FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Mylan and regularly during treatment.
Croatian: Prije početka uzimanja Olanzapine Mylan te redovito tijekom liječenja, liječnik bi Vam trebao obaviti krvne pretrage kako bi provjerio razinu šećera i određenih masnoća u krvi.
English: In cases where hepatitis (including hepatocellular, cholestatic or mixed liver injury) has been diagnosed, olanzapine treatment should be discontinued.
Croatian: Liječenje olanzapinom treba prekinuti u slučajevima kada se dijagnosticira hepatitis (uključujući hepatocelularno, kolestatsko ili miješano oštećenje jetre).
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high (≥ 2.26 mmol/l).
Croatian: Uočeno za početne normalne razine natašte (< 1,69 mmol/l) koje su porasle na visoke razine (≥ 2,26 mmol/l).
English: A lower starting dose of olanzapine should be considered in patients who are using fluvoxamine or any other CYP1A2 inhibitors, such as ciprofloxacin.
Croatian: U bolesnika koji uzimaju fluvoksamin ili bilo koje druge inhibitore CYP1A2, kao što je ciprofloksacin, treba razmotriti primjenu niže početne doze olanzapina.
English: Olanzapine Mylan 2.5 mg, 15 mg and 20 mg is available in packs containing 28 x 1 film-coated tablets.
Croatian: Olanzapine Mylan 2,5 mg, 15 mg i 20 mg dostupan je u pakiranjima s 28 × 1 filmom obloženih tableta.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 4.39-< 5.17 mmol/l) to high (≥ 5.17 mmol/l) were very common.
Croatian: Vrlo česte su bile promjene ukupnih razina kolesterola natašte od graničnih početnih vrijednosti (≥ 4,39-< 5,17 mmol/l) do visokih (≥ 5,17 mmol/l).
English: INFORMATION IN BRAILLE Olanzapine 2.5 mg
Croatian: PISMU Olanzapin 2,5 mg
English: INFORMATION IN BRAILLE Olanzapine 15 mg
Croatian: PISMU Olanzapin 15 mg
English: Metabolism and nutrition disorders Weight gain1 Elevated cholesterol levels2,3
Croatian: Poremećaji metabolizma i prehrane povećanje tjelesne težine1
English: INFORMATION IN BRAILLE Olanzapine 10 mg
Croatian: PISMU Olanzapin 10 mg
English: Skin and subcutaneous tissue disorders Rash
Croatian: Poremećaji kože i potkožnog tkiva osip reakcija fotoosjetljivosti alopecija
English: Olanzapine Mylan 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine.
Croatian: Olanzapine Mylan 7,5 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 7,5 mg olanzapina.
English: Each film-coated tablet contains 76 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 76 mg laktoze (u obliku monohidrata).
English: INFORMATION IN BRAILLE Olanzapine 5 mg
Croatian: PISMU Olanzapin 5 mg
English: 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets 28 x 1 film-coated tablets
Croatian: 10 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 35 filmom obloženih tableta 56 filmom obloženih tableta 70 filmom obloženih tableta 28 × 1 filmom obložena tableta
English: Gastrointestinal disorders Mild, transient anticholinergic effects including constipation and dry mouth
Croatian: Poremećaji probavnog sustava blagi, prolazni antikolinergički učinci uključujući konstipaciju i suha usta distenzija abdomena9 pankreatitis11
English: PHARMACEUTICAL FORM AND CONTENTS 35 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 100 filmom obloženih tableta
English: If you get any side effects, talk to your doctor or pharmacist.
Croatian: Ako imate bilo koji od navedenih simptoma, odmah se obratite svom liječniku ili bolnici.
English: The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 20 mg sadrži 0,20 mg sojinog lecitina.
English: The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 7,5 mg sadrži 0,18 mg sojinog lecitina.
English: There is a risk of feeling drowsy when you are given Olanzapine Mylan.
Croatian: Tijekom uzimanja Olanzapine Mylan postoji rizik da se osjećate pospano.
English: Olanzapine Mylan 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine.
Croatian: Olanzapine Mylan 20 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 20 mg olanzapina.
English: Immune system disorders
Croatian: Poremećaji probavnog sustava
English: 10 film-coated tablets 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets 28 x 1 film-coated tablets 98 x 1 film-coated tablets
Croatian: 10 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 35 filmom obloženih tableta 56 filmom obloženih tableta 70 filmom obloženih tableta 28 × 1 filmom obložena tableta 98 x 1 filmom obložena tableta
English: The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 10 mg sadrži 0,24 mg sojinog lecitina.
English: Component of a multipack, not to be sold separately.
Croatian: OBLIK I SADRŽAJ 35 filmom obloženih tableta Dio multipakiranja, ne smije se prodavati zasebno.
English: Each film-coated tablet contains 228 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 228 mg laktoze (u obliku monohidrata).
English: Each film-coated tablet contains 183 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 183 mg laktoze (u obliku monohidrata).
English: Each film-coated tablet contains 304 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 304 mg laktoze (u obliku monohidrata).
English: Olanzapine Mylan 7.5 mg film-coated tablets
Croatian: Olanzapine Mylan 7,5 mg filmom obložene tablete olanzapin
English: The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 2,5 mg sadrži 0,06 mg sojinog lecitina.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 7,5 mg olanzapina.
English: Seizures
Croatian: Pretrage
English: Olanzapine Mylan 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine.
Croatian: Olanzapine Mylan 2,5 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 2,5 mg olanzapina.
English: Tel: + 39 02 612 46921
Croatian: Mylan Italia S.r.l Tel: + 39 02 612 46921
English: Each film-coated tablet contains 152 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 152 mg laktoze (u obliku monohidrata).
English: Each film-coated tablet contains 244 mg lactose (as monohydrate).
Croatian: Svaka filmom obložena tableta sadrži 244 mg laktoze (u obliku monohidrata).
English: Neutropenia10
Croatian: trombocitopenija11
English: The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 15 mg sadrži 0,15 mg sojinog lecitina.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 20 mg olanzapina.
English: Hypersensitivity11
Croatian: Poremećaji imunološkog sustava preosjetljivost11
English: Tardive Dyskinesia
Croatian: Moguće nuspojave
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 2.5 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 2,5 mg olanzapina.
English: Olanzapine Mylan 20 mg film-coated tablets
Croatian: Olanzapine Mylan 20 mg filmom obložene tablete
English: • Seizures
Croatian: • Napadaji
English: Olanzapine Mylan 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine.
Croatian: Olanzapine Mylan 15 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 15 mg olanzapina.
English: Olanzapine Mylan 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine.
Croatian: Olanzapine Mylan 10 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 10 mg olanzapina.
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/breast enlargement in males
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija u muškaraca smanjen libido u muškaraca i žena amenoreja povećanje dojki galaktoreja u žena ginekomastija/povećanj e dojki u muškaraca prijapizam12
English: Olanzapine Mylan 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine.
Croatian: Olanzapine Mylan 5 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 5 mg olanzapina.
English: Olanzapine Mylan 7.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 7.5” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 7,5 mg su okrugle, konveksne, bijele filmom obložene tablete veličine 9,0 mm na kojima je s jedne strane utisnuta oznaka „OZ” iznad „7.5”, a s druge „G”.
English: The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin.
Croatian: Film ovojnica svake tablete od 5 mg sadrži 0,12 mg sojinog lecitina.
English: MARKETING AUTHORISATION NUMBERS
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Olanzapine Mylan 15 mg film-coated tablets
Croatian: Olanzapine Mylan 15 mg filmom obložene tablete
English: Neuroleptic malignant syndrome (see section
Croatian: dizartrija mucanje11 sindrom nemirnih nogu neuroleptički maligni sindrom (vidjeti dio 4.4)12
English: Olanzapine Mylan 2.5 mg film-coated tablets
Croatian: Olanzapine Mylan 2,5 mg filmom obložene tablete olanzapin
English: Olanzapine Mylan 10 mg film-coated tablets
Croatian: Olanzapine Mylan 10 mg filmom obložene tablete olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 10 mg olanzapina.
English: 13.4 mm x 7.3 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 20” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 20 mg su ovalne, konveksne, bijele filmom obložene veličine 13,4 mm × 7,3 mm tablete na kojima je s jedne strane utisnuta oznaka „OZ 20”, a s druge „G”.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 5 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 5 mg olanzapina.
English: Olanzapine Mylan 5 mg film-coated tablets
Croatian: Olanzapine Mylan 5 mg filmom obložene tablete olanzapin
English: Olanzapine Mylan 2.5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 2.5” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 2,5 mg su okrugle, konveksne, bijele filmom obložene tablete veličine 7,0 mm na kojima je s jedne strane utisnuta oznaka „OZ” iznad „2.5”, a s druge „G”.
English: Increased total bilirubin
Croatian: povišen ukupni bilirubin visoka razina mokraćne kiseline10
English: METHOD AND ROUTE OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT PRIMJENE LIJEKA Za primjenu kroz usta.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 15 mg olanzapine.
Croatian: NAVOĐENJE DJELATNE TVARI Svaka filmom obložena tableta sadrži 15 mg olanzapina.
English: Renal and/or hepatic impairment
Croatian: Oštećenje bubrega i/ili jetre
English: • Prostate problems
Croatian: • Tegobe s prostatom
English: Glucosuria
Croatian: Blisteri
English: 12.2 mm x 6.7 mm, ellipse-shaped, normal convex, white film-coated tablets debossed “OZ 15” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 15 mg su ovalne, konveksne, bijele filmom obložene veličine 12,2 mm × 6,7 mm tablete na kojima je s jedne strane utisnuta oznaka „OZ 15”, a s druge „G”.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 20 mg film-coated tablets olanzapine
Croatian: Olanzapine Mylan 20 mg filmom obložene tablete olanzapin
English: Bottles
Croatian: Boce:
English: Olanzapine Mylan 10 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 10” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 10 mg su okrugle, konveksne, bijele filmom obložene tablete veličine 10,2 mm na kojima je s jedne strane utisnuta oznaka „OZ” iznad „10”, a s druge „G”.
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Croatian: U kliničkim ispitivanjima olanzapina, posturalna hipotenzija nije bila često uočena u starijih bolesnika.
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/052
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/052
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/051
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/051
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/023
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/023
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/011
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/029
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/029
English: Olanzapine Mylan 5 mg are round, white film-coated tablets with sides that curve outwards, marked with “OZ over 5” on one side and “G” on the other side.
Croatian: Olanzapine Mylan 5 mg su okrugle, konveksne, bijele filmom obložene tablete veličine 8,0 mm na kojima je s jedne strane utisnuta oznaka „OZ” iznad „5”, a s druge „G”.
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/017
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/475/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/005
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/049
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/049
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/048
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/048
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/034
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/034
English: 28 x 1 film-coated tablets 56 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets
Croatian: 10 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 35 filmom obloženih tableta 56 filmom obloženih tableta 70 filmom obloženih tableta 28 × 1 filmom obložena tableta 56 × 1 filmom obložena tableta 98 x 1 filmom obložena tableta 100 × 1 filmom obložena tableta
English: 250 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 250 filmom obloženih tableta 500 filmom obloženih tableta
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 15 mg film-coated tablets olanzapine
Croatian: Olanzapine Mylan 15 mg filmom obložene tablete olanzapin
English: Smoking
Croatian: Pušenje
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/047
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/047
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness
Croatian: • kombinaciju vrućice, ubrzanog disanja, znojenja, ukočenosti mišića i omamljenosti ili pospanosti (učestalost ove nuspojave ne može se procijeniti iz dostupnih podataka).
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/050
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/475/050
English: For more information, see here.
Croatian: Za više informacija pogledajte ovdje.
English: What is Masiviera?
Croatian: Što je Masiviera?
English: The applicant requested a re-examination of the opinion.
Croatian: Podnositelj zahtjeva zahtijevao je ponovno ispitivanje mišljenja.
English: In addition, some concerns about the quality of the medicine were not yet resolved.
Croatian: Osim toga, još uvijek nisu riješene neke bojazni oko kvalitete lijeka.
English: The company that applied for authorisation is AB Science.
Croatian: Tvrtka koja je podnijela zahtjev je AB Science.
English: The company also presented various supporting analyses and information from a supportive study.
Croatian: Tvrtka je također dostavila različite pomoćne analize i informacije iz pomoćnog ispitivanja.
English: This means that it blocks certain enzymes known as tyrosine kinases.
Croatian: To znači da blokira određene enzime poznate kao tirozin kinaze.
English: It was to be available as tablets.
Croatian: Trebao je biti dostupan u obliku tableta.
English: The main measure of effectiveness was how long the patients survived with their disease.
Croatian: Glavna mjera djelotvornosti bilo je vrijeme koje je bolesnik preživio uz bolest.
English: It was to be used in combination with another cancer medicine, gemcitabine.
Croatian: Trebao se koristiti u kombinaciju s drugim lijekom protiv karcinoma, gemcitabinom.
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u kliničkom istraživanju ili u programu milosrdnog davanja lijeka te vam je potrebno više informacija o terapiji, obratite se liječniku koji vas liječi.
English: Although the company presented analyses suggesting that there was a benefit in a subgroup of patients with certain genetic changes associated with more aggressive disease, and in a subgroup of patients with pain, the study was not designed to show benefit in these smaller groups, and the Committee considered that further study would be needed to demonstrate such a benefit.
Croatian: Iako je tvrtka prikazala analize koje ukazuju da je postojala korist u podskupini bolesnika s određenim genetičkim promjenama povezanim s agresivnijom bolešću te u podskupini bolesnika koja je trpjela bol, ispitivanje nije osmišljeno kako bi pokazalo korist u tim manjim skupinama i Povjerenstvo je smatralo da će biti potrebna daljnja ispitivanja kako bi se dokazala takva korist.
English: In addition, Masiviera was associated with significant toxicity.
Croatian: Pored toga, lijek Masiviera povezan je sa značajnom toksičnošću.
English: Refusal of the marketing authorisation for Masiviera (masitinib)
Croatian: Odbijanje zahtjeva za odobrenje za stavljanje u promet lijeka Masiviera (masitinib)
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ovo odbijanje zahtjeva ima za bolesnike u kliničkim istraživanjima ili programima milosrdnog davanja lijeka?
English: What were the CHMP's main concerns that led to the refusal?
Croatian: Koja su glavna razmatranja CHMP dovela do odbacivanja zahtjeva?
English: By blocking these receptors, Masiviera might help in controlling cell division and thereby slow down the growth of the cancer.
Croatian: Blokadom ovih receptora Masiviera može pomoći u kontroli diobe stanica i tako usporiti rast karcinoma.
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 uporišta ovog zahtjeva, CHMP je ponovno pregledao početno mišljenje i potvrdio odbijanje odobrenja za stavljanje lijeka u promet 22. svibnja 2014.
English: Masiviera was expected to be used to treat adults with cancer of the pancreas (an organ of the digestive system) that is locally advanced or metastatic (has spread to other parts of the body), nonresectable (unsuitable for surgery) and is accompanied by at least moderate pain.
Croatian: Očekivalo se da će se Masiviera koristiti za liječenje odraslih bolesnika s karcinomom pankreasa (organa probavnog sustava) koji je lokalno uznapredovao ili metastatskog karcinoma (koji se proširio na druge dijelove tijela), neresektabilnog (neprikladnog za kirurški zahvat) te koji je popraćen barem umjerenom boli.
English: Refusal of the marketing authorisation for Masiviera (masitinib) EMA/327117/2014
Croatian: Odbijanje zahtjeva za odobrenje za stavljanje u promet lijeka Masiviera (masitinib) EMA/298222/2014
English: The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer.
Croatian: Tvrtka je dostavila rezultate jednog glavnog ispitivanja koje je uključivalo 353 bolesnika s uznapredovalim ili metastatskim karcinomom pankreasa.
English: Furthermore, the CHMP had concerns about the quality of the product, in particular about the impurities to which patients might be exposed and about whether commercial batches of the medicine would have the same quality as those used for the studies.
Croatian: Nadalje, CHMP je izrazio bojazan u pogledu kvalitete lijeka, posebice u vezi nečistoća kojima bi bolesnici mogli biti izloženi i o tome hoće li komercijalne serije lijeka imati istu kvalitetu kao i one korištene u ispitivanju.
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 Masiviera, intended for the treatment of advanced inoperable pancreatic cancer.
Croatian: Dana 23. siječnja 2014. godine, Povjerenstvo za humane lijekove (CHMP) usvojilo je negativno mišljenje i preporučilo odbijanje odobrenja za stavljanje u promet lijeka Masiviera koji je namijenjen za liječenje uznapredovalog, neoperabilnog karcinoma pankreasa.
English: Therefore, the CHMP concluded that the benefits of Masiviera did not outweigh its risks and maintained the previous recommendation that the medicine be refused marketing authorisation.
Croatian: Stoga je CHMP zaključio da koristi lijeka Masiviera nisu nadmašile njegove rizike te je zadržao prethodnu preporuku o odbijanju odobrenja za stavljanje lijeka u promet.
English: During the re-examination the CHMP looked again at the data from the company, including a proposal for a conditional authorisation in a restricted group of patients, and also consulted a group of experts in the treatment of pancreatic cancer.
Croatian: Tijekom ponovnog ispitivanja CHMP je ponovno pregledao tvrtkine podatke uključujući i prijedlog za uvjetno odobrenje u ograničenoj skupini bolesnika te se također konzultirao sa skupinom stručnjaka za liječenje karcinoma pankreasa.
English: The active substance in Masiviera, masitinib, is a tyrosine-kinase inhibitor.
Croatian: Djelatna tvar u lijeku Masiviera, masitinib, je inhibitor tirozin kinaze.
English: Masitinib was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 28 October 2009 for the treatment of pancreatic cancer.
Croatian: Masitinibu je dodijeljen status „lijeka siročeta” (lijeka za liječenje rijetkih bolesti) 28. listopada 2009. godine za liječenje karcinoma gušterače.
English: At the time of the initial evaluation, the CHMP noted that the results of the main study with Masiviera did not show effectiveness in the overall group of patients with advanced or metastatic pancreatic cancer.
Croatian: U vrijeme početne procjene, CHMP je zabilježio da rezultati glavnog ispitivanja lijeka Masiviera nisu pokazali djelotvornost u ukupnoj skupini bolesnika s uznapredovalim ili metastatskim karcinomom pankreasa.
English: The Committee confirmed its opinion that the effectiveness of Masiviera had not been sufficiently demonstrated in pancreatic cancer.
Croatian: Povjerenstvo je potvrdilo svoje mišljenje da djelotvornost lijeka Masiviera nije dostatno dokazana u bolesnika s karcinomom pankreasa.
English: Masiviera was compared with placebo (a dummy treatment) as an addition to treatment with gemcitabine.
Croatian: Masiviera je uspoređena s placebom (liječenje bez djelatne tvari) kao dodatak liječenju gemcitabinom.
English: Masiviera is an anticancer medicine that contains the active substance masitinib.
Croatian: Masiviera je lijek protiv karcinoma koji sadrži djelatnu tvar masitinib.
English: The effects of Masiviera were first tested in experimental models before being studied in humans.
Croatian: Prije ispitivanja na ljudima, učinci lijeka Masiviera prvo su ispitani na eksperimentalnim uzorcima.