FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have a low body weight.
Danish: - hvis du har svære leverproblemer.
English: Very common • Trembling
Danish: Meget almindelig • Rysten.
English: White cap imprinted with “R” & white body imprinted with “1.5”
Danish: Hvid hætte præget med "R" og hvid skal præget med "1.5"
English: Pallagi út 13
Danish: Swensweg 5
English: Gastrointestinal disorders Very common Very common Very common Common
Danish: Vaskulære sygdomme Meget sjælden Mave-tarmkanalen Meget almindelig Meget almindelig Meget almindelig Almindelig
English: Yellow iron oxide (E 172)
Danish: Rød jernoxid (E 172)
English: The patients studied had an MMSE (Mini-Mental State Examination) score of 10 - 24.
Danish: Patienterne i studiet havde en MMSE (Mini-Mental State Examination) score på 10 - 24.
English: • Aggression , feeling restless
Danish: • Aggressiv adfærd, rastløshed
English: Table 2 shows the adverse reactions reported in patients with dementia associated with Parkinson's disease treated with rivastigmine.
Danish: Tabel 2 viser de bivirkninger, der er rapporteret hos patienter, som modtog behandling med rivastigmin, og som havde demens, der var associeret med Parkinsons sygdom.
English: EU/1/09/513/006 EU/1/09/513/007 EU/1/09/513/008 EU/1/09/513/009 EU/1/09/513/010
Danish: EU/1/09/513/001 EU/1/09/513/002 EU/1/09/513/003 EU/1/09/513/004
English: Adjusted treatment difference n/a p-value versus placebo ITT - LOCF population (n=287)
Danish: Justeret behandlingsforskel ikke relevant p-værdi versus placebo ITT - LOCF population
English: CIBIC-Plus: improvement
Danish: ADAS-Cog: mindst 4pointsforbedring CIBIC-Plus: forbedring
English: Patients with severe hepatic impairment have not been studied (see section 4.4).
Danish: Patienter med stærkt nedsat leverfunktion er ikke blevet undersøgt (se pkt.
English: What Rivastigmine Teva contains
Danish: Rivastigmin Teva indeholder:
English: Not applicable
Danish: Generel utilpashed
English: Hard capsule Orange colour cap imprinted with “R” & orange color body imprinted with “4.5”
Danish: Orange hætte præget med "R" og orange skal præget med "4.5"
English: Subjects with renal impairment:
Danish: Personer med nedsat nyrefunktion:
English: Česká republika Teva Pharmaceuticals CR, s.r.o.
Danish: Teva Pharmaceuticals CR, s.r.o.
English: PSURs
Danish: PSUR
English: Rivastigmine Teva 1.5 mg hard capsules
Danish: Rivastigmin Teva 1,5 mg hårde kapsler
English: Rivastigmine Teva 3 mg hard capsules contains 3 mg rivastigmine as rivastigmine hydrogen tartrate Rivastigmine Teva 4.5 mg hard capsules contains 4.5 mg rivastigmine as rivastigmine hydrogen tartrate
Danish: Rivastigmin Teva 1,5 mg hårde kapsler indeholder 1,5 mg rivastigmin som rivastigminhydrogentartrat Rivastigmin Teva 3 mg hårde kapsler indeholder 3 mg rivastigmin som rivastigminhydrogentartrat Rivastigmin Teva 4,5 mg hårde kapsler indeholder 4,5 mg rivastigmin som rivastigminhydrogentartrat Rivastigmin Teva 6 mg hårde kapsler indeholder 6 mg rivastigmin som rivastigminhydrogentartrat
English: - If you are allergic (hypersensitive) to rivastigmine (the active substance in Rivastigmine Teva)
Danish: Tag IKKE Rivastigmin Teva - hvis du er overfølsom (allergisk) over for rivastigmin (det aktive stof i Rivastigmin Teva) eller et af de øvrige indholdsstoffer i Rivastigmin Teva, som er anført i pkt.
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide Magnesium stearate
Danish: Kapselindhold Mikrokrystallinsk cellulose Hypromellose Siliciumdioxid, kolloid Magnesiumstearat
English: Hepatobililary disorders Not known
Danish: Lever og galdeveje Ikke kendt
English: HOW TO STORE RIVASTIGMINE TEVA
Danish: SÅDAN SKAL DU TAGE RIVASTIGMIN TEVA
English: Hard capsule Orange cap imprinted with “R” & flesh color body imprinted with “6”
Danish: Orange hætte præget med "R" og hudfarvet skal præget med "6"
English: Rivastigmine Teva 4.5 mg hard capsules
Danish: Rivastigmin Teva 4,5 mg hårde kapsler
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Rivastigmin Teva, skal du henvende dig til den lokale repræsentant:
English: Patients with visual
Danish: Ældre patienter
English: - If you have gastrointestinal reactions such as feeling sick (nausea) and being sick (vomiting) and diarrhoea.
Danish: - hvis du har gener fra mave-tarmkanalen, såsom kvalme, opkastning og diarré.
English: Anxiety
Danish: Agitation
English: - This medicine has been prescribed for you.
Danish: - Lægen har ordineret Rivastigmin Teva til dig personligt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 1.5 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Rivastigmin Teva 1,5 mg hårde kapsler
English: Elevated liver function tests
Danish: Forhøjede leverfunktionstest
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 1.5 mg hard capsules
Danish: LÆGEMIDLETS NAVN Rivastigmin Teva 1,5 mg hårde kapsler
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 4.5 mg hard capsules
Danish: LÆGEMIDLETS NAVN Rivastigmin Teva 4,5 mg hårde kapsler
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister - Rivastigmine Teva 1.5 mg hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort - Rivastigmin Teva 1,5 mg hårde kapsler
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 6 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Rivastigmin Teva 6 mg hårde kapsler
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 4.5 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Rivastigmin Teva 4,5 mg hårde kapsler
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 3 mg hard capsules
Danish: LÆGEMIDLETS NAVN Rivastigmin Teva 3 mg hårde kapsler
English: Your doctor will tell you whether your illness allows you to drive vehicles and use machines safely.. Rivastigmine Teva may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose.If you feel dizzy or sleepy do not drive, use machines or perform any tasks that require your attention.
Danish: - hvis du har eller har haft uregelmæssig hjerterytme (puls) - hvis du har eller har haft mavesår - hvis du har eller har haft vandladningsbesvær - hvis du har eller har haft krampeanfald - hvis du har eller har haft astma eller en svær luftvejssygdom - hvis du har eller har haft nedsat nyrefunktion - hvis du har eller har haft nedsat leverfunktion - hvis du ryster meget - hvis din kropsvægt er lav
English: WHAT RIVASTIGMINE TEVA IS AND WHAT IT IS USED FOR The active substance of Rivastigmine Teva is rivastigmine Rivastigmine belongs to a class of substances called cholinesterase inhibitors.
Danish: Rivastigmin tilhører en medicingruppe, der kaldes kolinesterasehæmmere.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder rivastigminhydrogentartrat svarende til 4,5 mg rivastigmin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder rivastigminhydrogentartrat svarende til 1,5 mg rivastigmin
English: Excretion:
Danish: Udskillelse:
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister - Rivastigmine Teva 4.5 mg hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort - Rivastigmin Teva 4,5 mg hårde kapsler
English: NAME OF THE MEDICINAL PRODUCT Rivastigmine Teva 6 mg hard capsules
Danish: LÆGEMIDLETS NAVN Rivastigmin Teva 6 mg hårde kapsler
English: This medicinal product does not require any special storage conditions Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder rivastigminhydrogentartrat svarende til 6 mg rivastigmin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton - Rivastigmine Teva 3 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske - Rivastigmin Teva 3 mg hårde kapsler
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 1.5 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tabletbeholder - Selvklæbende papiretiket - Rivastigmin Teva 1,5 mg hårde kapsler
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister - Rivastigmine Teva 6 mg hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort - Rivastigmin Teva 6 mg hårde kapsler
English: Capsule contents Microcrystalline cellulose Hypromellose Colloidal silicon dioxide
Danish: Mikrokrystallinsk cellulose Hypromellose
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet Container - Self-adhesive, paper label - Rivastigmine Teva 4.5 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tabletbeholder - Selvklæbende papiretiket - Rivastigmin Teva 4,5 mg hårde kapsler
English: mg group, corresponding to this definition, was 9.3 mg.
Danish: Den gennemsnitlige aktuelle dagsdosis for responderende i 6 - 12 mg gruppen, der svarede til denne definition, var 9,3 mg.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 6 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tabletbeholder - Selvklæbende papiretiket - Rivastigmin Teva 6 mg hårde kapsler
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister - Rivastigmine Teva 3 mg hard capsules
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blisterkort - Rivastigmin Teva 3 mg hårde kapsler
English: Heptatitis
Danish: Bradykinesi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER En kapsel indeholder rivastigminhydrogentartrat svarende til 3 mg rivastigmin
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Tablet container - Self-adhesive, paper label - Rivastigmine Teva 3 mg hard capsules
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Tabletbeholder - Selvklæbende papiretiket - Rivastigmin Teva 3 mg hårde kapsler
English: Not known • Being violently sick (vomiting) that can cause tearing of the tube that connects your mouth with
Danish: • Voldsom opkastning, der kan medføre hul (ruptur) i spiserøret
English: Muscle rigidity
Danish: Sort jernoxid
English: Flesh colour cap imprinted with “R” & flesh color body imprinted with “3”
Danish: Hudfarvet hætte præget med "R" og hudfarvet skal præget med "3"
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 4.5 mg For a full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder rivastigminhydrogentartrat svarende til 4,5 mg rivastigmin.
English: Dose titration
Danish: Titandioxid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 1.5 mg For a full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder rivastigminhydrogentartrat svarende til 1,5 mg rivastigmin.
English: What Rivastigmine Teva looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 6 mg For a full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder rivastigminhydrogentartrat svarende til 6 mg rivastigmin.
English: or to any of the other ingredients of Rivastigmine Teva listed in section 6 of this leaflet - If this applies to you, tell your doctor and do not take Rivastigmine Teva.
Danish: Hvis dette gælder for dig, skal du fortælle det til din læge og ikke tage Rivastigmin Teva.
English: Rivastigmine Teva 6 mg
Danish: INFORMATION I BRAILLE-SKRIFT Rivastigmin Teva 6 mg
English: - HDPE tablet container with a polypropylene cap and induction seal: 250 capsules
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 250 hårde kapsler
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains rivastigmine hydrogen tartrate corresponding to rivastigmine 3 mg For a full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder rivastigminhydrogentartrat svarende til 3 mg rivastigmin.
English: Suomi/Finland ratiopharm Oy
Danish: België/Belgique/Belgien
English: Frequency categories are defined using the following convention: 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 available data)
Danish: Frekvenskategorier defineres under anvendelse af følgende konvention: meget almindelig (≥1/10);
English: Maintenance dose:
Danish: Oversigt over indlægssedlen:
English: BATCH NUMBER BN
Danish: BATCHNUMMER
English: • Slow heartbeat
Danish: • Langsom hjerterytme (puls)
English: Vascular Disorders Very rare
Danish: Ikke almindelig Sjælden Meget sjælden
English: Subjects with renal impairment
Danish: Personer med nedsat nyrefunktion
English: This dose may also be adjusted.
Danish: Denne dosis kan også justeres.
English: This was switched to a full marketing authorisation on 11 January 2007.
Danish: Den blev ændret til en fuldstændig markedsføringstilladelse den 11. januar 2007.
English: This is a summary of the European public assessment report (EPAR) for Sutent.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sutent.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent on 19 July 2006.
Danish: Europa-Kommissionen udstedte en betinget markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sutent den 19. juli 2006.
English: The full EPAR for Sutent can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Sutent findes på agenturets websted under ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.
Danish: Det primære effektmål i alle undersøgelserne var, hvor lang tid patienterne levede, uden at deres tumorer forværredes.
English: Other information about Sutent
Danish: Andre oplysninger om Sutent
English: It is available as capsules (12.5 mg, 25 mg, 37.5 mg and 50 mg).
Danish: Det fås som kapsler (12,5 mg, 25 mg, 37,5 mg, 50 mg).
English: A risk management plan has been developed to ensure that Sutent is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Sutent anvendes så sikkert som muligt.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Danish: Da virksomheden har indsendt de fornødne supplerende oplysninger, er godkendelsen ændret fra at være under særlige omstændigheder til at være en fuldgyldig godkendelse.
English: What measures are being taken to ensure the safe and effective use of Sutent?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Sutent?
English: This means that it blocks some specific enzymes known as protein kinases.
Danish: Det betyder, at stoffet blokerer nogle bestemte enzymer, der kaldes proteinkinaser.
English: For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sutent, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body.
Danish: Sutent anvendes til patienter med GIST, der ikke kan fjernes kirurgisk, eller som har bredt sig til andre dele af kroppen.
English: Treatment with Sutent should be started by doctors who have experience in administering cancer medicines.
Danish: Behandling med Sutent bør kun indledes af læger, som har erfaring i at administrere lægemidler mod kræft.
English: Sutent is used to treat adults with the following types of cancer:
Danish: Sutent anvendes til behandling af voksne med følgende kræftformer:
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sutent.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Sutent skal anvendes.
English: Sutent is a medicine that contains the active substance sunitinib.
Danish: Sutent er et lægemiddel, som indeholder det aktive stof sunitinib.
English: The CHMP decided that Sutent's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Sutent opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse.
English: The most common side effects with Sutent (seen in more than 1 in 10 patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), respiratory (such as shortness of breath and cough) and skin disorders (such as skin discoloration, dryness of the skin and rash), hair color changes, dysgeusia (taste disturbances), epistaxis (nosebleeds), loss of appetite, hypertension (high blood pressure), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), hypothyroidism (an underactive thyroid gland), insomnia (difficulty falling and staying asleep), dizziness, headache, arthralgia (joint pain), neutropenia (low levels of neutrophils, a type of white blood cell), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), and leucopenia (low white blood cell counts).
Danish: De hyppigste bivirkninger ved Sutent (som optræder hos mere end 1 ud af 10 patienter) er træthed, gastrointestinale gener (såsom diarré, kvalme, betændelse i mundslimhinden, fordøjelsesbesvær og opkastning), respirationsforstyrrelser (hoste og stakåndethed), hudlidelser ( misfarvning af huden, tør hud og udslæt), ændring af hårfarve, smagsforstyrrelser, epistaksis (næseblod), appetitløshed, hypertension (højt blodtryk), smertefuld rødme på hænder og fødder, hypotyreose (for lav produktion af skjoldbruskkirtelhormon), søvnløshed (vanskeligt ved at falde i søvn og sove), hovedpine, ledsmerter, neutropeni (lavt antal neutrofiler, der er en type hvide blodlegemer), trombocytopeni (lavt antal blodplader), anæmi (lavt antal røde blodlegemer), leukopeni (et lavt antal hvide blodlegemer).
English: Sutent is used if the disease is getting worse and the tumour cells are well-differentiated (similar to normal cells in the pancreas).
Danish: Sutent anvendes, hvis sygdommen forværres, og hvis tumorcellerne er veldifferentierede (er identiske med normale celler i pancreas).
English: Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours.
Danish: Sutent var mere effektivt end placebo til behandling af GIST og pancreatiske neuroendokrine tumorer.
English: The active substance in Sutent, sunitinib, is a protein kinase inhibitor.
Danish: Det aktive stof i Sutent, sunitinib, er en proteinkinasehæmmer.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sutent, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Sutent, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: • pancreatic neuroendocrine tumours (tumours of the hormone-producing cells in the pancreas) that have spread or cannot be removed with surgery.
Danish: • pancreatiske neuroendokrine tumorer (tumorer af de hormonproducerende celler i pancreas), der har spredt sig, eller som ikke kan fjernes kirurgisk.
English: For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
Danish: Til pancreatiske neuroendokrine tumorer var tallene 11,4 måneder i Sutentgruppen og 5,5 måneder i placebogruppen.
English: By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
Danish: Ved at blokere disse enzymer kan Sutent begrænse væksten og spredningen af kræften og afskære blodforsyningen, som får kræftcellerne til at vokse.
English: It is used after treatment with imatinib (another cancer medicine) has failed;
Danish: Det anvendes efter, at behandling med imatinib (et andet lægemiddel mod kræft) har været uden resultat
English: What is the risk associated with Sutent?
Danish: Hvilken risiko er der forbundet med Sutent?
English: For the full list of all side effects and restrictions with Sutent, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Sutent fremgår af indlægssedlen.
English: For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ‘rest period'.
Danish: Til GIST og metastatisk renalcellecarcinom gives Sutent i seks ugers cyklusser i doser a 50 mg én gang dagligt i fire uger efterfulgt af en "hvileperiode" på to uger.
English: Sutent was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma.
Danish: Sutent blev oprindeligt godkendt under "særlige omstændigheder", eftersom der afventedes yderligere dokumentation om lægemidlet, navnlig vedrørende behandling af renalcellecarcinom.
English: • gastrointestinal stromal tumour (GIST), a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs.
Danish: • gastrointestinal stromal tumor (GIST), som er en form for kræft i mave og tarme, hvor der opstår en ukontrolleret vækst af celler i disse organers støttevæv.
English: Sutent was also compared with another cancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
Danish: Sutent blev også sammenlignet med et andet lægemiddel mod kræft, interferon alfa, hos 750 patienter med metastatisk renalcellecarcinom, hvis kræft ikke tidligere var blevet behandlet.
English: Why has Sutent been approved?
Danish: Hvorfor blev Sutent godkendt?
English: Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.
Danish: Sutent blev sammenlignet med placebo (en virkningsløs behandling) hos 312 patienter med GIST, hvis tidligere behandling med imatinib ikke havde haft effekt, og hos 171 patienter med forværrede pancreatiske neuroendokrine tumorer, som ikke kunne fjernes kirurgisk.