FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore recommends the suspension of the marketing authorisations for all remaining medicinal products concerned by this referral procedure (annex IB), as bioequivalence vis-à-vis the EU reference medicinal products has not been demonstrated.
Croatian: CHMP stoga preporučuje suspenziju odobrenja za stavljanje lijeka u promet za sve preostale lijekove koji su obuhvaćeni ovim postupkom upućivanja (Prilog I.B) s obzirom na to da nije utvrđena bioekvivalencija u odnosu na referentne lijekove odobrene u EU-u.
English: If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects.
Croatian: Ako je bioraspoloživost generičkog lijeka veća od bioraspoloživosti referentnog lijeka, to može dovesti do većeg od namjeravanog izlaganja bolesnika djelatnoj tvari, što može dovesti do veće incidencije ili ozbiljnosti nuspojava.
English: Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for abacavir/lamivudinecontaining medicinal products (annex IA) and concludes that, with regards to marketing authorisation applications for abacavir/lamivudine-containing medicinal products, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data.
Croatian: Nakon procjene alternativnih podataka CHMP preporučuje zadržavanje odobrenja za stavljanje lijeka u promet za lijekove koji sadrže abakavir/lamivudin (Prilog I.A), uz zaključak da je u pogledu zahtjeva za odobrenje za stavljanje lijeka u promet za lijekove koji sadrže abakavir/lamivudin utvrđena bioekvivalencija u odnosu na referentni lijek odobren u EU-u na osnovi alternativnih podataka.
English: Therefore, for products either authorised or seeking a marketing authorisation based on data generated at Semler, bioequivalence is not established and benefit-risk balance cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded.
Croatian: Stoga za lijekove za koje je izdano odobrenje i za lijekove za koje je zatraženo odobrenje za stavljanje u promet na temelju podataka prikupljenih u tvrtki Semler nije utvrđena bioekvivalencija te se omjer rizika i koristi ne može smatrati pozitivnim jer se ne može isključiti mogućnost problema u pogledu sigurne primjene/podnošljivosti ili djelotvornosti.
English: Where the bioequivalence is not established, safety and efficacy cannot be extrapolated from the EU reference medicinal product to the generic medicinal product as the bioavailability of the active
Croatian: Ako bioekvivalencija nije utvrđena, podaci o sigurnosti i djelotvornosti ne mogu se ekstrapolirati iz referentnog lijeka odobrenog u EU-u na generički lijek jer se bioraspoloživost djelatne tvari tih dvaju lijekova može razlikovati.
English: − Authorised medicinal products and marketing authorisation applications for which no alternative bioequivalence data or a justification was submitted (annex IB).
Croatian: − odobrene lijekove i zahtjeve za odobrenje za stavljanje lijeka u promet za koje nisu dostavljeni alternativni podaci o bioekvivalenciji ili obrazloženja (Prilog I.B).
English: For a medicinal product with a marketing authorisation or marketing authorisation application under Article 10(1) of Directive 2001/83/EC as amended, bioequivalence is crucial for the conclusion that efficacy and safety are similar to that of the reference product.
Croatian: U skladu s člankom 10. stavkom 1. Direktive 2001/83/EZ, kako je izmijenjena, za lijekove za koje je izdano odobrenje za stavljanje u promet i za zahtjeve za stavljanje lijeka u promet, bioekvivalencija je ključna za donošenje zaključka da su djelotvornost i sigurnost slične onima referentnog lijeka.
English: • In some cases it was pointed out that products containing certain active substances could be eligible for biowaiver.
Croatian: • U nekim je slučajevima istaknuto da bi se na lijekove s određenim djelatnim tvarima moglo primijeniti izuzeće od ispitivanja bioekvivalencije.
English: For all other marketing authorisation applications (annex IB), the CHMP considers that the applicants did not submit information which allows to establish bioequivalence to the EU reference medicinal product, and therefore the marketing authorisation applications do not currently fulfil the criteria for authorisation.
Croatian: U pogledu preostalih zahtjeva za odobrenje za stavljanje lijeka u promet (Prilog I.B) CHMP smatra da podnositelji zahtjeva nisu dostavili informacije koje bi omogućile utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u i stoga zahtjevi za odobrenje za stavljanje lijeka u promet trenutačno ne ispunjavaju kriterije za davanje odobrenja.
English: Alternative data were submitted to demonstrate the bioequivalence of abacavir/lamivudine-containing medicinal products to an EU reference medicinal product.
Croatian: Dostavljeni su alternativni podaci kako bi se dokazala bioekvivalencija lijekova koji sadrže abakavir/lamivudin u odnosu na referentni lijek odobren u EU-u.
English: Some of these authorised medicinal products may be considered critical by the individual EU Member States on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Croatian: Pojedinačne države članice mogu neke od navedenih lijekova smatrati izrazito važnima na temelju evaluacije potencijalno nezadovoljene medicinske potrebe, uzimajući u obzir dostupnost primjerenih alternativnih lijekova u dotičnoj državi članici (ili više njih) i, prema potrebi, prirodu bolesti koja će se liječiti.
English: − Authorised medicinal products and marketing authorisation applications for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
Croatian: − odobrene lijekove i zahtjeve za odobrenje za stavljanje lijeka u promet za koje su dostavljeni alternativni podaci o bioekvivalenciji ili obrazloženja, ali koje je CHMP smatrao nedostatnima da bi se utvrdila bioekvivalencija u odnosu na referentni lijek odobren u EU-u (Prilog I.B);
English: An authorised medicinal product listed in Annex IB may be considered critical by the EU Member State(s) based on the evaluation of the potential unmet medical need, considering the availability of suitable alternative medicinal products in the respective EU Member State(s) and, as appropriate, the nature of the disease to be treated.
Croatian: Država članica EU-a (ili više njih) može ocijeniti da je lijek naveden u Prilogu I.B izrazito važan na temelju evaluacije potencijalno nezadovoljene medicinske potrebe, uzimajući u obzir dostupnost odgovarajućih alternativnih lijekova u dotičnoj državi članici EU-a (ili više njih) i, prema potrebi, prirodu bolesti koja će se liječiti.
English: • The CHMP concluded that, for both marketing authorisations and marketing authorisation applications referred to in annex IA, there was alternative data to establish bioequivalence vis-àvis the EU reference medicinal product.
Croatian: • CHMP je zaključio da su za odobrenja za stavljanje lijeka u promet i zahtjeve za odobrenje za stavljanje lijeka u promet iz Priloga I.A postojali alternativni podaci na osnovi kojih se utvrdila bioekvivalencija u odnosu na referentni lijek odobren u EU-u.
English: However, no formal request was submitted and the detailed information necessary to assess the appropriateness of a biowaiver was not made available by the MAHs/applicants.
Croatian: Međutim, nije podnesen službeni zahtjev, a nositelji odobrenja za stavljanje lijeka u promet/podnositelji zahtjeva nisu dostavili detaljne informacije potrebne za procjenu prikladnosti izuzeća od ispitivanja bioekvivalencije.
English: For these medicinal products considered critical by EU Member States, the marketing authorisation holders shall submit a bioequivalence study conducted vis-à-vis the EU Reference Medicinal Product within 12 months following Commission Decision.
Croatian: U slučaju lijekova koje države članice EU-a smatraju izrazito važnima nositelji odobrenja za stavljanje lijeka u promet dostavit će ispitivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u unutar 12 mjeseci nakon odluke Komisije.
English: Should during this period the EU Member State(s) consider a medicinal product not critical anymore, the suspension of the concerned marketing authorisation shall apply.
Croatian: Ako tijekom tog razdoblja država članica EU-a (ili više njih) zaključi da lijek više nije izrazito važan, primjenjuje se suspenzija dotičnog odobrenja za stavljanje lijeka u promet.
English: However, pharmacovigilance activities may lack the ability to detect a signal with regard to efficacy or safety and tolerability, therefore CHMP is of the opinion that the absence of any pharmacovigilance signal does not offer sufficient reassurance to conclude on a positive benefit-risk balance in the absence of the demonstration of bioequivalence with the EU reference medicinal product.
Croatian: Stoga je mišljenje CHMP-a da nepostojanje bilo kakvih signala farmakovigilancije ne pruža dostatno jamstvo da bi se donio zaključak o pozitivnom omjeru koristi i rizika u nedostatku dokaza bioekvivalencije s referentnim lijekom odobrenim u EU-u.
English: In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance cannot be considered positive.
Croatian: Direktive 2001/83/EZ ne mogu se smatrati ispunjenima te se djelotvornost i sigurnost navedenih lijekova ne može utvrditi i stoga se omjer koristi i rizika ne može smatrati pozitivnim.
English: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisations is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Croatian: Potrebno je suspendirati odobrenja za stavljanje u promet lijekova za koje nisu dostavljeni podaci ili obrazloženja o bioekvivalenciji ili za koje podaci i obrazloženja o bioekvivalenciji prema mišljenju CHMP-a nisu dostatni za utvrđivanje bioekvivalencije u odnosu na referentni lijek odobren u EU-u (Prilog I.B) s obzirom na to da su određeni podaci koji potkrepljuju odobrenja za stavljanje lijeka u promet netočni te da se omjer koristi i rizika tih odobrenja za stavljanje lijeka u promet ne smatra povoljnim u skladu s člankom 116.
English: For those products for which no alternative data is available to establish bioequivalence to an EU reference medicinal product, the main arguments put forward by the MAHs/applicants were as follows:
Croatian: Za lijekove za koje nisu dostupni alternativni podaci kojima bi se utvrdila bioekvivalencija s referentnim lijekovima odobrenima u EU-u
English: * This p value is not considered statistically significant.
Croatian: * Ova p-vrijednost se ne smatra statistički značajnom.
English: Do not use if box has been opened.
Croatian: Ne koristiti ako je kutija otvarana.
English: Can't be sold separately.
Croatian: Ne smije se prodavati odvojeno.
English: You may need a lower dose.
Croatian: Možda će Vam trebati niža doza.
English: The power to detect differences in these two studies was limited.
Croatian: Sposobnost otkrivanja razlika u ta dva ispitivanja bila je ograničena.
English: Talk to your doctor if you are intending to become pregnant.
Croatian: Razgovarajte sa svojim liječnikom ako planirate trudnoću.
English: It is important that you take CHAMPIX regularly at the same time each day.
Croatian: Važno je da CHAMPIX uzimate redovito, svakoga dana u isto vrijeme.
English: In case of overdose, standard supportive measures should be instituted as required.
Croatian: U slučaju predoziranja treba po potrebi primijeniti standardne potporne mjere.
English: CHAMPIX with food and drink
Croatian: CHAMPIX s hranom i pićem
English: Therefore, in some cases an adjustment of the dose may be necessary.
Croatian: Stoga u nekim slučajevima može biti potrebna prilagodba doze.
English: You should write this date on the pack as a reminder.
Croatian: Zapišite taj datum na pakiranje kao podsjetnik.
English: If, it is within 3-4 hours before your next dose, do not take the tablet that you have missed.
Croatian: Ako do Vaše sljedeće doze ima još 3-4 sata, nemojte uzeti propuštenu tabletu.
English: Take your box of tablets with you.
Croatian: Sa sobom ponesite pakiranje tableta.
English: Bottles: 2 years
Croatian: Bočice: 2 godine.
English: Blisters: 3 years
Croatian: Blisteri: 3 godine.
English: You are more likely to stop smoking if you are motivated to stop.
Croatian: Veći su izgledi da prestanete pušiti ako ste za to motivirani.
English: The cessation rates in this population were similar to those reported in the general population.
Croatian: Stopa prestanka u toj populaciji bila je slična onoj prijavljenoj u općoj populaciji.
English: The tablets should be swallowed whole with water and can be taken with or without food.
Croatian: Tablete treba progutati cijele s vodom i mogu se uzeti s hranom ili bez nje.
English: If you are allergic to varenicline or any of the other ingredients of this medicine (listed in section 6)
Croatian: - ako ste alergični na vareniklin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The patient should set a date to stop smoking.
Croatian: Bolesnik treba odrediti datum kada će prestati pušiti.
English: Date of latest renewal: 29 June 2016
Croatian: Datum posljednje obnove odobrenja: 29. lipnja 2016.
English: See the chart below for the usual dosing instructions which you should follow from Day 1.
Croatian: Sljedeća tablica sadrži upute o uobičajenom doziranju koje morate slijediti od prvog dana.
English: However, it is not known if CHAMPIX actually increases alcohol intoxication.
Croatian: Međutim, nije poznato povećava li CHAMPIX uistinu intoksikaciju alkoholom.
English: The elimination half-life of varenicline is approximately 24 hours.
Croatian: Poluvrijeme eliminacije vareniklina iznosi otprilike 24 sata.
English: Your doctor may decide to gradually lower your dose of CHAMPIX at the end of treatment.
Croatian: Vaš liječnik može odlučiti postupno smanjivati dozu lijeka CHAMPIX pri kraju liječenja.
English: Linearity/Non linearity
Croatian: Linearnost/nelinearnost
English: Do not take CHAMPIX:
Croatian: Nemojte uzimati CHAMPIX:
English: The day you stop smoking should usually be between day 8 and day 14.
Croatian: Trebali biste prestati pušiti između 8. i 14. dana.
English: As smoking induces CYP1A2, smoking cessation may result in an increase of plasma levels of CYP1A2 substrates.
Croatian: Budući da pušenje inducira CYP1A2, prestanak pušenja može dovesti do povišene razine supstrata CYP1A2 u plazmi.
English: The safety profile of varenicline was comparable to what was reported in other trials in the general population, including pulmonary safety.
Croatian: Sigurnosni profil vareniklina bio je usporediv s onime što je prijavljeno u drugim ispitivanjima u općoj populaciji, uključujući i sigurnost za pluća.
English: CHAMPIX is available in the following pack presentations:
Croatian: CHAMPIX je dostupan u sljedećim pakiranjima:
English: Patients should be treated with CHAMPIX for 12 weeks.
Croatian: Bolesnike treba liječiti lijekom CHAMPIX 12 tjedana.
English: Località Marino del Tronto, 63100 Ascoli Piceno (AP) Italy
Croatian: Località Marino del Tronto, 63100 Ascoli Piceno (AP), Italija
English: Varenicline distributes into tissues, including the brain.
Croatian: Vareniklin se raspodjeljuje u tkiva, uključujući mozak.
English: You start with the white tablet and then usually go to the light blue tablet.
Croatian: Liječenje počinje bijelim tabletama, a zatim se obično prelazi na svijetloplave tablete.
English: Depressed mood, rarely including suicidal ideation and suicide attempt, may be a symptom of nicotine withdrawal.
Croatian: Depresivno raspoloženje, koje rijetko uključuje suicidalne ideacije i pokušaj samoubojstva, može biti simptom ustezanja od nikotina.
English: Your doctor and pharmacist can provide advice, support and sources of further information to help ensure your attempt to stop smoking is successful.
Croatian: Vam dati savjet, potporu i izvore dodatnih informacija koji Vam mogu pomoći kako bi Vaš pokušaj prestanka pušenja bio uspješan.
English: Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided with additional advice and support.
Croatian: Veća je vjerojatnost da će terapija odvikavanja od pušenja biti uspješna u bolesnika koji su motivirani za prestanak pušenja te kojima su pruženi dodatni savjeti i potpora.
English: Other medicines and CHAMPIX
Croatian: Drugi lijekovi i CHAMPIX
English: CHAMPIX is for oral use and the tablets should be swallowed whole with water.
Croatian: CHAMPIX je namijenjen za peroralnu primjenu, a tablete treba progutati cijele s vodom.
English: Psychiatric Adverse Events Occurring in ≥ 1% of Patients from Pooled Data from 18 Clinical Trials:
Croatian: Psihijatrijski štetni događaji koji se pojavljuju u ≥ 1% bolesnika iz objedinjenih podataka iz 18 kliničkih ispitivanja:
English: Analyses of Clinical Trials:
Croatian: Analize kliničkih ispitivanja:
English: Patients were stratified by age (12-16 years of age and 17-19 years of age) and by body weight (≤55 kg and >55 kg).
Croatian: Bolesnici su bili stratificirani prema dobi (od 12 do 16 godina i od 17 do 19 godina) i prema tjelesnoj težini (≤ 55 kg i > 55 kg).
English: If you have a history of psychiatric disorder you should discuss this with your doctor.
Croatian: Ako ste bolovali od nekog psihičkog poremećaja, morate o tome razgovarati sa svojim liječnikom.
English: Get emergency medical help right away if you have symptoms of a heart attack or stroke.
Croatian: Odmah zatražite hitnu liječničku pomoć ako primijetite simptome srčanog ili moždanog udara.
English: Pharmacokinetics in special patient populations
Croatian: Farmakokinetika u posebnim populacijama bolesnika
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, fertility and embryo-foetal development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, plodnosti i embriofetalnog razvoja.
English: A causal relationship between these events and varenicline use has not been established.
Croatian: Uzročna veza između tih događaja i primjene vareniklina nije ustanovljena.
English: Patients with suicidal ideation and/or behaviour* [n (%)]** Patient-years of exposure
Croatian: Bolesnici sa suicidalnim ideacijama i/ili ponašanjem* [n (%)]** Bolesnik - godine izloženosti
English: These are equivalent to an estimated increase of 6.5 MACE events and 6.3 MACE events per 1,000 patient-years, respectively of exposure.
Croatian: To odgovara procijenjenom povećanju broja MACE događaja od 6,5 odnosno 6,3 događaja na 1000 bolesnik godina, ovisno o izloženosti.
English: The limited data available from this single smoking cessation study are not sufficient to allow for definitive conclusions to be drawn about the safety in patients with schizophrenia or schizoaffective disorder.
Croatian: Ograničeni podaci dostupni iz ovog jednog ispitivanja odvikavanja od pušenja nisu dostatni za donošenje konačnih zaključaka o sigurnosti primjene u bolesnika sa shizofrenijom ili shizoafektivnim poremećajem.
English: Before starting your course of CHAMPIX you should usually decide on a date in the second week of treatment (between day 8 and day 14) when you will stop smoking.
Croatian: Prije nego što počnete liječenje lijekom CHAMPIX, odredite datum u drugom tjednu liječenja (između 8. i 14. dana) kada ćete prestati pušiti.
English: All studies used statistical methods to control for confounding factors, including preferential prescribing of varenicline to healthier patients, although there is the possibility of residual confounding.
Croatian: Sva su ispitivanja upotrebljavala statističke metode za kontrolu zbunjujućih (engl. confounding) faktora, uključujući preferencijalno propisivanje vareniklina zdravijim bolesnicima, premda postoji mogućnost rezidualnih zbunjujućih učinaka.
English: Based on post marketing reports, bupropion may be associated with neuropsychiatric adverse events.
Croatian: Na temelju izvješća nakon stavljanja lijeka u promet, bupropion može biti povezan s neuropsihijatrijskim štetnim događajima.
English: If you accidentally take more CHAMPIX than your doctor prescribed, you must seek medical advice or go to the nearest hospital casualty department immediately.
Croatian: Ako slučajno uzmete više lijeka CHAMPIX nego što Vam je liječnik propisao, odmah morate potražiti savjet liječnika ili se uputiti u hitnu službu najbliže bolnice.
English: If you take more CHAMPIX than you should
Croatian: Ako uzmete više lijeka CHAMPIX nego što ste trebali
English: Few patients reported these events in the other three trials (4 varenicline, 3 placebo).
Croatian: Nekoliko je bolesnika prijavilo te događaje u ostala tri ispitivanja (4 na vareniklinu, 3 na placebu).
English: The efficacy of CHAMPIX in smoking cessation was demonstrated in 3 clinical trials involving chronic cigarette smokers ( 10 cigarettes per day).
Croatian: Djelotvornost lijeka CHAMPIX u odvikavanju od pušenja dokazana je u 3 klinička ispitivanja u kojima su sudjelovali kronični pušači ( 10 cigareta na dan).
English: There are no clinically meaningful differences in varenicline pharmacokinetics due to age, race, gender, smoking status, or use of concomitant medicinal products, as demonstrated in specific pharmacokinetic studies and in population pharmacokinetic analyses.
Croatian: Nema klinički značajnih razlika u farmakokinetici vareniklina s obzirom na dob, rasu, spol, pušački status ili istodobnu primjenu drugih lijekova, što je dokazano u posebnim farmakokinetičkim ispitivanjima i analizama populacijske farmakokinetike.
English: Clinicians should be aware of the possible emergence of serious neuropsychiatric symptoms in patients attempting to quit smoking with or without treatment.
Croatian: Kliničari moraju biti svjesni moguće pojave ozbiljnih neuropsihijatrijskih simptoma u bolesnika koji pokušavaju prestati pušiti sa ili bez liječenja.
English: *CA: Continuous Abstinence
Croatian: *CA: stopa kontinuirane apstinencije
English: Start at day 1
Croatian: Započeti 1. dan
English: CHAMPIX can be taken with or without food
Croatian: CHAMPIX se može uzimati s hranom ili bez nje.
English: Stop taking CHAMPIX and tell your doctor immediately if you experience any of the following signs and symptoms that may indicate a serious allergic reaction: swelling of the face, lips, tongue, gums, throat or body and/or difficulty breathing, wheezing.
Croatian: Prestanite uzimati CHAMPIX i odmah se obratite svom liječniku ako se u Vas pojavio neki od sljedećih znakova i simptoma koji može ukazivati na ozbiljnu alergijsku reakciju: oticanje lica, usnica, jezika, desni, grla ili tijela i/ili otežano disanje, piskanje pri disanju.
English: Maximum plasma concentrations of varenicline occur typically within 3-4 hours after oral administration.
Croatian: Maksimalne koncentracije vareniklina u plazmi obično se postižu otprilike 3-4 sata nakon peroralne primjene.