FrancophonIA/ELRC3.0 huggingface dataset:
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: Ivomec 10 mg/ml Injektionssuspensi on für Rinder, Schafe und Schweine
Slovenian: Ivomec 10 mg/ml Injektionssuspension für Rinder, Schafe und Schweine
English: Intervet International B.V. Wim de Korvrstraat 35, 5831 AA, Boxmeer, The Netherlands
Slovenian: Wim de Korvrstraat 35, 5831 AA, Boxmeer,
English: Discussion of specific issues raised in the referral notification
Slovenian: Razprava o specifičnih vprašanjih, zastavljenih med prijavo napotitvega postopka
English: VMD Animal Health Ltd. Közraktár u. 22/b.
Slovenian: Madžarska VMD Animal Health Ltd. Közraktár u. 22/b.
English: Of the formulation groups to which products were allocated in this procedure, two contained combination products; one with products containing the active substances ivermectin and clorsulon, and the second with products containing the active substances ivermectin and closantel.
Slovenian: Kombinirana zdravila so bila v dveh formulacijskih skupinah, v katere so bila zdravila razporejena v okviru tega postopka; v eni skupini so bila zdravila z zdravilnima učinkovinama ivermektin in klorsulon, v drugi skupini pa zdravila z zdravilnima učinkovinama ivermektin in klosantel.
English: the CVMP has recommended the amendment of the Marketing Authorisations for all injectable veterinary medicinal products containing ivermectin for use in cattle as refered in Annex I for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III.
Slovenian: CVMP priporoča dopolnilo dovoljenj za promet za vsa v Dodatku I navedena zdravila za injiciranje, ki vsebujejo ivermektin in se uporabljajo pri govedu ter imajo v Dodatku III opredeljene povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo.
English: A toxicological Acceptable Daily Intake (ADI) of 10 µg/kg bw/day (600 µg/person per day) was established based on the NOEL of 0.5 mg/kg bw/day retained from a 14-week dog study, applying a safety factor of 50.
Slovenian: Na podlagi odmerka brez opaznega učinka (NOEL) 0,5 mg/kg TM/dan, ugotovljenega v 14-tedenski študiji na psih, je bil z uporabo varnostnega faktorja 50 določen toksikološko sprejemljiv dnevni vnos (ADI) 10 µg/kg TM/dan (600 µg/osebo dnevno).
English: 4 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G.
Slovenian: Vet. Res. Comm. 9: 251-268 4 Wicks, S.R., Kaye, B., Weatherley, A.J., Lewis, D., Davison, E., Gibson, S.P., Smith, D.G.
English: 2.1 Calculation of a harmonised withdrawal period for ivermectin containing injectable products for use in cattle
Slovenian: 2.1 Izračun usklajene karence za zdravila za injiciranje, ki vsebujejo ivermektin, za uporabo pri govedu
English: Based on the 11 ivermectin residue depletion studies of adequate quality provided, the CVMP calculated the withdrawal periods for 12 products.
Slovenian: CVMP je na podlagi 11 predloženih študij izločanja ostankov ivermektina z zadostno kakovostjo izračunal karence za 12 zdravil.
English: B. For products listed in Annex I containing ivermectin as sole active ingredient or in combination with closantel:
Slovenian: B. Za zdravila iz Dodatka I, ki vsebujejo ivermektin kot edino zdravilno učinkovino ali v kombinaciji s klosantelom:
English: An attempt was made to find a correlation between the slopes or intercepts of the depletion curves and any of the following parameters: formulation group, bodyweight, breed, sex, age, and injection volume, using ANOVA or Pearson's methodology.
Slovenian: Z metodologijo ANOVA in Pearsonovo metodo so poskusili najti korelacijo med nakloni ali presečišči krivulj izločanja in katerim koli izmed naslednjih parametrov: formulacijsko skupino, telesno maso, pasmo, spolom, starostjo in injiciranim volumnom.
English: Therefore, a withdrawal period of at least 49 days will apply for the combination products in all cases.
Slovenian: Zato imajo kombinacijska zdravila v vseh primerih karenco najmanj 49 dni.
English: Slovak Republic Pharmagal spol.s.r.o.
Slovenian: Pharmagal spol.s.r.o.
English: • the CVMP considered that, taking into account the high variation observed, a single harmonised withdrawal period based on all available residue intake data should be established for all products concerned that contain ivermectin as the only active substance;
Slovenian: • CVMP je ob upoštevanju ugotovljene velike variacije menil, da je potrebno na podlagi vseh razpoložljivih podatkov o vnosu ostankov določiti enotno, usklajeno karenco za vsa zadevna zdravila, ki vsebujejo ivermektin kot edino zdravilno učinkovino.
English: Pharmacologically active substance
Slovenian: Farmakološka zdravilna učinkovina
English: Ganzestaartsedijk 8 - 5525 KC Duizel
Slovenian: Romunija PANTEX Ganzestaartsedijk 8 - 5525 KC Duizel The Netherlands
English: 3440 AB Woerden, The Netherlands
Slovenian: 3440 AB Woerden,
English: A safety span of 10% was considered appropriate as the studies were large and robust.
Slovenian: Ker so bile študije velike in robustne, se je za primernega štel 10-odstotni varnostni faktor.
English: Bayer Hungária Ltd. H-1123 Budapest Alkotás u. 50.
Slovenian: Madžarska Bayer Hungária Ltd. H-1123 Budapest
English: The harmonised withdrawal period of 49 days is relevant only to the ivermectin component of injectable products containing ivermectin.
Slovenian: Usklajena karenca v trajanju 49 dni velja le za ivermektinsko komponento zdravil za injiciranje.
English: Therefore, the Committee concluded that a harmonised withdrawal period of 49 days could be established for the ivermectin component of all injectable products containing ivermectin, for use in cattle.
Slovenian: Zato je Odbor zaključil, da se lahko za ivermektinsko komponento vseh zdravil za injiciranje z ivermektinom, ki se uporabljajo za govedo, določi usklajena karenca 49 dni.
English: Approach towards harmonisation of withdrawal periods http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf 2 CVMP Guideline on Injection Site Residues.
Slovenian: Pristop k usklajevanju karenc http://www.emea.europa.eu/pdfs/vet/swp/003695en.pdf
English: Box 78,
Slovenian: Mogilska 80,
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Czech Republic Bremer Pharma GmbH Cherbourger Str. 25
Slovenian: Romunija Bremer Pharma GmbH Cherbourger Str. 25
English: Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro Estrada de Albarraque 2710 - 335 Sintra Portugal
Slovenian: Portugalska Calier Portugal S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro
English: Invented name Strengths
Slovenian: Izmišljeno ime
English: Cattle: Meat and offal - 66 days.
Slovenian: Govedo: Meso in drobovina - 66 dni.
English: Since the withdrawal period calculated based on the clorsulon component for these product exceeds the 49 days derived for the ivermectin component, 66 days is recommended as the withdrawal period for the combination products containing ivermectin and clorsulon.
Slovenian: Ker karenca, izračunana za klorsulonsko komponento teh zdravil, presega 49-dnevno karenco, izpeljano za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klorsulonom določa karenca 66 dni.
English: ANNEX III AMENDMENT TO THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: DODATEK III DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO
English: AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas
Slovenian: Portugalska Merial Portuguesa - Saúde Animal, Lda AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas 2635-432 Rio de Mouro
English: BIOVET JSC 39 Petar Rakov Str. 4550 Pesthera Bulgaria
Slovenian: Bolgarija BIOVET JSC 39 Petar Rakov Str.
English: Alfasan International B.V., P.O.
Slovenian: Bolgarija Alfasan International B.V., P.O. Box 78,
English: For injectable veterinary medicinal products containing ivermectin in combination with another active substance residue depletion of the second active substance must also be considered, and a withdrawal period for the second active substance derived.
Slovenian: Pri zdravilih za injiciranje z ivermektinom v kombinaciji z drugo zdravilno učinkovino je potrebno upoštevati tudi izločanje zaostankov druge zdravilne učinkovine.
English: Marker residue Animal species MRLs
Slovenian: Živalska vrsta MRL Ciljna tkiva
English: If the withdrawal period determined on the basis of residue depletion data for the second active substance is less than 49 days, then a withdrawal period of 49 days is recommended for the product.
Slovenian: Če je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, krajša od 49 dni, se za zdravilo določi karenca v trajanju 49 dni.
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 4.11 Withdrawal period(s)
Slovenian: A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 4.11 Karenca(-e)
English: • the CVMP considered that for combination products containing ivermectin as well as a second active substance, residue depletion of the second active substance must also be considered when setting the withdrawal period and the withdrawal period for the product shall be the longest established for the individual components.
Slovenian: • CVMP je menil, da je treba pri določanju karence za kombinirana zdravila z ivermektinom in drugo zdravilno učinkovino upoštevati tudi izločanje ostankov druge zdravilne učinkovine in da je karenca za zdravilo daljša karenca, določena za posamezni komponenti.
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
Slovenian: Cross Vetpharm Group Ltd, Broomhill RoadTallaghtDublin 24Ireland
English: Cattle, Sheep, Goats, Pigs
Slovenian: Govedo, ovce, koze, prašiči
English: Closiver Injection Ivermectin 5 mg/ml, Closantel 125 mg/ml
Slovenian: Closiver Injection Ivermektin 5 mg/ml, klosantel 125 mg/ml
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients: 10.
Slovenian: A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon: 10.
English: Since this is below the 49 days limit applied for the ivermectin component, a withdrawal period of 49 days is recommended for the combination products containing ivermectin and closantel.
Slovenian: Ker je ta karenca krajša od mejnih 49 dni za ivermektinsko komponento, se za kombinirana zdravila z ivermektinom in klosantelom določa karenca 49 dni.
English: WITHDRAWAL PERIOD
Slovenian: Označevalec ostanka
English: A safety span of 30% was used in view of the large variation in the intake figures, which was primarily caused by the variation of residues found in injection sites.
Slovenian: Zaradi velike variacije vrednosti vnosa, ki je bila zlasti posledica variacije zaostankov na mestih injiciranja, so uporabili varnostni faktor 30 %.
English: DUTCH FARM VETERINARY PHARMACEUTICALS B.V.
Slovenian: Romunija DUTCH FARM VETERINARY PHARMACEUTICALS
English: If, on the other hand, the withdrawal period determined on the basis of residue depletion data for the second active substance is greater than 49 days, then the recommended withdrawal period for the product should be based on depletion of residues of the second active substance.
Slovenian: Če pa je karenca, določena na osnovi podatkov izločanja ostankov druge zdravilne učinkovine, daljša od 49 dni, se za zdravilo določi karenca na osnovi izločanja ostankov druge zdravilne učinkovine.
English: Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),
Slovenian: Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), Broomhill Road
English: Ivermectin 5 mg/ml, Closantel 125 mg/ml
Slovenian: Ivermektin 5 mg/ml, klosantel 125 mg/ml
English: Mogilska 80, 31546 Krakow Poland
Slovenian: 31546 Krakow
English: 2.2 Derivation of the withdrawal period for injectable veterinary medicinal products contains ivermectin as well as a second active substance (combination products)
Slovenian: 2.2 Izpeljava karence za zdravila v veterinarski medicini za injiciranje z ivermektinom ter drugo zdravilno učinkovino (kombinacijska zdravila)
English: Interchemie werken “de Adelaar” BV
Slovenian: Interchemie werken “de Adelaar” BV Horsterweg 26A
English: The Netherlands Dopharma Research B.V. Zalmweg 24
Slovenian: Nizozemska Dopharma Research B.V.
English: Gerbičeva 50, 1000 Ljubljana Slovenia
Slovenian: 1000 Ljubljana
English: A. For products listed in Annex I containing ivermectin and clorsulon as active ingredients:
Slovenian: A. Za zdravila iz Dodatka I, ki kot zdravilni učinkovini vsebujejo ivermektin in klorsulon:
English: Ivermectin
Slovenian: Ivermektin
English: Paramectin Injectie
Slovenian: Paramectin Injectável
English: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
Slovenian: Loughrea, Co. Galway, Ireland
English: DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.
Slovenian: Romunija DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. Jordan NA UR 11710 PO BOX 285
English: Other sources of variation connected to the subcutaneous use of ivermectin were therefore considered to be of more importance than formulation with regard to residue depletion and withdrawal periods.
Slovenian: Zato so glede izločanja zaostankov in karenc kot pomembnejše od formulacije šteli druge vire variacije, povezane s podkožno uporabo ivermektina.
English: INDUSTRIAL VETERINARIA, S.A.
Slovenian: Romunija FARMAVET S.A.
English: 5 Lifschitz, A., Virkel, G. Pis, A., Imperiale, F., Sanchez, S., Alvarez, L., Kujanek, R, Lanusse, C. (1999) Ivermectin disposition kinetics after subcutaneous and intramuscular administration of an oil-based formulation to cattle.
Slovenian: 49: 17-26 5 Lifschitz, A., Virkel, G. Pis, A., Imperiale, F., Sanchez, S., Alvarez, L., Kujanek, R, Lanusse, C. (1999)
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 66 days.
Slovenian: KARENCA Govedo: Meso in drobovina - 66 dni.
English: Bimeda (a division of Cross Vetpharm Group Limited) Broomhill Road Tallaght
Slovenian: Bimeda (a division of Cross Vetpharm Group Limited)
English: The Netherlands Chanelle Animal Health Ltd 7 Rodney Street
Slovenian: Nizozemska Chanelle Animal Health Ltd 7 Rodney Street
English: Centrovet Ltd.
Slovenian: Alstoe Ltd
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days
Slovenian: Govedo: Meso in drobovina - 49 dni
English: Cattle, Sheep, Reindeer, Pigs
Slovenian: Govedo, ovce, jeleni, prašiči
English: C/ Esmeralda, 19
Slovenian: INDUSTRIAL VETERINARIA, S.A. C/ Esmeralda, 19
English: The Netherlands Merial B.V. Kleermakerstraat 10
Slovenian: Kleermakerstraat 10
English: Baymec Trio 1% Ivermectin 10 mg/ml
Slovenian: Baymec Trio 1% Ivermektin 10 mg/ml
English: United Kingdom Chanelle Animal Health Ltd 7 Rodney Street
Slovenian: Portugalska Chanelle Animal Health Ltd 7 Rodney Street
English: Czech Republic Vétoquinol s.r.o., Zámečnícka 411,
Slovenian: Vétoquinol s.r.o., Zámečnícka 411, 288 02 Nymburk, Czech Republic
English: United Kingdom VIRBAC DE PORTUGAL Laboratorios LdaRua Dionísio Saraiva, Lote 1,
Slovenian: Portugalska VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1,
English: Belgium Laboratorios Calier SA Barcelones
Slovenian: Madžarska Laboratorios Calier SA Barcelones
English: Cattle, Reindeer, Pigs
Slovenian: Govedo, jeleni, prašiči
English: Wedemec R Ivermectin 10 mg/ml
Slovenian: Wedemec R Ivermektin 10 mg/ml
English: BOVIMEC B Ivermectin 10 mg/ml
Slovenian: BOVIMEC B Ivermektin 10 mg/ml
English: Diapec R Ivermectin 10 mg/ml
Slovenian: Diapec R Ivermektin 10 mg/ml
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE PACKAGE LEAFLET
Slovenian: DOPOLNILA, KI SE VKLJUČIJO V USTREZNA POGLAVJA NAVODIL ZA UPORABO
English: Slovak Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Slovenian: Slovenija MERIAL 29 avenue Tony Garnier 69007 LYON France
English: WITHDRAWAL PERIOD Cattle: Meat and offal - 49 days.
Slovenian: KARENCA Govedo: Meso in drobovina - 49 dni.
English: Subcutaneous Cattle, Sheep, Goats: 200 μg ivermectin/kg bw
Slovenian: Subkutana Govedo, ovce, koze: 200 μg ivermektina/kg TM
English: FROMMECTIN Ivermectin 10 mg/ml
Slovenian: FROMMECTIN Ivermektin 10 mg/ml
English: MAXIMEC Ivermectin 10 mg/ml
Slovenian: MAXIMEC Ivermektin 10 mg/ml
English: Subcutaneous 200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw
Slovenian: Subkutana 200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM
English: The Netherlands Cross Vetpharm Group Ltd, Broomhill Road
Slovenian: Nizozemska Cross Vetpharm Group Ltd, Broomhill Road
English: PROMECTINE Ivermectin 10 mg/ml
Slovenian: PROMECTINE Ivermektin 10 mg/ml
English: VETERMEC Ivermectin 10 mg/ml
Slovenian: VETERMEC Ivermektin 10 mg/ml
English: VALANEQ Ivermectin 10 mg/ml
Slovenian: VALANEQ Ivermektin 10 mg/ml
English: Ivotan LA Ivermectin 10 mg/ml
Slovenian: Ivotan LA Ivermektin 10 mg/ml
English: TIZOVAL Ivermectin 10 mg/ml
Slovenian: TIZOVAL Ivermektin 10 mg/ml
English: ECOMECTIN Ivermectin 10 mg/ml
Slovenian: ECOMECTIN Ivermektin 10 mg/ml
English: Czech Republic MERIAL 29 avenue Tony Garnier 69007 LYON
Slovenian: Romunija MERIAL 29 avenue Tony Garnier 69007 LYON France
English: Ivermektin S Ivermectin 10 mg/ml
Slovenian: Ivermektin S Ivermektin 10 mg/ml
English: Euromec Injectie Ivermectin 10 mg/ml
Slovenian: Euromec Injectie Ivermektin 10 mg/ml
English: Enovex Injection Ivermectin 10 mg/ml
Slovenian: Enovex Injection Ivermektin 10 mg/ml
English: Paramectin 1% Ivermectin 10 mg/ml
Slovenian: Paramectin 1% Ivermektin 10 mg/ml
English: Maximec Injectie Ivermectin 10 mg/ml
Slovenian: Maximec Injectie Ivermektin 10 mg/ml
English: IVERTIN Ivermectin 10 mg/ml
Slovenian: IVERTIN Ivermektin 10 mg/ml
English: Subcutaneous 200 μg ivermectin/kg bw, 5 mg closantel/kg bw
Slovenian: Subkutana 200 μg ivermektina/kg TM, 5 mg klosantela/kg TM
English: Subcutaneous Cattle, Sheep, Reindeer: 200 μg ivermectin/kg bw
Slovenian: Subkutana Govedo, ovce, jeleni: 200 μg ivermektina/kg TM
English: BOVECTIN Ivermectin 10 mg/ml
Slovenian: BOVECTIN Ivermektin 10 mg/ml
English: VIRBAMEC Ivermectin 10 mg/ml
Slovenian: VIRBAMEC Ivermektin 10 mg/ml
English: Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Slovenian: Ivermektin 10 mg/ml, klorsulon 100 mg/ml
English: BIMECTIN Ivermectin 10 mg/ml
Slovenian: BIMECTIN Ivermektin 10 mg/ml
English: Anisec Injection Ivermectin 10 mg/ml
Slovenian: Anisec Injection Ivermektin 10 mg/ml
English: United Kingdom Cross Vetpharm Group Ltd, Broomhill Road
Slovenian: Portugalska Cross Vetpharm Group Ltd, Broomhill Road
English: Alfamec 1 % Ivermectin 10 mg/ml
Slovenian: Alfamec 1 % Ivermektin 10 mg/ml
English: The withdrawal period for the product will be the longer of the withdrawal periods derived for the individual components.
Slovenian: Karenca za zdravilo je enaka daljši vrednosti od obeh karenc, sicer ugotovljeni za posamezni komponenti.
English: Ivomec 1% Ivermectin 10 mg/ml
Slovenian: Ivomec 1% Ivermektin 10 mg/ml
English: Biomectin 1% Ivermectin 10 mg/ml
Slovenian: Biomectin 1 % Ivermektin 10 mg/ml
English: Biomectin 1 % Ivermectin 10 mg/ml
Slovenian: Biomectin 1% Ivermektin 10 mg/ml
English: Iverktin Injection Ivermectin 10 mg/ml
Slovenian: Iverktin Injection Ivermektin 10 mg/ml
English: Virbamec F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Slovenian: Virbamec F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
English: Pandex 1% Ivermectin 10 mg/ml
Slovenian: Pandex 1% Ivermektin 10 mg/ml
English: The Netherlands Laboratorios Calier SA Barcelones
Slovenian: Nizozemska Laboratorios Calier SA Barcelones
English: IVOMEC F Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Slovenian: IVOMEC F Ivermektin 10 mg/ml, klorsulon 100 mg/ml
English: IVOMEC D Ivermectin 10 mg/ml, Clorsulon 100 mg/ml
Slovenian: IVOMEC D Ivermektin 10 mg/ml, klorsulon 100 mg/ml
English: Animec Injection Ivermectin 10 mg/ml
Slovenian: Animec Injection Ivermektin 10 mg/ml
English: Sumiject Injection Ivermectin 10 mg/ml
Slovenian: Sumiject Injection Ivermektin 10 mg/ml
English: Cevamec 1% Ivermectin 10 mg/ml
Slovenian: Cevamec 1% Ivermektin 10 mg/ml
English: Aniject Injection Ivermectin 10 mg/ml
Slovenian: Aniject Injection Ivermektin 10 mg/ml
English: Topimec Injection Ivermectin 10 mg/ml
Slovenian: Topimec Injection Ivermektin 10 mg/ml
English: Ecomectin 1% Ivermectin 10 mg/ml
Slovenian: Ecomectin 1 % Ivermektin 10 mg/ml
English: Ecomectin 1 % Ivermectin 10 mg/ml
Slovenian: Ecomectin 1% Ivermektin 10 mg/ml
English: Ivermectina 1% Ivermectin 10 mg/ml
Slovenian: Ivermectina 1% Ivermektin 10 mg/ml
English: Subcutaneous Cattle, Reindeer: 200 μg ivermectin/kg bw
Slovenian: Subkutana Govedo: 200 μg ivermektina/kg TM
English: Bimectin Injectie Ivermectin 10 mg/ml
Slovenian: Bimectin Injectie Ivermektin 10 mg/ml
English: Ivodad 1% Ivermectin 10 mg/ml
Slovenian: Ivodad 1% Ivermektin 10 mg/ml
English: Belgium Norbrook Laboratories Limited Station Works
Slovenian: Portugalska Norbrook Laboratories Limited Station Works
English: The Netherlands ECO Animal Health Ltd 78 Coombe Road
Slovenian: Nizozemska ECO Animal Health Ltd 78 Coombe Road
English: Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
Slovenian: VIRBAC DE PORTUGAL Laboratorios Lda Rua Dionísio Saraiva, Lote 1, 1° Andar, Sala 2,
English: Belgium ECO Animal Health Ltd 78 Coombe Road
Slovenian: Bolgarija ECO Animal Health Ltd 78 Coombe Road
English: IVERVETo 1 % Ivermectin 10 mg/ml
Slovenian: IVERVETo 1 % Ivermektin 10 mg/ml
English: Av.Los Cerrilos 602 Santiago,
Slovenian: Bolgarija Centrovet Ltd. Av.Los Cerrilos 602
English: Czech Republic ECO Animal Health Ltd 78 Coombe Road
Slovenian: Madžarska ECO Animal Health Ltd 78 Coombe Road
English: The Netherlands Norbrook Laboratories Limited Station Works
Slovenian: Nizozemska Norbrook Laboratories Limited Station Works
English: United Kingdom ECO Animal Health Ltd 78 Coombe Road
Slovenian: Romunija ECO Animal Health Ltd 78 Coombe Road
English: Jylamvo received a marketing authorisation valid throughout the EU on 29 March 2017.
Slovenian: Za zdravilo Jylamvo je bilo 29. marca 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: For inflammatory conditions it is taken once a week, on the same day each week.
Slovenian: Pri uporabi za vnetna stanja se jemlje enkrat tedensko, vedno na isti dan v tednu.
English: This especially affects fast-growing cells such as cancer cells.
Slovenian: To še zlasti vpliva na hitro rastoče celice, kot na primer rakave celice.
English: The doctor may check with the patient or the patient's carer that the medicine can reliably be taken once a week.
Slovenian: Zdravnik lahko pri bolniku ali njegovem skrbniku preveri, da se zdravilo zanesljivo jemlje enkrat tedensko.
English: Further information on Jylamvo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/jylamvo.
Slovenian: Nadaljnje informacije za zdravilo Jylamvo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/jylamvo.
English: What measures are being taken to ensure the safe and effective use of Jylamvo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jylamvo?
English: How often methotrexate is given depends on the other medicines it is used with.
Slovenian: Pogostost dajanja metotreksata je odvisna od drugih zdravil, s katerimi se uporablja.
English: The company provided data from the published literature on the benefits and risks of methotrexate in the approved uses.
Slovenian: Podjetje je predstavilo podatke iz objavljene literature o koristih in tveganjih metotreksata pri odobrenih uporabah.
English: It should be prescribed only by doctors with expertise in the use of methotrexate and a full understanding of the risks of methotrexate treatment.
Slovenian: Predpisovati bi ga morali le zdravniki s strokovnim znanjem na področju uporabe metotreksata in popolnim razumevanjem tveganj zdravljenja z metotreksatom.
English: Jylamvo (methotrexate)
Slovenian: Jylamvo (metotreksat)