FrancophonIA/ELRC3.0 huggingface dataset:
English: Interstitial lung disease (ILD) has been reported with teriflunomide in the postmarketing setting.
Slovenian: V obdobju po začetku trženja teriflunomida so poročali o intersticijski pljučni bolezni (ILD-interstitial lung disease).
English: Therefore, when warfarin is co-administered with teriflunomide, close INR follow-up and monitoring is recommended.
Slovenian: Zato je priporočljivo natančno spremljanje vrednosti INR, če se sočasno uporabljata varfarin in teriflunomid.
English: No dosage adjustment is necessary for patients with mild, moderate or severe renal impairment not undergoing dialysis.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic, ki se ne zdravijo z dializo, prilagoditev odmerka ni potrebna.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS UNIT-DOSE BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Slovenian: Zato pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic prilagoditve odmerka ni pričakovati.
English: Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Slovenian: Zato pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditve odmerka ni pričakovati.
English: Most cases were described as diffuse or generalised over the scalp (no complete hair loss reported) and occurred most often during the first 6 months and with resolution in 121 of 139 (87.1%) patients treated with teriflunomide 14 mg. Discontinuation because of alopecia was 1.3% in the teriflunomide 14 mg teriflunomide group, versus 0.1% in the placebo group.
Slovenian: Do teh učinkov je večinoma prišlo v prvih 6 mesecih zdravljenja, pri 121 od 139 bolnikov (87,1 %), zdravljenih s teriflunomidom 14 mg, pa je prišlo do resolucije.
English: Switching to or from AUBAGIO
Slovenian: Prehod na zdravilo AUBAGIO ali prehod z zdravila AUBAGIO na drugo zdravilo
English: AUBAGIO 14 mg film-coated tablets
Slovenian: IME ZDRAVILA AUBAGIO 14 mg filmsko obložene tablete
English: There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Slovenian: Po ponavljajočih se odmerkih teriflunomida so ugotovili povečanje povprečnih vrednosti Cmax (2,65-krat) in AUC (2,51-krat) rosuvastatina.
English: Hypersensitivity reactions (immediate or delayed) including anaphylaxis and angioedema
Slovenian: Bolezni živčevja parestezija, išias, sindrom karpalnega kanala hiperestezij a, nevralgija, periferna nevropatija preobčutlji vostne reakcije (takojšnje ali z zakasnitvij o), vključno z anafilaksijo in angioedem om
English: Hazard ratio (CI95%) 3-month Sustained Disability Progression week
Slovenian: (95-odstotni IZ) 3-mesečno ohranjeno napredovanje nezmožnosti v 108. tednu razmerje ogroženosti (95-odstotni IZ)
English: As AUBAGIO decreases the number of white cells in the blood this may affect your ability to fight the infection.
Slovenian: Ker zdravilo AUBAGIO zmanjšuje število belih krvničk v krvi,
English: How to store AUBAGIO
Slovenian: Shranjevanje zdravila AUBAGIO
English: Do not take AUBAGIO if you are, or think you may be pregnant.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, ne jemljite zdravila AUBAGIO.
English: Teriflunomide is contraindicated during breast-feeding (see section 4.3).
Slovenian: Jemanje teriflunomida med dojenjem je kontraindicirano (glejte poglavje 4.3).
English: Interstitial lung disease
Slovenian: Psihiatrične motnje tesnoba
English: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvarjenim delovanjem jeter prilagoditev odmerka ni potrebna.
English: Route/method of administration
Slovenian: Postopek in pot uporabe zdravila
English: Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Slovenian: 6-mesečno ohranjeno napredovanje nezmožnosti v 108. tednu razmerje ogroženosti (95-odstotni IZ)
English: Musculoskeletal pain,
Slovenian: Žilne bolezni glavobol hipertenzijab
English: Mild thrombocytopen ia (platelets <100G/l)
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenijab, anemija blaga trombocito penija (trombociti <100 g/l)
English: Menorrhagia
Slovenian: Sre
English: Tell your doctor immediately, if you notice any of the following serious side effects: - allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing.
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, se nemudoma posvetujte s svojim zdravnikom: - alergijske reakcije, ki lahko vključujejo simptome, kot so izpuščaj, koprivnica, oteklost ustnic, jezika ali obraza ali nenadno težko dihanje, - hude kožne reakcije, ki lahko vključujejo simptome, kot so izpuščaj na koži, nastajanje mehurjev ali razjede v ustih, - hude okužbe ali sepsa (vrsta okužbe, ki je lahko smrtno nevarna), ki lahko vključujejo simptome, kot so visoka telesna temperatura, tresenje, mrzlica, zmanjšan tok urina ali zmedenost, - resna bolezen jeter, ki lahko vključuje simptome, kot so porumenelost kože ali očesnih beločnic,
English: Vomiting, Toothache
Slovenian: Vistor hf.
English: Oral herpes, Tooth infection, Laryngitis, Tinea pedis
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mišičnoskeletne bolečine, mialgija, artralgija
English: Fri
Slovenian: Redki
English: Not known e increaseb
Slovenian: Sanofi AB
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Slovenian: FR - Francija EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 1045 Budapest
Slovenian: 1045 Budapest Hungary
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Slovenian: PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: CZ - Czech Republic
Slovenian: CZ - Češka Republika
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Slovenian: LEOVAN, M. LEWN & SIA EE Argonafton 22
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Slovenian: PL - Poljska Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
English: 2114 Aglantzia
Slovenian: 2114 Aglantzia Lefkosia
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Slovenian: FR - Francija CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Slovenian: EVAGGELOS KALOFOLIAS & SIA O.E.
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Slovenian: BG - Bolgarija Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: HU - Hungary sanofi-aventis zrt.
Slovenian: HUMadžarska sanofi-aventis zrt.
English: SI - Slovenia CSC Pharma d.o.o.
Slovenian: SI - Slovenija CSC Pharma d.o.o.
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Slovenian: ALET PHARMACEUTICALS M. Alexander 121
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Slovenian: RO - Romunija S.C. MAGISTRA C&C S.R.L.
English: Kato Patissia 10445
Slovenian: Kato Patissia 10445 Greece
English: 25125 Brescia Italy
Slovenian: 25125 Brescia
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Slovenian: SK - Slovaška Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Slovenian: BG - Bolgarija Sopharma AD 16 Iliensko shosse str. 1220 Sofia
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Slovenian: BG - Bolgarija Inbiotech Ltd 5A Triaditza str.
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Slovenian: BG - Bolgarija CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
English: 50 MG/5ML Oral suspension Oral use
Slovenian: 50 MG/5ML Oral suspension Peroralna uporaba
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Slovenian: BG - Bolgarija Actavis EAD 29 Atanas Dukov str. Sofia 1407
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Slovenian: FR - Francija THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: Agia Varvara 12351
Slovenian: Agia Varvara 12351 Greece
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Slovenian: RO - Romunija S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
English: N. Psychiko 15451
Slovenian: N. Psychiko 15451 Greece
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Slovenian: RO - Romunija LABORATORI GUIDOTTI SpA Via Livornese, 897
English: AT - Austria CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
Slovenian: AT - Avstrija CSC Pharmaceuticals Handels GmbH Heiligenstädter Straße 395 b A-1190 Wien
English: AT - Austria CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
Slovenian: AT - Avstrija CSC Pharmaceuticals Handels GmbH Gewerbestraße 18-20
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Slovenian: BIOMEDICA-CHEMICA A.E. G. Lyra 25
English: EL - Greece RAFARM AEBE Korintou 12
Slovenian: RAFARM AEBE Korintou 12
English: EL - Greece INTERMED ABEE Kalyftaki 27
Slovenian: INTERMED ABEE Kalyftaki 27
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Slovenian: RO - Romunija CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
English: Dolni Mecholupy Praha 10, CZ-10237 Czech Republic
Slovenian: Dolni Mecholupy Praha 10, CZ-10237
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Slovenian: CODAL SYNTO LTD 33 Thekla Lysioti str.
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Slovenian: RO - Romunija Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Slovenian: VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Slovenian: CHR. K. UNIMED LTD 21 Davlou
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Slovenian: BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Slovenian: MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Slovenian: PHARMACYPRIA HELLAS A.E. Paster 6
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Slovenian: ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Slovenian: RO - Romunija Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Slovenian: RO - Romunija S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Slovenian: Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Slovenian: COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235 Greece
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Slovenian: PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Slovenian: FARMANIC CHEMIPHARMA S.A. Fylis 137
English: BG - Bulgaria Zentiva k.s.
Slovenian: BG - Bolgarija Zentiva k.s.
English: Palaio Faliro Attikis 17564
Slovenian: Palaio Faliro Attikis 17564 Greece
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Slovenian: MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Slovenian: NORMA HELLAS A.E. Menandrou 54
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Slovenian: VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Slovenian: 21ST Km National Highway Athens-Lamia 14565 Greece
English: Powder for oral suspension
Slovenian: Prašek za peroralno suspenzijo
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Slovenian: REMEK PHARMACEUTICALS ABEE Pentelis 34
English: Almus Srl Via Cesarea, 11/10 16121 Genova Italy
Slovenian: Via Cesarea, 11/10 16121 Genova Italy
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Slovenian: FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Slovenian: BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Slovenian: NIMESIL, granule pentru suspensie orală, 100 mg mg/vrečica
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Slovenian: CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: 3508 Lemessos
Slovenian: 3508 Lemessos Cyprus
English: RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
Slovenian: RO - Romunija ANFARM HELLAS S.A. Perikleous 53-57
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Slovenian: RO - Romunija S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Slovenian: AULIN, granule pentru suspensie orală, 100 mg/plic mg/vrečica
English: 3505 Lemessos
Slovenian: 3505 Lemessos Cyprus
English: Kato Kifissia 14564
Slovenian: Kato Kifissia 14564 Greece
English: PL - Poland Medicom International s.r.o.
Slovenian: PL - Poljska Medicom International s.r.o.
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Slovenian: Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: SK - Slovakia Medicom International s.r.o.
Slovenian: SK - Slovaška Medicom International s.r.o.
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Slovenian: REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451 Greece
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Slovenian: MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Slovenian: ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A Holargos 15562
English: Kamatero Attikis 13451
Slovenian: Kamatero Attikis 13451 Greece
English: Athens 14564
Slovenian: Athens 14564 Greece
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Slovenian: 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: Constantinoupoleos Str. 1-10 Limassol, CY-3011
Slovenian: LV - Latvija Medochemie Ltd. Constantinoupoleos Str. 1-10 Limassol, CY-3011
English: LV - Latvia
Slovenian: LT - Litva
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Slovenian: Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Slovenian: Viale Fulvio Testi, 330 20126 Milano Italy
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Slovenian: RO - Romunija MEDOCHEMIE LTD. - CYPRUS, P.O. Box 51409
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Slovenian: PannonPharma Kft. Pannonpharma út 1. 7720, Pécsvárad Hungary
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Slovenian: 30 Km Athens-Lavrion Markopoulo 19003 Greece
English: LT - Lithuania Zentiva k.s.
Slovenian: LV - Latvija Zentiva k.s.
English: SK - Slovakia Laboratori Guidotti S.p.A.
Slovenian: SK - Slovaška Laboratori Guidotti S.p.A.
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Slovenian: BG - Bolgarija Laboratori Guidotti S.p.A.
English: Coated tablet
Slovenian: Filmsko obložena tableta
English: Film-coated tablet Oral use
Slovenian: Obložena tableta Peroralna uporaba
English: PL - Poland Zentiva a.s. U Kabelovny 130
Slovenian: PL - Poljska Zentiva a.s.
English: EL - Greece FARMILIA E.E.
Slovenian: FARMILIA E.E.
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Slovenian: Athinas 22 & Apollonos Gerakas Attikis 15344 Greece
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Slovenian: MED-ONE S.A., HELLAS Parnithos Avenue 211 Aharnai 13671
English: EL - Greece ANTOR EPE P. Mavromihali 1
Slovenian: ANTOR EPE P. Mavromihali 1 Vrilissia 15235 Greece
English: RO - Romania S.C.
Slovenian: RO - Romunija S.C. ARENA GROUP S.A.
English: MG/SACHET
Slovenian: MG/VREČICA
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Slovenian: 18th Km Marathonos Avenue Pallini Attikis 15351
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Slovenian: Eurodrug Lab. BV Laan Copes van Cattenbruch 74. 2585 GD, The Hague, The Netherlands
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Slovenian: LAVIPHARM HELLAS A.E. Agias Marinas Paiania Attikis 19002 Greece
English: Athens 10438
Slovenian: Favierou 48 Athens 10438 Greece
English: FARMA A.E. Aristotelous 73
Slovenian: FARMA A.E. Aristotelous 73 Athens 10434 Greece
English: FR - France HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
Slovenian: FR - Francija HELSINN BIREX PHARMACEUTICALS Ltd Damastown Mulhuddart
English: Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart Dublin-15
Slovenian: Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart Dublin 15
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Slovenian: ES - Španija HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
English: Hungary
Slovenian: Greece
English: Granules for oral solution in sachet
Slovenian: Zrnca za peroralno raztopino v vrečici
English: Limassol, CY-3505
Slovenian: Medochemie Ltd. P.O. Box 51409 Limassol, CY-3505 Cyprus
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Slovenian: ARMEDICA A.E. Agias Markellis 17 Athens 11855
English: 100mg/sachet Granules for oral suspension
Slovenian: 100mg/vrečica Zrnca za peroralno suspenzijo
English: Orodispersible tablet Oral use
Slovenian: Orodisperzibilna tableta
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Slovenian: (Menarini Group) Via Livornese 897
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Slovenian: ANFARM HELLAS S.A. Perikleous 53-57 Gerakas Attikis 153 44 Greece
English: 100 MG/TAB Effervescent tablet Oral use
Slovenian: 100 MG/TAB Šumeča tableta
English: LT - Lithuania Laboratori Guidotti S.p.A.
Slovenian: LV - Latvija Laboratori Guidotti S.p.A.
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Slovenian: LV - Latvija Helsinn Birex Pharmaceutical Ltd. Damastown, Mulhuddart
English: EL - Greece BROS EPE Avgis & Gallinis 15
Slovenian: BROS EPE Avgis & Gallinis 15 N. Kifissia 14564 Greece
English: 200 MG/SUPP Suppository
Slovenian: 200 MG/SVEČ Svečka
English: The warnings are appropriate.
Slovenian: Opozorila so ustrezna.
English: For the pour-on product 24 concerned member states (CMS) are involved: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain.
Slovenian: Za zdravilo v polivu je zadevnih 24 držav članic, in sicer Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Danska, Estonija, Francija, Grčija, Irska, Islandija, Italija, Latvija, Litva, Luksemburg, Madžarska, Nemčija, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija in Španija.
English: Efficacy was not assessed in this referral procedure.
Slovenian: Učinkovitost se v tem postopku predaje zadeve ni ocenjevala.
English: Add the following text in the relevant sections of the product information:
Slovenian: Dodajte naslednje besedilo v relevantnih poglavjih v podatkih o izdelku:
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Slovenian: Zdravilna učinkovina je dobro znana in je vključena med zdravila za uporabo v veterinarski medicini, ki so trenutno odobrena v EU.
English: Direct therapeutic benefit
Slovenian: Neposredne terapevtske koristi
English: The efficacy of Deltanil has been demonstrated according to current rules during the decentralised procedure.
Slovenian: Učinkovitost zdravila Deltanil je bila dokazana v skladu z veljavnimi pravili med decentraliziranim postopkom.
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Slovenian: Dodatne študije za dodatno raziskavo tveganja niso bile opravljene, ker trenutno na tem področju ni razpoložljivih smernic.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Slovenian: Odbor je glede na predložene podatke o težavah, na katere je bilo opozorjeno v prijavi, ki jo je prejel od Nemčije in Nizozemske, sklenil naslednje.
English: Risk management or mitigation measures
Slovenian: Ukrepi za obvladovanje tveganja ali njegovo zmanjšanje
English: The use of the products was not expected to pose a risk for soil, groundwater and surface water.
Slovenian: Uporaba zdravil naj ne bi povzročala tveganja za tla, podtalnico in površinske vode.
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of the products.
Slovenian: V njej so zagotovljene vse informacije, potrebne za ugotovitev tveganja za okolje, ki izhaja iz uporabe zdravil.
English: The reference member state (RMS) is the United Kingdom for both products.
Slovenian: Referenčna država članica za obe zdravili je Združeno kraljestvo.
English: The ERA was complete in terms of data requirements and quality of data.
Slovenian: Ocena tveganja za okolje je bila popolna, kar zadeva zahteve po podatkih in njihovo kakovost.
English: Quality, target animal safety, user safety and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Slovenian: V tem postopku predaje zadeve se kakovost, varnost ciljne živali, varnost uporabnika in ostanki niso ocenjevali, saj referenčna država članica ni izrazila pomislekov.
English: However, it was considered that information on the possible accumulation of deltamethrin in sediments should be communicated to the user in the product information.
Slovenian: Vendar pa je odbor menil, da bi bilo treba informacijo o mogočem kopičenju deltametrina v usedlinah uporabnikom sporočiti v informacijah o zdravilu.
English: The benefit-risk for the products can be considered to be positive.
Slovenian: Razmerje med koristmi in tveganjem zdravila se lahko šteje za ugodno.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine z naslednjimi dopolnili:
English: The amended Summaries of Product Characteristics and package leaflets of the reference Member State are set out in Annex III.
Slovenian: Spremenjena povzetka glavnih značilnosti zdravila in navodila za uporabo referenčne države članice so določeni v Prilogi III.