FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently (seen in ≥ 1 % of patients ) reported adverse reactions associated with the use of olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin, cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness, akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension, anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Danish: De hyppigst rapporterede (set hos ≥ 1 % af patienter) bivirkninger, som blev set i forbindelse med anvendelse af olanzapin i kliniske forsøg, var døsighed og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
English: Changes in total fasting cholesterol levels from borderline at baseline (≥ 5.17-< 6.2 mmol) to high (≥ 6.2 mmol) were very common.
Danish: Ændring i total fastende kolesterolniveau fra let forhøjet niveau ved baseline ( 5,17< 6,2 mmol/l) til højt niveau ( 6,2 mmol/l) var meget almindeligt.
English: Olanzapine Mylan 7.5 mg film-coated tablets Each film-coated tablet contains 7.5 mg olanzapine.
Danish: Olanzapine Mylan 7,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 7,5 mg olanzapin.
English: In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.
Danish: I kliniske forsøg var rapportering af forværret Parkinson symptomatologi og hallucinationer meget almindelig og hyppigere end for placebo (se pkt.
English: INFORMATION IN BRAILLE Olanzapine 2.5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Olanzapine 2,5 mg
English: 10 film-coated tablets
Danish: 10 filmovertrukne tabletter
English: INFORMATION IN BRAILLE Olanzapine 15 mg
Danish: INFORMATION I BRAILLE-SKRIFT Olanzapine 15 mg
English: PHARMACEUTICAL FORM AND CONTENTS 35 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD 100 filmovertrukne tabletter
English: 100 film-coated tablets
Danish: 100 filmovertrukne tabletter
English: Each film-coated tablet contains 76 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 76 mg lactose (som monohydrat).
English: Dystonia (including oculogyration)11
Danish: Dystoni (inklusive okulogyration)11 Tardiv dyskinesi11 Amnesi9
English: Olanzapine Mylan 20 mg film-coated tablets Each film-coated tablet contains 20 mg olanzapine.
Danish: Olanzapine Mylan 20 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 20 mg olanzapin.
English: Lactose monohydrate Maize starch
Danish: Prægelatineret majsstivelse
English: • Seizures
Danish: • Krampeanfald
English: INFORMATION IN BRAILLE Olanzapine 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Olanzapine 10 mg
English: Rhabdomyolysis11
Danish: Rabdomyolyse11
English: INFORMATION IN BRAILLE Olanzapine 5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Olanzapine 5 mg
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Mylan unless your doctor tells you to.
Danish: Din læge vil fortælle dig, hvor mange Olanzapine Mylan tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Olanzapine Mylan er 5-20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Olanzapine Mylan medmindre, at din læge siger det.
English: Each film-coated tablet contains 304 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 304 mg lactose (som monohydrat).
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.
Danish: Inden du påbegynder behandling med Olanzapine Mylan samt jævnligt i løbet af behandlingen, skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
English: Olanzapine Mylan 10 mg film-coated tablets
Danish: Olanzapine Mylan 10 mg filmovertrukne tabletter
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.
Danish: Olanzapine Mylan 20 mg er elipseformede normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ 20” på den ene side og ”G” på den anden side.
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.
Danish: Olanzapine Mylan 7,5 mg er runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ 7,5” på den ene side og ”G” på den anden side.
English: Weight should be monitored regularly, e.g. at baseline, 4, 8 and 12 weeks after starting olanzapine treatment and quarterly thereafter.
Danish: Patienter med diabetes mellitus eller patienter med risikofaktorer for udvikling af diabetes bør monitoreres regelmæssigt for dårligere blodsukkerkontrol.Vægten bør kontrolleres regelmæssigt, f.eks. ved baseline, 4, 8 og 12 uger efter start på olanzapinbehandling og derefter kvartalsvist.
English: Each film-coated tablet contains 228 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 228 mg lactose (som monohydrat).
English: Olanzapine Mylan 2.5 mg film-coated tablets Each film-coated tablet contains 2.5 mg olanzapine.
Danish: Olanzapine Mylan 2,5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 2,5 mg olanzapin.
English: Each film-coated tablet contains 183 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 183 mg lactose (som monohydrat).
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 7.5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 7,5 mg olanzapin.
English: Olanzapine Mylan 2.5 mg film-coated tablets
Danish: Olanzapine Mylan 2,5 mg filmovertrukne tabletter
English: How to take Olanzapine Mylan
Danish: Sådan skal du tage Olanzapine Mylan
English: In a multinational, double-blind, comparative study of schizophrenia, schizoaffective, and related disorders which included 1,481 patients with varying degrees of associated depressive symptoms (baseline mean of 16.6 on the Montgomery-Asberg Depression Rating Scale), a prospective secondary analysis of baseline to endpoint mood score change demonstrated a statistically significant improvement (p=0.001) favouring olanzapine (-6.0) versus haloperidol (-3.1).
Danish: Studiet viste en prospektiv sekundær analyse af ændring i stemningslejeniveauet fra før behandling til endt behandling en statistisk signifikant forbedring (p=0,001) til fordel for patienter behandlet med olanzapin (-6,0) i forhold til patienter behandlet med haloperidol (-3,1).
English: Each film-coated tablet contains 152 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 152 mg lactose (som monohydrat).
English: Each film-coated tablet contains 244 mg lactose (as monohydrate).
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 244 mg lactose (som monohydrat).
English: The film-coating of each 2.5 mg tablet contains 0.06 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,06 mg sojalecithin.
English: Olanzapine Mylan 5 mg film-coated tablets
Danish: Olanzapine Mylan 5 mg filmovertrukne tabletter
English: Olanzapine Mylan 15 mg film-coated tablets Each film-coated tablet contains 15 mg olanzapine.
Danish: Olanzapine Mylan 15 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 15 mg olanzapin.
English: Olanzapine Mylan 10 mg film-coated tablets Each film-coated tablet contains 10 mg olanzapine.
Danish: Olanzapine Mylan 10 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 10 mg olanzapin.
English: Danmark BGP Products ApS Tlf: +45 28116932
Danish: Tlf: +45 28116932
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.
Danish: Olanzapine Mylan 2,5 mg er runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ 2,5” på den ene side og ”G” på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 7.5 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 7,5 mg filmovertrukne tabletter olanzapin
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.
Danish: Olanzapine Mylan 20 mg filmovertrukne tabletter 13,4 mm x 7,3 mm, elipseformede normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ” over ”20” på den ene side og ”G” på den anden side.
English: Olanzapine Mylan 5 mg film-coated tablets Each film-coated tablet contains 5 mg olanzapine.
Danish: Olanzapine Mylan 5 mg filmovertrukne tabletter Hver filmovertrukket tablet indeholder 5 mg olanzapin.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 20 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 20 mg olanzapin.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Danish: Størrelsen af ændringer i faste totalkolesterol, LDL-kolesterol, triglycerider og prolaktin (se pkt.
English: 10.2 mm, round, normal convex, white film-coated tablets debossed “OZ” over “10” on one side and “G” on the other side.
Danish: 10,2 mm, runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ” over ”10” på den ene side og ”G” på den anden side.
English: BATCH NUMBER Batch
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Sedation affected mating performance of male rats.
Danish: Sedation påvirkede parringsevnen hos hanrotter.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 2.5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 2,5 mg olanzapin.
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.
Danish: 9,0 mm, runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ” over ”7.5” på den ene side og ”G” på den anden side.
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.
Danish: Olanzapine Mylan 15 mg er elipseformede, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ 15” på den ene side og ”G” på den anden side.
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.
Danish: 7,0 mm, runde, normal konvekse, hvide , filmovertrukne tabletter mærket med ”OZ” over ”2.5” på den ene side og ”G” på den anden side.
English: 8.0 mm, round, normal convex, white film-coated tablets debossed “OZ” over “5” on one side and “G” on the other side.
Danish: 8,0 mm, runde, normalkonvekse, hvide, filmovertrukne tabletter mærket med ”OZ” over ”5” på den ene side og ”G” på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 2.5 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 2,5 mg filmovertrukne tabletter 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.
Danish: Olanzapine Mylan 15 mg filmovertrukne tabletter 12,2 mm x 6,7 mm, elipseformede, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ” over ”15” på den ene side og ”G” på den anden side.
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.
Danish: Olanzapine Mylan 10 mg er runde, normal konvekse, hvide, filmovertrukne tabletter mærket med ”OZ 10” på den ene side og ”G” på den anden side.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/475/005
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/475/005
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 15 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 15 mg olanzapin.
English: Photosensitivity reaction
Danish: Lysfølsomhedsreak tion
English: The film-coating of each 20 mg tablet contains 0.20 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,20 mg sojalecithin.
English: - The active substance is olanzapine.
Danish: Olanzapine Mylan indeholder: - Aktivt stof: Olanzapin.
English: The film-coating of each 5 mg tablet contains 0.12 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,12 mg sojalecithin.
English: While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking.
Danish: De kan også falde, blive voldsomt trætte, få synsbedrag, forhøjet kropstemperatur, rødme i huden og få besvær med at gå.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 20 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 20 mg filmovertrukne tabletter olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 10 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 10 mg olanzapin.
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 5 mg olanzapine.
Danish: ANGIVELSE AF AKTIVT STOF Hver filmovertrukken tablet indeholder 5 mg olanzapin.
English: The film-coating of each 15 mg tablet contains 0.15 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,15 mg sojalecithin.
English: If you stop taking Olanzapine Mylan
Danish: Hvis du har taget for meget Olanzapine Mylan
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.
Danish: Olanzapine Mylan 5 mg er runde, normalkonvekse, hvide, filmovertrukne tabletter mærket med ”OZ 5” på den ene side og ”G” på den anden side.
English: Amnesia9
Danish: Epistaxis9
English: The film-coating of each 10 mg tablet contains 0.24 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,24 mg sojalecithin.
English: The film-coating of each 7.5 mg tablet contains 0.18 mg soya lecithin.
Danish: Filmovertrækket på 2,5 tabletten indeholder 0,18 mg sojalecithin.
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/052
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/052
English: Management
Danish: Behandling
English: España
Danish: Frankrig
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/049
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/049
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 10 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 10 mg filmovertrukne tabletter olanzapin
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/051
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/051
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 5 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 5 mg filmovertrukne tabletter olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Mylan 15 mg film-coated tablets olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Mylan 15 mg filmovertrukne tabletter olanzapin
English: • Keep this leaflet.
Danish: - Gem indlægssedlen.
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) Filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/047
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/047
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/048
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/048
English: MARKETING AUTHORISATION NUMBER EU/1/08/475/050
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/08/475/050
English: Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712
Danish: Tel: + 34 900 102 712
English: Nervous system disorders Somnolence Dizziness Akathisia6
Danish: Svimmelhed Akatisi6
English: France Mylan S.A.S
Danish: España Mylan Pharmaceuticals, S.L
English: BGP Products UAB Tel: +370 5 205 1288
Danish: Tel: +370 5 205 1288
English: Tabulated list of adverse reactions
Danish: Resumé af bivirkninger i tabelform
English: Drug withdrawal syndrome neonatal (see section 4.6)
Danish: (tabletkerne) lactosemonohydrat (se pkt.
English: In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).
Danish: Olanzapin er indiceret til forebyggelse af tilbagefald af de maniske eller depressive episoder i bipolær lidelse for patienter, hvis maniske episode har responderet på olanzapinbehandling (se pkt.
English: • a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness
Danish: • En kombination af feber, hurtigt åndedræt, svedtendens, muskelstivhed og sløvhed eller søvnighed (hyppigheden af denne bivirkning kan ikke bestemmes ud fra tilgængelige data).
English: Olanzapine Mylan with alcohol
Danish: Olanzapine Mylan.
English: • Prostate problems
Danish: • Problemer med prostata (blærehalskirtlen)
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/475/011
English: Smoking
Danish: Rygning
English: Bottles
Danish: Tabletkerne
English: MARKETING AUTHORISATION NUMBERS EU/1/08/475/023
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/475/023
English: What is Masiviera?
Danish: Hvad er Masiviera?
English: The company that applied for authorisation is AB Science.
Danish: Den virksomhed, der ansøgte om tilladelse, er AB Science.
English: EMA/327117/2014 EMEA/H/C/002659
Danish: Den 23. maj 2014 EMA/298222/2014 EMEA/H/C/002659
English: The company also presented various supporting analyses and information from a supportive study.
Danish: Virksomheden fremlagde desuden forskellige støttende analyser og oplysninger fra en støttende undersøgelse.
English: For more information, see here.
Danish: Yderligere information er her.
English: It was to be available as tablets.
Danish: Det var hensigten, at det skulle leveres som tabletter.
English: The effects of Masiviera were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Masiviera blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: In addition, some concerns about the quality of the medicine were not yet resolved.
Danish: Desuden var der stadig nogle uafklarede problemer om lægemidlets kvalitet.
English: Refusal of the marketing authorisation for Masiviera (masitinib)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masiviera (masitinib)
English: What was Masiviera expected to be used for?
Danish: Hvad forventedes Masiviera anvendt til?
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.
Danish: Hvis du deltager i en klinisk undersøgelse eller i et program for anvendelse med særlig udleveringstilladelse og behøver mere information om din behandling, bedes du kontakte den læge, der giver dig behandlingen.
English: How is Masiviera expected to work?
Danish: Hvordan forventes Masiviera at virke?
English: In addition, Masiviera was associated with significant toxicity.
Danish: Desuden havde Masiviera betydelig giftig virkning.
English: The main measure of effectiveness was how long the patients survived with their disease.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor længe patienterne overlevede med sygdommen.
English: It was to be used in combination with another cancer medicine, gemcitabine.
Danish: Det skulle have været brugt i kombination med et andet kræftmiddel, gemcitabin.
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.
Danish: Den 23. januar 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Masiviera til behandling af fremskreden inoperabel bugspytkirtelkræft.
English: Masiviera is an anticancer medicine that contains the active substance masitinib.
Danish: Masiviera er et kræftlægemiddel, der indeholder det aktive stof 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.
Danish: Derudover havde CHMP betænkeligheder dels ved produktets kvalitet, dels ved de urenheder, som patienterne kunne blive udsat for, og dels ved, om det markedsførte lægemiddel ville have samme kvalitet som det, der var anvendt til undersøgelserne.
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.
Danish: CHMP konkluderede derfor, at fordelene ved Masiviera ikke var større end risiciene, og udvalget fastholdt sin tidligere anbefaling om afslag på ansøgningen om markedsføringstilladelse.
English: Masiviera was compared with placebo (a dummy treatment) as an addition to treatment with gemcitabine.
Danish: Masiviera blev sammenlignet med placebo (virkningsløs behandling) som tillægsbehandling til gemcitabin.
English: The company presented results of one main study involving 353 patients with advanced or metastatic pancreatic cancer.
Danish: Virksomheden fremlagde resultater af én hovedundersøgelse hos 353 patienter med fremskreden metastatisk bugspytkirtelkræft.
English: Refusal of the marketing authorisation for Masiviera (masitinib) EMA/327117/2014
Danish: Afslag på ansøgningen om markedsføringstilladelse for Masiviera (masitinib) EMA/298222/2014
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.
Danish: Masiviera skulle have været anvendt til at behandle voksne med kræft i bugspytkirtlen, der er lokalt fremskreden eller har bredt sig til andre dele af kroppen (er metastatisk), ikke kan opereres og giver smerter af mindst moderat styrke.
English: By blocking these receptors, Masiviera might help in controlling cell division and thereby slow down the growth of the cancer.
Danish: Ved at hæmme disse receptorer skulle Masiviera kunne hæmme celledelingen og dermed bremse kræftens vækst og udbredelse.
English: The active substance in Masiviera, masitinib, is a tyrosine-kinase inhibitor.
Danish: Det aktive stof i Masiviera, masitinib, er en tyrosinkinasehæmmer.
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.
Danish: På tidspunktet for den oprindelige vurdering bemærkede CHMP, at hovedundersøgelsen med Masiviera som helhed ikke viste virkning hos patienter med fremskreden eller metastatisk bugspytkirtelkræft.