FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP endorsed the treatment and prevention of acute CINV and RINV for both formulationstablets and injection for solution.
Slovenian: CHMP je potrdil zdravljenje in preprečevanje akutne CINV (s kemoterapijo povzročeni slabost in bruhanje) in RINV (z radioterapijo povzročeni slabost in bruhanje) za obe formulaciji - tablete in raztopino za injiciranje.
English: The MAH also proposed to include ‘rash' as an adverse drug reaction with an uncommon frequency.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal tudi, da se med neželene učinke zdravila z občasno pogostnostjo vključijo „izpuščaji“.
English: Based on data provided by MAH, the intramuscular route of administration was not considered to be acceptable by the CHMP.
Slovenian: Na podlagi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, je CHMP menil, da intramuskularna uporaba ni sprejemljiva.
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Kytril and associated names (see Annex I).
Slovenian: • Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet, so bili ocenjeni na osnovi predložene dokumentacije in strokovne razprave v Odboru.
English: Kytril film-coated tablets are indicated in adults for prevention of delayed nausea and vomiting associated with chemotherapy and radiotherapy.'
Slovenian: Filmsko obložene tablete Kytril so indicirane pri odraslih za preprečevanje zakasnelih slabosti in bruhanja, povezanih s kemoterapijo in radioterapijo.“
English: The clinical data have not been considered substantial enough to support the use of Kytril for RINV or PONV in paediatric patients.
Slovenian: Klinični podatki niso bili dovolj pomembni, da bi podprli uporabo zdravila Kytril pri pediatričnih bolnikih z RINV ali PONV.
English: At the request of the CHMP the MAH re-submitted the reproductive data and an updated Nonclinical Overview.
Slovenian: Poglavje 5.3 - Predklinični podatki o varnosti Na zahtevo CHMP je imetnik dovoljenja za promet z zdravilom ponovno predložil podatke o reprodukciji in posodobljeni neklinični pregled.
English: The MAH's proposal not to include hypothetical symptoms listed in a minority of SmPC, but to remain consistent with wording provided in the CDS was accepted by the CHMP.
Slovenian: CHMP je sprejel predlog imetnika dovoljenja za promet z zdravilom, da se hipotetični simptomi, ki so bili navedeni v manjšem številu povzetkov glavnih značilnosti zdravila, ne vključijo, in da se ohrani skladnost z besedilom na podatkovnem listu s temeljnimi podatki.
English: The MAH also proposed Kytril solution for injection in children aged 2 years and above for the prevention and treatment of acute CINV, which was accepted by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je tudi predlagal, da se raztopina za injiciranje Kytril lahko uporablja za preprečevanje in zdravljenje akutne CINV pri otrocih, starih dve leti in več, kar je CHMP potrdil.
English: The SmPC does not recommend administration of Kytril solution for injection for paediatric use in RINV and PONV.
Slovenian: V povzetku glavnih značilnosti zdravila ni priporočena uporaba raztopine za injiciranje Kytril za pediatrično uporabo pri RINV in PONV.
English: Section 4.2 - Posology and method of administration The harmonised proposed text proposed by the MAH was accepted by the CHMP for both the tablets and solution for injection.
Slovenian: Usklajeno predlagano besedilo, ki ga je predložil imetnik dovoljenja za promet z zdravilom, je CHMP potrdil za tablete in raztopino za injiciranje.
English: --1 Rabies virus, strain SPBN GASGAS, live - 106.8 to 108.1 FFU* per 1.7 ml dose * Focus forming units
Slovenian: --1 Cepivo proti steklini, sev SPBN GASGAS, živo - 10
English: • The Committee considered the (Co-)Rapporteur's assessment report;
Slovenian: • odbor je upošteval poročilo o oceni (so-)poročevalca,
English: In addition, the applicant refers to relevant clinical guidelines.
Slovenian: Poleg tega se predlagatelj sklicuje na ustrezne klinične smernice.
English: This specific dose is also supported by bibliographical evidence submitted by the applicant.
Slovenian: Ta odmerek podpirajo tudi bibliografski dokazi, ki jih je predložil predlagatelj.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC where Germany raised objections as a potential serious risk to public health;
Slovenian: • odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES, pri čemer je Nemčija izrazila pomisleke zaradi morebitnega resnega tveganja za javno zdravje,
English: However, according to Notice to Applicants Volume 2A Chapter 1 Section 5.51 , a mixed-dossier can be accepted.
Slovenian: V skladu z Obvestilom predlagateljem, zvezek 2A, poglavje 1, oddelek 5.51, pa se lahko sprejme mešana dokumentacija.
English: This referral procedure concerns the products in UK, AT and DE.
Slovenian: Ta napotitveni postopek se nanaša na zdravila v Združenem kraljestvu, Avstriji in Nemčiji.
English: According to Article 10b of Directive 2001/83/EC, new clinical or non-clinical trials relating to the combination (although not the individual active substances) should be submitted.
Slovenian: V skladu s členom 10b Direktive 2001/83/ES je treba predložiti rezultate novih kliničnih ali nekliničnih preskušanj, ki se nanašajo na to kombinacijo (ne pa tudi na posamezne učinkovine).
English: The applicant has submitted a review of the literature relating to the use of diclofenac and omeprazole in combination.
Slovenian: Predlagatelj je predložil pregled literature, ki se nanaša na uporabo diklofenaka in omeprazola v kombinaciji.
English: DE is in agreement with the CHMP conclusion.
Slovenian: Nemčija se strinja z zaključkom odbora CHMP.
English: A decentralised procedure (DCP) with the UK as reference Member State (RMS) and AT, EE, LT, LV and MT as CMSs, concluded positively on 7 November 2016 (UK/H/6135/001/DC).
Slovenian: Decentralizirani postopek, pri katerem je bila referenčna država članica Združeno kraljestvo, Avstrija, Estonija, Litva, Latvija in Malta pa zadevne države članice, se je pozitivno končal 7. novembra 2016 (UK/H/6135/001/DC).
English: Data from studies of higher doses of diclofenac or other NSAIDs can be extrapolated to support the efficacy and safety of the specific combination.
Slovenian: Podatki iz študij z večjimi odmerki diklofenaka ali drugih NSAID se lahko uporabijo za sklepanje na varnost in učinkovitost te točno določene kombinacije.
English: It is noted that the bioequivalence has been demonstrated between the free combination of the recognised reference formulations of the individual mono-components and the proposed fixed combination product and there are no outstanding concerns regarding quality and non-clinical issues.
Slovenian: Poudariti je treba, da je bila dokazana bioekvivalenca med prosto kombinacijo priznanih referenčnih formulacij posameznih monokomponent in predlaganim zdravilom s fiksno kombinacijo ter da ni nerazrešenih pomislekov, kar zadeva kakovost in neklinične vidike.
English: However, the position of DE was that this particular combination of diclofenac/omeprazole in the specific doses 75 mg / 20 mg administered once daily has never been tested in any published study and no new clinical data has been generated.
Slovenian: Stališče Nemčije pa je, da točno ta kombinacija diklofenaka/omeprazola v točno določenih odmerkih 75 mg/20 mg, ki se daje enkrat dnevno, še nikoli ni bila preskušena v nobeni objavljeni študiji in niso bili ustvarjeni nobeni novi klinični podatki.
English: However, the CHMP took into consideration the Guideline on clinical development of fixed combination medicinal products2 and concluded by consensus that the development of Diotop 75 mg/20 mg is in line with it, since the Guideline does not preclude extrapolation from higher doses and different substances if scientifically justified.
Slovenian: Vendar je odbor CHMP upošteval Smernice o kliničnem razvoju zdravil s fiksno kombinacijo2 in zaključil, da se razvoj zdravila Diotop 75 mg/20 mg z njimi sklada, saj te smernice ne izključujejo sklepanja na podlagi večjih odmerkov in drugih snovi, če je to znanstveno upravičeno.
English: Moreover the mechanisms for both NSAID-associated GI toxicity and the gastro-protective efficacy of omeprazole are not expected to differ across the different non-selective NSAIDs studied, which are all associated with a risk of upper GI complications.
Slovenian: Poleg tega se mehanizmi z NSAID povezane gastrointestinalne toksičnosti in gastroprotektivne učinkovitosti omeprazola med različnimi proučevanimi neselektivnimi NSAID, ki so vsi povezani s tveganjem za zaplete v zgornjih prebavilih, medsebojno ne bi smeli razlikovati.
English: Bioequivalence has been demonstrated between Diotop 75 mg / 20 mg and the free combination of the recognised reference formulations of the individual mono-components.
Slovenian: Dokazana je bila bioekvivalenca med zdravilom Diotop 75 mg/20 mg in prosto kombinacijo priznanih referenčnih formulacij posameznih monokomponent.
English: Moreover, following an Article 30 procedure of Directive 2001/83/EC for Losec and associated names (EMEA/H/A-30/1001), the harmonised indications for omeprazole products include the prevention of NSAID-associated gastric and duodenal ulcers in patients at risk with omeprazole dosed at 20 mg
Slovenian: Direktive 2001/83/ES za zdravilo Losec in povezana imena (EMEA/H/A-30/1001) usklajene indikacije za zdravila, ki vsebujejo omeprazol, vključujejo preprečevanje z NSAID povezanih želodčnih in duodenalnih ulkusov pri ogroženih bolnikih z vsakodnevnim 20-miligramskim odmerkom omeprazola.
English: Therefore, the CHMP considered that in the context of the harmonised gastro protection indication for omeprazole products in the European Union, the totality of the data presented by the applicant and the well-known safety and efficacy profile of omeprazole and diclofenac, the therapeutic efficacy and the safety of Diotop 75 mg/20 mg is adequately justified.
Slovenian: Odbor CHMP je zato presodil, da sta glede na usklajeno indikacijo zdravil za zaščito želodca, ki vsebujejo omeprazol, v Evropski uniji, vse podatke, ki jih je predstavil predlagatelj, ter dobro poznani profil varnosti in učinkovitosti omeprazola in diklofenaka terapevtska učinkovitost in varnost zdravila Diotop 75 mg/20 mg zadovoljivo utemeljeni.
English: Notice to Applicants Volume 2A Chapter 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf daily.
Slovenian: Obvestilo predlagateljem, zvezek 2A, poglavje 1 https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/a/vol2a_chap1_201507.pdf zdravila za uporabo v humani medicini (CHMP).
English: • The Committee considered the totality of the data submitted by the applicant in support of Diotop 75 mg / 20 mg modified-release capsules, hard;
Slovenian: • odbor je upošteval vse podatke, ki jih je v podporo zdravilu Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem predložil predlagatelj,
English: The applicant Temmler Pharma GmbH submitted in Germany (DE) an application for a Marketing Authorisation (MA) for Diotop 75 mg / 20 mg modified-release hard capsules, under Article 10b of Directive 2001/83/EC.
Slovenian: Predlagatelj, podjetje Temmler Pharma GmbH, je v Nemčiji v skladu s členom 10b Direktive 2001/83/ES vložil vlogo za pridobitev dovoljenja za promet z zdravilom Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem.
English: In addition, there are literature data from several large RCTs supporting the safety and efficacy of omeprazole 20 mg daily for the treatment, maintenance and/or prevention of NSAID-associated gastroduodenal ulceration in patients with arthritis.
Slovenian: Poleg tega so v literaturi na voljo podatki iz več randomiziranih kliničnih preskušanj, ki podpirajo varnost in učinkovitost vsakodnevnega jemanja 20 mg omeprazola za zdravljenje, obvladovanje in/ali preprečevanje z NSAID povezanih želodčnih in duodenalnih ulkusov pri bolnikih z artritisom.
English: The reference member state (RMS) UK considers that the submitted evidence is adequate to support the safety and efficacy profile of Diotop 75 mg / 20 mg.
Slovenian: Referenčna država članica Združeno kraljestvo meni, da predloženi dokazi v zadostni meri podpirajo profil varnosti in učinkovitosti zdravila Diotop 75 mg/20 mg.
English: Based on the review of all available data, the CHMP considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation.
Slovenian: Na podlagi pregleda vseh razpoložljivih podatkov odbor CHMP meni, da je razmerje med koristmi in tveganji zdravila Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem in povezanih imen ugodno in zato priporoča izdajo dovoljenja za promet.
English: DE considered that extrapolation across different substances, doses and studies is not considered to be an acceptable approach and thus the safety and efficacy of Diotop 75 mg / 20 mg has not been sufficiently shown.
Slovenian: Nemčija je menila, da se sklepanje na podlagi drugih snovi, odmerkov in študij ne šteje za sprejemljiv pristop, zaradi česar varnost in učinkovitost zdravila Diotop 75 mg/20 mg nista bili zadovoljivo dokazani.
English: The 75 mg daily dose of diclofenac is approved for other diclofenac products in the EU for the symptomatic treatment of rheumatic disease.
Slovenian: Dnevni odmerek 75 mg diklofenaka je v Evropski uniji odobren za druga zdravila, ki vsebujejo diklofenak in se uporabljajo za simptomatsko zdravljenje revmatskih bolezni.
English: The relevant contribution of omeprazole to the desired therapeutic effect of the product has been demonstrated; the addition of a proton pump inhibitor in patients requiring long-term use of NSAIDs who are at risk of gastroduodenal ulceration has previously been recommended by the CHMP.
Slovenian: Dokazan je bil ustrezen prispevek omeprazola k želenemu terapevtskemu učinku zdravila; dodatek zaviralca protonske črpalke pri bolnikih, ki potrebujejo dolgotrajno zdravljenje z NSAID in pri katerih obstaja tveganje za nastanek želodčnih in duodenalnih ulkusov, je predhodno priporočil Odbor za
English: Each modified release capsule contains 75 mg diclofenac sodium (25 mg as gastroresistant pellets and 50 mg as prolonged release pellets) and 20 mg of omeprazole (gastro-resistant pellets).
Slovenian: Ena kapsula s prirejenim sproščanjem vsebuje 75 mg natrijevega diklofenakata (25 mg v obliki gastrorezistentnih pelet in 50 mg v obliki pelet s podaljšanim sproščanjem) in 20 mg omeprazola (gastrorezistentne pelete).
English: The DCP application was withdrawn from EE, LT, MT and LV during the national phase.
Slovenian: Vloga za pridobitev dovoljenja za promet po decentraliziranem postopku je bila v Estoniji, Litvi, na Malti in v Latviji umaknjena v nacionalni fazi.
English: The proposed indication is: symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers who are adequately controlled with diclofenac and omeprazole.
Slovenian: Predlagana indikacija je: simptomatsko zdravljenje revmatoidnega artritisa, osteoartritisa in ankilozirajočega spondilitisa pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek z nesteroidnimi protivnetnimi zdravili (NSAID) povezanih želodčnih in/ali duodenalnih ulkusov, ki se zadovoljivo obvladujejo z diklofenakom in omeprazolom.
English: Diotop 75 mg / 20 mg is intended for symptomatic treatment of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis in adult patients at risk of developing NSAID associated gastric and/or duodenal ulcers, who are adequately controlled with diclofenac and omeprazole.
Slovenian: Zdravilo Diotop 75 mg/20 mg je namenjeno za simptomatsko zdravljenje revmatoidnega artritisa, osteoartritisa in ankilozirajočega spondilitisa pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek z NSAID povezanih želodčnih in/ali duodenalnih ulkusov, ki se zadovoljivo obvladujejo z diklofenakom in omeprazolom.
English: CHMP also noted that there is a risk of GI complications with diclofenac 75 mg QD based on epidemiological data.
Slovenian: Odbor CHMP je poudaril tudi, da tveganje za zaplete v prebavilih pri vsakodnevnem jemanju diklofenaka v odmerku 75 mg izražajo tudi epidemiološki podatki.
English: The CHMP acknowledged that there is no literature data regarding the specific free combination of diclofenac 75 mg QD and omeprazole 20 mg QD.
Slovenian: Odbor CHMP je potrdil, da v literaturi ni podatkov o vsakodnevnem jemanju te točno določene proste kombinacije diklofenaka v odmerku 75 mg in omeprazola v odmerku 20 mg.
English: Diotop 75 mg / 20 mg is a fixed dose combination product consisting of diclofenac sodium and omeprazole.
Slovenian: Diotop 75 mg/20 mg je zdravilo s fiksno kombinacijo odmerkov, ki vsebuje natrijev diklofenakat in omeprazol.
English: The Committee, as a consequence, considers that the benefit-risk balance of Diotop 75 mg / 20 mg modified-release capsules, hard and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Slovenian: • odbor je menil, da predloženi bibliografski podatki zadovoljivo dokazujejo varnost in učinkovitost predlaganega zdravila s fiksno kombinacijo odmerkov odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Diotop 75 mg/20 mg trde kapsule s prirejenim sproščanjem in povezanih imen ugodno in zato priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA
English: EU/1/97/037/001 Vistide 75 mg/ml
Slovenian: EU/1/97/037/001 Vistide 75 mg/ml intravenska uporaba viala (steklena) 5 ml
English: 5 ml
Slovenian: 1 viala
English: Strength Pharmaceutical Form Route of administration
Slovenian: Zdravilo nima veā dovoljenja za promet
English: Packaging Content (concentration)
Slovenian: Številka EU izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: (In these studies efficacy was not investigated).
Slovenian: (Pri tem učinkovitost ni bila raziskana).
English: All dogs recovered without treatment.
Slovenian: Vsi psi so okrevali brez zdravljenja.
English: A further veterinary examination 30 days after treatment is recommended as some animals may require a second treatment.
Slovenian: Priporoča se veterinarski pregled 30 dni po zdravljenju, ker je lahko pri nekaterih živalih potrebno zdravljenje ponoviti.
English: The prandial state of the dog does not significantly affect the extent of its absorption.
Slovenian: Hranjenje psa ne vpliva občutno na obseg absorbcije.
English: The tablets should not be divided.
Slovenian: Tablet ne smete deliti.
English: Interactions with other medicinal products and other forms of interactions: None known.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Niso znane.
English: Date of first authorisation: 31/01/2018.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 31/01/2018.
English: The bioavailability of sarolaner following oral dosing was high at >85%.
Slovenian: Biološka razpoložljivost sarolanerja po peroralnem dajanju je visoka >85%.
English: A distribution study determined that 14C-sarolaner-related residues were widely distributed to the tissues.
Slovenian: Raziskave porazdelitve so določile, da so ostanki povezani z 14C-sarolanerjem široko porazdeljeni v tkivih.
English: Tablets can be administered with or without food.
Slovenian: Tablete se lahko daje s hrano ali brez.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz tega zdravila, je treba odstraniti v skladu z lokalnimi zahtevami.
English: Treatment should be continued until skin scrapings are negative on at least two consecutive occasions one month apart.
Slovenian: Zdravljenje je treba nadaljevati, dokler kožni ostružki niso negativni, najmanj dva zaporedna odvzema, v razmaku enega meseca.
English: For the treatment of demodicosis (Demodex canis).
Slovenian: Za zdravljenje demodikoze (Demodex canis).
English: These signs typically resolve without treatment.
Slovenian: Ti znaki navadno minejo brez zdravljenja.
English: The depletion from tissues was consistent with the plasma half-life.
Slovenian: Izločanje iz tkiv je bilo skladno z razpolovno dobo v plazmi.
English: Sarolaner was determined to have low clearance (0.12 ml/min/kg) and a moderate volume of distribution (2.81 l/kg).
Slovenian: Sarolaner ima nizek renalni očistek (0.12 ml/min/kg) in zmeren volumen porazdelitve (2.81 l/kg).
English: As demodicosis is a multi-factorial disease, it is advisable to also treat any underlying disease appropriately.
Slovenian: Ker je demodikoza večplastna bolezen, je priporočljivo, da obenem ustrezno zdravite tudi osnovno bolezen.
English: Ticks on the animal prior to administration are killed within 24 hours.
Slovenian: Klopi, ki so že na živali pred dajanjem zdravila, so ubiti znotraj 24 ur.
English: EU/2/17/220/001 (5 mg, 3 tablets) EU/2/17/220/002 (10 mg, 3 tablets) EU/2/17/220/003 (20 mg, 3 tablets) EU/2/17/220/004 (40 mg, 3 tablets) EU/2/17/220/005 (80 mg, 3 tablets) EU/2/17/220/006 (120 mg, 3 tablets)
Slovenian: EU/2/17/220/001 (5 mg, 3 tablete) EU/2/17/220/002 (10 mg, 3 tablete) EU/2/17/220/003 (20 mg, 3 tablete) EU/2/17/220/004 (40 mg, 3 tablete) EU/2/17/220/005 (80 mg, 3 tablete) EU/2/17/220/006 (120 mg, 3 tablete)
English: For each strength, the chewable tablets are available in a carton with 1 blister of 3 tablets.
Slovenian: Za vsako jakost so žvečljive tablete na voljo v kartonski škatli z 1 pretisnim omotom s po 3 tabletami.
English: To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Slovenian: Da bi preprečili otrokom dostop do zdravila, se mora iz pretisnega omota vzeti le posamezna tableta naenkrat in samo kadar je to potrebno.
English: For the treatment of demodicosis (caused by Demodex canis) the administration of a single dose once monthly for three consecutive months is efficacious and leads to a marked improvement of clinical signs.
Slovenian: Za zdravljenje demodikoze (ki jo povzroča Demodex canis) je uporaba enkratnega odmerka, enkrat mesečno, tri zaporedne mesece, učinkovita in vodi do izrazitega izboljšanja kliničnih znakov.
English: No treatment-related clinical signs were observed.
Slovenian: Pri tem niso opazili nobenih kliničnih znakov povezanih z zdravljenjem.
English: Laboratory studies in rats and rabbits have not produced any evidence of any teratogenic effects.
Slovenian: Z laboratorijskimi študijami na kuncih in podganah teratogeni učinki niso bili dokazani.
English: Mild and transient gastrointestinal signs such as vomiting and diarrhoea, transient neurological disorders such as tremor, ataxia or convulsion and systemic disorders such as lethargy, anorexia/inappetence may occur in very rare cases.
Slovenian: Blagi in prehodni gastrointestinalni znaki, kot so bruhanje in driska, prehodne nevrološke motnje, kot so tremor, ataksija ali konvulzije in sistemske motnje kot so letargija, anoreksija/inapetenca se lahko pojavijo v zelo redkih primerih.