FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore the CVMP considered that the indication for treatment of shock in horses should be removed from the product information;
Croatian: CVMP je stoga smatrao da je potrebno ukloniti indikaciju za liječenje šoka u konja iz informacija o proizvodu;
English: Consequently Germany considered that it is in the interest of consumer safety to evaluate the adequacy of the meat withdrawal periods in cattle and horses and the milk withdrawal periods in cattle.
Croatian: Kao posljedica toga, Njemačka je smatrala da je u interesu potrošača da procijeni adekvatnost karencije za meso stoke i konja te za mlijeko stoke.
English: 5830 AB Boxmeer THE NETHERLANDS
Croatian: 5830 AB Boxmeer NIZOZEMSKA
English: Conclusions on the benefit-risk balance
Croatian: Zaključci o omjeru dobrobiti i rizika
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Croatian: Deksametazon je sintetski glukokortikoid dugog djelovanja koji se djeluje protuupalno, protualergijski i glukoneogenetski kod primjene na poljoprivrednim i domaćim životinjama.
English: The other study was considered valid, however, the data set obtained from it did not allow the use of the statistical approach for the determination of withdrawal periods in accordance with the CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)2 as statistical criteria for the linear regression analysis were not fulfilled.
Croatian: Druga se studija smatrala valjanom no, podaci dobiveni iz nje nisu omogućavali upotrebu statističkog pristupa za određivanje karencija u skladu s CVMP napomenom za smjernicu: pristup prema harmonizaciji karencija (EMEA/CVMP/036/95)2 jer statistički kriteriji za analizu linearne regresije nisu ispunjeni.
English: Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses.
Croatian: Izbrisati, gdje je primjenjivo, sve reference za ponovan tretman kod goveda i konja i tretman u slučavevima šoka kod konja .
English: 3 CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
Croatian: 3 CVMP napomena za smjernice za određivanje karencije u mlijeku (EMEA/CVMP/473/98)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004496.pdf
English: No residue depletion or pharmacokinetic data are available for the much higher dosages recommended for the treatment of shock in horses.
Croatian: Nisu dostupni podaci o razgradnji rezidua ili farmakokinetici za puno više preporučene doze za liječenje šoka u konja.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Croatian: Popis imena, farmaceutskog oblika, jačine VMP, ciljnih vrsta, nositelja odobrenja država članica
English: Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I)
Croatian: Ukupni sažetak znanstvene procjene za Dexadreson 2 mg/ml i pridruženi nazivi te njegove generičke proizvode (vidjeti prilog I)
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products are solutions for injection which contain 2 mg dexamethasone per ml.
Croatian: Veterinarsko-medicinski proizvod Dexadreson 2 mg/ml i njegovi pridruženi nazivi i generički proizvodi otopine su za injekciju koje sadrže 2 mg deksametazona po ml.
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf below the MRL values in kidney and liver.
Croatian: VICH GL48: Studije za procjenu metabolizma i kinetike rezidua veterinarskih lijekova u životinja koje služe kao hrana: ispitivanja razgradnje markera rezidua za utvrđivanje karencije (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP napomena za smjernice: pristup prema harmonizaciji karencija (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf do karencije od 8 dana za liječenje pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
English: No residue depletion data are available in horses for the single or repeat dose treatment.
Croatian: Nisu dostupni podaci o razgradnji rezidua kod konja za liječenje jednom dozom ili ponovljenim dozama.
English: Therefore, none of the studies was conducted at the maximum intended dose as requested in VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)1 and safe withdrawal periods in cattle tissues and milk can only be set for single treatment.
Croatian: Stoga nijedno ispitivanje nije provedeno pri maksimalnoj namjeravanoj dozi kako to zahtijeva VICH GL48: Studije za procjenu metabolizma i kinetike rezidua veterinarskih lijekova u životinja koje služe kao hrana: studije razgradnje markera rezidua (EMA/CVMP/VICH/463199/2009)1 i sigurna karencija u tkivu stoke i mlijeku mogu se podesiti samo za pojedinačno liječenje.
English: The marketing authorisation holders agreed to remove the advice on repeat dose treatment in horses from the product information.
Croatian: Nositelji odobrenja slažu se da treba ukloniti savjet o liječenju ponovljenom dozom u konja iz informacija o proizvodu.
English: The residue depletion study in milk was considered acceptable, but the recommended method for the calculation of a milk withdrawal period according to the CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)3 - the Time to safe concentration (TTSC) methodcannot be used due to the insufficient number of animals included in the study.
Croatian: Ispitivanja razgradnje rezidua u mlijeku smatrano je prihvatljivim ali preporučena metoda za izračun karencije u mlijeku u skladu s napomenom CVMP za smjernice za određivanje karencija u mlijeku (EMEA/CVMP/473/98)3 - metoda mjerenja do sigurne koncentracije (TTSC) - ne može se koristiti zbog nedostatnog broja životinja uključenih u ispitivanje.
English: No safe withdrawal period for these dosages can be set and the CVMP considered that the shock indication should be withdrawn from the product information of Dexadreson and its generic products, where applicable.
Croatian: Nije moguće odrediti sigurne karencije za te doze te je CVMP smatrao da se indikacija šoka može povući iz informacija o proizvodu za Dexadreson i njegove generičke proizvode ako je to primjenjivo.
English: In the absence of residue depletion data at the maximum intended dose and further to the concerns expressed above, the marketing authorisation holders agreed to remove the advice on repeat dose treatment after 24-48 hours in cattle from the product information.
Croatian: U nedostatku podataka o razgradnji rezidua pri maksimalnoj namjeravanoj dozi te nadalje u vezi prethodno izraženih razloga za zabrinutost, nositelji odobrenja za stavljanje lijeka u promet dogovorili su se da uklone savjet o ponovljenom doziranju nakon 24-48 sati u stoke iz informacija o proizvodu.
English: Animal species
Croatian: Ciljne vrste
English: DOSAGES FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Croatian: DOZIRANJE ZA SVAKU CILJNU VRSTU ŽIVOTINJA, NAČIN I PUT(EVI) PRIMJENE
English: Cattle:
Croatian: Govedo:
English: Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS
Croatian: Wim de Körverstraat 35 5831, AN Boxmeer NIZOZEMSKA
English: • On the basis of the residue depletion data in cattle and the pharmacokinetic data in horses submitted by the marketing authorisation holders for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that withdrawal periods of 8 days for cattle meat and offal, 72 hours for cattle milk and 8 days for horse meat and offal were safe;
Croatian: • Na temelju podataka o razgradnji rezidua u stoke i farmakokinetičkih podataka u konja koje su podnijeli nositelji odobrenja za Dexadreson 2 mg/ml i njegove pridružene nazive te generičke proizvode, CVMP je smatrao da su karencije od 8 dana za meso stoke i iznutrice, 72 sata za mlijeko stoke i 8 dana za konjsko meso i iznutrice sigurne;
English: Annex III
Croatian: ANEKS III
English: Annex II
Croatian: Prilog II
English: As there were no residue depletion data with the recommended repeat dose treatment in cattle and horses, the CVMP concluded that the advice on repeat dose treatment in cattle and horses should be removed from the product information.
Croatian: S obzirom na nema podataka o razgradnji rezidua s preporučenim liječenje ponovljenom dozom u stoke i konja, CVMP je zaključio da savjet o liječenju ponovljenom dozom u stoke i konja treba ukloniti iz informacija o proizvodu.
English: Therefore a 20% safety span was applied to the observed period of 60 hours, resulting in a withdrawal period of 72 hours, i.e. 3 days, in milk from cows treated at a single dose of 0.06 mg dexamethasone per kg body weight.
Croatian: Stoga je primijenjen sigurnosni raspon od 20% na promatrano razdoblje od 60 sati što je uzrokovalo karenciju od 72 sata, tj. 3 dana u mlijeku krava liječenih pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
English: The same withdrawal period for edible tissues may be applied for cattle and horses for the same dosing regimen, resulting in a withdrawal period for horse meat and offal of 8 days for the single dose treatment of 0.06 mg dexamethasone per kg body weight.
Croatian: Ista karencija za jestiva tkiva može se primijeniti na stoku i konje za isti režim doziranja što je uzrokovali karenciju za konjsko meso i iznutrice od 8 dana za liječenje pojedinačnom dozom od 0,06 mg deksametazona po kg tjelesne težine.
English: Benefit-Risk Assessment
Croatian: Procjena omjera dobrobiti i rizika
English: United Kingdom Eurovet Animal Health B.V. Handelsweg 25
Croatian: Velika Britanija Eurovet Animal Health B.V.
English: As there were no data available to support safe withdrawal periods for horse meat and offal following administration of high dosages in case of treatment of shock, the CVMP concluded that the shock indication in horses should be removed from the product information for Dexadreson and its generic products, where applicable.
Croatian: S obzirom da nema dostupnih podataka koji bi podržali sigurne karencije za konjsko meso i iznutrice nakon primjene visokih doza u slučaju liječenja šoka, CVMP je zaključio da indikaciju šoka u konja treba ukloniti iz informacija o proizvodu za Dexadreson i njegove generičke proizvode gdje je to primjenjivo.
English: • In the absence of residue depletion or pharmacokinetic data for the higher dosages recommended for the indication concerning treatment of shock in horses, no safe withdrawal period for these dosages can be set for Dexadreson 2 mg/ml and associated names, and generic products thereof.
Croatian: • U nedostatku podataka o razgradnji rezidua ili farmakokinetičkih podataka za više doze preporučene za indikaciju liječenja šoka u konja nije moguće podesiti sigurnu karenciju za te doze za Dexadreson 2 mg/ml i pridružene nazive te njegove generičke proizvode.
English: • In the absence of residue depletion or pharmacokinetic data following a repeat treatment in cattle and horses for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that the advice on repeat dose treatment after 24-48 hours in cattle and horses should be removed from the product information;
Croatian: • U nedostatku podataka o razgradnji rezidua ili farmakokinetici, a nakon ponovljenog liječenje stoke i konja za Dexadreson 2 mg/ml i pridruženih naziva te njegovih generičkih proizvoda, CVMP je smatrao da treba ukloniti savjet o liječenju ponovljenom dozom nakon 24-48 sati u stoke i konja iz informacija o proizvodu.
English: Annex I
Croatian: Aneks I
English: Residue depletion data was made available and supported a cattle meat and offal withdrawal period of 8 days and a cattle milk withdrawal period of 72 hours, as well as a horse meat and offal withdrawal period of 8 days following a single injection at the recommended dose of 0.06 mg dexamethasone per kg body weight.
Croatian: Podaci o razgradnji rezidua postali su dostupni podržali su karenciju za meso stoke i iznutrice od 8 dana te 72 dana za mlijeko stoke kao i 8 dana za konjsko meso i iznutrice nakon pojedinačne injekcije pri preporučenoj dozi od 0,06 mg deksametazona po kg tjelesne težine.
English: Lithuania
Croatian: Litvanija
English: • the CVMP considered that the overall benefit-risk balance is positive for Dexadreson 2 mg/ml and associated names, and generic products thereof subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for Dexadreson 2 mg/ml and associated names, and generic products thereof (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
Croatian: CVMP je preporučio izmjene odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda Dexadreson 2 mg/ml i njegovih pridruženih naziva i generičkih proizvoda (vidjeti prilog I) kako bi se promijenili sažeci opisa svojstava, označavanje i upute o VMP u skladu s preporučenim promjenama u informacijama o proizvodu kako je to opisano u prilogu III.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflets
Croatian: Razlozi za izmjenu sažetaka opisa svojstava, označavanja i Uputa o VMP
English: Dopharma Research B.V. Zalmweg 24
Croatian: Dopharma Research B.V.
English: Six days after administration the residue concentrations were
Croatian: Šest dana nakon primjene koncentracije rezidua bile su ispod MRL vrijednosti u bubrezima i jetri.
English: United Kingdom Dopharma Research B.V. Zalmweg 24
Croatian: Velika Britanija Dopharma Research B.V.
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Ispravke u određenim dijelovima sažetka opisa svojstava, označavanju i uputi
English: Cattle
Croatian: Stoka
English: Applicant/marketing authorisation holder
Croatian: Nositelj odobrenja
English: Czech republic Intervet International B.V. Wim de Körverstraat 35
Croatian: Intervet International B.V.
English: Swallow the tablets whole with a glass of water.
Croatian: Progutajte tablete cijele uz čašu vode.
English: This difference is not considered clinically relevant.
Croatian: Ova se razlika ne smatra klinički značajnom.
English: You can take DIFICLIR before, during or after meals.
Croatian: DIFICLIR možete uzeti prije, tijekom ili nakon obroka.
English: Other possible side effects are the following:
Croatian: Druge moguće nuspojave su sljedeće:
English: DIFICLIR is available in:
Croatian: DIFICLIR je dostupan u:
English: Elimination through urine is negligible (<1%).
Croatian: Eliminacija putem mokraće je zanemariva (<1%).
English: Examples of such medicines are:
Croatian: Među tim lijekovima su, na primjer:
English: If you stop taking this medicine too soon, the infection may come back.
Croatian: Ako prerano prestanete uzimati ovaj lijek, infekcija se može vratiti.
English: Take the tablet as soon as you remember, unless it is time for the next dose.
Croatian: Uzmite tabletu čim se sjetite, osim ako je uskoro vrijeme za sljedeću dozu.
English: − decreased appetite
Croatian: − oslabljeni apetit
English: Adults and elderly (≥65 years of age)
Croatian: Odrasli i stariji (≥ 65 godina)
English: Take the medicine pack with you so the doctor knows what you have taken.
Croatian: Uzmite pakiranje lijeka sa sobom tako da liječnik zna što ste uzeli.
English: Date of latest renewal: 22 August 2016
Croatian: Datum posljednje obnove odobrenja: 22. kolovoza 2016.
English: DIFICLIR can be taken with or without food.
Croatian: DIFICLIR se može uzimati s hranom ili bez nje.
English: Antimicrobial spectrum
Croatian: Antimikrobni spektar
English: If you have taken more tablets than you should have, talk to a doctor.
Croatian: Ako ste uzeli više tableta nego što ste trebali, razgovarajte s liječnikom.
English: Description of the patient population in clinical trials
Croatian: Opis populacije bolesnika u kliničkim ispitivanjima
English: What you need to know before you take DIFICLIR
Croatian: Što morate znati prije nego počnete uzimati DIFICLIR
English: Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
Croatian: Potrebno je uzeti u obzir službene smjernice za ispravnu primjenu antibakterijskih lijekova.
English: In that case, skip the missed dose.
Croatian: U tom slučaju, preskočite propuštenu dozu.
English: Gender, weight and race
Croatian: Spol, tjelesna težina i rasa
English: DIFICLIR should not be used in children or adolescents aged below 18 years as there is no information on this use in this population.
Croatian: DIFICLIR se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina, jer nema podataka o njegovoj primjeni u ovoj populaciji.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost nuspojava definira se na sljedeći način: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Croatian: Kao mjeru opreza, bolje je izbjegavati primjenu lijeka DIFICLIR tijekom trudnoće.
English: Your doctor will tell you whether this medicine is suitable for you.
Croatian: Liječnik će Vam reći je li ovaj lijek pogodan za Vas.
English: The half life of fidaxomicin is approximately 8-10 h.
Croatian: Poluvijek fidaksomicina iznosi približno 8-10 sati.
English: If you take more DIFICLIR than you should
Croatian: Ako uzmete više DIFICLIR-a nego što ste trebali
English: This metabolite also shows antimicrobial activity (see section 5.1).
Croatian: Taj metabolit također pokazuje antimikrobno djelovanje (vidjeti dio 5.1).
English: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established.
Croatian: Sigurnost i djelotvornost fidaksomicina u djece u dobi do 18 godina nije još ustanovljena.
English: Your doctor will know whether your disease falls in the severe categories and will tell you whether this medicine is suitable for you.
Croatian: Liječnik će znati je li Vaša bolest u kategoriji teških slučajeva i reći će Vam je li ovaj lijek pogodan za Vas.
English: This is because it is not known whether fidaxomicin can harm your baby.
Croatian: To je zato što nije poznato može li fidaksomicin naškoditi Vašem djetetu.
English: This serious illness can result in painful, severe diarrhoea.
Croatian: Posljedica ove ozbiljne bolesti može biti bolan i težak proljev.
English: However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.
Croatian: Ipak, ne može se isključiti mogućnost nuspojava pa se preporučuju opće suportivne mjere.
English: The clinical relevance of MRP2 inhibition is not yet known.
Croatian: Klinički značaj inhibicije MRP2 još nije poznat.
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity, and reproductive toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i reproduktivne toksičnosti.
English: Plasma levels appear to be elevated in the elderly (age ≥ 65 years).
Croatian: Čini se da su koncentracije u plazmi povišene u starijih (u dobi od 65 ili više godina).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 December 2011
Croatian: Datum prvog odobrenja: 5. prosinca 2011.
English: Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak s obzirom na reprodukcijsku toksičnost.
English: If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Croatian: Ako tijekom liječenja DIFICLIROM nastupi jaka alergijska reakcija, potrebno je prekinuti primjenu lijeka i poduzeti odgovarajuće mjere.
English: No dose adjustment is considered necessary.
Croatian: Smatra se da nije potrebna prilagodba doze.
English: Metabolism and nutrition disorders decreased appetite
Croatian: Poremećaji metabolizma i prehrane smanjen apetit
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003 100 x 1 film-coated tablet EU/1/11/733/004 20 x 1 film-coated tablet 13.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/733/003 100 x 1 filmom obložena tableta EU/1/11/733/004 20 x 1 filmom obložena tableta 13. BROJ SERIJE
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DIFICLIR therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti hoće li se prekinuti dojenje ili će se trajno/privremeno prekinuti terapija lijekom DIFICLIR, pri čemu treba uzeti u obzir korist od dojenja za dijete i korist od terapije za ženu.
English: − dry mouth, altered taste (dysgeusia)
Croatian: − suha usta, promjena osjeta okusa (disgeuzija)
English: Effect on the intestinal flora
Croatian: Učinak na crijevnu floru
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics, ATC code: A07AA12
Croatian: Farmakoterapijska skupina: antidijaroici, crijevna protuupalna/antiinfektivna sredstva, antibiotici, ATK oznaka: A07AA12
English: 4.7 Effects on ability to drive and use machines DIFICLIR has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima DIFICLIR ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Croatian: Farmakokinetički/farmakodinamički (PK/PD) odnos
English: The main elimination pathways of systemically available fidaxomicin have not been characterized.
Croatian: Glavni putevi eliminacije sistemski raspoloživog fidaksomicina nisu opisani.
English: The most common side effects (may affect up to 1 in 10 people) are vomiting, nausea and constipation.
Croatian: Najčešće nuspojave (mogu se javiti u do 1 na 10 osoba) su povraćanje, mučnina i zatvor.
English: Core tablets:
Croatian: Jezgra tableta:
English: Reproductive and fertility parameters showed no statistically significant differences in rats treated with fidaxomicin at doses up to 6.3 mg/kg/day (intravenous).
Croatian: Parametri reproduktivne funkcije i plodnosti nisu bili statistički značajno različiti u štakora koji su primali fidaksomicin u dozama do 6,3 mg/kg na dan (intravenski).