FrancophonIA/ELRC3.0 huggingface dataset:
English: After treatment interruption and recovery of transaminase-values to ≤ 2.5 x ULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Danish: Efter afbrydelse af behandlingen og bedring af transaminase-værdierne til ≤ 2,5 x ULN ledsaget af en normaliseret bilirubin, reduceres den daglige dosis fra 200 mg to gange daglig til 150 mg to gange daglig og - hvis endnu en dosisreduktion anses for nødvendig - fra 150 mg to gange daglig til 100 mg to gange daglig.
English: Stratified by baseline ECOG PS (0 versus 1), brain metastases at baseline (yes versus no) and prior treatment with bevacizumab (yes versus no).
Danish: Stratificeret i henhold til ECOG-funktionsstatus ved baseline (0 versus 1), hjernemetastaser ved baseline (ja versus nej) og forudgående behandling med bevacizumab (ja versus nej).
English: Stable brain metastasis
Danish: Stabile hjernemetastaser
English: Black ink:
Danish: Sort trykfarve:
English: Common side effects(may affect up to 1 in10 people) Blood poisoning (sepsis) -please see above
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) Blodforgiftning (sepsis) - se ovenfor
English: Vargatef should therefore only be initiated at least 4 weeks after major surgery.
Danish: Efter et større kirurgisk indgreb bør der derfor gå mindst 4 uger før initiering af behandling med Vargatef.
English: Uncommon side effects (may affect up to 1 in 100 people) Occurrence of holes in the wall of your gut (gastrointestinal perforation) Serious liver problems
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) Forekomst af huller i tarmvæggen (gastrointestinal perforation) Alvorlige leverproblemer
English: Pharmacokinetic/pharmacodynamic relationship(s) In exploratory pharmacokinetic adverse event analyses, higher exposure to nintedanib tended to be associated with liver enzyme elevations, but not with gastrointestinal adverse events.
Danish: I eksplorative farmakokinetiske analyser af hændelser var der tendens til, at større eksponering for nintedanib var forbundet med forhøjede leverenzymer men ikke med gastrointestinale hændelser.
English: Tumour angiogenesis is an essential feature contributing to tumour growth, progression and metastasis formation and is predominantly triggered by the release of pro-angiogenic factors secreted by the tumour cell (i.e. VEGF and bFGF) to attract host endothelial as well as perivascular cells to facilitate oxygen and nutrient supply through the host vascular system.
Danish: Processen udløses hovedsagelig af frigivelse af pro-angiogene faktorer, som udskilles af tumorcellen (dvs. VEGF og bFGF) for at tiltrække værtens endotelceller og perivaskulære celler med henblik på at fremme oxygen- og næringstilførsel gennem værtens vaskulære system.
English: This daily dose should be split into two doses of two capsules about 12 hours apart, for example two capsules in the morning and two capsules in the evening.
Danish: Den daglige dosis skal opdeles i to doser a to kapsler, der skal tages med ca. 12 timers mellemrum, f.eks. to kapsler om morgenen og to kapsler om aftenen.
English: Recommended dose adjustments for Vargatef (nintedanib) in case of diarrhoea, vomiting and other non-haematological or haematological adverse reactions
Danish: Anbefalede dosisjusteringer af Vargatef (nintedanib) i tilfælde af diarré, opkastning og andre ikke-hæmatologiske eller hæmatologiske bivirkninger CTCAE* Bivirkning
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous system organs, with the most frequent being respiratory (see also section 4.4).
Danish: Blødningshændelser set i perioden efter markedsføringen omfatter, men er ikke begrænset til, mave-tarm-kanalen, åndedrætsorganerne og centralnervesystemet, og hyppigst åndedrætsorganerne (se også pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (100 mg)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON (100 MG)
English: Elevation of AST and/or ALT values to > 3 x ULN in conjunction with an increase of total bilirubin to ≥ 2 x ULN and ALKP < 2 x ULN
Danish: ASAT og/eller ALAT forhøjet til > 3 x ULN og total bilirubin forhøjet til ≥ 2 x ULN og ALKP < 2 x ULN
English: Uncommon side effects (may affect up to 1 in 100 people) Occurrence of holes in the wall of your gut (gastrointestinalperforation) Serious liver problems
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) Forekomst af huller i tarmvæggen (gastrointestinalperforation) Alvorligeleverproblemer
English: Low platelet count (thrombocytopenia)
Danish: Lavt antal blodplader (trombocytopeni)
English: Capsule content:Triglyceridesmedium-chain, hard fat, soya lecithin(E322)
Danish: Kapselindhold: Triglycerider mellemkædede, hårdt fedt, sojalecithin (E322) Kapselskal:
English: Based on increased exposure, the risk for adverse events may be increased in patients with mild hepatic impairment (Child Pugh A; see sections 4.2 and 5.2).
Danish: På grund af øget eksponering kan risikoen for bivirkninger være forøget hos patienter med let nedsat leverfunktion (Child Pugh A; se pkt.
English: For recommended measures and dosing adjustments in case of diarrhoea, see sections 4.4 and 4.2, respectively.
Danish: Vedrørende anbefalede foranstaltninger og dosisjusteringer i tilfælde af diarré henvises til henholdsvis pkt.
English: This daily dose should be split into two doses of one capsule about 12 hours apart, for example one capsule in the morning and one capsule in the evening.
Danish: Den daglige dosis skal opdeles i to doser a én kapsel, der skal tages med ca. 12 timers mellemrum, f.eks. én kapsel om morgenen og én kapsel om aftenen.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see also section 4.4).
Danish: Medmindre der kan fastslås en anden årsag, skal Vargatef seponeres permanent (se også pkt.
English: th percentile) relative to a patient with the median weight of 71.5 kg.
Danish: .percentilen) og faldt med 19 % hos en patient på 100 kg (95 % percentilen) i forhold til en patient med en medianvægt på 71,5 kg.
English: A multipack containing 120 capsules (2 boxes of 60 capsules each, bundled together by a wrapping foil).
Danish: En multipakning, der indeholder 120 kapsler (2 æsker med 60 kapsler i hver, sampakket i plastfolie).
English: For patients with tumour of adenocarcinoma histology, 15.8 % had disease stage < IIIB/IV, 15.2 %, had disease stage IIIB and 69.0 % had disease stage IV. 5.8 % of the adenocarcinoma patients entered the trial with locally recurrent disease stage as had been evaluated at baseline.
Danish: Blandt de patienter, der havde tumorer med adenokarcinom-histologi, havde 15,8 % sygdomsstadium < IIIB/IV, 15,2 % havde sygdomsstadium IIIB, og 69,0 % havde sygdomsstadium IV.
English: The majority of patients were non-Asian (81.6 %), the median age was 60.0 years, the baseline ECOG
Danish: De fleste patienter var ikke-asiatiske (81,6 %), medianalderen var 60,0 år, ECOGfunktionsstatus ved baseline var 0 (28,6 %) eller 1 (71,3 %); en enkelt patient havde en ECOGfunktionsstatus på 2 ved baseline.
English: th percentile) and increased by 13 % for a 76-year old patient (95
Danish: .percentilen) og steg med 13 % hos en 76-årig patient (95 % percentilen) i forhold til en patient med en medianalder på 62 år.
English: Unless there is an alternative cause established, Vargatef should be permanently discontinued (see section 4.2).
Danish: Medmindre der kan fastslås en anden årsag, skal Vargatef seponeres permanent (se pkt.
English: Warnings and precautions Talk to your doctor or pharmacist before taking this medicine - if you have or had liver problems, if you have or had bleeding problems, particularly recent bleeding in the lung - if you have or ever had problems with your kidney - if you take blood-thinning medicines (such as warfarin, phenprocoumon, heparin or acetylsalicylic acid) to prevent blood clotting.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager Vargatef - hvis du har eller har haft problemer med leveren, hvis du har eller har haft problemer med blødning - især blødning i lungerne for nylig.
English: Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173
Danish: Indehaver af markedsføringstilladelsen Boehringer Ingelheim International GmbH Binger Strasse 173
English: Vargatef 150 mg soft capsules
Danish: Vargatef 150 mg bløde kapsler
English: The safety, efficacy and pharmacokinetics of nintedanib have not been investigated in patients with severe hepatic impairment (Child Pugh C).
Danish: Nintedanibs sikkerhed, virkning og farmakokinetik er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child Pugh C).
English: Vargatef capsules must be taken orally, preferably with food, swallowed whole with water, and must not be chewed or crushed.
Danish: Vargatef kapsler skal tages oralt, helst sammen med mad.
English: Febrile neutropenia and sepsis (common, may affect up to 1 in 10 people) Treatment with Vargatef may lead to a reduced number of a type of your white blood cells (neutropenia) which are important for the body´s reaction against bacterial or fungal infections.
Danish: Behandling med Vargatef kan medføre, at antallet af den type hvide blodlegemer (neutropeni), der er vigtige for kroppens reaktion på bakterie- og svampeinfektioner, nedsættes.
English: After treatment interruption and recovery to grade 1 or baseline, dose reduction from 200 mg twice daily to 150 mg twice daily and - if a 2
Danish: Efter afbrydelse af behandlingen og bedring til grad 1 eller som ved baseline, dosisreduktion fra 200 mg to gange daglig til 150 mg to gange daglig og - hvis endnu en dosisreduktion anses for nødvendig - fra 150 mg to gange daglig til 100 mg to gange daglig.
English: No QT prolongation was observed for nintedanib in the clinical trial program (see section 5.1).
Danish: I det kliniske forsøgsprogram blev der ikke set tilfælde med QT-forlængelse ved behandling med nintedanib (se pkt.
English: OS analysis and follow-up PFS-analysis performed when 1121 death cases had been observed in the overall ITT population (535 events in adenocarcinoma patients).
Danish: OS-analyse og opfølgende PFS-analyse udført, da der var observeret 1.121 dødsfald i den samlede ITTpopulation (535 hændelser hos adenokarcinom-patienter) Odds ratio og p-værdi stammer fra en logistisk regressionsmodel korrigeret for ECOG-funktionsstatus ved baseline (0 versus 1).
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 x 1 bløde kapsler.
English: PHARMACEUTICAL FORM AND CONTENTS 60 x 1 soft capsule
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 60 x 1 bløde kapsler
English: How to take Vargatef
Danish: Sådan skal du tage Vargatef
English: Breast-feeding should be discontinued during treatment with Vargatef.
Danish: Amning skal ophøre under behandling med Vargatef.
English: Vargatef 100 mg soft capsules
Danish: Vargatef 100 mg bløde kapsler
English: The frequency of arterial thromboembolic events was comparable between the two treatment arms in the phase 3 trial 1199.13 (LUME-Lung 1).
Danish: I fase 3-forsøget 1199.13 (LUME-Lung 1) var hyppigheden af arterielle tromboemboliske hændelser sammenlignelig i de to behandlingsgrupper.
English: Treatment of patients with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment with Vargatef is not recommended (see sections 4.4 and 5.2).
Danish: Behandling med Vargatef anbefales ikke til patienter med moderat (Child Pugh B) og svært (Child Pugh C) nedsat leverfunktion (se pkt.
English: Printing ink:
Danish: Trykfarve:
English: One box containing 120 capsules (12 aluminium blisters of 10 capsules each).
Danish: En æske, der indeholder 120 kapsler (12 aluminiumsblistere med 10 kapsler i hver).
English: No dedicated trials investigating the effect of nintedanib on wound healing were performed.
Danish: Der er ikke udført målrettede forsøg til undersøgelse af nintedanibs indvirkning på sårheling.
English: Vargatef 100 mg soft capsules Each soft capsule contains 100 mg nintedanib (as esilate).
Danish: Vargatef 100 mg bløde kapsler Hver blød kapsel indeholder 100 mg nintedanib (som esilat).
English: Alanine aminotransferase (ALT) increased,
Danish: ALAT: Alaninaminotransferase
English: What Vargatef contains
Danish: Vargatef indeholder soja
English: Increased liver enzyme values (alanine aminotransferase, aspartate aminotransferase, blood alkaline phosphatase) in the blood as seen from blood tests Hair loss (alopecia)
Danish: Forhøjede leverenzymer (alaninaminotransferase, aspartataminotransferase, basisk fosfatase) i blodprøver
English: Vargatef 150 mg soft capsules Each soft capsule contains 150 mg nintedanib (as esilate).
Danish: Vargatef 150 mg bløde kapsler Hver blød kapsel indeholder 150 mg nintedanib (som esilat).
English: Each capsule contains 1.8 mg of soya lecithin.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver kapsel indeholder 1,8 mg sojalecithin.
English: One box contains 60 capsules (6 aluminium blisters of 10 capsules each).
Danish: En æske indeholder 60 kapsler (6 aluminiumsblistere med 10 kapsler i hver).
English: If relevant liver enzyme elevations are measured, interruption, dose reduction or discontinuation of the therapy with Vargatef may be required (see section 4.2).
Danish: Hvis der måles relevante forhøjelser af leverenzymer, kan afbrydelse, dosisreduktion eller seponering af behandlingen med Vargatef være nødvendig (se pkt.
English: Drug-induced liver injury
Danish: Lægemiddelinducer et leverskade
English: The excipients are:
Danish: - Øvrige indholdsstoffer:
English: Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with Vargatef (see section 4.2).
Danish: Håndtering af bivirkninger kan kræve afbrydelse, dosisreduktion eller seponering af behandlingen med Vargatef (se pkt.
English: Capsule shell: Gelatin, glycerol (85 %), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)
Danish: Gelatine, glycerol (85 %), titandioxid (E171), jernoxid, rød (E172), jernoxid, gul (E172)
English: By blocking the activity of these proteins, nintedanib can help stop the growth and spread of the cancer.
Danish: Nintedanib kan hæmme kræftcellers vækst og spredning ved at blokere aktiviteten af disse proteiner.
English: Iron oxide black (E172) Propylene glycol (E1520)
Danish: Jernoxid, sort (E172) Propylenglycol (E1520)
English: Shellac, iron oxide black (E172), propylene glycol (E1520)
Danish: Shellak, jernoxid, sort (E172), propylenglycol (E1520)
English: No adjustment of the starting dose is needed for patients with mild hepatic impairment (Child Pugh A) based on clinical data.
Danish: Kliniske data har vist, at det ikke er nødvendigt at justere startdosis til patienter med let nedsat leverfunktion (Child Pugh A).
English: Each capsule contains 1.2 mg of soya lecithin.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Hver kapsel indeholder 1,2 mg sojalecithin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/954/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/954/003
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: D-55216Ingelheim am Rhein Germany
Danish: D-55216 Ingelheim am Rhein Tyskland
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/954/004
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/954/004
English: Nausea ≥ grade 3 despite anti-emetic treatment Other non-haematological or haematological adverse reaction of ≥ grade 3
Danish: Andre ikke-hæmatologiske eller hæmatologiske bivirkninger ≥ grad 3
English: Each soft capsule contains100 mg nintedanib (as esilate).
Danish: Hver blød kapsel indeholder 100 mg nintedanib (som esilat).
English: Limited safety data are available in 9 patients with hepatocellular carcinoma and moderate hepatic impairment classified as Child Pugh B. Although no unexpected safety findings were reported in these patients, the data are insufficient to support a recommendation for treatment of patients with moderate hepatic impairment.
Danish: Selvom der ikke er rapporteret om uventede sikkerhedsrelaterede fund hos disse patienter, er dataene utilstrækkelige til at danne basis for, at man kan anbefale behandling af patienter med moderat nedsat leverfunktion.
English: What Vargatef looks like and contents of the pack Vargatef 100 mg soft capsules (capsules) are peach-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “100”.
Danish: Vargatef 100 mg bløde kapsler (kapsler) er ferskenfarvede, uigennemsigtige, aflange kapsler med Boehringer Ingelheims logo og tallet “100” præget med sort på den ene side.
English: In the clinical trial LUME-Lung 1 (see section 5.1), the majority of patients had mild to moderate diarrhoea.
Danish: 5.1) havde de fleste af patienterne mild til moderat diarré.
English: Interruption, dose reduction or discontinuation of therapy with Vargatef may be required (see section 4.2).
Danish: Afbrydelse, dosisreduktion eller seponering af behandlingen med Vargatef kan være nødvendig (se pkt.
English: What Vargatef looks like and contents of the pack Vargatef 150 mg soft capsules (capsules) are brown-coloured, opaque, oblong capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and the figure “150”.
Danish: Vargatef 150 mg bløde kapsler (kapsler) er brune, uigennemsigtige, aflange kapsler med Boehringer Ingelheims logo og tallet “150” præget med sort på den ene side.
English: 55216 Ingelheim am Rhein GERMANY
Danish: 55216 Ingelheim am Rhein TYSKLAND
English: Co-administration with nintedanib should be carefully considered.
Danish: Samtidig administration af Vargatef skal overvejes nøje.
English: Package leaflet: Information for the patient Vargatef 100 mg soft capsules nintedanib
Danish: Indlægsseddel: Information til patienten Vargatef 100 mg bløde kapsler nintedanib
English: What Vargatef contains The active substance is nintedanib.
Danish: Pakningsstørrelser og yderligere oplysninger Vargatef indeholder: - Aktivt stof: nintedanib.
English: What you need to know before you take Vargatef 3.
Danish: Det skal du vide, før du begynder at tage Vargatef Sådan skal du tage Vargatef Bivirkninger
English: No increased frequency of impaired wound healing was observed in the LUME-Lung 1 trial.
Danish: I LUME-Lung 1 studiet blev der ikke set nogen øget hyppighed af nedsat sårheling.
English: Package leaflet: Information for the patient Vargatef 150 mg soft capsules nintedanib
Danish: Indlægsseddel: Information til patienten Vargatef 150 mg bløde kapsler nintedanib
English: Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one side in black with the Boehringer Ingelheim company symbol and “150”.
Danish: Brun, uigennemsigtig, aflang kapsel af blød gelatine med Boehringer Ingelheims logo og tallet “150” præget med sort på den ene side.
English: Tell your doctor immediately if you develop fever.
Danish: Hvis du får feber, skal du omgående fortælle det til lægen.
English: Vargatef contains soya The capsules contain soya lecithin.
Danish: Kapslerne indeholder sojalecithin.
English: Abscesses
Danish: Bylder
English: NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg capsules Nintedanib
Danish: LÆGEMIDLETS NAVN Vargatef 100 mg kapsler nintedanib
English: Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one side in black with the Boehringer Ingelheim company symbol and “100”.
Danish: Ferskenfarvede, uigennemsigtige, aflange kapsler af blød gelatine med Boehringer Ingelheims logo og tallet “100” præget med sort på den ene side.
English: NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg capsules Nintedanib
Danish: LÆGEMIDLETS NAVN Vargatef 150 mg kapsler nintedanib
English: Vargatef 150 mg soft capsules Pack-size: 60 capsules.
Danish: Vargatef 100 mg bløde kapsler fås i tre pakningsstørrelser:
English: Your doctor will decide when to resume your treatment with this medicine - if you have cancer that has spread to the brain
Danish: - hvis du har kræft, der har bredt sig til hjernen.
English: Dose adjustment
Danish: Dosisjusteringer
English: NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg soft capsules nintedanib
Danish: LÆGEMIDLETS NAVN Vargatef 100 mg bløde kapsler nintedanib
English: Blood alkaline phosphatase (ALKP) increased
Danish: ALKP: Basisk fosfatase
English: NAME OF THE MEDICINAL PRODUCT Vargatef 150 mg soft capsules nintedanib
Danish: LÆGEMIDLETS NAVN Vargatef 150 mg bløde kapsler nintedanib
English: wrapped in plastic foil).
Danish: Nyresvigt (se pkt.
English: Glycerol (85 %) Titanium dioxide (E171)
Danish: Glycerol (85 %) Titandioxid (E171) Jernoxid, rød (E172) Jernoxid, gul (E172)
English: Decrease in the number of white blood cells (neutropenia) Inflammation of the mucous membranes lining the digestive tract includingsoresand ulcers in the mouth(mucositis,including stomatitis)
Danish: Betændelse i fordøjelseskanalens slimhinder, herunder betændelse og sår i munden (slimhindebetændelse ogmundbetændelse)
English: In the clinical trial (LUME-Lung 1; see section 5.1) with Vargatef, the frequency of bleeding in both treatment arms was comparable (see section 4.8).
Danish: 5.1) var hyppigheden af blødninger næsten den samme i de to behandlingsgrupper (se pkt.
English: Electrolyte imbalance
Danish: Ændret saltbalance
English: Aspartate aminotransferase (AST) increased,
Danish: ASAT: Aspartataminotransferase
English: NAME OF THE MEDICINAL PRODUCT Vargatef 100 mg soft capsules
Danish: LÆGEMIDLETS NAVN Vargatef 100 mg bløde kapsler Vargatef 150 mg bløde kapsler
English: Active brain metastasis
Danish: Aktive hjernemetastaser
English: Race
Danish: Kløe
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 19 March 2012.
Danish: Efter at virksomheden havde forelagt de supplerende oplysninger, det var blevet anmodet om, blev de »særlige omstændigheder« ophævet den 19. marts 2012.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velcade on 26 April 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Velcade den 26. april 2004.
English: The full EPAR for Velcade can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Velcade findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Velcade was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Danish: Velcade blev oprindelig godkendt under »særlige omstændigheder«, da der af videnskabelige årsager kun forelå begrænsede oplysninger på godkendelsestidspunktet.
English: This document is a summary of the European public assessment report (EPAR) for Velcade.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Velcade.
English: It blocks the proteasome, which is a system within the cells that breaks down proteins when they are no longer needed.
Danish: Det blokerer proteasomet, som er et system i cellerne, der nedbryder proteiner, når der ikke længere er behov for dem.
English: Other information about Velcade:
Danish: Andre oplysninger om Velcade:
English: The following is a list of main benefits shown in these studies:
Danish: Følgende gavnlige virkninger blev påvist i disse undersøgelser:
English: A risk management plan has been developed to ensure that Velcade is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Velcade anvendes så sikkert som muligt.