FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of Gardasil against the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 47.2% (95% CI: 33.5, 58.2).
Croatian: Djelotvornost cjepiva Gardasil obzirom na kombiniranu incidenciju perzistentne infekcije, genitalnih bradavica, vulvarnih i vaginalnih lezija, CIN-a bilo kojeg stupnja, AIS-a i karcinoma vrata maternice povezanih s HPV-om 6, 11, 16 ili 18 iznosila je 47,2% (95% CI: 33,5; 58,2).
English: Gardasil suspension for injection in a pre-filled syringe
Croatian: Gardasil suspenzija za injekciju u napunjenoj štrcaljki i.m. primjena
English: Gardasil can be administered according to a 2-dose schedule: - First injection: at chosen date - Second injection: 6 months after first injection If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.
Croatian: Gardasil se također može primijeniti i prema rasporedu za 3 doze: Prva injekcija: na odabrani datum
English: Gardasil, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Gardasil, suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: 20 single dose vials, 0.5 ml each.
Croatian: 10 jednodoznih bočica, svaka 0,5 ml. 20 jednodoznih bočica, svaka 0,5 ml.
English: Gardasil, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Croatian: Gardasil, suspenzija za injekciju- napunjena štrcaljka s 1 iglom, pakiranje od 1, 10, 20
English: Gardasil, suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Gardasil, suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: - Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm. - If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient's size and weight.
Croatian: - Gardasil je dostupan u napunjenoj štrcaljki spremnoj za primjenu u mišić (i.m.), poželjno u deltoidno područje nadlaktice.
English: Patients were followed for up to 4 years (median 3.6 years).
Croatian: Bolesnici su bili praćeni do 4 godine (medijan = 3,6 godina) Napomena: Točke procjene i intervali pouzdanosti prilagođeni su osobi-vremenu praćenja.
English: Gardasil suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Gardasil suspenzija za injekciju cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: Among women with an abnormal Pap test at Day 1 who were already infected with the relevant vaccine HPV types at Day 1, no vaccine efficacy was observed.
Croatian: Nije zamijećeno zaštitno djelovanje cjepiva među ženama s patološkim nalazima Papa testa prvoga dana ispitivanja koje su pri ulasku u ispitivanje već bile inficirane odgovarajućim tipovima HPV-a sadržanim u cjepivu.
English: • the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
Croatian: • djelotvornost cjepiva Gardasil protiv genitalnih bradavica povezanih s HPV-om tipova 6, 11, 16 i 18 iznosila je 99,0% (95% CI: 96,2; 99,9).
English: EU/1/06/357/007 - pack of 1 EU/1/06/357/008 - pack of 10 EU/1/06/357/021 - pack of 20
Croatian: EU/1/06/357/007 - pakiranje od 1 EU/1/06/357/008 - pakiranje od 10 EU/1/06/357/021 - pakiranje od 20
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate adjuvant (0.225 milligrams Al).
Croatian: L1 protein u obliku čestica nalik virusu proizvedenih u stanicama kvasca (Saccharomyces cerevisiae CANADE 3C-5 (soj 1895)) tehnologijom rekombinantne DNA. adsorbiran na amorfni aluminijev hidroksifosfat sulfat adjuvans (0,225 miligrama Al).
English: EU/1/06/357/003 - pack of 1 EU/1/06/357/004 - pack of 10 EU/1/06/357/019 - pack of 20
Croatian: EU/1/06/357/003 - pakiranje od 1 EU/1/06/357/004 - pakiranje od 10 EU/1/06/357/019 - pakiranje od 20
English: EU/1/06/357/001 - pack of 1 EU/1/06/357/002- pack of 10 EU/1/06/357/018- pack of 20
Croatian: EU/1/06/357/001- pakiranje od 1 EU/1/06/357/002- pakiranje od 10 EU/1/06/357/018- pakiranje od 20
English: EU/1/06/357/005 - pack of 1 EU/1/06/357/006 - pack of 10 EU/1/06/357/020 - pack of 20
Croatian: EU/1/06/357/005 - pakiranje od 1 EU/1/06/357/006 - pakiranje od 10 EU/1/06/357/020 - pakiranje od 20
English: Gardasil suspension for injection in a pre-filled syringe Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Croatian: Gardasil suspenzija za injekciju u napunjenoj štrcaljki cjepivo protiv humanog papilomavirusa [tipova 6, 11, 16, 18] (rekombinantno, adsorbirano)
English: Note: point estimates and confidence intervals are adjusted for person-time of follow-up.
Croatian: ***Bolesnici su bili praćeni do 4 godine (medijan 3,6 godina) Napomena: Točke procjene i intervali pouzdanosti prilagođeni su osobi-vremenu praćenja.
English: 1 dose vial, 0.5 ml.
Croatian: Jednodozna bočica, 0,5 ml.
English: Not known Hypersensitivity reactions including anaphylactic/anaphylactoid reactions*
Croatian: Infekcije i infestacije nepoznato celulitis na mjestu injiciranja * Poremećaji krvi i limfnog sustava nepoznato idiopatska trombocitopenična purpura*, limfadenopatija* Poremećaji imunološkog sustava nepoznato reakcije preosjetljivosti uključujući anafilaktičke/anafilaktoidne reakcije*
English: The reasoning being that:
Croatian: Razlog je sljedeći:
English: Qualitative and quantitative composition
Croatian: Kvalitativni i kvantitativni sastav
English: Meat and offal: 107 days.
Croatian: Meso i iznutrice: 107 dana.
English: Finally, consideration has been given to the analytical methods that were used.
Croatian: Naposljetku, razmotrene su primijenjene analitičke metode.
English: The differences between the two residues studies have been considered.
Croatian: Razmatrane su razlike između dvaju ispitivanja o reziduima.
English: Animal species
Croatian: Vrsta životinj
English: Information was received regarding the composition of the affected products (n = 5).
Croatian: Zaprimljene su informacije o sastavu predmetnih lijekova (n = 5).
English: Quality, target animal safety, user safety, environmental risk and parasitic resistance for the concerned veterinary medicinal products have not been assessed in this referral procedure.
Croatian: Kvaliteta, sigurnost ciljane životinje, sigurnost korisnika, rizik za okoliš i otpornost na parazite za predmetne veterinarsko-medicinske proizvode nije procijenjena u ovom arbitražnom postupku.
English: A 41-day withdrawal period was determined, following statistical evaluation of the residues depletion data using the WT1.4 software.
Croatian: Određeno je razdoblje karencije u trajanju od 41 dan, nakon statističke ocjene podataka o izlučivanju rezidua s pomoću softvera WT1.4.
English: There were no residues depletion data provided for the last two products mentioned.
Croatian: Nije bilo podataka o izlučivanju rezidua za posljednja dva navedena lijeka.
English: Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
Croatian: Ne primjenjivati unutar jedne godine prije prvog janjenja u ovaca namijenjenih za proizvodnju mlijeka za prehranu ljudi.
English: It is slowly released from plasma and very slowly metabolised, and is therefore retained in the circulation for a long time; the plasma elimination half-life in sheep is 22.7 days.
Croatian: Sporo se oslobađa iz plazme i vrlo se sporo metabolizira te se stoga dugo zadržava u cirkulaciji; vrijeme polueliminacije iz plazme u ovaca iznosi 22,7 dana.
English: The limit of detection for muscle was also lower in Study 1 (<2 µg/kg) than in Study 2 (492 µg/kg).
Croatian: Granica detekcije u mišiću ujedno je bila niža u 1. ispitivanju (<2 µg/kg) nego u 2. ispitivanju (492 µg/kg).
English: The last product is formulated with a large percentage of glycerol formal.
Croatian: Posljednji lijek formuliran je s velikim postotkom glicerol formala.
English: Both marketing authorisation holders provided reports detailing the validation of the analytical method used, and the performance characteristics were mostly described in accordance with current standards.
Croatian: Oba nositelja odobrenja za stavljanje u promet dostavila su izvješća s detaljima o potvrđivanju primijenjene analitičke metode, a karakteristike učinkovitosti ponajprije su opisane u skladu s postojećim standardima.
English: Not authorised for use in ewes producing milk for human consumption including during the dry period.
Croatian: Nije odobrena primjena u ovaca koje proizvode mlijeko za prehranu ljudi, uključujući tijekom suhostaja.
English: The two products used in the studies include almost the same excipients, but in different quantities.
Croatian: Dva lijeka primijenjena u ispitivanjima sadržavaju gotovo iste pomoćne tvari, ali u različitim količinama.
English: Most (90%) of a dose of closantel is excreted unchanged in the bile/faeces after intramuscular administration, but only 10% within 48 hours, after which the rate slows further so that 1 - 2% of the dose is eliminated each day.
Croatian: Većina (90 %) doze klozantela izlučuje se u nepromijenjenom stanju u žuči/fecesu nakon intramuskularne primjene, od čega samo 10 % unutar 48 sati, nakon čega se brzina dalje smanjuje tako da se svaki dan eliminira 1 % - 2 % doze.
English: This is considered to be an important parameter affecting the residues at the injection site.
Croatian: Smatra se da je to važan parametar koji utječe na rezidue na mjestu primjene injekcije.
English: Another (nationally-authorised) version of Flukiver Solution for Injection has been authorised in France since 1981; the marketing authorisation for this product was varied in 2016 and the withdrawal periods for sheep (meat and offal) were increased from 77 days to 107 days as a result of data provided during the variation procedure.
Croatian: Druga (nacionalno odobrena) verzija otopine za injekciju Flukiver odobrena je u Francuskoj od 1981.; odobrenje za stavljanje u promet ovog lijeka izmijenjeno je 2016., a razdoblje karencije za ovce (meso i iznutrice) povećano je sa 77 dana na 107 dana zbog podataka dobivenih tijekom postupka izmjene.
English: Closantel is a salicylanilide anthelmintic, a synthetic antiparasitic agent with efficacy against liver fluke, haematophagous nematodes and larval stages of some arthropods in sheep and cattle.
Croatian: Klozantel je salicilanilidni anthelmintik, sintetski antiparazitski agens djelotvoran protiv jetrenih parazita, hematofagnih nematoda i stadija ličinaka nekih člankonožaca u ovaca i goveda.
English: List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskomedicinskih proizvoda, vrsta životinja, putova primjene i nositelja odobrenja za stavljanje lijeka u promet u državama članicama
English: However, there are some significant differences between this and the other product formulations that are in the scope of this referral procedure.
Croatian: Međutim, postoje znatne razlike između te formulacije i drugih formulacija lijeka obuhvaćenih ovim arbitražnim postupkom.
English: • with regard to the need for a maximum injection volume to be recommended in case of any difference in depletion on injection site residues, the CVMP does not consider it necessary to restrict the use of these products in this way.
Croatian: • s obzirom na potrebu za preporukom najvećeg dopuštenog volumena injekcije u slučaju bilo kakve razlike u izlučivanju rezidua na mjestu primjene injekcije, CVMP ne smatra da je potrebno ograničiti primjenu tih lijekova na taj način.
English: The UK therefore considered that it is necessary to refer the matter to the CVMP in the interests of protecting consumer safety in the Union and requested the Committee to review all available residue depletion data and recommend withdrawal periods for sheep (meat and offal).
Croatian: Ujedinjena Kraljevina stoga je smatrala da je potrebno uputiti predmet CVMP-u u interesu zaštite sigurnosti potrošača u Uniji te je zatražila od Odbora da preispita sve dostupne podatke o izlučivanju rezidua i preporuči razdoblje karencije za ovce (meso i iznutrice).
English: The recommended doses are 2.5 mg or 5 mg closantel per kg body weight (bw) for cattle and sheep, depending on the parasitic species and/or parasitic life stage at the time of treatment.
Croatian: Preporučene doze jesu 2,5 mg ili 5 mg klozantela po kg tjelesne težine za goveda i ovce, ovisno o vrstama parazita i/ili životnom stadiju parazita u vrijeme liječenja.
English: The residue depletion data for the marker tissue, liver, do not allow for a statistical determination of a withdrawal period (the assumption of normal distribution of the errors was not met).
Croatian: Podatcima o izlučivanju rezidua za markersko tkivo, odnosno jetru, ne omogućuje se statističko određivanje razdoblja karencije (nije ispunjena pretpostavka normalne razdiobe pogrešaka).
English: When administered parenterally, closantel is absorbed relatively quickly into the systemic circulation (Tmax = 8 - 24 h) and is highly bound to albumin in the plasma.
Croatian: Kad se primjenjuje parenteralno, klozantel se relativno brzo apsorbira u sistemsku cirkulaciju (Tmax = 8 - 24 h) i ima visok postotak vezanja za albumin u plazmi.
English: The proposed sheep meat withdrawal period for the generic product, Santiola, was 77 days, in line with the Irish reference product (although the target species ‘sheep' was removed from the reference product during the application procedure for Santiola), but not in accordance with the data provided by France during the procedure.
Croatian: Predloženo razdoblje karencije ovčjeg mesa za generički lijek Santiola iznosilo je 77 dana, u skladu s irskim referentnim lijekom (iako je ciljna vrsta „ovca” uklonjena iz referentnog lijeka tijekom postupka podnošenja zahtjeva za lijek Santiola), ali ne u skladu s podatcima koje je dostavila Francuska tijekom postupka.
English: While the efficacy of the concerned products in sheep has not been specifically assessed as part of this referral, the products under assessment are considered to be effective in the treatment and prevention of infestations with named parasites.
Croatian: Budući da djelotvornost predmetnih lijekova u ovaca nije posebno procijenjena u okviru ovog arbitražnog postupka, lijekovi koji se procjenjuju smatraju se djelotvornima u liječenju i prevenciji infestacija navedenim parazitima.
English: The CVMP considered whether it would be necessary to restrict the volume of injection, to mitigate any uncertainties around the effect of formulation differences at the injection sites.
Croatian: CVMP je razmotrio bi li trebalo ograničiti volumen injekcije kako bi se ublažile bilo kakve nesigurnosti u pogledu učinka razlike u formulaciji na mjestu primjene injekcije.
English: However, considering the results of this pilot study, and the limited information that they provide, this conclusion might not be adequate, as the residue concentrations in the sampled tissues did not fall below the respective MRLs; therefore, it was not possible to know which would be the withdrawal period determining tissue from these data.
Croatian: Međutim, uzimajući u obzir rezultate tog pilotispitivanja i ograničene informacije koje ta ispitivanja pružaju, ovaj zaključak možda nije prikladan s obzirom na to da koncentracije rezidua u uzorkovanim tkivima nisu bile ispod najvećih dopuštenih količina rezidua; stoga iz tih podataka nije bilo moguće utvrditi s pomoću kojeg se tkiva određuje razdoblje karencije.
English: The reference product is Flukiver 50 mg/ml Solution for Injection, which has been authorised in various Member States since 1989.
Croatian: Referentni lijek je otopina za injekciju Flukiver 50 mg/ml, odobren u raznim državama članicama od 1989.
English: An additional risk mitigation measure of restricting the maximum injection volumes was considered by the CVMP, but ultimately it was decided that this was not required to ensure consumer safety.
Croatian: CVMP je razmatrao dodatnu mjeru ublažavanja rizika u smislu ograničavanja najvećih dopuštenih volumena injekcije, ali je na kraju odlučeno da to nije potrebno kako bi se zajamčila sigurnost potrošača.
English: In addition, different breeds of sheep were used in each of the studies provided.
Croatian: Osim toga, svako od navedenih ispitivanja provedeno je na različitim vrstama ovaca.
English: One of these products (‘Flukiver 5%') was used in the pivotal residues study, Study 1.
Croatian: Jedan od tih lijekova („Flukiver 5 %”) primijenjen je u glavnom ispitivanju o reziduima, odnosno 1. ispitivanju.
English: The study was conducted in 2016 with 20 treated animals (five mixed-sex groups of four animals) and a control group consisting of two untreated animals.
Croatian: Ispitivanje je provedeno 2016. na 20 liječenih životinja (pet skupina od četiri životinje obaju spolova) i kontrolnoj skupini koja se sastojala od dvije neliječene životinje.
English: • from the data provided, it is concluded that the full residues depletion study provided for ‘Flukiver 5%' (Study 1) could be considered as the pivotal study, as it was well-reported, and conformed well to current requirements.
Croatian: • iz dostavljenih podataka zaključeno je da se potpuno ispitivanje o izlučivanju rezidua provedeno za „Flukiver 5 %” (1. ispitivanje) može smatrati glavnim ispitivanjem s obzirom na to da je temeljito provedeno i da je u skladu s trenutačnim zahtjevima.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e., a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product Santiola, containing 50 mg closantel per ml, with Ireland as Reference Member State (IE/V/0377/001/DC).
Croatian: Zahtjev je podnesen u skladu s člankom 13. stavkom 1. Direktive 2001/82/EZ, tj. generički zahtjev za odobrenje za stavljanje lijeka u promet u skladu s decentraliziranim postupkom za veterinarskomedicinski proizvod Santiola koji sadržava 50 mg klozantela po ml, pri čemu je Irska bila referentna država članica (IE/V/0377/001/DC).
English: All edible tissues, including injection sites, were sampled on days 19, 40, 61, 89, and 103 after treatment and analysed using an SPE-LC-MS/MS method of analysis, validated in line with current requirements.
Croatian: Sva jestiva tkiva, uključujući mjesta primjene injekcije, uzorkovana su 19., 40., 61., 89. i 103. dana nakon liječenja te su analizirana s pomoću metode analize SPE-LC-MS/MS, koja je potvrđena u skladu s trenutačnim zahtjevima.
English: The first study used Merino crosses, which are bred for meat production, whereas the second study used Ripollesa, which are bred for both meat and milk production.
Croatian: Prvo je ispitivanje provedeno na križancima pasmine Merino, koji se uzgajaju za proizvodnju mesa, dok je drugo ispitivanje provedeno na pasmini Ripollesa, koja se uzgaja za proizvodnju mesa i mlijeka.
English: It cannot be concluded from the data available whether these breed differences had any influence on the depletion patterns seen.
Croatian: Iz dostupnih podataka ne može se zaključiti jesu li razlike u pasminama utjecale na uočene uzorke izlučivanja.
English: Both studies administered a dose of 5 mg/kg body weight; however, due to differences in the weights of the animals used in the two studies, the volume of product administered was different (6.7 - 8.4 ml administered in Study 1; 3.6 - 5.8 ml administered in Study 2).
Croatian: U obama ispitivanjima primijenjena je doza od 5 mg/kg tjelesne težine; međutim, zbog razlika u težinama životinja na kojima su provedena dva ispitivanja volumen primijenjenog lijeka bio je različit (6,7 - 8,4 ml primijenjeno je u 1. ispitivanju; 3,6 - 5,8 ml primijenjeno je u 2. ispitivanju).
English: Consideration has been given to the absolute amounts injected at the subcutaneous injection site.
Croatian: Razmotrene su apsolutne količine injicirane na mjestu supkutane primjene injekcije.
English: Evaluation and conclusions on the benefit-risk balance
Croatian: Ocjena i zaključci o omjeru koristi i rizika
English: Thus, it is considered that the rate of absorption from the injection site, which is measured in hours/days, will have a negligible influence on the rate of elimination from the edible tissues, which is measured in weeks.
Croatian: Stoga se smatra da će brzina apsorpcije iz mjesta primjene injekcije, mjerena u satima/danima, imati zanemariv utjecaj na brzinu eliminacije iz jestivih tkiva, koja se mjeri u tjednima.
English: Pharmacokinetics
Croatian: Farmakokinetika
English: To ensure the safety of consumers of food and food products derived from animals treated with products containing closantel, the European Commission has set MRLs for closantel in the edible tissues of sheep.
Croatian: Kako bi se zajamčila sigurnost potrošača hrane i prehrambenih proizvoda dobivenih od životinja liječenih lijekovima koji sadržavaju klozantel, Europska komisija odredila je najveće dopuštene količine rezidua klozantela u jestivim tkivima ovaca.
English: This mitigation measure was thoroughly evaluated and discussed by the CVMP, and determined to be unnecessary.
Croatian: Ta mjera ublažavanja rizika temeljito je ocijenjena i raspravljena u CVMP-u te je utvrđeno da nije potrebna.
English: The product used in Study 2 ‘Endoex Solucion Injectable', has a level of propylene glycol that is not comparable to the product used in Study 1.
Croatian: Lijek primijenjen u 2. ispitivanju, „Endoex Solucion Injectable”, sadržava razinu propilenglikola koja nije usporediva s lijekom primijenjenim u 1. ispitivanju.
English: Therefore, the Committee considered that the proposed WP of 107 days derived from Study 1 can be extrapolated to all concerned products.
Croatian: Stoga je Odbor smatrao da se predloženo razdoblje karencije od 107 dana navedeno u 1. ispitivanju može primijeniti na sve predmetne lijekove.
English: As data were collected for injection sites, only, in Study 2, it could have been possible to combine or compare data from studies 1 and 2 for depletion from this tissue, only.
Croatian: Kako su podatci prikupljeni samo za mjesta primjene injekcije, u 2. ispitivanju mogli su se kombinirati ili usporediti podatci iz 1. i 2. ispitivanja samo za izlučivanje iz tog tkiva.
English: The study was conducted in 2009, with 30 treated animals (5 mixed-sex groups of six animals) and a control group consisting of one untreated animal.
Croatian: Ispitivanje je provedeno 2009. na 30 liječenih životinja (pet skupina od šest životinja obaju spolova) i kontrolnoj skupini koja se sastojala od jedne neliječene životinje.
English: The viscosity of propylene glycol is greater than that of glycerol formal which is greater than the viscosity of water.
Croatian: Viskoznost propilenglikola veća je od viskoznosti glicerol formala, a ona je veća od viskoznosti vode.
English: Residues depletion data were submitted by two of the affected marketing authorisation holders.
Croatian: Podatke o izlučivanju rezidua dostavila su dva predmetna nositelja odobrenja za stavljanje u promet.
English: In the GLP study, the injection sites were sampled on days 2, 7, 14, 24 and 29 days after treatment and analysed using an HPLC-FD method of analysis, validated in line with current requirements.
Croatian: U ispitivanju usklađenom sa zahtjevima DLP-a, mjesta primjene injekcije uzorkovana su 2., 7., 14., 24. i 29. dana nakon liječenja te su analizirana s pomoću metode analize HPLC-FD, koja je potvrđena u skladu s trenutačnim zahtjevima.