FrancophonIA/ELRC3.0 huggingface dataset:
English: Surveillance data of the susceptibility of target field isolates from cattle, collected between 2004 and 2012 across Europe, show consistent efficacy of florfenicol with no finding of resistant isolates.
Slovenian: Nadzorni podatki o občutljivosti ciljnih terenskih izolatov goveda, zbranih med 2004 in 2012 v Evropi, kažejo dosledno učinkovitost florfenikola brez najdbe odpornih izolatov.
English: The in vitro Minimum Inhibitory Concentration (MIC) distribution values for these field isolates are presented in the table below.
Slovenian: Vrednosti distribucije in vitro minimalne inhibitorne koncentracije (MIC) za te terenske izolate so predstavljene v spodnji tabeli.
English: The impact of this difference on anti-inflammatory effects has not been investigated in field trials.
Slovenian: Vpliv te razlike na protivnetni učinek ni bil raziskan v terenskih študijah.
English: The genes corresponding to these mechanisms are coded on mobile genetic elements such as plasmids, transposon or genes cassettes.
Slovenian: Geni, ki ustrezajo tem mehanizmom so kodirani na mobilnih genetskih elementih kot so plazmidi, transpozoni ali genske kasete.
English: The single dose volume should not exceed 15 ml per injection site.
Slovenian: Volumen enega odmerka ne sme presegati 15 ml na mestu injiciranja.
English: MRLs (µg/kg)
Slovenian: MRL (µg/kg)
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: Pomožne snovi, navedene v poglavju 6.1 SPC so dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben.
English: Date of first authorisation: 15/05/2017.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15/05/2017
English: Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing.
Slovenian: Kadar je mogoče, naj se zdravilo za uporabo v veterinarski medicini uporablja le na podlagi testiranja občutljivosti.
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''.
English: Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Slovenian: Pri uporabi zdravila za uporabo v veterinarski medicini je potrebno upoštevati uradno, nacionalno in regionalno antimikrobno politiko.
English: Florfenicol
Slovenian: Florfenikol
English: During injection of this product animals may exhibit signs of moderate pain, manifested as movement of the head or neck.
Slovenian: Med injiciranjem zdravila lahko živali kažejo znake zmerne bolečine, ki se kažejo kot gibanje glave ali vratu.
English: Cattle.
Slovenian: Govedo.
English: It reduces leukocyte infiltration into the inflamed tissue.
Slovenian: Zmanjšuje infiltracijo leukocitov v vnetnem tkivu.
English: Avoid use in severely dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Slovenian: Izogibajte se uporabi pri zelo dehidriranih, hipovolemičnih ali hipotenzivnih živalih, ker je možna nevarnost ledvične toksičnosti.
English: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE
Slovenian: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne Francija
English: Meloxicam Meloxicam Bovine 20
Slovenian: Meloksikam Meloksikam Govedo 20
English: The bioavailability of meloxicam in this combination product is lower compared to the use of meloxicam when administered on its own.
Slovenian: Biorazpoložljivost meloksikama v tej kombinaciji je nižja v primerjavi z uporabo meloksikama, ki ga dajemo samostojno.
English: The injection should only be given in the neck area.
Slovenian: Injicirajte le na področju vratu.
English: People with known hypersensitivity to florfenicol, meloxicam or to any of the excipients should avoid contact with the veterinary medicinal product.
Slovenian: Osebe z znano preobčutljivostjo na florfenikol, meloksikam ali katerokoli pomožno snov, naj se izogibajo stiku z zdravilom.
English: Do not use in adult bulls intended for breeding.
Slovenian: Ne uporabite pri odraslih bikih namenjenih za vzrejo.
English: To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.
Slovenian: Da bi zagotovili pravilno odmerjanje, je potrebno kar se da natančno določiti telesno težo živali, da se izognemo premajhnemu odmerku.
English: Marketing authorisation holder and manufacturer responsible for batch release: Ceva Santé Animale
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij: Ceva Santé Animale
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or when there is evidence of ulcerogenic gastrointestinal lesions.
Slovenian: Ne uporabite pri živalih z oslabljeno jetrno, srčno ali ledvično funkcijo in hemoragičnimi motnjami ali v primeru dokazanih ulcerogenih gastrointestinalnih poškodb.
English: Resistance to florfenicol is mainly mediated by an efflux system due to a specific (Flo-R) or multidrug transporter (AcrAB-TolC).
Slovenian: Odpornost na florfenikol je vglavnem mediirana z iztočnim sistemom zaradi specifičnega (Flo-R) ali večprepustnega transporterja (AcrAB-TolC).
English: Repeated weekly administration of overdoses (3x and 5x the recommended dose) in calves was associated with decreased milk consumption, decreased weight gain, loose faeces or diarrhoea.
Slovenian: Ponavljajoče se tedensko dajanje prevelikega odmerka (3x in 5x priporočenega odmerka) teletom je bilo povezano z zmanjšanim zauživanjem mleka, zmanjšanjem pridobivanja telesne teže, mehkim blatom ali drisko.
English: Meloxicam is extensively bound to plasma proteins (97%) and is distributed in all well-perfused organs.
Slovenian: Meloksikam se v veliki meri veže na plazemske beljakovine (97%) in se porazdeli v dobro prekrvavljene organe.
English: The extent of these adverse effects was dose-dependent.
Slovenian: Obseg neželenih učinkov je bil odvisen od odmerka.
English: Do not use in pregnant cows, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Slovenian: Ne uporabite pri brejih živalih, katerih mleko je namenjeno prehrani ljudi, v obdobju 2 mesecev pred pričakovanim porodom.
English: Not for animals from which milk is produced for human consumption
Slovenian: Ni za živali katerih mleko se uporablja v prehrani ljudi
English: Range (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
Slovenian: Vrednost (µg/ml) MIC50 (µg/ml) MIC90 (µg/ml)
English: Florfenicol is a synthetic broad-spectrum antibiotic effective against most Gram-positive and Gramnegative bacteria isolated from domestic animals.
Slovenian: Florfenikol je sintetični široko spektralni antibiotik učinkovit proti večini gram-pozitivnih in gramnegativnih bakterij izoliranih pri domačih živalih.
English: Milk: Not authorised for use in lactating animals producing milk for human consumption.
Slovenian: Mleko: ni dovoljena uporaba pri živalih, katerih mleko je namenjeno prehrani ljudi.
English: To a minor extent it also inhibits collagen-induced thrombocyte aggregation.
Slovenian: V manjšem obsegu zavira tudi kolagensko inducirano zlepljanje trombocitov.
English: For the 250 ml vials, the rubber stopper may safely be punctured up to 20 times.
Slovenian: Pri 250 ml viali lahko gumijast zamašek varno prebodete do 20 krat.
English: Fertility Do not use in adult bulls intended for breeding (see section 4.3).
Slovenian: Plodnost Ne uporabite pri odraslih bikih namenjenih za vzrejo (glej poglavje 4.3).
English: Sum of florfenicol and its metabolites measured as florfenicolamine
Slovenian: Seštevek florfenikola in metabolitov izmerjenih kot florfenikolamin
English: The active substances in Zeleris are allowed substances as described in table 1 of the annex to Commission Regulation (EU) No 37/2010:
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovine v zdravilu Zeleris so dovoljene učinkovine, kot so navedene v tabeli 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št. 37/2010:
English: Pack size: 1 vial per cardboard box
Slovenian: 1 viala v kartonski škatli.
English: Species
Slovenian: Vrsta
English: Shelf life after first opening the immediate packaging: 28 days.
Slovenian: Rok uporabnosti po prvem odpiranju vsebnika: 28 dni.
English: Therefore, the veterinary medicinal product should not be administered by pregnant women.
Slovenian: Zato naj tega zdravila ne dajejo nosečnice.
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovine ali na katero koli pomožno snov.
English: The safety of the veterinary medicinal product has not been established in breeding, pregnant and lactating animals.
Slovenian: Varnost zdravila v obdobju vzrejanja, brejosti in laktacije ni bila ugotovljena.
English: Muscle Liver Kidney Milk
Slovenian: Mišice Jetra Ledvice Mleko
English: Florfenicol is largely distributed in the whole body and has a low plasma protein binding (approximately 20%).
Slovenian: Florfenikol se v veliki meri porazdeli po celem telesu in ima nizko vezavo na plazemske beljakovine (približno 20%).
English: Macroscopic intestinal lesions were observed post-mortem (presence of fibrin, abomasal ulcers, haemorrhagic dots and thickening of the abomasal wall).
Slovenian: Post-mortem so bile opažene makroskopske intestinalne poškodbe (prisotnost fibrina, ulkus siriščnika, pikčaste krvavitve in zadebelitev stene siriščnika).
English: Pharmacotherapeutic group: Antibacterials for systemic use, amphenicols, combinations.
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje sistemskih infekcij, amfenikoli, kombinacije.
English: Florfenicol acts by inhibiting protein synthesis at the ribosomal level and its action is bacteriostatic and time-dependent.
Slovenian: Florfenikol zavira sintezo beljakovin na ravni ribosoma in deluje bakteriostatično ter odvisno od časa.
English: Fertility Do not use in adult bulls intended for breeding (see section “Contraindications”).
Slovenian: Plodnost Ne uporabite pri odraslih bikih namenjenih za vzrejo (glej poglavje ''Kontraindikacije'').
English: Resistance to florfenicol in the target pathogens has only been reported on rare occasions, and was associated with efflux pump and the presence of the floR gene.
Slovenian: Odpornost na florfenikol v ciljnih patogenih je bila opažena le v redkih primerih in je bila povezana z iztočno črpalko in prisotnostjo floR gena.
English: Meloxicam also has anti-endotoxic properties, because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin after administration in calves, lactating cows and pigs.
Slovenian: Meloksikam ima tudi antiendotoksične lastnosti, saj so dokazali, da zavira nastajanje tromboksana B2, izzvano z vnosom endotoksina E. coli po uporabi pri teletih, kravah v laktaciji in prašičih.
English: Use during pregnancy, lactation or lay
Slovenian: Uporaba v obdobju brejosti, laktacije ali nesnosti
English: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects.
Slovenian: Meloksikam je nesteroidno protivnetno zdravilo (NSAID) iz skupine oksikamov, ki deluje z zaviranjem tvorbe prostaglandinov in tako deluje protivnetno, antieksudativno, analgetično in antipiretično.
English: Translucent multi-layered plastic vials (polypropylene/ethylene vinyl alcohol/polypropylene) with chlorobutyl rubber stoppers and aluminium and plastic flip capsules, containing 50 ml, 100 ml or 250 ml.
Slovenian: Prosojne večplastne plastične viale (polipropilen/etilen vinil alkohol/polipropilen) s klorbutilnim gumijastim zamaškom in aluminijasto ter plastično flip kapsulo, ki vsebujejo 50 ml, 100 ml ali 250 ml. Velikost pakiranja:
English: Repeated weekly administration of a 5x dose was fatal in 7 out of 8 calves after the third administration.
Slovenian: Ponavljajoče se tedensko dajanje 5x odmerka je bilo smrtno za 7 od 8 telet po tretjem dajanju.
English: Overdose (symptoms, emergency procedures, antidotes), if necessary In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated as well as a single administration of 3 times (3x) the recommended dose.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) Pri teletih, ki še ne prežvekujejo, je bilo ponavljajoče se dajanje priporočenega odmerka enkrat na teden v obdobju treh tednov dobro sprejeto, kot tudi enkratni odmerek trikratnega (3x) priporočenega odmerka.
English: Florfenicol is considered to be a bacteriostatic agent, but in vitro studies demonstrate its bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Slovenian: Florfenikol se smatra kot bakteriostatik, vendar in vitro študije kažejo njegove baktericidne lastnosti proti Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
English: For Mannheimia haemolytica, Pasteurella multocida and Histophilus somni the following breakpoints have been determined by CLSI (Clinical and Laboratory Standards institute) for bovine respiratory pathogens: susceptible ≤ 2 µg/ml, intermediate: 4 µg/ml, resistant: ≥ 8 µg/ml.
Slovenian: Za bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni so bile določene naslednje mejne vrednosti po CLSI (Clinical and Laboratory Standards institute) za florfenikol za goveje respiratorne patogene: dovzetni ≤ 2 µg/ml, vmesni: 4 µg/ml, odporni: ≥ 8 µg/ml.
English: Each ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak ml vsebuje:
English: Interactions with other medicinal products and other forms of interaction Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ne uporabite istočasno z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
English: In pre-ruminant calves, repeated administration of the recommended dose once per week for three weeks was well tolerated, as well as a single administration of 3 times (3x) the recommended dose.
Slovenian: Pri teletih, ki še ne prežvekujejo, je bilo ponavljajoče se dajanje priporočenega odmerka enkrat na teden v obdobju treh tednov dobro sprejeto, kot tudi enkratni odmerek trikratnega (3x) priporočenega odmerka.
English: Dimethyl sulfoxide Glycerol formal, stabilised
Slovenian: Glicerolformal, stabiliziran
English: Repeated weekly administration of a 3x dose was fatal in 1 out of 8 calves after the third administration.
Slovenian: Ponavljajoče se tedensko dajanje 3x odmerka je bilo smrtno za 1 od 8 telet po tretjem dajanju.
English: EXP Once broached, use within 28 days.
Slovenian: EXP Načeto zdravilo uporabite v 28 dneh.
English: ATCvet code: QJ01BA99.
Slovenian: Oznaka ATC vet: QJ01BQ99
English: Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Slovenian: Laboratorijski testi kažejo, da florfenikol deluje proti večini pogosto izoliranih bakterijskih patogenov, ki sodelujejo pri respiratorni bolezni goveda, kar vključuje tudi bakterije Mannheimia haemolytica, Pasteurella multocida in Histophilus somni.
English: SPECIFIC PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: MANUFACTURER'S BATCH NUMBER
Slovenian: PROIZVAJALČEVA ŠTEVILKA SERIJE Lot
English: The product is slightly irritant to the eye. Rinse any splashes from eyes immediately with plenty of water.
Slovenian: Takoj sperite morebitne vbrizge v oko z veliko količino vode.
English: Animal species
Slovenian: Živalsk a vrsta
English: Efficacious plasma levels of florfenicol are maintained above the MIC90 of 1 µg/ml, 0.5µg/mL and 0.2 µg/ml for 72 h, 120 h and 160 h, respectively.
Slovenian: Učinkovit plazemski nivo florfenikola vzdrži nad MIC90 1 µg/ml, 0,5µg/ml in 0,2 µg/ml 72 ur, 120 ur in 160 ur.
English: Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Slovenian: Ne uporabite istočasno z glukokortikoidi, drugimi nesteroidnimi protivnetnimi zdravili ali antikoagulanti.
English: Solution for injection.
Slovenian: FARMACEVTSKA OBLIKA Raztopina za injiciranje.
English: No entry Antiinflammatory agents/Nonsteroidal antiinflammatory agents
Slovenian: Brez vnosa proti vnetna/ nesteroidna protivnetna zdravila
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE Subkutana uporaba.
English: After subcutaneous administration of the product at recommended dose of 1 ml/10 kg bodyweight maximum mean plasma concentration (Cmax) of 4.6 mg/l and 2.0 mg/l occurred 10 hours (h) and 7 h after dosing for florfenicol and meloxicam respectively.
Slovenian: Po subkutanem dajanju zdravila v priporočenem odmerku 1 ml/10 kg telesne teže je bila povprečna maksimalna plazemska koncentracija (Cmax) 4,6 mg/l in 2,0 mg/l dosežena v 10 urah in 7 ur po dajanju za florfenikol in meloksikam.
English: A single subcutaneous injection at a dosage of 40 mg florfenicol/kg bodyweight and 0.5 mg meloxicam/ kg bodyweight (i.e. 1 ml/10 kg bodyweight).
Slovenian: Ena subkutana injekcija odmerka 40 mg florfenikola/kg telesne teže in 0,5 mg meloksikama/kg telesne teže (to je 1 ml/10 kg telesne teže).
English: EXP Once broached, use within 28 days, by __/__/__.
Slovenian: Načeto zdravilo uporabite v 28 dneh, do _/_/_.
English: Antiinfectious agents/Antibi otics
Slovenian: Protibakterij ska zdravila/anti biotiki
English: Florfenicol is mainly excreted via the urine and to a small extent via the faeces with a half-life of about 60 h. Meloxicam excretion is equally divided between urine and faeces, with a half-life of about 23 h.
Slovenian: Florfenikol se v glavnem izloča z urinom in v manjši meri z blatom, z razpolovno dobo približno 60 ur.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo Zdravilo je rahlo dražeče za oči.
English: EU/2/17/210/001 EU/2/17/210/002 EU/2/17/210/003
Slovenian: EU/2/17/210/002
English: Excipients:
Slovenian: Karenca:
English: Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle florfenicol / meloxicam
Slovenian: Zeleris 400 mg/ml + 5 mg/ml raztopina za injiciranje za govedo florfenikol / meloksikam
English: Injection site reactions (mostly swelling, induration, heat and pain) were very commonly observed after subcutaneous administration of the product.
Slovenian: Po subkutanem dajanju zdravila je bila zelo pogosto opažena reakcija na mestu injiciranja (predvsem oteklina, zatrdlina, toplota in bolečina).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial of 100 ml and 250 ml
Slovenian: PODATKI NA STIČNI OVOJNINI Viala 100 ml in 250 ml
English: PACKAGE LEAFLET Zeleris 400 mg/ml + 5 mg/ml solution for injection for cattle
Slovenian: NAVODILO ZA UPORABO Zeleris 400 mg/ml + 5 mg/ml raztopina za injiciranje za govedo
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Slovenian: B POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Rp-Vet.
English: 1 ml contains 400 mg of florfenicol and 5 mg of meloxicam.
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGE(IH) SESTAVIN 1 ml vsebuje 400 mg florfenikola in 5 mg meloksikama Bistra rumena raztopina.
English: florfenicol 400 mg/ml meloxicam 5 mg/ml
Slovenian: NAVEDBA UČINKOVIN(E) Florfenikol 400 mg/ml Meloksikam 5 mg/ml
English: Cardboard box with 1 vial of 50 ml, 100 ml or 250 ml.
Slovenian: Kartonska škatla z 1 vialo 50 ml, 100 ml ali 250 ml. Ni nujno, da so v prometu vsa navedena pakiranja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 50 ml, 100 ml and 250 ml vials
Slovenian: Kartonska škatla s 50 ml vialo Kartonska škatla s 100 ml vialo Kartonska škatla s 250 ml vialo
English: Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta Rok uporabnosti po prvem odpiranju stične ovojnine: 28 dni 6.4.
English: 400 mg/ml florfenicol 5 mg/ml meloxicam
Slovenian: KOLIČINA UČINKOVIN(E) 400 mg/ml florfenikol 5 mg/ml meloksikam
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: Mannheimia haemolytica, Pasteurella multocida and Histophilus somni susceptible to florfenicol.
Slovenian: INDIKACIJA(E) Za zdravljenje goveje respiratorne bolezni (BRD) povezane z zvišano telesno temperaturo, ki jo povzročajo Mannheimia haemolytica, Pasteurella multocida in Histophilus somni, občutljivi na florfenikol.
English: Dose dependent maternotoxic and foetotoxic effects have been observed after oral administration of meloxicam to pregnant rats.
Slovenian: Po peroralnem dajanju meloksikama brejim podganam je bil opažen od odmerka odvisen maternotoksični in fetotoksični učinek.
English: 400 mg Meloxicam 5 mg.
Slovenian: Meloksikam……..5 mg
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 50 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: This overview was last updated in 01-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 01-2019.
English: Further information on Adcetris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Adcetris.
Slovenian: Nadaljnje informacije o zdravilu Adcetris so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Adcetris.
English: A complete response is when a patient has no signs of cancer.
Slovenian: Popoln odziv pomeni, da bolnik nima nikakršnih znakov raka.
English: The main measure of effectiveness was the percentage of patients who responded completely or partially to treatment.
Slovenian: Glavno merilo učinkovitosti je bil delež bolnikov, ki so se popolnoma ali deloma odzvali na zdravljenje.
English: This means that there is more evidence to come, especially about the medicine's long-term effects, which are needed to confirm the positive benefit-risk balance.
Slovenian: To pomeni, da se pričakujejo dodatni dokazi o zdravilu, zlasti o njegovih dolgotrajnih učinkih, ki so potrebni za potrditev pozitivnega ravnovesja med koristmi in tveganji.
English: The benefit was sustained during 3 years of follow-up.
Slovenian: V treh letih spremljanja so bile koristi še vedno nespremenjene.
English: What measures are being taken to ensure the safe and effective use of Adcetris?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Adcetris?
English: The medicine is given by a 30 minute infusion (drip) into a vein every 2 or 3 weeks.
Slovenian: Zdravilo se daje s 30-minutnim infundiranjem (kapalno infuzijo) v veno vsake dva ali tri tedne.
English: The main measure of effectiveness was how long patients lived without their disease getting worse.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja bolnikov brez poslabšanja bolezni.
English: Other information about Adcetris
Slovenian: Druge informacije o zdravilu Adcetris