FrancophonIA/ELRC3.0 huggingface dataset:
English: Age, gender, weight and race were included as factors assessed in the population pharmacokinetic model to evaluate vorapaxar pharmacokinetics in healthy subjects and patients:
Croatian: U populacijski farmakokinetički model kojim se ispitivala farmakokinetika vorapaksara u zdravih ispitanika i bolesnika, bili su uključeni i ocijenjeni faktori dobi, spola, tjelesne težine i rase:
English: Conjunctival haemorrhage, diplopia
Croatian: Poremećaji oka konjunktivalno krvarenje, diplopija
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa
English: Haemorrhage
Croatian: pvrijednost
English: There is limited clinical experience with prasugrel and no experience with ticagrelor in the Phase 3 studies.
Croatian: Kliničko iskustvo s prasugrelom u ispitivanjima faze 3 je ograničeno, a iskustva s tikagrelorom nema.
English: No dose adjustment is required for patients with mild hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim oštećenjem funkcije jetre.
English: Hazard ratio is Zontivity group versus placebo group
Croatian: Broj bolesnika pod rizikom: Zontivity Placebo
English: Vorapaxar exposure increases in an approximately dose-proportional manner following single doses of 1 to 40 mg and multiple doses of 0.5 to 2.5 mg of vorapaxar sulfate.
Croatian: Nakon jednokratnih doza od 1 do 40 mg te višekratnih doza od 0,5 do 2,5 mg vorapaksarsulfata, izloženost vorapaksaru povećava se približno proporcionalno povećanju doze.
English: Tel.: +48 22 549 51 00 msdpolska@merck.com
Croatian: MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00 msdpolska@merck.com
English: The adverse reactions of bleeding in Table 1 are summarized for the TRA 2°P TIMI 50 study.
Croatian: Nuspojave krvarenja iz ispitivanja TRA 2ºP - TIMI 50 sažeto su prikazane u Tablici
English: No dose adjustment is necessary for patients with renal impairment, including subjects with ESRD.
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega, uključujući ispitanike u terminalnoj fazi bubrežne bolesti.
English: The mean estimated vorapaxar Cmax and AUC were 24% and 22% higher in Asian patients compared to that of Caucasians.
Croatian: Rasa U Azijata je srednja procijenjena vrijednost Cmax i AUC-a vorapaksara bila 24% odnosno 22% viša nego u bijelaca.
English: Zontivity 2 mg film-coated tablets Vorapaxar
Croatian: Zontivity 2 mg filmom obložene tablete vorapaksar
English: However, reduced renal function is a risk factor for bleeding and should be considered before initiating Zontivity.
Croatian: Međutim, smanjena funkcija bubrega faktor je rizika za krvarenje te se mora uzeti u obzir prije početka liječenja lijekom Zontivity.
English: Weight
Croatian: Tjelesna težina
English: Stroke
Croatian: Doziranje
English: Discontinuation of Zontivity
Croatian: Prekid liječenja lijekom Zontivity
English: Reduced hepatic function is a risk factor for bleeding and should be considered before initiating Zontivity.
Croatian: Smanjena funkcija jetre je faktor rizika za krvarenje te se mora uzeti u obzir prije početka liječenja lijekom Zontivity.
English: Non-bleeding adverse reactions in Table 1 are summarized for both the TRA 2°P TIMI 50 and TRACER studies.
Croatian: Nuspojave nevezane uz krvarenje iz ispitivanja TRA 2ºP - TIMI 50 i TRACER sažeto su prikazane u Tablici 1. (Vidjeti Tablicu 1).
English: Manufacturer
Croatian: FARMACEUTSKI
English: Merck Sharp & Dohme Ltd
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Proizvođač Merck Sharp & Dohme Ltd
English: Reduced renal function is a risk factor for bleeding and should be considered before initiating Zontivity.
Croatian: Smanjena funkcija bubrega faktor je rizika za krvarenje te se mora uzeti u obzir prije početka liječenja lijekom Zontivity.
English: * Each patient was counted only once (first component event) in the component summary that contributed to the primary efficacy endpoint K-M estimate at 1,080 days Hazard ratio is Zontivity group versus placebo group Cox proportional hazard model with covariates treatment and stratification factors (qualifying atherosclerotic disease and planned thienopyridine use)
Croatian: * Svaki je bolesnik uračunat samo jednom (prvi događaj iz objedinjene mjere ishoda) u ukupan zbroj objedinjenih događaja koji su pridonijeli mjeri primarnog ishoda za djelotvornost.
English: • Severe hepatic impairment.
Croatian: • Teško oštećenje funkcije jetre.
English: Renal impairment
Croatian: Dani od randomizacije
English: In healthy volunteer studies, no changes in platelet P-selectin and soluble CD40 ligand (sCD40L) expression or coagulation test parameters (TT, PT, aPTT, ACT, ECT) occurred after single or multiple dose (28 days) administration of vorapaxar.
Croatian: liganda (sCD40L) niti parametrima testova koagulacije (TV, PV, APTV, VK, VZ).
English: Magyarország MSD Pharma Hungary Kft. Tel.: +361 888 53 00 hungary_msd@merck.com
Croatian: Tel.: +361 888 53 00 hungary_msd@merck.com
English: Hepatic Impairment
Croatian: Infarkt miokarda
English: Severe hepatic impairment
Croatian: Teško oštećenje funkcije bubrega
English: Post-MI or PAD Patients with No History of Stroke or TIA
Croatian: Bolesnici koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u Placebo
English: Tel: + 385 1 6611 333 croatia_info@merck.com
Croatian: Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333 croatia_info@merck.com
English: TIMI Bleeding Category
Croatian: Kategorija krvarenja prema TIMI kriterijima Značajno
English: Wound haemorrhage
Croatian: Mjere ishoda
English: The results for the bleeding endpoints in the post-MI or PAD patients with no history of stroke or TIA are shown in Table 2.
Croatian: Tablica 2 prikazuje rezultate za mjere ishoda povezane s krvarenjem u bolesnika koji su pretrpjeli IM ili imaju PAD, a u anamnezi nisu imali moždani udar ni TIA-u.
English: • If you get any side effects, talk to your doctor, pharmacist, or nurse.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: Hepatic impairment
Croatian: Moždani udar
English: Vorapaxar inhibits thrombin-induced platelet aggregation in in vitro studies.
Croatian: U ispitivanjima in vitro, vorapaksar inhibira trombinom induciranu agregaciju trombocita.
English: Outcome of a procedure under Article 13 of Regulation (EC) 1234/2008
Croatian: Ishod postupka u skladu s člankom 13. Uredbe (EZ) 1234/2008
English: The company wanted this change to be recognised in Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain and Sweden.
Croatian: Tvrtka je željela da se ta izmjena prizna u Austriji, Belgiji, Češkoj Republici, Danskoj, Estoniji, Francuskoj, Njemačkoj, Grčkoj, Irskoj, Italiji, Latviji, Luksemburgu, Nizozemskoj, Norveškoj, Poljskoj, Portugalu, Španjolskoj i Švedskoj.
English: The sooner it is taken after having unprotected sex the more effective it will be.
Croatian: Što ga se prije primjeni nakon nezaštićenog spolnog odnosa, to je djelotvorniji.
English: Why was Levonelle reviewed?
Croatian: Zašto je Levonelle ponovno pregledan?
English: What is Levonelle?
Croatian: Što je Levonelle?
English: Levonelle has been authorised in the EU under a mutual recognition procedure based on an initial authorisation granted by the United Kingdom on 15 June 2004.
Croatian: Lijek Levonelle odobren je u EU-u u okviru postupka međusobnog priznavanja na temelju prvotnog odobrenja koje je 15. lipnja 2004. izdala Ujedinjena Kraljevina.
English: The company that markets these medicines is Gedeon Richter Plc.
Croatian: Te lijekove stavlja u promet tvrtka Gedeon Richter Plc.
English: In most EU Member States Levonelle and associated names can be obtained without a prescription.
Croatian: U većini država članica EU-a lijek Levonelle i povezani nazivi mogu se nabaviti bez recepta.
English: No increased risk of side effects is expected from the higher dose.
Croatian: Ne očekuje se povećanje rizika ili pojava nuspojava uzrokovanih primjenom veće doze.
English: It is available as a single tablet containing 1500 microgram levonorgestrel or as two tablets each containing 750 microgram levonorgestrel.
Croatian: Dostupan je kao jedna tableta koja sadržava 1 500 mikrograma levonorgestrela ili dvije tablete od kojih svaka sadržava 750 mikrograma levonorgestrela.
English: This review only covered the 1500 microgram tablets.
Croatian: Tim pregledom obuhvaćene su samo tablete od 1 500 mikrograma.
English: Levonelle contains levonorgestrel, which works mainly by preventing or delaying ovulation.
Croatian: Lijek Levonelle sadržava levonorgestrel, koji djeluje uglavnom tako da sprečava ili odgađa ovulaciju.
English: Although the review did not cover the 750 microgram Levonelle tablets, the CHMP recommended that similar changes should be considered for these medicines.
Croatian: Iako pregled nije obuhvatio tablete lijeka Levonelle od 750 mikrograma, CHMP je preporučio da bi trebalo uzeti u obzir slične izmjene za taj lijek.
English: This could mean that the contraceptive effects of Levonelle are reduced.
Croatian: To bi moglo upućivati na smanjeno kontraceptivno djelovanje lijeka Levonelle.
English: On 26 May 2016, the European Medicines Agency completed a review for the emergency contraceptive Levonelle (levonorgestrel, 1500 microgram tablets) and associated names.
Croatian: Europska agencija za lijekove dovršila je 26. svibnja 2016. pregled hitnog kontraceptiva Levonelle (levonorgestrel, tablete od 1 500 mikrograma) i povezanih naziva.
English: On 1 October 2015, the UK referred the matter to the CHMP for arbitration.
Croatian: Ujedinjena Kraljevina uputila je predmet CHMP-u na arbitražu 1. listopada 2015.
English: Levonelle is an emergency contraceptive used to prevent unintended pregnancy when taken within 72 hours (3 days) of unprotected intercourse or failure of a contraceptive method.
Croatian: Lijek Levonelle je hitni kontraceptiv koji se primjenjuje unutar 72 sata (tri dana) od nezaštićenog spolnog odnosa ili neuspjeha kontraceptiva radi sprečavanja neželjene trudnoće.
English: In addition there were concerns that, since Levonelle is available without prescription in many EU Member States, any new advice issued could lead to medication errors as there may not always be a consultation with a healthcare professional prior to taking the medicine.
Croatian: Nadalje, budući da je lijek Levonelle dostupan bez recepta u mnogim državama članicama EU-a, pojavila se zabrinutost da bi pružanje novih savjeta moglo dovesti do medikacijskih pogrešaka jer se bolesnici možda neće uvijek savjetovati sa zdravstvenim radnicima prije uzimanja lijeka.
English: Based on data on interactions with these medicines, which all increase the activity of the liver enzyme CYP3A4, as well as data on combined hormonal contraceptives, the CHMP concluded that interactions between these medicines and Levonelle may prevent Levonelle from working effectively and could lead to contraceptive failure.
Croatian: Na temelju podataka o međusobnom djelovanju s tim lijekovima, koji pojačavaju djelovanje jetrenog enzima CYP3A4, kao i podataka o kombiniranim hormonskim kontraceptivima, CHMP je zaključio da međusobno djelovanje između tih lijekova i lijeka Levonelle može umanjiti njegovu djelotvornosti i dovesti do neuspjeha kontraceptiva.
English: However, when this is not an option, the CHMP considered that doubling the dose of Levonelle from 1500 to 3000 microgram is recommended to compensate for the reduction in blood levonorgestrel levels.
Croatian: Međutim, ako je ta mogućnost isključena, CHMP je zaključio da se udvostručenje doze lijeka Levonelle s 1 500 na 3 000 mikrograma preporučuje kako bi se nadoknadilo smanjenje razine levonorgestrela u krvi.
English: The grounds for the referral were concerns from Italy that there are insufficient clinical data to support doubling the dose of Levonelle in cases where the woman is also taking a medicine that interacts with Levonelle.
Croatian: Razlog za upućivanje na arbitražu bila je zabrinutost koju je izrazila Italija da ne postoji dovoljno kliničkih podataka koji idu u prilog udvostručivanju doze lijeka Levonelle u žena koje također uzimaju lijek koji ima uzajamno djelovanje s lijekom Levonelle.
English: Although the Member States agreed that efavirenz interacts with levonorgestrel and that this information should be included in the product information, the Member States were unable to reach an agreement on how this interaction should be managed and whether specific recommendations such as dose adjustment were required for women taking Levonelle while on efavirenz or other medicines which also reduce levonorgestrel levels.
Croatian: Iako se države članice slažu oko toga da efavirenz uzajamno djeluje s levonorgestrelom i da bi ta informacija trebala biti navedena u informacijama o lijeku, nisu mogle postići dogovor o načinu upravljanja interakcijom i potrebi uvođenja posebnih preporuka kao što je prilagodba doze za žene koje uzimaju lijek Levonelle zajedno s efavirenzom ili drugim lijekovima koji također smanjuju razine levonorgestrela.
English: The CHMP recommended that women who use liver enzyme inducers should instead use a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) which is not affected by liver enzyme inducing medicines.
Croatian: CHMP je preporučio da bi žene koje upotrebljavaju induktore jetrenih enzima trebale umjesto njih upotrebljavati nehormonske hitne kontraceptive (tj. intrauterini uložak na bazi bakra) na koje ne utječu lijekovi koji induciraju enzime.
English: Feedback was sought from patients and relevant healthcare professionals to ensure that women could identify when to use a double dose versus a single dose based on the information provided.
Croatian: Od bolesnika i mjerodavnih zdravstvenih radnika tražila se povratna informacija kako bi se osiguralo da žene na temelju pruženih informacija mogu utvrditi kada uzeti dvostruku, a kada jednostruku dozu.
English: The European Commission issued an EU-wide legally binding decision to implement the CHMP recommendations on Levonelle on 01/08/2016.
Croatian: Europska komisija objavila je 01.08. 2016. odluku o provedbi preporuka CHMP-a o lijeku Levonelle koja je zakonski obvezujuća na području cijelog EU-a.
English: On 17 September 2014, the company for Levonelle applied for a change to the marketing authorisation to include the HIV medicine efavirenz as an interacting medicine in the product information.
Croatian: Tvrtka koja lijek Levonelle stavlja u promet podnijela je 17. rujna 2014. zahtjev za izmjenu odobrenja za stavljanje lijeka u promet kako bi se u informacijama o lijeku navelo da je lijek za liječenje HIV-a efavirenz lijek koji ima uzajamno djelovanje.
English: The application was based on a study that showed that blood levels of levonorgestrel were reduced by
Croatian: Zahtjev se temeljio na ispitivanju koje je pokazalo da je u
English: The CHMP noted that the reductions in blood levels of levonorgestrel seen with efavirenz were similar to those seen with other medicines (so-called liver enzyme inducers) that interact with levonorgestrel (including certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort).
Croatian: CHMP je ocijenio da je smanjenje razine levonorgestrela u krvi pri uzimanju efavirenza slično onome koje je uočeno za ostale lijekove (tzv. induktori jetrenih enzima) koji uzajamno djeluju s levonorgestrelom (uključujući određene lijekove za liječenje tuberkuloze i epilepsije te biljne lijekove koji sadržavaju gospinu travu).
English: However, Levonelle should only be used with these medicines when a non-hormonal emergency contraceptive (i.e. a copper intrauterine device) is not an option.
Croatian: Međutim, lijek Levonelle trebao bi se upotrebljavati s tim lijekovima samo ako je isključena mogućnost nehormonskog hitnog kontraceptiva (npr. intrauterini uložak na bazi bakra).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that when Levonelle is taken together with certain interacting medicines (including the HIV medicine efavirenz and ritonavir, certain medicines for tuberculosis and epilepsy and herbal medicines containing St John's wort) the dose of Levonelle should be doubled.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji preporučio je da bi dozu lijeka Levonelle trebalo udvostručiti kada se on uzima zajedno s određenim lijekovima koji uzajamno djeluju (uključujući lijekove za liječenje HIV-a efavirenz i ritonavir, određene lijekove za liječenje tuberkuloze i epilepsije te biljne lijekove koji sadržavaju gospinu travu).
English: around 50% in women taking efavirenz, which is known to increase the activity of a particular liver enzyme (CYP3A4) which is involved in the breakdown of levonorgestrel.
Croatian: žena koje su uzimale efavirenz, za koji se zna da pojačava djelovanje određenog jetrenog enzima (CYP3A4) koji sudjeluje u razgradnji levonorgestrela, došlo do smanjenja razine levonorgestrela u krvi za otprilike 50 %.
English: In order to ensure the correct use of Levonelle, the CHMP also recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Croatian: CHMP je također preporučio da se radi osiguranja pravilne primjene lijeka Levonelle na vanjskoj oznaci kutije i u uputi o lijeku navede savjet o tome kada uzeti dvostruku dozu lijeka.
English: In order to ensure the correct use of Levonelle, the CHMP recommended including advice on when to take a double dose on the medicine's outer carton as well as in the package leaflet.
Croatian: CHMP je preporučio da se radi osiguranja pravilne primjene lijeka Levonelle na vanjskoj oznaci kutije i u uputi o lijeku navede savjet o tome kada uzeti dvostruku dozu lijeka.
English: 23 May 2014
Croatian: 23. svibnja 2014.
English: It was to be available as capsules.
Croatian: Dostupan je kao kapsule.
English: What is Nerventra?
Croatian: Što je Nerventra?
English: Outcome of re-examination
Croatian: Ishod ponovne procjene
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zatražio je ponovno ispitivanje mišljenja.
English: The CHMP opinion has no consequences on these trials.
Croatian: Mišljenje CHMP-a nema posljedice na ova ispitivanja.
English: If you are taking part in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom ispitivanju i potrebne su vam dodatne informacije o liječenju, kontaktirajte liječnika koji Vam propisuje liječenje.
English: Both studies lasted two years and the main measure of effectiveness was based on the reduction in the number of relapses per patient per year (what is known as the ‘annualised relapse rate').
Croatian: Oba su ispitivanja trajala dvije godine, a glavna mjera djelotvornosti temeljila se na smanjivanju broja relapsa po bolesniku po godini (poznato pod nazivom „godišnja stopa relapsa”).
English: In addition, the Committee was not convinced about the effectiveness of the company's proposed measures to prevent pregnancies in women who would take the medicine.
Croatian: Nadalje, Povjerenstvo nije bilo uvjereno u djelotvornost predloženih mjera tvrtke za sprječavanje trudnoća u žena koje uzimaju lijek.
English: Refusal of the marketing authorisation for Nerventra (laquinimod)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Nerventra (laquinimod)
English: The effects of Nerventra were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Nerventra po prvi put je testirano u eksperimentalnim modelima prije provođenja ispitivanja u ljudima.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 May 2014.
Croatian: Nakon razmatranja razloga za ovaj zahtjev, CHMP je ponovno ispitao prvotno mišljenje i potvrdio je odbijanje izdavanja odobrenja za stavljanje lijeka u promet od dana 22. svibnja 2014.
English: During the re-examination, the CHMP considered advice from an expert group in neurology.
Croatian: Tijekom ponovne procjene, CHMP je razmotrio savjet stručne grupe za područje neurologije.
English: There was also a possible risk (again from animal studies) of effects on the unborn baby when the medicine is taken by pregnant women.
Croatian: Prisutan je također moguć rizik (ponovno na temelju ispitivanja provedenih u životinja) od djelovanja na nerođenu djecu ako trudnice uzimaju lijek.
English: The expert group advised that the risks seen in animal studies could have been acceptable if a clear benefit was seen in clinical studies, although a strict pregnancy prevention scheme would have been required.
Croatian: Stručna grupa je savjetovala da rizici uočeni u ispitivanjima životinja mogu biti prihvatljivi ako su jasne koristi uočene u kliničkim ispitivanjima, iako bi bio potrebna stroga shema za prevenciju trudnoće.
English: The exact way Nerventra works is not known, but it is believed to have a modulator effect on the immune system (the body's defences).
Croatian: Točan način djelovanja lijeka Nerventra nije poznat, no vjeruje se da ima modulatorsko djelovanje na imunosni sustav (obranu tijela).
English: On 23 January 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Nerventra, intended for the treatment of multiple sclerosis.
Croatian: Dana 23. siječnja 2014. godine, Povjerenstvo za lijekove za humanu uporabu (CHMP) usvojilo je negativno mišljenje kojim se preporuča odbijanje izdavanja odobrenja za stavljanje u promet lijeka Nerventra, predviđenog za liječenje multiple skleroze.
English: The CHMP noted that the effect of the medicine in preventing relapses was modest, and though its effect in slowing the worsening of disability was encouraging it still needed to be confirmed.
Croatian: CHMP je zaključio da je djelovanje lijeka u sprječavanju bilo umjereno, i iako je njegovo djelovanje u usporavanju pogoršanja invalidnosti bilo ohrabrujuće, i dalje je zahtijevalo potvrdu.
English: Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Nerventra (laquinimod) EMA/405462/2014
English: At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear.
Croatian: U trenutku prve preporuke, CHMP je bio zabrinut zbog rezultata prikupljenih iz ispitivanja provedenih u životinja koja su pokazala veći broj rakova nakon dugoročnog izlaganja lijeku, te je zaključeno da sličan dugoročan rizik od raka ne može biti isključen u slučaju ljudi, posebice ako se uzme u obzir da nije jasan način na koji lijek djeluje u tijelu.
English: How is Nerventra expected to work?
Croatian: Kako je Nerventra trebao djelovati?
English: Nerventra is a medicine that contains the active substance laquinimod.
Croatian: Nerventra je lijek koji sadrži djelatnu tvar lakinimod.
English: Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga je Povjerenstvo zaključilo da koristi od lijeka Nerventra u ispitanoj dozi nisu dostatne kako bi nadmašile potencijalne rizike u bolesnika s relapsno-remitirajućom multiplom sklerozom i održale svoju preporuku da se lijeku uskrati izdavanje odobrenja za stavljanje u promet.