FrancophonIA/ELRC3.0 huggingface dataset:
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional
Slovenian: Za dodatne informacije glejte povzetka glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
English: Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval of tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Slovenian: Sočasna uporaba zdravila Victrelis s takrolimusom zahteva bistveno zmanjšanje odmerka in podaljšanje intervala odmerjanja takrolimusa.
English: Table 6 Sustained Virologic Response (SVR)*, End of Treatment (EOT) and HCV Relapse Rates
Slovenian: Preglednica 6 Trajen virološki odziv (SVR)*, konec zdravljenja (KZ) in HCV recidiv † - deleži pri preiskovancih s sočasno okužbo s HIV, ki se še niso zdravili
English: Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema) have been observed during combination therapy with Victrelis, peginterferon alfa, and ribavirin.
Slovenian: Med kombiniranim zdravljenjem z zdravilom Victrelis, peginterferonom alfa in ribavirinom so opazili resne, akutne preobčutljivostne reakcije (npr. urtikarijo, angioedem).
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines (alprazolam, midazolam, triazolam).
Slovenian: Med sočasno uporabo zdravila Victrelis in intravenskih benzodiazepinov (alprazolama, midazolama, triazolama) je treba bolnika natančno klinično spremljati glede depresije dihanja in/ali dolgotrajne sedacije.
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose.
Slovenian: Za dodatne informacije o zmanjšanju odmerka oz. prenehanju uporabe peginterferona alfa in/ali ribavirina glejte povzetek glavnih značilnosti zdravila za peginterferon alfa in ribavirin.
English: Complete blood counts (with white blood cell differential counts) should be obtained at pretreatment, and at Treatment Weeks 2, 4, 8, 12 and should be monitored closely at other time points, as clinically appropriate.
Slovenian: Preiskavo popolne krvne slike (z diferencialno sliko belih krvnih celic) je treba opraviti pred zdravljenjem in 2., 4., 8. ter 12. teden zdravljenja in jo skrbno spremljati, ko je klinično primerno.
English: Very common (may affect more than 1 in 10 people) General: headache; chills, fever; feeling sick (nausea); flu-like symptoms; feeling dizzy, low energy; not being able to sleep; low appetite, weight loss; shortness of breath Mouth, nose or throat: cough; dry mouth; funny taste Skin and hair: dry skin, itching, rash; hair loss or thinning of hair Joints and muscles: unusual weakness; painful, swollen joints; muscle ache not caused by exercise
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) Splošno: glavobol, mrzlica, zvišana telesna temperatura, siljenje na bruhanje (navzea), gripi podobni simptomi, omotica, pomanjkanje energije, nespečnost, slab apetit, hujšanje, težko dihanje (kratka sapa)
English: Gastroenteritis*, pneumonia*, staphylococcal infection*, candidiasis, ear infection, fungal skin infection, nasopharyngitis, onychomycosis, pharyngitis, respiratory tract infection, rhinitis, skin infection, urinary tract
Slovenian: Neželeni učinek bronhitis*, celulitis*, herpes simpleks, gripa, glivična okužba v ustih, sinuzitis gastroenteritis*, pljučnica*, stafilokokna okužba*, kandidoza, okužba ušesa, glivična okužba kože, nazofaringitis, onihomikoza, faringitis, okužba dihal, rinitis, okužba kože, okužba sečil epiglotitis*, vnetje srednjega ušesa, sepsa Benigne, maligne in neopredeljene neoplazme (vključno s cistami in polipi) neoplazma na ščitnici (vozliči)
English: Epistaxis, nasal congestion, oropharyngeal pain, respiratory tract congestion, sinus congestion, wheezing Pleuritic pain*, pulmonary embolism*, dry throat, dysphonia, increased upper airway secretion, oropharyngeal blistering
Slovenian: plevralna bolečina*, pljučna embolija*, suho žrelo, disfonija, močnejša sekrecija v zgornjih dihalih, orofaringealni mehurji
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 44 weeks (Victrelis-PR48).
Slovenian: • Peginterferon alfa-2b + ribavirin 4 tedne in nato 800 mg zdravila Victrelis trikrat na dan + peginterferon alfa-2b + ribavirin 44 tednov (Victrelis-PR48).
English: • Store outside of the refrigerator at or below 30C for a period of not more than 3 months until expiry.
Slovenian: • Shranjujte izven hladilnika pri temperaturi do 30 C ne več kot 3 mesece in do izteka roka uporabnosti.
English: • Peginterferon alfa-2b + ribavirin for 4 weeks followed by Victrelis 800 mg three times daily + peginterferon alfa-2b + ribavirin for 32 weeks.
Slovenian: • Peginterferon alfa-2b + ribavirin 4 tedne in nato 800 mg zdravila Victrelis trikrat na dan + peginterferon alfa-2b + ribavirin 32 tednov.
English: Reminder: Please also read the “Do not use” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Slovenian: Opozorilo: Preden začnete jemati zdravilo Victrelis, prosimo, preberite tudi poglavje "Ne jemljite zdravila" v navodilu za uporabo za peginterferon alfa in ribavirin.
English: Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Slovenian: Preiskovanci so bili randomizirani v razmerju 2:1 ter razdeljeni glede na cirozo/fibrozo in HCV-RNA v izhodišču
English: Table 4
Slovenian: RESPOND-2
English: Sexual: missing menstrual period; heavy or prolonged menstrual period; uterine bleeding (i.e., prolonged >7 days or excessive bleeding at irregular or more frequent than normal intervals, bleeding occurring in menopausal women at least 6 months to 1 year after cessation of cycles) Mental illness: anger; hostile attitude or behaviour; threatening behaviour; substance abuse problems, abnormal behaviour; feeling of confusion; thoughts of suicide; sudden intense fear or apprehension; feeling you are being persecuted; difficulty solving problems Muscles: pain in your bones; local or widespread pain
Slovenian: Duševne bolezni: jeza, sovražnost ali sovražno obnašanje, grozeče obnašanje, težave z zlorabo substanc, nenormalno obnašanje, občutek zmedenosti, razmišljanje o samomoru, nenaden močan strah ali bojazen, preganjavica, težave pri reševanju problemov Mišice: bolečina v kosteh, lokalna ali široko razširjena bolečina
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, zaviralci proteaz,
English: Stomach and gut: pain in stomach and in the upper right side of the stomach or back; a burning feeling in the stomach, upset stomach; feeling bloated, burping (belching) Anus: wind (flatulence); piles (haemorrhoids); difficulty passing stools (constipation) Urinary: going to the toilet to urinate more often than usual Sexual: a decrease in sex drive; difficulty getting or keeping an erection Mental illness: changes in mood, feeling agitated; memory loss, trouble concentrating Chest: difficulty breathing; chest discomfort, chest pain; heavy feeling in the chest, with
Slovenian: Želodec in črevo: bolečina v želodcu in zgornji desni strani trebuha ali hrbta, pekoč občutek v želodcu, razdražen želodec, napihnjenost, spahovanje Zadnjik: vetrovi (flatulenca), zlata žila (hemoroidi), težave pri iztrebljanju blata (zaprtje) Sečila: pogostejše uriniranje kot po navadi
English: Relapser: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but had undetectable HCV-RNA at the end of treatment.
Slovenian: Bolnik z recidivom: preiskovanec, pri katerem po najmanj 12 tednih predhodnega zdravljenja s peginterferonom alfa-2b in ribavirinom ni bil dosežen SVR, je pa imel nezaznavno HCV-RNA ob
English: Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Slovenian: Za informacijo o zmanjšanju odmerka in/ali prekinitvi oz. ukinitvi uporabe ribavirina glejte povzetek glavnih značilnosti zdravila za ribavirin.
English: If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue
Slovenian: TZ vrednost HCV-RNA večjo ali enako 100 i.e./ml: ukinite zdravljenje s tremi
English: Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with direct-acting antivirals not given in combination with peginterferon alfa and ribavirin.
Slovenian: Med zdravljenjem ali po zdravljenju z neposredno delujočimi protivirusnimi zdravili, ki jih niso uporabljali v kombinaciji s peginterferonom alfa in ribavirinom, so poročali o primerih reaktivacije HBV, nekaterih s smrtnim izidom.
English: It is not known whether boceprevir is excreted in human breast milk.
Slovenian: Ni znano, ali se boceprevir
English: The subjects were then continued on different treatment regimens based on TW 8 response-guide therapy (Victrelis-RGT).
Slovenian: Preiskovanci so nato nadaljevali zdravljenje po različnih shemah, upoštevaje zdravljenje glede na odziv v 8.
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in patients co-infected with hepatitis B virus
Slovenian: Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C genotipa 1 pri bolnikih, ki imajo sočasno okužbo z virusom hepatitisa B (HBV) in HCV, nista bili raziskani.
English: Not studied
Slovenian: Medsebojno delovanje ni raziskano.
English: Relapse rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable at EOT and not missing EOF data.
Slovenian: Delež recidiva je bilo razmerje števila preiskovancev z nezaznavno HCV-RNA na koncu zdravljenja (KZ) in zaznavno HCV-RNA na koncu spremljanja (KS) med preiskovanci, ki so imeli nezaznavno HCV-RNA ob KZ in niso imeli manjkajočih podatkov na KS.
English: No dose adjustment of omeprazole or Victrelis is recommended.
Slovenian: Prilagoditev odmerka omeprazola ali zdravila Victrelis ni potrebna.
English: 3 mg daily + ethinyl estradiol 0.02 mg daily + Victrelis 800 mg three times daily)
Slovenian: Noretindron†/etinilestradiol: (noretindron 1 mg na dan + etinilestradiol 0,035 mg na dan + zdravilo Victrelis 800 mg trikrat na dan)
English: Refer to Summary of Product Characteristics for ribavirin and peginterferon alfa for additional information.
Slovenian: Za dodatne informacije glejte povzetek glavnih značilnosti zdravila za ribavirin in peginterferon alfa.
English: No dose adjustment required for Victrelis or tenofovir.
Slovenian: Odmerka zdravila Victrelis ali tenofovirja ni treba prilagoditi.
English: Victrelis in combination with peginterferon alfa and ribavirin is not recommended in patients who
Slovenian: Uporaba zdravila Victrelis v kombinaciji s peginterferonom alfa in ribavirinom ni priporočljiva pri bolnikih, ki imajo v izhodišču število trombocitov < 100.000/mm
English: Medicines metabolized primarily by CYP3A4/5 may have increased exposure when administered with Victrelis, which could increase or prolong their therapeutic and adverse reactions (see Table 2).
Slovenian: Izpostavljenost zdravilom, ki se presnavljajo primarno s CYP3A4/5, se lahko med uporabo z zdravilom Victrelis poveča.
English: This is not observed in mice
Slovenian: Pri miših ali opicah tega niso opazili.
English: o Subjects with a detectable HCV-RNA at TW 8 but subsequently undetectable at TW 12 (late responders) were changed in a blinded fashion to placebo at the TW 36 visit and continued treatment with peginterferon alfa-2b + ribavirin for an additional 12 weeks, for a total treatment duration of 48 weeks.
Slovenian: TZ na "slep" način prešli na placebo ter nadaljevali zdravljenje s peginterferonom alfa-2b in ribavirinom dodatnih 12 tednov, tako da je
English: No dose adjustment of buprenorphine/naloxone or Victrelis is recommended.
Slovenian: Prilagoditev odmerkov buprenorfina/naloksona ali zdravila Victrelis ni potrebna.
English: Talk to your doctor or pharmacist before taking your medicine if you:
Slovenian: Pred začetkom jemanja zdravila se posvetujte z zdravnikom ali farmacevtom:
English: No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment.
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvaro jeter odmerka zdravila Victrelis ni treba prilagoditi.
English: A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4).
Slovenian: Rezultati iz študije s peginterferonom alfa-2b pri že zdravljenih bolnikih so bili skladni z rezultati iz
English: Merck Sharp & Dohme d.o.o.
Slovenian: Česká republika Merck Sharp & Dohme s.r.o.
English: Erectile dysfunction Amenorrhoea, menorrhagia, metrorrhagia
Slovenian: amenoreja, menoragija, metroragija
English: Skin and hair: cold sores, tingling or numbness of the skin; reduced feeling or sense of touch; skin rash, patchy skin rash, red skin; red raised skin rash sometimes with pus-filled blisters; hot, tender and red skin, sometimes with fever and chills; increased sweating; skin disease with thick patches of red skin - often with silvery scales Joints and muscles: muscle spasm; feeling tired, muscle weakness, feeling cold; back pain,
Slovenian: Oči in ušesa: suhost oči, zvonjenje v ušesih, spremembe vida Usta, nos in žrelo: bolečina v ustih, zobobol, bolečina pri požiranju, krvavitev iz nosu, zamašen nos, spremembe voha, boleče in privzdignjene lehe v ustih, občutek velike žeje ter suha usta ali suha koža, oteklost ščitnice, vratu ali glasilk, zmanjšano delovanje ščitnice, bolečnost ali oteklost v ustih, pekoč občutek na jeziku, občutek napetosti in polnosti v nosu, licih in za očmi - včasih z utripajočo bolečino, zvišano telesno temperaturo ali zamašenim nosom (sinuzitis) Koža, lasje in dlake: herpes, mravljinčenje ali omrtvičenost kože, zmanjšan občutek ali zaznava dotika, kožni izpuščaj, lisast kožni izpuščaj, rdeča koža, rdeč privzdignjen kožni izpuščaj, včasih z gnojnimi mehurji, vroča, občutljiva in rdeča koža, včasih z zvišano telesno temperaturo in mrzlico, močnejše znojenje, kožna bolezen z debelimi rdečimi lisami - pogosto s
English: Boceprevir also undergoes, to a lesser extent, oxidative metabolism
Slovenian: V manjši meri se boceprevir presnovi tudi oksidativno s CYP3A4/5.
English: Reminder: Please also read the “Possible side effects” in the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.
Slovenian: Opozorilo: Preden začnete jemati zdravilo Victrelis, prosimo, preberite tudi poglavje "Možni neželeni učinki" v navodilih za uporabo za peginterferon alfa in ribavirin.
English: It is not recommended to co-administer lopinavir/ritonavir and Victrelis.
Slovenian: Sočasne uporabe lopinavirja/ritonavirja in zdravila Victrelis ne priporočamo.
English: SVR § % (n/N) EOT % (n/N) Relapse
Slovenian: SVR (n/N) KZ % (n/N) Recidiv (n/N)
English: No dose adjustment of Victrelis is required in patients with any degree of renal impairment (see
Slovenian: Pri bolnikih z okvaro ledvic (ne glede na stopnjo) odmerka zdravila Victrelis ni treba prilagoditi
English: The SVR rates in subjects randomized to receive ribavirin dose reduction and randomized to receive
Slovenian: Delež SVR pri preiskovancih, randomiziranih v skupino, ki je prejemala zmanjšan odmerka ribavirina, in preiskovancih, randomiziranih v skupino, ki je prejemala eritropoetina, je bil primerljiv.
English: PROTON PUMP INHIBITOR Omeprazole*: (omeprazole 40 mg daily + Victrelis 800 mg three times daily)
Slovenian: Escitalopram* (escitalopram 10 mg enkratni odmerek + zdravilo Victrelis 800 mg trikrat na dan)
English: It is not recommended to co-administer darunavir/ritonavir and Victrelis.
Slovenian: Sočasne uporabe darunavirja/ritonavirja in zdravila Victrelis ne priporočamo.
English: • The Patient Information Leaflet
Slovenian: Shranjevanje pri bolniku
English: EXP
Slovenian: aspermija
English: Relapsers
Slovenian: Izdelovalec
English: HCV Relapse Rate was the proportion of subjects with undetectable HCV-RNA at End of Treatment (EOT) and detectable HCV-RNA at End of Follow-up (EOF) among subjects who were undetectable
Slovenian: Delež HCV recidiva je bilo razmerje števila preiskovancev z nezaznavno HCV-RNA na koncu zdravljenja (KZ) in zaznavno HCV-RNA na koncu spremljanja (KS) pri preiskovancih, ki so imeli nezaznavno HCV-RNA ob KZ in niso imeli manjkajočih podatkov na KS.
English: Cases of pancytopenia have been reported in patients receiving Victrelis in combination with peginterferon alfa and ribavirin.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Victrelis v kombinaciji s peginterferonom alfa in ribavirinom, so poročali o primerih pancitopenije.
English: Please refer to the Summary of Product Characteristics for peginterferon alfa for the contraindication in patients with decompensated liver disease.
Slovenian: Glede kontraindikacij pri bolnikih z dekompenzirano boleznijo jeter, prosimo, glejte povzetek glavnih značilnosti zdravila za peginterferon alfa.
English: HCV protease monotherapy
Slovenian: 1 HCV-RNA v plazmi
English: Pregnancy must be avoided due to the use of Victrelis with ribavirin.
Slovenian: Zaradi uporabe zdravila Victrelis z ribavirinom ženska ne sme zanositi.
English: Maximum daily dose of Victrelis is 2,400 mg. Administration without food could be associated with a net loss of efficacy due to sub-optimal exposure.
Slovenian: Pri uporabi brez hrane bi se zaradi suboptimalne izpostavljenosti lahko zmanjšala učinkovitost zdravila.
English: No clinically significant differences in pharmacokinetic parameters were observed between patients with end-stage renal disease (ESRD) and healthy subjects.
Slovenian: Med bolniki s končno odpovedjo ledvic in zdravimi preiskovanci niso ugotovili klinično pomembnih razlik v farmakokinetičnih parametrih.
English: These are called peginterferon alfa and ribavirin.
Slovenian: Med preiskovanci, ki so prejemali samo peginterferon alfa-2b in ribavirin, je
English: Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being
Slovenian: Duševne bolezni: spremembe razpoloženja, občutek, da vam življenje razpada, videnje, občutenje ali slišanje stvari, ki niso resnične (halucinacije), misli na samomor, poskus samomora, občutek velike sreče (manija) in potem občutek globoke žalosti ali ničvrednosti Prsni koš: kratka sapa v leže, resna okužba pljuč, npr. pljučnica, ostre bolečine v prsnem košu, ki se poslabšajo pri dihanju, bolečina za prsnico, ki se lahko širi v vrat in rame Srce in obtočila: srčni infarkt, prenehanje dihanja, krvni strdek v nogi ali roki, zmanjšan pretok krvi v delih možganov (npr. omotica, dvojni vid ali šibkost obeh strani telesa)
English: Plasma trough concentrations of Victrelis were decreased when administered with efavirenz.
Slovenian: V primeru uporabe skupaj z efavirenzem se je najmanjša koncentracija zdravila Victrelis v plazmi zmanjšala.
English: FW 24.
Slovenian: v plazmi 24. teden spremljanja.
English: Administer peginterferon alfa and ribavirin for 4 weeks, and then
Slovenian: Trajanje zdravljenja = 28 tednov 1. 4 tedne uporabljajte peginterferon alfa in ribavirin, nato
English: 22 July 2010
Slovenian: 22 julija 2010
English: The proposal was rejected by the majority of CVMP members.
Slovenian: Predlog je večina članov CVMO zavrnila.
English: The application was submitted in the framework of Article 32 of Directive 2001/82/EC, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Poland, Portugal, Slovakia, Spain and Sweden.
Slovenian: Vloga je bila predložena v skladu s členom 32 Direktive 2001/82/ES, kakor je bila spremenjena, pri čemer je bilo Združeno kraljestvo referenčna država članica, Avstrija, Belgija, Ciper, Češka republika, Danska, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Luksemburg, Nizozemska, Norveška, Poljska, Portugalska, Slovaška, Španija in Švedska pa zadevne države članice.
English: The Mutual Recognition Procedure UK/V/0321/001/MR started on 1 May 2008.
Slovenian: Postopek medsebojnega priznavanja UK/V/0321/001/MR se je začel 1. maja 2008.
English: The opinion was converted into a Decision by the European Commission on 22 July 2010.
Slovenian: Mnenje je bilo spremenjeno v odločbo Evropske komisije dne 22 julija 2010.
English: Article 33(4) of Directive 2001/82/EC, as amended.
Slovenian: Clen 33(4) Direktive 2001/82/ES, kakor je bila spremenjena.
English: The referral procedure started on 12 November 2008.
Slovenian: Napotitveni postopek se je začel 12. novembra 2008.
English: Given that no absolute majority was attained, the opinion of 15 July 2009 stands.
Slovenian: Glede na to, da ni bila dosežena absolutna večina, mnenje z dne 15 julija 2009 še vedno velja.
English: The Rapporteur and Co-Rapporteur appointed were: Prof. Christian Friis and Dr Valda Sejane, respectively.
Slovenian: Za poročevalca in soporočevalca sta bila imenovana: prof. Christian Friis oziroma dr. Valda Sejane.
English: On 4 November 2008, the United Kingdom, referred the matter to the Agency under Article 33(4) of Directive 2001/82/EC, due to concerns, raised by Belgium and Sweden, that the efficacy of the product has not been sufficiently demonstrated.
Slovenian: Združeno kraljestvo je 4. novembra 2008 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na agencijo zaradi zadržkov, ki sta jih izpostavili Belgija in Švedska, in sicer, da učinkovitost zdravila ni bila zadostno dokazana.
English: Oral explanations were given on 16 June 2009.
Slovenian: Ustna pojasnila je podal 16. junija 2009.
English: During its 15-17 September 2009 meeting, the CVMP appointed Dr David Murphy as rapporteur and Dr Jiří Bureš as co-rapporteur for the re-examination of the above mentioned opinion.
Slovenian: Na zasedanju CVMP od 15. do 17. septembra 2009 je bil dr. David Murphy imenovan za poročevalca in dr. MJiří Bureš za soporočevalca v postopku ponovne proučitve zgoraj omenjenega mnenja.
English: The detailed grounds for the re-examination were submitted by CEVA Animal Health Ltd on 21 September 2009 and the re-examination procedure started on 22 September 2009.
Slovenian: Podrobne razloge za ponovno proučitev je družba CEVA Animal Health Ltd predložila 21. septembra 2009, postopek ponovne presoje pa se je začel 22. septembra 2009.
English: On 5 August 2009, CEVA Animal Health Ltd notified the Agency of its intention to request a reexamination of the CVMP opinion of 15 July 2009.
Slovenian: Dne 5. avgusta 2009 je družba CEVA Animal Health Ltd obvestila agencijo, da namerava zaprositi za ponovno ovrednotenje mnenja CVMP z dne 15. julija 2009.
English: Written explanations were provided by the Applicant on 16 February 2009.
Slovenian: Predlagatelj je pisna pojasnila predložil 16. februarja 2009.
English: Based on the evaluation of the rapporteurs' assessment of the currently available data, the CVMP considered that the application does not satisfy the criteria for authorisation in respect of efficacy.
Slovenian: Na podlagi ocene poročevalčevega vrednotenja trenutno razpoložljivih podatkov je Odbor za zdravila za uporabo v veterinarski medici (CVMP) menil, da vloga glede učinkovitosti ne ustreza merilom za odobritev.