FrancophonIA/ELRC3.0 huggingface dataset:
English: EQUEST GEL ORAL 18,92 mg/g
Slovenian: EQUEST GEL ORAL 18,92 mg/g moksidektin peroralni gel
English: Cydectin TriclaMox 5 mg/ml + 200 mg/ml kožni poliv, raztopina za govedo
Slovenian: Cydectin TriclaMox 5 mg/ml + 200 mg/ml kožni poliv, raztopina za govedo moksidektin, triklabendazol kožni poliv, raztopina
English: Pramoxiquest Oral Gel for Horses and Ponies
Slovenian: Pramoxiquest Oral Gel for Horses and Ponies moksidektin, prazikantel peroralni gel
English: In cattle, topical administration of the pour-on combination products (moxidectin in combination with triclabendazole) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, trematode (fluke) and certain arthropod infestations.
Slovenian: Pri govedu je topična uporaba kombiniranih zdravil v obliki kožnega poliva (moksidektin v kombinaciji s triklabendazolom) namenjena za zdravljenje glist v prebavilih, glist v dihalih, trematodov (metljajev) in določenih infestacij s členonožci.
English: A. For veterinary medicinal products listed in Annex I as pour-on solution and administered to cattle containing 5 mg moxidectin per ml or 5 mg moxidectin and 200 mg triclabendazole per ml
Slovenian: A. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki kožnega poliva, raztopine, za dajanje govedu, in vsebujejo 5 mg moksidektina na ml ali 5 mg moksidektina in 200 mg triklabendazola na ml
English: Equimoxectin 18,92 mg/g
Slovenian: Equimoxectin 18,92 mg/g moksidektin peroralni gel
English: 15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link authorisation holders concluded that exposure of surface water to moxidectin is unlikely or extremely low.
Slovenian: 15 OECD guideline for the testing of chemicals no. 222: Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei) - link
English: C. For veterinary medicinal products listed in Annex I as oral solution and administered to sheep containing 1 mg moxidectin per ml or 1 mg moxidectin and 50 mg triclabendazole per ml
Slovenian: C. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki peroralne raztopine, za dajanje ovcam, in vsebujejo 1 mg moksidektina na ml ali 1 mg moksidektina in 50 mg triklabendazola na ml
English: For the assessment of the potential for bioaccumulation, one GLP compliant laboratory study was provided.
Slovenian: V zvezi z oceno kopičenja v organizmih je bila predložena ena laboratorijska študija, skladna z dobro laboratorijsko prakso.
English: Persistence
Slovenian: Obstojnost
English: Grounds for amendment of the summaries of product characteristics, labelling and package leaflets
Slovenian: Podlaga za dopolnilo povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo
English: EQUEST 18,92 mg/g peroralni gel za konje in ponije
Slovenian: EQUEST 18,92 mg/g peroralni gel za konje in ponije moksidektin peroralni gel
English: Equest 18,92 mg/g perorální gel
Slovenian: Equest 18,92 mg/g perorální gel moksidektin peroralni gel
English: EQUEST GEL ORALE Moxidectin Oral gel
Slovenian: Equest Gel Oral moksidektin peroralni gel
English: Iceland Zoetis Finland Oy Tietokuja 4
Slovenian: Islandija Zoetis Finland Oy Tietokuja 4
English: Equest 18.92 mg/g gel oral chevaux, poneys
Slovenian: Equest 18.92 mg/g gel oral chevaux, poneys moksidektin peroralni gel
English: Cattle
Slovenian: PARA GANADO VACUNO
English: 19,5 mg/g 121,7 mg/g
Slovenian: 19,5 mg/g 121,7 mg/g konji
English: D. For veterinary medicinal products listed in Annex I as solution for injection and administered to sheep containing 10 mg moxidectin per ml or 20 mg moxidectin per ml
Slovenian: D. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki raztopine za injiciranje, za dajanje ovcam, in vsebujejo 10 mg moksidektina na ml ali 20 mg moksidektina na ml
English: In sheep, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, larvae of bot fly and mange mites.
Slovenian: Pri ovcah je subkutana uporaba zdravil za injiciranje namenjena za zdravljenje in preprečevanje glist v prebavilih, glist v dihalih, ličink nosnih zoljev in govejih srbcev.
English: EQUEST 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
Slovenian: EQUEST 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys moksidektin peroralni gel
English: In sheep, oral administration of the monoproducts is intended for the treatment and prevention of gastro-intestinal nematodes and respiratory tract nematodes.
Slovenian: Pri ovcah je peroralna uporaba zdravil z eno samo učinkovino namenjena za zdravljenje in preprečevanje glist v prebavilih in glist v dihalih.
English: In sheep, oral administration of the combination products is intended for the treatment of gastrointestinal nematodes, respiratory tract nematodes and trematode (fluke) infestations.
Slovenian: Pri ovcah je peroralna uporaba kombiniranih zdravil namenjena za zdravljenje glist v prebavilih, glist v dihalih in infestacij s trematodi (metljaji).
English: EQUEST PRAMOX, geriamasis gelis
Slovenian: EQUEST PRAMOX, geriamasis gelis moksidektin, prazikantel peroralni gel
English: In cattle, subcutaneous administration of the injectable products is intended for the treatment and prevention of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice and mange mites.
Slovenian: Pri govedu je subkutana uporaba zdravil za injiciranje namenjena za zdravljenje in preprečevanje glist v prebavilih, glist v dihalih, govejih zoljev, uši in govejih srbcev.
English: Zermex 0.1% w/v Oral Solution for Sheep
Slovenian: Zermex 0.1% w/v Oral Solution for Sheep moksidektin peroralna raztopina ovce
English: EQUIMOXECTIN 18,92 mg/g gel oral para equino y ponis
Slovenian: EQUIMOXECTIN 18,92 mg/g gel oral para equino y ponis moksidektin peroralni gel
English: Cydectin 0.1% sol orale ovins
Slovenian: Cydectin 0.1% sol orale ovins moksidektin peroralna raztopina ovce
English: CYDECTIN 2% sheep Moxidectin Solution for injection
Slovenian: CYDECTIN 2% sheep moksidektin raztopina za injiciranje ovce subkutano
English: B. For veterinary medicinal products listed in Annex I as solution for injection and administered to cattle containing 10 mg moxidectin per ml or 100 mg moxidectin per ml
Slovenian: B. Za zdravila za uporabo v veterinarski medicini, navedena v Prilogi I, ki so v obliki raztopine za injiciranje, za dajanje govedu, in vsebujejo 10 mg moksidektina na ml ali 100 mg moksidektina na ml
English: Romania Zoetis Belgium SA Rue Laid Burniat, 1
Slovenian: Romunija Zoetis Belgium SA Rue Laid Burniat, 1
English: Two GLP compliant studies on algae were performed in accordance with OECD guideline no. 2015.
Slovenian: Na algah sta bili opravljeni dve študiji, skladni z dobro laboratorijsko prakso in smernico OECD št.
English: Equest Pramox perorální gel
Slovenian: Equest Pramox perorální gel moksidektin prazikantel peroralni gel
English: Luxemburg Zoetis Belgium SA Rue Laid Burniat, 1
Slovenian: Luksemburg Zoetis Belgium SA Rue Laid Burniat, 1
English: Slovenia Zoetis Belgium SA Rue Laid Burniat, 1
Slovenian: Slovenija Zoetis Belgium SA Rue Laid Burniat, 1
English: The non-standard field studies indicated that the risk derived from laboratory tests may not fully reflect what is observed under field conditions of use; differences were shown in sensitivity of dung beetle and dung fly and additionally a lower toxicity of moxidectin compared to other avermectins.
Slovenian: Dokazali so razlike v občutljivosti iztrebkarja in jesenske muhe ter dodatno manjšo strupenost moksidektina v primerjavi z drugimi avermektini.
English: Equipramox perorální gel
Slovenian: Equimoxectin moksidektin peroralni gel
English: Slovenia Continental Farmaceutica, Rue Laid Burniat 1,
Slovenian: Slovenija Continental Farmaceutica, Rue Laid Burniat 1,
English: Zermex 1% w/v Solution for Injection for Sheep
Slovenian: Zermex 1% w/v Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
English: PECsurfacewater run-off (ng/l) 0.239 (cattle, solution for injection containing 100 mg moxidectin per ml)
Slovenian: PECtla_konstantna_vrednost (ng/kg) 3 690 (govedo, raztopina za injiciranje, ki vsebuje 100 mg moksidektina na ml)
English: Dung fauna
Slovenian: Organizmi v gnoju
English: CYDECTIN 5 mg/ml POUR-ON - Lösung zum Übergießen für Rinder
Slovenian: CYDECTIN 5 mg/ml POUR-ON - Lösung zum Übergießen für Rinder moksidektin kožni poliv, raztopina govedo topično - na hrbet živali
English: Zermex 100 mg/ml LA Solution for Injection for Cattle
Slovenian: Zermex 100 mg/ml LA Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
English: Equest orale gel, 18,92 mg/g, orale gel voor paarden en pony's
Slovenian: Equest orale gel, 18,92 mg/g, orale gel voor paarden en pony's moksidektin peroralni gel
English: EQUEST PRAMOX perorálny gél
Slovenian: EQUEST PRAMOX perorálny gél moksidektin, prazikantel peroralni gel
English: EQUIMOXECTIN 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys
Slovenian: EQUIMOXECTIN 18,92 mg/g, Gel zum Eingeben für Pferde und Ponys moksidektin peroralni gel
English: CYDECTIN LA Cattle Moxidectin Solution for injection
Slovenian: CYDECTIN LA Cattle moksidektin raztopina za injiciranje govedo subkutano
English: Moxiquest 18.92 mg/g Oral Gel for Horses & Ponies
Slovenian: Moxiquest 18.92 mg/g Oral Gel for Horses & Ponies moksidektin peroralni gel
English: CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link OECD guideline for the testing of chemicals no. 201: Freshwater Alga and Cyanobacteria, Growth Inhibition Test - link OECD guideline for the testing of chemicals no. 202: Daphnia sp.
Slovenian: 4 CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - EMA/CVMP/ERA/418282/2005-Rev.1- Corr. - link lahko uporabi le kot podporna informacija, vendar ni del ocene obstojnosti, kopičenja v organizmih in strupenosti.
English: Following treatment of horses with the product, levels of moxidectin that are potentially toxic to dung beetles and flies may be excreted over a period of more than 1 week and may decrease dung fauna abundance.
Slovenian: Po zdravljenju konjev s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho in iztrebkarja, lahko izločajo več kot 1 teden in v tem obdobju lahko zmanjšajo številčnost organizmov v gnoju.
English: In cattle, topical administration of the pour-on monoproducts (moxidectin only) is intended for the treatment of gastro-intestinal nematodes, respiratory tract nematodes, warble grubs, lice, mange mites and horn flies.
Slovenian: Pri govedu je topična uporaba zdravil v obliki kožnega poliva z eno samo zdravilno učinkovino (samo moksidektinom) namenjena za zdravljenje glist v prebavilih, glist v dihalih, govejih zoljev, uši, govejih srbcev in rogovih muh.
English: Iceland Continental Farmaceutica Rue Laid Burniat 1,
Slovenian: Islandija Continental Farmaceutica Rue Laid Burniat 1,
English: Moxidectin, triclabendazole
Slovenian: Cydectin TriclaMox moksidektin, triklabendazol peroralna raztopina
English: EQUEST GEL ORAL 18,92 mg/g, gel oral para caballos y ponis
Slovenian: EQUEST GEL ORAL 18,92 mg/g, gel oral para caballos y ponis moksidektin peroralni gel
English: 18,92 mg Horse and pony
Slovenian: 18,92 mg konji in poniji
English: Based on the excretion profile of moxidectin when administered as the oral formulation to sheep, treated animals should not have access to watercourses during the first 3 days after treatment.
Slovenian: Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki peroralne formulacije pri ovcah, zdravljene živali v prvih 3 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
English: Based on the excretion profile of moxidectin when administered as the injectable formulation to sheep, treated animals should not have access to watercourses during the first 11 days after treatment.
Slovenian: Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije z injiciranjem pri ovcah, zdravljene živali v prvih 11 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
English: Dung flies were shown to be the most sensitive species as demonstrated in laboratory tests and in field studies.
Slovenian: Kot so pokazali laboratorijski testi in terenske študije, je bila jesenska muha najobčutljivejša vrsta.
English: Slovakia
Slovenian: Litva
English: Topical - on the back of the animal
Slovenian: moksidektin kožni poliv, raztopina govedo topično - na hrbet živali
English: Zermex 20 mg/ml LA Solution for Injection for Sheep
Slovenian: Zermex 20 mg/ml LA Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
English: Moxidectin triclabendazole
Slovenian: moksidektin triklabendazol peroralna raztopina
English: Equest Oral Gel 18.92 mg/g Oral Gel for Horses and Ponies
Slovenian: Equest Oral Gel 18.92 mg/g Oral Gel for Horses and Ponies moksidektin peroralni gel
English: Equest Pramox 19,5 mg/g + 121,7 mg/g peroralni gel
Slovenian: Equest Pramox 19,5 mg/g + 121,7 mg/g moksidektin prazikantel peroralni gel
English: Symec 1 mg/ml oral solution for sheep
Slovenian: Symec 1 mg/ml oral solution for sheep moksidektin peroralna raztopina ovce
English: Moxodectin 1 mg/ml oral solution for sheep
Slovenian: Moxodectin 1 mg/ml oral solution for sheep moksidektin peroralna raztopina ovce
English: Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the 10 days after treatment.
Slovenian: Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije za injiciranje, zdravljene živali v 10 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
English: Belgium Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
Slovenian: Zoetis Belgium SA Rue Laid Burniat 1, 1348 Louvain-la-Neuve Belgium
English: EQUEST GEL ORAL, 18,92 mg/g, gel oral para cavalos e póneis
Slovenian: EQUEST GEL ORAL, 18,92 mg/g, gel oral para cavalos e póneis moksidektin peroralni gel
English: Based on the excretion profile of moxidectin when administered as the injectable formulation, treated animals should not have access to watercourses during the first 10 days after treatment.
Slovenian: Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki formulacije za injiciranje, zdravljene živali v prvih 10 dneh po zdravljenju ne smejo imeti dostopa do vodotokov.
English: Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.
Slovenian: Na podlagi profila izločanja moksidektina, kadar se uporablja v obliki kožnega poliva, zdravljene živali v prvem tednu po zdravljenju ne smejo imeti dostopa do vodotokov.
English: EQUEST ORAL GEL, 18.92 mg/g, oral gel for horses and ponies
Slovenian: EQUEST ORAL GEL, 18.92 mg/g, oral gel for horses and ponies moksidektin peroralni gel
English: EQUEST PRAMOX 19,5 mg/g + 121,7 mg/g Gel zum Eingeben für Pferde
Slovenian: EQUEST PRAMOX 19,5 mg/g + 121,7 mg/g Gel zum Eingeben für Pferde moksidektin, prazikantel peroralni gel
English: Cydectin 0,1% w/v orale oplossing voor schapen
Slovenian: Cydectin 0,1% w/v orale oplossing voor schapen moksidektin peroralna raztopina ovce
English: Equimoxectin 18,92 mg/g orale gel voor paarden en ponies
Slovenian: Equimoxectin 18,92 mg/g orale gel voor paarden en ponies moksidektin peroralni gel
English: *-PEC calculation for direct excretion by sheep is not necessary as per CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-Rev.1) but was calculated by a marketing authorisation holder to cover every possible scenario.
Slovenian: (EMEA/CVMP/ERA/418282/2005-Rev.1) ni potrebno, vendar jo je imetnik dovoljenja za promet z zdravilom izračunal, da bi vključil vsak možen scenarij.
English: Equipramox 19,5 mg/g + 121,7 mg/g peroralni gel
Slovenian: Equipramox 19,5 mg/g + 121,7 mg/g moksidektin prazikantel peroralni gel
English: Cydectin 0.1% w/v Oral Solution for Sheep
Slovenian: Cydectin 0.1% w/v Oral Solution for Sheep moksidektin peroralna raztopina ovce
English: Moxigro 1 mg/ml Oral Solution for Sheep
Slovenian: Moxigro 1 mg/ml Oral Solution for Sheep moksidektin peroralna raztopina ovce
English: Equipramox 19,5 mg/g +121,7 mg/g Gel zum Eingeben für Pferde
Slovenian: Equipramox 19,5 mg/g +121,7 mg/g Gel zum Eingeben für Pferde moksidektin, prazikantel peroralni gel
English: Subcutaneous
Slovenian: Strupenost
English: Moxidectin praziquantel
Slovenian: Equipramox moksidektin prazikantel peroralni gel
English: The CVMP considered that assessment of secondary poisoning can only be used as supportiveinformation but is not part of the PBT assessment.
Slovenian: Odbor CMVP je presodil, da se ocena sekundarne zastrupitve
English: Equipramox perorálny gél
Slovenian: Equipramox perorálny gél moksidektin, prazikantel peroralni gel
English: Cydectin 1% w/v Solution for Injection for Sheep
Slovenian: Cydectin 1% w/v Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
English: 18,92 mg/g Horse and Pony
Slovenian: 18.92 mg/g konji in poniji
English: CYDECTIN 1% Moxidectin Solution for injection
Slovenian: Cydectin 1% Injektionslösung moksidektin raztopina za injiciranje govedo subkutano
English: CYDECTIN 10% LA Moxidectin Solution for injection
Slovenian: Cydectin 10% LA Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
English: Moxidectin, praziquantel
Slovenian: Equipramox moksidektin, prazikantel peroralni gel
English: The first study with the common carp (Cyprinus carpio), was performed in accordance with OECD guideline no. 2039 and a LC50 value for moxidectin was established as 0.11 µg/l based on geometric mean of measured test concentrations.
Slovenian: Koncentracija brez opaženega učinka (NOEC) je bila določena kot ≥ 0,11 mg/l na podlagi geometrične srednje vrednosti izmerjenih testnih koncentracij.
English: 5 mg/ml 200 mg/ml
Slovenian: 1 mg/ml 50 mg/ml ovce
English: Cydectin 20 mg/ml LA Solution for Injection for Sheep
Slovenian: Cydectin 20 mg/ml LA Solution for Injection for Sheep moksidektin raztopina za injiciranje ovce subkutano
English: Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of 4 days and may decrease dung fly abundance during that period.
Slovenian: Po zdravljenju ovc s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 dni in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
English: EQUIPRAMOX 19,5 mg/g + 121,7 mg/g, geriamasis gelis
Slovenian: EQUIPRAMOX 19,5 mg/g + 121,7 mg/g, geriamasis gelis moksidektin, prazikantel peroralni gel
English: Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel
Slovenian: Equest Pramox 19.5 mg/g + 121.7 mg/g Oral Gel moksidektin peroralni gel
English: Lithuania Continental Farmaceutica Rue Laid Burniat 1,
Slovenian: Slovaška Continental Farmaceutica Rue Laid Burniat 1,
English: Sweden Zoetis Finland Oy Tietokuja 4
Slovenian: Norveška Zoetis Finland Oy Tietokuja 4
English: Following treatment of sheep with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Slovenian: Po zdravljenju ovc s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 tedne in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
English: 18,92 mg/g Horse and pony
Slovenian: 18,92 mg / g konji in poniji
English: Cydectin 1% w/v Injectable Solution for Sheep
Slovenian: Cydectin 1% w/v Injectable Solution for Sheep moksidektin raztopina za injiciranje ovce subkutano
English: Moxidectin, Praziquantel
Slovenian: moksidektin, prazikantel peroralni gel
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 2 weeks and may decrease dung fly abundance during that period.
Slovenian: Po zdravljenju goveda s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 2 tedna in lahko v tem obdobju zmanjšajo številčnost jesenske muhe.
English: Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period of more than 4 weeks and may decrease dung fly abundance during that period.
Slovenian: Po zdravljenju goveda s tem zdravilom se ravni moksidektina, ki so potencialno strupene za jesensko muho, lahko izločajo več kot 4 tedna in v tem obdobju lahko zmanjšajo številčnost jesenske muhe.
English: Sweden Continental Farmaceutica Rue Laid Burniat 1,
Slovenian: Norveška Continental Farmaceutica Rue Laid Burniat 1,
English: EQUEST PRAMOX 19,5 mg/g en 121,7 mg/g orale gel
Slovenian: EQUEST PRAMOX 19,5 mg/g en 121,7 mg/g orale gel moksidektin, prazikantel peroralni gel
English: Cydectin 1% w/v Solution for Injection for Cattle
Slovenian: Cydectin 1% w/v Solution for Injection for Cattle moksidektin raztopina za injiciranje govedo subkutano
English: Cydectin 0.1% orale Lösung für Schafe
Slovenian: Cydectin 0.1% orale Lösung für Schafe moksidektin peroralna suspenzija ovce
English: Belgium Continental Farmaceutica Rue Laid Burniat 1,
Slovenian: Nizozemska Continental Farmaceutica Rue Laid Burniat 1,
English: Denmark Continental Farmaceutica Rue Laid Burniat 1,
Slovenian: Madžarska Continental Farmaceutica Rue Laid Burniat 1,
English: Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies
Slovenian: Equimoxectin 18.92 mg/g, Oral Gel for Horses and Ponies moksidektin peroralni gel
English: Two GLP compliant studies on acute toxicity to daphnids were provided.
Slovenian: V zvezi z akutno strupenostjo za vodne bolhe sta bili predloženi dve študiji, skladni z dobro laboratorijsko prakso.
English: These measures will help to protect the environment.
Slovenian: Na ta način boste pomagali zaščiti okolje.
English: What Prevora is and what it is used for.
Slovenian: Kaj je Prevora in za kaj se uporablja.
English: Consequently, the signs and symptoms have not been identified.
Slovenian: Posledično, znaki in simptomi niso bili odkriti.
English: Detailed information on this medicinal product is available on the website of
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani
English: You may need to read it again.
Slovenian: Utegnete jih ponovno rabiti.
English: 4.8 Undesirable effects
Slovenian: 4.8 Nezaželeni učinki
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Slovenian: Po odločitvi Komisije bodo pristojni organi držav članic v povezavi z referenčno državo članico posodobili informacije o zdravilu skladno z zahtevami.
English: 5.3 Preclinical safety data Preclinical data reveal no special hazard for humans.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki ne kažejo nobenega posebnega tveganja za človeka.
English: Further information.
Slovenian: Dodatne informacije.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so nezaželeni učinki predstavljeni po padajoči resnosti.
English: Possible side effects.
Slovenian: Mogoči stranski učinki.
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Slovenian: ŠTEVILKA(E) DOVOLJENJA ZA PROMET Z ZDRAVILOM <[se izpolni na nacionalni ravni]>
English: This leaflet was last approved in
Slovenian: Ta navodila so bila nazadnje odobrena
English: 6.2 Incompatibilities
Slovenian: 6.2 Nekompatibilnosti