FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the assessment of the grounds for the re-examination, the CHMP noted that the results from the new bioequivalence study became available after the CHMP adopted its opinion and were therefore not available to the CHMP during its initial assessment.
Slovenian: Odbor CHMP je ovrednotil gradivo za ponovno presojo in ugotovil, da so izsledki nove študije biološke enakovrednosti postali dostopni po sprejetju mnenja in odboru CHMP torej niso bili na voljo med njegovo prvotno oceno.
English: Grounds for suspension of the marketing authorisations
Slovenian: Podlaga za začasni umik dovoljenj za promet z zdravilom
English: The CHMP was requested to assess whether the deficiencies in conduct of bio-analytical studies performed by the Cetero Research facilities in Houston (Texas, USA) have impact on the benefit/risk of the concerned medicinal products and to give its opinion on whether the marketing authorisations for authorised medicinal products for which studies have been carried out or samples analysed by Cetero Research, during the identified time period, should be maintained, varied, suspended or withdrawn.
Slovenian: Odbor CHMP je bil naprošen, da oceni, ali pomanjkljivosti v izvedbi bioanalitičnih študij, opravljenih v ustanovi Cetero Research v Houstonu (Teksas, ZDA), vplivajo na razmerje med tveganji in koristmi pri uporabi zadevnih zdravil, ter za mnenje o tem, ali je treba dovoljenja za promet z odobrenimi zdravili, za katera so bile v ustanovi Cetero Research v navedenem časovnem obdobju opravljene študije ali analizirani vzorci , ohraniti, spremeniti, začasno umakniti ali ukiniti.
English: The CHMP noted the absence of samples from the critical pivotal bioequivalence study 10540314 and that there is therefore no possibility to reanalyse the data.
Slovenian: Odbor CHMP je upošteval odsotnost vzorcev iz kritične ključne študije biološke enakovrednosti 10540314 in dejstvo, da zaradi tega ni mogoče ponovno analizirati podatkov.
English: The CHMP was of the opinion that the previous conclusions regarding bioequivalence will need to be confirmed by repeating the bioequivalence study.
Slovenian: Menil je, da bo treba prejšnje zaključke glede biološke enakovrednosti potrditi s ponovno izvedbo študije biološke enakovrednosti.
English: Annex II Scientific conclusions and grounds for suspension of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za začasni umik dovoljenj za promet z zdravilom
English: The MAH submitted grounds for the re-examination, which consisted of a new bioequivalence study (study 2016_FENOF_11), carried out to replace the pivotal bioequivalence study (study 10540314), for which serious doubts were raised regarding the reliability and the correctness of the data.
Slovenian: Imetnik dovoljenja za promet je predložil gradivo za ponovno presojo, in sicer podatke iz nove študije biološke enakovrednosti (študija 2016_FENOF_11), ki je bila opravljena kot nadomestilo za ključno študijo biološke enakovrednosti (študijo 10540314) v zvezi s katero so bili izraženi pomisleki glede njene zanesljivosti in pravilnosti podatkov.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 10540314, submitted in support of the marketing authorisations, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to their reference product, the CHMP was unable to conclude on the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy.
Slovenian: Zaradi resnih pomislekov glede zanesljivosti in pravilnosti podatkov iz kritične ključne študije biološke enakovrednosti 10540314, predložene kot podpora dovoljenju za promet z zdravilom, in zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy ter njunega referenčnega zdravila, odbor CHMP ni mogel sklepati o biološki enakovrednosti zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy are both available as 160mg tablets.
Slovenian: Zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy sta na voljo v obliki 160-miligramskih tablet.
English: Fenofibrato Pensa and Fenofibrato Ranbaxy contain fenofibrate, a drug of the fibrate class.
Slovenian: Zdravili Fenofibrato Pensa in Fenofibrato Ranbaxy vsebujeta fenofibrat, učinkovino iz razreda fibratov.
English: In conclusion, the CHMP considered that the potential deficiencies in the conduct of bio-analytical studies by the Cetero Research facilities invalidate the pivotal bioequivalence study.
Slovenian: Odbor CHMP je sklenil, da morebitne pomanjkljivosti v izvedbi bioanalitičnih študij, opravljenih v ustanovi Cetero Research, razveljavijo ključno študijo biološke enakovrednosti.
English: Having assessed the available data, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisations.
Slovenian: Na podlagi ocene razpoložljivih podatkov ima odbor CHMP še vedno resne dvome zaradi ugotovitev inšpekcijskega pregleda prostorov ustanove Cetero Research v Houstonu (Teksas, ZDA) glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti, predložene kot podpora dovoljenju za promet z zdravilom.
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Slovenian: • Odbor je menil, da so razpoložljivi podatki povzročili resne dvome glede dokazov o biološki enakovrednosti zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy ter referenčnega zdravila v EU zaradi pomislekov glede zanesljivosti podatkov, ki so bili izpostavljeni v ugotovitvah inšpekcijskega pregleda ustanove Cetero Research.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy to its EU reference product, the benefit-risk balance of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be considered to be favourable.
Slovenian: Zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravil Fenofibrato Pensa ter Fenofibrato Ranbaxy in referenčnim zdravilom v EU, razmerja med tveganji in koristmi pri zdravilih Fenofibrato Pensa in Fenofibrato Ranbaxy ni mogoče obravnavati kot pozitivnega.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Fenofibrato Pensa and Fenofibrato Ranbaxy with the EU reference product.
Slovenian: • Odbor je menil, da odgovori imetnika dovoljenja za promet z zdravilom niso zadostni, da bi odpravili resne dvome glede dokazov o biološki enakovrednosti zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy ter referenčnega zdravila v EU.
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Fenofibrato Pensa and Fenofibrato Ranbaxy cannot be confirmed.
Slovenian: Menil je tudi, da zaradi resnih dvomov glede dokazov o biološki enakovrednosti ni mogoče potrditi razmerja med tveganji in koristmi zdravil Fenofibrato Pensa in Fenofibrato Ranbaxy,
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration, applicants in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe, predlagateljev v državah članicah
English: Delivrie 0,02 mg/3 mg Filmtabletten ethinylestradiol : 0.02 mg/ Drospirenone : 3 mg
Slovenian: Delivrie 0,02 mg/3 mg Filmtabletten
English: Refer also to section 4.8
Slovenian: Glej tudi poglavje 4.8.
English: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011
Slovenian: EU/2/10/119/001 EU/2/10/119/002 EU/2/10/119/003 EU/2/10/119/004 EU/2/10/119/005 EU/2/10/119/006 EU/2/10/119/007 EU/2/10/119/008 EU/2/10/119/009 EU/2/10/119/010 EU/2/10/119/011 EU/2/10/119/012
English: There is no specific antidote to this product.
Slovenian: Za to zdravilo ni specifičnega antidota.
English: Treatment duration:
Slovenian: Trajanje zdravljenja:
English: The tablets are flavoured and studies (in healthy Beagle dogs) show they are likely to be taken voluntarily by most dogs.
Slovenian: Tablete so okusne in študije (na zdravih beaglih) so pokazale, da jih večina psov vzame prostovoljno.
English: If such use cannot be avoided, these animals require careful veterinary monitoring.
Slovenian: Če se temu ne morete izogniti, potrebujejo te živali skrben veterinarski nadzor.
English: The elimination half-life (t1/2) is 1.38 (± 0.24) hours.
Slovenian: Razpolovni čas (t1/2) je 1.38 (± 0.24) ure.
English: Do not use in dogs less than 10 weeks of age.
Slovenian: Ne uporabite pri psih mlajših od 10 tednov.
English: The choice of the most suitable tablet type or tablet parts is left to the discretion of the veterinarian based on the circumstances in each case, without leading to important over- or underdosing.
Slovenian: Izbira najprimernejšega tipa tablet ali delov tablet je prepuščena odločitvi veterinarja glede na okoliščine vsakega primera, da ne vodi do prevelikega ali premajhnega odmerjanja.
English: Lactose monohydrate Povidone K25
Slovenian: Laktoza monohidrat Povidon K25
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko Komisijo o načrtih trženja zdravila, za katerega je bilo izdano to dovoljenje za promet.
English: Although no data are available in dogs, studies with laboratory animals have shown effects on their fertility and foetal development.
Slovenian: Podatki pri psih niso na voljo, vendar so študije na laboratorijskih živalih pokazale učinke na njihovo plodnost in razvoj zarodka.
English: The following table is presented as an example of how the tablets and tablet parts could be used in order to reach the recommended dose.
Slovenian: Tabela prikazuje, kako se lahko uporablja tablete in dele tablet, da se zagotovi priporočljiv odmerek.
English: Since the safety of the medicinal product has not been adequately demonstrated in young animals, careful monitoring is advised during the treatment of young dogs aged less than 6 months.
Slovenian: Varnost zdravila pri mladih živalih ni bila ustrezno raziskana, zato se priporoča skrbno spremljanje zdravljenja mladih psov mlajših od 6 mesecev.
English: The peak concentration (Cmax) is 0.3918 (± 0.09021) µg/ml, area under the curve (AUC) is 1.676 (± 0.4735) µg.hr/ml, and oral bioavailability is 44.53 (± 10.26) percent.
Slovenian: Največja koncentracija (Cmax) je 0.3918 (± 0.09021) µg/ml, področje pod krivuljo (AUC) je 1.676 (± 0.4735) µg.h/ml in peroralna biodostopnost je 44.53 (± 10.26) procentov.
English: • Relief of pain and inflammation associated with osteoarthritis: 6 months.
Slovenian: • Lajšanje bolečine in vnetij povezanih z osteoartritisom: 6 mesecev.
English: Pack sizes of 8, 32 or 144 tablets.
Slovenian: Velikosti pakiranj 8, 32 ali 144 tablet.
English: After oral administration in dogs at the recommended dose of 2 mg/kg without food, cimicoxib is rapidly absorbed and the time to maximal concentration (Tmax) is 2.25 (± 1.24) hours.
Slovenian: Po peroralnem dajanju priporočenega odmerka 2 mg/kg psom brez hrane se cimikoksib hitro absorbira in čas do maksimalne koncentracije (Tmax) je 2.25 (± 1.24) uri.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
English: Pharmacotherapeutic group: non-steroidal anti-inflammatory drug, ATCvet code: QM01AH93
Slovenian: Farmakoterapevtska skupina: nesteroidna protivnetna in protirevmatična zdravila, oznaka ATC vet: QM01AH93
English: Avoid using this product in any animals which are dehydrated, hypovolaemic or hypotensive, as it may increase the risk of renal toxicity.
Slovenian: Izognite se uporabi zdravila pri živalih, ki so dehidrirane, hipovolemične ali hipotenzične, saj lahko to poveča tveganje za ledvično toksičnost.
English: The recommended dose of cimicoxib is 2 mg per kg bodyweight, once daily.
Slovenian: Priporočen odmerek cimikoksiba je 2 mg na kg telesne mase enkrat dnevno.
English: Do not use in breeding, pregnant or lactating animals (see Section 12 “Special precautions for dogs”).
Slovenian: Ne uporabite pri vzrejnih živalih ali pri živalih v obdobju brejosti ali laktacije (glej Poglavje 12 “Posebna opozorila pri psih ”).
English: 8 tablets 32 tablets 144 tablets 45 tablets
Slovenian: 8 tablet 32 tablet 144 tablet 45 tablet
English: The oral administration of cimicoxib with food did not significantly influence the bioavailability but decreased significantly the observed Tmax.
Slovenian: Peroralno dajanje cimikoksiba s hrano ni signifikantno vplivalo na biodostopnost, vendar pa je signifikantno znižalo Tmax.
English: People with a known hypersensitivity to cimicoxib should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na cimikoksib naj se izogibajo stiku z zdravilom.
English: Any divided tablets should be stored in the blister pack/bottle.
Slovenian: Razdeljene tablete je treba shranjevati v pretisnem omotu/plastenki.
English: Use in animals suffering from impaired cardiac, renal or hepatic function, may involve additional risk.
Slovenian: Uporaba pri živalih s prizadeto srčno ali jetrno funkcijo predstavlja dodatno tveganje.
English: COX-1 is usually a constitutive enzyme expressed in tissues, which synthesize products responsible for normal physiologic functions (e.g. in the gastro-intestinal tract and kidneys).
Slovenian: COX-1 je običajno konstitutivni encim, izražen v tkivih, ki sintetizirajo produkte odgovorne za normalne fiziološke funkcije (npr. v gastrointestinalnem traktu in ledvicah).
English: As with any NSAID, overdose may cause gastrointestinal, kidney, or liver toxicity in sensitive or compromised dogs.
Slovenian: Kot pri vseh NSAID lahko prevelik odmerek povzroči gastrointestinalno, ledvično ali jetrno toksičnost pri občutljivih ali ogroženih psih.
English: All strengths of Cimalgex tablets are available in the following pack sizes and types:
Slovenian: Vse jakosti Cimalgex tablet so na voljo v naslednjih velikostih in tipih pakiranj:
English: COX-2 is involved in the production of mediators, including PGE2, that induce pain, exudation, inflammation and fever.
Slovenian: COX-2 je vključena v produkcijo mediatorjev, vključno s PGE2, ki inducirajo bolečino, eksudacijo, vnetje in vročino.
English: Furthermore, in very rare cases, renal failure has been reported.
Slovenian: Nadalje, v zelo redkih primerih so poročali o odpovedi ledvic.
English: • Plastic (HDPE) bottle with child resistant plastic (PP) closure packaged into an outer cardboard box.
Slovenian: • Plastična (HDPE) steklenica s plastičnim zamaškom varnim za otroke pakirana v kartonsko škatlo.
English: • Aluminium blisters (each strip containing 8 tablets) packaged into an outer cardboard box.
Slovenian: • Aluminijasti pretisni omoti (vsak pretisni omot vsebuje 8 tablet) pakirani v kartonsko škatlo.
English: In an overdose study where 3 times (5.8 to 11.8 mg/kg body weight) and 5 times (9.7 to 19.5 mg/kg body weight) the recommended dose was administered to dogs for a period of 6 months, a dose related increase in gastrointestinal disturbances, which affected all dogs in the highest dose group, was noted.
Slovenian: V študijah prevelikega odmerjanja, kjer so psom dajali 3-kratni (5.8 do 11.8 mg/kg telesne mase) in 5kratni (9.7 do 19.5 mg/kg telesne mase) priporočeni odmerek 6 mesecev, so opazili, da so se gastrointestinalne motnje povečale v odvisnosti od odmerka.
English: All strengths are available in the following pack sizes and types:
Slovenian: Vse jakosti so na voljo v naslednjih velikostih in tipih pakiranj:
English: Vétoquinol SA Magny-Vernois 70200 Lure France
Slovenian: Vétoquinol SA Magny-Vernois 70200 Lure Francija
English: Metabolism of cimicoxib is extensive.
Slovenian: Metabolizem cimikoksiba je obsežen.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 45 tablets
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 45 tablet
English: Vétoquinol SA Magny Vernois 70200 Lure France
Slovenian: Vétoquinol SA Magny Vernois 70200 Lure Francija
English: For longer-term treatment, regular monitoring should be undertaken by the veterinarian.
Slovenian: Pri dolgotrajnem zdravljenju mora veterinar le to redno spremljati.
English: The tablets can be divided into equal thirds.
Slovenian: Tablete se lahko razdeli na enake tretjine.
English: The cyclo-oxygenase enzyme (COX) is present in two isoforms.
Slovenian: Encim ciklooksigenaza (COX) je prisoten v dveh izooblikah.
English: The cyclooxygenase 1 enzyme (COX-1) which has protective functions, for example, in the digestive tract and kidneys, is not inhibited by cimicoxib.
Slovenian: Encima ciklooksigenaza 1 (COX-1), ki ima zaščitne funkcije, na primer v prebavnem traktu in ledvicah, cimikoksib ne inhibira.
English: Cimalgex tablets can be administered with or without food.
Slovenian: Cimalgex tablete se lahko dajejo s hrano ali brez nje.
English: Pretreatment with other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed before the commencement of treatment with Cimalgex.
Slovenian: Predhodno zdravljenje z drugimi protivnetnimi učinkovinami lahko povzroči dodatne ali povečane neželene učinke, zato je treba dajanje teh zdravil prekiniti za določen čas, preden se začne zdravljenje s Cimalgex.
English: Cimalgex should not be administered in conjunction with corticosteroids or other NSAIDs.
Slovenian: Cimalgex se ne sme dajati skupaj s kortikosteroidi ali drugimi NSAID.
English: The metabolising enzymes have not been fully investigated and slower metabolism (up to four-fold increased exposure) has been noted in some individuals.
Slovenian: Pri nekaterih posameznikih je bil opažen počasnejši metabolizem (do štirikrat povečana izpostavljenost).
English: In very rare cases, increases in kidney function results (renal biochemistry parameters) were noted.
Slovenian: V zelo redkih primerih so opazili povečanje rezultatov delovanja ledvic (ledvičnih biokemijskih parametrov).
English: Similar dose related changes to haematology and white blood cell counts, as well as renal integrity, were also noted.
Slovenian: Opazili so tudi podobne od odmerka odvisne spremembe v hematologiji in številu belih krvnih celic ter tudi na ledvicah.
English: In very rare cases, increases in renal biochemistry parameters were noted.
Slovenian: V zelo redkih primerih so opazili povečanje ledvičnih biokemijskih parametrov.
English: Crospovidone Sodium laurylsulfate Macrogol 400
Slovenian: Krospovidon Natrijev lavrilsulfat Makrogol 400
English: • Management of peri-operative pain due to orthopaedic or soft tissue surgeries: one dose 2 hours prior to surgery, followed by 3 to 7 days of treatment, based on the judgment of the attending veterinarian.
Slovenian: • Peri-operativne bolečine zaradi ortopedskih operacij ali operacij mehkih tkiv: en odmerek 2 uri pred operacijo, zdravljenje traja 3 do 7 dni, odvisno od presoje lečečega veterinarja.
English: It selectively inhibits the cyclooxygenase 2 enzyme (COX-2), which is responsible for pain, inflammation or fever.
Slovenian: Selektivno inhibira encim ciklooksigenazo 2 (COX-2), ki je odgovoren za bolečino, vnetje ali vročino.
English: Pack sizes of 45 tablets.
Slovenian: Pakiranje s 45 tabletami.
English: COX-2 on the other hand, is mainly inducible and synthesized by macrophages and inflammatory cells after stimulation by cytokines and other mediators of inflammation.
Slovenian: COX-2 na drugi strani pa je v glavnem sprožen, sintetizirajo ga makrofagi in vnetne celice po stimulaciji s citokini in ostalimi mediatorji vnetja.
English: Do not use in dogs suffering from stomach or digestive system disorders or in dogs with bleeding problems.
Slovenian: Ne uporabite pri psih z želodčnimi in prebavnimi motnjami ali pri psih s težavami s krvavitvami.
English: ANNEX 1 SUMMARY OF PRODUCT CHARACTERISTICS
Slovenian: DODATEK I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
English: Do not use at the same time as corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Ne uporabite istočasno s kortikosteroidi ali ostalimi nesteroidnimi protivnetnimi zdravili (NSAID).
English: Sodium stearyl fumarate Pork liver powder
Slovenian: Natrijev stearilfumarat Prašek iz prašičjih jeter
English: METHOD AND ROUTES OF ADMINISTRATION Read the package leaflet before use.
Slovenian: NAČIN IN POTI UPORABE Pred uporabo preberite navodilo za uporabo.
English: Cimicoxib is a non-steroidal anti-inflammatory drug belonging to the coxib group and acting by selective inhibition of the enzyme cyclo-oxygenase 2.
Slovenian: Cimikoksib je nesteroidno protivnetno zdravilo, ki pripada skupini koksibov in deluje s selektivno inhibicijo encima ciklooksigenaze 2.
English: In an artificially induced pain model in dogs it was shown that the pain and inflammation reducing effects of cimicoxib lasted for approximately 10-14 hours.
Slovenian: V umetno ustvarjenem modelu bolečine je bilo prikazano, da je učinek cimikoksiba na bolečino in vnetje trajal približno 10-14 ur.
English: If any observed adverse effect persists after stopping treatment, the advice of a veterinarian should be sought.
Slovenian: Če katerikoli neželeni učinek traja še po prekinitvi zdravljenja, se je treba takoj posvetovati z veterinarjem.
English: In an in vivo inflammatory acute pain model, it was shown that the simulated effect of cimicoxib lasted for approximately 10-14 hours.
Slovenian: V in vivo akutnem vnetnem bolečinskem modelu je bilo prikazano, da je stimulirajoči učinek cimikoksiba trajal približno 10-14 ur.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI
English: After oral administration in dogs at the recommended doses, cimicoxib is rapidly absorbed.
Slovenian: Po peroralnem dajanju priporočenega odmerka psom se cimikoksib hitro absorbira.
English: Bodyweight kg
Slovenian: Telesna masa kg
English: The treatment-free period should take into account the pharmacokinetic properties of the veterinary medicinal products used previously.
Slovenian: Pri določanju obdobja brez zdravil je treba upoštevati farmakokinetične lastnosti predhodno uporabljenih zdravil.
English: Do not use in dogs suffering from gastrointestinal disorders or haemorrhagic disorders.
Slovenian: Ne uporabite pri psih z gastrointestinalnimi in hemoragičnimi motnjami.
English: The treatment-free period should take into account the pharmacokinetic properties of the veterinary medicinal product used previously.
Slovenian: Pri določanju obdobja brez zdravil je treba upoštevati farmakokinetične lastnosti predhodno uporabljenega zdravila.