FrancophonIA/ELRC3.0 huggingface dataset:
English: The median time to PSA progression per PCWG2 criteria was 11.2 months for patients treated with enzalutamide and 2.8 months for patients who received placebo [HR = 0.17 (95% CI: 0.15, 0.20), p < 0.0001].
Danish: Mediantiden til PSA-progression ifølge PCWG2-kriterier var 11,2 måneder for patienter behandlet med enzalutamid og 2,8 måneder for patienter, der fik placebo [HR = 0,17 (95 % KI: 0,15, 0,20), p < 0,0001].
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER 8.
English: Enzalutamide is a potent enzyme inducer and increases the synthesis of many enzymes and transporters; therefore, interaction with many common medicinal products that are substrates of enzymes or transporters is expected.
Danish: Enzalutamid er en stærk enzyminduktor og øger syntesen af mange enzymer og transportører.
English: Co-administration of enzalutamide has no clinically relevant effect on the pharmacokinetics of intravenous docetaxel (see section 4.5); however, an increase in the occurrence of docetaxel-induced neutropenia cannot be excluded.
Danish: Ved samtidig administration har enzalutamid ingen klinisk relevant effekt på farmakokinetikken af intravenøs docetaxel (se pkt.
English: Xtandi - 40 mg film-coated tablets Each film-coated tablet contains 40 mg of enzalutamide.
Danish: Xtandi - 40 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 40 mg enzalutamid.
English: Each Xtandi 40 mg film-coated tablet contains 40 mg of enzalutamide.
Danish: Hver Xtandi 40 mg filmovertrukken tablet indeholder 40 mg enzalutamid.
English: If you are having sex with a pregnant woman, use a condom to protect the unborn child. - Female caregivers see section 3 ‘How to take Xtandi' for handling and use.
Danish: Kvindelige omsorgspersoner henvises til punkt 3 "Sådan skal du tage Xtandi" vedrørende håndtering og brug.
English: Enzalutamide is metabolised by CYP2C8 and to a lesser extent by CYP3A4/5 (see section 4.5), both of which play a role in the formation of the active metabolite.
Danish: CYP2C8 og i mindre grad af CYP3A4/5 (se pkt.
English: • Proton pump inhibitor (e.g. omeprazole)
Danish: • Protonpumpehæmmer (f.eks. omeprazol)
English: Xtandi 80 mg
Danish: LÆGEMIDLETS NAVN Xtandi 80 mg
English: - Do not chew, dissolve or open the soft capsules before swallowing.
Danish: De bløde kapsler må ikke tygges, opløses eller åbnes, før de synkes.
English: Xtandi - 40 mg film-coated tablets Yellow round - film-coated tablets, debossed with E 40.
Danish: Xtandi - 40 mg filmovertrukne tabletter Gule, runde - filmovertrukne tabletter, præget med E 40.
English: • Cardiac glycosides (e.g. digoxin)
Danish: • Hjerteglykosider (f.eks. digoxin)
English: België/Belgique/Belgien
Danish: België/Belgique/Belgien Astellas Pharma B.V.
English: In another phase 3 clinical trial (PREVAIL) in chemo-naïve patients, patients receiving enzalutamide demonstrated a significantly higher total PSA response rate (defined as a ≥ 50% reduction from baseline), compared with patients receiving placebo, 78.0% versus 3.5% (difference = 74.5%, p < 0.0001).
Danish: I et andet klinisk fase 3-studie (PREVAIL) med kemoterapi-naive patienter viste patienter, der fik enzalutamid, en signifikant højere total PSA-responsrate (defineret som ≥ 50 % reduktion fra baseline) sammenlignet med patienter, der fik placebo, 78,0 % versus 3,5 % (forskel = 74,5 %, p < 0,0001).
English: Each Xtandi 80 mg film-coated tablet contains 80 mg of enzalutamide.
Danish: Hver Xtandi 80 mg filmovertrukken tablet indeholder 80 mg enzalutamid..
English: How Xtandi works
Danish: Sådan virker Xtandi
English: The median time to initiation of cytotoxic chemotherapy was 28.0 months for patients receiving enzalutamide and 10.8 months for patients receiving placebo [HR = 0.35 (95% CI: 0.30, 0.40), p < 0.0001].
Danish: Mediantiden til initiering af cytotoksisk kemoterapi var 28,0 måneder for patienter, der fik enzalutamid, og 10,8 måneder for patienter, der fik placebo [HR = 0,35 (95 % KI: 0,30, 0,40), p <
English: Figure 3: Kaplan-Meier Curves of progression-free survival in the STRIVE study (intent-totreat analysis)
Danish: Figur 3: Kaplan-Meier-kurver for progressionsfri overlevelse i STRIVE-studiet (intent-to-treatanalyse)
English: Figure 1: Kaplan-Meier Curves of metastasis-free survival in the PROSPER study (intent-totreat analysis)
Danish: Figur 1: Kaplan-Meier-kurver for metastasefri overlevelse i PROSPER-studiet (intent-to-treatanalyse)
English: 40 mg film-coated tablets
Danish: 40 mg filmovertrukne tabletter
English: Very common: asthenia, fatigue
Danish: Meget almindelig: Asteni, træthed behandlingskomplikationer Almindelig: Fald
English: Astellas Pharma s.r.o.
Danish: Česká republika Astellas Pharma s.r.o.
English: glycerol, titanium dioxide (E171), and purified water.
Danish: Indholdsstoffer i den bløde kapselskal: Gelatine, sorbitol-sorbitan-opløsning (se punkt 2), glycerol, titandioxid (E 171) og renset vand.
English: Xtandi 40 mg film-coated tablets enzalutamide
Danish: Xtandi 40 mg filmovertrukne tabletter enzalutamid
English: Median MFS
Danish: Vistor hf
English: The median time to PSA progression was 8.3 months for patients treated with enzalutamide and 3.0 months for patients who received placebo [HR = 0.25 (95% CI: 0.20, 0.30), p < 0.0001].
Danish: Mediantiden indtil PSA-progression var 8,3 måneder for patienter behandlet med enzalutamid og 3,0 måneder for patienter, som modtog placebo [HR = 0,25 (95 % KI: 0,20, 0,30), p <0,0001].
English: 80 mg film-coated tablets
Danish: 80 mg filmovertrukne tabletter
English: Pre-specified interim analysis Number of deaths (%) Median survival, months (95% CI)
Danish: Forudspecificeret interimanalyse Antal dødsfald (%)
English: - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine) - Treat gout (e.g. colchicine) - Treat stomach disorders (e.g. omeprazole) - Prevent heart conditions or strokes (e.g. dabigatran etexilate) - Prevent organ rejection (e.g. tacrolimus)
Danish: behandling af søvnproblemer (f.eks. zolpidem) behandling af hjertesygdomme eller sænkning af blodtryk (f.eks. bisoprolol, digoxin, diltiazem, felodipin, nicardipin, nifedipin, propranolol, verapamil) behandling af alvorlig sygdom relateret til betændelse (f.eks. dexamethason, prednisolon) behandling af HIV-infektion (f.eks. indinavir, ritonavir) behandling af bakterieinfektioner (f.eks. clarithromycin, doxycyclin) behandling af skjoldbruskkirtelsygdomme (f.eks. levothyroxin) behandling af urinsyregigt (f.eks. colchicin) behandling af mavelidelser (f.eks. omeprazol) forebyggelse af hjertesygdomme eller slagtilfælde (f.eks. dabigatran-etexilat) forebyggelse af organafstødning (f.eks. tacrolimus)
English: CYP2C8 inhibitors
Danish: CYP2C8-hæmmere
English: The analysis involved 448 skeletal-related events, of which 277 events (62%) were radiation to bone, 95 events (21%) were spinal cord compression, 47 events (10%) were pathologic bone fracture, 36 events (8%) were change in antineoplastic therapy to treat bone pain, and 7 events (2%) were surgery to bone.
Danish: Analysen omfattede 448 skeletrelaterede hændelser, hvoraf 277 (62 %) var strålebehandling af knogler, 95 (21 %) var rygmarvskompression,
English: If you take more Xtandi than you should
Danish: Hvis du har taget for meget Xtandi
English: xtandi 40 mg
Danish: LÆGEMIDLETS NAVN Xtandi 40 mg
English: Xtandi 80 mg film-coated tablets enzalutamide
Danish: Xtandi 80 mg filmovertrukne tabletter enzalutamid
English: Astellas Pharma Europe B.V. Sylviusweg 62
Danish: Astellas Pharma Europe B.V.
English: Seizures
Danish: Amning
English: Astellas Pharma B.V. Tel: + 31 (0)71 5455745
Danish: Tel: + 31 (0)71 5455745
English: Astellas Pharma Ltd. Tel: +44 (0)203 379 8700
Danish: Tel: + 44 (0)203 379 8700
English: nicardipine, nifedipine, propranolol, verapamil) - Treat serious disease related to inflammation (e.g. dexamethasone, prednisolone) - Treat HIV infection (e.g. indinavir, ritonavir) - Treat bacterial infections (e.g. clarithromycin, doxycycline) - Treat thyroid disorders (e.g. levothyroxine)
Danish: behandling af hjertesygdomme eller sænkning af blodtryk (f.eks. bisoprolol, digoxin, diltiazem, felodipin, nicardipin, nifedipin, propranolol, verapamil) behandling af alvorlig sygdom relateret til betændelse (f.eks. dexamethason, prednisolon) behandling af HIV-infektion (f.eks. indinavir, ritonavir) behandling af bakterieinfektioner (f.eks. clarithromycin, doxycyclin) behandling af skjoldbruskkirtelsygdomme (f.eks. levothyroxin) behandling af urinsyregigt (f.eks. colchicin) behandling af mavelidelser (f.eks. omeprazol) forebyggelse af hjertesygdomme eller slagtilfælde (f.eks. dabigatran-etexilat) forebyggelse af organafstødning (f.eks. tacrolimus)
English: Breast-feeding
Danish: Polyvinylacetatphthalat
English: Following oral administration of the soft capsule formulation (Xtandi 160 mg daily) in patients with metastatic CRPC, the steady-state plasma mean Cmax values for enzalutamide and its active metabolite are 16.6 μg/mL (23% CV) and 12.7 μg/mL (30% CV), respectively.
Danish: Efter oral administration af den bløde kapselformulering (Xtandi 160 mg dagligt) til patienter med metastatisk CRPC er de gennemsnitlige
English: Package leaflet: Information for the patient Xtandi 40 mg film-coated tablets
Danish: INFORMATION I BRAILLESKRIFT xtandi 40 mg filmovertrukne tabletter
English: Posology
Danish: TILLADELSEN
English: Astellas Pharma S.p.A. Tel: + 39 02 921381
Danish: Tel: + 39 02 921381
English: Seizure
Danish: Elimination
English: Linearity
Danish: Gelatine
English: PC: SN: NN:
Danish: SN:
English: EU/1/13/846/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/846/003
English: Capsule shell Gelatin
Danish: Mave-tarm-kanalen
English: EU/1/13/846/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/846/002
English: This improves the ability to produce antibodies.
Danish: Derved øges evnen til at danne antistoffer.
English: Vaccination with Vaxelis should be carried out according to official recommendations.
Danish: Vaccination med Vaxelis bør foretages i henhold til officielle anbefalinger.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Danish: Dette er med til at beskytte mod de sygdomme, som disse bakterier og virus fremkalder.
English: With regard to safety, the CHMP considered that overall its safety profile is similar to other vaccines.
Danish: Hvad angår sikkerheden fandt CHMP, at den overordnede sikkerhedsprofil svarer til andre vacciners.
English: This is a summary of the European public assessment report (EPAR) for Vaxelis.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vaxelis.
English: The full EPAR and risk management plan summary for Vaxelis 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 Vaxelis findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These antibody levels have been previously shown to protect against these diseases.
Danish: Disse koncentrationer af antistoffer er tidligere påvist at beskytte mod disse sygdomme.
English: A risk management plan has been developed to ensure that Vaxelis is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vaxelis anvendes så sikkert som muligt.
English: It is used in babies and toddlers aged from six weeks to protect against the following infectious diseases:
Danish: Den kan anvendes hos spædbørn og småbørn over seks uger til at beskytte mod følgende smitsomme sygdomme:
English: Other information about Vaxelis
Danish: Andre oplysninger om Vaxelis
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis'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 Vaxelis opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This means that some of the active substances are fixed onto minute particles of aluminium compounds.
Danish: Det vil sige, at nogle af de aktive stoffer er hæftet på ganske små partikler af aluminiumforbindelser.
English: What measures are being taken to ensure the safe and effective use of Vaxelis?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vaxelis?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend itself against diseases.
Danish: Vacciner virker ved at "lære" organismens naturlige forsvar (immunsystemet) at forsvare organismen mod sygdomme.
English: A booster dose should be given at least six months after the last of these initial doses.
Danish: Der bør gives en forstærkerdosis (boosterdosis) mindst seks måneder efter den sidste af disse indledende doser.
English: It can only be obtained with a prescription.
Danish: Lægemidlet udleveres kun efter recept.
English: Vaxelis is a vaccine.
Danish: Vaxelis er en vaccine.
English: The recommended initial vaccination schedule is either two or three doses, given at least one month apart to children aged over six weeks.
Danish: Den anbefalede indledende vaccinationsplan er enten to eller tre doser, der gives med mindst én måneds mellemrum til børn over seks uger.
English: They then received a booster dose shortly after their first birthday.
Danish: De fik derefter en boosterdosis kort efter et-årsalderen.
English: It is not intended to provide practical advice on how to use Vaxelis.
Danish: Det er ikke en praktisk vejledning i, hvordan Vaxelis bør anvendes.
English: What is Vaxelis and what is it used for?
Danish: Hvad er Vaxelis, og hvad anvendes det til?
English: Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life.
Danish: Vaxelis er undersøgt i to hovedundersøgelser med over 2 500 spædbørn og småbørn over 6 uger, som fik enten to eller tre doser af vaccinen i de første seks levemåneder.
English: It must not be used in children who have an uncontrolled or severe illness affecting the brain or nervous system, such as uncontrolled epilepsy (fits), unless the condition has stabilised with treatment and the benefit of vaccination clearly outweighs the risk.
Danish: Det må ikke anvendes til børn med ukontrolleret eller svær hjerne- eller nervesygdom såsom (anfald af) ukontrolleret epilepsi, medmindre sygdommen er stabiliseret ved behandling, og fordelene ved vaccination klart overstiger risikoen.
English: Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.
Danish: Begge undersøgelser viste, at Vaxelis frembringer tilstrækkelige koncentrationer af antistoffer til at beskytte mod alle disse seks sygdomme hos mellem 90 og 100 % af de børn, der fuldfører vaccinationsprogrammet med Vaxelis.
English: What are the risks associated with Vaxelis?
Danish: Hvilke risici er der forbundet med Vaxelis?
English: The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis.
Danish: Virkningerne af Vaxelis blev sammenlignet med virkningerne af en anden vaccine, Infanrix hexa, der er sammensat med henblik på at beskytte mod de samme seks sygdomme som Vaxelis.
English: Why is Vaxelis approved?
Danish: Hvorfor blev Vaxelis godkendt?
English: • diphtheria (a highly contagious disease that affects the throat and skin, and can cause damage to the heart and other organs);
Danish: • difteri (en meget smitsom sygdom, der angriber halsen og huden og kan beskadige hjertet og andre organer)
English: Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Danish: Vaxelis må ikke anvendes hos børn, der nogensinde har haft en allergisk reaktion over for Vaxelis eller en vaccine med samme komponenter, herunder de stoffer, der er anvendt ved fremstilling af vaccinen, og som er til stede i yderst små mængder (såsom antibiotikaene neomycin og streptomycin).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vaxelis, 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 Vaxelis, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against.
Danish: Vaxelis indeholder små mængder materiale udvundet af de virus og bakterier, som det beskytter mod.
English: Vaxelis is given by injection into a muscle, normally in the upper thigh or the shoulder.
Danish: Vaxelis gives ved indsprøjtning i en muskel, normalt i overlåret eller skulderen.
English: The vaccine is ‘adsorbed' on aluminium compounds.
Danish: Vaccinen har sat sig på overfladen (er "adsorberet") på aluminiumforbindelser.
English: • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
Danish: • børnelammelse, polio (poliomyelitis, en sygdom, der angriber nerverne og kan medføre muskelsvaghed eller lammelse)
English: For more information about treatment with Vaxelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vaxelis, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It must not be used in children who have ever had encephalopathy (a brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components.
Danish: Det må ikke anvendes hos børn, der nogensinde har en hjernesygdom (encefalopati) af ukendt årsag inden for syv dage efter at være blevet vaccineret med en vaccine indeholdende komponenter fra kighoste (pertussis).
English: • invasive diseases (such as pneumonia and meningitis) caused by H. influenzae type-b bacteria
Danish: • indtrængende (invasive) sygdomme (såsom lungebetændelse og meningitis) forårsaget af bakterien H. influenzae type b (Hib).
English: The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting.
Danish: De hyppigste bivirkninger ved Vaxelis er smerter, hævelse og rødme på injektionsstedet, irritabilitet, grådreaktion, søvnighed, feber, nedsat appetit og opkastning.
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Danish: Difteri, stivkrampe, pertussis (acellulær, komponent-), hepatitis B (rDNA), poliomyelitis (inaktiveret) og Haemophilus type b konjugeret vaccine (adsorberet)
English: • tetanus (lockjaw, usually caused by infection of a wound);
Danish: • stivkrampe (tetanus, opstår sædvanligvis ved infektion i sår)
English: Vaxelis or an appropriate combination of other vaccines can be used for the booster dose.
Danish: Som boosterdosis kan anvendes Vaxelis eller en passende kombination af andre vacciner.
English: For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Vaxelis, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In these studies, children also received other vaccines according to local vaccination schedules to protect against other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and varicella.
Danish: I disse undersøgelser fik børnene i henhold til lokale vaccinationsplaner også andre vacciner som beskyttelse mod andre børnesygdomme såsom rotavirus-forårsaget mavetarmkatar, mæslinger, fåresyge, røde hunde og skoldkopper.
English: • pertussis (whooping cough);
Danish: • kighoste (pertussis)
English: The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis.
Danish: Det vigtigste mål for effektiviteten var dannelse af en koncentration af antistoffer, der vides at beskytte mod difteri, stivkrampe, polio, hepatitis B og infektioner med H. influenzae type b, og som forventes at beskytte mod kighoste.
English: For the full list of all side effects reported with Vaxelis, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Vaxelis fremgår af indlægssedlen.
English: What benefits of Vaxelis have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Vaxelis?
English: Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses.
Danish: Vaxelis er en vaccine, der indeholder aktive stoffer afledt af difteri-, stivkrampe-, kighoste- og Haemophilus influenzae type b-bakterier, hepatitis B-virus og inaktiverede poliovirus.
English: How is Vaxelis used?
Danish: Hvordan anvendes Vaxelis?
English: How does Vaxelis work?
Danish: Hvordan virker Vaxelis?
English: • hepatitis B (a viral liver infection);
Danish: • den virusforårsagede leverbetændelse hepatitis B
English: Vaxelis is available in pre-filled syringes as a suspension for injection.
Danish: Vaxelis fås som injektionsvæske, suspension, i fyldte sprøjter.
English: The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib.
Danish: Udvalget fandt det påvist, at Vaxelis medfører dannelse af beskyttende koncentrationer af antistoffer mod difteri, stivkrampe, kighoste, hepatitis B-virus, poliovirus og Hib.
English: When a child is given the vaccine, the immune system recognises the materials from the bacteria and viruses as foreign and makes antibodies against them.
Danish: Når et barn bliver vaccineret, opfatter immunsystemet bakterie- og virusmaterialet i vaccinen som "fremmed" og danner antistoffer mod dem. Immunsystemet vil derefter kunne danne antistoffer hurtigere, hvis personen naturligt udsættes for de samme bakterier eller virus.
English: 14 June 2010
Danish: 14. juni 2010
English: The European Commission issued a decision on 14 June 2010.
Danish: Europa-Kommissionen traf en afgørelse den 14. juni 2010.
English: It was used in combination with an appropriate diet.
Danish: Det blev anvendt i kombination med en passende diæt.
English: The review was carried out under an ‘Article 107' procedure1.
Danish: Revurderingen fandt sted inden for rammerne af en procedure i henhold til artikel 1071.
English: Prof. Philippe Lechat (France)
Danish: Prof. Philippe Lechat (Frankrig)
English: based on each patient's symptoms and risk profile.
Danish: som er baseret på de enkelte patienters symptomer og risikoprofil.
English: This has been known to make patients feel less hungry (appetite suppressant).
Danish: Det er kendt som et middel, der får patienterne til at føle sig mindre sultne (et appetithæmmende middel).
English: What is benfluorex?
Danish: Hvad er benfluorex?
English: 2 Benfluorex-containing products are also authorised but not marketed in Cyprus and Luxemburg.
Danish: 2 Lægemidler, der indeholder benfluorex, er også godkendt, men markedsføres ikke, i Cypern og Luxemburg.