FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently-available data, the CVMP concluded that the overall benefitrisk balance for veterinary medicinal products containing 50 mg closantel per ml (as a single active substance) presented as solutions for injection for subcutaneous use in sheep, is positive and agreed that the withdrawal periods (meat and offal) for sheep should be harmonised and amended to provide assurance for consumer safety.
Croatian: Na temelju ocjene trenutačno dostupnih podataka, CVMP je zaključio da je ukupni omjer koristi i rizika za veterinarsko-medicinske proizvode koji sadržavaju 50 mg klozantela po ml (kao jedinu djelatnu tvar) u obliku otopine za injekciju za supkutanu primjenu u ovaca pozitivan te se složio da bi se razdoblja karencije (za meso i iznutrice) za ovce trebala uskladiti i izmijeniti kako bi se zajamčila sigurnost potrošača.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for the concerned products is positive and recommended amendments to the withdrawal periods for sheep to provide assurance for consumer safety.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji zaključio je da je ukupni omjer koristi i rizika za te proizvode pozitivan te je preporučio izmjenu razdoblja karencije za ovce kako bi se zajamčila sigurnost potrošača.
English: 28 February 2014
Croatian: 28. veljače 2014.
English: The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Croatian: Zaključno mišljenje promijenjeno je u Odluku Europske komisije dana 28. veljače 2014.
English: The referral started on 7 November 2012.
Croatian: Postupak upućivanja započet je 7. studenog 2012.
English: Veterinary Medicines
Croatian: Veterinarsko-medicinski proizvodi
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Croatian: Ima antibakterijsko djelovanje protiv širokog spektra gram-negativnih i gram-pozitivnih bakterija.
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Croatian: Podnositelji zahtjeva i nositelji odobrenja dostavili su pisana pojašnjenja dana 15. veljače 2013. i 9. rujna 2013.
English: International non-proprietary name (INN): enrofloxacin
Croatian: Međunarodni nezaštićeni naziv (INN): enrofloksacin
English: The CVMP was requested to consider the indications, dosage regimens and withdrawal periods for chickens and turkeys in order to ensure consumer safety, efficacious treatment in chickens and turkeys, as well as lower the risk of development of antimicrobial resistance to enrofloxacin.
Croatian: Od CVMP-a zatraženo je da razmotri indikacije, režime doziranja i razdoblja karencije za piliće i purane kako bi se osigurala sigurnost potrošača, djelotvorno liječenje u pilića i purana kao i smanjio rizik od razvoja antimikrobijske otpornosti na enrofloksacin.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Croatian: Enrofloksacin je sintetsko kemoterapijsko sredstvo iz kategorije derivata fluorokinolona karboksilne kiseline.
English: The condition on the marketing authorisations is in Annex IV.
Croatian: Uvjeti o odobrenjima za stavljanje VMP-a u promet navedeni su u Dodatku IV.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information and conditions of the marketing authorisations.
Croatian: Na temelju ocjene trenutno dostupnih podataka, CVMP je zaključio da cjelokupni omjer koristi i rizika za ove proizvode ostaje pozitivan, no predmetom je izmjena u informacijama o VMP-u i uvjetima o odobrenju za stavljanje VMP-a u promet.
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Croatian: Jukes kao izvjestitelja i E-M.
English: Therefore on 7 November 2013 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for all veterinary medicinal products containing enrofloxacin to be administered via drinking water to chickens and/or turkeys.
Croatian: Stoga, Odbor je konsenzusom usvojio pozitivno mišljenje dana 7. studenog 2013. godine preporučujući izmjene uvjeta odobrenja za stavljanje VMP-a u promet za sve veterinarsko-medicinske proizvode koji sadrže enrofloksacin, a primjenjuju se putem vode za piće u pilića i/ili purana.
English: Enrofloxacin is for veterinary use only.
Croatian: Enrofloksacin je namijenjen samo za primjenu na području veterine.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Croatian: Znanstveni zaključci navedeni su u Dodatku II zajedno s dopunama relevantnih dijelova Sažetka opisa svojstava VMP-a, naljepnice i upute o VMP-u u Dodatku III.
English: On 18 October 2012, the United Kingdom presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC, regarding all veterinary medicinal products containing enrofloxacin to be administered via the drinking water to chickens and/or turkeys.
Croatian: Direktive 2001/82/EC, u vezi sa svim veterinarsko-medicinskim proizvodima koji sadrže enrofloksacin za primjenu putem vode za piće u pilića i/ili purana.
English: The duration of treatment depends on the patient's condition and response to treatment.
Croatian: Trajanje liječenja ovisi o stanju bolesnika i odgovoru na liječenje.
English: There were several measures of effectiveness in the studies.
Croatian: U ispitivanjima je primjenjeno nekoliko mjerila djelotvornosti.
English: • decompensated liver disease (when the liver does not work normally).
Croatian: • dekompenziranom bolešću jetre (kada jetra ne funkcionira normalno).
English: Zeffix lamivudine
Croatian: Zeffix lamivudin
English: The recommended dose of Zeffix is 100 mg once a day.
Croatian: Preporučena doza lijeka Zeffix jest 100 mg jedanput na dan.
English: The full EPAR for Zeffix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zeffix nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (100 mg) and an oral solution (5 mg/ml).
Croatian: Dostupan je u obliku tableta (od 100 mg) i oralne otopine (od 5 mg/ml).
English: Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Croatian: Lamivudin onemogućuje da virus stvara DNK i tako sprečava njegovo umnožavanje i širenje.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix on 29 July 1999.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zeffix na snazi u Europskoj uniji od 29. srpnja 1999.
English: It is used in patients with:
Croatian: Primjenjuje se u bolesnika s:
English: • compensated liver disease (when the liver is damaged but works normally), who also show signs that the virus is still multiplying and have signs of liver damage (raised levels of the liver enzyme alanine aminotransferase [ALT] and signs of damage when liver tissue is examined under a microscope).
Croatian: • kompenziranom bolešću jetre (kada je jetra oštećena, ali još normalno funkcionira) koji također pokazuju znakove umnožavanja virusa i znakove oštećenja jetre (povišene razine jetrenog enzima alanina aminotransferaze [ALT] i znakove oštećenja pri mikroskopskom ispitivanju tkiva jetre).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zeffix.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Zeffix.
English: Other information about Zeffix:
Croatian: Ostale informacije o lijeku Zeffix:
English: Zeffix was as effective as alfa-interferon.
Croatian: Lijek Zeffix pokazao se jednako djelotvornim kao alfa-interferon.
English: This document is a summary of the European public assessment report (EPAR) for Zeffix.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zeffix.
English: Lamivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Croatian: Lamivudin ometa djelovanje virusnog enzima koji se naziva DNK polimeraza, a koji sudjeluje u stvaranju virusne DNK.
English: For more information about treatment with Zeffix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zeffix pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: These are patients infected with hepatitis B virus that has mutated (changed), leading to a form of chronic hepatitis B that is more difficult to treat.
Croatian: To su bolesnici koji su zaraženi virusom hepatitisa B koji je mutirao (izmijenio se) i koji dovodi do tipa kroničnog hepatitisa B koji je teže liječiti.
English: Doses lower than 100 mg need to be given using the oral solution.
Croatian: Doze manje od 100 mg trebaju se primjenjivati u obliku oralne otopine.
English: If the hepatitis B virus can still be found in the blood after six months of treatment, the doctor should consider switching treatment or adding another medicine for hepatitis B to reduce the risk of resistance.
Croatian: Ako se virus hepatitisa B još uvijek nalazi u krvi nakon šest mjeseci liječenja, liječnik treba razmotriti mogućnost prelaska na drugi lijek ili dodavanja drugog lijeka za liječenje hepatitisa B kako bi se smanjio rizik od rezistencije.
English: Treatment with Zeffix should be started by a doctor who has experience in the management of chronic hepatitis B.
Croatian: Liječenje lijekom Zeffix treba započeti liječnik s iskustvom u liječenju kroničnog hepatitisa B.
English: Zeffix is a medicine that contains the active substance lamivudine.
Croatian: Zeffix je lijek koji sadrži djelatnu tvar lamivudin.
English: To reduce the risk of resistance, Zeffix must be used in combination with another anti-hepatitis B medicine that does not cause resistance in the same way as Zeffix.
Croatian: Kako bi se smanjio rizik od rezistencije, lijek Zeffix mora se primjenjivati u kombinaciji s drugim lijekom za liječenje hepatitisa B koji ne uzrokuje rezistenciju na isti način kao lijek Zeffix.
English: The CHMP decided that Zeffix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi lijeka Zeffix nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Why has Zeffix been approved?
Croatian: Zašto je Zeffix odobren?
English: Zeffix is used to treat adults (aged 18 years or over) who have chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Croatian: Lijek Zeffix primjenjuje se u liječenju odraslih osoba (u dobi od 18 igodina ili starijih) koje imaju kronični (dugotrajni) hepatitis B (bolest jetre izazvanu infekcijom virusom hepatitisa B).
English: The active substance in Zeffix, lamivudine, is an antiviral agent that belongs to the class ‘nucleoside analogues'.
Croatian: Djelatna tvar u lijeku Zeffix, lamivudin, antiviralni je agens koji pripada razredu „analoga nukleozida”.
English: In addition, information was presented on the use of Zeffix in patients with decompensated liver disease.
Croatian: Osim toga, predočeni su podaci o primjeni lijeka Zeffix u bolesnika s dekompenziranom bolešću jetre.
English: Because the hepatitis B virus can become resistant to Zeffix, the doctor should only consider prescribing Zeffix if other treatments that are less likely to lead to resistance cannot be used;
Croatian: Budući da virus hepatitisa B može postati rezistentan na lijek Zeffix, liječnik treba propisati Zeffix samo u slučaju kada nije primjenjivo liječenje za koje je manje vjerojatno da će rezultirati rezistencijom na lijek;
English: The most common side effect with Zeffix (seen in more than 1 patient in 10) is raised ALT levels.
Croatian: Najčešća je nuspojava lijeka Zeffix (zabilježena u više od 1 na 10 bolesnika) povećana razina ALT-a.
English: These included looking at how the liver damage had evolved after a year of treatment using a liver biopsy (when a small sample of liver tissue is taken and examined under a microscope), as well as measuring other signs of the disease such as the levels of ALT or of hepatitis B virus DNA circulating in the blood.
Croatian: Primjenjivana mjerila temeljila su se na promatranju razvoja oštećenja jetre nakon jedne godine liječenja putem biopsije jetre (postupak u kojem se uzima mali uzorak jetrenog tkiva koji se zatim promatra pod mikroskopom) te na mjerenju drugih znakova bolesti, prmjerice mjerenju razina ALT-a ili DNK virusa hepatitisa B koji cirkuliraju u krvi.
English: What is the risk associated with Zeffix?
Croatian: Koji su rizici povezani s lijekom Zeffix?
English: What is Zeffix?
Croatian: Što je Zeffix?
English: In patients with decompensated liver disease, Zeffix also reduced levels of hepatitis B virus DNA and ALT.
Croatian: U bolesnika s dekompenziranom bolešću jetre, liječene lijekom Zeffix dovelo je i dosmanjenja razina DNK virusa hepatitisa B i ALT-a.
English: About half of the patients taking Zeffix had an improvement in liver damage assessed in a biopsy, compared with about a quarter of the patients who took placebo.
Croatian: Rezultati biopsije pokazali su da je u otprilike polovice bolesnika koji su uzimala lijek Zeffix došlo do poboljšanja stanja oštećene jetre u usporedbi s otprilike četvrtinom bolesnika koji su uzimali placebo.
English: The other two studies compared Zeffix taken on its own with alfa-interferon (another treatment used in chronic hepatitis B) on its own and with the combination of Zeffix and alfa-interferon.
Croatian: U drugim dvama ispitivanjima lijek Zeffix, primjenjen kao monoterapija, uspoređen je s alfa-interferonom (drugom terapijom koja se primjenjuje za liječenje kroničnog hepatitisa B) primjenjenim kao monoterapija te s kombiniranom primjenom lijeka Zeffix i alfa-interferona.
English: The dose needs to be lower in patients who have reduced kidney function.
Croatian: U bolesnika sa smanjenom funkcijom bubrega doza treba biti manja.
English: For the full list of all side effects or restrictions with Zeffix, see the package leaflet.
Croatian: Potpuni popis nuspojava ili ograničenja zabilježenih pri primjeni lijeka Zeffix potražite u uputi o lijeku.
English: What is Zeffix used for?
Croatian: Za što se Zeffix koristi?
English: What benefit has Zeffix shown during the studies?
Croatian: Koje su koristi lijeka Zeffix utvrđene u ispitivanjima?
English: How is Zeffix used?
Croatian: Kako se Zeffix koristi?
English: In patients with compensated liver disease, Zeffix was more effective than placebo in slowing down the progression of liver disease.
Croatian: LijekZeffix pokazao se djelotvornijim od placeba u usporavanju razvoja bolesti jetre u bolesnika s kompenziranom bolešću jetre.
English: How does Zeffix work?
Croatian: Kako djeluje Zeffix?
English: Zeffix has been studied in five main studies involving a total of 1,083 adults with compensated liver disease due to chronic hepatitis B. Three studies compared Zeffix with placebo (a dummy treatment), one of which looked particularly at ‘HBeAg-negative' patients.
Croatian: Lijek Zeffix ispitivan je u okviru pet glavnih ispitivanja na ukupno 1083 odrasle osobe s kompenziranom bolešću jetre koja je nastala kao posljedica kroničnog hepatitisa B.
English: How has Zeffix been studied?
Croatian: Kako je lijek Zeffix ispitivan?
English: Both are anti-hypertensive medicines that have been available separately in the European Union (EU) since the mid-1990s.
Croatian: Obje tvari su antihipertenzivni lijekovi koji su zasebno dostupni u Europskoj uniji (EU) od sredine 1990-tih godina.
English: The full EPAR for Exforge can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Exforge nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Exforge is taken by mouth as one tablet once a day with some water.
Croatian: Exforge se uzima peroralno kao jedna tableta jednom na dan s malo vode.
English: Other information about Exforge
Croatian: Ostale informacije o lijeku Exforge
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Exforge.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenilo lijek da bi donio svoje mišljenje za izdavanje odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Exforge.
English: This is a summary of the European public assessment report (EPAR) for Exforge.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Exforge.
English: The European Commission granted a marketing authorisation valid throughout the EU for Exforge on 17 January 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Exforge na snazi u Europskoj uniji od 16. siječnja 2007.
English: For more information about treatment with Exforge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Exforge pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: The fifth, smaller study compared the combination with lisinopril and hydrochlorothiazide (another combination used to treat hypertension) in 130 patients with severe hypertension.
Croatian: Peto, manje ispitivanje usporedilo je ovu kombinaciju s lizinoprilom i hidroklorotiazidom (druge kombinacije koja se koristi za liječenje hipertenzije) u 130 bolesnika s ozbiljnom hipertenzijom.
English: The most common side effects with Exforge (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Croatian: Najčešće nuspojave lijeka Exforge (koje se mogu javiti u 1 do 10 osoba na 100 osoba) su glavobolja, nazofaringitis (upala nosa i grla), influenca (gripa), hipokalemija (mala koncentracija kalija u krvi), različiti tipovi edema (oticanje), iscrpljenost (umor), rumenilo (crvenilo), astenija (slabost) i napadaji vrućine.
English: By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced.
Croatian: Snižavanjem krvnog tlaka smanjuju se i rizici povezani s visokim krvnim tlakom, poput primjerice moždanog udara.
English: The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Exforge and people taking the separate medicines.
Croatian: Farmaceutska je tvrtka također dostavila dokaz da su koncentracije amlodipina i valsartana u krvi bile jednake u osoba koje su uzimale Exforge i osoba koje su uzimale druge lijekove.
English: In the studies comparing the combination in patients who were already taking either amlodipine or valsartan, the blood pressure in patients taking valsartan alone had fallen by 6.6 mmHg after eight weeks, compared with 9.6 and 11.4 mmHg in the patients adding 5 or 10 mg amlodipine, respectively.
Croatian: U ispitivanjima koja su usporedila kombinaciju u bolesnika koji su već uzimali amlodipin ili valsartan, krvni tlak u bolesnika koji su uzimali samo valsartan snizio se za 6,6 mmHg nakon osam tjedana u usporedbi s 9,6 i 11,4 mmHg u bolesnika koji su dodali 5 ili 10 mg amlodipina.
English: The CHMP decided that Exforge's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Exforge nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction.
Croatian: Kada ioni kalcija ulaze u stanice, u mišićima stjenka krvnih žila dolazi do kontrakcije.
English: The dose of Exforge to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Croatian: Doza lijeka Exforge koja se primjenjuje ovisi o dozama amlodipina ili valsartana koje je bolesnik ranije uzimao.
English: Exforge must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Croatian: Exforge se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na amlodipin ili druge lijekove iz klase „derivati dihidropiridina”, na valsartan ili bilo koju drugu pomoćnu tvar.
English: What is the risk associated with Exforge?
Croatian: Koji su rizici povezani s lijekom Exforge?
English: Exforge must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Croatian: Exforge se ne smije primjenjivati u bolesnika koji imaju ozbiljno oštećenje jetre ili probleme sa žući, tj. u bolesnika s određenim srčanim tegobama i bolesnika s ozbiljnom hipotenzijom (niskim krvnim tlakom).
English: Exforge is a medicine that contains two active substances, amlodipine and valsartan.
Croatian: Exforge je lijek koji sadrži dvije djelatne tvari, amlodipin i valsartan.
English: Why has Exforge been approved?
Croatian: Zašto je Exforge odobren?
English: Exforge must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Croatian: Exforge se također ne smije primjenjivati u kombinaciji s lijekovima koji sadrže aliskiren (koriste se također za liječenje esencijalne hipertenzije) u bolesnika s dijabetesom tipa 2 ili u bolesnika s umjerenim do ozbiljnim oštećenjem bubrega.
English: What is Exforge used for?
Croatian: Za što se Exforge koristi?
English: Exforge is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Croatian: Exforge se primjenjuje u bolesnika koji imaju esencijalnu hipertenziju (visoki krvni tlak), koji nije odgovarajuće kontroliran samo amlodipinom ili valsartanom. „Esencijalno” znači da hipertenzija nema očiti uzrok.
English: What benefit has Exforge shown during the studies?
Croatian: Koje su koristi lijeka Exforge utvrđene u ispitivanjima?
English: What is Exforge?
Croatian: Što je Exforge?
English: For the full list of all side effects reported with Exforge, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Exforge potražite u uputi o lijeku.
English: Exforge contains two active substances, amlodipine and valsartan.
Croatian: Exforge sadrži dvije djelatne tvari: amlodipin i valsartan.
English: How is Exforge used?
Croatian: Kako djeluje Exforge?
English: How has Exforge been studied?
Croatian: Kako je lijek Exforge ispitivan?
English: How does Exforge work?
Croatian: Kako se Exforge primjenjuje?
English: Date of first authorisation: 6 May 2019
Croatian: Datum prvog odobrenja: 6. svibnja 2019.
English: You may require medical attention.
Croatian: Možda će Vam biti potrebna medicinska pomoć.