natgillin/translations-raw huggingface dataset:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
- občasni (pri več kot 1, toda manj kot 10 živalih od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
Parasites need to start feeding on the host to become exposed to lotilaner; therefore the risk of the transmission of parasite borne diseases cannot be completely excluded. 
Zajedavci so izpostavljeni lotilanerju šele, ko se začnejo hraniti na gostitelju, zato tveganja prenosa zajedavskih bolezni ni mogoče popolnoma izključiti.
For optimal control of tick and flea infestations, the veterinary medicinal product should be administered at monthly intervals and continued throughout the flea and/or tick season based on local epidemiological situations. 
Za optimalen nadzor infestacij z bolhami in klopi je treba zdravilo za uporabo v veterinarski medicini dajati v enomesečnih intervalih in dajanje nadaljevati skozi celotno sezono bolh in/ali klopov na podlagi lokalnih epidemioloških situacij.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. 
V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Credelio 900 mg chewable tablets for dogs: 2 years 
Credelio 900 mg žvečljive tablete za pse: 2 leti
Lotilaner is a potent inhibitor of gamma-aminobutyric acid (GABA)-gated chloride channels, resulting in rapid death of ticks and fleas. 
Lotilaner močno zavira klorove kanalčke, ki jih proži gama-aminobutirična kislina (GABA), s čimer povzroči hitro smrt klopov in bolh.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each chewable tablet contains: Credelio chewable tablets lotilaner (mg) 
NAVEDBA UČINKOVIN(E) IN DRUGIH SESTAVIN Vsaka žvečljiva tableta vsebuje: Credelio žvečljive tablete lotilaner (mg)
Lotilaner is metabolized to a small extent into more hydrophilic compounds which are observed in faeces and urine. 
Lotilaner se v majhni meri metabolizira v bolj hidrofilne spojine, ki so jih ugotovili v blatu in urinu.
Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue FRANCE 
Elanco France S.A.S., 26 rue de la Chapelle, 68330 Huningue, Francija
The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 20 to 43 mg lotilaner/kg bodyweight. 
Zdravilo za uporabo v veterinarski medicini je treba dati v skladu z naslednjo razpredelnico, da se zagotovi odmerek od 20 do 43 mg lotilanerja/kg telesne mase.
MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/016-21 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/206/016-21
NAME OF THE VETERINARY MEDICINAL PRODUCT Credelio 12 mg (0.5-2.0 kg) 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Credelio 12 mg (0,5-2,0 kg)
56 mg lotilaner 112 mg lotilaner 225 mg lotilaner 450 mg lotilaner 900 mg lotilaner 
56 mg lotilanerja 112 mg lotilanerja 225 mg lotilanerja 450 mg lotilanerja 900 mg lotilanerja
Credelio chewable tablets lotilaner (mg) 
Credelio žvečljive tablete lotilaner (mg)
Body weight of cat (kg) 
Telesna masa mačke (kg)
The tablets are packaged in aluminium/aluminium blisters packaged into an outer cardboard box. 
Tablete so pakirane v pretisne omote iz aluminija/aluminija in zunanjo kartonsko škatlo.
The veterinary medicinal product kills existing and newly emerged fleas on cats before they can lay eggs. 
Zdravilo za uporabo v veterinarski medicini uničuje že prisotne in nove bolhe na mačkah, preden lahko izležejo jajčeca.
48 mg lotilaner 
12 mg lotilanerja 48 mg lotilanerja
Do not use this veterinary medicinal product after the expiry date which is stated on the carton box and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na kartonski škatli in pretisnem omotu za oznako »EXP«.
Existing I. ricinus ticks on the animal prior to administration are killed within 8 hours. 
Klopi I. ricinus, ki so prisesani že pred dajanjem zdravila, so uničeni v 8 urah.
The veterinary medicinal product kills existing and newly emerged fleas on dogs before they can lay eggs. 
Zdravilo za uporabo v veterinarski medicini uničuje že prisotne in nove bolhe na psih, preden lahko izležejo jajčeca.
Pharmacotherapeutic group: ectoparasiticides for systemic use, isoxazolines. 
Farmakoterapevtska skupina: učinkovine proti ektoparazitom za sistemsko zdravljenje, izoksazolini.
The flavoured veterinary medicinal product should be administered in accordance with the following table to ensure a single dose of 6 to 24 mg lotilaner/kg bodyweight. 
Aromatizirano zdravilo za uporabo v veterinarski medicini je treba dati v skladu z naslednjo razpredelnico, da se zagotovi enkraten odmerek od 6 do 24 mg lotilanerja/kg telesne mase.
Credelio 56 mg, 112 mg, 225 mg, 450 mg chewable tablets for dogs: 3 years 
Credelio 56 mg, 122 mg, 225 mg, 450 mg žvečljive tablete za pse: 3 leti
Laboratory studies in rats have not produced any evidence of teratogenic effects. 
Z laboratorijskimi študijami na podganah niso bili dokazani nobeni teratogeni učinki.
Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the cat has access. 
Zdravilo tako prekine življenjski cikel bolhe in prepreči kontaminacijo z bolhami na območjih, do katerih ima mačka dostop.
The major route of elimination is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose). 
Glavna pot izločanja je izločanje z žolčem, medtem ko se izloča skozi ledvice v manjši meri (manj kot
Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached at 4 hours. 
Lotilaner se po peroralnemu dajanju z lahkoto absorbira in v 4 urah doseže najvišjo koncentracijo v krvi.
Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours. 
Lotilaner se po peroralnemu dajanju z lahkoto absorbira in v 2 urah doseže najvišjo koncentracijo v krvi.
Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access. 
Zdravilo tako prekine življenjski cikel bolhe in prepreči kontaminacijo z bolhami na območjih, do katerih ima pes dostop.
Use only accordingly to the benefit-risk assessment of the responsible veterinarian. 
Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Each tablet strength is available in pack sizes of 1, 3 or 6 tablets. 
Vsaka jakost tablet je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
Administer with or after food. 
Dajte s hrano ali po njej.
Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females. 
Z laboratorijskimi študijami na podganah niso bili dokazani nobeni teratogeni učinki ali kakršni koli neželeni učinki na sposobnost razmnoževanja samcev in samic.
This long terminal half-life provides effective blood concentrations for the entire duration of the interdosing interval. 
Tako dolg končni razpolovni čas zagotavlja, da ostane koncentracija zdravila v krvi učinkovita ves čas med posameznimi odmerki.
This terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval. 
Ta končni razpolovni čas zagotavlja, da ostane koncentracija zdravila v krvi učinkovita ves čas med posameznimi odmerki.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use. 
ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
EU/2/17/206/001 (56 mg lotilaner; 1 chewable tablet) EU/2/17/206/002 (56 mg lotilaner; 3 chewable tablets) EU/2/17/206/003 (56 mg lotilaner; 6 chewable tablets) EU/2/17/206/004 (112 mg lotilaner; 1 chewable tablet) EU/2/17/206/005 (112 mg lotilaner; 3 chewable tablets) EU/2/17/206/006 (112 mg lotilaner; 6 chewable tablets) EU/2/17/206/007 (225 mg lotilaner; 1 chewable tablet) EU/2/17/206/008 (225 mg lotilaner; 3 chewable tablets) EU/2/17/206/009 (225 mg lotilaner; 6 chewable tablets) EU/2/17/206/010 (450 mg lotilaner; 1 chewable tablet) EU/2/17/206/011 (450 mg lotilaner; 3 chewable tablets) EU/2/17/206/012 (450 mg lotilaner; 6 chewable tablets) EU/2/17/206/013 (900 mg lotilaner; 1 chewable tablet) 
EU/2/17/206/001 (56 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/002 (56 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/003 (56 mg lotilanerja; 6 žvečljivih tablet) EU/2/17/206/004 (112 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/005 (112 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/006 (112 mg lotilanerja; 6 žvečljivih tablet) EU/2/17/206/007 (225 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/008 (225 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/009 (225 mg lotilanerja; 6 žvečljivih tablet) EU/2/17/206/010 (450 mg lotilanerja; 1 žvečljiva tableta)
Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females. 
Z laboratorijskimi študijami na podganah niso bili dokazani nobeni neželeni učinki na sposobnost razmnoževanja samcev in samic.
EU/2/17/206/016 (12 mg lotilaner; 1 chewable tablet) EU/2/17/206/017 (12 mg lotilaner; 3 chewable tablet) EU/2/17/206/018 (12 mg lotilaner; 6 chewable tablet) EU/2/17/206/019 (48 mg lotilaner; 1 chewable tablet) EU/2/17/206/020 (48 mg lotilaner; 3 chewable tablet) EU/2/17/206/021 (48 mg lotilaner; 6 chewable tablet) 
EU/2/17/206/016 (12 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/017 (12 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/018 (12 mg lotilanerja; 6 žvečljivih tablet) EU/2/17/206/019 (48 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/020 (48 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/021 (48 mg lotilanerja; 6 žvečljivih tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (cats) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (mačke)
Each strength of Credelio chewable tablets for cats is available in pack sizes of 1, 3 or 6 tablets. 
Vsaka jakost žvečljivih tablet Credelio za mačke je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets. 
Vsaka jakost žvečljivih tablet Credelio je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience. 
Glede na post-marketinške izkušnje na področju varnosti zdravila so zelo redko poročali o blagih in prehodnih želodčno-črevesnih motnjah, kot sta bruhanje in diareja.
for cats (0.5-2.0 kg) for cats (>2-8.0 kg) 
za mačke (0,5-2,0 kg) za mačke (> 2-8,0 kg)
1 tablet 3 tablets 6 tablets 
6 tablet
All safety and efficacy data have been acquired from dogs and puppies 8 weeks of age and older and 1.3 kg of body weight and greater. 
Vsi podatki o varnosti in učinkovitosti so bili pridobljeni pri psih in pasjih mladičih, starih 8 tednov ali več in s telesno maso 1,3 kg ali več.
ADVICE ON CORRECT ADMINISTRATION Administer the veterinary medicinal product with food or within 30 minutes after feeding. 
NASVET O PRAVILNI UPORABI ZDRAVILA Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance. 
Bolhe in klopi so izpostavljeni učinkovini šele, ko se prisesajo na gostitelja in se začnejo hraniti.
Credelio is a palatable chewable flavoured tablet. 
Zdravilo Credelio je okusna žvečljiva tableta z dodano aromo.
EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets) 
EU/2/17/206/013 (900 mg lotilanerja; 1 žvečljiva tableta) EU/2/17/206/014 (900 mg lotilanerja; 3 žvečljive tablete) EU/2/17/206/015 (900 mg lotilanerja; 6 žvečljivih tablet)
Administer the veterinary medicinal product with food or within 30 minutes after feeding. 
Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg. 
Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočeni odmerek 20-43
Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more. 
Podatki o varnosti in učinkovitosti so bili pridobljeni pri mačkah, starih 8 tednov ali več in s telesno maso 0,5 kg ali več.
Existing ticks on the animal prior to administration are killed within 18 hours. 
Klopi, ki so prisesani že pred dajanjem zdravila, so uničeni v 18 urah.
Body weight of dog (kg) 
Telesna masa psa (kg)
White to beige round chewable tablets with brownish spots. 
Bele do rjavkaste okrogle žvečljive tablete z rjavkastimi pikami.
All safety and efficacy data have been acquired from cats and kittens 8 weeks of age and older and 0.5 kg of body weight and greater. 
Vsi podatki o varnosti in učinkovitosti so bili pridobljeni pri mačkah in mačjih mladičih, starih 8 tednov ali več in s telesno maso 0,5 kg ali več.
Blisters (dogs) 
Pretisni omot (psi)
NAME OF THE MARKETING AUTHORISATION HOLDER 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco
Lotilaner, a pure enantiomer from the isoxazoline class is active against fleas (Ctenocephalides felis and Ctenocephalides canis) as well as the tick species Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus. 
Ctenocephalides canis) ter klopom Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in Rhipicephalus sanguineus.
Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus). 
Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
In in vitro studies, the activity of lotilaner against some arthropod species was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin). 
V in vitro študijah odpornost proti organoklornim spojinam (ciklodieni, npr. dieldrin), fenilpirazolom (npr. fipronil), neonikotinoidom (npr. imidakloprid), formamidinom (npr. amitraz) in piretroidom (npr. cipermetrin) ni vplivala na delovanje lotilanerja proti nekaterim vrstam členonožcev.
PACKAGE LEAFLET: Credelio 12 mg chewable tablets for cats (0.5-2.0 kg) Credelio 48 mg chewable tablets for cats (>2.0-8.0 kg) 
Credelio 12 mg žvečljive tablete za mačke (0,5-2,0 kg) Credelio 48 mg žvečljive tablete za mačke (> 2,0-8,0 kg)
Fleas on the animal prior to administration are killed within 6 hours. 
Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 6 urah.
No adverse reactions were observed following oral administration to puppies aged 8-9 weeks and weighing 1.3-3.6 kg treated with overdoses of up to 5 times the maximum recommended dose (43 mg, 129 mg and 215 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals. 
Po peroralnem dajanju prevelikih odmerkov, ki so do petkrat presegali največji priporočeni odmerek (43 mg, 129 mg in 215 mg lotilanerja/kg telesne mase), pasjim mladičem, starim 8-9 tednov in s telesno maso 1,3-3,6 kg, osemkrat v mesečnih presledkih, niso opazili nobenih neželenih učinkov.
Credelio 56 mg chewable tablets for dogs (1.3-2.5 kg) Credelio 112 mg chewable tablets for dogs (>2.5-5.5 kg) Credelio 225 mg chewable tablets for dogs (>5.5-11 kg) Credelio 450 mg chewable tablets for dogs (>11-22 kg) Credelio 900 mg chewable tablets for dogs (>22-45 kg) 
Credelio 56 mg žvečljive tablete za pse (1,3-2,5 kg) Credelio 112 mg žvečljive tablete za pse (> 2,5-5,5 kg) Credelio 225 mg žvečljive tablete za pse (> 5,5-11 kg) Credelio 450 mg žvečljive tablete za pse (> 11-22 kg) Credelio 900 mg žvečljive tablete za pse (> 22-45 kg)
Use of this veterinary medicinal product in puppies younger than 8 weeks of age or less than 1.3 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian. 
To zdravilo za uporabo v veterinarski medicini uporabite pri pasjih mladičih, mlajših od 8 tednov ali s telesno maso, manjšo od 1,3 kg, le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour 
6.1 Seznam pomožnih snovi celuloza, uprašena laktoza monohidrat silicifirana mikrokristalna celuloza aroma suhega mesa krospovidon povidon K30 natrijev lavrilsulfat silicijev dioksid, koloidni, brezvodni magnezijev stearat
The safety of the veterinary medicinal product in breeding dogs has not been established. 
Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ni bila dokazana.
Treatment of flea and tick infestations in dogs. 
INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri psih.
For the treatment of flea and tick infestations on cats. 
INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri mačkah.
The activity of lotilaner was not affected by resistance to organochlorines (cyclodienes, e.g. dieldrin), phenylpyrazoles (e.g. fipronil), neonicotinoids (e.g. imidacloprid), formamidines (e.g. amitraz) and pyrethroids (e.g. cypermethrin). 
dieldrin), fenilpirazolom (npr. fipronil), neonikotinoidom (npr. imidakloprid), formamidinom (npr. amitraz) in piretroidom (npr. cipermetrin) ni vplivala na delovanje lotilanerja.
Silicified microcrystalline cellulose Cellulose, powdered Lactose monohydrate Povidone K30 
6.1 Seznam pomožnih snovi kvas v prahu (aroma) silicifirana mikrokristalna celuloza celuloza, uprašena laktoza monohidrat povidon K30 krospovidon natrijev lavrilsulfat vanilin (aroma) silicijev dioksid, koloidni, brezvodni magnezijev stearat
10 DATE OF REVISION OF THE TEXT DD/MM/YYYY 
DD/MM/LLLL
Fleas on the animal prior to administration are killed within 8 hours. 
Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 8 urah.
Use of this veterinary medicinal product in kittens younger than 8 weeks of age or less than 0.5 kg of body weight should be based on a benefit-risk assessment by the responsible veterinarian. 
To zdravilo za uporabo v veterinarski medicini uporabite pri mačjih mladičih, mlajših od 8 tednov ali s telesno maso, manjšo od 0,5 kg, le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (dogs) 
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (psi)
For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration. 
Proti klopom začne zdravilo učinkovati v 48 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
PHARMACEUTICAL FORM Chewable tablet. 
Žvečljiva tableta.
The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation. 
Varnost zdravila za uporabo v veterinarski medicini pri mačkah v obdobju brejosti in laktacije ni bila dokazana.
For fleas, the onset of efficacy is within 12 hours of attachment for one month after product administration. 
Proti bolham začne zdravilo učinkovati v 12 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
For cats of more than 8 kg body weight, use an appropriate combination of available strengths to achieve the recommended dose of 6-24 mg/kg. 
Ustrezna kombinacija tablet Pri mačkah s telesno maso, večjo od 8 kg, uporabite ustrezno kombinacijo razpoložljivih jakosti tablet,
This veterinary medicinal product provides immediate and persistent killing activity for 1 month for fleas (Ctenocephalides felis and C. canis) and ticks (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus, and Dermacentor reticulatus). 
(Ctenocephalides felis in C. canis) ter klope (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus in Dermacentor reticulatus), ki traja 1 mesec.
For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration. 
Proti klopom začne zdravilo učinkovati v 24 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
No adverse reactions were observed following oral administration to kittens aged 8 weeks and weighing 0.5 kg treated with overdoses of more than 5 times the maximum recommended dose rate (130 mg lotilaner/kg bodyweight) on eight occasions at monthly intervals. 
Po peroralnem dajanju prevelikih odmerkov, ki so več kot petkrat presegali največji priporočeni odmerek (130 mg lotilanerja/kg telesne mase), mačjim mladičem, starim 8 tednov in s telesno maso
Special precautions to be taken by the person administering the veterinary medicinal product to animals: 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi zdravila si umijte roke.
For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration. 
Proti bolham začne zdravilo učinkovati v 4 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established. 
Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ter psicah v obdobju brejosti in laktacije ni bila dokazana.
The safety of the veterinary medicinal product in breeding queens has not been established. 
Varnost zdravila za uporabo v veterinarski medicini pri mačjih samicah, namenjenih za vzrejo, ni bila dokazana.
This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus). 
5.1 Farmakodinamične lastnosti Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
For the treatment of flea and tick infestations in dogs. 
4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje infestacij z bolhami in klopi pri psih.
• The Committee considered the referral under Article 31 of Directive 2001/83/EC; 
• Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES.
In 24.3% of cases, the indication was unknown. 
V 24,3 % primerov indikacija ni bila znana.
These results were pooled without confirming the beneficial effect . 
Ti rezultati so bili združeni brez potrditve ugodnih učinkov.
These pathologies lead ultimately to blindness. 
Te patologije na koncu privedejo do slepote.
Otology - Ear, Nose and Throat (ENT) 
Otologija - ušesa, nos in grlo (ORL)
Finally, the most recent study using an appropriate methodology was submitted only for safety purpose as the efficacy objective was not reached (France ARMD 2, 2008). 
Končno, najnovejša študija, v kateri so uporabljali ustrezno metodologijo, je bila predložena le za namene varnosti, saj cilj učinkovitosti ni bil dosežen (Francija ARMD 2, 2008).
Each study generally included multiple objectives (pharmacodynamic or clinical evaluations). 
Vsaka študija je na splošno zajemala več ciljev (farmakodinamičnih ali kliničnih ocenitev).
Trimetazidine medicinal products have been authorised in 21 European Member states. 
Zdravila, ki vsebujejo trimetazidin, so odobrena v 21 državah članicah Evropske unije.
The analysis performed by the MAH has been repeated independently by the Italian Institutes of Health (ISS). 
Analizo, ki jo je opravil imetnik dovoljenja za promet z zdravilom, je neodvisno ponovil Italijanski zdravstveni inštitut (ISS - Italian Institutes of Health).
Overall summary of the scientific evaluation of trimetazidine containing medicinal products (see Annex I) 
Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo trimetazidin (glejte Prilogo I)