FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: Credelio 56 mg, 112 mg, 225 mg, 450 mg chewable tablets for dogs: 3 years
Slovenian: Credelio 56 mg, 122 mg, 225 mg, 450 mg žvečljive tablete za pse: 3 leti
English: Laboratory studies in rats have not produced any evidence of teratogenic effects.
Slovenian: Z laboratorijskimi študijami na podganah niso bili dokazani nobeni teratogeni učinki.
English: Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the cat has access.
Slovenian: Zdravilo tako prekine življenjski cikel bolhe in prepreči kontaminacijo z bolhami na območjih, do katerih ima mačka dostop.
English: The major route of elimination is biliary excretion and renal excretion is the minor route of elimination (less than 10% of the dose).
Slovenian: Glavna pot izločanja je izločanje z žolčem, medtem ko se izloča skozi ledvice v manjši meri (manj kot
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached at 4 hours.
Slovenian: Lotilaner se po peroralnemu dajanju z lahkoto absorbira in v 4 urah doseže najvišjo koncentracijo v krvi.
English: Following oral administration, lotilaner is readily absorbed and peak blood concentration is reached within 2 hours.
Slovenian: Lotilaner se po peroralnemu dajanju z lahkoto absorbira in v 2 urah doseže najvišjo koncentracijo v krvi.
English: Therefore, the product breaks the flea life cycle and prevents environmental flea contamination in areas to which the dog has access.
Slovenian: Zdravilo tako prekine življenjski cikel bolhe in prepreči kontaminacijo z bolhami na območjih, do katerih ima pes dostop.
English: Use only accordingly to the benefit-risk assessment of the responsible veterinarian.
Slovenian: Uporabite le v skladu z oceno razmerja korist-tveganje odgovornega veterinarja.
English: Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Slovenian: Vsaka jakost tablet je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
English: Administer with or after food.
Slovenian: Dajte s hrano ali po njej.
English: Laboratory studies in rats have not produced any evidence of teratogenic effects, or any adverse effect on the reproductive capacity of males and females.
Slovenian: Z laboratorijskimi študijami na podganah niso bili dokazani nobeni teratogeni učinki ali kakršni koli neželeni učinki na sposobnost razmnoževanja samcev in samic.
English: This long terminal half-life provides effective blood concentrations for the entire duration of the interdosing interval.
Slovenian: Tako dolg končni razpolovni čas zagotavlja, da ostane koncentracija zdravila v krvi učinkovita ves čas med posameznimi odmerki.
English: This terminal half-life provides effective blood concentrations for the entire duration of the inter-dosing interval.
Slovenian: Ta končni razpolovni čas zagotavlja, da ostane koncentracija zdravila v krvi učinkovita ves čas med posameznimi odmerki.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use.
Slovenian: ODMERKI ZA POSAMEZNE ŽIVALSKE VRSTE TER POT(I) IN NAČIN UPORABE ZDRAVILA
English: 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)
Slovenian: 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)
English: Laboratory studies in rats have not produced any evidence of any adverse effect on the reproductive capacity of males and females.
Slovenian: Z laboratorijskimi študijami na podganah niso bili dokazani nobeni neželeni učinki na sposobnost razmnoževanja samcev in samic.
English: 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)
Slovenian: 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)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (cats)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (mačke)
English: Each strength of Credelio chewable tablets for cats is available in pack sizes of 1, 3 or 6 tablets.
Slovenian: Vsaka jakost žvečljivih tablet Credelio za mačke je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
English: Each strength of Credelio chewable tablets is available in pack sizes of 1, 3 or 6 tablets.
Slovenian: Vsaka jakost žvečljivih tablet Credelio je na voljo v velikostih pakiranj z 1, 3 ali 6 tabletami.
English: Mild and transient gastrointestinal effects such as vomiting and diarrhoea have been reported to occur very rarely based on post-marketing safety experience.
Slovenian: 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.
English: for cats (0.5-2.0 kg) for cats (>2-8.0 kg)
Slovenian: za mačke (0,5-2,0 kg) za mačke (> 2-8,0 kg)
English: 1 tablet 3 tablets 6 tablets
Slovenian: 6 tablet
English: 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.
Slovenian: 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.
English: ADVICE ON CORRECT ADMINISTRATION Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Slovenian: NASVET O PRAVILNI UPORABI ZDRAVILA Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
English: Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Slovenian: Bolhe in klopi so izpostavljeni učinkovini šele, ko se prisesajo na gostitelja in se začnejo hraniti.
English: for cats (0.5-2.0 kg) for cats (>2.0-8.0 kg)
Slovenian: za mačke (0,5-2,0 kg) za mačke (> 2,0-8,0 kg)
English: Credelio is a palatable chewable flavoured tablet.
Slovenian: Zdravilo Credelio je okusna žvečljiva tableta z dodano aromo.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/206/001-015
Slovenian: EU/2/17/206/001-015
English: EU/2/17/206/014 (900 mg lotilaner; 3 chewable tablets) EU/2/17/206/015 (900 mg lotilaner; 6 chewable tablets)
Slovenian: 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)
English: Administer the veterinary medicinal product with food or within 30 minutes after feeding.
Slovenian: Zdravilo za uporabo v veterinarski medicini dajte s hrano ali v 30 minutah po hranjenju.
English: Use an appropriate combination of available strengths to achieve the recommended dose of 2043 mg/kg.
Slovenian: Uporabite ustrezno kombinacijo razpoložljivih jakosti tablet, da dosežete priporočeni odmerek 20-43
English: Safety and efficacy data has been studied in cats aged 8 weeks and older with a body weight of 0.5 kg or more.
Slovenian: Podatki o varnosti in učinkovitosti so bili pridobljeni pri mačkah, starih 8 tednov ali več in s telesno maso 0,5 kg ali več.
English: Existing ticks on the animal prior to administration are killed within 18 hours.
Slovenian: Klopi, ki so prisesani že pred dajanjem zdravila, so uničeni v 18 urah.
English: Body weight of dog (kg)
Slovenian: Telesna masa psa (kg)
English: White to beige round chewable tablets with brownish spots.
Slovenian: Bele do rjavkaste okrogle žvečljive tablete z rjavkastimi pikami.
English: 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.
Slovenian: 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.
English: Blisters (dogs)
Slovenian: Pretisni omot (psi)
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Elanco
English: 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.
Slovenian: Ctenocephalides canis) ter klopom Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus in Rhipicephalus sanguineus.
English: Lotilaner, a pure enantiomer from the isoxazoline class, is active against fleas (Ctenocephalides felis and Ctenocephalides canis) and ticks (Ixodes ricinus).
Slovenian: Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
English: for dogs (1.3-2.5 kg) for dogs (>2.5-5.5 kg) for dogs (>5.5-11 kg) for dogs (>11-22 kg) for dogs (>22-45 kg)
Slovenian: za pse (1,3-2,5 kg) za pse (> 2,5-5,5 kg) za pse (> 5,5-11 kg) za pse (> 11-22 kg) za pse (> 22-45 kg)
English: 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).
Slovenian: 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.
English: 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)
Slovenian: Credelio 12 mg žvečljive tablete za mačke (0,5-2,0 kg) Credelio 48 mg žvečljive tablete za mačke (> 2,0-8,0 kg)
English: Fleas on the animal prior to administration are killed within 6 hours.
Slovenian: Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 6 urah.
English: 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.
Slovenian: 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.
English: 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)
Slovenian: 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)
English: 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.
Slovenian: 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.
English: Cellulose, powdered Lactose monohydrate Silicified microcrystalline cellulose Meat dry flavour
Slovenian: 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
English: The safety of the veterinary medicinal product in breeding dogs has not been established.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ni bila dokazana.
English: Treatment of flea and tick infestations in dogs.
Slovenian: INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri psih.
English: For the treatment of flea and tick infestations on cats.
Slovenian: INDIKACIJA(E) Zdravljenje infestacij z bolhami in klopi pri mačkah.
English: 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).
Slovenian: dieldrin), fenilpirazolom (npr. fipronil), neonikotinoidom (npr. imidakloprid), formamidinom (npr. amitraz) in piretroidom (npr. cipermetrin) ni vplivala na delovanje lotilanerja.
English: Silicified microcrystalline cellulose Cellulose, powdered Lactose monohydrate Povidone K30
Slovenian: 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
English: 10 DATE OF REVISION OF THE TEXT DD/MM/YYYY
Slovenian: DD/MM/LLLL
English: Fleas on the animal prior to administration are killed within 8 hours.
Slovenian: Bolhe, ki so prisesane že pred dajanjem zdravila, so uničene v 8 urah.
English: 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.
Slovenian: 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.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (dogs)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (psi)
English: For ticks, the onset of efficacy is within 48 hours of attachment for one month after product administration.
Slovenian: Proti klopom začne zdravilo učinkovati v 48 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
English: PHARMACEUTICAL FORM Chewable tablet.
Slovenian: Žvečljiva tableta.
English: The safety of the veterinary medicinal product in cats has not been established during pregnancy and lactation.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini pri mačkah v obdobju brejosti in laktacije ni bila dokazana.
English: For fleas, the onset of efficacy is within 12 hours of attachment for one month after product administration.
Slovenian: Proti bolham začne zdravilo učinkovati v 12 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
English: 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.
Slovenian: Ustrezna kombinacija tablet Pri mačkah s telesno maso, večjo od 8 kg, uporabite ustrezno kombinacijo razpoložljivih jakosti tablet,
English: 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).
Slovenian: (Ctenocephalides felis in C. canis) ter klope (Rhipicephalus sanguineus, Ixodes ricinus, I. hexagonus in Dermacentor reticulatus), ki traja 1 mesec.
English: For ticks, the onset of efficacy is within 24 hours of attachment for one month after product administration.
Slovenian: Proti klopom začne zdravilo učinkovati v 24 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
English: 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.
Slovenian: 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
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo: Po uporabi zdravila si umijte roke.
English: For fleas, the onset of efficacy is within 4 hours of attachment for one month after product administration.
Slovenian: Proti bolham začne zdravilo učinkovati v 4 urah po tem, ko se zajedavec prisesa na žival, in učinkuje en mesec po dajanju zdravila.
English: The safety of the veterinary medicinal product in breeding, pregnant and lactating dogs has not been established.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini pri psih, namenjenih za vzrejo, ter psicah v obdobju brejosti in laktacije ni bila dokazana.
English: The safety of the veterinary medicinal product in breeding queens has not been established.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini pri mačjih samicah, namenjenih za vzrejo, ni bila dokazana.
English: This veterinary medicinal product provides immediate and persistent killing activity for 1 month against fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).
Slovenian: 5.1 Farmakodinamične lastnosti Lotilaner, čisti enantiomer iz razreda izoksazolinov, učinkuje proti bolham (Ctenocephalides felis in
English: For the treatment of flea and tick infestations in dogs.
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Zdravljenje infestacij z bolhami in klopi pri psih.
English: • The Committee considered the referral under Article 31 of Directive 2001/83/EC;
Slovenian: • Odbor je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES.
English: In 24.3% of cases, the indication was unknown.
Slovenian: V 24,3 % primerov indikacija ni bila znana.
English: These results were pooled without confirming the beneficial effect .
Slovenian: Ti rezultati so bili združeni brez potrditve ugodnih učinkov.
English: These pathologies lead ultimately to blindness.
Slovenian: Te patologije na koncu privedejo do slepote.
English: Otology - Ear, Nose and Throat (ENT)
Slovenian: Otologija - ušesa, nos in grlo (ORL)
English: 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).
Slovenian: 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).
English: Each study generally included multiple objectives (pharmacodynamic or clinical evaluations).
Slovenian: Vsaka študija je na splošno zajemala več ciljev (farmakodinamičnih ali kliničnih ocenitev).
English: Trimetazidine medicinal products have been authorised in 21 European Member states.
Slovenian: Zdravila, ki vsebujejo trimetazidin, so odobrena v 21 državah članicah Evropske unije.
English: The analysis performed by the MAH has been repeated independently by the Italian Institutes of Health (ISS).
Slovenian: Analizo, ki jo je opravil imetnik dovoljenja za promet z zdravilom, je neodvisno ponovil Italijanski zdravstveni inštitut (ISS - Italian Institutes of Health).
English: Overall summary of the scientific evaluation of trimetazidine containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo trimetazidin (glejte Prilogo I)
English: In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
Slovenian: V primeru dvoma je treba bolnike napotiti k nevrologu na ustrezne preiskave.
English: Ophthalmology
Slovenian: Oftalmologija
English: It should be noted that the study was conducted using the Bruce protocol that it is known to underestimate the treatment effect of drugs compared to the modified Bruce protocol.
Slovenian: Opozoriti je treba, da je bila študija opravljena z Bruceovim protokolom, za katerega je znano, da podcenjuje učinke zdravljenja z zdravili v primerjavi s prilagojenim Bruceovim protokolom.
English: Of the ten studies submitted, nine do not apply the relevant methodological principles currently required to demonstrate efficacy.
Slovenian: Od desetih predloženih študij jih devet ne uporablja ustreznih metodoloških načel, ki so potrebna za dokazovanje učinkovitosti.
English: Among these studies, five studies were conducted against placebo including the additional study published in 1990 by Coyas.
Slovenian: Med temi študijami je bilo pet študij izvedenih s placebom, vključno z dodatno študijo, ki jo je leta 1990 objavil Coyas.
English: Therefore, the results which were presented as supporting a similar efficacy than trimetazidine are not reliable.
Slovenian: Zato rezultati, predstavljeni v podporo podobni učinkovitosti, kot jo ima trimetazidin, niso zanesljivi.
English: In addition, Vitte study (2002) had the same methodological weaknesses as the Wayoff and Morgon studies.
Slovenian: Tudi študija Vitte (2002) je vsebovala enake metodološke šibkosti kot študiji Wayoff in Morgon.
English: These changes are considered adequate to manage the risk of pakinsonian symptoms and tremors.
Slovenian: Te spremembe se smatrajo za zadostne za upravljanje s tveganjem simptomov pakinsonove bolezni in tremorjev.
English: The study results may thus be considered conservative in terms of magnitude of the effect of trimetazidine.
Slovenian: Rezultati študije se lahko zato obravnavajo kot konservativni v smislu obsega učinka trimetazidina.
English: The clinical experience with trimetazidine dates back to the early 70s.
Slovenian: Klinične izkušnje s trimetazidinom segajo v zgodnja sedemdeseta leta.
English: Trimetazidine has no hemodynamic effect on blood pressure or heart rate.
Slovenian: Trimetazidin nima hemodinamskega učinka na krvni tlak ali srčni utrip.
English: The new proposed wording in the angina pectoris indication is in accordance with the available efficacy and safety data assessed.
Slovenian: Novo predlagano besedilo za indikacijo angine pektoris je v skladu z ocenjenimi razpoložljivimi podatki o učinkovitosti in varnosti.