FrancophonIA/ELRC3.0 huggingface dataset:
English: Contains sunset yellow FCF aluminium lake (E110).
Croatian: Sadrži sunset yellow FCF aluminium lake (E110).
English: Bleeding risk associated with timing of loading dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Croatian: Rizik od krvarenja povezan s vremenom primjene udarne doze kod NSTEMI U kliničkom ispitivanju u bolesnika s NSTEMI (ispitivanje ACCOAST), u kojem su bolesnici bili podvrgnuti koronarnoj angiografiji unutar 2 do 48 sati nakon randomizacije, bolesnici koji su primili udarnu dozu od 30 mg u prosjeku 4 sata prije koronarne angiografije te zatim udarnu dozu od 30 mg u vrijeme perkutane koronarne intervencije imali su povećan rizik od krvarenja nevezanog za CABG tijekom postupka, a nisu imali nikakve dodatne koristi u odnosu na bolesnike koji su primili udarnu dozu od 60 mg u vrijeme perkutane koronarne intervencije (vidjeti dijelove 4.2 i 4.4).
English: Prasugrel Mylan should be given as a single 60 mg loading dose and then continued at a 5 mg once daily dose.
Croatian: Treba dati jednokratnu udarnu dozu lijeka Prasugrel Mylan od 60 mg, a zatim nastaviti liječenje u dozi od 5 mg jedanput na dan.
English: Crospovidone Colloidal anhydrous silica Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza manitol krospovidon silicijev dioksid, koloidni, bezvodni magnezijev stearat
English: No dosage adjustment is necessary for patients with renal impairment, including patients with end stage renal disease (ESRD).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem bubrega, uključujući i bolesnike u terminalnoj fazi bubrežne bolesti.
English: Because of the potential for increased risk of bleeding, warfarin and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Croatian: Zbog mogućeg povećanog rizika od krvarenja, istodobna primjena varfarina i lijeka Prasugrel Mylan mora se odvijati uz oprez (vidjeti dio 4.4).
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Croatian: Objedinjeni događaji iz primarne mjere ishoda: smrt zbog kardiovaskularnog (KV) uzroka, nesmrtonosni IM ili nesmrtonosni moždani udar
English: Primary Individual Outcome Events
Croatian: Objedinjeni događaji iz primarne mjere ishoda
English: The incidence of Non-CABG-related TIMI major bleeding, including life-threatening and fatal, as well as TIMI minor bleeding, was statistically significantly higher in subjects treated with prasugrel compared to clopidogrel in the UA/NSTEMI and All ACS populations.
Croatian: Incidencija značajnih krvarenja (prema TIMI kriterijima) nevezanih uz CABG, uključujući po život opasna i smrtonosna krvarenja, kao i manjih krvarenja (prema TIMI kriterijima) bila je statistički značajno viša u bolesnika liječenih prasugrelom u odnosu na one liječene klopidogrelom u populaciji bolesnika koji su imali UA/NSTEMI kao i u populaciji svih bolesnika s akutnim koronarnim sindromom.
English: 2.0% (0.1% fatal)a
Croatian: 2,0% (0,1% smrtonosna)a
English: Prasugrel must not be used in patients with severe hepatic impairment (see section 4.3).
Croatian: Prasugrel se ne smije primjenjivati u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.3).
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84, 90 or 98 filmcoated tablets.
Croatian: OPA/Aluminij/PE/Sredstvo za sušenje/PE- pakiranja s aluminijskim blisterima sadrže 28, 30, 84, 90 ili 98 filmom obloženih tableta.
English: Non-CABG-related TIMI major or minor bleeding rates: Weight
Croatian: Stope značajnih odnosno manjih krvarenja (prema TIMI kriterijima) nevezanih uz CABG: Tjelesna težina
English: Safety in patients with acute coronary syndrome undergoing PCI was evaluated in one clopidogrel controlled study (TRITON) in which 6741 patients were treated with prasugrel (60 mg loading dose and 10 mg once daily maintenance dose) for a median of 14.5 months (5802 patients were treated for over 6 months; 4136 patients were treated for more than 1 year).
Croatian: Sigurnost prasugrela u bolesnika s akutnim koronarnim sindromom podvrgnutih PCI-ju procijenjena je u jednom ispitivanju kontroliranom klopidogrelom (TRITON), u kojemu je 6741 bolesnik liječen prasugrelom (udarna doza od 60 mg i doza održavanja od 10 mg jedanput na dan).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 10 MG FILMOM OBLOŽENIM TABLETAMA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER CARTON OF 5 MG FILM-COATED TABLETS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER S 5 MG FILMOM OBLOŽENIM TABLETAMA
English: Tell your doctor promptly if you notice any of the following:
Croatian: Što prije obavijestite liječnika ako primijetite neki od sljedećih simptoma:
English: 2.2% (0.2% fatal)a
Croatian: 2,2% (0,2% smrtonosna)a
English: Each bottle contains a desiccant labelled “DO NOT EAT” and 28 or 30 film-coated tablets.
Croatian: Jedna bočica sadrži 28 ili 30 filmom obloženih tableta i sredstvo za sušenje s oznakom „NE GUTATI”.
English: Do not break or crush the tablet.
Croatian: Tablete se ne smiju lomiti niti drobiti.
English: b Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Croatian: b Svako intrakranijalno krvarenje ili svako klinički zamjetno krvarenje udruženo s padom vrijednosti hemoglobina ≥ 5 g/dl.
English: How to store Prasugrel Mylan
Croatian: Kako čuvati Prasugrel Mylan
English: 3.8% (0.2% fatal)
Croatian: 3,8% (0,2% smrtonosna)
English: • Emphasis that: ◦ Severe haemorrhagic events are more frequent in patients ≥75 years of age (including fatal events) or those weighing <60 kg ◦ Treatment with prasugrel is generally not recommended for patients of ≥75 years of age.
Croatian: • Mora se naglasiti da: ◦ su epizode značajnog krvarenja češće u bolesnika u dobi od ≥ 75 godina (uključujući i smrtonosna krvarenja) te onih tjelesne težine < 60 kg.
English: Prasugrel Mylan 5 mg: Do not store above 30°C.
Croatian: Prasugrel Mylan 5 mg: Ne čuvati na temperaturi iznad 30°C.
English: OPA/Aluminium/PE/Desiccant/PE- Aluminium blister packs containing 28, 30, 84 or 98 film-coated tablets.
Croatian: OPA/Aluminij/PE/Sredstvo za sušenje/PE- pakiranja s aluminijskim blisterima sadrže 28, 30, 84 ili 98 filmom obloženih tableta.
English: Hazard Ratio (HR) (95% CI)
Croatian: ASK Klopidogrel +ASKOmjer hazarda Prasugrel + (HR) (95% CI) p-vrijednost
English: Prasugrelb + ASA (N=1740)
Croatian: Prasugrelb + ASK (N =
English: Non fatal MI
Croatian: Nije primjenjivo.
English: BOTTLE CARTON AND BOTTLE LABEL OF 10 MG FILM-COATED TABLETS
Croatian: KUTIJA BOCE I NALJEPNICA BOCE S 10 MG FILMOM OBLOŽENIM TABLETAMA
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Croatian: c Svako intrakranijalno krvarenje ili svako klinički zamjetno krvarenje udruženo s padom vrijednosti hemoglobina ≥ 5 g/dl.
English: BOTTLE CARTON AND BOTTLE LABEL OF 5 MG FILM-COATED TABLETS
Croatian: KUTIJA ZA BOCU I NALJEPNICA BOCE S 5 MG FILMOM OBLOŽENIM TABLETAMA
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Prasugrel Mylan should be co-administered with caution (see section 4.4).
Croatian: Prasugrel Mylan treba primjenjivati uz oprez u bolesnika koji su na kroničnoj terapiji NSAIL-ima (uključujući COX-2 inhibitore) (vidjeti dio 4.4).
English: LIST OF EXCIPIENTS Contains sunset yellow FCF aluminium lake (E110).
Croatian: POPIS POMOĆNIH TVARI Sadrži sunset yellow FCF aluminium lake (E110).
English: Prasugrel Mylan is for oral use.
Croatian: Prasugrel Mylan je za peroralnu primjenu.
English: Prasugrel Mylan 10 mg: Do not store above 25°C.
Croatian: Prasugrel Mylan 10 mg: Ne čuvati na temperaturi iznad 25°C.
English: Thrombotic thrombocytopaenic purpura (TTP)
Croatian: Poremećaji krvi i limfnog sustava anemija trombocitopenija trombotična trombocitopenična purpura (TTP)
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 10 mg film-coated tablets prasugrel STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Croatian: NAZIV LIJEKA Prasugrel Mylan 10 mg filmom obložene tablete prasugrel NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 10 mg prasugrela u obliku prasugrelbesilata.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa hemoptiza
English: Clopidogrelb + ASA (N=1736)
Croatian: Klopidogrelb + ASK (N =
English: • Before you take Prasugrel Mylan:
Croatian: • Prije nego uzmete Prasugrel Mylan:
English: Prasugrel was administered without regard to food in TRITON.
Croatian: Prasugrel se u ispitivanju TRITON primjenjivao neovisno o obroku.
English: BLISTER CARTON OF 5 MG FILM-COATED TABLETS
Croatian: KUTIJA BLISTERA S 5 MG FILMOM OBLOŽENIM TABLETAMA
English: Requiring inotropes Requiring surgical intervention Requiring transfusion (≥4 units) TIMI minor bleedingf a Centrally adjudicated events defined by the Thrombolysis in Myocardial Infarction (TIMI) Study
Croatian: Manje krvarenje prema TIMIf a Centralno određeni događaji definirani prema kriterijima ispitivačke skupine za trombolizu u infarktu miokarda (engl.
English: BLISTER CARTON OF 10 MG FILM-COATED TABLETS
Croatian: KUTIJA BLISTERA S 10 MG FILMOM OBLOŽENIM TABLETAMA
English: Prasugrel Mylan 10 mg: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Croatian: Prasugrel Mylan 10 mg: Jedna tableta sadrži 10 mg prasugrela u obliku prasugrelbesilata.
English: Your doctor should prescribe a daily dose of 5 mg as there is a greater risk of bleeding in patients older than 75 years - a recent serious injury - recent surgery (including some dental procedures) - recent or recurrent bleeding from the stomach or intestines (e.g. a stomach ulcer or colon polyps) body weight of less than 60 kg.
Croatian: - ako ste nedavno imali ozbiljnu ozljedu - ako ste nedavno imali operaciju (uključujući i neke stomatološke zahvate) - ako ste nedavno krvarili iz želuca ili crijeva ili često imate takva krvarenja (npr. želučani vrijed ili crijevne polipe) ako Vam je tjelesna težina manja od 60 kg.
English: Yellow film-coated, capsule shaped, biconvex tablet, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side and ‘M' on the other side.
Croatian: Žuta, bikonveksna filmom obložena tableta u obliku kapsule, dimenzija 8,15 mm × 4,15 mm s utisnutom oznakom „PH3” na jednoj strani tablete i „M” na drugoj strani tablete.
English: 2.6% (0.3% fatal)
Croatian: 2,6% (0,3% smrtonosna)
English: Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets prasugrel
Croatian: Prasugrel Mylan 5 mg filmom obložene tablete Prasugrel Mylan 10 mg filmom obložene tablete prasugrel
English: Prasugrel Mylan 5 mg film-coated tablets are yellow film-coated, capsule shaped, biconvex tablets, of dimensions 8.15 mm × 4.15 mm, debossed with ‘PH3' on one side of the tablet and ‘M' on the other side.
Croatian: Prasugrel Mylan 5 mg filmom obložene tablete su žute, bikonveksne filmom obložene tablete u obliku kapsule dimenzija 8,15 mm × 4,15 mm s utisnutom oznakom „PH3” na jednoj strani tablete i „M” na drugoj strani tablete.
English: Prasugrel Mylan 5 mg: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Croatian: Prasugrel Mylan 5 mg: Jedna tableta sadrži 5 mg prasugrela u obliku prasugrelbesilata.
English: How to take Prasugrel Mylan
Croatian: Kako uzimati Prasugrel Mylan
English: Each tablet contains 0.016 mg of sunset yellow FCF aluminium lake (E110).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Jedna tableta sadrži 0,016 mg sunset yellow FCF aluminum lake (E110)
English: Prasugrel Mylan 10 mg film-coated tablets are beige film-coated, capsule shaped, biconvex tablets, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side of the tablet and ‘M' on the other side.
Croatian: Prasugrel Mylan 10 mg filmom obložene tablete su bež, bikonveksne filmom obložene tablete u obliku kapsule dimenzija 11,15 mm × 5,15 mm s utisnutom oznakom „PH4” na jednoj strani tablete i „M” na drugoj strani tablete.
English: f Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Croatian: d *IKK = intrakranijalno krvarenje e Klinički zamjetno krvarenje udruženo s padom vrijednosti hemoglobina od ≥ 3 g/dl ali < 5 g/dl.
English: Prasugrel Mylan 5 mg film-coated tablets prasugrel
Croatian: Prasugrel Mylan 5 mg filmom obložene tablete prasugrel
English: Non-CABG-related TIMI major or minor bleeding rates: Age
Croatian: Stope značajnih odnosno manjih krvarenja (prema TIMI kriterijima) nevezanih uz CABG: Dob
English: Prasugrel 5 mg provided greater antiplatelet effect than clopidogrel 75 mg. Prasugrel should be used with caution in patients ≥75 years old and in patients weighing <60 kg (see sections 4.2, 4.4 and 4.8).
Croatian: Prasugrel treba primjenjivati uz oprez u bolesnika u dobi od ≥ 75 godina te u bolesnika tjelesne težine < 60 kg (vidjeti dijelove 4.2, 4.4 i 4.8).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Mylan S.A.S.
Croatian: OD LIJEKA, AKO JE POTREBNO 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Mylan S.A.S.
English: - have a medical condition that is currently causing bleeding, such as bleeding from your stomach or intestines.
Croatian: - ako bolujete od neke bolesti koja trenutno izaziva krvarenje, kao što je krvarenje iz želuca ili crijeva - ako ste ikada imali moždani udar ili tranzitornu ishemijsku ataku (TIA) - ako bolujete od teške bolesti jetre.
English: Prasugrel Mylan 10 mg film-coated tablets prasugrel
Croatian: Prasugrel Mylan 10 mg filmom obložene tablete prasugrel
English: Beige film-coated, capsule shaped, biconvex tablet, of dimensions 11.15 mm × 5.15 mm, debossed with ‘PH4' on one side and ‘M' on the other side.
Croatian: Žuta, bikonveksna filmom obložena tableta u obliku kapsule, dimenzija 11.15 mm × 5,15 mm s utisnutom oznakom „PH4” na jednoj strani tablete i „M” na drugoj strani tablete.
English: NAME OF THE MEDICINAL PRODUCT Prasugrel Mylan 5 mg film-coated tablets Prasugrel Mylan 10 mg film-coated tablets
Croatian: Prasugrel Mylan 5 mg filmom obložene tablete Prasugrel Mylan 10 mg filmom obložene tablete
English: INFORMATION IN BRAILLE prasugrel Mylan 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU prasugrel Mylan 5 mg
English: EU/1/18/1273/001 EU/1/18/1273/003 EU/1/18/1273/005 EU/1/18/1273/006 EU/1/18/1273/007 EU/1/18/1273/008
Croatian: EU/1/18/1273/001 EU/1/18/1273/003 EU/1/18/1273/005 EU/1/18/1273/006 EU/1/18/1273/007
English: Mean steady-state inhibition of platelet aggregation was 74% and 69% respectively for 5 µM ADP and 20 µM ADP, and was achieved following 3 to 5 days of administration of the 10 mg prasugrel maintenance dose preceded by a 60 mg loading dose.
Croatian: Stanje dinamičke ravnoteže postignuto je nakon 3 - 5 dana primjene doze održavanja od 10 mg prasugrela, kojoj je prethodila udarna doza od 60 mg.
English: • A copy of the SPC
Croatian: • Primjerak sažetka opisa svojstava lijeka
English: CV death, nonfatal MI, or nonfatal stroke
Croatian: smrt zbog KV uzroka, nesmrtonosni IM ili nesmrtonosni moždani udar smrt zbog KV uzroka nesmrtonosni IM 6,7
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is an azo colouring agent, which may cause allergic reactions.
Croatian: Sunset yellow FCF aluminium lake je azo bojilo koje može uzrokovati alergijske reakcije.
English: In a 30 month study (TRILOGY-ACS) in 9326 patients with UA/NSTEMI ACS medically managed without revascularisation (non-licensed indication), prasugrel did not significantly reduce the frequency of the composite endpoint of CV death, MI or stroke compared to clopidogrel.
Croatian: ACS liječen bez revaskularizacije (neodobrena indikacija), prasugrel nije značajno smanjio učestalost objedinjene mjere ishoda, koja je uključivala kardiovaskularnu smrt, infarkt miokarda ili moždani udar, u usporedbi s klopidogrelom.
English: 117 Allee des Parcs, 69 800 Saint Priest, France 12.
Croatian: 117 Allee des Parcs, 69 800 Saint Priest, Francuska 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1273/001
English: e Clinically overt bleeding associated with a fall in haemoglobin of ≥3 g/dL but <5 g/dL.
Croatian: Bolesnici mogu biti uključeni u više od jednog retka. e IKK = intrakranijalno krvarenje f Klinički zamjetno krvarenje udruženo s padom vrijednosti hemoglobina od ≥ 3 g/dl ali < 5 g/dl.
English: Prasugrel Mylan 10 mg contains sunset yellow FCF aluminium lake (E110) and sodium Sunset yellow FCF aluminium lake is a colouring agent, which may cause allergic reactions.
Croatian: Sunset yellow FCF aluminium lake je bojilo koje može uzrokovati alergijske reakcije.
English: Each tablet contains prasugrel besilate equivalent to 5 mg prasugrel.
Croatian: Jedna tableta sadrži 5 mg prasugrela u obliku prasugrelbesilata.
English: Post-procedural haemorrhage
Croatian: Prijavljivanje nuspojava
English: - have severe liver disease.
Croatian: Oštećenje jetre
English: Each tablet contains prasugrel besilate equivalent to 10 mg prasugrel.
Croatian: Jedna tableta sadrži 10 mg prasugrela u obliku prasugrelbesilata.
English: It was to be used in combination with other medicines.
Croatian: Trebao se koristiti u kombinaciji s drugim lijekovima.
English: Remaining clinical trials were expected to finish on schedule by July 2014.
Croatian: Očekuje se da će preostala klinička ispitivanja završiti prema rasporedu, do srpnja 2014.
English: It was to be available as capsules (120 mg).
Croatian: Trebao je biti dostupan u obliku kapsula (120 mg).
English: The company had not yet responded to the questions at the time of the withdrawal.
Croatian: Tvrtka još nije bila odgovorila na pitanja u vrijeme povlačenja.
English: The withdrawal letter is available here.
Croatian: Pismo o povlačenju zahtjeva dostupno je ovdje.
English: 27 June 2014 EMA/354906/2014 EMEA/H/C/003720
Croatian: EMA/445616/2014 EMEA/H/C/003720
English: If you are 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 te vam je potrebno više informacija o vašem liječenju, obratite se svom liječniku.
English: In addition, results of tests on capsules stored in nonrefrigerated conditions showed that they did not dissolve as expected, which could affect the release of the active substance from the capsule.
Croatian: Osim toga, rezultati ispitivanja na kapsulama pohranjenim u nerashlađenim uvjetima pokazali su da se nisu otopile na očekivani način što bi moglo utjecati na otpuštanje djelatne tvari iz kapsule.
English: The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika čije krvne pretrage nisu pokazale nikakav znak virusa hepatitisa C 12 tjedana nakon završetka liječenja.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that since several new treatments for hepatitis C had become available after the application was first made, there was no longer an unmet medical need for such a medicine.
Croatian: U svojem pismu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da, s obzirom da je od podnošenja zahtjeva za odobrenje postalo dostupno nekoliko novih terapija, medicinske potrebe za takvim lijekom više ne postoje.
English: This stops the hepatitis C virus from multiplying and infecting new cells.
Croatian: Time zaustavlja umnožavanje virusa C i njegovo inficiranje novih stanica.
English: A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
Croatian: Četvrto ispitivanje koje je uključivalo 308 bolesnika ispitivalo je učinke liječenja lijekom Faldeprevir Boehringer Ingelheim u bolesnika koji su također imali HIV infekciju.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Faldaprevir Boehringer Ingelheim.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su u ovom trenutku uključeni u klinička ispitivanja u kojima se koristi Faldaprevir Boehringer Ingelheim.
English: On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Croatian: Dan 10. lipnja 2014. tvrtka Boehringer Ingelheim International GmbH službeno je obavijestila Povjerenstvo za humane lijekove (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Faldaprevir Boehringer Ingelheim za liječenje hepatitisa C.
English: Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Croatian: Faldaprevir Boehringer Ingelheim bio je predviđen za liječenje odraslih osoba s kroničnim (dugotrajnim) hepatitisom C (infektivnom bolesti koja utječe na jetru, a uzrokuje je virus hepatitisa C).
English: Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Croatian: Faldaprevir Boehringer Ingelheim je antivirusni lijek koji sadrži djelatnu tvar faldaprevil.
English: The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Croatian: Djelatna tvar u lijeku Faldaprevir Boehringer Ingelheim, faldaprevir, blokira djelovanje enzima naziva „NS3/4A serinska proteaza” kod virusa hepatitisa C koje je neophodno za umnožavanje virusa.
English: Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Croatian: Postoji nekoliko varijeteta (genotipa) virusa hepatitisa C: Faldaprevir Boehringer Ingelheim namijenjen je za upotrebu protiv genotipa 1 virusa hepatitisa C.
English: Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Faldaprevir Boehringer Ingelheim did not outweigh its risks.
Croatian: Sukladno navedenome, do vremena povlačenja CHMP je smatrao da, zbog zabrinutosti oko kvalitete, koristi lijeka Faldaprevir Boehringer Ingelheim ne nadmašuju s njim povezane rizike.
English: What is Faldaprevir Boehringer Ingelheim?
Croatian: Što je Faldaprevir Boehringer Ingelheim?
English: The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Croatian: Tvrtka je predočila podatke koji su obuhvaćali rezultate tri glavna ispitivanja koja su uključivala 1 705 bolesnika s kroničnim hepatitisom C kod kojih je faldaprevir uspoređivan s placebom (liječenjem bez
English: What was Faldaprevir Boehringer Ingelheim expected to be used for?
Croatian: Za što se Faldaprevir Boehringer Ingelheim trebao koristiti?