FrancophonIA/ELRC3.0 huggingface dataset:
English: Adverse reactions have been assigned to the frequency categories in Table 1 where possible based on the incidence of comparable adverse reactions reports in a pooled dataset from the ISEL, INTEREST and IPASS phase III clinical trials (2462 gefitinib-treated patients).
Croatian: Kategorije učestalosti nuspojava u Tablici 1 određene su, kad je to bilo moguće, na temelju incidencije usporedivih prijava nuspojava u zbirnim podacima iz kliničkih ispitivanja faze III ISEL, INTEREST i IPASS (2462 bolesnika liječena gefitinibom).
English: Lactose monohydrate Microcrystalline cellulose (101) Crospovidone (Type A) Povidone (K30) Sodium laurilsulfate Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična (101) krospovidon (vrsta A) povidon (K30) natrijev laurilsulfat magnezijev stearat
English: It comes in PVC/PVDC/Aluminium blisters in packs of 30 film-coated tablets or in PVC/PVDC/Aluminium perforated unit dose blisters in packs of 30x1 film-coated tablets.
Croatian: Dostupne su u PVC/PVDC/aluminijskim blisterima u pakiranjima od 30 filmom obloženih tableta ili u PVC/PVDC/aluminijskim perforiranim blisterima s jediničnim dozama u pakiranjima od 30x1 filmom obložena tableta.
English: Uncommon Pancreatitis Gastrointestinal perforation
Croatian: Pankreatitis Gastrointestinalna perforacija
English: Active substances that may have their plasma concentrations altered by gefitinib In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6.
Croatian: Djelatne tvari čija se koncentracija u plazmi može promijeniti djelovanjem gefitiniba In vitro studije pokazale su da gefitinib ima ograničen potencijal za inhibiciju CYP2D6.
English: In a post-marketing surveillance study in Japan (3350 patients) the reported rate of ILD-type events in patients receiving gefitinib was 5.8%.
Croatian: U ispitivanju praćenja lijeka u razdoblju nakon stavljanja u promet u Japanu (3350 bolesnika) zabilježena je stopa nuspojava tipa ILD-a od 5,8% u bolesnika koji su primali gefitinib.
English: Time to treatment failurea,b
Croatian: Vrijeme do prestanka odgovora na liječenjea,b
English: • Vomiting.
Croatian: • povraćanje
English: In that study ctDNA derived from serum, not plasma was used for EGFR mutation analysis using the EGFR Mutation Test Kit (DxS) (N= 86).
Croatian: U tom se ispitivanju za analizu mutacije EGFR-a koristila ctDNK iz seruma, a ne iz plazme, a provedena je uz pomoć kompleta testnih reagensa EGFR Mutation Test Kit (DxS) (N=86).
English: In this study gefitinib exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of gefitinib.
Croatian: U tom se ispitivanju izloženost gefitinibu nije povećala s povećanjem doze, a nuspojave su uglavnom bile blage do umjereno teške i sukladne poznatom sigurnosnom profilu gefitiniba.
English: Table 2 - Summary of baseline mutation status for tumour and ctDNA samples in all screened patients evaluable for both samples
Croatian: Tablica 2 - Sažetak početnog statusa mutacije u uzorcima tumora i ctDNK kod svih bolesnika koji su pristupili probiru i kod kojih su se mogla ocijeniti oba uzorka
English: • If it is less than 12 hours until your next dose: skip the missed tablet.
Croatian: • Ako je do sljedeće doze ostalo manje od 12 sati: preskočite propuštenu tabletu.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar iste kategorije učestalosti, nuspojave su navedene u padajućem nizu prema ozbiljnosti.
English: • Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Croatian: • hemoragijski cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem uz prisutnost krvi u mokraći).
English: V.J.
Croatian: Pg-p.
English: Concomitant medicinal products that induce CYP3A4 (e.g. phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort, Hypericum perforatum) should be avoided.
Croatian: Treba izbjegavati istodobnu primjenu lijekova koji induciraju CYP3A4 (npr. fenitoin, karbamazepin, rifampicin, barbiturati ili gospina trava, Hypericum perforatum).
English: PVC/PVDC/Aluminium blister in cartons containing 30 film-coated tablets.
Croatian: PVC/PVDC/aluminijski blister u kutiji s 30 filmom obloženih tableta.
English: The IFUM study was a single-arm, multicentre study conducted in Caucasian patients (n=106) with activating, sensitizing EGFR mutation positive NSCLC to confirm that the activity of gefitinib is similar in Caucasian and Asian populations.
Croatian: Multicentrično ispitivanje s jednom skupinom, IFUM, provedeno je na ispitanicima bijele rase (n=106) s rakom pluća nemalih stanica (NSCLC) s aktivirajućom senzibilizirajućom mutacijom EGFR s ciljem potvrde da je aktivnost gefitiniba jednaka u populaciji bijelaca i azijata.
English: INFORMATION IN BRAILLE gefitinib mylan 250 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU gefitinib mylan 250 mg
English: The increase may be clinically relevant since adverse reactions are related to dose and exposure.
Croatian: Povećanje može biti klinički značajno, jer su nuspojave povezane s dozom i izloženošću.
English: Conjunctivitis, blepharitis, and dry eye*, mainly mild (CTC grade 1).
Croatian: Konjunktivitis, blefaritis i suhoća oka*, uglavnom blagi (CTC stupanj 1)
English: HR in the overall population, or otherwise 95% confidence intervals for HR c Confidence interval entirely below non-inferiority margin of 1.154
Croatian: Interval pouzdanosti je u cijelosti ispod granice neinferiornosti od 1,154.
English: Interstitial lung disease (1.3%), often severe (CTC grade 3-4).
Croatian: Intersticijska bolest pluća (1,3%), često teška (CTC stupanj 3 ili 4).
English: Interstitial lung disease (ILD) which may be acute in onset, has been observed in 1.3% of patients receiving gefitinib, and some cases have been fatal (see section 4.8).
Croatian: Intersticijska bolest pluća (engl. interstitial lung disease, ILD), koja može nastupiti u akutnom obliku, zabilježena je u 1,3% bolesnika liječenih gefitinibom, a u nekim je slučajevima imala smrtni ishod (vidjeti dio 4.8).
English: Uncommon Corneal erosion, reversible and sometimes in association with aberrant eyelash growth.
Croatian: Erozija rožnice, reverzibilna i ponekad udružena s aberantnim rastom trepavica Keratitis (0,12%)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING POUCH
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VREĆICA
English: Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ≥ 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).
Croatian: Istodobna primjena gefitiniba s ranitidinom u dozi koja uzrokuje trajno povišenje želučanog pH ≥ 5, u zdravih je dobrovoljaca uzrokovala smanjenje prosječnog AUC-a gefitiniba za 47% (vidjeti dijelove 4.4 i 5.2).
English: The recommended posology of Gefitinib Mylan is one 250 mg tablet once a day.
Croatian: Preporučena doza lijeka Gefitinib Mylan je jedna tableta od 250 mg jednom na dan.
English: 1.7 times higher in females than males
Croatian: 0,0397 1,7 puta veći u žena nego u muškaraca
English: Haemorrhage, such as epistaxis and haematuria.
Croatian: Krvarenje, kao što su epistaksa i hematurija
English: In EGFR mutation-positive patients, significantly more gefitinib-treated patients experienced an improvement in quality of life and lung cancer symptoms vs carboplatin/paclitaxel (see Table 4).
Croatian: Među bolesnicima pozitivnima na mutaciju EGFR-a, poboljšanje kvalitete života i simptoma raka pluća zabilježeno je u značajno većem broju onih liječenih gefitinibom u odnosu na one liječene karboplatinom/paklitakselom (vidjeti Tablicu 4).
English: In a Japanese pharmacoepidemiological case control study in 3,159 patients with NSCLC receiving gefitinib or chemotherapy who were followed up for 12 weeks, the following risk factors for developing ILD (irrespective of whether the patient received gefitinib or chemotherapy) were identified: smoking, poor performance status (PS≥ 2), CT scan evidence of reduced normal lung (≤ 50%), recent diagnosis of NSCLC (< 6 months), pre-existing ILD, older age (≥ 55 years old) and concurrent cardiac disease.
Croatian: U farmakoepidemiološkom ispitivanju parova (engl. case-control) provedenom u Japanu na 3159 bolesnika s NSCLC-om liječenih gefitinibom ili kemoterapijom koji su praćeni tijekom 12 tjedana, utvrđeni su sljedeći čimbenici rizika za razvoj ILD-a (bez obzira jesu li bolesnici primali gefitinib ili kemoterapiju): pušenje, loše opće stanje (PS (engl. performance status) ≥ 2), CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), nedavno dijagnosticiran NSCLC
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 250 mg of gefitinib.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
English: Gefitinib Mylan is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4).
Croatian: Gefitinib Mylan indiciran je kao monoterapija za liječenje odraslih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica (engl. non-small cell lung cancer, NSCLC) s aktivirajućim mutacijama tirozin kinaze receptora epidermalnog faktora rasta (engl. epidermal growth factor receptor tyrosine kinase, EGFR-TK) (vidjeti dio 4.4).
English: Pre-treatment with itraconazole (a potent CYP3A4 inhibitor) resulted in an 80% increase in the mean AUC of gefitinib in healthy volunteers.
Croatian: Prethodno liječenje itrakonazolom (snažan inhibitor CYP3A4) u zdravih je dobrovoljaca izazvalo porast prosječnog AUCa gefitiniba za 80%.
English: The randomised phase III INTEREST study was conducted in patients with locally advanced or metastatic NSCLC who had previously received platinum-based chemotherapy.
Croatian: Randomizirano kliničko ispitivanje faze III (INTEREST) provedeno je u bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća ne-malih stanica koji su prethodno liječeni kemoterapijom temeljenom na platini.
English: • Nail problems.
Croatian: • problemi s noktima
English: • Cystitis (burning sensations during urination and frequent, urgent need to urinate).
Croatian: • cistitis (osjećaj pečenja prilikom mokrenja te učestala, hitna potreba za mokrenjem).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘ sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. zanemarive količine natrija.
English: a Values presented are for gefitinib versus placebo.
Croatian: Prikazane su vrijednosti za gefitinib u usporedbi s placebom.
English: Interstitial lung disease (ILD) has occurred in 1.3% of patients, often severe (CTC grade 3-4).
Croatian: Intersticijska bolest pluća (ILD) se javila u 1,3% bolesnika i često je bila teška (CTC stupanj 3 ili 4).
English: In the IPASS trial, gefitinib demonstrated superior PFS, ORR, QoL and symptom relief with no significant difference in overall survival compared to carboplatin/paclitaxel in previously untreated patients, with locally advanced or metastatic NSCLC, whose tumours harboured activating mutations of the EGFR tyrosine kinase.
Croatian: U ispitivanju IPASS, gefitinib se pokazao boljim što se tiče preživljenja bez progresije bolesti, stope objektivnog odgovora, kvalitete života i olakšanja simptoma, dok nije bilo značajne razlike u ukupnom preživljenju u usporedbi s liječenjem karboplatinom/paklitakselom u prethodno neliječenih bolesnika s lokalno uznapredovalim ili metastatskim rakom pluća nemalih stanica, koji imaju tumor s aktivirajućom mutacijom tirozin kinaze EGFR-a.
English: Idifarma Desarrollo Farmacéutico, S.L.
Croatian: Idifarma Desarrollo Farmacéutico, S.L. Polígono Mocholí
English: Table 4 - Quality of life outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study
Croatian: Tablica 4 - Ishodi kvalitete života za gefitinib u usporedbi s karboplatinom/paklitakselom u ispitivanju IPASS
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Croatian: Natrij Ovaj lijek sadržava manje od 1 mmol natrija (23 mg) po tableti, tj. zanemarive količine natrija.
English: Primary endpoint overall survivala,b,c
Croatian: Primarna mjera ishoda: ukupno preživljenjea,b,c
English: Very common Elevations in alanine aminotransferase, mainly mild to moderate.
Croatian: Povišenje vrijednosti alanin aminotransferaze, većinom blago do umjereno
English: • Protein in your urine (shown in a urine test).
Croatian: • proteini u mokraći (u nalazima pretraga mokraće)
English: HR 0.82 [0.70 to 0.96] 18.9 m vs. 17.2 m a b
Croatian: HR 0,82 [0,70 do 0,96] 18,9 m vs 17,2 m a
English: HR Hazard ratio (hazard ratios <1 favour gefitinib).
Croatian: HR Omjer hazarda (omjer hazarda < 1 ide u korist gefitiniba).
English: • Inflammation of the liver.
Croatian: • upala jetre.
English: PVC/PVDC/Aluminium perforated unit dose blister in cartons containing 30x1 film-coated tablets.
Croatian: PVC/PVDC/aluminijski perforirani blister s jediničnim dozama u kutiji s 30x1 filmom obloženom tabletom.
English: How to take Gefitinib Mylan
Croatian: Kako uzimati Gefitinib Mylan
English: Some lung problems may get worse during treatment with Gefitinib Mylan.
Croatian: Neke tegobe s plućima mogu se pogoršati tijekom liječenja lijekom Gefitinib Mylan. - ako ste nekad imali tegoba s jetrom.
English: Each film-coated tablet contains 250 mg of gefitinib.
Croatian: Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
English: 117 Allée des Parcs 69800 Saint-Priest
Croatian: 69800 Saint Priest
English: Table 5 - Efficacy outcomes for gefitinib versus docetaxel from the INTEREST study Population
Croatian: Tablica 5 - Ishodi djelotvornosti za gefitinib u usporedbi s docetakselom u INTEREST ispitivanju
English: a Values presented are for gefitinib versus docetaxel.
Croatian: Prikazane su vrijednosti za gefitinib u usporedbi s docetakselom.
English: Numbers in square brackets are 95% confidence intervals for HR Number of patients randomised.
Croatian: Brojevi u uglatim zagradama predstavljaju 95%-tni interval pouzdanosti za omjer hazarda.
English: Very common Anorexia mild or moderate (CTC grade 1 or 2).
Croatian: Anoreksija blaga ili umjerena (CTC stupanj 1 ili 2)
English: • Fever.
Croatian: • vrućica
English: Odds of EGFR mutation
Croatian: Izgledi za mutaciju EGFR
English: Each tablet contains 161.0 mg of lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom Jedna tableta sadržava 161,0 mg laktoze (u obliku hidrata) Za cjeloviti popis pomoćnih tvari vidjeti dio 6.1.
English: How to store Gefitinib Mylan
Croatian: Kako čuvati Gefitinib Mylan
English: Table 6 Efficacy outcomes for gefitinib versus placebo from the ISEL study Population
Croatian: Tablica 6 - Ishodi djelotvornosti za gefitinib u usporedbi s placebom u ispitivanju ISEL Populacija
English: Values presented are for gefitinib versus carboplatin/paclitaxel.
Croatian: Prikazane su vrijednosti za gefitinib u usporedbi s karboplatinom/paklitakselom.
English: *from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Croatian: 40/235 (17%) žena su M+ 35/551 (6%) muškaraca su M+ *iz sljedećih studija: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
English: Numbers in square brackets are 95%confidence intervals for HR. c Stratified log-rank test for overall; otherwise cox proportional hazards model.
Croatian: Stratificirani log-rank test za ukupno; u protivnom Coxov model proporcionalnih hazarda.
English: Primary endpoint overall survivala,b
Croatian: Primarna mjera ishoda ukupno preživljenjea,b
English: Table 3 - Efficacy outcomes for gefitinib versus carboplatin/paclitaxel from the IPASS study Population
Croatian: Tablica 3 - Ishodi djelotvornosti za gefitinib u usporedbi s karboplatinom/paklitakselom u IPASS ispitivanju
English: Gefitinib Mylan 250 mg film-coated tablets gefitinib
Croatian: Gefitinib Mylan 250 mg filmom obložene tablete gefitinib
English: 30x1 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 30 filmom obloženih tableta 30x1 filmom obložena tableta
English: Gefitinib Mylan contains lactose.
Croatian: Gefitinib Mylan sadrži laktozu.
English: INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin (see section 4.4).
Croatian: U nekih bolesnika koji su istodobno uzimali varfarin prijavljene su povišene vrijednosti INR-a i/ili krvarenja (vidjeti dio 4.4).
English: International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Croatian: U nekih bolesnika koji su zajedno s gefitinibom uzimali varfarin zabilježen je porast međunarodnog normaliziranog omjera (engl. international normalised ratio, INR) i/ili epizode krvarenja (vidjeti dio 4.5).
English: • Red and sore eyelids.
Croatian: • crveni i bolni kapci
English: Progression free survivala,b
Croatian: Preživljenje bez progresije bolestia,b
English: Vomiting, mainly mild or moderate (CTC grade 1 or 2).
Croatian: Povraćanje, većinom blago ili umjereno (CTC stupanj 1 ili 2)
English: Gefitinib Mylan contains sodium
Croatian: Gefitinib Mylan sadrži natrij
English: EGFR mutation-positive
Croatian: Pozitivni na mutaciju EGFR
English: Elevations in aspartate aminotransferase, mainly mild to moderate.
Croatian: Povišenje vrijednosti aspartat aminotransferaze, većinom blago do umjereno Povišenje vrijednosti ukupnog bilirubina, većinom blago do umjereno
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 250 mg of gefitinib.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 250 mg gefitiniba.
English: Proportion of tumour M- that are M- by ctDNA)
Croatian: Udio M- tumora kod kojih je ctDNK bio M
English: Asiansc
Croatian: Azijatic
English: Cutaneous vasculitis
Croatian: Kožni vaskulitis
English: NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg tablets gefitinib
Croatian: NAZIV LIJEKA Gefitinib Mylan 250 mg tablete gefitinib
English: • Dry mouth.
Croatian: Kroz usta.
English: Active substances that may increase gefitinib plasma concentrations In vitro studies have shown that gefitinib is a substrate of p-glycoprotein (Pgp).
Croatian: In vitro ispitivanja pokazala su da je gefitinib supstrat P-glikoproteina (Pgp).
English: smoking, CT scan evidence of reduced normal lung (≤ 50%), pre-existing ILD, older age (≥ 65 years old), and extensive areas adherent to pleura (≥ 50%).
Croatian: Rizik smrtnosti bolesnika u kojih se razvio ILD tijekom liječenja gefitinibom ili kemoterapijom bio je veći u bolesnika sa sljedećim čimbenicima rizika: pušenje, CT-om dokazano smanjenje normalnog plućnog tkiva (≤ 50%), otprije postojeći ILD, starija dob (≥ 65 godina) te opsežne pleuralne priraslice (≥ 50%).
English: Numbers in square brackets are 96% confidence interval for overall survival
Croatian: Brojevi u uglatim zagradama predstavljaju 96%-tni interval pouzdanosti za omjer hazarda za ukupno preživljenje u ukupnoj populaciji, odnosno 95%-tni interval pouzdanosti za omjer hazarda.
English: Gefitinib Mylan contains lactose
Croatian: Gefitinib Mylan sadrži laktozu
English: Nausea, mainly mild (CTC grade 1).
Croatian: Astenija, pretežno blaga (CTC stupanj 1)
English: Medicinal products that cause significant sustained elevation in gastric pH, such as proton-pump inhibitors and h2-antagonists may reduce bioavailability and plasma concentrations of gefitinib and, therefore, may reduce efficacy.
Croatian: Lijekovi koji uzrokuju značajno trajno povišenje želučanog pH, kao što su inhibitori protonske pumpe i antagonisti
English: NAME OF THE MEDICINAL PRODUCT Gefitinib Mylan 250 mg film-coated tablets gefitinib
Croatian: NAZIV LIJEKA Gefitinib Mylan 250 mg filmom obložene tablete
English: B. PACKAGE LEAFLET
Croatian: Tablica 1 - Nuspojave
English: Very common Diarrhoea, mainly mild or moderate (CTC grade 1 or 2).
Croatian: Proljev, većinom blag ili umjeren (CTC stupanj 1 ili
English: FACT-L QoL improvement ratea
Croatian: Stopa poboljšanja kvalitete života prema FACT-La
English: Asiansd
Croatian: Doziranje
English: Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia.
Croatian: Dehidracija kao posljedica proljeva, mučnina, povraćanje ili anoreksija Suha usta*, pretežno blaga (CTC stupanj 1)
English: HR 1.020 [0.905, 1.150]c 7.6 m vs 8.0 m p=0.7332
Croatian: HR 1,020 7,6 m vs 8,0 m p=0,7332
English: The withdrawal letter is available here.
Croatian: Dopis o povlačenju dostupan je ovdje
English: It was to be available as 300 mg tablets.
Croatian: Dostupan je u obliku tableta od 300 mg.
English: EMA/261739/2015 EMEA/H/C/002830
Croatian: 21. svibnja 2015. EMA/386107/2015 EMEA/H/C/002830
English: What is Corluxin?
Croatian: Što je Corluxin?
English: Corluxin was not compared with any other medicine.
Croatian: Corluxin nije uspoređen niti s jednim drugim lijekom.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da povlači zahtjev zbog strateških poslovnih razloga.
English: The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment.
Croatian: Tijekom ispitivanja promatrana su poboljšanja razine šećera u krvi i krvnog tlaka nakon 24 tjedana terapije lijekom Corluxin.
English: On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Croatian: Dana 23. ožujka 2015., tvrtka FGK Representative Service GmbH službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoju zahtjev za odobrenje za stavljanje u promet lijeka Corluxin, za liječenje Cushingovog sindroma.
English: Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Croatian: Povlačenje zahtjeva za odobrenje za stavljanje u promet lijeka Corluxin (mifepriston)
English: The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
Croatian: CHMP je također izrazio zabrinutost u vezi s glavnim ispitivanjem, navodeći, između ostalog, nedostatak usporednog lijeka.
English: Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Croatian: Bolesnici s Cushingovim sindromom mogu patiti od „centripetalnog” povećanja tjelesne težine (zahvaća lice i torzo, no ne i udove), povećanja masnoga tkiva iznad ključne kosti i sa stražnje strane vrata, zaobljenog lica, lakog nastanka modrica, prekomjernog rasta grubih dlaka na licu, slabljenja mišića i kosti, depresije, dijabetesa i povišenog krvnog tlaka.
English: The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition.
Croatian: Podnositelj zahtjeva dostavio je podatke iz glavnog ispitivanja koje je obuhvatilo 50 bolesnika s Cushingovim sindromom koji su imali dijabetes i/ili visoki krvni tlak, dvije najčešće karakteristike tog stanja.
English: The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
Croatian: CHMP je izrazio zabrinutost u vezi s proizvodnjom lijeka, uključujući kontrolu nečistoća i testiranje gotovog lijeka.