxetin „Kwizda“ 20mgKapseln
FLUOX-PUREN 20mg Tabletten 
FLUOX-PUREN 20mg Tabletten 20 mg
Mirtazapine KRKA 15 mg 
MIRTAZAPINA DAVUR 15 mg
MIRZATEN 30 mg filmtabletta 
MIRZATEN 30 mg filmtabletta 30mg
Mirtagamma 15 mg Filmtabletten 
Mirtagamma 15 mg Filmtabletten 15 mg
Ennos 20mgFilmtabletten 
Ennos 20mg-Filmtabletten
VENLAFAXINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo VENLAFAKSIN Država članica Imetnik dovoljenja za promet z zdravilom
Efectin ER 150mgKapseln 
Efectin ER 150mg-Kapseln 150mg
SERLIFT 50 MG 50 mg 
SERLIFT 50 MG
Fluoxetin-TEVA 20 mg Tabletten 
Fluoxetin-TEVA 20 mg Tabletten 20 mg
Paroxat 20mgFilmtabletten 
Paroxat 20mg-Filmtabletten
Mirtazapina KRKA 30 mg 
MIRTAZAPINA DAVUR 30 mg
PARETIN 20 mg filmtabletta 
PARETIN 20 mg filmtabletta 20mg
ATOMOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo ATOMOKSETIN Država članica Imetnik dovoljenja za promet z zdravilom
Mirtazapin NM Pharma 45 mg 
Mirtazapin NM Pharma
EFECTIN 37,5 mg tabletta 
EFECTIN 37,5 mg tabletta 37,5mg
Mirtagamma 45 mg Filmtabletten 
Mirtagamma 45 mg Filmtabletten 45 mg
PARETIN 40 mg filmtabletta 
PARETIN 40 mg filmtabletta 40mg
Paroxetin Copyfarm 30 mg 
Paroxetin Copyfarm
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten 
Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 15 mg Filmtabletten 15.45mg
Intravenous infusion 
Raztopina za intravensko infundiranje
MIRTAZAPINA BEXAL 30 mg 
MIRTAZAPINA BAYVIT 30 mg
REMERON 45 mg filmtabletta 
REMERON 45 mg filmtabletta 45mg
REBOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo REBOKSETIN Država članica Imetnik dovoljenja za promet z zdravilom
Fluoxetine Sandoz 20, capsules 
Fluoxetine Sandoz 20, capsules 20 mg
Fluoxetin "1A Farma" 20 mg 
Fluoxetin "1A Farma"
H. Lundbeck A/S, Ottiliavej, 9 DK2500 Valby - Copenhagen Dinamarca 
Portugalska H. Lundbeck A/S, Ottiliavej, 9 DK2500 Valby - Copenhagen Dinamarca
Mirtazza 15 mg Filmtabletten 
Mirtazza 15 mg Filmtabletten 15 mg
Fluoxetin HEXAL 20mg Kapseln 
Fluoxetin HEXAL 20mg Kapseln 20 mg
Paroxetine Merck 20 mg, tabletten 
Paroxetine Merck 20 mg, tabletten 20 mg
Portugal 
Algés Portugal
Modified-release tablet capsule Oral use 
Tableta/kapsula z prirejenim sproščanjem
REXETIN 30 mg filmtabletta 
REXETIN 30 mg filmtabletta 30mg
BESITRAN 100 mg tablets 
BESITRAN 100 mg tablets 100 mg
Mirtagamma 30 mg Filmtabletten 
Mirtagamma 30 mg Filmtabletten 30 mg
Fluoxetin "Copyfarm" 20 mg 
Fluoxetin "Copyfarm"
CITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo CITALOPRAM Država članica Imetnik dovoljenja za promet z zdravilom
ZOLOFT 50 MG 50 mg 
ZOLOFT 50 MG
Mirtapin Merck Generics 45 mg 
MIRTAZAPINA MERCK 45 mg
Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K. 
Velika Britanija Arrow Generics limited, Unit 2, Eastman Way, Stevenage, Herts SG1 4SZ, U.K.
REMERON 30 mg filmtabletta 
REMERON 30 mg filmtabletta 30mg
MirtaLich 45 mg Filmtabletten 
MirtaLich 45 mg Filmtabletten 45 mg
Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K. 
Velika Britanija Ranbaxy (UK) Limited; CP House, 97107 Uxbridge Road, Ealing, London W5 5TL, U.K.
Glaxopar 20mgFilmtabletten 
Glaxopar 20mg-Filmtabletten 20mg
Remeron 45mgFilmtabletten 
Remeron 45mg-Filmtabletten 45mg
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten 
Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 30 mg Filmtabletten 30.90mg
Mirtapin Merck Generics 15 mg 
MIRTAZAPINA MERCK 15 mg
Netherlands Sandoz B.V. Postbus 216 
Nizozemska Sandoz B.V.
Mirtazapin "HEXAL" 15 mg 
Mirtazapin "Combino Pharm" 15 mg
Remergil 30mg Filmtabletten 
Remergil 30mg Filmtabletten 30 mg
Mirtazza 45 mg Filmtabletten 
Mirtazza 45 mg Filmtabletten 45 mg
Mirtazapin "HEXAL" 45 mg 
Mirtazapin "Combino Pharm" 45 mg
Miraflores 1495-153 Algés Portugal 
4450-013 Matosinhos Portugal
Mirtazapin Arrow 15 mg 
MIRTAZAPINA RIMAFAR 15 mg
Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl Áustria 
Portugalska Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl Áustria
Fluoxetin Stada 20 mg Tabletten 
Fluoxetin Stada 20 mg Tabletten 20 mg
Paroc 20 mg Filmtabletten 20 mg 
ParoLich 20 mg Filmtabletten 20 mg
ESCITALOPRAM containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo ESCITALOPRAM Država članica Imetnik dovoljenja za promet z zdravilom
Mirtaron 45mgFilmtabletten 
Mirtaron 45mg-Filmtabletten 45mg
SERTRALIX 50 mg tablets 
SERTRALIX 50 mg tablets 50 mg
Cipralex 5mg-Filmtabletten 
Cipralex 5mg-Filmtabletten 5mg
Netherlands Hexal B.V. Postbus 251 
Nizozemska Hexal B.V.
Germany ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten 
Nemčija ct-Arzneimittel GmbH Lengeder Str. 42a D-13407 Berlin mirtazapin-ct 45 mg Filmtabletten 46.35mg
MirtaLich 15 mg Filmtabletten 
MirtaLich 15 mg Filmtabletten 15 mg
Remeron 15mgFilmtabletten 
Remeron 15mg-Filmtabletten 15mg
Mirtazapine KRKA 45 mg 
MIRTAZAPINA RATIOPAHRM 45 mg
H. Lundbeck A/S, Ottiliavej, 9 DK-2500 Valby - Copenhagen, Denmark 
Portugalska H. Lundbeck A/S, Ottiliavej, 9 DK-2500 Valby - Copenhagen, Denmark
Netherlands Pharmachemie B.V. Postbus 552 
Nizozemska Pharmachemie B.V.
Paluxetil 20mgFilmtabletten 
Paluxetil 20mg-Filmtabletten 20mg
Mirtazelon 15 mg Filmtabletten 
Mirtazelon 15 mg Filmtabletten 15 mg
Mirtazapin "Lichtenstein" 15 mg 
Mirtazapin "Lichtenstein"
Mirtazapin "HEXAL" 30 mg 
Mirtazapin "Combino Pharm" 30 mg
Sandoz GmbH, Biochemiestrasse 10 A-6250 Kundl,.Austria 
Madžarska Sandoz GmbH, Biochemiestrasse 10 A-6250 Kundl,.Austria
Mirtaron 15mgFilmtabletten 
Mirtaron 15mg-Filmtabletten 15mg
Paroc 40 mg Filmtabletten 40 mg 
Paroxat 40 mg Filmtabletten 40 mg
Fluoxetin AL 20 mg Tabletten 
Fluoxetin AL 20 mg Tabletten 20 mg
FLUVOXAMINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo FLUVOKSAMIN Država članica Imetnik dovoljenja za promet z zdravilom
Mirtazelon 45 mg Filmtabletten 
Mirtazelon 45 mg Filmtabletten 45 mg
SERTRALINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo SERTRALIN Država članica Imetnik dovoljenja za promet z zdravilom
Paroxetine Gf 20 mg, tabletten 
Paroxetine Gf 20 mg, tabletten 20 mg
Mirtaron 30mgFilmtabletten 
Mirtaron 30mg-Filmtabletten 30mg
Mianserine MG Pharma 30 mg 
Mianserine MG Pharma
Fluxil 20mg-Kapseln 20mg 
Flux „Hexal“ 20mg-Kapseln 20mg
Mirtazelon 30 mg Filmtabletten 
Mirtazelon 30 mg Filmtabletten 30 mg
ParoxetinHEXAL 40 40 mg 
ParoxetinHEXAL 40
Mirtazapin ratiopharm 45 mg 
MIRTAZAPINA RATIOMED 45 mg
Mirtazza 30 mg Filmtabletten 
Mirtazza 30 mg Filmtabletten 30 mg
Fluoxetine Gf 20 mg, capsules 
Fluoxetine Gf 20 mg, capsules 20 mg
Paroksetiini Glaxosmithkline 
Paroksetiini Glaxosmithkline 20 mg
Mirtazapin Imi Pharma 15 mg 
Mirtazapin Imi Pharma
MIRTAZAPINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo MIRTAZAPIN Država članica Imetnik dovoljenja za promet z zdravilom
Mirtazapin Arrow 30 mg 
MIRTAZAPINA RIMAFAR 30 mg
Mianserin NM Pharma 10 mg 
Mianserin NM Pharma
ZOLOFT 100 MG 100 mg 
ZOLOFT 100 MG
MERCK PAROXETINE 20 mg 
PAROXETINA TAMARANG 20 mg
PAROXETINA TAMARANG 
PAROXETINE TEVA
Fluoxetine CF 20 mg, capsules 
Fluoxetine CF 20 mg, capsules 20 mg
Sandoz GmbH, Biochemiestrasse 10°, 6250 Kundl, Austria 
Madžarska Sandoz GmbH, Biochemiestrasse 10°, 6250 Kundl, Austria
Mirtabene 30mgFilmtabletten 
Mirtabene 30mg-Filmtabletten 30mg
Paroxetin ratiopharm 10 mg 
PAROXETINE RATIOPHARM 30 mg
Film-coated tablets 
Obložena tableta Peroralna uporaba
PAROGEN 20 mg filmtabletta 
Paroc 20 mg Filmtabletten
MIANSERINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo MIANSERIN Država članica Imetnik dovoljenja za promet z zdravilom
MIRTAZAPIN /GENERICS 
MIRTAZAPIN /GENERICS 30/mg
Fluoxetin "Alpharma" 20 mg 
Fluoxetin "Alpharma"
Sertralin STADA 100 mg 
SERTRALIN HEXAL 100 100 mg
Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl, Austria 
Portugalska Sandoz GmbH, Biochemiestrasse, 10 A-6250 Kundl, Austria
Fluoxetine Merck 20 mg, capsules 
Fluoxetine Merck 20 mg, capsules 20 mg
ParoxetinHEXAL 20 20 mg 
PAROXETINHEXAL 20
Remeron 30mgFilmtabletten 
Remeron 30mg-Filmtabletten 30mg
FLUOXETINE containing medicinal products with Marketing Authorisation in the European Union Member State Marketing Authorisation Holder Invented Name 
Zdravila z dovoljenjem za promet v Evropski uniji, ki vsebujejo FLUOKSETIN Država članica Imetnik dovoljenja za promet z zdravilom
Meat and offal: cattle: 22 days. 
Meso in organi: Govedo:22 dni.
EU number 
EU (MA) številka
Cattle 
Karenca
Subcutaneous use Vial (glass) 500 ml 
Govedo Subkutana uporaba
This summary was last updated on 14/03/2011. 
Povzetek je bil nazadnje posodobljen dne 14/03/2011.
It is widespread in countries bordering the Mediterranean Sea. 
Razširjen je v deželah ob Sredozemskem morju.
These reactions resolve spontaneously within two days to two weeks. 
Te reakcije spontano izzvenijo v dveh dneh do dveh tednih.
The European Commission granted a marketing authorisation valid throughout the European Union, for CaniLeish to Virbac S.A. on 14/03/2011. 
Evropska komisija je dovoljenje za promet z zdravilom CaniLeish, veljavno po vsej Evropski uniji, odobrila družbi Virbac S.A. dne 14/03/2011.
Other information about CaniLeish: 
Druge informacije o zdravilu CaniLeish:
CaniLeish is a vaccine. 
Zdravilo CaniLeish je cepivo.
In case of accidental self-injection, the advice of a doctor should be sought immediately. 
V primeru nenamernega samoinjiciranja se je treba takoj posvetovati z zdravnikom.
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. 
Prva injekcija se vbrizga po dopolnjenem šestem mesecu starosti, druga tri tedne kasneje, tretja pa tri tedne po drugi injekciji.
The risk of vaccine-induced infection can be excluded since the vaccine does not contain parasites. 
Tveganje za okužbo, povzročeno s cepivom, je izključeno, saj cepivo ne vsebuje parazitov.
A number of laboratory trials where dogs were submitted to experimental infection were also presented. 
Predstavljena so bila tudi številna laboratorijska preskušanja, v katerih so bili psi izpostavljeni poskusni okužbi.
Leishmania infantum is a parasite that causes leishmaniosis. 
Leishmania infantum je parazit, ki povzroča leishmaniozo.
The parasite is transmitted from an infected dog to a non-infected dog by the bites of sand flies. 
Parazit se z okuženega na neokuženega psa prenaša s pikom peščenih muh.
What benefit has CaniLeish shown during the studies? 
Kakšne koristi je zdravilo CaniLeish izkazalo med študijami?
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. 
Pojavijo se lahko tudi drugi prehodni znaki, pogosto opaženi po cepljenju, kot so hipertermija (zvišana telesna temperatura), apatija (pomanjkanje vitalnosti) in prebavne motnje, ki lahko trajajo od enega do šest dni.
In the future, if the animals are exposed to Leishmania infantum parasite, the immune system will be able to respond more quickly. 
Ob ponovni izpostavitvi parazitu Leishmania infantum v prihodnosti se bo imunski sistem živali tako hitreje odzval.
It is available as a powder and solvent that is made up into suspension for injection. 
Na voljo je v obliki praška in vehikla za pripravo suspenzije za injiciranje.
The vaccine was generally well tolerated as shown by the absence of major adverse reactions. 
Cepivo so psi na splošno dobro prenašali, saj se niso pojavile hujše neželene reakcije.
The efficacy of vaccination in dogs already infected was not investigated and therefore cannot be recommended. 
Učinkovitost cepljenja pri že okuženih psih ni bila proučena, zato cepljenje v tem primeru ni priporočljivo.
After injection, some dogs can have moderate and temporary local reactions, such as swelling, nodule (hardening), pain on palpation or erythema (reddening). 
Pri nekaterih psih se lahko po injiciranju pojavijo zmerne in prehodne lokalne reakcije, kot so oteklina, vozli (otrdelost), bolečine na otip ali eritem (pordelost).
Infected dogs play a central role in the accidental transmission of parasites to humans. 
Okuženi psi imajo osrednjo vlogo pri nenamernem prenosu parazita na človeka.
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. 
Učinkovitost cepiva so proučevali v eni glavni terenski študiji, ki je trajala dve leti in je vključevala cepljene in kontrolne pse, ki so bili izpostavljeni naravni okužbi na območjih z visokim tveganjem za okužbo.
What is the risk associated with CaniLeish? 
Kakšna tveganja so povezana z zdravilom CaniLeish?
Allergic-type reactions are uncommon and if a dog shows signs of an allergic reaction, they should be given appropriate symptomatic treatment. 
Alergijske reakcije so občasne in če se pojavijo, je psu treba nuditi ustrezno simptomatsko zdravljenje.
CaniLeish is a vaccine that contains a number of proteins that are released from the Leishmania infantum parasite during its growth. 
Zdravilo CaniLeish je cepivo, ki vsebuje številne beljakovine, ki jih izloča parazit Leishmania infantum med svojo rastjo.
CaniLeish contains an ‘adjuvant' (a highly purified fraction of Quillaja saponaria) to enhance the immune response. 
Cepivo CaniLeish vsebuje „adjuvans“ (prečiščeni ekstrakt Quillaja saponaria), ki okrepi imunski odziv.
In dogs developing leishmaniosis (active infection or disease) despite vaccination, proceeding with vaccine injections showed no benefit. 
Pri psih, pri katerih se je kljub cepljenju razvila leishmanioza (aktivna okužba ali bolezen), ponavljanje cepljenja ni pokazalo nobene koristi.
Why has CaniLeish been approved? 
Zakaj je bilo zdravilo CaniLeish odobreno?
When CaniLeish is given to dogs the immune system recognises the proteins as ‘foreign' and make defences against it. 
Ko pes prejme cepivo CaniLeish, imunski sistem prepozna beljakovine kot „tujek“ in proti njim začne tvoriti protitelesa.