FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 bag (or more)
Slovenian: 1 vrečka (ali več)
English: Intravenous use bag (FEP)
Slovenian: Vreča (FEP)
English: Dispersion for infusion
Slovenian: Intravenska uporaba
English: The following indication should be deleted:
Slovenian: Izbriše se naslednja indikacija:
English: The usual dose is one capsule a day.
Slovenian: Običajni odmerek je ena kapsula na dan.
English: One capsule daily.
Slovenian: Ena kapsula na dan.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, v skladu s postopki iz poglavja 4 naslova III Direktive 2001/83/ES.
English: Section 3
Slovenian: Poglavje 3
English: Section 1
Slovenian: Poglavje 1
English: Section 4.1: Therapeutic indications
Slovenian: Poglavje 4.1: Terapevtske indikacije
English: These amendments to the relevant sections of the Product Information are the outcome of the referral procedure.
Slovenian: Spremembe zadevnih poglavij informacij o zdravilu so rezultat napotitvenega postopka.
English: Adjuvant treatment in secondary prevention after myocardial infarction, in addition to other standard therapy (e.g. statins, anti-platelet medicinal products, beta-blockers, ACE inhibitors).
Slovenian: Adjuvantno zdravljenje pri sekundarni preventivi po miokardnem infarktu kot dodatek drugi standardni terapiji (npr. statinom, antitrombocitnim zdravilom, zaviralcem adrenergičnih receptorjev beta, zaviralcem ACE).
English: Annex III Amendments to relevant sections of the Product Information
Slovenian: Priloga III Spremembe zadevnih poglavij informacij o zdravilu
English: Post Myocardial Infarction
Slovenian: Po miokardnem infarktu
English: Existing relevant information on use after a heart attack should be deleted.
Slovenian: Obstoječe informacije o uporabi po srčnem napadu, je treba izbrisati, kot je ustrezno.
English: The heading and information on dose after a heart attack should be deleted: Dose after a heart attack
Slovenian: Izbrisati je treba naslov in informacije o odmerku po srčnem napadu:
English: Existing relevant text in section 5.1 of the SmPC in relation to “secondary prevention after myocardial infarction” indication should be deleted.
Slovenian: Obstoječe besedilo v poglavju 5.1 povzetka glavnih značilnosti zdravila v povezavi s „sekundarno preventivo po miokardnem infarktu“, je treba izbrisati, kot je ustrezno.
English: For omega-3 containing medicinal products, the existing package leaflet shall be amended (deletion of the text as appropriate) as provided below:
Slovenian: Obstoječe informacije o zdravilih, ki vsebujejo omega-3 maščobne kisline, se popravijo tako, kot je navedeno spodaj (izbrisati besedilo, kot je ustrezno):
English: Section 4.2: Posology and method of administration Information related to “secondary prevention after myocardial infarction” indication should be deleted: Post Myocardial Infarction
Slovenian: Izbrisati je treba besedilo, ki se nanaša na indikacijo „sekundarna preventiva po miokardnem infarktu“: Po miokardnem infarktu
English: B. Package Leaflet: Information for the patient
Slovenian: B. Navodilo za uporabo
English: The absolute bioavailability was 74%.
Slovenian: Absolutna biorazpoložljivost je 74%.
English: ATC vet code: QP53BE01.
Slovenian: Oznaka ATC vet: QP53BE01.
English: Date of first authorisation: 20/05/2019
Slovenian: Datum pridobitve dovoljenja za promet: 20/05/2019
English: No evidence of enterohepatic recycling has been observed.
Slovenian: Ni dokazov o enterohepatičnem recikliranju.
English: The periodic safety update report (PSUR) submissions shall be synchronised and submitted at the same frequency as for the reference product.
Slovenian: Oddaja posodobljenih poročil o varnosti zdravila (PSUR) bo sinhronizirana in oddana z enako frekvenco kot pri referenčnem zdravilu.
English: 1 tablet 3 tablets 6 tablets 15 tablets
Slovenian: 1 tableta 3 tablete 6 tablet 15 tablet
English: As demodicosis is a multi-factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
Slovenian: Ker je demodikoza bolezen, na katero vplivajo številni dejavniki, je priporočljivo, če le mogoče, primerno zdraviti tudi osnovno bolezen.
English: This results in uncontrolled activity of the central nervous system and death of insects or acarines.
Slovenian: To ima za posledico nekontrolirano aktivnost centralnega živčevja in smrt insektov ali pršic.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli stranske učinke, tudi tiste, ki niso omenjeni v tem navodilu za uporabo, ali če mislite da zdravilo ni delovalo, obvestite svojega veterinarja.
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: Return the blister with the remaining chewable tablets into the carton.
Slovenian: Omot s preostalimi žvečljivimi tabletami vrnite v škatlico.
English: Pharmacotherapeutic group: Ectoparasiticides for systemic use.
Slovenian: Farmakoterapevtska skupina: Ektoparazitiki za sistemsko uporabo.
English: The tablets should not be divided.
Slovenian: Tablet se ne sme lomiti.
English: One treatment kills ticks for up to one month.
Slovenian: Eno zdravljenje ubija klope do 1 mesec.
English: EU/2/19/240/001 EU/2/19/240/002 EU/2/19/240/003 EU/2/19/240/004 EU/2/19/240/005 EU/2/19/240/006 EU/2/19/240/007 EU/2/19/240/008 EU/2/19/240/009 EU/2/19/240/010 EU/2/19/240/011 EU/2/19/240/012 EU/2/19/240/013 EU/2/19/240/014
Slovenian: EU/2/19/240/001 EU/2/19/240/002 EU/2/19/240/003 EU/2/19/240/004 EU/2/19/240/005 EU/2/19/240/006 EU/2/19/240/007 EU/2/19/240/008 EU/2/19/240/009 EU/2/19/240/010
English: Most reported adverse reactions were self-limiting and of short duration.
Slovenian: Večina neželenih učinkov o katerih so poročali je minila sama od sebe in so bili kratkotrajni.
English: Wash hands after handling the product.
Slovenian: Po rokovanju z zdravilom si umijte roke.
English: The veterinary medicinal product is individually packaged in thermoformed laminated PVC blisters with paper-backed aluminium (Aclar/PVC/Alu).
Slovenian: Zdravilo za uporabo v veterinarski medicini je posamično pakirano v toplotno oblikovane laminirane PVC pretisne omote s hrbtom iz aluminiranega papirja(Aclar/PVC/Alu).
English: For dogs above 50 kg bodyweight, use an appropriate combination of chewable tablets of different/same strengths.
Slovenian: Za pse nad 50 kg telesne mase uporabite ustrezno kombinacijo žvečljivih tablet iste ali različne jakosti.
English: The terminal plasma half-life is approximately 2 weeks in most dogs; however, half-life of afoxolaner can differ between dogs (e.g. in one study, t½ in Collies at 25 mg/kg bodyweight was up to 47.7 days) with no effect on safety.
Slovenian: Končni razpolovni čas v plazmi je pri večini psov približno 2 tedna; vendar pa razpolovni čas lahko variira med posameznimi psi (na primer, v eni študiji je bil pri psih pasem coli pri 25 mg/kg telesne mase ugotovljen razpolovni čas do 47,7 dni) brez vpliva na varnost.
English: In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 2 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Slovenian: Ker ni razpoložljivih podatkov, mora zdravljenje mladičev, mlajših od 8 tednov in/ali psov, lažjih od 2 kg temeljiti na oceni razmerja korist-tveganje odgovornega veterinarja.
English: Laboratory studies in rats and rabbits 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 in kuncih niso bili dokazani teratogeni učinki ali drugi neželeni učinki na reproduktivno sposobnost samcev in samic.
English: Strength and number of chewable tablets to be administered
Slovenian: Jakost in število žvečljivih tablet za dajanje
English: In-vitro experiments demonstrated that P-glycoprotein efflux does not occur, confirming that afoxolaner is not a substrate for the P-glycoprotein transporters.
Slovenian: In-vitro študije so dokazale, da ne pride do iztoka P-glikoproteinov, kar potrjuje, da afoksolaner ni substrat za P-glikoproteinski transport.
English: common (more than 1 but less than 10 animals in 100 animals treated) uncommon (more than 1 but less than 10 animals in 1,000 animals treated) rare (more than 1 but less than 10 animals in 10,000 animals treated) very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Severe cases may require prolonged monthly treatments.
Slovenian: hujših primerih bolezni je lahko potrebnih več mesečnih zdravljenj.
English: Treatment of flea infestation in dogs (Ctenocephalides felis and C. canis) for at least 5 weeks.
Slovenian: Zdravljenje infestacije z bolhami pri psih (Ctenocephalides felis and C. canis) vsaj 5 tednov.
English: Afoxolaner in the dog is metabolised to more hydrophilic compounds and then eliminated.
Slovenian: Afoksolaner se pri psih metabolizira v bolj hidrofilne komponente in se nato izloči.
English: Afoxolaner MERIAL kills fleas within 8 hours and ticks within 48h.
Slovenian: Zdravilo Afoxolaner MERIAL ubije bolhe v največ 8 urah in klope najkasneje v 48 urah.
English: The product should be administered at a dose of 2.7-7 mg/kg bodyweight in accordance with the following table:
Slovenian: Zdravilo uporabljajte v odmerku 2,7-7 mg/kg telesne mase, glede na spodnjo tabelo:
English: If the dog does not accept the tablets directly they may be administered with food.
Slovenian: Če pes ne sprejme samih tablet, mu jih ponudite v hrani.
English: Parasites need to start feeding on the host to become exposed to afoxolaner; therefore the risk of the transmission of parasite borne diseases cannot be excluded.
Slovenian: Paraziti se morajo začeti hraniti, da pridejo v stik z afoksolanerom, zato prenosa s paraziti prenosljivih bolezni ni mogoče izključiti.
English: The mean maximum concentration (Cmax) was 1,655 ± 332 ng/ml in plasma at 2-4 hours (Tmax) after a 2.5 mg/kg afoxolaner dose.
Slovenian: Srednja maksimalna koncentracija v plazmi (Cmax) je 1,655 ± 332 ng/ml 2-4 ure (Tmax) po dajanju odmerka 2,5 mg/kg afoksolanera.
English: Afoxolaner acts at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Slovenian: Afoksolaner deluje na od ligandov odvisne klorove kanalčke, predvsem tiste, ki so pod vplivom nevrotransmiterja gamaaminobutirične kisline (GABA), s čimer zavirajo pre- in post-sinaptični prehod kloridnih ionov skozi celično membrano.
English: The tablets are chewable and palatable to most dogs.
Slovenian: Tablete so žvečljive in okusne večini psov.
English: Monthly administration of the product until two negative skin scrapings are obtained one month apart.
Slovenian: Zdravilo se daje enkrat mesečno do dveh negativnih ostružkov kože, vzetih v razmiku 1 meseca.
English: Afoxolaner is an insecticide and acaricide belonging to the isoxazoline family.
Slovenian: Afoksolaner je insekticid in akaricid iz skupine isoksazolinov.
English: Afoxolaner distributes into tissues with a volume of distribution of 2.6 ± 0.6 l/kg and a systemic clearance value of 5.0 ± 1.2 ml/hr/kg.
Slovenian: Afoksolaner se v tkiva prerazporedi z volumnom distribucije 2.6 ± 0,6 l/kg in sistemskim clearance 5,0 ± 1,2 ml/uro/kg.
English: After oral administration in dogs, afoxolaner was shown to have high systemic absorption following administration.
Slovenian: Po peroralnem dajanju pri psih ima afoksolaner visoko sistemsko absorbcijo.
English: Each chewable tablet contains: Afoxolaner MERIAL
Slovenian: Vsaka tableta vsebuje: Afoxolaner MERIAL
English: For each strength, the chewable tablets are available in the following pack sizes: Carton with 1 blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Slovenian: Za vsako jakost so žvečljive tablete pakirane v naslednjih velikostih pakiranja: Škatlica z 1 pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z 1 žvečljivo tableto.
English: Monthly administration of the product for two consecutive months.
Slovenian: Dajanje enkrat mesečno dva zaporedna meseca.
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in breeding dogs.
Slovenian: Varnost zdravila za uporabo v veterinarski medicini v obdobju brejosti in laktacije ali razploda ni bila ugotovljena.
English: Monthly intervals throughout the flea and/or tick seasons, based on local epidemiological situations.
Slovenian: Zdravite v mesečnih intervali skozi vso sezono bolh/klopov, na podlagi lokalnih epidemioloških razmer.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Mild gastrointestinal effects (vomiting, diarrhoea), pruritus, lethargy, anorexia, and neurological signs (convulsions, ataxia and muscle tremors) have been reported very rarely.
Slovenian: Zelo redko so se pojavili blagi gastrointestinalni učinki (bruhanje, driska), pruritus, letargija, anoreksija in nevrološki znaki (konvulzije, ataksija in mišični tremor).
English: Treatment of tick infestation in dogs (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
Slovenian: Zdravljenje infestacije s klopi pri psih (Dermacentor reticulatus, Ixodes ricinus, Rhipicephalus sanguineus).
English: Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Slovenian: Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Treatment of demodicosis (caused by Demodex canis):
Slovenian: Zdravljenje demodikoze (ki jo povzroča Demodex canis):
English: Bodyweight of dog (kg)
Slovenian: Telesna masa psa (kg)
English: Treatment of demodicosis (caused by Demodex canis).
Slovenian: Zdravljenje demodikoze (ki jo povzroča Demodex canis).
English: The selective toxicity of afoxolaner between insect/acarines and mammals may be inferred by the differential sensitivity of the insect/acarines' GABA receptors versus mammalian receptors.
Slovenian: Sklepa se, da je selektivna toksičnost afoksolanera drugačna pri insektih/pršicah in sesalcih zaradi razlike v občutljivosti GABA receptorjev.
English: The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Slovenian: Zdravilo je lahko del strategije zdravljenja in preprečevanja alergijskih dermatitisov, ki jih povzroča bolhavost
English: EU/2/19/240/015 EU/2/19/240/016
Slovenian: EU/2/19/240/011 EU/2/19/240/012 EU/2/19/240/013 EU/2/19/240/014 EU/2/19/240/015 EU/2/19/240/016
English: One carton contains one blister of 1, 3 or 6 chewable tablets or 15 blisters of 1 chewable tablet.
Slovenian: Ena škatla z enim pretisnim omotom z 1, 3 ali 6 žvečljivimi tabletami, ali 15 pretisnih omotov z
English: Afoxolaner (mg)
Slovenian: afoksolaner (mg)
English: The product kills fleas before egg production and therefore prevents household contamination.
Slovenian: Zdravilo ubije bolhe preden lahko izležejo jajčeca, zato preprečuje kontaminacijo okolice z razvojnimi oblikami.
English: Further monthly administration of the product may be required based on clinical assessment and skin scrapings.
Slovenian: Na podlagi klinične ocene in kožnega ostružka je lahko potrebno z mesečnim zdravljenjem še nadaljevati.
English: Afoxolaner is active against adult fleas as well as several tick species such as Dermacentor reticulatus and D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum and Haemaphysalis longicornis.
Slovenian: Afoksolaner učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so Dermacentor reticulatus in D. variabilis, Ixodes ricinus and I. scapularis, Rhipicephalus sanguineus, Amblyomma americanum, in Haemaphysalis longicornis.
English: Treatment of flea and tick infestations:
Slovenian: Razpored zdravljenja: Zdravljenje infestacij z bolhami in klopi:
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli po EXP. Za shranjevanje zdravila niso potrebna posebna navodila.
English: Dogs 2-4 kg Dogs >4-10 kg Dogs >10-25 kg Dogs >25-50 kg
Slovenian: Psi 2 4 kg Psi >4-10 kg Psi >10-25 kg Psi >25-50 kg
English: Chewable tablets
Slovenian: Žvečljive tablete
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca zdravila, odgovornega za sproščanje serij MERIAL
English: The metabolites and parent compound are eliminated from the body via urinary and biliary excretion with the majority eliminated in the bile.
Slovenian: Metaboliti in izhodiščna snov se izločilo iz telesa preko ledvic in jeter, večinoma preko žolča.
English: For oral use.
Slovenian: Peroralno dajanje.
English: Fleas and ticks must attach to the host and commence feeding in order to be exposed to the active substance.
Slovenian: Da pride do izpostavljenosti učinkovini, se morajo bolhe in klopi pritrditi na gostitelja in pričeti s hranjenjem.
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis):
Slovenian: Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis):
English: {DD/MM/YYYY}
Slovenian: DD/MM/LLLL
English: Soy protein fines Braised beef flavouring Povidone (E1201) Macrogol 400
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob proteini soje okus govedine povidon (E1201) makrogol 400 makrogol 4000 makrogol 15 hidroksistearat glicerol (E422)
English: Treatment of sarcoptic mange (caused by Sarcoptes scabiei var. canis).
Slovenian: Zdravljenje garjavosti (ki jo povzroča Sarcoptes scabiei var. canis).
English: MERIAL
Slovenian: KARENCA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla
English: chewable tablets for dogs 2-4 kg chewable tablets for dogs >4-10 kg chewable tablets for dogs >10-25 kg chewable tablets for dogs >25-50 kg
Slovenian: Žvečljive tablete za pse 2 4 kg Žvečljive tablete za pse >4 10 kg Žvečljive tablete za pse >10 25 kg Žvečljive tablete za pse >25 50 kg
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals To prevent children from getting access to the veterinary medicinal product, remove only one chewable tablet at a time from the blister.
Slovenian: Iz omota odstranite le eno tableto naenkrat, da bi preprečili otrokom morebiten dostop do zdravila za uporabo v veterinarski medicini.
English: Mottled red to reddish brown, circular shaped (tablets for dogs 2-4 kg), or rectangular shaped (tablets for dogs >4-10 kg, tablets for dogs >10-25 kg and tablets for dogs >25-50 kg).
Slovenian: Lisaste rdeče ali rdeče-rjave, okrogle (tablete za pse 2-4 kg) ali pravokotne tablete (tablete za pse >4-10 kg, tablete za pse >10-25 kg in tablete za pse >25-50 kg).
English: No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of two to four weeks.
Slovenian: 6-kratnim zdravljenjem s 5-kratnikom največjega odmerka v dvotedenskih do štiritedenskih intervalih.
English: No adverse reactions were observed in healthy Beagle puppies over 8 weeks of age when treated with 5 times the maximum dose repeated 6 times at intervals of 2-4 weeks.
Slovenian: Pri zdravih mladičih pasme beagle, starih 8 tednov in več niso opazili nobenih neželenih učinkov med
English: Afoxolaner MERIAL tablets are chewable and palatable to most dogs.
Slovenian: Zdravilo Afoxolaner MERIAL učinkuje na odrasle bolhe kot tudi številne vrste klopov, kot so
English: Afoxolaner MERIAL 11 mg dogs 2-4 kg Afoxolaner MERIAL 28 mg dogs >4-10 kg Afoxolaner MERIAL 68 mg dogs >10-25 kg Afoxolaner MERIAL 136 mg dogs >25-50 kg afoxolaner
Slovenian: Afoxolaner MERIAL 11 mg psi 2-4 kg Afoxolaner MERIAL 28 mg psi >4-10 kg Afoxolaner MERIAL 68 mg psi >10-25 kg Afoxolaner MERIAL 136 mg psi >25-50 kg
English: To be supplied only on veterinary prescription.
Slovenian: Pretisni omot IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Afoxolaner MERIAL 11 mg chewable tablets for dogs 2-4 kg Afoxolaner MERIAL 28 mg chewable tablets for dogs >4-10 kg Afoxolaner MERIAL 68 mg chewable tablets for dogs >10-25 kg Afoxolaner MERIAL 136 mg chewable tablets for dogs >25-50 kg
Slovenian: Afoxolaner MERIAL 11 mg žvečljive tablete za pse 2-4 kg Afoxolaner MERIAL 28 mg žvečljive tablete za pse >4-10 kg Afoxolaner MERIAL 68 mg žvečljive tablete za pse >10-25 kg Afoxolaner MERIAL 136 mg žvečljive tablete za pse >25-50 kg
English: EMEA/H/C/product number
Slovenian: EMEA/H/C/številka zdravila
English: The main measure of effectiveness was based on the proportion of patients who had a complete response to treatment.
Slovenian: Glavno merilo učinkovitosti je temeljilo na deležu bolnikov, ki so se na zdravljenje v celoti odzvali.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Slovenian: Če ste vključeni v klinično preskušanje ali program sočutne uporabe in potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je zdravljenje predpisal.
English: In particular, the Committee could not conclude on the clinical benefit of the medicine.
Slovenian: Odbor zlasti ni mogel podati sklepa o klinični koristi zdravila.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Istodax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Istodax je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 15 November 2012.
Slovenian: Po preučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 15. novembra 2012 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
English: Refusal of the marketing authorisation for Istodax (romidepsin) EMA/725439/2012
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Istodax (romidepsin) EMA/725439/2012
English: The effects of Istodax were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Istodax so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: In the study, Istodax was not compared with any other treatment.
Slovenian: V študiji zdravila Istodax niso primerjali z nobeno drugo obliko zdravljenja.