FrancophonIA/ELRC3.0 huggingface dataset:
English: In these categories of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or the national Competent Authorities, depending on the current vaccination policies against bluetongue virus.
Slovenian: Pri teh kategorijah živali lahko cepivo uporabimo le na podlagi ocene o koristi in tveganju, ki jo pripravita pristojni veterinar in/ali nacionalni pristojni organ, odvisno od veljavnega programa cepljenja proti virusu bolezni modrikastega jezika..
English: MANUFACTURER'S BATCH NUMBER Lot{number}
Slovenian: IZDELOVALČEVA ŠTEVILKA SERIJE
English: In very rare cases vaccination may result in a slight rise in temperature (usually not more than 0.5 °C, in individual cases up to about 2 °C) for up to three days after vaccination, and temporary swellings at the injection site.
Slovenian: V zelo redkih primerih cepljenje lahko povzroči blago povišanje telesne temperature (običajno ne za več kot 0,5°C, pri posamičnih živalih do približno 2°C), kar traja do tri dni po cepljenju, in začasno oteklino na mestu vboda.
English: In cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of the vaccinated animals.
Slovenian: Pri govedu lahko majhne otekline otipamo do šest tednov po cepljenju pri približno tretjini cepljenih živali.
English: Bovilis BTV8 is an inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Slovenian: Bovilis BTV8 je inaktivirano virusno cepivo za vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika.
English: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The NETHERLANDS
Slovenian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer NIZOZEMSKA
English: 4.3 Contraindications None.
Slovenian: 4.3 Kontraindikacije
English: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer The NETHERLANDS
Slovenian: Intervet International BV Wim de Körverstraat 35, 5831 AN Boxmeer NIZOZEMSKA
English: The safety and efficacy of the vaccine has not been established in breeding males.
Slovenian: Varnost in učinkovitost cepiva nista dokazani pri plemenskih samcih.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako ciljno vrsto
English: Shake the bottle before use and periodically during use.
Slovenian: Vialo pred uporabo in občasno med uporabo pretresite.
English: (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants
Slovenian: (*pri piščancih vzbudi titer protiteles z nevtralizirajočim učinkom na virus ≥ 5,0 log2) Dodatki
English: IMMUNOLOGICAL PROPERTIES ATCvet code: Sheep: QI04AA02 Cattle: QI02AA08 Inactivated viral vaccine, to stimulate active immunity against bluetongue virus serotype 8.
Slovenian: ovce: QI04AA02 goveda: QI02AA08 Inaktivirano virusno cepivo za vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika
English: Sodium chloride Maleic acid Simeticone emulsion Aluminium hydroxide Saponin
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol natrijev klorid maleinska kislina emulzija simetikona aluminijev hidroksid saponin voda za injekcije
English: PACKAGE LEAFLET FOR: Bovilis BTV8 suspension for injection for cattle and sheep
Slovenian: Bovilis BTV8 suspenzija za injiciranje za govedo in ovce
English: Shelf life after first opening the immediate packaging: 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: 8 ur, če cepivo ni izpostavljeno temperaturi nad 37 °C ali kontaminirano.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (1 ml) contains:
Slovenian: En odmerek (1 ml) vsebuje:
English: Special precautions for use in animals: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za uporabo pri živalih Cepite samo zdrave živali.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this 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: Cattle and sheep.
Slovenian: Govedo in ovce
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Slovenian: Pri drugih domačih in divjih vrstah prežvekovalcev, za katere menimo, da jih ogroža okužba, je treba cepivo uporabiti previdno in ga pred masovnim cepljenjem testirati na majhnem številu živali.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis BTV8
Slovenian: Bovilis BTV8
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/106/001-014
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10./106./001-014
English: Onset of immunity:
Slovenian: Začetek imunosti:
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROSTITEV SERIJE
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: Inkompatibilnosti Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Opalescent pink with resuspendable sediment.
Slovenian: Suspenzija za injiciranje Opalescentno roza s sedimentom, ki se resuspendira.
English: In sheep, these swellings typically last for up to three weeks, while in cattle small palpable swellings may still be present up to six weeks after vaccination in approximately one third of vaccinates.
Slovenian: Pri ovcah traja oteklina do tri tedne, medtem ko lahko pri govedu majhne otekline otipamo do šest tednov po cepljenju pri približno tretjini cepljenih živali.
English: EXP {month/year} Once broached, use within 8 hours.
Slovenian: Odprto zdravilo uporabite v 8 urah.
English: Duration of immunity: 6 months.
Slovenian: Trajanje imunosti:
English: Bluetongue virus serotype 8 (prior to inactivation): 500 antigenic units*.
Slovenian: Virus bolezni modrikastega jezika, serotip 8 (pred inaktivacijo): 500 antigenskih enot*
English: In sheep, swellings may still be palpable after six weeks.
Slovenian: Pri ovcah so lahko otekline otipljive še po šestih tednih.
English: In sheep these swellings typically last for up to three weeks.
Slovenian: Pri ovcah traja oteklina do tri tedne.
English: Any person intending to manufacture, import, possess, sell, supply and use Bovilis BTV8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Bovilis BTV8, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred izdelovanjem, uvozom/vnoson, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Slovenian: Ker trajanje imunosti še ni natančno določeno, mora shemo revakcinacije odobriti pristojni organ ali odgovorni veterinar ob upoštevanju lokalne epidemiološke situacije.
English: PET vials of 10, 20, 50, 100, 200, 250 or 500 ml, with a rubber stopper and aluminium cap.
Slovenian: Viale iz PET po 10, 20, 50, 100, 200, 250 ali 500 ml z gumijastimi zamaški in aluminijastimi zaporkami
English: Vials: 100 ml 200 ml 250 ml 500 ml
Slovenian: Viale 100 ml 200 ml 250 ml 500 ml
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP.Once broached use within 8 hours, provided the product is not subject to temperatures above 37 °C or contaminated.
Slovenian: Odprto zdravilo uporabite v 8 urah, če zdravilo ni izpostavljen temperaturi nad 37 °C ali kontaminirano.
English: To stimulate active immunity in cattle from 6 weeks of age against bluetongue virus serotype 8 to reduce viraemia*.
Slovenian: Vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika pri govedu od starosti 6 tednov, da zmanjšamo viremijo.
English: Shelf life of the veterinary medicinal product as packaged for sale for 10, 20, 50 ml vials: 2 years Shelf life of the veterinary medicinal product as packaged for sale for 100, 200, 250, 500 ml vials: 1 year.
Slovenian: Rok uporabnosti zdravila za uporabo v veterinarski medicini v pakiranju za prodajo za viale po 100, 200, 250, 500 ml: 1 leto
English: No adverse reactions other than those described in section 4.6 were observed following administration of a double dose in cattle and sheep.
Slovenian: Dajanje dvojnega odmerka pri govedu in ovcah ni povzročilo neželenih reakcij, ki bi se razlikovale od reakcij, opisanih v poglavju 4.6.
English: CLINICAL PARTICULARS
Slovenian: IMUNOLOŠKE LASTNOSTI
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Bluetongue virus serotype 8: 500 antigenic units/ml.
Slovenian: Serotip 8 virusa bolezni modrikastega jezika: 500 antigenskih enot/ml
English: Cattle from 6 weeks of age: subcutaneous injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Slovenian: Govedo od 6 mesecev starosti: dva odmerka po 1 ml subkutano v razmiku približno 3 tednov.
English: Sheep from 1 month of age: subcutaneous injection of a single dose of 1 ml.
Slovenian: Ovce od starosti 1 meseca: enkratni odmerek po 1 ml subkutano.
English: Active ingredient: bluetongue virus serotype 8: 500 antigenic units* (* inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2) Adjuvants: aluminium hydroxide, saponin.
Slovenian: Zdravilna učinkovina: serotip 8 virusa bolezni modrikastega jezika: 500 antigenskih enot* (*pri piščancih vzbudi titer protiteles z nevtralizirajočim učinkom na virus ≥ 5,0 log2.)
English: To be supplied only on veterinary prescription.
Slovenian: Na veterinarski recept
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (10, 20, 50, 100, 200, 250 or 500 ml) PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials (100, 200, 250 or 500 ml PET vials)
Slovenian: Kartonska škatla (10, 20, 50, 100, 200, 250 ali 500 ml)
English: The vaccine is presented in cardboard boxes with 1 or 10 PET vials containing 10, 20, 50, 100, 200, 250 or 500 ml, closed with a rubber stopper and aluminium cap.
Slovenian: Cepivo je pakirano v kartonske škatle z 1 ali 10 vialami iz PET po 10, 20, 50, 100, 200, 250 ali
English: TARGET SPECIES Cattle and sheep
Slovenian: Goveda in ovce
English: Veterinary medicinal product subject to prescription.
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
English: Fertility:
Slovenian: Plodnost
English: Sheep from 1 month of age: injection of a single dose of 1 ml.
Slovenian: Osnovno cepljenje: Ovce od starosti 1 meseca: enkratni odmerek po 1 ml
English: Cattle from 6 weeks of age: injection of two doses of 1 ml, administered with an interval of approximately 3 weeks.
Slovenian: Osnovno cepljenje: Govedo od 6 mesecev starosti: dva odmerka po 1 ml v razmiku približno 3 tednov.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: Bovilis BTV8suspenzija za injiciranje za govedo in ovce IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJE, ČE STA RAZLIČNA
English: To stimulate active immunity in sheep from 1 month of age against bluetongue virus serotype 8 to prevent viraemia*.
Slovenian: Ovce Vzbujanje aktivne imunosti proti serotipu 8 virusa bolezni modrikastega jezika pri ovcah od starosti 1
English: Subcutaneous use.
Slovenian: Subkutana uporaba Ovce
English: Date of last renewal:
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Pregnancy and lactation: The vaccine can be used during pregnancy and lactation.
Slovenian: LLahko se uporablja v obdobju brejosti in laktacije.
English: 4.11 Withdrawal period(s)
Slovenian: 6.3 Rok uporabnosti
English: Contraindications relating to children less than 3 years of age and breastfeeding women were not included due to the lack of adequate data to support such contraindications.
Slovenian: Kontraindikacije, ki se nanašajo na otroke, mlajše od 3 let, in doječe matere, niso bile vključene zaradi pomanjkanja ustreznih podatkov za podporo takim kontraindikacijam.
English: Overall summary of the scientific evaluation by the CHMP
Slovenian: Splošni povzetek znanstvenega vrednotenja odbora CHMP
English: Also patients with severe renal impairment may require a lower initial dose, with subsequent adjustments.
Slovenian: Tudi pri bolnikih s hudo ledvično okvaro je morda potreben manjši začetni odmerek z naknadnimi prilagoditvami.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission (EC) notified the European Medicines Agency's Secretariat of an official referral under Article 30 of Directive 2001/83/EC in order to resolve the divergences amongst the nationally approved SmPCs and thus to harmonise its divergent SmPCs across the EU.
Slovenian: Zaradi razhajajočih se nacionalnih odločitev, ki so jih sprejele države članice v zvezi z odobritvijo zgoraj navedenega zdravila (in povezanih imen), je Evropska komisija obvestila sekretariat Evropske agencije za zdravila o uradni napotitvi v skladu s členom 30 Direktive 2001/83/ES z namenom razrešitve razhajanj med nacionalno odobrenimi povzetki glavnih značilnosti zdravila in uskladitve razhajajočih se informacij po vsej EU.
English: The contraindications in section 4.3 were also amended to include the wording related to the contraindication of cardiotoxic risk of haloperidol.
Slovenian: Spremenjene so bile tudi kontraindikacije v poglavju 4.3, da vključujejo tudi besedilo v zvezi s kontraindikacijo glede tveganja kardiotoksičnosti haloperidola.
English: Haldol Decanoate has been approved nationally in the EU with many differences in the wording of the summary of product characteristics (SmPC), in the various Member States.
Slovenian: Zdravilo Haldol Decanoate je bilo odobreno na nacionalni ravni v EU z veliko razlikami v besedilu povzetka glavnih značilnosti zdravila v posameznih državah članicah.
English: In patients with hepatic impairment, it is recommended to halve the initial dose, since haloperidol is extensively metabolised in the liver.
Slovenian: Pri bolnikih z jetrno okvaro je priporočljivo prepoloviti začetni odmerek, saj se haloperidol obsežno presnavlja v jetrih.
English: Annex II Scientific conclusions
Slovenian: Priloga II
English: Based on the review of all available data and the consultations with the Healthcare Professionals Organisations (HCPOs), the CHMP recommended the following revision and harmonisation of the product information for Haldol Decanoate and associated names.
Slovenian: Na podlagi pregleda vseh razpoložljivih podatkov in posvetovanj z organizacijami zdravstvenih delavcev je odbor CHMP priporočil naslednjo spremembo in uskladitev informacij o zdravilu za zdravilo Haldol Decanoate in povezana imena.
English: The active substance haloperidol is a potent central dopamine type 2 receptor antagonist, lacking antihistaminergic or anticholinergic activity at recommended doses, and exerts minimal alpha 1 adrenergic activity.
Slovenian: Zdravilna učinkovina haloperidol je močan antagonist osrednjega dopaminskega receptorja tipa 2, ki nima antihistaminergičnega ali antiholinergičnega delovanja v priporočenih odmerkih in ima minimalno adrenergično delovanje alfa 1.
English: Given that the maximum dose of oral haloperidol in the elderly is 5 mg/day and applying the conversion factor of 15, the maximum haloperidol decanoate dose must not be in excess of 75 mg/4wk in the elderly unless elderly patients have already received higher haloperidol (oral or decanoate) doses for long-standing schizophrenia with acceptable tolerability.
Slovenian: Glede na to da je največji odmerek peroralnega haloperidola pri starejših bolnikih 5 mg/dan, pri uporabi konverzijskega faktorja 15 največji odmerek haloperidoldekanoata pri starejših bolnikih ne sme biti večji od 75 mg/4 tedne, razen če so starejši bolniki že prejeli večje odmerke haloperidola (peroralno ali v obliki dekanoata) za dolgoletno shizofrenijo in so jih sprejemljivo prenašali.
English: However specific guidance on switching from other antipsychotics has not been proposed due to limited data.
Slovenian: Vendar zaradi pomanjkanja podatkov natančnejša navodila za prehod z drugih antipsihotikov niso bila predlagana.
English: The proposal for the posology wording in section 4.2 has been revised with regard to transition from oral haloperidol, continuation of treatment, and supplementation with non-decanoate haloperidol up to the maximum oral dose, in adults and the elderly.
Slovenian: Predlog besedila odmerjanja v poglavju 4.2 je bil spremenjen glede prehoda s peroralnega haloperidola, nadaljevanja zdravljenja in dodajanja haloperidola brez dekanoata do največjega peroralnega odmerka pri odraslih in starejših bolnikih.
English: Haldol Decanoate - an ester of haloperidol and decanoic acid, is a depot antipsychotic belonging to the butyrophenone group.
Slovenian: Zdravilo Haldol Decanoate, ki vsebuje ester haloperidola in dekanojsko kislino, je depo antipsihotik, ki spada v skupino butirofenonov.
English: The final indication agreed for Haldol decanoate is for the maintenance treatment of schizophrenia and schizoaffective disorder in adult patients currently stabilised with oral haloperidol.
Slovenian: Usklajena indikacija za zdravilo Haldol Decanoate je vzdrževalno zdravljenje shizofrenije in shizoafektivne motnje pri odraslih bolnikih, ki sta trenutno stabilizirani s peroralnim haloperidolom.
English: Based on clinical trial data, guideline recommendations and expert consultations by the marketing authorisation holder (MAH) and by the HCPOs, a conversion factor of 10 to 15 is supported when switching from oral haloperidol to the longacting injectable (LAI) Haldol Decanoate.
Slovenian: Na podlagi podatkov iz kliničnih preskušanj in priporočil iz smernic ter posvetovanj s strokovnjaki, opravljenih pri imetniku dovoljenja za promet z zdravilom in organizacijah zdravstvenih delavcev, obstaja podpora za konverzijski faktor 10 do 15 pri prehodu s peroralnega haloperidola na zdravilo Haldol Decanoate z dolgotrajnim delovanjem za injiciranje.
English: As Haldol Decanoate is an injectable long-acting depot formulation recommended to be used every 4 weeks, in order to avoid medication errors in which either haloperidol injectable or haloperidol decanoate are administered in error, the MAH has committed to conduct further post-marketing safety analysis after completion of the Art 30 referral, while assessing the need for changing the name of the medicinal product thereafter.
Slovenian: Da bi preprečili napake pri zdravljenju zaradi nenamernega dajanja haloperidola za injiciranje ali haloperidoldekanoata v povezavi s priporočilom, da se zdravilo Haldol Decanoate v depo formulaciji za injiciranje z dolgotrajnim delovanjem daje vsake 4 tedne, se je imetnik dovoljenja za promet zavezal, da po končani napotitvi v skladu s členom 30 izvede dodatno analizo varnosti po dajanju zdravila na trg p in oceni potrebo po spremembi imena zdravila.
English: After intramuscular injection (IM), Haldol Decanoate is gradually released from muscle tissue and hydrolysed slowly into free haloperidol, which enters the systemic circulation.
Slovenian: postopoma sprosti iz mišičnega tkiva in počasi hidrolizira v prosti haloperidol, ki vstopi v krvni obtok.
English: A critical evaluation of the MAH's proposed harmonised SmPC is discussed below.
Slovenian: V nadaljevanju je obravnavana kritična ocena usklajenega povzetka glavnih značilnosti zdravila, ki ga je predlagal imetnik dovoljenja za promet z zdravilom.
English: Patients were followed up on average for 3.8 years.
Slovenian: Bolnike so spremljali povprečno 3,8 let.
English: It is given independent of meals and preferably at the same time each day.
Slovenian: Daje se neodvisno od obrokov, po možnosti vsak dan ob istem času.
English: These side effects usually pass after a few days or weeks of treatment.
Slovenian: Učinka običajno izzvenita v nekaj dneh ali tednih zdravljenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Victoza on 30 June 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Victoza, veljavno po vsej Evropski uniji, izdala 30. junija 2009.
English: Victoza liraglutide
Slovenian: Victoza liraglutid
English: What measures are being taken to ensure the safe and effective use of Victoza?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Victoza?
English: Cardiovascular events occurred in 13% (608 out of 4668) of patients taking Victoza compared with 14.9% (694 out of 4672) of patients taking placebo.
Slovenian: Do srčnožilnih dogodkov je prišlo pri 13 % (608 od 4668) bolnikov, ki so prejemali zdravilo Victoza, v primerjavi s 14,9 % (694 od 4672) bolnikov, zdravljenih s placebom.
English: The full EPAR for Victoza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Victoza je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Victoza.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Victoza.
English: The main measure of effectiveness was the occurrence of one of three major cardiovascular events: stroke, heart attack or death caused by cardiovascular disease.
Slovenian: Glavno merilo učinkovitosti je bil pojav enega od treh glavnih srčnožilnih dogodkov: možganske kapi, srčnega napada ali smrti zaradi srčnožilne bolezni.
English: This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Slovenian: To pomeni, da deluje na enak način kot inkretini (hormoni, proizvedeni v črevesju), in sicer s povečevanjem količine insulina, ki ga sprošča trebušna slinavka ob odzivu na hrano.
English: The study involved 9,340 patients with type 2 diabetes who already had cardiovascular disease (such as angina, heart attack or stroke).
Slovenian: V tej študiji je sodelovalo 9 340 bolnikov s sladkorno boleznijo tipa 2, ki so že imeli srčnožilne bolezni (kot je angina pektoris, srčni napad ali kap).
English: Other information about Victoza
Slovenian: Druge informacije o zdravilu Victoza
English: Victoza was compared with placebo and all patients also received standard care.
Slovenian: Zdravilo Victoza so primerjali s placebom in vsi bolniki so prejemali standardno oskrbo.
English: • on its own when use of metformin (another medicine for type 2 diabetes) is not recommended;
Slovenian: • samostojno, če uporaba metformina (drugega zdravila za zdravljenje sladkorne bolezni tipa 2) ni priporočljivo;
English: This compared with a reduction of 0.5 percentage points with glimepiride.
Slovenian: To je primerljivo z zmanjšanjem za 0,5 odstotne točke ob uporabi glimepirida.
English: The European Medicines Agency decided that Victoza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Victoza večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.