FrancophonIA/ELRC3.0 huggingface dataset:
English: Caution should be exercised in patients with low leukocyte and/or neutrophil counts for any reason, in patients receiving medicines known to cause neutropenia, in patients with a history of drug-induced bone marrow depression/toxicity, in patients with bone marrow depression caused by concomitant illness, radiation therapy or chemotherapy and in patients with hypereosinophilic conditions or with myeloproliferative disease.
Slovenian: To velja tudi za bolnike, pri katerih se je v preteklosti pojavilo z zdravili povzročeno zavrto delovanje kostnega mozga ali so prejemali zdravila, toksična za kostni mozeg, pri bolnikih z zavrtim delovanjem kostnega mozga zaradi sočasne bolezni, obsevanja ali kemoterapije ter pri bolnikih s hipereozinofilnimi stanji ali mieloproliferativno boleznijo.
English: 7 film-coated tablets
Slovenian: 7 filmsko obloženih tablet
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/breast enlargement in males
Slovenian: Amenoreja Povečanje dojk Galaktoreja pri ženskah
English: INFORMATION IN BRAILLE Olanzapine 7.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 7,5 mg
English: Skin and subcutaneous tissue disorders Rash
Slovenian: Bolezni kože in podkožja Izpuščaj
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high (≥ 6.2 mmol/l).
Slovenian: 3 Opazovano pri osnovnih normalnih ravneh na tešče (< 5,17 mmol/l), ki so se povišale na visoke (≥ 6,2 mmol/l).
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
Slovenian: 10 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 35 filmsko obloženih tablet 56 filmsko obloženih tablet 70 filmsko obloženih tablet 28 x 1 filmsko obložena tableta
English: Tardive Dyskinesia
Slovenian: Tardivne diskinezije
English: Tel: +33 4 37 25 75 00
Slovenian: Mylan S.A.S Tel: +33 4 37 25 75 00
English: Olanzapine Mylan 2.5 mg, 15 mg and 20 mg is available in packs containing 28 x 1 film-coated tablets.
Slovenian: Zdravilo Olanzapin Mylan 2,5 mg, 15 mg in 20 mg je na voljo v pakiranjih po 28 x 1 filmsko obloženo tableto.
English: Renal and/or hepatic impairment
Slovenian: Okvarjeno delovanje ledvic in/ali jeter
English: INFORMATION IN BRAILLE Olanzapine 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 20 mg
English: 35 film-coated tablets
Slovenian: 35 filmsko obloženih tablet
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNIH OMOTIH ALI DVOJNIH TRAKOVIH
English: Olanzapine Mylan 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine.
Slovenian: Olanzapin Mylan 7,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 7,5 mg olanzapina.
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
Slovenian: 10 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 35 filmsko obloženih tablet 56 filmsko obloženih tablet 70 filmsko obloženih tablet 28 x 1 filmsko obložena tableta 98 x 1 filmsko obloženih tablet
English: Talk to your doctor or pharmacist before you take Olanzapine Mylan.
Slovenian: Pred začetkom jemanja zdravila Olanzapin Mylan se posvetujte z zdravnikom ali farmacevtom.
English: Drug withdrawal syndrome neonatal (see section 4.6)
Slovenian: Odtegnitveni sindrom pri novorojenčk u (glejte poglavje 4.6)
English: 10 film-coated tablets
Slovenian: 10 filmsko obloženih tablet
English: Olanzapine Mylan contains the active substance olanzapine.
Slovenian: Zdravilo Olanzapin Mylan vsebuje zdravilno učinkovino olanzapin.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥ 0.01 % and < 0.1 %) when olanzapine is stopped abruptly.
Slovenian: Redko (≥ 0,01 % in < 0,1 %) so pri nenadni prekinitvi zdravljenja z olanzapinom poročali o akutnih simptomih, kot so znojenje, nespečnost, tresenje, občutek tesnobe, slabost ali bruhanje.
English: • Diabetes
Slovenian: • sladkorno bolezen
English: Pyrexia10
Slovenian: Pireksija10
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (≥ 5.17 mmol/l) were observed commonly.
Slovenian: 15 Pogosto so opazovali spremembe v ravneh celokupnega holesterola na tešče z normalnih osnovnih vrednosti (< 4,39 mmol/l), ki so se povišale na visoke (≥ 5,17 mmol/l).
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olanzapine Mylan.
Slovenian: - Pri bolnikih, ki so jemali zdravilo Olanzapin Mylan, so opazili visoke ravni krvnega sladkorja in visoke ravni maščob (trigliceridov in holesterola).
English: PHARMACEUTICAL FORM Film-coated tablet (tablet).
Slovenian: FARMACEVTSKA OBLIKA filmsko obložena tableta
English: Changes in fasting glucose from borderline at baseline (≥ 5.56-< 7 mmol/l) to high (≥ 7 mmol/l) were very common.
Slovenian: Zelo pogoste so bile spremembe v ravneh glukoze na tešče z mejnih osnovnih vrednosti (≥ 5,56 mmol/l - < 7 mmol/l) na visoke (≥ 7 mmol/l).
English: The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.
Slovenian: Filmska obloga ene 20 mg tablete vsebuje 0,20 mg sojinega lecitina.
English: Restless legs syndrome
Slovenian: Sindrom nemirnih nog
English: INFORMATION IN BRAILLE Olanzapine 2.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 2,5 mg
English: The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.
Slovenian: Filmska obloga ene 7,5 mg tablete vsebuje 0,18 mg sojinega lecitina.
English: Olanzapine Mylan 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine.
Slovenian: Olanzapin Mylan 20 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 20 mg olanzapina.
English: INFORMATION IN BRAILLE Olanzapine 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 15 mg
English: Postural hypotension was infrequently observed in the elderly in olanzapine clinical trials.
Slovenian: V kliničnih preskušanjih olanzapina so pri starejših redko poročali o posturalni hipotenziji.
English: Film-coated tablets
Slovenian: Filmsko obložena 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.
Slovenian: Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 4,39 mmol/l - < 5,17 mmol/l) na visoke (≥ 5,17 mmol/l).
English: EU/1/08/475/006
Slovenian: EU/1/08/475/005 EU/1/08/475/006
English: Each film-coated tablet contains 304 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 304 mg laktoze (kot monohidrat).
English: Each film-coated tablet contains 228 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 228 mg laktoze (kot monohidrat).
English: INFORMATION IN BRAILLE Olanzapine 10 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 10 mg
English: INFORMATION IN BRAILLE Olanzapine 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI olanzapin 5 mg
English: Each film-coated tablet contains 183 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 183 mg laktoze (kot monohidrat).
English: The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.
Slovenian: Filmska obloga ene 10 mg tablete vsebuje 0,24 mg sojinega lecitina.
English: Only take other medicines while you are on Olanzapine Mylan if your doctor tells you that you can. You might feel drowsy if Olanzapine Mylan is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Slovenian: Če jemljete zdravilo Olanzapin Mylan v kombinaciji z zdravili za zdravljenje depresije, zdravili za zdravljenje občutkov tesnobe ali zdravili, ki vam pomagajo spati (pomirjevala), se lahko počutite zaspani.
English: Olanzapine Mylan 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine.
Slovenian: Olanzapin Mylan 2,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 2,5 mg olanzapina.
English: The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.
Slovenian: Filmska obloga ene 2,5 mg tablete vsebuje 0,06 mg sojinega lecitina.
English: EU/1/08/475/024
Slovenian: EU/1/08/475/023 EU/1/08/475/024
English: The metabolism of olanzapine may be induced by smoking.
Slovenian: Kajenje lahko sproži presnavljanje olanzapina.
English: EU/1/08/475/012
Slovenian: EU/1/08/475/011 EU/1/08/475/012
English: BOTTLE LABEL AND CARTON LABEL
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI OZNAKA NA PLASTENKI IN ŠKATLI
English: What Olanzapine Mylan contains
Slovenian: Kaj vsebuje zdravilo Olanzapin Mylan
English: Each film-coated tablet contains 244 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 244 mg laktoze (kot monohidrat).
English: • Seizures
Slovenian: • krče
English: PHARMACEUTICAL FORM AND CONTENTS 35 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Filmsko obložene tablete 100 filmsko obloženih tablet
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.
Slovenian: Olanzapin Mylan 20 mg filmsko obložene tablete 13,4 mm × 7,3 mm, elipsaste, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ 20” na eni strani in “G” na drugi strani.
English: Each film-coated tablet contains 152 mg lactose (as monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 152 mg laktoze (kot monohidrat).
English: Olanzapine Mylan 20 mg are oval-shaped, white film-coated tablets with sides that curve outwards, marked with “OZ 20” on one side and “G” on the other side.
Slovenian: Zdravilo Olanzapin Mylan 20 mg so ovalne, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z“OZ 20” na eni strani in “G” na drugi strani.
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.
Slovenian: Zdravilo Olanzapin Mylan 7,5 mg so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 7.5” na eni strani in “G” na drugi strani.
English: Olanzapine Mylan 7.5 mg film-coated tablets
Slovenian: Olanzapin Mylan 7,5 mg filmsko obložene tablete
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 7,5 mg olanzapina.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Slovenian: Zelo pogoste so bile spremembe v ravneh celokupnega holesterola na tešče z mejnih osnovnih vrednosti (≥ 5,17 mmol/l - < 6,2 mmol/l) na visoke (≥ 6,2 mmol/l).
English: The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.
Slovenian: Filmska obloga ene 15 mg tablete vsebuje 0,15 mg sojinega lecitina.
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Slovenian: 7 Pri nenadni prekinitvi zdravljenja z olanzapinom so poročali o akutnih simptomih kot so znojenje, nespečnost, tresenje, tesnoba, slabost in bruhanje.
English: Olanzapine Mylan 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine.
Slovenian: Olanzapin Mylan 15 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 15 mg olanzapina.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 2.5 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 2,5 mg olanzapina.
English: Discontinuation symptoms7, 12
Slovenian: Nevroleptični maligni sindrom (glejte poglavje 4.4)12 Odtegnitveni simptomi7, 12
English: Olanzapine Mylan 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine.
Slovenian: Olanzapin Mylan 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg olanzapina.
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.
Slovenian: Zdravilo Olanzapin Mylan 2,5 mg, so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 2.5” na eni strani in “G” na drugi strani.
English: Olanzapine Mylan 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine.
Slovenian: Olanzapin Mylan 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg olanzapina.
English: Danmark BGP Products ApS Tlf: +45 28116932
Slovenian: Tlf: +45 28116932
English: Patients with known risk of narrow-angle glaucoma.
Slovenian: Bolniki z ugotovljenim tveganjem za glavkom z zaprtim zakotjem.
English: Olanzapine Mylan 2.5 mg film-coated tablets
Slovenian: Olanzapin Mylan 2,5 mg filmsko obložene tablete
English: The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin.
Slovenian: Filmska obloga ene 5 mg tablete vsebuje 0,12 mg sojinega lecitina.
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.
Slovenian: Zdravilo Olanzapin Mylan 10 mg so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 10” na eni strani in “G” na drugi strani.
English: This will usually pass on its own but if it does not, tell your doctor.
Slovenian: V kolikor ne izzveni spontano, obvestite zdravnika.
English: Olanzapine Mylan 20 mg film-coated tablets
Slovenian: Olanzapin Mylan 20 mg filmsko obložene tablete olanzapin
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.
Slovenian: Olanzapin Mylan 15 mg filmsko obložene tablete 12,2 mm × 6,7 mm, elipsaste, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ 15” na eni strani in “G” na drugi strani.
English: 9.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “7.5” on one side and “G” on the other side.
Slovenian: 9,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “7.5” na eni strani in “G” na drugi strani.
English: Olanzapine Mylan 15 mg are oval-shaped, white film-coated tablets with sides that curve outwards, marked with “OZ 15” on one side and “G” on the other side.
Slovenian: Zdravilo Olanzapin Mylan 15 mg so ovalne, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z“OZ 15” na eni strani in “G” na drugi strani.
English: 8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” on the other side.
Slovenian: 8,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “5” na eni strani in “G” na drugi strani.
English: 7.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “2.5” on one side and “G” on the other side.
Slovenian: 7,0 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “2.5” na eni strani in “G” na drugi strani.
English: 10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and “G” on the other side.
Slovenian: 10,2 mm, okrogle, obojestransko izbočene, bele filmsko obložene tablete z vtisnjeno oznako “OZ” nad “10” na eni strani in “G” na drugi strani.
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Slovenian: Zelo redko (≥ 0.1 % in < 1 %) so poročali o občasnih povezavah med zdravljenjem z olanzapinom in vensko tromboembolijo.
English: Tabulated list of adverse reactions
Slovenian: Tabela neželenih učinkov
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg olanzapine.
Slovenian: NAVEDBA ELE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 20 mg olanzapina.
English: Olanzapine Mylan 10 mg film-coated tablets
Slovenian: Olanzapin Mylan 10 mg filmsko obložene tablete
English: Olanzapine Mylan 5 mg film-coated tablets
Slovenian: Olanzapin Mylan 5 mg filmsko obložene tablete
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 15 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 15 mg olanzapina.
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.
Slovenian: Zdravilo Olanzapin Mylan 5 mg, so okrogle, bele filmsko obložene tablete s stranmi, ki so ukrivljene navzven, označene z “OZ nad 5” na eni strani in “G” na drugi strani.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 5 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 5 mg olanzapina.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg olanzapine.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg olanzapina.
English: Olanzapine Mylan 15 mg film-coated tablets
Slovenian: Olanzapin Mylan 15 mg filmsko obložene tablete olanzapin
English: Bottles
Slovenian: Plastenka
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/052
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/052
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/017
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/017
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/048
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/048
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/029
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/029
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 2.5 mg film-coated tablets olanzapine
Slovenian: Olanzapin Mylan 2,5 mg filmsko obložene tablete olanzapin
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/049
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/049
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 7.5 mg film-coated tablets olanzapine
Slovenian: Olanzapin Mylan 7,5 mg filmsko obložene tablete olanzapin
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/050
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/050
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/047
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/047
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/034
Slovenian: ŠTEVILKA DOVOLJENJA ZA PROMET EU/1/08/475/034
English: General disorders and administration site conditions Asthenia
Slovenian: Splošne težave in spremembe na mestu aplikacije Astenija
English: Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
Slovenian: Pri bolnikih, ki so se zdravili z olanzapinom, so o epileptičnih napadih poročali občasno.
English: Metabolism and nutrition disorders Weight gain1 Elevated cholesterol levels2,3
Slovenian: Presnovne in prehranske motnje Povečanje telesne mase1
English: Patients should be advised not to breast feed an infant if they are taking olanzapine.
Slovenian: Če jemljejo olanzapin, naj se bolnicam dojenje dojenčka odsvetuje.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 10 mg film-coated tablets olanzapine
Slovenian: Olanzapin Mylan 10 mg filmsko obložene tablete olanzapin
English: High Uric Acid10
Slovenian: Visoke vrednosti sečne kisline10
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 5 mg film-coated tablets olanzapine
Slovenian: Olanzapin Mylan 5 mg filmsko obložene tablete olanzapin
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2008
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 23 May 2014
Slovenian: 23. maj 2014
English: The company also presented various supporting analyses and information from a supportive study.
Slovenian: Družba je predstavila tudi različne podporne analize in informacije iz podporne študije.
English: For more information, see here.
Slovenian: Več informacij je na voljo tukaj.
English: In addition, some concerns about the quality of the medicine were not yet resolved.
Slovenian: Poleg tega niso bili razrešeni nekateri zadržki glede kakovosti zdravila.
English: It was to be available as tablets.
Slovenian: Na voljo naj bi bilo v obliki tablet.
English: The main measure of effectiveness was how long the patients survived with their disease.
Slovenian: Glavno merilo učinkovitosti je bil čas preživetja bolnikov z boleznijo.
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.
Slovenian: Čeprav je družba predstavila analize, ki nakazujejo na koristi v podskupini bolnikov z določenimi genetskimi spremembami, povezanimi z agresivnejšo boleznijo, in v podskupini bolnikov z bolečinami, študija ni bila zasnovana za prikaz koristi v teh manjših skupinah, zato je Odbor menil, da bi bila za dokaz te koristi potrebna dodatna študija.
English: This means that it blocks certain enzymes known as tyrosine kinases.
Slovenian: To pomeni, da zavira določene encime, imenovane tirozin-kinaze.
English: The effects of Masiviera were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Masiviera so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: In addition, Masiviera was associated with significant toxicity.
Slovenian: Poleg tega je bilo zdravilo Masiviera povezano s pomembno toksičnostjo.
English: The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer.
Slovenian: Družba je predstavila rezultate ene glavne študije, v katero je bilo vključenih 353 bolnikov z napredovalim ali metastatskim rakom trebušne slinavke.
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.
Slovenian: Med ponovnim pregledom je odbor CHMP znova pregledal podatke družbe, vključno s predlogom za pogojno odobritev pri omejeni skupini bolnikov, in se prav tako posvetoval s skupino strokovnjakov za zdravljenje raka trebušne slinavke.
English: Refusal of the marketing authorisation for Masiviera (masitinib)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Masiviera (masitinib)
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.
Slovenian: Nadalje je imel pomisleke glede kakovosti zdravila, še zlasti glede nečistoč, ki bi jim lahko bili izpostavljeni bolniki, in ali bi bila kakovost komercialnih serij zdravila enaka kakovosti serij, ki so jih uporabili za študije.
English: What is Masiviera?
Slovenian: Kaj je zdravilo Masiviera?
English: By blocking these receptors, Masiviera might help in controlling cell division and thereby slow down the growth of the cancer.
Slovenian: receptorjev lahko zdravilo Masiviera pomaga pri nadzorovanju celične delitve ter s tem upočasni rast raka.
English: It was to be used in combination with another cancer medicine, gemcitabine.
Slovenian: Zdravilo naj bi se uporabljalo v kombinaciji z drugim zdravilom proti raku, tj. gemcitabinom.
English: Refusal of the marketing authorisation for Masiviera (masitinib) EMA/327117/2014
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Masiviera (masitinib) EMA/298222/2014