natgillin/translations-raw huggingface dataset:
There was an increase in mean rosuvastatin Cmax and AUC (2.65- and 2.51-fold, respectively), following repeated doses of teriflunomide.
Teriflunomiidi korduvate annuste järgselt tõusid rosuvastatiini keskmine Cmax ja AUC (vastavalt 2,65 ja 2,51 korda).
A total of 618 patients were randomised to receive 7 mg (n=205) or 14 mg (n=216) of teriflunomide or placebo (n=197).
Kokku 618 patsienti (naisi 67,8% ja mehi 32,2%) juhuslikustati saama ravi teriflunomiidiga annuses 7 mg (n=205) või 14 mg (n=216) või platseebot (n=197).
• Summary of Product Characteristics (SmPC)
• ravimi omaduste kokkuvõte,
The median EDSS score at baseline was 2.50; 298 patients (25.5%) had an EDSS score › 3.5 at baseline.
298 patsiendi (25,5%) EDSS skoor uuringu alguses oli >3,5.
Musculoskeletal pain,
Lihas-skeleti valu Müalgia
Effect of teriflunomide on warfarin
Teriflunomiidi toime varfariinile
• Potential risk of teratogenicity o To check pregnancy status before starting treatment o To educate female patients of child-bearing potential on the need for effective contraception before starting, and during treatment with teriflunomide o To inform their doctor immediately if they stop contraception, or prior to changing contraceptive measures o If female patients become pregnant despite using contraceptive measures, they should stop teriflunomide and contact their doctor immediately who should: Consider and discuss with the patient the accelerated elimination procedure encourage them to enrol in a pregnancy registry (in countries where a pregnancy registry is on-going),
− kui naine rasestub vaatamata rasestumisvastase vahendi kasutamisele, tuleb terflunomiidi võtmine lõpetada ja otsekohe võtta ühendust oma arstiga, kes peab kaaluma kiirendatud eliminatsiooniprotseduuri ja arutama seda patsiendiga julgustama patsienti registreeruma rasedusregistrisse (maades, kus rasedusregister toimib);
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigo carmine aluminum lake (E132).
hüpromelloos, titaandioksiid (E171), talk, makrogool 8000, indigokarmiini alumiiniumlakk (E132).
• cholestyramine 8 g is administered 3 times daily for a period of 11 days, or cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated,
• manustatakse 8 g kolestüramiini 3 korda ööpäevas 11 päeva jooksul või 4 g kolestüramiini 3
How to take AUBAGIO
Kuidas AUBAGIO't kasutada
Therefore no dose adjustment is anticipated in mild, moderate and severe renal-impaired patients.
Seetõttu ei annuse kohandamine kerge, mõõduka ega raske neerupuudulikkusega patsientidel ootuspärane.
Teriflunomide may cause serious birth defects when administered during pregnancy.
Raseduse ajal kasutatuna võib teriflunomiid põhjustada tõsiseid väärarenguid.
• 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
− peatada ravi teriflunomiidiga otsekohe, kui nad kahtlustavad endal rasedust, ning võtta otsekohe ühendust oma arstiga;
Hazard ratio (CI95%) 6-month Sustained Disability Progression week
Riskide suhe (CI95%) puude püsiv progresseerumine 6 kuud 108. nädalal
How to store AUBAGIO
Kuidas AUBAGIO't säilitada
Elevations of liver enzymes have been observed in patients receiving teriflunomide (see section 4.8).
Teriflunomiidiga ravitavatel patsientidel on täheldatud maksaensüümide aktiivsuse tõusu (vt lõik 4.8).
Haematological effects
Hematoloogilised toimed
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.
14 mg/ööpäevas, võrreldes 2,0% platseebot saanud patsientidest; - diastoolne vererõhk oli >90 mm Hg 21,4% patsientidest, kellele manustati teriflunomiidi
Switching to or from AUBAGIO
Üleminek ravile või ravilt AUBAGIO'ga
- 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
(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.
The CNS is made up of the brain and spinal cord.
Kesknärvisüsteem koosneb peaajust ja seljaajust.
Gastrointestinal disorders
Viiruslik gastroenteriit Suulimaskesta herpes
- 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)
- 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
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.
− allergilised reaktsioonid, mille sümptomid võivad olla lööve, nõgestõbi, huulte, keele või näo turse või ootamatu hingamisraskus:
The film-coated tablets are for oral use.
Õhukese polümeerikattega tabletid on suukaudseks manustamiseks.
Teriflunomide is contraindicated in patients with severe hepatic impairment (see section 4.3).
Teriflunomiid on vastunäidustatud raske maksakahjustusega patsientidele (vt lõik 4.3).
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.
Haiguse kõrge aktiivsusega patsientide alarühmas (n=127) TEMSO-uuringus täheldati samalaadset ravitoimet ägenemiste ja 3-kuulise puude püsiva progresseerumise suhtes.
There were no external malformations in the offspring of male rats administered teriflunomide prior to mating with untreated female rats.
Isasrottide, kellele manustati enne ravimata emasrottidega paaritumist teriflunomiidi, poegadel ei täheldatud väliseid väärarendeid.
Blood pressure elevation should be appropriately managed before and during treatment with teriflunomide.
Enne ravi ja ravi ajal teriflunomiidiga peab kõrgenenud vererõhku asjakohaselt ravima.
• 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.
− 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;
Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study
Peamised tulemused 14 mg annuse korral ravikavatsuslikus populatsioonis TEMSO-uuring
AUBAGIO is for oral use.
AUBAGIO on suukaudne ravim.
ILD and worsening of pre-existing ILD have been reported during treatment with leflunomide, the parent compound of teriflunomide.
Turuletulekujärgselt on teatatud interstitsiaalsest kopsuhaigusest seoses teriflunomiidiga ning olemasoleva interstitsiaalse kopsuhaiguse süvenemisest seoses leflunomiidiga, mis on teriflunomiidi lähteaine.
Calendar days Mon
Kalendripäevad E
• Affects liver function
• mõjutab maksatalitlust,
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING WALLET
KESKMISEL PAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED TASKU
cysts and polyps) There does not appear to be an increased risk of malignancy with teriflunomide in the clinical trial experience.
Healoomulised, pahaloomulised ja täpsustamata neoplasmad (k.a tsüstid ja polüübid) Kliiniliste uuringute põhjal pahaloomuliste kasvajate tekkerisk teriflunomiidiga ilmselt ei suurene.
To encourage the patients to read the PIL thoroughly 4.
Üleskutse patsientidele lugeda hoolikalt pakendi infolehte Kui patsient rasestub
The volume of distribution is 11 l after a single intravenous (IV) administration.
Jaotusruumala pärast ühekordset intravenoosset (i.v.)
Contents of the pack and other information
Kuidas AUBAGIO't säilitada Pakendi sisu ja muu teave
Therefore no dose adjustment is anticipated in mild and moderate hepatic-impaired patients.
Seetõttu ei ole annuse kohandamine kerge kuni mõõduka maksakahjustusega patsientidel ootuspärane.
AUBAGIO 14 mg film-coated tablets
AUBAGIO 14 mg õhukese polümeerikattega tabletid
Paraesthesia, Sciatica, Carpal tunnel syndrome
Karpaaltunneli sündroom
España sanofi-aventis S.A. Tel: +34 93 485 94 00
Tel: +34 93 485 94 00 sanofi-aventis S.A.
SANOFI BULGARIA EOOD Tел: +359 2 970 53 00
Tел: +359 2 9705300
• 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
− patsiendi teavitamine maksahaiguse nähtudest ja sümptomitest ning vajadusest teavitada tervishoiutöötajat, kui need tekivad;
- 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
− 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,
Use in males
Kasutamine meestel
- you have high blood pressure (hypertension) whether it is controlled with medicines or not.
AUBAGIO'ga; palun lugege lõiku 4; - kui teil on kõrge vererõhk (hüpertensioon), sõltumata sellest, kas te ravite seda või mitte.
Headache
Hüpertensioonb
No dosage adjustment is necessary for patients with mild and moderate hepatic impairment.
Kerge ja mõõduka maksakahjustusega patsientidel ei ole annuse kohandamine vajalik.
Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Τηλ: +357 22 871600
EL - Greece PHARMACEUTICAL INDUSTRY PROEL EPAM.
EL - Kreeka PHARMACEUTICAL INDUSTRY PROEL EPAM.
HU - Hungary sanofi-aventis zrt.
HU - Ungari sanofi-aventis zrt.
List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Lisa I Ravimite nimetuste, ravimvormide, tugevuste, manustamisviisi ja müügiloa hoidjate loetelu liikmesriikides
HU - Hungary PannonPharma Kft. Pannonpharma út 1.
PannonPharma Kft. Pannonpharma út 1.
EL - Greece EVAGGELOS KALOFOLIAS & SIA O.E.
EL - Kreeka EVAGGELOS KALOFOLIAS & SIA O.E.
EL - Greece LEOVAN, M. LEWN & SIA EE Argonafton 22
EL - Kreeka LEOVAN, M. LEWN & SIA EE Argonafton 22
RO - Romania S.C. MAGISTRA C&C S.R.L.
RO - Rumeenia S.C. MAGISTRA C&C S.R.L.
BG - Bulgaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
BG - Bulgaaria Sopharma AD 16 Iliensko shosse str. 1220 Sofia
EL - Greece ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
EL - Kreeka ANTONIOS POLYCHRONIS OF MARINOU Ethnikis Antistaseos 6A
BG - Bulgaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
BG - Bulgaaria Chaikapharma - Highquality medicines AD, 1 G.M.Dimitrov Blvd
7720, Pécsvárad
7720, Pécsvárad Hungary
EL - Greece ALET PHARMACEUTICALS M. Alexander 121
EL - Kreeka ALET PHARMACEUTICALS M. Alexander 121
BG - Bulgaria Inbiotech Ltd 5A Triaditza str.
BG - Bulgaaria Inbiotech Ltd 5A Triaditza str.
SK - Slovakia Zentiva k.s., Evropská 846/176a, 160 00, Praha
SK - Slovakkia Zentiva k.s., Evropská 846/176a, 160 00, Praha
CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
CY - Küpros MEDOCHEMIE LTD 1-10 Constantinoupoleos str. P.O.Box 51409
EL - Greece INTERMED ABEE Kalyftaki 27
EL - Kreeka INTERMED ABEE Kalyftaki 27
HU - Hungary Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
Eurodrug Lab. BV Laan Copes van Cattenbruch 74.
BG - Bulgaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
BG - Bulgaaria CSC Pharmaceuticals Ltd-Bulgaria EOOD, 10 Assen Jordanov str.,
FR - France THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
THERABEL LUCIEN PHARMA 19 rue Alphonse de Neuville 75017 PARIS
FR - France CLL PHARMA Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03
Nice Premier - Arenas 455, promenade des Anglais 06299 NICE Cedex 03 France
RO - Romania S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
RO - Rumeenia S.C. FARMEX COMPANY SRL Str.Drumul Potcoavei nr. 30, Pipera Voluntari, Jud.
RO - Romania LABORATORI GUIDOTTI SpA Via Livornese, 897
RO - Rumeenia LABORATORI GUIDOTTI SpA Via Livornese, 897
SI - Slovenia CSC Pharma d.o.o.
SI - Sloveenia CSC Pharma d.o.o.
CY - Cyprus CHR. K. UNIMED LTD 21 Davlou
CY - Küpros CHR. K. UNIMED LTD 21 Davlou
EL - Greece B.I.
EL - Kreeka B.I.
EL - Greece MED-ONE S.A., HELLAS Parnithos Avenue 211
EL - Kreeka MED-ONE S.A., HELLAS Parnithos Avenue 211
RO - Romania MEDOCHEMIE LTD. - CYPRUS, P.O.
RO - Rumeenia MEDOCHEMIE LTD. - CYPRUS, P.O.
EL - Greece ANTOR EPE P. Mavromihali 1
EL - Kreeka ANTOR EPE P. Mavromihali 1
RO - Romania CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
RO - Rumeenia CSC PHARMACEUTICALS HANDELS GmbH Gewerbestrasse 18-20 Gewerbegebiet Klein-Engersdorf A-2102 Bisamberg Austria
EL - Greece DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
EL - Kreeka DEMO ABEE 21ST Km National Highway Athens-Lamia 14565 Greece
CY - Cyprus CODAL SYNTO LTD 33 Thekla Lysioti str.
CY - Küpros CODAL SYNTO LTD 33 Thekla Lysioti str.
BG - Bulgaria Zentiva k.s.
BG - Bulgaaria Zentiva k.s.
EL - Greece FARMILIA E.E.
EL - Kreeka FARMILIA E.E.
EL - Greece RAFARM AEBE Korintou 12
EL - Kreeka RAFARM AEBE Korintou 12
EL - Greece S.J.A.
EL - Kreeka S.J.A.
EL - Greece HELP ABEE Valaoritou 10
EL - Kreeka HELP ABEE Valaoritou 10
EL - Greece KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
EL - Kreeka KLEVA EPE Parnithos Avenue 189 Aharnai Attikis 13671 Greece
EL - Greece BROS EPE Avgis & Gallinis 15
EL - Kreeka BROS EPE Avgis & Gallinis 15
RO - Romania Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
RO - Rumeenia Zentiva k.s., U kabelovny 130, Dolní Měcholupy 102 37, Praha 10, Czech Republic
EL - Greece BIOMEDICA-CHEMICA A.E. G. Lyra 25
EL - Kreeka BIOMEDICA-CHEMICA A.E. G. Lyra 25
EL - Greece FARMANIC CHEMIPHARMA S.A. Fylis 137
EL - Kreeka FARMANIC CHEMIPHARMA S.A. Fylis 137
EL - Greece VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
EL - Kreeka VELKA HELLAS AEBE Kapodistriou & Korinthou 12 Neo Psychiko 15451
CY - Cyprus CDL PHARMACEUTICAL LTD 5 Diomedous str.
CY - Küpros CDL PHARMACEUTICAL LTD 5 Diomedous str.
RO - Romania Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
RO - Rumeenia Dr. REDDY'S LABORATORIES ROMÂNIA S.R.L, Str. Nicolae Caramfil nr. 71-73, et. 5 spaţiul 10, sector 1, Bucureşti
EL - Greece BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
EL - Kreeka BOEHRINGER INGELHEIM HELLAS S.A. Ellinikou 2
EL - Greece VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
EL - Kreeka VIOFAR EPE Ethnikis Antistaseos & Trifyllias Aharnai 13671
RO - Romania S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
RO - Rumeenia S.C. LABORMED PHARMA S.A. B-dul Theodor Pallady nr. 44B sector 3, Bucuresti
EL - Greece MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
EL - Kreeka MEDARTE PHARMACEUTICLS ABEE Spyrou Vretou 10
EL - Greece VOCATE PHARMAKEFTIKI A.E. Gounari 150
EL - Kreeka VOCATE PHARMAKEFTIKI A.E. Gounari 150
EL - Greece BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
EL - Kreeka BALU EPE 30 Km Athens-Lavrion Markopoulo 19003
EL - Greece NORMA HELLAS A.E. Menandrou 54
EL - Kreeka NORMA HELLAS A.E. Menandrou 54
EL - Greece REMEK PHARMACEUTICALS ABEE Pentelis 34
EL - Kreeka REMEK PHARMACEUTICALS ABEE Pentelis 34
EL - Greece ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
EL - Kreeka ELPEN A.E. PHARMACEUTICAL INDUSTRY, Marathonos Avenue 95
EL - Greece PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
EL - Kreeka PHARMATHEN INTERNATIONAL S.A. GREECE, Dervenakion 4
EL - Greece PHARMACYPRIA HELLAS A.E. Paster 6
EL - Kreeka PHARMACYPRIA HELLAS A.E. Paster 6
EL - Greece MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
EL - Kreeka MEDICHROM A.E. 6 Km Markopoulou-Koropi Avenue Markopoulo Mesogeion 19003 Greece
EL - Greece MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
EL - Kreeka MINERVA PHARMAKEFTIKI A.E. Kifissou Avenue 132
SK - Slovakia Medicom International s.r.o.
SK - Slovakkia Medicom International s.r.o.
AULIN, granule pentru suspensie orală, 100 mg/plic mg/sachet
AULIN, granule pentru suspensie orală, 100 mg/plic
EL - Greece FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
EL - Kreeka FINIXFARM EPE Dervenakion 38 & Sahini Gerakas 15344
EL - Greece ARMEDICA A.E. Agias Markellis 17
EL - Kreeka ARMEDICA A.E. Agias Markellis 17
50 MG/5ML Oral suspension Oral use
50 MG/5ML Suukaudne suspensioon
RO - Romania S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
RO - Rumeenia S.C. SLAVIA PHARM SRL Str. Ştirbei Vodă nr. 53-55 sector 1, Bucureşti
EL - Greece REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
EL - Kreeka REMEDINA ABEE Gounari 25 & Areos Kamatero Attikis 13451
EL - Greece LAVIPHARM HELLAS A.E. Agias Marinas
EL - Kreeka LAVIPHARM HELLAS A.E. Agias Marinas
LT - Lithuania Zentiva k.s.
LT - Leedu Zentiva k.s.
ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
RO - Rumeenia S.C. ARENA GROUP S.A. Str. Ştefan Mihăileanu, Nr. 31, Sector 2, Bucureşti,
BG - Bulgaria Actavis EAD 29 Atanas Dukov str. Sofia 1407
BG - Bulgaaria Actavis EAD 29 Atanas Dukov str.
EL - Greece BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
EL - Kreeka BIOSPRAY ABEE 18TH Km Marathonos Avenue Pallini 15344
PL - Poland Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5,
Pabianickie Zakłady Farmaceutyczne Polfa S.A. Marszałka J. Piłsudskiego 5, 95-200 Pabianice
LT - Lithuania Medochemie Ltd. P.O.
LT - Leedu Medochemie Ltd. P.O.
FR - France EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A
EG LABO - Laboratoires EuroGenerics "Le Quintet" - Bâtiment A 12, rue Danjou
EL - Greece ANFARM HELLAS S.A. Perikleous 53-57
EL - Kreeka ANFARM HELLAS S.A. Perikleous 53-57
EL - Greece FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
EL - Kreeka FARMEDIA A.E. Athinas 22 & Apollonos Gerakas Attikis 15344
EL - Greece GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
EL - Kreeka GENEPHARM A.E. 18th Km Marathonos Avenue Pallini Attikis 15351
RO - Romania ANFARM HELLAS S.A. Perikleous 53-57
RO - Rumeenia ANFARM HELLAS S.A. Perikleous 53-57
SK - Slovakia Laboratori Guidotti S.p.A.
SK - Slovakkia Laboratori Guidotti S.p.A.
BG - Bulgaria Laboratori Guidotti S.p.A.
BG - Bulgaaria Laboratori Guidotti S.p.A.
Italfarmaco S.p.A. Viale Fulvio Testi, 330 20126 Milano Italy
Viale Fulvio Testi, 330 20126 Milano Italy
NIMESIL, granule pentru suspensie orală, 100 mg mg/sachet
NIMESIL, granule pentru suspensie orală, 100 mg
MG/SACHET
MG/SUPOSIIT
EL - Greece COUP ABEE Agias Varvaras 53-55 Dafni, Athens 17235
EL - Kreeka COUP ABEE Agias Varvaras 53-55
ES - Spain HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
ES - Hispaania HELSINN BIREX PHARMACEUTICALS LTD. Damastown Mulhuddart
LT - Lithuania Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
LT - Leedu Helsinn Birex Pharmaceuticals Ltd. Damastown Mulhuddart
LT - Lithuania Laboratori Guidotti S.p.A.
LT - Leedu Laboratori Guidotti S.p.A.
Hungary
HU - Ungari
Rua João deDeus,19 Venda Nova
Rua João deDeus,19 Venda Nova 2700-487 Amadora Portugal
PL - Poland Laboratori Guidotti S.p.A. (Menarini Group) Via Livornese 897
(Menarini Group) Via Livornese 897
Orodispersible tablet Oral use
Suukaudse suspensiooni pulber
100mg/sachet Granules for oral suspension
100 mg/kotike Suukaudse suspensiooni graanulid
HU - Hungary Lab. Guidotti S.p.A.
Lab. Guidotti S.p.A.
The warnings are appropriate.
Nimetatud hoiatused on asjakohased.
The active substance is well known and is included in veterinary medicinal products currently authorised in the EU.
Toimeaine on hästi tuntud ja kuulub praegu ELis lubatud veterinaarravimite hulka.
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.
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.
Efficacy was not assessed in this referral procedure.
Käesolevas esildismenetluses efektiivsust ei hinnatud.
No additional studies were carried out in order to further refine the risk as guidance in this area is not currently available.
Täiendavaid uuringuid riskide täpsustamiseks läbi ei viidud, sest hetkel ei ole selles valdkonnas kättesaadavaid suuniseid.
The benefit-risk for the products can be considered to be positive.
Ravimite kasulikkuse ja riski tasakaalu võib pidada positiivseks.
The ERA was complete in terms of data requirements and quality of data.
Keskkonnaohu hindamine oli andmenõuete ja andmete kvaliteedi poolest täielik.
Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany and the Netherlands.
Arvestades esitatud andmeid, tegi komitee Saksamaalt ja Madalmaadelt saadud teatises tõstatatud küsimuste kohta järgmised järeldused.
The use of the products was not expected to pose a risk for soil, groundwater and surface water.
Ravimite kasutamine eeldatavasti ei tekita riski mullale, põhjaveele ja pinnaveele.
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.
Kvaliteeti, sihtloomade ohutust, kasutajate ohutust ja ravimijääke kõnealuses esildismenetluses ei hinnatud, sest viiteliikmesriik ei teatanud asjaomastest kahtlustest.
Risk management or mitigation measures
Riskijuhtimise või riskivähendusmeetmed
Using these data PNECs were derived using the appropriate assessment factors.
Kasutades neid andmeid, saadi nõuetekohaseid hindamistegureid kasutades PNECväärtused.