FrancophonIA/ELRC3.0 huggingface dataset:
English: Fosamprenavir/saquinavir/ efavirenz
Croatian: Fosamprenavir/sakvinavir/ efavirenz
English: Concomitant use of posaconazole and efavirenz should be avoided unless the benefit to the patient
Croatian: Istovremenu primjenu posakonazola i efavirenza treba izbjegavati osim ako je potencijalna korist za bolesnika veća od potencijalnog rizika.
English: Efavirenz Teva", at the start of Section 2.
Croatian: Ti su lijekovi navedeni u odlomku „Ne uzimajte Efavirenz Teva“, na početku dijela 2.
English: OPIOIDS
Croatian: TABLETA
English: Nervous system symptoms usually begin soon after therapy onset and generally resolve after the first 24 weeks.
Croatian: Simptomi živčanog sustava obično se javljaju ubrzo nakon započinjanja liječenja i uglavnom nestanu nakon prva 2-4 tjedna.
English: AUC: ↑ 11% (↑ 5 to ↑ 18) Cmax: ↑ 16% (↑ 6 to ↑ 26) Cmin: ↑ 13% (↑ 1 to ↑ 26) (CYP3A4 induction) The increase in efavirenz pharmacokinetic parameters is not considered clinically significant.
Croatian: AUC: ↑ 11% (↑ 5 do ↑ 18) Cmax: ↑ 16% (↑ 6 do ↑ 26) Cmin: ↑ 13% (↑ 1 do ↑ 26)
English: - Tell your doctor:
Croatian: Obavijestite svog liječnika ako primijetite neku od sljedećih nuspojava:
English: ↔efavirenz
Croatian: - zamagljen vid
English: AUC: ↓ 39% (↓ 27 to ↓ 50) Cmax: ↓ 29% (↓ 15 to ↓ 40) Cmin: ↓ 46% (↓ 31 to ↓ 58)
Croatian: Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58)
English: As a result, the amounts of Efavirenz Teva or other medicines in your blood may be affected.
Croatian: Kao rezultat toga mogu se promijeniti koncentracije lijeka Efavirenz
English: AUC: ↓ 18% (↓ 10 to ↓ 26) Cmax: ↓ 24% (↓ 15 to ↓ 32)
Croatian: AUC: ↓ 18% (↓ 10 do ↓ 26) Cmax: ↓ 24% (↓ 15 do ↓ 32) Cmin: ↓ 10% (↑ 1 do ↓ 19)%
English: AUC: ↑ 7% (↑ 1 to ↑ 14) Cmax: ↑ 16% (↑ 2 to ↑ 32) These changes are not considered clinically significant.
Croatian: AUC: ↑ 7% (↑ 1 do ↑ 14) Cmax: ↑ 16% (↑ 2 do ↑ 32)
English: CCR5 antagonist Maraviroc/efavirenz (100 mg twice daily/600 mg once daily)
Croatian: Maravirok/efavirenz (100 mg dvaput na dan/600 mg jedanput na dan)
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Croatian: Uz hormonske kontraceptive treba koristiti i pouzdanu mehaničku metodu kontracepcije (vidjeti dio
English: Teva, your doctor may need to adjust your dose of the calcium channel blocker.
Croatian: Sažetak opisa svojstava lijeka za blokator kalcijevih kanala).
English: The frequency category of "rare" was defined per A Guideline on Summary of Product Characteristics (SmPC) (rev. 2, Sept. 2009) on the basis of an estimated upper bound of the 95% confidence interval for 0 events given the number of patients treated with efavirenz in these clinical trials (n=3,969).
Croatian: 2, rujan 2009.) na temelju procjene gornje granice 95%-tnog intervala pouzdanosti za 0 događaja,
English: Efavirenz was not mutagenic or clastogenic in conventional genotoxicity assays.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Uobičajeni testovi genotoksičnosti nisu pokazali mutagene niti klastogene učinke efavirenza.
English: In order to improve the tolerability of nervous system adverse reactions, bedtime dosing is recommended (see section 4.8).
Croatian: smanjenje koncentracije i neobični snovi (vidjeti dio 4.8).
English: Concomitant administration with efavirenz should be avoided due to the risk for QTc prolongation (see section 4.3).
Croatian: od pojave produljenja QTc intervala (vidjeti dio 4.3).
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Efavirenz protokol
English: Atazanavir/ritonavir/efavirenz (400 mg once daily/100 mg once daily/600 mg once daily, all administered with food)
Croatian: ANTI-INFEKTIVI HIV - antivirusni lijekovi Inhibitori proteaze (IP) Atazanavir/ritonavir/efavirenz (400 mg jedanput na dan/100 mg jedanput na dan /600 mg jedanput na dan, sve uzimati uz hranu)
English: Uncommon Tinnitus†, vertigo Vascular disorders
Croatian: Poremećaji uha i labirinta manje često tinitus†, vertigo
English: Annex II Conditions to the marketing authorisation(s)
Croatian: Uvjeti odobrenja za stavljanje u promet
English: For N-nitrosodimethylamine (NDMA) and N nitrosodiethylamine (NDEA) the MAH must introduce the following specifications for the drug substance: 1) Limits for NDMA and NDEA outlined below should be implemented for a transitional period of 2 years:
Croatian: Za N-nitrozodimetilamin (NDMA) i N-nitrozodietilamin (NDEA) nositelj odobrenja za stavljanje lijeka u promet mora uvesti sljedeće specifikacije za djelatnu tvar lijeka:
English: Due date
Croatian: Krajnji rok
English: Conditions to the MA
Croatian: NDMA
English: Valsartan 320
Croatian: Prilog II.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Croatian: Informacije o lijeku ostaju u skladu s konačnom verzijom donesenom tijekom postupka Koordinacijske skupine kako je navedeno u Prilogu III. mišljenju CHMP-a.
English: In January 2018, Syner-Medica Ltd sumitted a mutual recognition application for Syner-Kinase 10,000 IU, 25,000 IU, 100,000 IU, 250,000 IU and 500,000 IU powder for solution for injection or infusion in France, Germany, Spain and the Netherlands with the United Kingdom as the reference Member State (RMS).
Croatian: U siječnju 2018. tvrtka Syner-Medica Ltd podnijela je zahtjev za uzajamno priznavanje za prašak za otopinu za injekciju ili infuziju Syner-Kinase u dozama od 10 000 IU, 25 000 IU, 100 000 IU, 250 000 IU i 500 000 IU u Francuskoj, Njemačkoj, Španjolskoj i Nizozemskoj, pri čemu je Ujedinjena Kraljevina referentna država članica.
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Croatian: • Odbor je razmotrio postupak upućivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: Urokinase is considered to have a well-established use in the above indications within the European Union and on 29 September 2006, Syner-Kinase was granted a marketing authorisation in the UK according to Article 10(a) of Directive 2001/83/EC.
Croatian: Smatra se da je primjena urokinaze u navedenim indikacijama provjerena u Europskoj uniji, te je 29. rujna 2006. izdano odobrenje za stavljanje u promet lijeka Syner-Kinase u Ujedinjenoj Kraljevini u skladu s člankom 10. točkom (a) Direktive 2001/83/EZ.
English: The UK therefore triggered a referral under Article 29(4) of Directive 2001/83/EC.
Croatian: Stoga je Ujedinjena Kraljevina pokrenula postupak upućivanja u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ.
English: • The Committee concluded that the purification process of the active substance is suitable for the removal of possible viral and prion impurities.
Croatian: • Odbor je zaključio da je postupak pročišćavanja djelatne tvari prikladan za uklanjanje mogućih nečistoća u obliku virusa i priona.
English: Urokinase is used for the lysis of blood clots in the following conditions: thrombosed intravascular catheters and cannulae; extensive acute proximal deep vein thrombosis; acute massive pulmonary embolism and acute occlusive peripheral arterial disease with limb threatening ischemia.
Croatian: Urokinaza se primjenjuje za lizu krvnih ugrušaka kod sljedećih stanja: trombozirani intravaskularni kateteri i kanile; ekstenzivna akutna tromboza proksimalnih dubokih vena; akutna raširena plućna embolija i akutna okluzivna periferna arterijska bolest s prijetećom ishemijom ekstremiteta.
English: • The Committee concluded that manufacture of the semi-purified urokinase is adequately validated and controlled, and that reassurance has been provided that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Croatian: • Odbor je zaključio da je proizvodnja polupročišćene urokinaze validirana i kontrolirana na odgovarajući način, te da je pruženo jamstvo da se taj intermedijer proizvodi na lokaciji koja je u skladu s načelima i smjernicama dobre proizvođačke prakse.
English: Urokinase is a serine protease that catalyses conversion of plasminogen to plasmin with resultant fibrinolytic and thrombolytic properties.
Croatian: Urokinaza je serinska proteaza koja katalizira pretvorbu plazminogena u plazmin s rezultirajućim fibrinolitičkim i trombolitičkim svojstvima.
English: Finally, evidence has been provided that the manufacture of semi-purified urokinase is adequately validated and controlled and in compliance with good manufacturing practices and all concerns raised over the quality and manufacturing of Syner-Kinase are considered solved.
Croatian: Naposljetku, pruženi su dokazi da je proizvodnja polupročišćene urokinaze validirana i kontrolirana na odgovarajući način i u skladu s dobrom proizvođačkom praksom te se smatra da su uklonjeni svi razlozi za zabrinutost koji se odnose na kvalitetu i proizvodnju lijeka Syner-Kinase.
English: The Committee, as a consequence, considers that the benefit-risk balance of Syner-Kinase and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Croatian: Odbor, posljedično, smatra da je omjer koristi i rizika od lijeka Syner-Kinase i pridruženih imena povoljan te stoga preporučuje izdavanje odobrenja za stavljanje u promet lijeka navedenog u Prilogu I. mišljenju CHMP-a.
English: The mutual recognition procedure was closed on day 90, with the four concerned Member States raising potential serious risk to public health (PSRPH) in relation to the lack of bridging data between the product applied for and the product(s) described in literature that was used to demonstrate the benefit/risk of Syner-Kinase, the adventitious agent safety with respect to viral and prion clearance and the lack of adequate quality of the process validation of the semi-purified urokinase and lifetime of columns used for urokinase purification.
Croatian: Postupak uzajamnog priznavanja zaključen je 90. dana, a četiri dotične države članice iznijele su prigovor u vezi s potencijalnim ozbiljnim rizikom za javno zdravlje (PSRPH) koji se odnosi na nepovezanost podataka o lijeku za koji je podnesen zahtjev i podataka o lijekovima opisanima u literaturi korištenoj za dokazivanje omjera koristi i rizika od lijeka Syner-Kinase, sigurnost od stranih tvari s obzirom na klirens virusa i priona, neodgovarajuću kvalitetu validacije procesa za polupročišćenu urokinazu i vijek trajanja stupaca korištenih za pročišćavanje urokinaze.
English: • The Committee concluded that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data available are adequate to support its proposed use.
Croatian: • Odbor je zaključio da je lijek Syner-Kinase usporediv s lijekovima koji sadržavaju urokinazu navedenima u objavljenoj literaturi, te da su dostupni podatci dostatni kako bi se potkrijepila predložena primjena lijeka.
English: The MAH/applicant has successfully demonstrated that the virus removal/inactivation steps are appropriately controlled and will provide the final reports of the virus and TSE removal studies and the updated risk assessment analysis by 31 May 2019 to the relevant national competent authorities.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet / podnositelj zahtjeva uspješno je dokazao da su koraci uklanjanja/inaktivacije virusa odgovarajuće kontrolirani te će mjerodavnim nacionalnim nadležnim tijelima do 31. svibnja 2019. dostaviti konačna izvješća o ispitivanjima uklanjanja virusa i TSE-a te ažuriranu analizu procjene rizika.
English: The CHMP also requested the MAH/applicant to provide further information to support the viral and prion clearance capacity of the process and justify the adequacy of the procedures to support the suitability of viral and prion removal, including transmissible spongiform encephalopathies (TSE) infectivity reduction.
Croatian: CHMP je također zatražio od nositelja odobrenja za stavljanje lijeka u promet / podnositelja zahtjeva da dostavi dodatne informacije koje podupiru kapacitet klirensa virusa i priona te da opravda prikladnost postupaka kako bi se potkrijepila prihvatljivost uklanjanja virusa i priona, uključujući smanjenje infektivnosti TSE-a (transmisivna spongiformna encefalopatija).
English: Based on the data provided, it is considered that the comparability of Syner-Kinase and urokinase products used in the literature studies cited in the submission has been sufficiently demonstrated.
Croatian: Na temelju dostavljenih podataka, smatra se da je dostatno dokazana usporedivost lijeka Syner-Kinase i lijekova koji sadržavaju urokinazu korištenih u ispitivanjima iz literature koja su navedena u podnesku.
English: The CHMP considered, as a consequence, that the benefit-risk balance of Syner-Kinase is favourable.
Croatian: Slijedom toga CHMP smatra da je omjer koristi i rizika od lijeka Syner-Kinase povoljan.
English: As part of this procedure, the CHMP requested the applicant to justify that the available data on SynerKinase, including its comparison to the urokinase products mentioned in the literature, are adequate to support its positive benefit/risk balance in the proposed indications.
Croatian: Kao dio tog postupka, CHMP je od podnositelja zahtjeva zatražio da dokaže da su dostupni podatci o lijeku Syner-Kinase, uključujući usporedbu s lijekovima koji sadržavaju urokinazu navedenima u literaturi, dostatni kako bi se potkrijepio pozitivan omjer koristi i rizika u predloženim indikacijama.
English: Finally, the CHMP requested the MAH/applicant to provide further information to demonstrate that the manufacturing steps for semi-purified urokinase have been satisfactorily validated, and also that the control strategy for column lifetime during the manufacture of the active pharmaceutical ingredient is suitable.
Croatian: Naposljetku, CHMP je zatražio od nositelja odobrenja za stavljanje lijeka u promet / podnositelja zahtjeva da dostavi dodatne informacije kako bi se dokazalo da su faze proizvodnje polupročišćene urokinaze zadovoljavajuće validirane, te da je kontrolna strategija za vijek trajanja stupca tijekom proizvodnje djelatnog farmaceutskog sastojka prikladna.
English: The MAH/applicant has provided relevant data to justify the extrapolation of the data available in the literature on the benefit and risks of urokinase in the indications applied for.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet / podnositelj zahtjeva dostavio je relevantne podatke kako bi se opravdala ekstrapolacija podataka dostupnih u literaturi o omjeru koristi i rizika od urokinaze u prijavljenim indikacijama.
English: • The Committee considered the totality of the data submitted by the MAH/applicant in relation to the objections raised as potential serious risk to public health.
Croatian: podnositelj zahtjeva dostavio u vezi s iznesenim primjedbama o potencijalnom ozbiljnom riziku za javno zdravlje.
English: The MAH/applicant has provided further comparative studies between Syner-Kinase active ingredient (API) and the API's in the urokinase products used in the literature studies cited in the submission, as well as data demonstrating the consistency of the product overtime despite the changes made to the product during its lifecycle.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet / podnositelj zahtjeva dostavio je dodatna usporedna ispitivanja djelatnog farmaceutskog sastojka lijeka SynerKinase i djelatnih farmaceutskih sastojaka lijekova koji sadržavaju urokinazu korištenih u ispitivanjima iz literature koja su navedena u podnesku, kao i podatke kojima se dokazuje ujednačenost kvalitete lijeka unatoč promjenama tijekom njegova vijeka trajanja.
English: Furthermore, confirmation was required that the semi-purified urokinase is manufactured in accordance with GMP.
Croatian: Nadalje, trebalo je potvrditi da je polupročišćena urokinaza proizvedena u skladu sa zahtjevima dobre proizvođačke prakse.
English: A referral was thus triggered at the CMD(h) but at D60 of the procedure, the PSRPH issues remained unresolved.
Croatian: Stoga je predmet upućen Koordinacijskoj skupini za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMD(h)), no 60. dana postupka pitanja koja se odnose na potencijalni ozbiljni rizik za javno zdravlje bila su i dalje neriješena.
English: 1 September 2014
Croatian: 1. rujna 2014.
English: Article 34 of Directive 2001/82/EC, as amended
Croatian: Direktive 2001/82/EZ, kako je izmijenjena.
English: It has antibacterial activity against a broad spectrum of Gram-negative and Grampositive bacteria.
Croatian: Posjeduje antibakterijsku aktivnost protiv širokog spektra gram-negativnih i gram-pozitivnih bakterija.
English: Written explanations were provided by the marketing authorisation holders on 17 June 2013, 10 January 2014 and 12 March 2014.
Croatian: Nositelji odobrenja podnijeli su pisana objašnjenja 17. lipnja 2013., 10. siječnja 2014. i 12. ožujka 2014.
English: The Committee adopted a positive opinion by majority on 9 April 2014.
Croatian: Povjerenstvo je većinski usvojilo pozitivno mišljenje 9. travnja 2014.
English: The referral procedure started on 7 November 2012.
Croatian: Postupak procjene započeo je 7. studenog 2012.
English: The final opinion was converted into a Decision by the European Commission on 1 September 2014.
Croatian: Europska Komisija pretvorila je konačno mišljenje u odluku 1. rujna 2014.
English: The Committee appointed M. Holzhauser-Alberti as rapporteur and C. Muñoz Madero as co-rapporteur.
Croatian: Holzhauser-Albertija kao ocjenitelja i C. Muñoza Madera kao suocjenitelja.
English: Enrofloxacin is a synthetic chemotherapeutic agent from the class of the fluoroquinolone carboxylicacid derivatives.
Croatian: Enrofloksacin je sintetički kemoterapeutik iz klase fluorokinolonskih derivata karboksilične kiseline.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom njihovih pridruženih naziva ostaje pozitivan te podložan promjenama u informacijama o proizvodu.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, labelling and package leaflet in Annex III.
Croatian: Znanstveni zaključci nalaze se u Prilogu II. skupa sa Sažetkom opisa svojstava, označivanjem i uputom o VMP-u u Prilogu III.
English: Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names are solutions for injection containing enrofloxacin at 25 mg/ml, 50 mg/ml and 100 mg/ml respectively.
Croatian: Baytril 2,5% injekcijska otopina, Baytril 5% injekcijska otopina i Baytril 10% injekcijska otopina i njihovi pridruženi nazivi otopine su za injekcije koje sadrže enrofloksacin u količinama od 25 mg/ml, 50 mg/ml odnosno 100 mg/ml.
English: Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names, on 26 October 2012 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the divergence in the product information of nationally authorised products across the European Union.
Croatian: Zbog različitih nacionalnih odluka koje su donijele države članice s obzirom na ciljne vrste, indikacije, doziranje i karencije, a u vezi odobrenja za Baytril 2,5% injekcijsku otopinu, Baytril 5% injekcijsku otopinu i Baytril 10% injekcijsku otopinu i njihove pridružene nazive, 26. listopada 2012. godine Francuska je uputila predmet na arbitražu na CVMP u skladu s člankom 34. stavkom 1.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names remains positive, subject to amendments in the product information.
Croatian: Na temelju procjene trenutno dostupnih podataka CVMP je smatrao da profil koristi i rizika lijekova Baytril 2,5% injekcijske otopine, Baytril 5% injekcijske otopine i Baytril 10% injekcijske otopine i
English: Opinion following an Article 341 referral for Baytril 2.5% injectable, Baytril 5% injectable and Baytril 10% injectable and their associated names
Croatian: Baytril 2,5% injekcijsku otopinu, Baytril 5% injekcijsku otopinu, Baytril 10% injekcijsku otopinu i njihove pridružene nazive
English: 28 months.
Croatian: 28 mjeseci.
English: After taking one of them, wait at least 2 to 3 hours before taking the other.
Croatian: Poslije uzimanja jednog od njih pričekajte najmanje 2 do 3 sata prije uzimanja drugog.
English: The results are given in Table 2.
Croatian: Rezultati su prikazani u Tablici 2.
English: In individual cases, only some of these symptoms and/or findings may be evident.
Croatian: pojedinačnim slučajevima mogu se javiti samo neki od tih simptoma i/ili nalaza.
English: The INR values increased on average by 13% [CI90 6-19%].
Croatian: INR vrijednosti porasle su prosječno za 13% [CI90 6-19%].
English: Review of treatment is recommended if such symptoms develop.
Croatian: Preporučuje se revidirati terapiju ako se razviju takvi simptomi.
English: Approximately 92% of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Croatian: Približno 92% doze eliminira se tijekom ß-faze s kratkim poluvremenom eliminacije od 30 minuta.
English: • if you have liver disease;
Croatian: Teva); • ako imate bolest jetre;
English: Other important side effects which may occur:
Croatian: Druge važne nuspojave koje se mogu pojaviti:
English: • Risk Management Plan (RMP)
Croatian: LIJEKA • Plan upravljanja rizicima (RMP)
English: See Section 2 Warnings and precautions.
Croatian: Pogledajte dio 2. Upozorenja i mjere opreza.
English: It is estimated that 80-90% of the dose is excreted in faeces, although this has not been confirmed in man.
Croatian: Procjenjuje se da se 80-90% doze izlučuje stolicom, premda to nije potvrđeno na ljudima.
English: 1 h 20 min CI95% 45 min, 1 h 56 min
Croatian: 1 h 20 min CI95% 45 min, 1 h 56
English: Your doctor may need to review your treatments.
Croatian: Liječnik će možda trebati ponovno razmotriti Vašu terapiju.
English: The amount of levodopa available to the brain is increased.
Croatian: Količina levodope dostupna mozgu se povećava.
English: The (Z)-isomer and traces of other metabolites account for the remaining 5%.
Croatian: (Z)-izomer i tragovi drugih metabolita čine preostalih 5%.
English: • if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
Croatian: • ako ste alergični na entakapon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6);
English: The pharmacokinetic properties of entacapone are similar in both young and elderly adults.
Croatian: Farmakokinetička svojstva entakapona slična su i u mladih i u starijih osoba.
English: Entacapone can be taken with or without food (see section 5.2).
Croatian: Entakapon se može uzimati s hranom ili bez nje (vidjeti dio 5.2).
English: Be particularly careful when you drive or when you use tools or machinery.
Croatian: Budite posebno oprezni kada vozite ili koristite alate ili strojeve.
English: Isolated cases of rhabdomyolysis have been reported.
Croatian: Zabilježeni su izolirani slučajevi rabdomiolize.
English: If this happens, you should not drive or use any tools or machines (see Driving and using machines).
Croatian: Ako uočite da Vam se to zbiva, ne smijete voziti niti koristiti alate i strojeve (vidjeti Upravljanje vozilima i strojevima).
English: Of the metabolites found in urine only about 1% have been formed through oxidation.
Croatian: Od metabolita nađenih u mokraći samo je oko 1% nastalo oksidacijom.
English: The major part (95%) of the product excreted in urine is conjugated with glucuronic acid.
Croatian: Najveći dio (95%) lijeka izlučenog mokraćom konjugiran je s glukuronskom kiselinom.
English: Approximately 10-20% is excreted in urine.
Croatian: Približno 10-20% izlučuje se mokraćom.