FrancophonIA/ELRC3.0 huggingface dataset:
English: Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
Slovenian: 2750 Ballerup Denmark
English: FENOFIBRATE ALTER 160 mg, comprimé tablet
Slovenian: FENOFIBRATE ALTER 160 mg, comprimé
English: FENOFIBRATE WINTHROP 160 mg, comprimé tablet
Slovenian: FENOFIBRATE WINTHROP 160 mg, comprimé tableta
English: Lipantil Micro 267 mg capsules, hard hard capsules
Slovenian: Lipantil Micro 267 mg capsules, hard
English: 600 MG/TAB Film coated tablet
Slovenian: 600 MG/TAB filmsko obložena tableta
English: Lipantil Micro 67 mg capsules, hard hard capsules
Slovenian: Lipantil Micro 67 mg capsules, hard
English: FENOFIBRATE BIOGARAN 145 mg, comprimé tablet
Slovenian: FENOFIBRATE BIOGARAN 145 mg, comprimé tableta
English: LIPOFOR CAPSULES 300mg 300mg capsules
Slovenian: LIPOFOR CAPSULES 300mg 300mg
English: FENOFIBRATE ARROW 160 mg, comprimé tablet
Slovenian: FENOFIBRATE ARROW 160 mg, comprimé tableta
English: Prolonged-released tablet
Slovenian: tableta s podaljšanim sproščanjem
English: D-64295 Darmstadt Germany durafenat retard
Slovenian: D-64295 Darmstadt Nemčija durafenat retard trda kapsula s podaljšanim sproščanjem
English: Bezafibrat HEXAL 400mg retard Retardtabletten
Slovenian: Bezafibrat HEXAL 400mg retard Retardtabletten tableta s podaljšanim sproščanjem
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Iceland
Slovenian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220, Islandija
English: IT - Italy Doc Generici Srl Via Manuzio, 7
Slovenian: Doc Generici Srl Via Manuzio, 7 20124 MILANO Italija
English: FR - France Sanofi Aventis France 1-13 Bd Romain Rolland 75014 Paris
Slovenian: FR - Francija Sanofi Aventis Francija 1-13 Bd Romain Rolland 75014 Paris
English: Centrafarm Services B.V. Postbus 289
Slovenian: Centrafarm Services B.V.
English: Lipcor 200 mg - Kapseln 200 mg capsule, hard
Slovenian: Lipcor 200 mg - Kapseln 200 mg
English: ES - Spain SOLVAY PHARMA, S.A.Avda.
Slovenian: SOLVAY PHARMA, S.A.Avda.
English: 160 MG/CAP HARD CAPSULES ORAL
Slovenian: 160 MG/CAP trda kapsula
English: FENOFIBRATE BIOGARAN 160 mg, comprimé tablet
Slovenian: FENOFIBRATE BIOGARAN 160 mg, comprimé tableta
English: FENOFIBRATE ACTAVIS 160 mg, comprimé tablet
Slovenian: FENOFIBRATE ACTAVIS 160 mg, comprimé
English: Fenofibrat STADA 250 mg Hartkapseln, retardiert
Slovenian: Fenofibrat STADA 250 mg Hartkapseln, retardiert trda kapsula s podaljšanim sproščanjem
English: FR - France Mylan SAS 117, allée des Parcs 69800 Saint Priest France
Slovenian: FR - Francija Mylan SAS 117, allée des Parcs 69800 Saint Priest Francija
English: CY - Cyprus Varnavas Hadjipanayis Ltd, 7 Androcleous street
Slovenian: Varnavas Hadjipanayis Ltd, 7 Androcleous street P.O.Box 21229
English: Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Iceland
Slovenian: Actavis Group PTC ehf, Reykjavíkurvegi 76-78 220 Hafnarfjördur Islandija
English: Fenofibrat-ratiopharm 250 mg Retardkapseln
Slovenian: Fenofibrat-ratiopharm 250 mg Retardkapseln trda kapsula s podaljšanim sproščanjem
English: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Iceland
Slovenian: Actavis Group Ptc Ehf, Reykjavikurvegi 76-78 Hafnarfirdi, Is-220 Islandija
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
Slovenian: MEDOCHEMIE LTD 1-10 Constantinoupoleos street, P.O.Box 51409
English: 200 MG/CAP HARD CAPSULES ORAL
Slovenian: 200 MG/CAP trda kapsula
English: FR - France Qualimed 117, allée des Parcs 69800 Saint Priest France
Slovenian: FR - Francija Qualimed 117, allée des Parcs 69800 Saint Priest Francija
English: Fenofibrate containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo zdravilno učinkovino fenofibrat in imajo dovoljenje za promet v EU
English: 200 mg coated tablet
Slovenian: 200 mg filmsko obložena tableta
English: IPOLIPID CAPSULES 300mg 300mg capsules
Slovenian: IPOLIPID CAPSULES 300mg 300mg
English: Lipsin 100 mg - Kapseln 100 mg capsule, hard
Slovenian: Lipsin 100 mg - Kapseln 100 mg
English: FENOFIBRATE ENIREX 160 mg, comprimé pelliculé
Slovenian: FENOFIBRATE ENIREX 160 mg, comprimé pelliculé 160 mg
English: Lipsin retard 250 mgKapseln prolonged release capsule, hard
Slovenian: Lipsin retard 250 mgKapseln trda kapsula s podaljšanim sproščanjem
English: CY - Cyprus MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
Slovenian: MEDOCHEMIE LTD 1-10 Constantinoupoleos street P.O.Box 51409
English: FENOSUP LIDOSE 160 MG 160 mg capsule hard
Slovenian: FENOSUP LIDOSE 160 MG 160 mg
English: 400 mg Prolonged release coated tablet
Slovenian: 400 mg, comprimé enrobé à libération prolongée tableta s podaljšanim sproščanjem
English: SKSlovakia
Slovenian: PTPortugalskaska
English: Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
Slovenian: DE - Nemčija Actavis Group PTC ehf Reykjavikurvegur 76-78IS-220 Hafnarfjördur
English: CY - Cyprus MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
Slovenian: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street P.O.Box 51409
English: FR - France Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
Slovenian: Laboratoires FOURNIER SA 28, boulevard Clémenceau 21000 Dijon
English: DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA Greschbachstr.
Slovenian: DE - Nemčija DOCPHARM Arzneimittelvertrieb GmbH & Co.KGaA
English: FENOFIBRATE ALMUS 160 mg, comprimé tablet
Slovenian: FENOFIBRATE ALMUS 160 mg, comprimé
English: ES - Spain SOLVAY PHARMA S.A.Avda.
Slovenian: SOLVAY PHARMA S.A.Avda.
English: Fenofibrat-CT 250mg Retardkapseln
Slovenian: Fenofibrat-CT 250mg Retardkapseln trda kapsula s podaljšanim sproščanjem
English: FR - France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France
Slovenian: 15, boulevard Charles de Gaulle 92700 Colombes Francija
English: DEGermany ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm
Slovenian: DE - Nemčija ratiopharm GmbH Graf-Arco-Str. 3 D-89079 Ulm Nemčija
English: 11-15 Quai Dion Bouton 92800 Puteaux
Slovenian: 92800 Puteaux
English: Bezafibrat-ratiopharm 400 mg Retardtabletten
Slovenian: Bezafibrat-ratiopharm 400 mg Retardtabletten tableta s podaljšanim sproščanjem
English: FENOFIBRATE MYLAN 160 mg, comprimé pelliculé
Slovenian: FENOFIBRATE MYLAN 160 mg, comprimé pelliculé 160 mg
English: IT - Italy Solvay Pharma Spa Via della Libertà 30
Slovenian: Solvay Pharma Spa Via della Libertà 30 100 95 Grugliasco Italija
English: ACTAVIS GROUP PTC EHF Reykjavikuregur 76-78 220 Hafnarfjordur Iceland
Slovenian: Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Islandija
English: RORomania sanofi-aventis france 1-13, boulevard Romain Rolland 75014 Paris
Slovenian: RO - Romunija sanofi-aventis Francija 1-13, boulevard Romain Rolland 75014 Paris
English: Lopid filmcoated tablet
Slovenian: Lopid obložena tableta
English: Lipox Bezafibrat 400 mg Retardtabletten
Slovenian: Lipox Bezafibrat 400 mg Retardtabletten tableta s podaljšanim sproščanjem
English: Gemfibrozil Sandoz filmcoated tablet
Slovenian: Gemfibrozil Sandoz
English: Innogem hard capsule
Slovenian: trda kapsula s prirejenim sproščanjem
English: Prolonged-release capsules
Slovenian: Fenobrat trda kapsula s podaljšanim sproščanjem
English: DKDenmark
Slovenian: SANDOZ
English: Prolonged-release tablet
Slovenian: Bezalip Retard tableta s podaljšanim sproščanjem
English: FR - France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Slovenian: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest Francija
English: FR - France QUALIMED 117, allée des Parcs 69800 Saint-Priest France
Slovenian: QUALIMED 117, allée des Parcs 69800 Saint-Priest Francija
English: GEMFIBROZILO FERMON 900 mg film coated tablets oral
Slovenian: GEMFIBROZILO FERMON 900 mg
English: FR - France RANBAXY PHARMACIE GENERIQUES
Slovenian: FR - Francija Ranbaxy Pharmacie Génériques 11-15 Quai Dion Bouton
English: Attiki
Slovenian: Actavis
English: Lipox Bezafibrat 400mg Retardtabletten
Slovenian: Lipox Bezafibrat 400mg Retardtabletten tableta s podaljšanim sproščanjem
English: 400 mg tablet
Slovenian: 400 mg filmsko obložena tableta
English: Prolonged release coated tablet
Slovenian: Bezalip obložena tableta s podaljšanim sproščanjem
English: GEMFIBROZILO FERMON 600 mg film coated tablets oral
Slovenian: GEMFIBROZILO FERMON 600 mg
English: ET - Estonia Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
Slovenian: Laboratoires Fournier S.A. 28 Boulevard Clemenceau 21000 Dijon
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris FRANCE
Slovenian: SANOFI AVENTIS Francija 1-13, boulevard Romain Rolland 75014 Paris Francija
English: FR - France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris
Slovenian: SANOFI AVENTIS Francija 1-13, boulevard Romain Rolland 75014 Paris
English: LIPOFIB 160 mg capsules
Slovenian: LIPOFIB 160 mg
English: Befibrat 200mg Dragees 200 mg
Slovenian: FENOGAL 200 LIDOSE 200 mg
English: FENOFIBRATO RANBAXY 160mg film coated tablets oral
Slovenian: FENOFIBRATO RANBAXY 160mg
English: filmcoated tablets
Slovenian: Fibrocit tableta
English: The European Commission issued a decision on 11 September 2012.
Slovenian: Evropska komisija je odločbo izdala dne 11. septembra 2012.
English: The company wanted the authorisation to be recognised in France and the United Kingdom (the ‘concerned Member States').
Slovenian: Družba je želela, da dovoljenje za promet z zdravilom priznajo tudi v Franciji in Združenem kraljestvu („zadevni državi članici“).
English: In addition, the available data on the safety and effectiveness of the medicine were not sufficient to compensate for the lack of bioequivalence.
Slovenian: Poleg tega razpoložljivi podatki o varnosti in učinkovitosti zdravila niso zadostovali, da bi nadomestili neobstoj biološke enakovrednosti.
English: However, the Member States were not able to reach an agreement and the French medicines regulatory agency referred the matter to the CHMP for arbitration on 23 February 2012.
Slovenian: Vendar pa države članice niso uspele doseči soglasja, zato je francoska regulatorna agencija za zdravila 23. februarja 2012 zadevo napotila na CHMP v arbitražo.
English: Mifepristone Linepharma is already authorised through a decentralised procedure in Denmark, Finland, Island, Norway and Sweden.
Slovenian: Zdravilo Mifepristone Linepharma je bilo po decentraliziranem postopku že odobreno na Danskem, Finskem, v Islandiji, na Norveškem in Švedskem.
English: On 21 June 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Mifepristone Linepharma.
Slovenian: Evropska agencija za zdravila je 21. junija 2012 končala arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Mifepristone Linepharma.
English: It contains the active substance mifepristone, which works by blocking the effects of the hormone progesterone, which plays an important role in the maintenance of pregnancy.
Slovenian: Vsebuje zdravilno učinkovino mifepriston, ki deluje tako, da zavira učinke hormona progesterona, ki ima pomembno vlogo pri vzdrževanju nosečnosti.
English: In addition, the Committee recommended that a prospective observational study should be performed to monitor how Mifepristone Linepharma is prescribed.
Slovenian: Poleg tega je priporočil, da se izvede prospektivna opazovalna študija za spremljanje predpisovanja zdravila Mifepristone Linepharma.
English: This means that it is similar to a ‘reference medicine' called Mifegyne containing the same active substance.
Slovenian: To pomeni, da je podobno referenčnemu zdravilu Mifegyne, ki vsebuje isto zdravilno učinkovino.
English: However, the difference was not considered to be of concern as the safety and effectiveness of mifepristone at much higher doses of up to 600 mg is well established and has been confirmed by the supportive studies with Mifepristone Linepharma.
Slovenian: Vendar pa ta razlika ni bila ocenjena kot zaskrbljujoča, saj sta varnost in učinkovitost mifepristona dokazani v veliko večjih odmerkih, vse do 600 mg, in potrjeni s podpornimi študijami z zdravilom Mifepristone Linepharma.
English: The CHMP also concluded that the product information should include a statement that doses higher than 200 mg should not be given.
Slovenian: Zaključil je tudi, da morajo informacije o zdravilu vsebovati opozorilo, da se odmerki, večji od 200 mg, ne smejo predpisovati.
English: Why was Mifepristone Linepharma reviewed?
Slovenian: Zakaj je bilo zdravilo Mifepristone Linepharma pregledano?
English: Mifepristone Linepharma is a medicine used for terminating pregnancy.
Slovenian: Zdravilo Mifepristone Linepharma je zdravilo, ki se uporablja za prekinitev nosečnosti.
English: Mifepristone Linepharma is given as a single dose of 200 mg, followed 36 - 48 hours later by a dose of another medicine called gemeprost.
Slovenian: Zdravilo Mifepristone Linepharma se daje v enkratnem odmerku 200 mg, ki mu čez 36 do 48 ur sledi odmerek drugega zdravila, imenovanega gemeprost.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Mifepristone Linepharma outweigh its risks, and recommended that the marketing authorisation granted in Sweden be recognised in other Member States of the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi zdravila Mifepristone Linepharma odtehtajo njegova tveganja, in priporočil, da se dovoljenje za promet z zdravilom, ki je bilo odobreno na Švedskem, prizna tudi v drugih državah članicah EU.
English: Therefore, based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Mifepristone Linepharma outweigh its risks and recommended that the marketing authorisation for Mifepristone Linepharma be granted in all concerned Member States.
Slovenian: Tako je na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru ta zaključil, da koristi zdravila Mifepristone Linepharma odtehtajo z njim povezana tveganja, in priporočil, da se dovoljenje za promet z zdravilom Mifepristone Linepharma odobri v vseh zadevnih državah članicah.
English: Both medicines are available as 200 mg tablets but whereas Mifegyne was authorised to be given at doses of 600 mg and 200 mg, Mifepristone Linepharma was only authorised at the 200 mg dose.
Slovenian: Obe zdravili sta na voljo v obliki 200miligramskih tablet, vendar je bilo zdravilo Mifegyne odobreno v odmerkih 600 mg in 200 mg, zdravilo Mifepristone Linepharma pa le v odmerku 200 mg.
English: The CHMP noted that the data submitted by the company showed a small deviation of Mifepristone Linepharma from the acceptable range for bioequivalence with the reference medicine, with Mifepristone Linepharma 200 mg producing slightly higher levels of active substance in the body than Mifegyne 200 mg.
Slovenian: CHMP je ugotovil, da podatki, ki jih je predložila družba, kažejo na majhno odstopanje zdravila Mifepristone Linepharma od sprejemljivega razpona za biološko enakovrednost z referenčnim zdravilom, pri čemer privede zdravilo Mifepristone Linepharma 200 mg do rahlo višje ravni zdravilne učinkovine v telesu kot zdravilo Mifegyne 200 mg.
English: Mifepristone Linepharma is a ‘hybrid medicine'.
Slovenian: Zdravilo Mifepristone Linepharma je „hibridno zdravilo“.
English: Linepharma France submitted an application for Mifepristone Linepharma for mutual recognition on the basis of the initial authorisation granted by Sweden on 3 December 2010.
Slovenian: Družba Linepharma France je predložila vlogo za medsebojno priznavanje zdravila Mifepristone Linepharma na podlagi prvotnega dovoljenja za promet z zdravilom, odobrenega na Švedskem dne stran 2/2
English: What is Mifepristone Linepharma?
Slovenian: Kaj je zdravilo Mifepristone Linepharma?
English: The grounds for the referral were that Mifepristone Linepharma had not been shown to be bioequivalent to the reference medicine, Mifegyne 200 mg.
Slovenian: Razlog za napotitev je bilo dejstvo, da za zdravilo Mifepristone Linepharma ni bila dokazana biološka enakovrednost zdravilu Mifegyne 200 mg.
English: 28 February 2014
Slovenian: 28. februar 2014
English: The final opinion was converted into a Decision by the European Commission on 28 February 2014.
Slovenian: Končno mnenje je bilo spremenjeno v sklep Evropske komisije dne 28. februarja 2014.
English: The referral started on 7 November 2012.
Slovenian: Napotitveni postopek se je začel dne 7. novembra 2012.
English: The Committee appointed H. Jukes as rapporteur and E-M. Vestergaard as co-rapporteur.
Slovenian: Odbor je za poročevalko imenoval H. Jukes, za soporočevalko pa E-M. Vestergaard.
English: Written explanations were provided by the applicants and marketing authorisation holders on 15 February 2013 and on 9 September 2013.
Slovenian: Predlagatelji in imetniki dovoljenja za promet z zdravilom so 15. februarja 2013 in 9. septembra 2013 predložili pisna pojasnila.
English: The condition on the marketing authorisations is in Annex IV.
Slovenian: Pogoji dovoljenj za promet z zdravili so v Prilogi IV.
English: International non-proprietary name (INN): enrofloxacin
Slovenian: Mednarodno nelastniško ime (INN): enrofloksacin
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Slovenian: Deluje antibakterijsko na širok spekter gramnegativnih in grampozitivnih bakterij.
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.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v Prilogi III.
English: Veterinary Medicines
Slovenian: Zdravila za uporabo v veterinarski medicini
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Slovenian: Enrofloksacin je sintetično kemoterapevtsko sredstvo iz skupine derivatov fluorokinolon karboksilne kisline.
English: Enrofloxacin is for veterinary use only.
Slovenian: Enrofloksacin je namenjen le za uporabo v veterinarski medicini.
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.
Slovenian: Odbor CVMP so prosili, naj preveri indikacije, režime odmerjanja in karence za piščance in purane, da bi zagotovili varnost potrošnikov, učinkovito zdravljenje piščancev in puranov ter zmanjšali tveganje razvoja odpornosti mikroorganizmov proti enrofloksacinu.
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.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da je splošno razmerje med tveganji in koristmi za ta zdravila še vedno pozitivno, če se upoštevajo spremembe informacij o zdravilu in pogojev dovoljenj za promet z zdravili.
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.
Slovenian: Združeno kraljestvo je dne 18. oktobra 2012 agenciji predložilo obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje.
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.
Slovenian: Odbor je zato 7. novembra 2013 soglasno sprejel pozitivno mnenje, v katerem je priporočil spremembo pogojev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo enrofloksacin in se dajejo piščancem in/ali puranom v vodo za pitje.
English: Content (concentration)
Slovenian: Vsebnost (koncentracija)
English: 240 ml (10 mg/ml)
Slovenian: 240 ml (10 mg/ml) 1 plastenka, (240 ml)+ 10 ml peroralna odmerna brizga in nastavek
English: 10 mg/ml
Slovenian: 10 mg/ml peroralna raztopina peroralna uporaba plastenka (HDPE)
English: Oral solution
Slovenian: Pakiranje
English: There were several measures of effectiveness in the studies.
Slovenian: V študijah je bilo uporabljenih več meril učinkovitosti.
English: It is used in patients with:
Slovenian: Uporablja se pri bolnikih:
English: The duration of treatment depends on the patient's condition and response to treatment.
Slovenian: Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje.
English: Zeffix lamivudine
Slovenian: Zeffix lamivudin
English: The recommended dose of Zeffix is 100 mg once a day.
Slovenian: Priporočeni odmerek zdravila Zeffix je 100 mg enkrat na dan.
English: • decompensated liver disease (when the liver does not work normally).
Slovenian: • z dekompenzirano jetrno boleznijo (jetra ne delujejo normalno).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zeffix on 29 July 1999.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zeffix, veljavno po vsej Evropski uniji, izdala 29. julija 1999.
English: It is available as tablets (100 mg) and an oral solution (5 mg/ml).
Slovenian: Na voljo je v obliki tablet (100 mg) in peroralne raztopine (5 mg/ml).
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.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Zeffix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lamivudine stops the virus making DNA and prevents it from multiplying and spreading.
Slovenian: Lamivudin ustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
English: This document is a summary of the European public assessment report (EPAR) for Zeffix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zeffix.
English: Other information about Zeffix:
Slovenian: Druge informacije o zdravilu Zeffix:
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.
Slovenian: To so bolniki, okuženi z virusom hepatitisa B, ki je mutiral (se spremenil), kar je povzročilo obliko kroničnega hepatitisa B, ki jo je težje zdraviti.
English: The CHMP decided that Zeffix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Zeffix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
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).
Slovenian: • s kompenzirano jetrno boleznijo (jetra so poškodovana, a delujejo normalno), ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake poškodb jeter (povišane ravni jetrnega encima alanin-aminotransferaze [ALT] in znake poškodb, ki so vidni pod mikroskopom).