FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from a drug-drug interaction study in 32 healthy volunteers indicate that on the first day of oral administration of 300 mg idebenone t.i.d., the metabolism of midazolam, a CYP3A4 substrate, was not modified when both drugs were administered together.
Slovenian: Podatki študije interakcij med zdravili pri 32 zdravih prostovoljcih kažejo, da se prvi dan peroralne uporabe 300 mg idebenona trikrat na dan presnova midazolama, substrata encima CYP3A4, pri sočasni uporabi obeh zdravil ni spremenila.
English: Orange, round, biconvex film-coated tablet of 10 mm diameter, engraved with the Santhera logo on one side and ‘150' on the other side.
Slovenian: Oranžna, okrogla, bikonveksna filmsko obložena tableta s premerom 10 mm ter logotipom Santhera na eni strani in »150« na drugi.
English: CRS-untreated (N=94)
Slovenian: CRS-nezdravljeni (N = 94)
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Slovenian: E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI DOVOLJENJA ZA PROMET Z ZDRAVILOM V IZJEMNIH OKOLIŠČINAH
English: Clinical particulars 4.1 Therapeutic indications
Slovenian: 4.1 Terapevtske indikacije
English: - Your doctor will prescribe Raxone to you only if the benefits of the treatment are greater than the risks to the unborn child. - Raxone may pass into the mother's milk.
Slovenian: - Zdravnik vam bo zdravilo Raxone predpisal samo, če so koristi zdravljenja večje od tveganj za nerojenega otroka.
English: After repeated administration Cmax and AUC of midazolam were increased by 28% and 34%, respectively, when midazolam was administered in combination with 300 mg idebenone t.i.d.
Slovenian: Po ponavljajoči uporabi se je vrednost Cmax midazolama povečala za 28 %, AUC pa za 34 %, če so midazolam uporabljali v kombinaciji s 300 mg idebenona trikrat na dan.
English: Due to the high first-pass effect, the plasma concentrations of idebenone were generally only measurable up to 6 hours after oral administration of 750 mg Raxone, given either as a single oral dose or after repeated (14 days) t.i.d dosing.
Slovenian: Zaradi velikega učinka prvega prehoda je mogoče koncentracije idebenona v plazmi izmeriti samo do 6 ur po peroralni uporabi 750 mg zdravila Raxone v obliki enkratnega ali večkratnih (14 dni) odmerkov trikrat na dan.
English: What Raxone is and what it is used for
Slovenian: Kaj je zdravilo Raxone in za kaj ga uporabljamo
English: A post-hoc responder analysis was performed in RHODOS evaluating the proportion of patients who had a clinically relevant recovery of VA from baseline in at least one eye, defined as either: (i) improvement in VA from unable to read a single letter to able to read at least 5 letters on the ETDRS chart; or (ii) improvement in VA by at least 10 letters on the ETDRS chart.
Slovenian: V študiji RHODOS so izvedli analizo odzivnih bolnikov post hoc, s katero so ocenili delež bolnikov s klinično pomembno povrnitvijo VA od izhodišča v vsaj enem očesu, kar je bilo opredeljeno kot: (i) izboljšanje VA od nezmožnosti branja ene črke do zmožnosti branja vsaj 5 črk na lestvici ETDRS ali
English: Idebenone is used to treat vision impairment in adults and adolescents with an eye disease called Leber's Hereditary Optic Neuropathy (LHON).
Slovenian: Idebenon se uporablja za zdravljenje poslabšanja vida pri odraslih in mladostnikih z očesno boleznijo, imenovano Lebrova dedna optična nevropatija (LHON).
English: The primary endpoint “best recovery of visual acuity (VA)” was defined as the result from the eye experiencing the most positive improvement in VA from baseline to week 24 using ETDRS charts.
Slovenian: Primarni opazovani dogodek »najboljša povrnitev vidne ostrine (VA- visual acuity)« je bil opredeljen kot rezultat na očesu z največjim izboljšanjem VA od izhodišča do 24. tedna, pri čemer so uporabili lestvice ETDRS.
English: Raxone is indicated for the treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON) (see section 5.1).
Slovenian: Zdravilo Raxone je indicirano za zdravljenje vidne okvare pri mladostnikih in odraslih z Leberjevo dedno optično nevropatijo (LHON- Leber's Hereditary Optic Neuropathy) (glejte poglavje 5.1).
English: No data regarding a continuous treatment with idebenone beyond 6 months is available from controlled clinical trials.
Slovenian: V nadzorovanih kliničnih preskušanjih ni nobenih podatkov o neprekinjenem zdravljenju z idebenonom, ki traja dlje kot 6 mesecev.
English: If you take more Raxone than you should, talk to your doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Raxone, kot bi smeli Če ste vzeli večji odmerek zdravila Raxone, kot bi smeli, se takoj posvetujte z zdravnikom.
English: - Do not crush or chew the tablets.
Slovenian: - Tablet ne smete zdrobiti ali žvečiti.
English: White high-density polyethylene bottles with white polypropylene child-resistant tamper-evident twist-off caps containing 180 film-coated tablets.
Slovenian: Bele plastenke iz polietilena velike gostote z belimi polipropilenskimi, za otroke varnimi navojnimi zaporkami z zaščito pred nedovoljenim odpiranjem, ki vsebujejo 180 filmsko obloženih tablet.
English: Pharmacotherapeutic group: Psychoanaleptics, Other psychostimulants and nootropics; ATC code: N06BX13
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Psihoanaleptiki, Drugi psihostimulansi in učinkovine za obnavljanje celic CŽS; oznaka ATC: N06BX13
English: The most commonly reported adverse reactions to idebenone are mild to moderate diarrhoea (usually not requiring the discontinuation of the treatment), nasopharyngitis, cough and back pain.
Slovenian: Povzetek varnostnega profila zdravila Najpogosteje poročani neželeni učinki idebenona so blaga do zmerna driska (ki navadno ne zahteva prekinitve zdravljenja), nazofaringitis, kašelj in bolečina v hrbtu.
English: The European Medicines Agency will review any new information which may become available every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
English: In vivo idebenone is a mild inhibitor of CYP3A4.
Slovenian: Idebenon je blag zaviralec CYP3A4 in vivo.
English: In a single-visit observational follow-up study of RHODOS VA assessments from 58 patients obtained on average 131 weeks after discontinuation of treatment indicates that the effect of Raxone may be maintained.
Slovenian: 58 bolnikih, ki se je izvedla povprečno 131 tednov po koncu zdravljenja, so ugotovili, da je učinek zdravila Raxone mogoče vzdrževati.
English: Raxone contains sunset yellow (E110) which may cause allergic reactions.
Slovenian: Sončno rumeno barvilo Zdravilo Raxone vsebuje sončno rumeno barvilo (E110), ki lahko povzroči alergijske reakcije.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: The main route of elimination is metabolism, with the majority of dose excreted via the kidneys as metabolites.
Slovenian: Glavna pot izločanja je presnova, pri čemer se večina odmerka izloči skozi ledvice v obliki presnovkov.
English: If you forget to take Raxone
Slovenian: Če ste pozabili vzeti zdravilo Raxone
English: Patients with hepatic or renal impairment have not been investigated.
Slovenian: Jetrna ali ledvična okvara Bolnikov z jetrno ali ledvično okvaro niso proučevali.
English: Metabolism occurs by means of oxidative shortening of the side chain and by reduction of the quinone ring and conjugation to glucuronides and sulphates.
Slovenian: Presnova poteka prek oksidativnega krajšanja stranske verige, manjšanja kinonskega obroča in konjugacije glukuronidov ter sulfatov.
English: What Raxone looks like and contents of the pack
Slovenian: Izgled zdravila Raxone in vsebina pakiranja
English: Following oral administration pharmacologically relevant concentrations of idebenone are detectable in the aqueous humor of the eye.
Slovenian: Po peroralni uporabi je mogoče farmakološko pomembne koncentracije idebenona zaznati v prekatni vodki očesa.
English: Patients received either 900 mg/day Raxone or placebo for a period of 24 weeks (6 months).
Slovenian: Bolniki so 24 tednov (6 mesecev) prejemali 900 mg zdravila Raxone na dan ali placebo.
English: - Raxone contains lactose (a type of sugar).
Slovenian: - Zdravilo Raxone vsebuje laktozo (vrsto sladkorja).
English: Each film-coated tablet contains 150 mg idebenone.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg idebenona.
English: If you stop taking Raxone
Slovenian: Če ste prenehali jemati zdravilo Raxone
English: In the EAP the number of responders increased with longer treatment duration, from 19 out of 62 patients (30.6%) at 6 months to 17 out of 47 patients (36.2%) at 12 months.
Slovenian: (30,6 %) po 6 mesecih do 17 izmed 47 bolnikov (36,2 %) po 12 mesecih.
English: Idebenone, a short-chain benzoquinone, is an anti-oxidant assumed to be capable of transferring electrons directly to complex III of the mitochondrial electron transport chain, thereby circumventing complex I and restoring cellular energy (ATP) generation under experimental conditions of complex I deficiency.
Slovenian: Idebenon, benzokinon s kratko verigo, je antioksidant, za katerega se predvideva, da elektrone prenaša neposredno v kompleks III mitohondrijske verige za prenos elektronov, pri tem pa obide kompleks I in ponovno vzpostavi ustvarjanje celične energije (ATP) pri eksperimentalnih pogojih pomanjkanja kompleksa I. Podobno lahko idebenon pri LHON prenaša elektrone neposredno v kompleks III verige za prenos elektronov in pri tem obide kompleks I, na katerega vplivajo vse tri primarne mutacije mtDNA, ki povzročajo LHON, kar ponovno vzpostavi ustvarjanje celične ATP.
English: Raxone contains lactose.
Slovenian: Zdravilo Raxone vsebuje laktozo.
English: Tablet film-coating: macrogol, poly(vinyl alcohol), talc, titanium dioxide, sunset yellow (E110).
Slovenian: Filmska obloga tablete: makrogol, polivinil alkohol, smukec, titanov dioksid, sončno rumeno barvilo (E110).
English: Treatment should be initiated and supervised by a physician with experience in LHON.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora začeti in nadzorovati zdravnik z izkušnjami z LHON.
English: Bronchitis
Slovenian: - bronhitis
English: Contains lactose and sunset yellow (E110).
Slovenian: Vsebuje laktozo in sončno rumeno barvilo (E110).
English: Raxone contains a substance called idebenone.
Slovenian: Zdravilo Raxone vsebuje zdravilno učinkovino, imenovano idebenon.
English: In order to further investigate the benefits of Raxone in the treatment of LHON patients, the MAH should conduct and submit the results of an external natural history controlled, open-label intervention study to assess the efficacy and safety of Raxone in the treatment of LHON patients, including long-term treatment.
Slovenian: mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate zunanje, nadzorovane, odprte, intervencijske študije pojava in poteka LHON, ki bo ocenila učinkovitost in varnost zdravila Raxone pri zdravljenju bolnikov z LHON, vključno z dolgotrajnim zdravljenjem.
English: How to take Raxone
Slovenian: Kako jemati zdravilo Raxone
English: No specific dose adjustment is required for the treatment of LHON in elderly patients.
Slovenian: Pri starejših bolnikih za zdravljenje LHON posebno prilagajanje odmerka ni potrebno.
English: Fax: +49 (0) 7621 1690 201
Slovenian: Nemčija tel.: +49 (0) 7621 1690 200 faks: +49 (0) 7621 1690 201 e-pošta: office@santhera.com
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone K25, magnesium stearate and colloidal silica.
Slovenian: Jedro tablete: laktoza monohidrat, mikrokristalna celuloza, natrijev karmelozat, premreženi, povidon K25, magnezijev stearat in koloidni silicijev dioksid.
English: Raxone is not expected to affect your ability to drive or use machines.
Slovenian: Učinek zdravila Raxone na sposobnost vožnje in upravljanja strojev se ne pričakuje.
English: Therefore, CYP3A4 substrates known to have a narrow therapeutic index such as alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus,
Slovenian: CYP3A4, za katere je znano, da imajo ozek terapevtski indeks, kot so alfentanil, astemizol, terfenadin, cisaprid, ciklosporin, fentanil, pimozid, kinidin, sirolimus, takrolimus ali alkaloidi rženega rožička (ergotamin, dihidroergotamin), pri bolnikih, ki prejemajo idebenon, uporabljati previdno.
English: The following adverse reactions emerging from clinical trials in LHON patients or reported postmarketing in other indications are tabulated below.
Slovenian: V spodnji preglednici so povzeti neželeni učinki, ki so se pojavili med kliničnimi preskušanji pri bolnikih z LHON ali v obdobju trženja pri drugih indikacijah.
English: Hepatobiliary disorders Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, gammalutamyltransferase increased, blood bilirubin increased, hepatitis
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišana raven alanin-aminotransferaze, zvišana raven aspartat-aminotransferaze, zvišana raven alkalne fosfataze v krvi, zvišana raven laktat-dehidrogenaze v krvi, zvišana raven gama-glutamiltransferaze, zvišana raven bilirubina v krvi, hepatitis neznana
English: - LHON can lead to loss of eyesight due to the inactivity of cells responsible for vision.
Slovenian: - Zaradi neaktivnosti celic, odgovornih za vid, lahko LHON povzroči izgubo vida.
English: Endpoint (ITT)
Slovenian: Opazovani dogodek (ITT)
English: feeling restless, lacking energy - nausea, vomiting, loss of appetite, stomach ache - high levels of some liver enzymes in the body which mean you have liver problems - shown in tests, high levels of “bilirubin” - this can make your skin and the whites of your eyes look yellow, hepatitis - rash, itching - pain in extremity - high levels of nitrogen in the blood - shown in tests change in urine colour - generally feeling unwell
Slovenian: omotica, glavobol, nemir, pomanjkanje energije, - siljenje na bruhanje, bruhanje, izguba teka, bolečina v želodcu, - visoke ravni nekaterih jetrnih encimov v telesu, kar pomeni, da imate težave z jetri (kar se ugotovi s preiskavami), visoke ravni »bilirubina« (kar lahko obarva kožo in beločnice rumeno),
English: Your doctor will check your eye-sight before you start taking this medicine and then at regular visits while you are taking it.
Slovenian: Pred začetkom jemanja tega zdravila in ob rednih obiskih med njegovim jemanjem bo zdravnik preverjal vid.
English: Name and address of the manufacturer responsible for batch release
Slovenian: A. IPROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij
English: In RHODOS and the EAP in LHON, a total of 3 patients between the ages of 9 and 11 years and 27 patients between the ages of 12 and 17 years received idebenone at 900 mg/day for up to 33 months.
Slovenian: V študiji RHODOS in EAP pri LHON so 3 bolniki, stari od 9 do 11 let, in 27 bolnikov, starih od 12
English: Best recovery of VA (mean ± SE; 95%CI)
Slovenian: (povprečje ± SE; 95-% IZ)
English: Clinical safety and efficacy of idebenone in LHON have been assessed in one double-blind, randomised, placebo-controlled study (RHODOS).
Slovenian: randomizirani, s placebom nadzorovani študiji (RHODOS).
English: Main secondary endpoint: Change in best VA (mean ± SE; 95% CI)
Slovenian: Glavni sekundarni opazovani dogodek: sprememba najboljše VA
English: Nervous system disorders Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Slovenian: agitacija, diskinezija, hiperkinezija, poriomanija, omotica, glavobol, nemir, stupor neznana
English: Raxone 150 mg film-coated tablets idebenone
Slovenian: Raxone 150 mg filmsko obložene tablete idebenon
English: Therefore, caution should be exercised when prescribing Raxone to patients with hepatic or renal impairment.
Slovenian: Kadar se zdravilo Raxone predpiše bolnikom z jetrno ali ledvično okvaro, je treba biti previden.
English: Raxone 150 mg film-coated tablets
Slovenian: Raxone 150 mg filmsko obložene tablete
English: - Raxone contains a colourant called “sunset yellow” (also called E110).
Slovenian: - Zdravilo Raxone vsebuje barvilo, imenovano »sončno rumeno« (tj. E110).
English: CARTONS/ HDPE BOTTLE LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLE/OZNAKA NA VSEBNIKU IZ HDPE
English: Chromaturia
Slovenian: Kromaturija
English: Idebenone may inhibit P-glycoprotein (p-gp) with possible exposure increases of e.g. dabigatran etexilate, digoxin or aliskiren.
Slovenian: Idebenon lahko zavira P-glikoprotein (p-gp) z morebitnim povečanjem izpostavljenosti npr.
English: Raxone contains lactose and sunset yellow (E110)
Slovenian: Zdravilo Raxone vsebuje laktozo in sončno rumeno barvilo (E110).
English: What you need to know before you take Raxone Do not take Raxone if you are allergic to idebenone or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na idebenon ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Common (may affect up to 1 in 10 people): - diarrhoea (mild to moderate that usually does not require discontinuation of treatment) - back pain
Slovenian: - driska (blaga do zmerna, ki navadno ne zahteva prekinitve zdravljenja),
English: Back pain
Slovenian: - bolečina v hrbtu.
English: Raxone may make your urine become reddish brown.
Slovenian: Zdravilo Raxone lahko urin obarva rdečerjavo.
English: - Tell your doctor if your urine changes colour.
Slovenian: - Če opazite spremembo barve urina, o tem obvestite zdravnika.
English: Depending on the time since symptom onset and the proportion of RGCs already affected, idebenone can promote recovery of vision in patients who experience vision loss.
Slovenian: Idebenon lahko spodbuja vračanje vida pri bolnikih z izgubo vida, kar je odvisno od časa od pojava simptomov in deleža prizadetih RGC.
English: Blood cholesterol increased, blood triglycerides increased
Slovenian: Presnovne in prehranske motnje zvišana raven holesterola v krvi, zvišana raven trigliceridov v krvi neznana
English: Talk to your doctor before you stop taking this medicine.
Slovenian: Preden prenehate jemati to zdravilo, se posvetujte z zdravnikom.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Povidone K25
Slovenian: Jedro tablete laktoza monohidrat mikrokristalna celuloza natrijev karmelozat, premreženi povidon K25 magnezijev stearat koloidni silicijev dioksid
English: Nausea, vomiting, anorexia, dyspepsia
Slovenian: Bolezni prebavil driska pogosti navzeja, bruhanje, anoreksija, dispepsija neznana
English: Titanium dioxide Sunset yellow FCF (E110)
Slovenian: Obloga makrogol 3350 polivinil alkohol smukec titanov dioksid sončno rumeno barvilo FCF (E110)
English: movements that you cannot control, a tendency to wonder away, feeling dizzy, headache,
Slovenian: (halucinacije), občutek vzburjenja, nenadzorovani gibi, nagnjenost k brezciljnem beganju,
English: How to store Raxone
Slovenian: Shranjevanje zdravila Raxone
English: Preferred Term
Slovenian: Organski sistem Prednostni izraz
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj zelo pogosti
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, especially any of the following: - antihistamines to treat allergies (astemizole, terfenadine) - to treat heartburn (cisapride) - to treat muscle and speech tics associated with Tourette syndrome (pimozide) - to treat hearth rhythm disorders (quinidine) - to treat migraine (dihydroergotamine, ergotamine) - to put you to sleep called “anaesthetics” (alfentanil) - to treat inflamation in rheumatoid arthritis and psoriasis (cyclosporine) - to prevent the rejection of an organ transplant (sirolimus, tacrolimus) - to treat strong pain called “opioids” (fentanyl)
Slovenian: ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, predvsem naslednja zdravila: - antihistaminiki za zdravljenje alergij (astemizol, terfenadin), - za zdravljenje zgage (cisaprid),
English: Package leaflet: Information for the user Raxone 150 mg film-coated tablets idebenone
Slovenian: Navodilo za uporabo Raxone 150 mg filmsko obložene tablete idebenon
English: If you are breast-feeding your doctor will discuss with you whether to stop breast-feeding or to stop taking the medicine.
Slovenian: ali morate prekiniti dojenje ali prenehati uporabljati to zdravilo.
English: Unknown frequency (frequency cannot be estimated from the available data): - bronchitis - changes in blood test results: low level of white blood cells, or low level of red blood cells, or low level of platelets - increased cholesterol or fat in the blood -shown in tests - fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited,
Slovenian: - zvišana raven holesterola ali maščob v krvi, kar se ugotovi s preiskavami, - epileptični napadi, občutek zmedenosti, vidno in slušno zaznavanje stvari, ki niso resnične
English: Agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia
Slovenian: Bolezni krvi in limfatičnega sistema agranulocitoza, anemija, levkocitopenija, trombocitopenija, nevtropenija neznana
English: See section 4.
Slovenian: (Preglednica 1).
English: - Raxone film-coated tablets are orange, round tablets of 10 mm diameter, engraved with the
Slovenian: - Filmsko obložene tablete zdravila Raxone so oranžne, okrogle tablete s premerom 10 mm ter logotipom Santhera na eni strani in »150« na drugi - Zdravilo Raxone je na voljo v plastenkah.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije splošno slabo počutje neznana
English: Azotaemia, chromaturia
Slovenian: - nazofaringitis (prehlad), - kašelj.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj, pruritus neznana
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva bolečina v hrbtu pogosti bolečina v udu neznana
English: Very common (may affect more than 1 in 10 people): - nasopharyngitis (cold) - cough
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: - Raxone is supplied in white plastic bottles.
Slovenian: - Zdravilo Raxone lahko prehaja v materino mleko.
English: These reactions are usually short lived and go away within 5 to 15 days but could last up to 49 days.
Slovenian: Te reakcije so običajno kratkotrajne in izginejo v petih do 15 dneh, lahko pa trajajo do 49 dni.
English: In case of eye contact the affected area should be rinsed immediately with water.
Slovenian: V primeru stika z očmi je treba prizadeto področje nemudoma izprati z vodo.
English: The full EPAR for Zeleris can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila Zeleris je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Zeleris:
Slovenian: Druge informacije o zdravilu Zeleris:
English: Zeleris florfenicol / meloxicam
Slovenian: Zeleris florfenikol/meloksikam
English: Zeleris should not be administered by pregnant women.
Slovenian: Zdravila Zeleris ne smejo dajati nosečnice.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zeleris on 15 May 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zeleris, veljavno po vsej Evropski uniji, izdala 15/05/2017.