FrancophonIA/ELRC3.0 huggingface dataset:
English: Anticholinergic activity While olanzapine demonstrated anticholinergic activity in vitro, experience during the clinical trials revealed a low incidence of related events.
Danish: Antikolinerg aktivitet Selvom olanzapin udviste antikolinerg aktivitet in vitro, frembød kliniske studier en lav forekomst af dertil relaterede hændelser.
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16
Danish: Meget almindelig: Nedsat total bilirubin, forhøjet GGT, forhøjedt plasmaprolaktin16
English: Reversible neutropenia, thrombocytopenia, or anemia developed in a few dogs treated with 8 or 10 mg/kg/day (total olanzapine exposure [AUC] is 12- to 15-fold greater than that of a man given a 12-mg dose).
Danish: Reversibel neutropeni, trombocytopeni eller anæmi udvikledes hos enkelte hunde, som blev behandlet med 8 eller 10 mg/kg/dag (total olanzapin dosis (AUC) var 12-15 gangehøjere end human dosis på 12 mg).
English: In an 18-month co-therapy study in manic or mixed episode patients stabilised with olanzapine plus a mood stabiliser (lithium or valproate), long-term olanzapine co-therapy with lithium or valproate was not statistically significantly superior to lithium or valproate alone in delaying bipolar recurrence, defined according to syndromic (diagnostic) criteria.
Danish: I et 18 måneders co-terapi studie af maniske eller blandede episoder hos patienter stabiliseret med olanzapin samt en stemningsstabilisator (lithium eller valproat), viste langtids olanzapin co-terapi med lithium eller valproat sig ikke statistisk signifikant overlegen overfor lithium eller valproat alene i forsinkelse bipolære tilbagefald, defineret i overensstemmelse med det syndromiske (diagnostiske) kriterium..
English: Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term-exposure (at least 48 weeks) were very common (64.4 %, 31.7 % and 12.3 % respectively).
Danish: Patienter med vægtøgning på ≥ 7 %, ≥ 15 % og ≥25 % af baseline kropsvægt ved langvarig eksponering (mindst 48 uger) var meget almindelig (henholdsvis 64,4 %, 31,7% og 12,3%).
English: Mild, transient anticholinergic effects including constipation and dry mouth
Danish: Lette forbigående antikolinerge virkninger, herunder forstoppelse og mundtørhed
English: 13 Following short term treatment (median duration 22 days), weight gain ≥ 7 % of baseline body weight (kg) was very common (40.6 %), ≥ 15 % of baseline body weight was common (7.1 %) and ≥ 25 % was common (2.5 %).
Danish: 13 Efter kortvarig behandling (gennemsnitlig varighed 22 dage), var øget vægt ≥ 7 % af baseline legemsvægt (kg) meget almindelig (40,6%), ≥ 15 % af baseline legemsvægt var almindelig (7,1%) og ≥ 25% var almindelig (2,5%).
English: Ventricular tachycardia/fibrillation, sudden death (see section
Danish: Ventrikulær takykardi/ventri kel-flimren Pludselig død (se pkt.
English: • Restless legs syndrome
Danish: • Restless legs-syndrom (stærk uro i underbenene)
English: Do not drink any alcohol if you have been given Olanzapine Glenmark Europe as together with alcohol it may make you feel drowsy.
Danish: Brug af Olanzapine Glenmark Europe sammen med alkohol Drik ikke nogen form for alkohol, når du får Olanzapine Glenmark Europe, da det sammen med alkohol kan gøre dig døsig.
English: 20 mg olanzapine - The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),
Danish: Øvrige indholdstoffer er mannitol (E 421), mikrokrystallinsk cellulose, aspartam (E 951), crospovidon, magnesiumstearat.
English: What you need to know before you take Olanzapine Glenmark Europe
Danish: Det skal du vide, før du begynder at tage Olanzapine Glenmark Europe
English: 15 Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high
Danish: 15 Ændringer i de totale kolesterolniveauer ved faste fra normale ved baseline (< 4.39 mmol/l) op til (≥
English: Increased appetite
Danish: Glukosuri Øget appetite
English: 3 Observed for fasting normal levels at baseline (< 5.17 mmol/l) which increased to high
Danish: 3Observeret for fastende normalt niveau ved baseline (< 5,17 mmol/l), der blev øget til højt niveau
English: • Urinary incontinence, lack of ability to urinate.
Danish: • Ufrivillig vandladning (urininkontinens); vandladningsbesvær.
English: In preclinical studies, olanzapine exhibited a range of receptor affinities (Ki< 100 nM) for serotonin 5 HT2A/2C, 5 HT3, 5 HT6; dopamine D1, D2, D3, D4, D5; cholinergic muscarinic receptors M1-M5; α 1 adrenergic; and histamine H1 receptors.
Danish: I prækliniske studier udviste olanzapin affinitet (Ki < 100 nM) til serotonin 5 HT2A/2C, 5 HT3, 5 HT6, dopamin D1, D2, D3, D4, D5, kolinerge muskarine receptorer M1-M5, á1 -adrenerge og histamin H1 receptorer.
English: Amenorrhea Breast enlargement Galactorrhea in females Gynaecomastia/breast enlargement in males
Danish: Amenorré Brystforstørrelse Galaktorré hos kvinder Gynækomasti/brys tfor-størrelse hos mænd
English: You should not be given this medicine when breast-feeding, as small amounts of Olanzapine Glenmark Europe can pass into breast milk.
Danish: Du bør ikke anvende denne medicin under graviditet, medmindre du har talt med din læge om det. Du bør ikke få denne medicin, mens du ammer, da små mængder Olanzapine Glenmark Europe kan overføres til modermælken.
English: Photosensitivity reaction
Danish: Lysfølsomhedsrea ktion
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.
Danish: Akutte symptomer såsom perspiration, søvnløshed, rysten, angst, kvalme eller opkastning er rapporteret sjældent (≥ 0,01 % og < 0,1 %) når olanzapin stoppes pludseligt.
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % versus 1.5 %, respectively).
Danish: I placebokontrollerede kliniske forsøg (af 6-12 ugers varighed) med ældre patienter (gennemsnitlig alder 78 år) med demensrelateret psykose og/eller adfærdsforstyrrelse var der en dobbelt s å høj forekomst af dødsfald hos de olanzapinbehandlede patienter i forhold til de placebobehandlede patienter (henholdsvis 3,5 % og 1,5 %).
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to <
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10).
English: The frequency terms listed are defined as follows: Very common (≥ 1/10 ), common (≥ 1/100 to<
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥1/100 til < 1/10).
English: 14 Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (≥ 1.467
Danish: 14 Observerede normalniveauer ved faste ved baseline (< 1.016 mmol/l, som steg til (≥ 1.467 mmol/l)
English: In healthy elderly (65 and over) versus non-elderly subjects, the mean elimination half-life was prolonged (51.8 versus 33.8 hr) and the clearance was reduced (17.5 versus 18.2 l/hr).
Danish: Hos raske ældre forsøgspersoner ( 65 år) versus ikke-ældre var den gennemsnitlige eliminationshalveringstid forlænget (51,8 versus 33,8 timer) og clearance var reduceret (17,5 versus 18,2 l/time).
English: Fatigue Oedema Pyrexia10
Danish: Asteni Træthed Ødemer Pyreksi10
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glenmark Arzneimittel GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Glenmark Arzneimittel GmbH 3.
English: How to take Olanzapine Glenmark Europe
Danish: Sådan skal du tage Olanzapine Glenmark Europe
English: 70 orodispersible tablets
Danish: 28 orodispergible tabletter 56 orodispergible tabletter 70 orodispergible tabletter
English: Hepatobiliary disorders Transient, asymptomatic elevations of hepatic aminotransferases (ALT, AST), especially in early treatment (see section 4.4)
Danish: Forbigående, asymptomatisk forhøjede leveraminotransfer aser (ALAT, ASAT), særlig initialt i behandlingen (se pkt.
English: Investigations Elevated plasma prolactin levels8
Danish: Forhøjede plasmaprolaktinniveauer8
English: What Olanzapine Glenmark Europe is and what it is used for What you need to know before you take Olanzapine Glenmark Europe How to take Olanzapine Glenmark Europe Possible side effects
Danish: Det skal du vide, før du begynder at tage Olanzapine Glenmark Europe Sådan skal du tage Olanzapine Glenmark Europe Bivirkninger
English: What Olanzapine Glenmark Europe contains
Danish: Olanzapine Glenmark Europe indeholder:
English: mmol/l) and changes in fasting triglycerides from borderline at baseline (≥ 1.016 mmol/l - < 1.467 mmol/l) to high (≥ 1.467 mmol/l).
Danish: og ændringer i triglycerider ved faste fra grænser ved baseline (≥ 1.016 mmol/l - < 1.467 mmol/l) op til (≥ 1.467 mmol/l).
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 forbindelsemed anvendelse af olanzapin i kliniske forsøg, var døsighed og vægtøgning, eosinofili, forhøjede niveauer af prolaktin, kolesterol, glucose og triglycerider (se pkt.
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section
Danish: Udvikling eller forværring af diabetes lejlighedsvist sammen med ketoacidose eller koma, heriblandt dødelige tilfælde (se
English: Discontinuation symptoms7, 12
Danish: Abstinenssymptom er712
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 20 mg olanzapine
Danish: Hver orodispergible tablet indeholder 20 mg olanzapin
English: Yellow coloured circular flat bevelled edge tablets with ‘B' debossed on one side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'B' præget på den ene side.
English: Amenorrhea Breast enlargement Galactorrhea in females
Danish: Brystforstørrelse Galaktorré hos kvinder
English: Excipient with known effect: Each orodispersible tablet contains 0.23 mg of aspartame For the full list of excipients, see section 6.1
Danish: Hver orodispergible tablet indeholder 0,23 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Urinary incontinence, urinary retention
Danish: Urininkontinens, Urinretention Vandladningsbesvæ r11
English: Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine Glenmark Europe and regularly during treatment.
Danish: Inden du påbegynder behandling med Olanzapine Glenmark Europe samt jævnligt i løbet af behandlingen skal din læge tage blodprøver for at kontrollere indholdet af sukker og fedt i dit blod.
English: Thromboembolism
Danish: Trombocytopeni
English: INFORMATION IN BRAILLE Olanzapine Glenmark Europe 15 mg orodispersible tablets 17.
Danish: INFORMATION I BRAILLE-SKRIFT Olanzapine Glenmark Europe 15 mg orodispergible tabletter.
English: You can also place the tablet in a full glass or cup of water or other suitable beverage (orange juice, apple juice, milk or coffee) and stir.
Danish: Den vil blive opløst med det samme i munden, så du let kan synke den. Du kan også lægge tabletten i et glas vand, appelsinjuice, æblejuice eller mælk eller i en kop kaffe.
English: Olanzapine Glenmark Europe 20 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Olanzapine Glenmark Europe 20 mg: leveres som gule, cirkulære orodispergible tabletter med flad afrundet kant med 'OL' præget på den ene side og F præget på den anden side.
English: Rare side effects (may affect up to 1 in 1000 people) include:
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter) omfatter.
English: • Sleepiness
Danish: • ledsmerter
English: Olanzapine Glenmark Europe 10 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘D' debossed on other side.
Danish: Olanzapine Glenmark Europe 10 mg: leveres som gule, cirkulære orodispergible tabletter med flad afrundet kant med 'OL' præget på den ene side og 'D' præget på den anden side.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I PRODUKTRESUM E
English: - The active substance is olanzapine - Each Olanzapine Glenmark Europe orodispersible tablet contains, 5 mg, 10 mg, 15 mg, or
Danish: Hver Olanzapine Glenmark Europe orodispergible tablet indeholder enten 5 mg, 10 mg, 15 mg eller 20 mg olanzapin.
English: Other medicines and Olanzapine Glenmark Europe Only take other medicines while you are on Olanzapine Glenmark Europe if your doctor tells you that you can. You might feel drowsy if Olanzapine Glenmark Europe is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).
Danish: Du kan komme til at føle dig døsig, hvis Olanzapine Glenmark Europe tages sammen med depressionsmidler eller medicin til behandling af angst eller søvnløshed (sovepiller).
English: Development or exacerbation of diabetes occasionally associated with ketoacidosis or coma, including some fatal cases (see section 4.4)
Danish: Udvikling eller forværring af diabetes lejlighedsvist sammen med ketoacidose eller koma, heriblandt dødelige tilfælde (se pkt.
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Glenmark Europe unless your doctor tells you to.
Danish: Brug af anden medicin sammen med Olanzapine Glenmark Tag kun anden medicin sammen med Olanzapine Glenmark Europe, hvis din læge siger, at du må.
English: Olanzapine Glenmark Europe 15 mg: yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Olanzapine Glenmark Europe 15 mg: leveres som gule, cirkulære orodispergible tabletter med flad afrundet kant med 'OL' præget på den ene side og E præget på den anden side.
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘D' debossed on one side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og 'D' præget på den anden side.
English: Olanzapine Glenmark Europe with alcohol
Danish: Olanzapine Glenmark Europe indeholder aspartam
English: If you forget to take Olanzapine Glenmark Europe Take your tablets as soon as you remember.
Danish: Hvis du har glemt at tage Olanzapine Glenmark Europe Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
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: EU/1/09/588/001 EU/1/09/588/002
Danish: EU/1/09/588/001 EU/1/09/588/002 EU/1/09/588/003
English: Yellow coloured circular flat bevelled edge tablets with ‘OL' debossed on one side and ‘E' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og E præget på den anden side.
English: Your doctor will tell you how many Olanzapine Glenmark Europe orodispersible tablets to take and how long you should continue to take them.
Danish: Din læge vil fortælle dig, hvor mange Olanzapine Glenmark Europe orodispergible tabletter, du skal tage og i hvor lang tid, du skal tage dem. Dagsdosis for Olanzapine Glenmark Europe orodispergible tabletter er mellem 5mg og 20 mg. Konsulter din læge, hvis dine symptomer vender tilbage, men stop ikke med at tage Olanzapine Glenmark Europe medmindre, din læge siger det.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark Europe 5 mg orodispergible tabletter Olanzapin 2.
English: PHARMACEUTICAL FORM AND CONTENTS Orodispersible tablet
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE)
English: Systemic Symptoms (DRESS)
Danish: Lægemiddelfremka ldt reaktion med eosinofili og systemiske symptomer (DRESS) (hyppighed ikke kendt)
English: Olanzapine Glenmark Europe 20 mg orodispersible tablets Olanzapine
Danish: Olanzapine Glenmark Europe 20 mg orodispergible tabletter
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 10 mg olanzapine.
Danish: Hver orodispergible tablet indeholder 10 mg olanzapin
English: The frequency terms listed are defined as follows: Very common (≥ 1/10), common (≥ 1/100 to <1/ 10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the data available).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000til < 1/100), sjælden (≥1/10.000til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Olanzapine Glenmark Europe 5 mg orodispersible tablets Olanzapine
Danish: Olanzapine Glenmark Europe 5 mg orodispergible tabletter
English: The frequency terms listed are defined as follows: Very common (≥1/10), common (≥ 1/100 to < 1/10 %), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the data available).
Danish: Hyppighederne er defineret som følgende: Meget almindelig (≥ 1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til 1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Olanzapine Glenmark Europe 15 mg orodispersible tablets Olanzapine
Danish: Olanzapine Glenmark Europe 15 mg orodispergible tabletter
English: Yellow coloured circular flat bevelled edge with ‘OL' debossed on one side and ‘F' debossed on other side.
Danish: Gule, cirkulære tabletter med flad afrundet kant med 'OL' præget på den ene side og F præget på den anden side.
English: Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine
Danish: Olanzapine Glenmark Europe 10 mg orodispergible tablette
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 15 mg olanzapine.
Danish: Hver orodispergible tablet indeholder 15 mg olanzapin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 20 mg olanzapine Excipient with known effect: Each orodispersible tablet contains 0.92 mg of aspartame For the full list of excipients, see section 6.1
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver orodispergible tablet indeholder 20 mg olanzapin Hjælpestof som behandleren skal være opmærksom på:
English: phosphokinase11
Danish: Trombocytop eni11
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each orodispersible tablet contains 5 mg olanzapine.
Danish: Hver orodispergible tablet indeholder 5 mg olanzapin
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg olanzapine Excipient with known effect: Each orodispersible tablet contains 0.46 mg of aspartame For the full list of excipients, see section 6.1
Danish: Hver orodispergible tablet indeholder 0,46 mg aspartam Alle hjælpestoffer er anført under pkt.6.1
English: Olanzapine Glenmark Europe is used to treat the following conditions:
Danish: Olanzapine Glenmark Europe 5 mg leveres som:
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Glenmark Europe 10 mg orodispersible tablets Olanzapine
Danish: LÆGEMIDLETS NAVN Olanzapine Glenmark Europe 20 mg orodispergible tabletter Olanzapin 2.
English: OTHER COMDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 15 mg Olanzapine Excipient with known effect: Each orodispersible tablet contains 0.69 mg of aspartame For the full list of excipients, see section 6.1
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver orodispergible tablet indeholder 15 mg olanzapin Hjælpestof, som behandleren skal være opmærksom på:
English: Oedema
Danish: Rabdomyoly
English: In particular, tell your doctor if you are taking:
Danish: Det er især vigtigt at fortælle lægen, hvis du tager: • Medicin for Parkinsons sygdom.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 June 2017
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23.
English: The CHMP noted there was inadequate information in several areas of the application, including on the manufacture of the medicine, its testing in humans and animals and its safety.
Danish: CHMP bemærkede, at der ikke forelå tilstrækkelige oplysninger på flere områder i ansøgningen, herunder om fremstillingen af lægemidlet, afprøvningen heraf på mennesker og dyr samt dets sikkerhed.
English: What was Zafiride expected to be used for?
Danish: Hvad forventedes Zafiride anvendt til?
English: What is Zafiride?
Danish: Hvad er Zafiride?
English: The medicine was intended for those patients whose cancer has worsened within 6 months of treatment with cancer medicines including pemetrexed.
Danish: Lægemidlet var tiltænkt patienter, hvis kræft er blevet forværret inden for 6 måneder fra behandlingen med lægemidler mod kræft, herunder pemetrexed.
English: Once attached to these receptors, it damages the walls of the blood vessels supplying the tumours, thereby helping to slow down the growth of the cancer.
Danish: Når det har bundet sig til disse receptorer, ødelægger det væggene i de blodkar, der forsyner tumorerne, hvorved kræftens vækst bremses.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zafiride did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Zafiride ikke opvejede risiciene.
English: With regard to the medicine's effectiveness, the main study did not show convincingly that Zafiride was better than placebo at prolonging lives in the intended patients.
Danish: For så vidt angår lægemidlets effektivitet, påviste den overordnede undersøgelse ikke på overbevisende måde, at Zafiride var bedre end placebo med hensyn til at forlænge livet hos de involverede patienter.
English: The company's application included results from a main study in 400 patients which looked at how long patients lived when treated with Zafiride in combination with other cancer medicines.
Danish: Virksomhedens ansøgning indeholdt resultater fra en overordnet undersøgelse på 400 patienter af, hvor længe patienter levede, når de blev behandlet med Zafiride i kombination med andre lægemidler mod kræft.
English: Zafiride is a medicine containing the active substance NGR-human tumour necrosis factor alpha.
Danish: Zafiride er et lægemiddel, der indeholder det aktive stof NGR human tumor nekrosefaktor alpha.