FrancophonIA/ELRC3.0 huggingface dataset:
English: Macrogolglycerol hydroxystearate/Polyoxyl 40 hydrogenated castor oil: 40.5 mg/capsule.
Slovenian: Makrogolglicerol hidroksistearat: 40,5 mg na kapsulo.
English: Active herpes simplex infections should be allowed to clear before treatment with Sandimmun Neoral is initiated, but are not necessarily a reason for treatment withdrawal if they occur during therapy unless infection is severe.
Slovenian: Vendar pa le-te niso nujno razlog za ukinitev zdravila, če se pojavijo med zdravljenjem, razen če gre za hudo okužbo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA IN NALEPKA NA STEKLENICI
English: If you are not sure, talk to your doctor before taking Sandimmun Neoral.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Sandimmun Neoral posvetujte s svojim zdravnikom.
English: • Methotrexate.
Slovenian: Navodilo shranite.
English: Each capsule contains 100 mg of the active substance ciclosporin.
Slovenian: Ena kapsula vsebuje 100 mg zdravilne učinkovine ciklosporina.
English: Haemolytic uraemic syndrome, microangiopathic haemolytic anaemia
Slovenian: Zdravilo Sandimmun Neoral vsebuje makrogolglicerol hidroksistearat
English: Low doses of Sandimmun Neoral should be used to treat mild, chronic GVHD.
Slovenian: Bolnika s kronično blago reakcijo presadka proti prejemniku je treba zdraviti z nizkimi odmerki zdravila Sandimmun Neoral.
English: Hyperglycaemia, anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia Nervous system disorders
Slovenian: Bolezni kože in podkožja zelo pogosti hirzutizem pogosti akna, hipertrihoza občasni alergijski izpuščaji
English: Do not take Sandimmun Neoral and tell your doctor if the above applies to you.
Slovenian: Če zgornje velja za vas, ne jemljite zdravila Sandimmun Neoral, ampak to povejte svojemu zdravniku.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml contains 100 mg ciclosporin
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml vsebuje 100 mg ciklosporina.
English: • The other ingredients are: o Capsule content: alpha-tocopherol, ethanol anhydrous, propylene glycol, corn oil-monodi-triglycerides, macrogolglycerol hydroxystearate / polyoxyl 40 hydrogenated castor oil.
Slovenian: Vsebina kapsule alfa-tokoferol brezvodni etanol propilenglikol mono-di-trigliceridi koruznega olja makrogolglicerol hidroksistearat / polioksil 40 hidrogenirano ricinusovo olje
English: Do not take Sandimmun Neoral: - if you are allergic to ciclosporin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Sandimmun Neoral: - če ste alergični na ciklosporin ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - skupaj s pripravki, ki vsebujejo Hypericum perforatum (šentjanževko); - skupaj s pripravki, ki vsebujejo dabigatran eteksilat (za preprečevanje nastajanja krvnih strdkov po operaciji) ali bosentan oziroma aliskiren (za zniževanje visokega krvnega tlaka).
English: Imprint
Slovenian: Statin
English: The total dose each day is usually between 3 mg per kilogram of your body weight and 5 mg per kilogram body weight.
Slovenian: Huda oblika revmatoidnega artritisa - Celotni dnevni odmerek je običajno od 3 do 5 mg na kilogram telesne mase v dveh deljenih odmerkih.
English: disorientation, disturbance of vision, unconsciousness, sense of weakness in the limbs, impaired movements.
Slovenian: • simptomi možganskih okvar, ki lahko vključujejo nenadne epileptične napade, duševno zmedenost, nespečnost, dezorientiranost, motnje vida, nezavest, občutek šibkosti v okončinah, oteženo premikanje
English: 25 mg/ml powder for suspension for injection subcutaneous use vial (glass)
Slovenian: 25 mg/ml prašek za suspenzijo za injiciranje subkutana uporaba viala (steklo)
English: Treatments were given monthly for 6 months.
Slovenian: Zdravljenje je bilo izvedeno enkrat mesečno v šestih mesecih.
English: This means that it kills parasites like worms that live inside the body of animals.
Slovenian: To pomeni, da ubije zajedavce, kot so črvi, ki živijo v telesu živali.
English: Further information on Nexgard Spectra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
Slovenian: Nadaljnje informacije za zdravilo Nexgard Spectra so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
English: The most common side effects (affecting inbetween 1 to 10 animals in 1,000 animals) were vomiting, diarrhoea, lack of energy, decreased appetite, and itching, which generally were short-lived and resolved spontaneously.
Slovenian: Najpogostejši neželeni učinki (ki prizadenejo od 1 do 10 živali od 1 000) so bili bruhanje, driska, pomanjkanje energije, zmanjšan tek in srbenje, ki pa so bili na splošno kratkotrajni in so izzveneli sami od sebe.
English: The European Medicines Agency decided that Nexgard Spectra's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Nexgard Spectra večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Nexgard Spectra received a marketing authorisation valid throughout the EU on 15 January 2015.
Slovenian: Za zdravilo Nexgard Spectra je bilo 15. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: In the case of accidental ingestion, particularly in the case of children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Slovenian: V primeru nenamernega zaužitja, predvsem pri otrocih, nemudoma poiščite zdravniško pomoč in zdravniku pokažite navodilo za uporabo ali nalepko.
English: Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Slovenian: Ker se morajo bolhe in klopi začeti hraniti s krvjo psa, da bi jih zdravilo lahko uničilo, ni mogoče izključiti tveganja za prenos bolezni, s katerimi so ti zajedavci lahko okuženi.
English: The appropriate strength of tablets should be used according to the dog's weight.
Slovenian: Ustrezna jakost tablete se določi glede na telesno maso psa.
English: The effectiveness of Nexgard Spectra was investigated in both laboratory and field studies.
Slovenian: Učinkovitost zdravila Nexgard Spectra so proučevali v laboratorijskih in terenskih študijah.
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the carton.
Slovenian: Tablete je treba shranjevati v pretisnih omotih, dokler jih ne potrebujete, pretisne omote pa je treba shranjevati v škatli.
English: For prevention of lungworm disease, in areas where infection regularly occurs, and for prevention of eye worm, monthly treatment is given.
Slovenian: Za preprečevanje okužb s pljučno glisto na območjih, kjer se redno pojavlja, in za preprečevanje okužbe z očesnimi črvi, se izvaja mesečno zdravljenje.
English: After which, further flea and tick treatment should be continued with a monovalent product containing a single active substance.
Slovenian: Potem je treba zdravljenje nadaljevati z monovalentnim zdravilom, ki vsebuje samo eno učinkovino.
English: Nexgard Spectra (afoxolaner/milbemycin oxime)
Slovenian: Nexgard Spectra (afoksolaner/milbemicin oksim)
English: The active substances in Nexgard Spectra work by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the parasitic organism.
Slovenian: Učinkovine v zdravilu Nexgard Spectra delujejo tako, da ovirajo pot, po kateri potujejo signali med živčnimi celicami v živčnem sistemu zajedavcev, kar povzroči paralizo in pogin zajedavskih organizmov.
English: For more information about using Nexgard Spectra, see the package leaflet or contact your veterinarian or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Nexgard Spectra glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
English: A laboratory study involved 20 dogs artificially infected with lungworm larvae.
Slovenian: V laboratorijsko študijo je bilo vključenih 20 psov, namerno okuženih z ličinkami pljučne gliste.
English: Other information about Nexgard Spectra
Slovenian: Druge informacije o zdravilu Nexgard Spectra
English: Why is Nexgard Spectra authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Nexgard Spectra odobreno v EU?
English: Nexgard Spectra reduced the number of fleas and ticks by at least 95% and was at least as effective as pyriprole.
Slovenian: Zdravilo Nexgard Spectra je zmanjšalo število bolh in klopov za najmanj 95 % in je bilo vsaj tako učinkovito kot piriprol.
English: Milbemycin oxime acts as an ‘endoparasiticide'.
Slovenian: Milbemicin oksim deluje kot „endoparaziticid“.
English: Nexgard Spectra is available as chewable tablets in five different strengths for use in dogs of different weights.
Slovenian: Zdravilo Nexgard Spectra je na voljo v obliki žvečljivih tablet petih različnih jakosti, namenjenih za uporabo pri psih z različno telesno maso.
English: For demodectic mange, treatment should be repeated monthly until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) whereas for sarcoptic mange treatment is given monthly for two months, or longer based on clinical signs and skin scrapings.
Slovenian: Za zdravljenje garjavice vrste Demodex canis je treba zdravljenje ponavljati enkrat na mesec dokler garjavica ni uspešno odpravljena (kar se potrdi z dvema negativnima ostružkoma kože, vzetima z enomesečnim razmikom), medtem ko je treba pri garjavici vrste Sarcoptes scabiei zdravilo dajati v mesečnih presledkih dva meseca ali dlje, odvisno od kliničnih znakov in ostružkov kože.
English: The study showed that Nexgard Spectra was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Slovenian: Študija je pokazala, da je bilo zdravilo Nexgard Spectra učinkovito pri zdravljenju infestacij z bolhami in klopi pri psih do 30 dni po zdravljenju.
English: An overview of Nexgard Spectra and why it is authorised in the EU
Slovenian: Pregled zdravila Nexgard Spectra in zakaj je odobreno v EU
English: The study showed that Nexgard Spectra was effective in reducing gut worms and was at least as effective as the milbemycin oxime and praziquantel.
Slovenian: Študija je pokazala, da je bilo zdravilo Nexgard Spectra učinkovito pri zmanjševanju črevesnih zajedavcev in da je bilo vsaj tako učinkovito kot milbemicin oksim in prazikvantel.
English: Afoxolaner acts as an ‘ectoparasiticide'.
Slovenian: Afoksolaner deluje kot „ektoparaziticid“.
English: In a field study conducted at sites in Europe where cases of eye worm are known to exist, dogs were confirmed free of eye worm at the start of the study.
Slovenian: Na krajih v Evropi, kjer je znana prisotnost očesnega črva, so izvedli terensko študijo, v katero so bili vključeni psi, ki na začetku študije niso bili okuženi.
English: Ten dogs were given Nexgard Spectra and the other 10 were untreated.
Slovenian: Deset psov je nato prejelo zdravilo Nexgard Spectra, deset pa jih niso zdravili.
English: Flea and tick infestations
Slovenian: Infestacije z bolhami in klopi
English: What is Nexgard Spectra and what is it used for?
Slovenian: Kaj je zdravilo Nexgard Spectra in za kaj se uporablja?
English: Nexgard Spectra is a veterinary medicine used to treat infestations with fleas, ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs when prevention of heartworm disease (caused by a worm that infects the heart and blood vessels and is transmitted by mosquitoes), lungworm disease, eye worm and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required.
Slovenian: Nexgard Spectra je zdravilo za uporabo v veterinarski medicini za zdravljenje infestacij z bolhami in klopi ter garjavice vrste Demodex canis in Sarcoptes scabiei (kožne garjavosti, ki jo povzročata dve vrsti garjavcev) pri psih, kadar je treba tudi preprečiti okužbe s srčno glisto (ki jo povzroči glista, ki okuži srce in krvne žile in se prenaša s komarji), okužbe s pljučno glisto, okužbe z očesnimi črvi in/ali zdraviti črevesne zajedavce (trakulje, gliste, bičeglavce).
English: Nexgard Spectra reduced the number of live mites by 96% 56 days after starting treatment and by 98% 84 days after starting treatment.
Slovenian: Zdravilo Nexgard Spectra je v 56 dneh po začetku zdravljenja zmanjšalo število živih garjavcev za 96 %, 84 dni po začetku zdravljenja pa za 98 %.
English: What are the risks associated with Nexgard Spectra?
Slovenian: Kakšna tveganja so povezana z zdravilom Nexgard Spectra?
English: Thirty seven dogs were treated with Nexgard Spectra and 42 dogs were treated with afoxolaner alone, which has no action against eye worm.
Slovenian: Z zdravilom Nexgard Spectra so zdravili 37 psov, 42 psov pa je prejemalo samo afoksolaner, ki proti očesnim črvom ni učinkovit.
English: Nexgard Spectra reduced the number of live mites by 99% 28 days after starting treatment and by 100% 56 days after starting treatment.
Slovenian: Zdravilo Nexgard Spectra je v 28 dneh po začetku zdravljenja zmanjšalo število živih garjavcev za 99%, 56 dni po začetku zdravljenja pa za 100%.
English: What benefits of Nexgard Spectra have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Nexgard Spectra izkazalo v študijah?
English: Field studies involving 84 dogs in Japan and 320 dogs in the USA, none of which had heartworm before the treatment started, showed that Nexgard Spectra given monthly for six months prevented heartworm infection.
Slovenian: Terenske študije s 84 predhodno neokuženimi psi na Japonskem in 320 predhodno neokuženimi psi v ZDA so pokazale, da so bile okužbe s srčno glisto preprečene, če se je zdravilo Nexgard Spectra dajalo šest mesecev zapored enkrat mesečno.
English: For prevention of heartworm disease, treatment is given monthly during the mosquito season.
Slovenian: Za preprečevanje okužb s srčno glisto se zdravljenje izvaja vsak mesec v obdobju, ko so dejavni komarji.
English: Nexgard Spectra contains the active substances afoxolaner and milbemycin oxime.
Slovenian: Zdravilo Nexgard Spectra vsebuje učinkovini afoksolaner in milbemicin oksim.
English: In a field study, 408 dogs with gut worm infections were given either a single treatment with Nexgard Spectra or a medicine containing milbemycin oxime and praziquantel (another medicine for worms).
Slovenian: V terensko študijo glede črevesnih zajedavcev je bilo vključenih 408 psov, okuženih s črevesnimi zajedavci, ki so prejeli bodisi enojni odmerek zdravila Nexgard Spectra bodisi zdravilo, ki vsebuje milbemicin oksim in prazikvantel (drugo zdravilo proti črevesnim zajedavcem).
English: In a field study, 324 dogs with flea and/or tick infestations were given a single treatment with Nexgard Spectra or a spot-on medicine containing another active substance, pyriprole, that controls fleas and ticks.
Slovenian: V terenski študiji je 324 psov z infestacijami z bolhami in/ali klopi prejelo bodisi enojni odmerek zdravila Nexgard Spectra bodisi zdravilo za kožni nanos z učinkovino piriprol, ki nadzoruje število bolh in klopov.
English: How does Nexgard Spectra work?
Slovenian: Kako zdravilo Nexgard Spectra deluje?
English: All the dogs treated with Nexgard Spectra were free of eye worm at day 180 compared to 43% in the afoxolaner-treated group.
Slovenian: Po 180 dneh noben od psov, ki so prejemali zdravilo Nexgard Spectra, ni bil okužen z očesnim črvom, v primerjavi s 43 % v skupini, ki je prejemala samo afoksolaner.
English: In order to be exposed to afoxolaner, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Slovenian: Da bi bili bolhe in klopi izpostavljeni afoksolanerju, se morajo pritrditi na kožo in se začeti hraniti s krvjo psa. Afoksolaner ubije bolhe, preden izležejo jajčeca, s čimer pomaga zmanjšati kontaminacijo okolice psa.
English: In a field study, 19 dogs with demodectic mange were treated with Nexgard Spectra monthly on three occasions.
Slovenian: V terensko študijo je bilo vključenih 19 psov z garjavico vrste Demodex canis, ki so prejeli zdravilo enkrat mesečno tri mesece zapored.
English: In a field study, 27 dogs with sarcoptic mange were treated with Nexgard Spectra monthly for two months.
Slovenian: Terenska študija je vključevala 27 psov z garjavico vrste Sarcoptes Scabiei, ki so prejeli zdravilo enkrat mesečno dva meseca zapored.
English: How is Nexgard Spectra used?
Slovenian: Kako se zdravilo Nexgard Spectra uporablja?
English: Treatment for fleas and ticks should be repeated at monthly intervals during the flea or tick seasons; Nexgard Spectra can be used as part of the seasonal treatment of fleas and ticks in dogs infected with gut worms.
Slovenian: Zdravilo Nexgard Spectra se lahko uporablja kot del sezonskega zdravljenja infestacij z bolhami in klopi pri psih, okuženih s črevesnimi zajedavci.
English: Nexgard Spectra reduced worm counts by 95% at 90-92 days after treatment.
Slovenian: 90-92 dni po zdravljenju zmanjšalo število glist za 95 %.
English: A single dose of Nexgard Spectra is given to treat gut worms.
Slovenian: Za zdravljenje okužbe s črevesnimi zajedavci se daje enkraten odmerek zdravila Nexgard Spectra.
English: Demodectic mange
Slovenian: Zdravljenje demodikoze (ki jo povzroča Demodex canis)
English: Oral explanations were heard on 10 October 2007.
Slovenian: Ustna pojasnila so bila podana 10. oktobra 2007.
English: The applicability of the following question of the VICH GL6 was considered:
Slovenian: Preučena je bila uporabnost naslednjega vprašanja VICH GL6:
English: 3 Conclusions and recommendations
Slovenian: Zaključki in priporočila
English: A white homogenous paste
Slovenian: Bela homogena pasta
English: These points were included in the List of Questions that the Committee for Veterinary Medicinal Products adopted on 11 July 2007.
Slovenian: Te točke so bile vključene v seznam vprašanj, ki jih je Odbor za zdravila za uporabo v veterinarski medicini sprejel 11. julija 2007.
English: No risk mitigation measures are considered appropriate.
Slovenian: Nikakršni ukrepi za zmanjšanje tveganja niso ocenjeni kot primerni.
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Slovenian: V skladu s členom 33(4) Direktive Sveta 2001/82/ES, kakor je bila spremenjena, je bila zadeva napotena na CVMP.
English: Czech Republic As above
Slovenian: Češka republika Kot zgoraj
English: Ivermectin-containing products are widely used in these species.
Slovenian: Zdravila, ki vsebujejo ivermektin, se pri teh vrstah široko uporabljajo.
English: However some consideration to this is given on the document that can be summarised as follows:
Slovenian: Vendar pa je bil v zvezi s tem podan določen zadržek, ki ga je mogoče povzeti na naslednji način:
English: The referral procedure started on 11 July 2007.
Slovenian: Postopek napotitve se je pričel 11. julija 2007.
English: The Marketing Authorisation Holder submitted written responses to the List of Questions on 12 September 2007.
Slovenian: Imetnik dovoljenja za promet je predložil pisne odgovore na seznam vprašanj 12. septembra 2007.
English: The referral relates to the concerns raised by Germany that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Slovenian: Napotitev se nanaša na zadržke Nemčije, da utegne to zdravilo za uporabo v veterinarski medicini predstavljati potencialno resno tveganje za javno zdravje, in sicer na iz naslednjih razlogov:
English: In addition, he considers that since this is a generic, there will not be an additional risk to the environment.
Slovenian: Nadalje meni še, da zdravilo zaradi svoje generične narave ne bo predstavljalo dodatnega tveganja za okolje.
English: The product under referral is intended for horses only.
Slovenian: Zdravilo, za katero je bil sprožen napotitveni postopek, je namenjeno samo za konje.
English: The List of Questions was sent to the Marketing Authorisation Holder.
Slovenian: Seznam vprašanj je bil predložen imetniku dovoljenja za promet.
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved at day 90 during the Coordination group procedure.
Slovenian: Veljavni Povzetek glavnih značilnosti zdravila, Označevanje in Navodilo za uporabo so končne različice, potrjene 90. dan v okviru postopka Skupine za usklajevanje.
English: • An updated Environmental Risk Assessment
Slovenian: • posodobljeno oceno tveganja za okolje
English: One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight).
Slovenian: Ena brizga paste na 100 kg telesne mase (na osnovi priporočenega odmerka 200 mikrogramov ivermektina na kg telesne mase).
English: Although oral paste is not used in major species (cattle, sheep, pigs), oral forms exist.
Slovenian: Čeprav se peroralna pasta ne uporablja pri pomembnejših vrstah (govedo, ovce, prašiči), so peroralne oblike na voljo.
English: On the basis of the grounds for referral, the points considered by the CVMP were:
Slovenian: Na osnovi podlage za napotitev je CVMP obravnaval naslednje točke:
English: Despite this, Step 16 of the Phase I decision tree would indicate that a Phase II assessment is required for a product of this nature i.e. ecto/endoparasiticide for major species.
Slovenian: Ne glede na to bi iz koraka 16 odločitvenega drevesa za fazo I sledilo, da je faza II ocenjevanja za tovrstno zdravilo, tj. ekto-/endoparaziticid za pomembnejše vrste, potrebna.
English: Ecomectin 18.7 mg/g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids: Parascaris equorum, Pinworms: Oxyuris equim, Neck threadworms: Onchocerca spp, Stomach bots: Gasterophilus spp
Slovenian: Zdravilo Ecomectin 18,7 mg/g peroralna pasta za konje je namenjeno za uporabo pri konjih za zdravljenje okužb z nematodi ali artropodi, ki jih povzročajo Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, mali strongilidi (vključno s sevi, odpornimi na benzimidazol): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., askaridi: Parascaris equorum, podančice: Oxyuris equim, nitasti zajedavci iz rodu Onchocerca : Onchocerca spp, trebušni zolji: Gasterophilus spp.
English: The applicant does not provide a formal justification for exemption of Phase II.
Slovenian: Predlagatelj ni predložil formalne utemeljitve za izvzetje faze II.
English: Ireland notified the EMEA on 4 July 2007 that the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMD(v)) failed to reach an agreement regarding Ecomectin 18.7 mg/g Oral Paste for Horses.
Slovenian: Irska je dne 4. julija 2007 obvestila EMEA, da usklajevalna skupina za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila v veterinarski medicini (CMD(v)) ni uspela doseči soglasja glede peroralne paste za konje Ecomectin 18,7 mg/g.
English: The Marketing Authorisation Holder provided the following information:
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil naslednje informacije:
English: 2 Information in respect to environmental risk assessment
Slovenian: Informacije v zvezi z oceno tveganja za okolje
English: The time frame agreed by the CVMP on 11 July 2007 was 58 days.
Slovenian: CVMP je dne 11. julija 2007 določil časovni okvir 58 dni.
English: • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.
Slovenian: • celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD(v) v zvezi z oceno tveganja za okolje.