FrancophonIA/ELRC3.0 huggingface dataset:
English: This indication concerns use in chronic heart failure New York Heart Association (NYHA) class II to IV with systolic dysfunction, in patients in sinus rhythm with heart rate ≥75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Croatian: New York Heart Association (NYHA)) sa sistoličkom disfunkcijom, u bolesnika sa sinusnim ritmom sa frekvencijom srca ≥75 bpm, u kombinaciji sa standardnom terapijom, uključujući terapiju beta blokatorima ili ako je terapija beta blokatorima kontraindicirana ili se ne podnosi.
English: Although it does not fully explain the findings, a contributor to the increased risk of CV events appears to be the high starting dose and maximum dose used in the SIGNIFY study, exceeding the currently approved maximum dose.
Croatian: Iako u potpunosti ne objašnjava nalaze, čini se da velika početna doza i maksimalna doza primijenjena u ispitivanju SIGNIFY, koja premašuje trenutno odobrenu maksimalnu dozu, doprinose povećanom riziku od događaja CV-a.
English: Furthermore a drug utilisation study shall be performed to describe the characteristics of users of ivabradine, patterns of use and assess adherence to the risk minimisation measures.
Croatian: Nadalje ispitivanje iskoristivosti lijeka provest će se kako bi se opisale značajke korisnika ivabradina, obrasci primjene i ocjena postupanja u skladu s mjerama za smanjivanje rizika.
English: Patients exposed to 10 mg dose versus not exposed to 10 mg showed a higher risk for bradycardia (E=2.54 [1.54-4.82]), observation supported by data from two small parallel studies also using the 10 mg dose.
Croatian: Bolesnici izloženi dozi od 10 mg u odnosu na one koji nisu izloženi dozi od 10 mg pokazali su veći rizik od bradikardije (E=2,54 [1,544,82]), pri čemu je opservacija podržana podacima iz dva mala paralelna ispitivanja koja su također koristila dozu od 10 mg.
English: The MAH will conduct a drug utilisation study to describe the characteristics of users of ivabradine, as well as describing the patterns of use of ivabradine and adherence to the risk minimisation measures.
Croatian: Nositelj odobrenja provest će ispitivanje iskoristivosti lijeka kako bi opisao karakteristike korisnika ivabradina, kao i obrasce primjene ivabradina i postupanje u skladu s mjerama smanjivanja rizika.
English: The PRAC is therefore of the opinion that the benefit-risk balance of ivabradine remains favourable taking into account the product information amendments and subject to the risk minimisation measures and additional pharmacovigilance activities agreed.
Croatian: Stoga je PRAC mišljenja da omjer koristi i rizika ivabradina ostaje povoljan uzimajući u obzir dopune informacija o proizvodu; te je predmetom mjera za smanjivanje rizika i usuglašenih dodatnih aktivnosti na području farmakovigilancije.
English: Nevertheless information monitoring of patients for AF needs to be reinforced.
Croatian: Bez obzira na to, potrebno je više informacija o praćenju bolesnika s AF-om.
English: Systolic Heart failure treatment with the If inhibitor ivabradine Trial.
Croatian: 2 Ispitivanje liječenja sistoličkog zatajenja srca liječeno uzročnim inhibitorom ivabradina.
English: MorBidity-mortality EvAlUaTion of the If inhibitor ivabradine in patients with coronary disease and left ventricULar dysfunction.
Croatian: 1 Ocjena morbiditeta i mortaliteta uzročnog inhibitora ivabradina u bolesnika s koronarnom bolesti i disfunkcijom lijeve klijetke.
English: Concomitant use of diltiazem/verapamil (which also have an additional heart rate lowering effect) and strong CYP3A4 inhibitors have also shown to increase the incidence of bradycardia events and the risk of MI. Concomitant treatment is currently not recommended but this should be strengthened to a contraindication to minimize the risk of clinically relevant interactions.
Croatian: Utvrđeno je da istovremena primjena diltiazema/verapamila (koji također imaju dodatno djelovanje na snižavanje frekvencije srca) i snažnih inhibitora CYP3A4 također povisuje incidenciju događaja bradikardije i rizik od MI-a.
English: dose in the SIGNIFY study (higher than the current approved 7.5 mg b.i.d.
Croatian: U bolesnika titriranih na maksimalnu dozu od 10 mg b.i.d. u ispitivanju SIGNIFY (veća doza od trenutno odobrene doze od 7,5 mg b.i.d.), većina završnih točaka nastupila je u najvišoj dozi.
English: Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease.
Croatian: 3 Ispitivanje koje je ocjenjivalo omjer koristi morbiditeta i mortaliteta uzročnog inhibitora ivabradina u bolesnika s bolesti koronarne arterije.
English: On the basis of efficacy and safety data from studies that became available after the initial marketing authorisation including the BEAUTIFUL1 study, the indication was extended in October 2009 to include combination with beta-blockers in patients whose angina is inadequately controlled with an optimal beta-blocker dose and whose heart rate is >60 bpm.
Croatian: Na temelju djelotvornosti i podataka za sigurnu primjenu iz ispitivanja koja su postala dostupna nakon prvog odobrenja za stavljanje lijeka u promet uključujući i ispitivanje BEAUTIFUL1, indikacija je proširena u listopadu 2009.
English: Scientific conclusions 1 - PRAC recommendation
Croatian: - Preporuke PRAC-a
English: Ivabradine, a specific heart rate lowering agent, has demonstrated symptomatic improvement of angina symptoms in patients with stable CAD. A large study in patients with CAD and left ventricular dysfunction (BEAUTIFUL study) could not demonstrate a benefit in terms of CV outcome.
Croatian: Ivabradin, specifično sredstvo za snižavanje frekvencije srca, pokazao je simptomatička poboljšanja u simptomima angine u bolesnika sa stabilnim CAD-om.
English: (Invented) name
Croatian: (Zaštićeno) ime
English: Strength Pharmaceutical Form
Croatian: Doza Farmaceutski oblik
English: blister (alu/alu)
Croatian: 188 tableta blister (alu/alu)
English: EU Number
Croatian: Broj (EU) odobrenja
English: Pack size bottle (HDPE)
Croatian: Veličina pakovanja boca (HDPE)
English: Member State EU/EEA
Croatian: Država članica EU/EEA
English: These warnings are appropriate.
Croatian: Ova su upozorenja primjerena.
English: Animal species
Croatian: Životinjska vrsta
English: Northern Ireland
Croatian: Sjeverna Irska
English: Direct therapeutic benefit
Croatian: Izravna terapijska korist
English: The ERA was full and complete in terms of data requirements.
Croatian: ERA je bio iscrpan i potpun u smislu zahtjeva za podacima.
English: Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik
English: The reference Member State is the United Kingdom.
Croatian: Referentna država članica je Ujedinjena Kraljevina.
English: Assessment of the data submitted
Croatian: Procjena dostavljenih podataka
English: Considering the data submitted, the Committee concluded as follows on issues raised in the notification received from Germany.
Croatian: Razmotrivši dostavljene podatke, Povjerenstvo je u vezi s problemima navedenima u obavijesti koju je podnijela Njemačka zaključilo na sljedeći način.
English: In conclusion eprinomectin was not considered to be a PBT compound.
Croatian: Zaključno, eprinomektin se ne smatra PBT spojem.
English: Quality, target animal safety, user safety, residues and resistance were not assessed in this referral procedure, but all risks were addressed during the decentralised procedure.
Croatian: U ovom postupku upućivanja nisu procijenjeni kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika, rezidui i otpornost, no svi su rizici ispitani tijekom decentraliziranog postupka.
English: Based on available data, the P and T criteria are met and so the remaining B component should be fully assessed.
Croatian: Na temelju dostupnih podataka, kriteriji P i T su ispunjeni, tako da je potrebna potpuna procjena preostale komponente B.
English: 4.5 Special precautions for use iii.
Croatian: 4.5 Posebne mjere opreza prilikom primjene iii.
English: Introduction
Croatian: Uvod
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina veterinarskih medicinskih proizvoda, životinjskih vrsta, putova primjene, država članica koje su podnijele zahtjev
English: It provided all the information required to be able to make a conclusion on the environmental risk presented by the use of this product.
Croatian: On sadrži sve informacije potrebne za donošenje zaključka o riziku za okoliš prisutnom uslijed primjene ovog proizvoda.
English: Other precautions
Croatian: Druge mjere opreza
English: The risk to aquatic ecosystems will be further reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.
Croatian: Rizik za vodene ekosustave će se dodatno smanjiti tako da se liječena goveda drže dalje od vodotoka tijekom dva do pet tjedana nakon liječenja.
English: The concerned Member States involved are Germany and the Netherlands.
Croatian: Njemačka i Nizozemska su države članice sudionice u postupku.
English: However, Germany considered no acceptable data in the environmental risk assessment has been provided on bioaccumulation in order to assess the B criterion.
Croatian: No, Njemačka je smatrala da u postupku procjene rizika za okoliš nisu dostavljeni prihvatljivi podaci o bioakumulaciji kako bi se ocijenio kriterij B.
English: Eprinomectin has a n-octanol/water partition coefficient (KOW, expressed as log KOW) of 6.5 which was tested in a valid KOW study according to guideline 117 of the Organisation for Economic Co-operation and Development (OECD)4.
Croatian: Eprinomektin sadrži koeficijent raspodjele n-oktanola/vode (KOW, izraženo kao log KOW) u vrijednosti 6,5 što je ispitano u valjanom ispitivanju koeficijenta KOW u skladu sa smjernicom br. 117 Organizacije za ekonomsku suradnju i razvoj (OECD)4.
English: The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of eprinomectin (and products of the same anthelmintic class) in cattle.
Croatian: Rizik za vodene ekosustave i faune balege može se smanjiti izbjegavanjem suviše česte i ponavljane primjene eprinomektina (i proizvoda istog razreda antihelmintika) u goveda.
English: Like other macrocyclic lactones, eprinomectin has the potential to adversely affect non-target organisms.
Croatian: Kao i drugi makrociklički laktoni, eprinomektin ima mogućnost štetnog djelovanja na ne ciljane organizme.
English: Evaluation of secondary poisoning showed the risk quotient values for terrestrial and aquatic predators were <1 and further assessment was not required.
Croatian: Evaluacija sekundarnog trovanja dokazala je da su vrijednosti kvocijenta rizika za kopnene i vodene predatore <1, te daljnja procjena nije bila potrebna.
English: The active substance is well known and is included in veterinary medicinal products currently authorised in the EU for use in cattle.
Croatian: Djelatna je tvar dobro poznata i sadržana je u veterinarsko-medicinskim proizvodima koji su trenutno odobreni u EU-u za primjenu na stoci.
English: Potential serious risks were identified during the decentralised procedure by Germany who considered that eprinomectin might potentially be a PBT (persistent, bioaccumulative and toxic) substance.
Croatian: Njemačka je tijekom decentraliziranog postupka utvrdila potencijalne ozbiljne rizike, te je zaključila da eprinomektin može biti potencijalno PBT (dugotrajna, bioakumulativna i toksična) tvar.
English: SPECIAL WARNINGS
Croatian: POSEBNA UPOZORENJA
English: Following treatment, excretion of potentially toxic levels of eprinomectin may take place over a period of several weeks.
Croatian: Nakon liječenja, tijekom razdoblja od nekoliko tjedana može doći do izlučivanja potencijalno toksičnih razina eprinomektina.
English: The valid Summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Croatian: Valjani Sažetak opisa svojstava, označavanje i uputa o veterinarsko-medicinskom proizvodu su konačne inačice sačinjene tijekom postupka skupine za koordinaciju sa sljedećim izmjenama:
English: Add the following text in the relevant sections of the product information:
Croatian: Sljedeći tekst dodajte u odgovarajuće dijelove upute o veterinarsko-medicinskom proizvodu:
English: Therefore, a referral to CVMP under Article 33(4) of Directive 2001/82/EC was made.
Croatian: Stoga je provedeno upućivanje CVMPu sukladno članku 33. stavku 4. Direktive 2001/82/EZ.
English: Eprinomectin fulfils the 'P' criterion as a conclusion from the PBT assessment and has a high adsorption coefficient (KOC).
Croatian: Eprinomektin ispunjava kriterij „P”, što proizlazi kao zaključak procjene PBT-a, a ima visoki koeficijent apsorpcije (KOC).
English: A screening for PBT properties as required by the CVMP guidelines indicated that eprinomectin fulfils the criteria for 'P' and 'T' but it was considered not to be 'B'.
Croatian: Probiranje za svojstva PBT, kako je predviđeno smjernicama CVMP-a, pokazalo je da eprinomektin ispunjava kriterije za „P” i „T”, no ne smatra se da je „B”.
English: 4 OECD guidelines for the testing of chemicals, Test No. 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en duration of eprinomectin excretion and the keep off from water bodies two to five weeks after treatment.
Croatian: 117: Partition Coefficient (n octanol/water), HPLC Method: http://www.oecd-ilibrary.org/environment/test-no-117partition-coefficient-n-octanol-water-hplc-method_9789264069824-en OECD guidelines for the testing of chemicals, Test No.305: Bioaccumulation in Fish: Aqueous and Dietary Exposure: http://www.oecdilibrary.org/content/book/9789264185296-en eprinomektina i držanju podalje od vodenih površina dva do pet tjedana nakon liječenja.
English: Results from a bioaccumulation study according to OECD guideline 3055 demonstrate that eprinomectin is not likely to concentrate to levels that would pose a risk to aquatic organisms.
Croatian: Rezultati ispitivanja bioakumulacije sukladno smjernici br. 3055 OECDa pokazuju da nije izgledno koncentriranje eprinomektina u razinama koje bi predstavljale rizik za vodene organizme.
English: The benefit of the products is treatment and control of infections from gastrointestinal roundworms (adults and fourth stage larvae), lungworms (adults and fourth stage larvae), warbles (parasitic stages, mange mites, lice and horn flies by using this product.
Croatian: Korist od VMP-a je liječenje i kontrola infekcija uzrokovanih gastrointestinalnim oblićima (odraslima i u četvrtom stupnju ličinke), plućnim vlascima (odraslima i u četvrtom stupnju ličinke), štrkovima (stupnjevima parazita), šugarcima, ušima i rožnim muhama primjenom ovog proizvoda.
English: Risk assessment
Croatian: Procjena rizika
English: Eprinomectin residues will be introduced into the environment following direct excretion onto pasture.
Croatian: Rezidui eprinomektina dospijevaju u okoliš nakon izravne ekskrecije na pašnjak.
English: Eprinomectin is very toxic to aquatic organisms, is persistent in soils and may accumulate in sediments.
Croatian: Eprinomektin je vrlo otrovan za vodene organizme, dugo se zadržava u tlu i može se akumulirati u sedimentima.
English: Germany Norbrook Laboratories Limited
Croatian: Njemačka Norbrook Laboratories Limited
English: The application in question, submitted via the decentralised procedure, is a ‘hybrid' application according to Art. 13(3) of Directive 2001/82/EC, as amended, referring to the reference product Eprinex Pour-On Solution for Beef and Dairy Cattle authorised in the United Kingdom.
Croatian: Predmetni zahtjev, dostavljen putem decentraliziranog postupka, predstavlja „hibridni” zahtjev u skladu s člankom 13. stavkom 3. Direktive 2001/82/EZ, s izmjenama, u vezi s referentnim VMP-om Eprinex otopinom za polijevanje po koži goveda i mliječnih pasmina stoke koja je odobrena u Ujedinjenoj Kraljevini.
English: Faeces containing eprinomectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Croatian: Feces koji sadrži eprinomektin a koji liječene životinje izluče na pašnjak može smanjiti obilnost organizama koji se hrane balegom što može utjecati na razgradnju balege.
English: The use of the product poses a risk for aquatic organisms in groundwater and surface water as well as for dung fauna.
Croatian: Primjena proizvoda predstavlja rizik za vodene organizme u podzemnim vodama kao i za faunu u balezi.
English: Based on the identified risks in the ERA RMM were proposed to address the risk.
Croatian: Na temelju rizika navedenih u ERA-u, predložene su RMM s ciljem uklanjanja rizika.
English: The deriving bioaccumulation potential and the potential for being considered a PBT compound and secondary poisoning were addressed as required by VICH and CVMP guidelines.
Croatian: Proizlazeći potencijal bioakumulacije, potencijal da se VMP smatra PBT spojem, kao i potencijal za sekundarno trovanje, obrađeni su kako je to predviđeno smjernicama VICH-a i CVMP-a.
English: Based on the fate data of eprinomectin and the outcome of the PBT assessment it was additionally considered to address the persistency in soil.
Croatian: Na temelju podataka o sudbini za eprinomektin i ishoda procjene PBT-a, dodatno je razmatrana potreba ispitivanja dugotrajnosti u tlu.
English: Annex II
Croatian: Dodatak II
English: In order to address the concerns raised by the referral, the applicant provided an environmental risk assessment (ERA) in accordance with VICH guidelines GL61 and GL382 and in accordance with the CVMP guideline in support of VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)3.
Croatian: Kako bi se obratila pozornost na zabrinutosti istaknute prilikom upućivanja, podnositelj zahtjeva dostavio je procjenu rizika za okoliš (ERA) u skladu sa smjernicama VICH-a GL61 i GL382, te u skladu sa smjernicama CVMP-a koje su sukladne sa smjernicama VICH-a GL6 i GL38 (EMEA/CVMP/ERA/418282/2005)3.
English: These characteristics are also addressed in the SPC and the package leaflet with the information "... is persistent in soils and may accumulate in sediments ".
Croatian: Ove su karakteristike također navedene u sažetku opisa svojstava VMP-a i uputi o lijeku uz informaciju „... dugotrajan je u tlu i može se akumulirati u sedimentima”.
English: An ERA in accordance with VICH and CVMP guidelines was provided which contained a mixture of published and bespoke studies from the applicant and addressed all aspects of environmental risk.
Croatian: Podnositelj zahtjeva dostavio je ERA u skladu sa smjernicama VICH-a i CVMP-a koji je sadržavao kombinaciju objavljenih i posebno naručenih ispitivanja, te je obuhvatio sve aspekte rizika za okoliš.
English: Having considered all the overall submitted data in writing the CVMP concluded that the ERA for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle shows that the product is not expected to pose a risk for the environment when used as recommended in the SPC which includes following the recommended RMM.
Croatian: Nakon što je razmotrio cjelokupne dostavljene podatke u pisanom obliku, CVMP je zaključio da ERA za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke dokazuje kako se ne očekuje da VMP predstavlja rizik za okoliš ako se koristi kako je preporučeno u sažetku opisa svojstava VMP-a, što uključuje i primjenu preporučenih RMM-a.
English: Additionally, risk mitigation measures (RMM) have been considered and proposed for the risk identified for dung insects.
Croatian: Nadalje, razmotrene su mjere za smanjivanje rizika (RMM), te su iste predložene za utvrđeni rizik za balegare.
English: On the basis of the ERA no other RMMs were proposed by the applicant.
Croatian: Podnositelj zahtjeva nije predložio nikakve druge RMM-ove na temelju ERA-a.
English: The amended summary of product characteristics and package leaflet of the reference Member State are set out in Annex III.
Croatian: Izmijenjeni sažetak opisa svojstava VMP-a i uputa o lijeku referentne države članice sadržani su u Dodatku III.
English: Annex III
Croatian: Dodatak III
English: Annex I
Croatian: Dodatak I
English: Because eprinomectin is a parasiticide a Phase II assessment according to VICH GL38 was presented
Croatian: Budući da je eprinomektin paraziticid, za djelatnu tvar dostavljena je procjena Faze II sukladno smjernicama VICH-a
English: Consequently in order to mitigate the risk for dung insects RMM were included in the product information.
Croatian: Slijedom toga, kako bi se smanjio rizik za balegare, RMM-ovi su uključeni u informacije o VMP-u.
English: 5.3 Environmental properties
Croatian: 5.3 Svojstva koja se tiču zaštite okoliša
English: Amendments in the relevant sections of the Summary of product characteristics and package leaflet
Croatian: Izmjene u odgovarajućim dijelovima Sažetka opisa svojstava i upute o veterinarsko-medicinskom proizvodu
English: Package leaflet:
Croatian: Uputa o VMP:
English: The benefit-risk for the product can be considered to be positive.
Croatian: Omjer koristi i rizika za VMP može se smatrati pozitivnim.
English: Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle contains eprinomectin, a synthetic avermectin.
Croatian: Norbonex 5 mg/ml otopina za polijevanje po koži goveda i mliječnih pasmina stoke sadrži eprinomektin, sintetski avermektin.
English: The RMM and warnings in the summary of product characteristics (SPC) and package leaflet address the risk to dung fauna and aquatic organisms by advising on the frequency of re-treatments, the
Croatian: Mjere za upravljanje rizikom ili smanjivanje rizika RMM i upozorenja u sažetku opisa svojstava VMP-a (SPC), kao i u uputi o lijeku, navode rizik za faunu u balezi i vodene organizme te sadrže savjete o učestalosti ponovnih liječenja, trajanju ekskrecije
English: Benefit-risk assessment
Croatian: Procjena koristi i rizika
English: Therefore, the CVMP recommended the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle with amendment to the summary of product characteristics and package leaflet of the reference Member State.
Croatian: Stoga je CVMP preporučio izdavanje odobrenja za stavljanje VMP-a u promet za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke s dopunom u sažetku opisa svojstava VMP-a i uputi o lijeku referentne države članice.
English: Route of administration
Croatian: Put primjene
English: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf for the active ingredient in order to assess the fate of the substance and the effects on organisms that might occur in the environment by the use of the product.
Croatian: 3 CVMP Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC 500004386.pdf
English: Co. Down
Croatian: Down
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Norbonex 5 mg/ml Pour-On Solution for Beef and Dairy Cattle
Croatian: Znanstveni zaključci i razlozi za izdavanje odobrenja za stavljanje VMP-a u promet za Norbonex 5 mg/ml otopinu za polijevanje po koži goveda i mliječnih pasmina stoke