FrancophonIA/ELRC3.0 huggingface dataset:
English: LPV/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Danish: cLPV/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter en gang dagligt).
English: • If tenofovir disoproxil or an H2-receptor antagonist is needed, a dose increase to atazanavir 400 mg with ritonavir 100 mg with TDM may be considered (see sections 4.6 and 5.2).
Danish: Hvis det er nødvendigt at anvende tenofovirdisoproxil eller en H2-receptorantagonist, bør det overvejes at øge dosis af atazanavir til 400 mg med 100 mg ritonavir under TDM.
English: Atazanavir Mylan 300 mg hard capsules
Danish: Atazanavir Mylan 300 mg hårde kapsler
English: The mechanism of the clarithromycin/atazanavir interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen for clarithromycin/atazanavir er CYP3A4-hæmning.
English: ANTIBIOTICS Clarithromycin 500 mg twice daily
Danish: Clarithromycin 500 mg 2 gange dagligt (atazanavir 400 mg 1 gang dagligt)
English: Each capsule contains 150 mg atazanavir (as sulphate)
Danish: Hver kapsel indeholder 150 mg atazanavir (som sulfat).
English: ANTINEOPLASTICS AND IMMUNOSUPRESSANTS Antineoplastics
Danish: ANTINEOPLASTISKE OG IMMUNSUPRIMERENDE MIDLER
English: Diltiazem Cmin ↑142% (↑114%
Danish: Diltiazem Cmax ↑98% (↑78% ↑119%) Diltiazem Cmin ↑142% (↑114%
English: PVC/PVDC/Aluminium blisters containing 30, 30 x 1 (unit dose) capsules.
Danish: PVC/PVDC/Al-blisterpakning, der indeholder 30, 30 x 1 (enkeltdosis) kapsler.
English: Voriconazole 200 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Danish: Voriconazol 200 mg 2 gange dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Famotidine 40 mg twice daily Atazanavir AUC ↓24% (↓36%
Danish: Atazanavir, doseret 1 time efter ddI+d4T (fastende) Atazanavir AUC ↔3% (↓36%
English: atazanavir Cmax ↓ 25%
Danish: atazanavir AUC ↓ 35% atazanavir Cmax ↓ 25% atazanavir Cmin ↓ 49%
English: Capsule shell body 150 mg
Danish: Underdel af kapselskal, 150 mg
English: Ethinyloestradiol 35 µg + norethindrone
Danish: Ethinylestradiol 35 µg + norethindron (atazanavir 400 mg 1 gang dagligt)
English: Atazanavir, simultaneous administration with ddI+d4T (fasted)
Danish: Atazanavir, samtidig administration af ddI+d4T (fastende) Atazanavir AUC ↓87% (↓92%
English: a,b
Danish: 4.6 og
English: PVC/PVDC/Aluminium blisters containing 60, 60 x 1 (unit dose) capsules.
Danish: PVC/PVDC/Al-blisterpakning, der indeholder 60, 60 x 1 (enkeltdosis) kapsler.
English: ANTI-HCV AGENTS Grazoprevir 200 mg once daily (atazanavir 300 mg / ritonavir 100 mg once daily)
Danish: Grazoprevir 200 mg 1 gang dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Iron oxide yellow (E172) Iron oxide red (E172) Titanium dioxide (E171) Gelatin
Danish: Gul jernoxid (E172) Rød jernoxid (E172) Titandioxid (E171)
English: Atazanavir Mylan capsules with ritonavir
Danish: Tabel 1: Dosering af Atazanavir Mylan-kapsler med ritonavir til pædiatriske patienter
English: De novo substitutions in treatment naive patients failing therapy with atazanavir +
Danish: De novo substitutioner hos behandlingserfarne patienter med svigt i behandling med atazanavir + ritonavir (studie 045, 48 uger)
English: CORTICOSTEROIDS Fluticasone propionate intranasal 50 µg 4 times daily for 7 days
Danish: Fluticasonpropionat intranasalt 50 µg 4 gange dagligt i 7 dage (ritonavir 100 mg kapsler 2 gange dagligt)
English: The mechanism of interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen er CYP3A4hæmning.
English: BLISTERS FOR 200 MG HARD CAPSULES
Danish: 200 mg hårde kapsler
English: Atazanavir Mylan 300 mg hard capsules atazanavir
Danish: Atazanavir Mylan 300 mg hårde kapsler atazanavir
English: Phenobarbital and phenytoin should be used with caution in
Danish: Phenobarbital og phenytoin bør anvendes med forsigtighed sammen med atazanavir/ritonavir.
English: Voriconazole 50 mg twice daily (atazanavir 300 mg/ritonavir 100 mg once daily)
Danish: Voriconazol 50 mg 2 gange dagligt (atazanavir 300 mg/ritonavir 100 mg 1 gang dagligt)
English: Lopinavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Danish: bATV/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter en gang dagligt).
English: This medicine comes in blister packs containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Danish: Atazanavir Zonisamide Mylan 200 mg hårde kapsler Lægemidlet fås i blisterpakninger, der indeholder 30, 60 eller 60 × 1 (enkeltdosis) kapsler eller i flasker med 60 hårde kapsler.
English: Sirolimus
Danish: SEDATIVA
English: Atazanavir Mylan with ritonavir is contraindicated in patients with moderate hepatic insufficiency (see sections 4.2, 4.4 and 5.2).
Danish: Atazanavir Mylan med ritonavir er kontraindiceret hos patienter med moderat nedsat leverfunktion (se pkt.
English: Each capsule contains 300 mg atazanavir (as sulphate)
Danish: Hver kapsel indeholder 300 mg atazanavir (som sulfat).
English: No single dose of famotidine should exceed 20 mg, and the total daily dose of famotidine should not exceed 40 mg.
Danish: Dosis af protonpumpehæmmere bør ikke overstige dosis svarende til omeprazol 20 mg.
English: Each capsule contains 200 mg atazanavir (as sulphate)
Danish: Hver kapsel indeholder 200 mg atazanavir (som sulfat).
English: * In a combined analysis, atazanavir 300 mg and ritonavir 100 mg (n=33) was compared to
Danish: * Atazanavir 300 mg og ritonavir 100 mg (n=33) er i en kombineret analyse sammenlignet med atazanavir 400 mg uden ritonavir (n=28).
English: Other side effects reported for patients treated with atazanavir are the following:
Danish: Der er indberettet nyresten hos patienter behandlet med atazanavir.
English: Ethinyloestradiol Cmin ↑91% (↑57%
Danish: Ethinylestradiol AUC ↑48% (↑31% Ethinylestradiol Cmax ↑15% (↓1% Ethinylestradiol Cmin ↑91% (↑57%
English: Capsule shell body 200 mg
Danish: Underdel af kapselskal, 200 mg
English: 30 hard capsules 60 hard capsules.
Danish: LÆGEMIDDELFORM OG INDHOLD 60 hårde kapsler.
English: Table 1: Dose for paediatric patients (6 to less than 18 years of age and weighing at least 15 kg) for
Danish: (fra 6 år til under 18 år og med en legemsvægt på mindst 15 kg)
English: All patients HIV RNA <400 copies/ml, %
Danish: HIV-RNA <400 kopier/ml, % a Alle patienter
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 150 mg kapsler
English: BLISTERS FOR 300 MG HARD CAPSULES
Danish: 300 mg hårde kapsler
English: ANTIFUNGALS Ketoconazole 200 mg once daily
Danish: Ketoconazol 200 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt)
English: ritonavir Cmax ↓ 27%
Danish: ritonavir AUC ↓ 36% ritonavir Cmax ↓ 27% ritonavir Cmin ↓ 45%
English: Capsule shell body 300 mg
Danish: Underdel af kapselskal, 300 mg
English: 3) and the mean baseline plasma HIV-1 RNA level was 4.4 log10 copies/ml (range: 2.6 to 5.88 log10 copies/ml).
Danish: NA aMiddel CD4-celletal ved baseline var 337 celler/mm3 (område: 14 til 1.543 celler/mm3) og middel plasma HIV-1 RNA niveauet var 4,4 log10 kopier/ml (område: 2,6 til 5,88 log10 kopier/ml).
English: Voriconazole Cmin ↓39% (↓49%
Danish: Voriconazol Cmax ↓10% (↓22% ↓4%) Voriconazol Cmin ↓39% (↓49%
English: The withdrawal of ritonavir from the boosted regimen of atazanavir is not recommended, but may be considered in adults patients at the dose of 400 mg once daily with food only under the following combined restrictive conditions:
Danish: Seponering af ritonavir fra det boostede atazanavir -regime frarådes, men en dosis på 400 mg atazanavir en gang dagligt sammen med føde kan overvejes hos voksne patienter under følgende kombinerede restriktive forhold: intet tidligere virologisk svigt udetekterbar virusbelastning i de seneste 6 måneder med det nuværende regime virusstammer, som ikke har HIV-resistensassocierede mutationer (RAM) på det nuværende regime.
English: This medicine comes in blister packs containing 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Danish: Atazanavir Zonisamide Mylan 150 mg hårde kapsler Lægemidlet fås i blisterpakninger, der indeholder 60 eller 60 × 1 (enkeltdosis) kapsler eller i flasker med 60 hårde kapsler.
English: The mechanism of diltiazem/atazanavir interaction is CYP3A4 inhibition.
Danish: Interaktionsmekanismen for diltiazem/atazanavir er CYP3A4hæmning.
English: Week 48: -3% [-7.6%, 1.5%] Week 96: 2.2% [-2.3%, 6.7%] HIV RNA <50 copies/ml, % by Baseline Characteristic d
Danish: Uge 96: 2.2% [-2.3%, 6.7%]
English: With tenofovir disoproxil fumarate 300 mg once daily (equivalent to 245 mg tenofovir disoproxil) In HIV-infected patients with atazanavir/ritonavir at the recommended dose of 300/100 mg once daily
Danish: Med tenofovirdisoproxilfumarat 300 mg 1 gang dagligt (ækvivalent med 245 mg tenofovirdisoproxil)
English: using PDE5 inhibitors for erectile dysfunction with atazanavir (see section 4.4).
Danish: Patienterne bør advares om risikoen for disse bivirkninger ved brug af PDE5-hæmmere mod erektil dysfunktion samtidig med atazanavir (se pkt.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Der er mange faktorer, der øger risikoen for dette: varighed af behandling med flere slags antiretroviral medicin, brug af binyrebarkhormon, alkoholforbrug, alvorligt nedsat immunforsvar samt (over-)vægt (højt BMI).
English: Atazanavir/RTV with tenofovir disoproxil fumarate/emtricitabine (fixed dose 300 mg/200 mg tablets once daily).
Danish: c Lopinavir/RTV med tenofovirdisoproxilfumarat/emtricitabin (fast dosis på 300 mg/200 mg tabletter en gang dagligt).
English: Cardiac disorders:
Danish: EREKTIL DYSFUNKTION
English: 100 to <200 cells/mm
Danish: 100 to <200 celler/mm3 75 (n=106)
English: If the combination is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; doses of proton pump inhibitors comparable to omeprazole 20 mg should not be exceeded (see section 4.4).
Danish: Dosis af protonpumpehæmmere svarende til omeprazol 20 mg bør ikke overskrides (se pkt.
English: (300 mg/100 mg once daily) n=440
Danish: Atazanavir/ritonavirb (300 mg/100 mg én gang dagligt) n=440
English: Atazanavir Cmin ↓20% (↓31% ↓8%) In Healthy volunteers with atazanavir/ritonavir at an increased dose of 400/100 mg once daily
Danish: Raske frivillige, der får en øget dosis atazanavir/ritonavir på 400/100 mg 1 gang dagligt
English: 6.4 Special precautions for storage
Danish: 6.3 Opbevaringstid
English: Reproductive system and breast disorders: uncommon: gynaecomastia General disorders and administration site conditions:
Danish: Almene symptomer og reaktioner på administrationsstedet:
English: Nevirapine 200 mg twice daily
Danish: Famotidin 40 mg 2 gange dagligt
English: e)
Danish: NN:
English: (n=392
Danish: (n=392f)
English: The mechanism of interaction is CYP3A4 inhibition by atazanavir and/or ritonavir.
Danish: Interaktionsmekanismen er atazanavir - og/eller ritonavirhæmning af CYP3A4.
English: BOTTLE LABEL FOR 300 MG HARD CAPSULES
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BLISTERPAKNING TIL 300 MG HÅRDE KAPSLER
English: atazanavir 400 mg without ritonavir (n=28).
Danish: Atazanavir 300 mg med ritonavir 100 mg Farmakokinetisk parameter 2. trimester (n=9)
English: TM
Danish: SN:
English: (atazanavir 400 mg once daily with ritonavir 200 mg once daily)
Danish: Efavirenz 600 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 200 mg 1 gang dagligt)
English: (atazanavir 400 mg once daily with ritonavir 100 mg once daily)
Danish: Omeprazol 40 mg 1 gang dagligt (atazanavir 400 mg 1 gang dagligt med ritonavir 100 mg 1 gang dagligt)
English: Each hard capsule contains 200 mg of atazanavir (as sulphate).
Danish: ANGIVELSE AF AKTIVT STOF Hver hård kapsel indeholder 200 mg atazanavir (som sulfat) 3.
English: Atazanavir Cmin ↑91% (↑66%
Danish: Atazanavir Cmax ↔6% (↓7% ↑20%) Atazanavir Cmin ↑91% (↑66%
English: This summary was last updated in 11-2014.
Danish: Dette sammendrag blev sidst ajourført i 11-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vargatef on 21 November 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vargatef den 21. november 2014.
English: The recommended dose is 200 mg taken twice a day (around 12 hours apart).
Danish: Den anbefalede dosis er 200 mg to gange dagligt (tages med cirka 12 timers mellemrum).
English: This is a summary of the European public assessment report (EPAR) for Vargatef.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vargatef.
English: The full EPAR and risk management plan summary for Vargatef can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vargatef findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Vargatef
Danish: Andre oplysninger om Vargatef
English: Vargatef is available as capsules (100 and 150 mg) to be taken by mouth, preferably with food.
Danish: Vargatef leveres som kapsler (100 og 150 mg), der tages gennem munden, helst sammen med et måltid.
English: A risk management plan has been developed to ensure that Vargatef is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vargatef anvendes så sikkert som muligt.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vargatef's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vargatef opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: In addition, the company that markets Vargatef will conduct studies to find ways to identify those patients who are most likely to benefit from treatment with the medicine.
Danish: Desuden skal den virksomhed, der markedsfører Vargatef, udføre undersøgelser for at finde metoder til at udpege de patienter, der har størst chance for at få fordel af behandlingen med lægemidlet.
English: What measures are being taken to ensure the safe and effective use of Vargatef?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vargatef?
English: These enzymes can be found in certain receptors (such as VEGF, FGF and PDGF receptors) on the surface of cancer cells and on the cells of the surrounding tissue (e.g. blood vessel), where they activate several processes including cell division and the growth of new blood vessels.
Danish: Disse enzymer findes i visse receptorer (såsom VEGF-, FGF- og PDGF-receptorerne) på overfladen af kræftcellerne og på cellerne i det omgivende væv (f.eks. blodkar), hvor de aktiverer forskellige processer, bl.a. celledeling og vækst af nye blodkar.
English: What is Vargatef and what is it used for?
Danish: Hvad er Vargatef, og hvad anvendes det til?
English: If severe side effects persist, treatment should be permanently discontinued.
Danish: I tilfælde af vedvarende svære bivirkninger skal behandlingen helt standses.
English: Treatment with Vargatef may continue after stopping docetaxel, for as long as the disease improves or remains stable and the side effects are tolerable.
Danish: Behandlingen med Vargatef skal fortsætte efter ophør med docetaxel, så længe sygdommen er i bedring eller stabil, og bivirkningerne er tålelige.
English: Vargatef must not be used in patients who are hypersensitive (allergic) to nintedanib, peanut or soya, or any of the other ingredients.
Danish: Vargatef må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for nintedanib, jordnødder, soja eller andre af indholdsstofferne.
English: Vargatef contains the active substance nintedanib.
Danish: Vargatef indeholder det aktive stof nintedanib.
English: Why is Vargatef approved?
Danish: Hvorfor er Vargatef blevet godkendt?
English: It is not intended to provide practical advice on how to use Vargatef.
Danish: Det er ikke en praktisk vejledning i, hvordan Vargatef bør anvendes.
English: If severe side effects develop, the doctor may decide to interrupt treatment with Vargatef and resume it at a lower dose.
Danish: Ved svære bivirkninger kan lægen beslutte at stoppe behandlingen med Vargatef og senere genoptage den med en lavere dosis.
English: The medicine is used in combination with a chemotherapy medicine called docetaxel in patients who have already received previous treatment with chemotherapy.
Danish: Lægemidlet anvendes i kombination med kemoterapilægemidlet docetaxel hos patienter, der i forvejen har fået kemoterapi.
English: Vargatef can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Danish: Vargatef udleveres kun efter recept, og ordination og behandling bør indledes og tilses af en læge med erfaring i brug af kræftmedicin.
English: The most common side effects with Vargatef (which may affect more than 1 in 10 people) include diarrhoea, vomiting and increased blood levels of certain liver enzymes (a sign of possible liver problems).
Danish: De hyppigste bivirkninger ved Vargatef (som optræder hos mere end 1 ud af 10 patienter) er diarré, opkastning og øget indhold i blodet af bestemte leverenzymer (som kan være et tegn på leverproblemer).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vargatef, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vargatef, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: What are the risks associated with Vargatef?
Danish: Hvilke risici er der forbundet med Vargatef?
English: Vargatef is used to treat a type of non-small cell lung cancer called ‘adenocarcinoma', when the cancer is locally advanced, metastatic (when cancer cells have spread from the original site to other parts of the body) or locally recurrent (when the cancer has come back in the same area).
Danish: Vargatef anvendes til behandling af en form for ikke-småcellet lungekræft (adenokarcinom), hvor kræften er lokalt fremskreden, har bredt sig fra udgangsstedet til andre dele af kroppen (er metastatisk) eller er vendt tilbage på det sted, hvor den oprindeligt er opstået (lokalt recidiv).
English: For more information about treatment with Vargatef, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vargatef, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: By blocking these enzymes, nintedanib helps to reduce the growth and spread of the cancer and to cut off the blood supply that keeps cancer cells growing.
Danish: Ved at blokere disse enzymer bremser Vargatef kræftens vækst og spredning og afskærer blodforsyningen, som sætter kræftcellerne i stand til at vokse.
English: The active substance in Vargatef, nintedanib, blocks the activity of some enzymes known as tyrosine kinases.
Danish: Det aktive stof i Vargatef, nintedanib, blokerer visse enzymer af typen tyrosinkinase.
English: The CHMP noted that Vargatef was effective at slowing down disease progression and prolonging life in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type.
Danish: CHMP bemærkede, at Vargatef var effektivt til at bremse udviklingen i sygdommen og forlænge livet hos den undergruppe af patienter, der havde ikke-småcellet lungekræft af typen adenokarcinom.
English: For the full list of all side effects and restrictions with Vargatef, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Vargatef fremgår af indlægssedlen.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom cycle, Vargatef is given on days 2 to 21 with docetaxel being given on day 1.
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Because Vargatef must not be given on the same day as docetaxel and because docetaxel is given on day 1 of a 21-day treatment
Danish: Eftersom Vargatef ikke må gives samme dag som docetaxel, og docetaxel gives på dag 1 i en 21-dages behandlingscyklus, gives Vargatef på dag 2-21, efter at der er givet docetaxel på dag 1.
English: Vargatef is a cancer medicine used to treat adults with a type of lung cancer known as non-small cell lung cancer.
Danish: Vargatef er et lægemiddel mod kræft og anvendes til behandling af voksne med ikke-småcellet lungekræft.
English: For practical information about using Vargatef, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vargatef, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In a main study involving 1,314 patients with advanced or recurrent non-small cell lung cancer that did not respond to a previous treatment, Vargatef taken in combination with docetaxel was shown to be more effective than docetaxel alone at delaying progression of the cancer.
Danish: En hovedundersøgelse omfattede 1 314 patienter med fremskreden eller tilbagevendende ikkesmåcellet lungekræft, som ikke havde reageret på forudgående behandling.
English: What benefits of Vargatef have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vargatef?
English: How is Vargatef used?
Danish: Hvordan anvendes Vargatef?
English: How does Vargatef work?
Danish: Hvordan virker Vargatef?
English: For further information, see the package leaflet.
Danish: Yderligere oplysninger fremgår af indlægssedlen.
English: Regarding its safety, although more side effects were reported in patients treated with Vargatef plus docetaxel than in those treated with docetaxel alone, the side effects were considered manageable with dose reductions, supportive treatments and treatment interruptions.
Danish: Hvad sikkerheden angår, var der flere bivirkninger hos patienter behandlet med Vargatef plus docetaxel end hos dem, der fik docetaxel alene.
English: In addition, Vargatef led to an improvement in overall survival (how long patients lived) in the subgroup of patients with non-small cell lung cancer of the adenocarcinoma type: overall survival was 12.6 months in patients treated with Vargatef plus docetaxel, compared with 10.3 months in patients treated with docetaxel alone.
Danish: Den totale overlevelse var 12,6 måneder hos patienter, der blev behandlet med Vargatef plus docetaxel, sammenlignet med 10,3 måneder hos dem, der blev behandlet med docetaxel alene.
English: Progression-free survival (the time patients lived without their disease getting worse) was 3.5 months in patients receiving Vargatef plus docetaxel, compared with 2.7 months in patients receiving docetaxel alone.
Danish: De patienter, der fik Vargatef plus docetaxel, overlevede i 3,5 måneder uden forværring af sygdommen (progressionsfri overlevelse).
English: The Committee recommended that a further overdose study should be submitted.
Danish: Udvalget anbefalede, at der blev forelagt endnu en overdoseringsundersøgelse.
English: These reactions are very rare (affecting less than 1 bird in 10,000).
Danish: Sådanne reaktioner er meget sjældne (berører mindre end én ud af 10 000 fugle).
English: This summary was last updated in July 2014.
Danish: Dette sammendrag blev senest ajourført i 07-2014.
English: Hands and equipment should be washed and disinfected after vaccination to avoid spread of the virus.
Danish: Hænder og udstyr skal vaskes og desinficeres efter vaccination for at undgå spredning af virusset.