FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Estonian: Seetõttu ei annuse kohandamine kerge, mõõduka ega raske neerupuudulikkusega patsientidel ootuspärane.
English: Teriflunomide may cause serious birth defects when administered during pregnancy.
Estonian: Raseduse ajal kasutatuna võib teriflunomiid põhjustada tõsiseid väärarenguid.
English: • For women of child-bearing potential o to emphasise the need for effective contraception during treatment with teriflunomide o to stop treatment with teriflunomide immediately if they suspect they might be pregnant and also to contact their doctor immediately
Estonian: − peatada ravi teriflunomiidiga otsekohe, kui nad kahtlustavad endal rasedust, ning võtta otsekohe ühendust oma arstiga;
English: Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Estonian: Riskide suhe (CI95%) puude püsiv progresseerumine 6 kuud 108. nädalal
English: How to store AUBAGIO
Estonian: Kuidas AUBAGIO't säilitada
English: Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Estonian: Teriflunomiidiga ravitavatel patsientidel on täheldatud maksaensüümide aktiivsuse tõusu (vt lõik 4.8).
English: Haematological effects
Estonian: Hematoloogilised toimed
English: In placebo-controlled studies the following was established: - systolic blood pressure was >140 mm Hg in 19.9% of patients receiving 14 mg/day teriflunomide as compared to 15.5% receiving placebo; - systolic blood pressure was >160 mm Hg in 3.8% of patients receiving 14 mg/day teriflunomide as compared to 2.0% receiving placebo; - diastolic blood pressure was >90 mm Hg in 21.4% of patients receiving 14 mg/day teriflunomide as compared to 13.6% receiving placebo.
Estonian: 14 mg/ööpäevas, võrreldes 2,0% platseebot saanud patsientidest; - diastoolne vererõhk oli >90 mm Hg 21,4% patsientidest, kellele manustati teriflunomiidi
English: Switching to or from AUBAGIO
Estonian: Üleminek ravile või ravilt AUBAGIO'ga
English: France sanofi-aventis France Tél: 0 800 222 555
Estonian: Tél: 0 800 222 555
English: - Feeling your heartbeat - Increase in blood pressure - Being sick (vomiting), toothache, upper abdominal pain - Rash, acne - Pain of the tendons, joints, bones, muscle pain (musculoskeletal pain), - Needing to urinate more often than usual - Heavy periods - Pain - Lack of energy or feeling weak (asthenia) - Weight loss
Estonian: (karpaalkanali sündroom); - tuntav südamekloppimine; - vererõhu tõus; - halb enesetunne (oksendamine), hambavalu; valu ülakõhus; - lööve, akne; - kõõluste, liigeste, luude või lihaste valu (lihas-skeleti valu); - tavalisest sagedasema urineerimise vajadus; - vererohked menstruatsioonid; - valu; - jõuetus või nõrkustunne (asteenia); - kehakaalu langus.
English: The CNS is made up of the brain and spinal cord.
Estonian: Kesknärvisüsteem koosneb peaajust ja seljaajust.
English: Gastrointestinal disorders
Estonian: Viiruslik gastroenteriit Suulimaskesta herpes
English: - Mild allergic reactions - Feeling anxious - Pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
Estonian: - surisemis- või torkimistunne, nõrkustunne, tuimus, surisev või torkiv tunne või valu alaseljas või jalas (ishias); käte ja sõrmede tuimus, põletustunne, surisev või torkiv tunne või valu
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.
Estonian: − allergilised reaktsioonid, mille sümptomid võivad olla lööve, nõgestõbi, huulte, keele või näo turse või ootamatu hingamisraskus:
English: The film-coated tablets are for oral use.
Estonian: Õhukese polümeerikattega tabletid on suukaudseks manustamiseks.
English: Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Estonian: Teriflunomiid on vastunäidustatud raske maksakahjustusega patsientidele (vt lõik 4.3).
English: A consistent treatment effect on relapses and time to 3-month sustained disability progression in a subgroup of patients in TEMSO (n 127) with high disease activity was observed.
Estonian: Haiguse kõrge aktiivsusega patsientide alarühmas (n=127) TEMSO-uuringus täheldati samalaadset ravitoimet ägenemiste ja 3-kuulise puude püsiva progresseerumise suhtes.
English: There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Estonian: Isasrottide, kellele manustati enne ravimata emasrottidega paaritumist teriflunomiidi, poegadel ei täheldatud väliseid väärarendeid.
English: Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Estonian: Enne ravi ja ravi ajal teriflunomiidiga peab kõrgenenud vererõhku asjakohaselt ravima.
English: • Alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) o Liver enzymes should be assessed every two weeks during the first 6 months of treatment, and every 8 weeks thereafter or as indicated by clinical signs and symptoms such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
Estonian: − maksaensüüme tuleb hinnata esimesel 6 ravikuul iga kahe nädala järel ja seejärel iga 8 nädala järel või kui see on näidustatud kliiniliste nähtude ja sümptomite alusel, nt selge põhjuseta iiveldus, oksendamine, kõhuvalu, väsimus, anoreksia, ikterus ja/või tume uriin; ALAT (SGPT) tõusu korral 2…3 korda üle normväärtuse ülapiiri (upper limit of normal, ULN) on vajalik iganädalane monitooring;
English: Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study
Estonian: Peamised tulemused 14 mg annuse korral ravikavatsuslikus populatsioonis TEMSO-uuring
English: AUBAGIO is for oral use.
Estonian: AUBAGIO on suukaudne ravim.
English: ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Estonian: Turuletulekujärgselt on teatatud interstitsiaalsest kopsuhaigusest seoses teriflunomiidiga ning olemasoleva interstitsiaalse kopsuhaiguse süvenemisest seoses leflunomiidiga, mis on teriflunomiidi lähteaine.
English: Calendar days Mon
Estonian: Kalendripäevad E
English: • Affects liver function
Estonian: • mõjutab maksatalitlust,
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
Estonian: KESKMISEL PAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED TASKU
English: cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Estonian: Healoomulised, pahaloomulised ja täpsustamata neoplasmad (k.a tsüstid ja polüübid) Kliiniliste uuringute põhjal pahaloomuliste kasvajate tekkerisk teriflunomiidiga ilmselt ei suurene.
English: To encourage the patients to read the PIL thoroughly 4.
Estonian: Üleskutse patsientidele lugeda hoolikalt pakendi infolehte Kui patsient rasestub
English: The volume of distribution is 11 l after a single intravenous (IV) administration.
Estonian: Jaotusruumala pärast ühekordset intravenoosset (i.v.)
English: Contents of the pack and other information
Estonian: Kuidas AUBAGIO't säilitada Pakendi sisu ja muu teave
English: Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Estonian: Seetõttu ei ole annuse kohandamine kerge kuni mõõduka maksakahjustusega patsientidel ootuspärane.
English: AUBAGIO 14 mg film-coated tablets
Estonian: AUBAGIO 14 mg õhukese polümeerikattega tabletid
English: Paraesthesia, Sciatica, Carpal tunnel syndrome
Estonian: Karpaaltunneli sündroom
English: España sanofi-aventis S.A. Tel: +34 93 485 94 00
Estonian: Tel: +34 93 485 94 00 sanofi-aventis S.A.
English: SANOFI BULGARIA EOOD Tел: +359 2 970 53 00
Estonian: Tел: +359 2 9705300
English: • Risk of hepatic effects o liver function tests are needed prior to treatment and periodically during treatment o To educate the patient about the signs and symptoms of liver disease and the need to report to their HCP if they experience any of them
Estonian: − patsiendi teavitamine maksahaiguse nähtudest ja sümptomitest ning vajadusest teavitada tervishoiutöötajat, kui need tekivad;
English: - severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth - severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion - serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain - inflammation of the lungs which might include symptoms of shortness of breath or persistent cough - inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
Estonian: − rasked infektsioonid või sepsis (nakkuslikud põletikud või bakterid veres, mis võib olla eluohtlik), mille sümptomid võivad olla kõrge palavik, värisemine, külmavärinad, vähenenud uriinieritus või segasus,
English: Use in males
Estonian: Kasutamine meestel
English: - you have high blood pressure (hypertension) whether it is controlled with medicines or not.
Estonian: AUBAGIO'ga; palun lugege lõiku 4; - kui teil on kõrge vererõhk (hüpertensioon), sõltumata sellest, kas te ravite seda või mitte.
English: Headache
Estonian: Hüpertensioonb
English: No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Estonian: Kerge ja mõõduka maksakahjustusega patsientidel ei ole annuse kohandamine vajalik.
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Estonian: Τηλ: +357 22 871600
English: 1045 Budapest
Estonian: 1045 Budapest Hungary
English: EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
Estonian: EL - Kreeka PHARMACEUTICAL INDUSTRY PROEL EPAM.
English: HU - Hungary sanofi-aventis zrt.
Estonian: HU - Ungari sanofi-aventis zrt.
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Estonian: Lisa I Ravimite nimetuste, ravimvormide, tugevuste, manustamisviisi ja müügiloa hoidjate loetelu liikmesriikides
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Estonian: PannonPharma Kft. Pannonpharma út 1.
English: EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
Estonian: EL - Kreeka EVAGGELOS KALOFOLIAS & SIA O.E.
English: EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
Estonian: EL - Kreeka LEOVAN, M. LEWN & SIA EE Argonafton 22
English: RO - Romania S.C. MAGISTRA C&C S.R.L.
Estonian: RO - Rumeenia S.C. MAGISTRA C&C S.R.L.
English: BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
Estonian: BG - Bulgaaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
English: EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
Estonian: EL - Kreeka ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
English: BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
Estonian: BG - Bulgaaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
English: 7720, Pécsvárad
Estonian: 7720, Pécsvárad Hungary
English: EL - Greece ALET PHARMACEUTICALS M. Alexander 121
Estonian: EL - Kreeka ALET PHARMACEUTICALS M. Alexander 121
English: BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
Estonian: BG - Bulgaaria Inbiotech Ltd 5A Triaditza str.
English: SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
Estonian: SK - Slovakkia Zentiva k.s., Evropská 846/176a, 160 00, Praha
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
Estonian: CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
English: EL - Greece INTERMED ABEE Kalyftaki 27
Estonian: EL - Kreeka INTERMED ABEE Kalyftaki 27
English: HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Estonian: Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
English: BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
Estonian: BG - Bulgaaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
English: FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
Estonian: THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
English: FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Estonian: Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03 France
English: RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
Estonian: RO - Rumeenia S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
English: RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
Estonian: RO - Rumeenia LABORATORI GUIDOTTI SpA Via Livornese, 897
English: SI - Slovenia CSC Pharma d.o.o.
Estonian: SI - Sloveenia CSC Pharma d.o.o.
English: CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
Estonian: CY - Küpros CHR. K. UNIMED LTD 21 Davlou
English: EL - Greece B.I.
Estonian: EL - Kreeka B.I.
English: EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
Estonian: EL - Kreeka MED-ONE S.A., HELLAS Parnithos Avenue 211
English: RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
Estonian: RO - Rumeenia MEDOCHEMIE LTD. - CYPRUS, P.O.
English: EL - Greece ANTOR EPE P. Mavromihali 1
Estonian: EL - Kreeka ANTOR EPE P. Mavromihali 1
English: RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
Estonian: RO - Rumeenia CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
English: EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
Estonian: EL - Kreeka DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
English: CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
Estonian: CY - Küpros CODAL SYNTO LTD 33 Thekla Lysioti str.
English: BG - Bulgaria Zentiva k.s.
Estonian: BG - Bulgaaria Zentiva k.s.
English: EL - Greece FARMILIA E.E.
Estonian: EL - Kreeka FARMILIA E.E.
English: EL - Greece RAFARM AEBE Korintou 12
Estonian: EL - Kreeka RAFARM AEBE Korintou 12
English: EL - Greece S.J.A.
Estonian: EL - Kreeka S.J.A.
English: EL - Greece HELP ABEE Valaoritou 10
Estonian: EL - Kreeka HELP ABEE Valaoritou 10
English: EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
Estonian: EL - Kreeka KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
English: EL - Greece BROS EPE Avgis & Gallinis 15
Estonian: EL - Kreeka BROS EPE Avgis & Gallinis 15
English: RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
Estonian: RO - Rumeenia Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
English: EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
Estonian: EL - Kreeka BIOMEDICA-CHEMICA A.E. G. Lyra 25
English: EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
Estonian: EL - Kreeka FARMANIC CHEMIPHARMA S.A. Fylis 137
English: EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
Estonian: EL - Kreeka VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
English: CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
Estonian: CY - Küpros CDL PHARMACEUTICAL LTD 5 Diomedous str.
English: RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
Estonian: RO - Rumeenia Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
English: EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
Estonian: EL - Kreeka BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
English: EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
Estonian: EL - Kreeka VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
English: RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
Estonian: RO - Rumeenia S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
English: EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
Estonian: EL - Kreeka MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
English: EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
Estonian: EL - Kreeka VOCATE PHARMAKEFTIKI A.E. Gounari 150
English: EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
Estonian: EL - Kreeka BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
English: EL - Greece NORMA HELLAS A.E. Menandrou 54
Estonian: EL - Kreeka NORMA HELLAS A.E. Menandrou 54
English: EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
Estonian: EL - Kreeka REMEK PHARMACEUTICALS ABEE Pentelis 34
English: EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
Estonian: EL - Kreeka ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
English: EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
Estonian: EL - Kreeka PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
English: EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
Estonian: EL - Kreeka PHARMACYPRIA HELLAS A.E. Paster 6
English: EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
Estonian: EL - Kreeka MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
English: EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
Estonian: EL - Kreeka MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
English: SK - Slovakia Medicom International s.r.o.
Estonian: SK - Slovakkia Medicom International s.r.o.
English: AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
Estonian: AULIN, granule pentru suspensie orală, 100 mg/plic
English: EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
Estonian: EL - Kreeka FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
English: EL - Greece ARMEDICA A.E. Agias Markellis 17
Estonian: EL - Kreeka ARMEDICA A.E. Agias Markellis 17
English: 50 MG/5ML Oral suspension Oral use
Estonian: 50 MG/5ML Suukaudne suspensioon
English: RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
Estonian: RO - Rumeenia S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
English: EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
Estonian: EL - Kreeka REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
English: EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
Estonian: EL - Kreeka LAVIPHARM HELLAS A.E. Agias Marinas
English: LT - Lithuania Zentiva k.s.
Estonian: LT - Leedu Zentiva k.s.
English: ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
Estonian: RO - Rumeenia S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
English: BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
Estonian: BG - Bulgaaria Actavis EAD 29 Atanas Dukov str.
English: EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
Estonian: EL - Kreeka BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
English: PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Estonian: Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5, 95-200 Pabianice
English: LT - Lithuania Medochemie Ltd. P.O.
Estonian: LT - Leedu Medochemie Ltd. P.O.
English: FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
Estonian: EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A 12, rue Danjou
English: EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
Estonian: EL - Kreeka ANFARM HELLAS S.A. Perikleous 53-57
English: EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
Estonian: EL - Kreeka FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
English: EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
Estonian: EL - Kreeka GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
English: RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
Estonian: RO - Rumeenia ANFARM HELLAS S.A. Perikleous 53-57
English: SK - Slovakia Laboratori Guidotti S.p.A.
Estonian: SK - Slovakkia Laboratori Guidotti S.p.A.
English: BG - Bulgaria Laboratori Guidotti S.p.A.
Estonian: BG - Bulgaaria Laboratori Guidotti S.p.A.
English: Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Estonian: Viale Fulvio Testi, 330 20126 Milano Italy
English: NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
Estonian: NIMESIL, granule pentru suspensie orală, 100 mg
English: MG/SACHET
Estonian: MG/SUPOSIIT
English: EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
Estonian: EL - Kreeka COUP ABEE Agias Varvaras 53-55
English: ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
Estonian: ES - Hispaania HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
English: LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
Estonian: LT - Leedu Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
English: LT - Lithuania Laboratori Guidotti S.p.A.
Estonian: LT - Leedu Laboratori Guidotti S.p.A.
English: Hungary
Estonian: HU - Ungari
English: Rua João deDeus,19 Venda Nova
Estonian: Rua João deDeus,19 Venda Nova 2700-487 Amadora Portugal
English: PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
Estonian: (Menarini Group) Via Livornese 897
English: Orodispersible tablet Oral use
Estonian: Suukaudse suspensiooni pulber
English: 100mg/sachet Granules for oral suspension
Estonian: 100 mg/kotike Suukaudse suspensiooni graanulid
English: HU - Hungary Lab. Guidotti S.p.A.
Estonian: Lab. Guidotti S.p.A.
English: The warnings are appropriate.
Estonian: Nimetatud hoiatused on asjakohased.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Estonian: Toimeaine on hästi tuntud ja kuulub praegu ELis lubatud veterinaarravimite hulka.
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.
Estonian: Kriipsmanustatava ravimi 24 asjaomast liikmesriiki on Austria, Belgia, Bulgaaria, Eesti, Hispaania, Iirimaa, Island, Itaalia, Kreeka, Küpros, Leedu, Luksemburg, Madalmaad, Poola, Portugal, Prantsusmaa, Rootsi, Rumeenia, Saksamaa, Slovakkia, Sloveenia, Taani, Tšehhi Vabariik ja Ungari.
English: Efficacy was not assessed in this referral procedure.
Estonian: Käesolevas esildismenetluses efektiivsust ei hinnatud.
English: No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Estonian: Täiendavaid uuringuid riskide täpsustamiseks läbi ei viidud, sest hetkel ei ole selles valdkonnas kättesaadavaid suuniseid.
English: The benefit-risk for the products can be considered to be positive.
Estonian: Ravimite kasulikkuse ja riski tasakaalu võib pidada positiivseks.
English: The ERA was complete in terms of data requirements and quality of data.
Estonian: Keskkonnaohu hindamine oli andmenõuete ja andmete kvaliteedi poolest täielik.
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Estonian: Arvestades esitatud andmeid, tegi komitee Saksamaalt ja Madalmaadelt saadud teatises tõstatatud küsimuste kohta järgmised järeldused.
English: The use of the products was not expected to pose a risk for soil, groundwater and surface water.
Estonian: Ravimite kasutamine eeldatavasti ei tekita riski mullale, põhjaveele ja pinnaveele.
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.
Estonian: Kvaliteeti, sihtloomade ohutust, kasutajate ohutust ja ravimijääke kõnealuses esildismenetluses ei hinnatud, sest viiteliikmesriik ei teatanud asjaomastest kahtlustest.
English: Risk management or mitigation measures
Estonian: Riskijuhtimise või riskivähendusmeetmed