FrancophonIA/ELRC3.0 huggingface dataset:
English: Since the arguments presented in relation to lack of formulation effect and bioequivalence are not considered to be conclusive, the withdrawal period must be based on the assessment of the residue depletion studies.
Croatian: S obzirom da se argumenti dostavljeni u vezi s manjkom djelotvornosti formulacije i biološkom ekvivalentnošću ne smatraju uvjerljivima, karencija se mora temeljiti na ocijeni ispitivanja deplecije rezidua.
English: In the opinion of the MAH the pH of the medicated drinking water solutions is mainly dependant on the quality of the water used, while the formulation of the powder, i.e. which acid is used as a stabiliser, has only a limited effect.
Croatian: Nositelj odobrenja za stavljanje u promet mišljenja je da pH vrijednost otopina voda za piće koje sadrže veterinarskomedicinski proizvod uvelike ovisi o kvaliteti korištene vode, dok formulacija praška, odnosno kiselina koja se koristi kao stabilizator ima samo ograničeni učinak.
English: Residue levels in the other tissues were below their respective MRLs from 4 days onwards.
Croatian: Razine rezidua u ostalim tkivima bile su ispod njihovih dotičnih maksimalnih razina rezidua od četvrtog dana nadalje.
English: The study was well conducted and reported.
Croatian: Ispitivanje je dobro provedeno te su podnijeti valjani izvještaji.
English: The CVMP considers that the MAH has not provided a sound justification as to why the findings from the 1999 residue depletion study should be ignored.
Croatian: CVMP je mišljenja da nositelj odobrenja za stavljanje u promet nije dostavio utemeljeno obrazloženje u vezi s razlogom za neuvažavanje rezultata ispitivanja deplecije rezidua iz 1999. godine.
English: The end result of that study was a withdrawal period of 12 days, whereas the 2011 study and all other studies for products that the MAH considered bioequivalent lead to a shorter withdrawal period.
Croatian: Konačan rezultat ovog ispitivanja bila je karencija u trajanju od 12 dana, pri čemu ispitivanje iz 2011. godine kao i sva ostala ispitivanja za proizvode, koje je nositelj odobrenja za stavljanje u promet smatrao biološkim ekvivalentima, navode kraće karencije.
English: As a result, the withdrawal period of 6 days, as proposed by the MAH, is considered to be inadequate to ensure consumer safety.
Croatian: Slijedom navedenog, karencija od 6 dana, koju predlaže nositelj odobrenja za stavljanje u promet, smatra se neprimjerenom za osiguravanje sigurnosti potrošača.
English: The MAH argued that even though Soludox contains tartaric acid as a stabiliser while all other doxycycline powders contain citric acid, the solubility of all products is the same and hence the amount of active substance in the chicken's tissues would be the same.
Croatian: Nositelj odobrenja za stavljanje u promet argumentirao je da iako Soludox sadrži tartarnu kiselinu kao stabilizator, dok je kod ostalih prašaka koji također sadrže doksiciklin upotrjebljena limunska kiselina, topljivost svih proizvoda je jednaka, te bi stoga količina djelatne tvari u tkivu pilića bila jednaka.
English: • the CVMP on the basis of the available residue depletion data considered that a withdrawal period of 9 days should be established for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days; the CVMP recommended the granting of the variation to the terms of the marketing authorisations for Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC) in accordance with the recommended changes in the relevant sections of the product information as set out in Annex III.
Croatian: • CVMP je na temelju dostupnih podataka za depleciju rezidua utvrdio da karencija od 9 dana mora biti određena za pileće meso i iznutrice pri dozi od 20 mg/kg tjelesne mase kroz 4 uzastopna dana; CVMP je preporučio odobravanje izmjene uvjeta odobrenja za stavljanje u promet za prašak Soludox 500 mg/g za uporabu u vodi a piće za svinje i piliće (NL/V/0141/001/DC) i prašak Soludox 500 mg/g za uporabu u vodi a piće za svinje i piliće (UK/V/0349/001/DC) u skladu s preporučenim izmjenama u relevantnim odjeljcima informacija o proizvodu kako je navedeno u Dodatku III.
English: The MAH could not provide a sound scientific justification for dismissing the results from the 1999 study and considering only the most recent study.
Croatian: Nositelj odobrenja za stavljanje u promet nije bio u stanju dostaviti utemeljeno znanstveno opravdanje za neuvažavanje rezultata ispitivanja iz 1999. godine te uzimanje samo u obzir posljednjeg ispitivanja.
English: Chickens: - Meat and offal: 9 days, following a dose rate of 20 mg/kg body weight for 4 days.
Croatian: Kokoši: - Meso i iznutrice: 9 dana, nakon doze od 20 mg/kg tjelesne mase tijekom 4 dana.
English: The MAH has provided data from three residue depletion studies.
Croatian: Nositelj odobrenja za stavljanje u promet dostavio je podatke tri ispitivanja deplecije rezidua.
English: The MAH's grounds for re-examination focused on the fact that, as a powder for oral administration via the drinking water, Soludox can be considered to be bioequivalent to all other doxyclycline containing products for use in drinking water, and that therefore, the shorter withdrawal periods approved for these products would also be appropriate for Soludox.
Croatian: Obrazloženje za ponovno ispitivanje od strane nositelja odobrenja za stavljanje u promet usredotočeno je na činjenicu da se Soludox, kao prašak za oralno davanje putem vode za piće, može smatrati biološkim ekvivalentom svih ostalih proizvoda koji sadrže doksiciklin, a koji se koriste u vodi za piće, te bi stoga kraća karencija odobrena za ove proizvode bila primjerena i za Soludox.
English: The animals were given the correct dose and the product was administered appropriately.
Croatian: Životinjama je dana ispravna doza i proizvod je ispravno dan.
English: Two residue depletion studies, one from 1999 and one from 2011, were considered by the CVMP as providing adequate data from which to derive a withdrawal period.
Croatian: CVMP je mišljenja da dva ispitivanja deplecije rezidua, jedno provedeno 1999. godine i jedno provedeno 2011. godine, pružaju dostatne podatke, na temelju kojih se može zaključiti karencija.
English: In support of this, an argument has been provided regarding the aligning of the withdrawal period for the product under discussion with those for other similar products on the grounds that bioequivalence can be assumed since it is an oral solution and the active substance is fully solubilised when in aqueous solution.
Croatian: U potvrdu istog naveden je argument u vezi s usklađivanjem razdoblja karencije za predmetni proizvod s razdobljima za slične proizvode uz obrazloženje da se biološka ekvivalentnost može pretpostaviti s obzirom da je to oralna otopina, te da je djelatna tvar u potpunosti topljiva u vodenoj otopini.
English: After reviewing the documentation submitted by the MAH, the CVMP concluded that there were not sufficient scientific grounds to revise its conclusions of 7 March 2013, which recommended a withdrawal period of 9 days for chicken for the dose of 20 mg/kg bw for 4 consecutive days.
Croatian: Nakon pregleda dokumentacije koju je dostavio nositelj odobrenja za stavljanje u promet, CVMP je zaključio da ne postoji dovoljno znanstvenih temelja za reviziju vlastitog zaključka od dana 7. ožujka 2013. godine, kojim se preporuča karencija u trajanju od 9 dana za piliće za dozu od 20 mg/kg tjelesne mase kroz 4 uzastopna dana.
English: In order to address the concerns raised by the Netherlands, the MAH was requested to provide all available residue data for use of the product in chickens at the dose of 20 mg/kg body weight, together with an expert comment on the data and a justification for the meat withdrawal period in chickens.
Croatian: Sa ciljem uklanjanja zabrinutosti koju je izrazila Nizozemska, od nositelja odobrenja za stavljanje u promet zatraženo je da dostavi sve dostupne podatke o ostacima tvari (reziduama) za uporabu proizvoda kod pilića pri dozi od 20 mg/kg tjelesne mase, zajedno sa stručnim komentarima podataka i obrazloženjem karencije za piliće meso.
English: It is not felt that this can be used to support the MAH's disregard for the 1999 study since birds of various breed, weight and age will be treated with this product.
Croatian: Smatra se da ove razlike ne mogu ići u prilog neuvažavanju ispitivanja iz 1999. godine od strane nositelja odobrenja za stavljanje u promet, s obzirom da će ptice različitih pasmina, mase i starosti biti liječene ovim proizvodom.
English: During the worksharing procedure a potential serious risk to human health was identified by the Netherlands regarding the appropriate withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Croatian: Tijekom postupka podjele rada, Nizozemska je utvrdila potencijalno ozbiljan rizik za ljudsko zdravlje u vezi s odgovarajućom karencijom za pileće meso i iznutrice u slučaju doze od 20 mg/kg tjelesne mase kroz 4 uzastopna dana.
English: Latvia
Croatian: Letonija
English: Based on the results of the study a chicken meat withdrawal period of 5 days was supported using the CVMP accepted alternative approach.
Croatian: Na temelju rezultata ispitivanja, potvrđena je karencija za pileće meso u trajanju od 5 dana primjenom alternativnog pristupa prihvaćenog od strane CVMP-a.
English: Based on the results from this study which was assessed during the variation application and was deemed adequately performed a chicken meat withdrawal period of 6 days was supported using the CVMP accepted alternative approach.
Croatian: Na temelju rezultata ovog ispitivanja, koje je ocijenjeno tijekom prijave izmjene i smatralo se primjereno provedeno, karencija za pileće meso u trajanju od 6 dana potvrđena je primjenom statističkog pristupa prihvaćenog od strane CVMP-a.
English: As a result, the MAH proposes a meat withdrawal period of 6 days in chickens for Soludox 500 mg/g powder for use in drinking water for pigs and chickens when medicated at a dose of 20 mg/kg for 4 consecutive days.
Croatian: Rezultat toga je preporuka nositelja odobrenja za stavljanje u promet da karencija za meso iznosi 6 dana kod pilića za prašak Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće prilikom liječenja dozom od 20 mg/kg kroz 4 uzastopna dana.
English: Following the review of all the data provided, the CVMP considered that only the two later residues depletion studies (from 1999 and 2011) should be taken into account in order to establish a withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Croatian: Po pregledu svih dostavljenih podataka, CVMP je zaključio da se samo dva posljednja ispitivanja (iz 1999. i 2011. godine) mogu uzeti u razmatranje da bi se utvrdila karencija za pileće meso i iznutrice pri dozi od 20 mg/kg tjelesne mase kroz 4 uzastopna dana.
English: Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names (see annex I) contains doxycycline hyclate as active ingredient.
Croatian: Prašak Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće te povezane nazive (vidjeti Dodatak I) sadrži doksiciklin hiklat kao djelatnu tvar.
English: Based on the results a chicken meat withdrawal period of 12 days was supported using the CVMP accepted statistical approach.
Croatian: Na temelju rezultata, karencija za pileće meso iznosi 12 dana, što je potvrđeno primjenom statističkog pristupa prihvaćenog od strane CVMP-a.
English: Furthermore, the test product and Soludox 500 mg/g powder for use in drinking water for pigs and chickens have different composition.
Croatian: Osim toga, testni proizvod i prašak Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće imaju različiti sastav.
English: However, it is not felt that this can be used to support the MAH's disregard for the 1999 study since birds of various weights and from different breeds will be treated with this product.
Croatian: No, ne smatra se da se ove razlike mogu uzeti kao temelj za neuvažavanje ispitivanja provedenog 1999. godine od strane nositelja odobrenja za stavljanje u promet, s obzirom da će ptice različitih masa i različitih pasmina biti liječene ovim proizvodom.
English: The marketing authorisation holder (MAH) Eurovet Animal Health BV, submitted an application for a type II variation to shorten the withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days.
Croatian: Nositelj odobrenja za stavljanje u promet, društvo Eurovet Animal Health BV, podnio je zahtjev za izmjenu tipa II u vezi sa skraćivanjem karencije za pileće meso i iznutrice u slučaju doze od 20 mg/kg tjelesne mase kroz 4 uzastopna dana.
English: Grounds for the variation to the terms of the marketing authorisations
Croatian: Osnove za izmjenu uvjeta odobrenja za stavljanje u promet
English: Regarding the residue depletion studies that were submitted, the MAH could not explain why the studies lead to different withdrawal periods.
Croatian: Vezano uz dostavljena ispitivanja deplecije rezidua, nositelj odobrenja za stavljanje u promet nije mogao objasniti zašto su u ispitivanjima dobivene različite karencije.
English: Residue depletion data from a study conducted in 2011 have been provided.
Croatian: Dostavljeni su podaci deplecije rezidua prikupljeni ispitivanjem provedenim 2011. godine.
English: • the CVMP reviewed all available data submitted by the MAH, to support the withdrawal period for chicken meat and offal at a dose rate of 20 mg/kg body weight for 4 consecutive days;
Croatian: • CVMP je pregledao sve dostupne podatke dostavljene od strane nositelja odobrenja za stavljanje u promet dostavljene u potkrjepu karencije za pileće meso i iznutrice pri dozi od 20 mg/kg tjelesne mase kroz 4 uzastopna dana;
English: Determination of the withdrawal period for chicken for the dose of 20 mg/kg body weight for 4 consecutive days
Croatian: Utvrđivanje karencije za piliće za dozu od 20 mg/kg tjelesne mase kroz 4 uzastopna dana
English: Residue depletion data from a study conducted in 1999 have been provided.
Croatian: Dostavljeni su podaci deplecije rezidua prikupljeni ispitivanjem provedenim 1999. godine.
English: Residue depletion data from a study conducted in 1993 have been provided.
Croatian: Dostavljeni su podaci ispitivanja deplecije rezidua provedenog 1993. godine.
English: Overall summary of the scientific evaluation of Soludox 500 mg/g powder for use in drinking water for pigs and chickens and associated names (see annex I)
Croatian: Konačan sažetak znanstvene evaluacije praška Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće i povezane nazive (vidjeti Dodatak I)
English: The type II variation has been subject to a worksharing procedure (UK/V/xxxx/WS/006) by the veterinary Coordination Group for Mutual Recognition and Decentralised Procedures (CMD(v)) according to Article 20 of Commission Regulation (EC) No 1234/2008 involving Soludox 500 mg/g powder for use in drinking water for pigs and chickens (NL/V/0141/001/DC) and Soludox 500 mg/g powder for use in drinking water for pigs and chickens (UK/V/0349/001/DC).
Croatian: Uredbe Komisije (EZ) br. 1234/2008, kojim su obuhvaćeni prašak Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće (NL/V/0141/001/DC) i prašak Soludox 500 mg/g za uporabu u vodi za piće za svinje i piliće (UK/V/0349/001/DC).
English: Summary of Product Characteristics:
Croatian: Sažetak opisa svojstava lijeka:
English: Amendments in the relevant sections of the summary of product characteristics, labelling and package leaflet
Croatian: Dodatak III Sažetak opisa svojstava lijeka, označavanje i uputa o lijeku
English: Instead, a 9 days withdrawal period for chicken meat and offal is recommended following a dose rate of 20 mg/kg body weight for 4 consecutive days.
Croatian: Umjesto navedenog razdoblja, nakon doze od 20 mg/kg tjelesne mase kroz 4 uzastopna dana preporuča se razdoblje karencije za pileće meso i iznutrice u trajanju od 9 dana.
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Karenca
English: There are two authorised dosages: 10 mg/kg body weight for 4 consecutive days, for which the withdrawal period is 3 days, and 20 mg/kg body weight for 4 consecutive days for which the withdrawal period is 12 days.
Croatian: Predviđene su dvije odobrene doze: 10 mg/kg tjelesne mase kroz 4 uzastopna dana.
English: WITHDRAWAL PERIOD
Croatian: Načina primjene
English: The recommended dose is 150 mg (2 injections).
Croatian: Preporučena doza je 150 mg (2 injekcije).
English: The doctor may decide to stop treatment if the condition does not improve after 16 weeks.
Croatian: Liječnik može odlučiti prekinuti liječenje ako se stanje ne popravi nakon 16 tjedana.
English: Further information on Skyrizi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Skyrizi.
Croatian: Više informacija o lijeku Skyrizi nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Skyrizi.
English: What is Skyrizi and what is it used for?
Croatian: Što je Skyrizi i za što se koristi?
English: The first two doses of 150 mg are given 4 weeks apart while subsequent doses are given every 12 weeks.
Croatian: Prve dvije doze od 150 mg daju se u razmaku od 4 tjedna, dok se naknadne doze daju svakih 12 tjedana.
English: There are few side effects, the most important one being infection.
Croatian: Zabilježeno je malo nuspojava, od kojih je najvažnija infekcija.
English: The European Medicines Agency therefore decided that Skyrizi's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Skyrizi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: What measures are being taken to ensure the safe and effective use of Skyrizi?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Skyrizi?
English: Studies have shown that Skyrizi is highly effective at clearing the skin and the positive effects are maintained with continued use.
Croatian: Ispitivanja su pokazala da je Skyrizi vrlo učinkovit u čišćenju kože te da se pozitivni učinci mogu održavati redovitom uporabom.
English: After being trained, patients may inject Skyrizi themselves if the doctor considers it appropriate.
Croatian: Nakon obuke bolesnici mogu sami ubrizgavati lijek Skyrizi ako to liječnik smatra primjerenim.
English: It is used in adults with moderate to severe disease and who require systemic treatment (treatment with medicines given by mouth or by injection).
Croatian: Primjenjuje se u odraslih osoba s umjerenim do teškim stadijem bolesti kojima je potrebno sistemsko liječenje (terapija lijekovima koji se uzimaju na usta ili putem injekcije).
English: The most common side effect with Skyrizi (which may affect more than 1 in 10 people) is upper respiratory infection (nose and throat infection).
Croatian: Najčešće nuspojave lijeka Skyrizi (koje se mogu javiti u više od 1 na 10 osoba) je infekcija gornjih dišnih puteva (upala nosa i grla).
English: Improvements in symptoms were maintained after 52 weeks of treatment with Skyrizi.
Croatian: Ublažavanje simptoma održano je nakon 52 tjedna terapije lijekom Skyrizi.
English: Side effects reported with Skyrizi are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Skyrizi pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Skyrizi authorised in the EU?
Croatian: Zašto je lijek Skyrizi odobren u EU-u?
English: Skyrizi must not be used in patients who have an ongoing infection that the doctor considers important.
Croatian: Skyrizi se ne smije primjenjivati u bolesnika s postojećom infekcijom koju liječnik smatra ozbiljnom.
English: Skyrizi is available in pre-filled syringes.
Croatian: Skyrizi je dostupan u napunjenim štrcaljkama.
English: In 4 main studies involving over 2,100 patients with moderate to severe disease who required systemic treatment, Skyrizi was more effective than placebo (a dummy treatment) and comparator medicines at improving symptoms.
Croatian: U četirima glavnim ispitivanjima koja su obuhvatila više od 2 100 bolesnika s umjerenim do ozbiljnim stadijem bolesti kojima je bila potrebna sistemska terapija, Skyrizi se pokazao učinkovitijim od placeba (prividnog liječenja) i usporednih lijekova u ublažavanju simptoma.
English: As for all medicines, data on the use of Skyrizi are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Skyrizi kontinuirano se prate.
English: It is injected under the skin in an area that is clear of psoriasis, usually in the thighs or belly.
Croatian: Lijek se ubrizgava pod kožu u području koje nije zahvaćeno psorijazom, obično u butinu ili trbuh.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Skyrizi have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Skyrizi nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Skyrizi and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Skyrizi i zašto je odobren u EU-u
English: Skyrizi can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Croatian: Skyrizi se izdaje samo na liječnički recept i namijenjen je za primjenu pod nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju plak-psorijaze.
English: The active substance in Skyrizi, risankizumab, is a monoclonal antibody (a type of protein) that is designed to attach to interleukin 23 and block its activity.
Croatian: Djelatna tvar u lijeku Skyrizi , risankizumab, monoklonsko je protutijelo (vrsta bjelančevine) osmišljeno da se veže na interleukin 23 i blokira njegovo djelovanje.
English: What are the risks associated with Skyrizi?
Croatian: Koji su rizici povezani s lijekom Skyrizi?
English: Interleukin 23 is a messenger molecule of the body's immune system (the body's natural defences) and is involved in causing inflammation that is linked to the formation of plaque psoriasis.
Croatian: Molekula interleukin 23 glasnik je imunosnog sustava organizma (prirodne obrane tijela), uključena u nastanak upale povezane s razvojem plak-psorijaze.
English: By blocking the action of interleukin 23, risankizumab reduces inflammation and symptoms associated with the disease.
Croatian: Blokiranjem aktivnosti interleukina 23, risankizumab smanjuje upalu i simptome bolesti.
English: In a second part of this study, some patients who first received Skyrizi were then switched to placebo after 28 weeks while others remained on Skyrizi.
Croatian: U drugom dijelu tog ispitivanja neki od bolesnika koji su primali Skyrizi prebačeni su na terapiju placebom nakon 28 tjedana, dok su drugi nastavili primati Skyrizi.
English: For more information about using Skyrizi, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Skyrizi pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Skyrizi is a medicine used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Croatian: Skyrizi je lijek za liječenje osoba s plak-psorijazom, bolešću koja na koži uzrokuje crvenkasta žarišta koja se ljušte.