FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of a 100 mg dose of a solution formulation of sorafenib, 96 % of the dose was recovered within 14 days, with 77 % of the dose excreted in faeces, and 19 % of the dose excreted in urine as glucuronidated metabolites.
Danish: Efter oral administration af en 100 mg dosis af en sorafenibopløsning blev 96 % af dosis genfundet i løbet af 14 dage.
English: The median PFS was 167 days for patients randomised to sorafenib compared to 84 days for placebo patients (HR = 0.44; 95 % CI: 0.35 - 0.55; p < 0.000001).
Danish: Den gennemsnitlige PFS var 167 dage for patienter randomiseret til sorafenib sammenlignet med 84 dage for placebopatienter (HR = 0,44; 95 % CI: 0,35 - 0,55; p < 0,000001).
English: m. b. H. Tel: +43-(0)1-711 46-0
Danish: Tel: +43-(0)1-711 46-0
English: Blood and lymphatic system disorders lymphopenia leucopenia neutropenia anaemia thrombocytopenia
Danish: Blod og lymfesystem lymfopeni leukopeni neutropeni anæmi trombocytopeni
English: In study 100554 (HCC), 0.99% of those treated with sorafenib and 1.1% receiving placebo were reported with these events.
Danish: I studie 100554 (HCC) blev disse bivirkninger set hos 0,99 % af de patienter, der blev behandlet med sorafenib, og hos 1,1 % af de patienter, der fik placebo.
English: In these studies CTCAE Grade 3 hypokalaemia occurred in 1.1% and 0.4% of sorafenib treated patients and 0.2% and 0.7% of patients in the placebo group.
Danish: I disse studier forekom CTCAE grad 3 hypokaliæmi hos 1,1 % og 0,4 % af de sorafenib-behandlede patienter og hos 0,2 % og 0,7 % af patienterne i placebogruppen.
English: In two randomised trials investigating patients with Non-Small Cell Lung Cancer in the subgroup of patients with squamous cell carcinoma treated with sorafenib as add-on to paclitaxel/carboplatin, the HR for overall survival was found to be 1.81 (95% CI 1.19; 2.74) and as add-on to gemcitabine/cisplatin 1.22 (95% CI 0.82; 1.80).
Danish: I to randomiserede studier, der undersøgte patienter med ikke-småcellet lungekræft, var hazard ratio (HR) for den samlede overlevelse 1,81 (95% CI 1,19; 2,74) i undergruppen af patienter med pladecellekarcinom, som blev behandlet med sorafenib som tillæg til paclitaxel/carboplatin, og 1,22 (95% CI 0,82; 1,80) ved tillæg til gemcitabin/cisplatin.
English: Take special care with Nexavar
Danish: Vær ekstra forsigtig med at tage Nexavar
English: In study 11213 (RCC) adverse events consistent with congestive heart failure were reported in 1.7% of patients treated with sorafenib and 0.7% receiving placebo.
Danish: I studie 11213 (RCC) blev der set bivirkninger, der svarer til hjerteinsufficiens, hos 1,7 % af de patienter, der blev behandlet med sorafenib, og hos 0,7 % af de patienter, der fik placebo.
English: Hypocalcaemia in DTC
Danish: Hypokalcæmi ved DTC
English: Skin and subcutaneous tissue disorders dry skin rash alopecia hand foot skin reaction** erythema pruritus keratoacanthoma/ squamous cell cancer of the skin dermatitis exfoliative acne skin desquamation hyperkeratosis eczema erythema multiforme radiation recall dermatitis StevensJohnson syndrome leucocytoclastic vasculitis toxic epidermal necrolysis*
Danish: Hud og subkutane væv tør hud hududslæt alopeci hånd-fod-hudreaktion** erytem pruritus keratoakantom/ spinocellulært karcinom i huden dermatitis exfoliativa akne hudafskalning hyperkeratose eksem erythema multiforme radiation recall dermatit StevensJohnsons syndrom Leukocytoklastisk vasculitis toksisk epidermal nekrolyse*
English: Τηλ: +30 210 61 87 500
Danish: Bayer Ελλάς ΑΒΕΕ Τηλ: +30 210 61 87 500
English: may affect up to 1 in 10 people - flu-like illness - indigestion (dyspepsia) - difficulty swallowing (dysphagia) - inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation) - low calcium levels in the blood (hypocalcaemia) - low potassium levels in the blood (hypokalaemia) - low blood sugar level (hypoglycaemia) - muscle pain (myalgia) - disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy) - depression - erection problems (impotence) - altered voice (dysphonia) - acne - inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation) - heart failure - heart attack (myocardial infarction) or chest pain - tinnitus (ringing sound in the ear) - kidney failure - abnormally high levels of protein in the urine (proteinuria) - general weakness or loss of strength (asthenia) - decrease in the number of white blood cells (leucopenia and neutropenia) - decrease in the number of red blood cells (anaemia) - low number of platelets in the blood (thrombocytopenia) - inflammation of hair follicles (folliculitis) - underactive thyroid gland (hypothyroidism) - low sodium levels in the blood (hyponatraemia) - distortion of the sense of taste (dysgeusia) - red in the face and often other areas of the skin (flushing) - runny nose (rhinorrhoea) - heartburn (gastro oesophageal reflux disease) - skin cancer (keratoacanthomas/squamous cell cancer of the skin) - a thickening of the outer layer of the skin (hyperkeratosis) - a sudden, involuntary contraction of a muscle (muscle spasms)
Danish: Almindelige bivirkninger forekommer hos op til 1 ud af 10 behandlede - influenzalignende sygdom - dårlig fordøjelse (dyspepsi) - synkebesvær - betændelseslignende reaktion i munden eller tør mund, smerter i tungen (stomatitis og slimhinde inflammation) - lavt calciumindhold i blodet (hyperkalcæmi) - lavt kaliumindhold i blodet (hypokaliæmi) - lavt blodsukkerniveau (hypoglykæmi) - muskelsmerter (myalgi) - føleforstyrrelser i fingre og tæer, inklusive stikken og følelsesløshed (perifer sensorisk neuropati) - depression - erektionsproblemer (impotens) - ændret stemme - akne - betændt, tør eller skællende hud (dermatitis, hudafskalning) - hjertesvigt - hjerteanfald (myokardieinfarkt) eller brystsmerter - tinnitus (susen for ørerne) - nyresvigt - unormalt højt indhold af proteiner i urinen (proteinuri) - generel svaghed eller tab af styrke - nedsat antal hvide blodlegemer (leukopeni og neutropeni) - nedsat antal røde blodlegemer (anæmi) - lavt antal blodplader (trombocytopeni) - infektion i hårsækkene - nedsat aktivitet i skjoldbruskkirtlen (hypotyroidisme) - lavt natriumindhold i blodet (hyponatriæmi) - smagsforstyrrelser - rødme i ansigt og ofte på andre hudområder (flushing) - næseflåd - halsbrand (gastroøsofageal refluks) - hudkræft (keratoakantom)/spinocellulært karcinom i huden) - fortykkelse af hudens øverste lag (hyperkeratose) - pludselige, ufrivillige muskelsammentrækninger (muskelspasmer)
English: No studies have been conducted to investigate the pharmacokinetics of sorafenib in paediatric patients.
Danish: Der er ikke foretaget studier for at undersøge farmakokenitikken af sorafenib hos børn.
English: CTCAE Grade 3 or 4 amylase elevations were reported in 1 % and 2 % of patients in the sorafenib group in study 1 and study 3, respectively, compared to 3 % of patients in each placebo group.
Danish: Stigningerne af amylase CTCAE Grad 3 eller 4 blev rapporteret hos 1 % og 2 % af patienterne i sorafenib-gruppen i henholdsvis studie 1 og studie 3, sammenlignet med 3 % af patienterne i hver placebogruppe.
English: The aetiology of hypophosphataemia associated with sorafenib is not known.
Danish: Ætiologien om hypofosfatæmi associeret med sorafenib er ikke kendt.
English: CTCAE grade 3 hypocalcaemia (6.0 - 7.0 mg /dL) occurred in 1.1% and 1.8% of sorafenib treated patients and 0.2% and 1.1% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia (< 6.0 mg/dL) occurred in 1.1% and 0.4% of sorafenib treated patients and 0.5% and 0% of patients in the placebo group in study 1 and 3, respectively.
Danish: CTCAE grad 3 hypokalcæmi (6,0-7,0 mg/dl) forekom hos 1,1% og 1,8% af de patienter, der blev behandlet med sorafenib, og hos 0,2% og 1,1% af patienterne i placebogruppen, og CTCAE grad 4 hypokalcæmi (< 6,0 mg/dl) forekom hos 1,1% og 0,4% af de patienter, der blev behandlet med sorafenib, og hos 0,5% og 0% af patienterne i placebogruppen i henholdsvis studie 1 og 3.
English: Paclitaxel/carboplatin o Administration of paclitaxel (225 mg/m2) and carboplatin (AUC = 6) with sorafenib (≤ 400 mg twice daily), administered with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration), resulted in no significant effect on the pharmacokinetics of paclitaxel.
Danish: Indgift af paclitaxel (225 mg/m2) og carboplatin (AUC = 6) sammen med sorafenib (≤ 400 mg to gange dagligt), indgivet med en 3-dages pause i doseringen af sorafenib (to dage før og på dagen for indgift af paclitaxel/carboplatin), havde ingen signifikant virkning på paclitaxels farmakokinetik.
English: Co-administration of capecitabine (750-1050 mg/m2 twice daily, Days 1-14 every 21 days) and sorafenib (200 or 400 mg twice daily, continuous uninterrupted administration) resulted in no significant change in sorafenib exposure, but a 15-50% increase in capecitabine exposure and a 0-52% increase in 5-FU exposure.
Danish: Samtidig indgift af capecitabin (750-1.050 mg/m2 to gange dagligt på dag 1-14 hver 21. dag) og sorafenib (200 eller 400 mg to gange dagligt med kontinuerlig, uafbrudt indgift) medførte ingen signifikant ændring i sorafenib-eksponering, men en 15-50 % stigning i capecitabin-eksponering og en 0-52 % stigning i 5-FU-eksponering.
English: Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of sorafenib, or in severe or persistent cases, permanent discontinuation of sorafenib (see section 4.8).
Danish: Håndtering af dermatologisk toksicitet kan indebære topikal behandling for at lindre symptomer, midlertidig afbrydelse af behandlingen og/eller dosisjustering af sorafenib.
English: Sorafenib inhibited CYP2B6, CYP2C8 and CYP2C9 in vitro with similar potency.
Danish: Sorafenib hæmmede CYP2B6, CYP2C8 og CYP2C9 i samme grad in vitro.
English: The aetiology of hypocalcaemia associated with sorafenib is not known.
Danish: Ætiologien af hypokalcæmi i forbindelse med sorafenib kendes ikke.
English: The clinical significance of the increases in sorafenib and paclitaxel exposure, upon co-administration of sorafenib without a break in dosing, is unknown.
Danish: Den kliniske betydning af stigningen i sorafenib- og paclitaxeleksponering ved samtidig indgift af sorafenib uden en pause i doseringen er ikke kendt.
English: Sorafenib inhibits tumour growth of a broad spectrum of human tumour xenografts in athymic mice accompanied by a reduction of tumour angiogenesis.
Danish: Sorafenib hæmmer tumorvækst i et bredt spektrum af humant tumorvæv implanteret i mus uden tymus fulgt af en reduktion af tumorangiogenese.
English: Rare: may affect up to 1 in 1,000 people - allergic reaction with swelling of the skin (e. g. face, tongue) that may cause difficulty in breathing or swallowing (angioedema) - abnormal heart rhythm (QT prolongation) - inflammation of the liver, which may lead to nausea, vomiting, abdominal pain, and jaundice
Danish: Sjældne bivirkninger forekommer hos op til 1 ud af 1.000 behandlede - allergisk reaktion med hævelser i huden (f.eks. ansigt og tunge), hvilket kan medføre vejrtrækningsbesvær eller synkebesvær (angioødem) - unormal hjerterytme (QT-forlængelse) - betændelse i leveren, hvilket kan medføre kvalme, opkastning, mavesmerter og gulsot
English: - The other ingredients are: Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
Danish: Tabletkerne: Croscarmellosenatrium; cellulose, mikrokrystallinsk; hypromellose; natriumlaurilsulfat; magnesiumstearat.
English: o Co-administration of paclitaxel (225 mg/m2, once every 3 weeks) and carboplatin (AUC=6) with sorafenib (400 mg twice daily, without a break in sorafenib dosing) resulted in a 47% increase in sorafenib exposure, a 29% increase in paclitaxel exposure and a 50% increase in 6OH paclitaxel exposure.
Danish: Samtidig indgift af paclitaxel (225 mg/m2 én gang hver tredie uge) og carboplatin (AUC=6) sammen med sorafenib (400 mg to gange dagligt uden pause i doseringen af sorafenib) medførte en 47 % stigning i sorafenib-eksponering, en 29 % stigning i paclitaxel-eksponering og en 50 % stigning i 6OH-paclitaxel-eksponering.
English: dyspepsia dysphagia gastro oesophageal reflux disease pancreatitis gastritis gastrointestinal perforations*
Danish: Mave-tarmkanalen diarré kvalme opkastning obstipation stomatitis (inklusive tør mund og glossodyni) dyspepsi dysfagi gastroøsefageal refluks-sygdom pankreatitis gastritis gastrointestinale perforationer*
English: CTCAE Grade 3 hypophosphataemia (1 - 2 mg/dl) in study 1 occurred in 13 % of sorafenib treated patients and 3 % of patients in the placebo group, in study 3 in 11 % of sorafenib treated patients and 2 % of patients in the placebo group.
Danish: I studie 1 forekom hypofosfatæmi CTCAE Grad 3 (1 - 2 mg/dl) hos 13 % af patienterne behandlet med sorafenib og hos 3 % af patienterne i placebogruppen, i studie 3 hos 11 % af patienterne behandlet med sorafenib og hos 2 % af patienterne i placebogruppen.
English: Inducers of metabolic enzymes
Danish: Inducere af metabolismeenzymer
English: General disorders and administration site conditions fatigue pain (including mouth, abdominal, bone, tumour pain and headache)
Danish: Almene symptomer og reaktioner på administrationsstedet træthed smerter (inklusive smerter fra mund, abdomen, skelet og tumor samt hovedpine) feber asteni influenzalignende sygdom mucosainflammation
English: Reproductive system and breast disorders erectile dysfunction gynaecomastia
Danish: Det reproduktive system og mammae erektil dysfunktion gynækomasti
English: Croscarmellose sodium Microcrystalline cellulose Hypromellose Sodium laurilsulfate Magnesium stearate
Danish: Croscarmellosenatrium Cellulose, mikrokrystallinsk Hypromellose Natriumlaurilsulfat Magnesiumstearat
English: Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
Danish: Nexavar er indiceret til behandling af hepatocellulært karcinom hos patienter (se pkt.
English: The median OS was not reached in the sorafenib arm and was 36.5 months in the placebo arm. One hundred fifty seven (75%) patients randomised to placebo and 61 (30%) patients randomised to sorafenib received open-label sorafenib.
Danish: 157 (75%) patienter, der var randomiseret til placebo, og 61 (30 %) patienter randomiseret til sorafenib fik open-label-sorafenib.
English: No formal studies of the effect of sorafenib on wound healing have been conducted.
Danish: Der er ikke foretaget metodiske studier vedrørende effekten af sorafenib på sårheling.
English: There are no data for patients with Child-Pugh C (severe) hepatic impairment.
Danish: Der er ingen data for patienter med Child-Pugh C (svært) nedsat leverfunktion.
English: If you are concerned, talk to a doctor.
Danish: Tal med Deres læge, hvis De er bekymret.
English: Each tablet contains 200 mg of sorafenib (as tosylate).
Danish: Hver tablet indeholder 200 mg sorafenib (som tosylat).
English: CTCAE Grade 3 or 4 lipase elevations occurred in 11 % and 9 % of patients in the sorafenib group in study 1 (RCC) and study 3 (HCC), respectively, compared to 7 % and 9 % of patients in the placebo group.
Danish: Stigninger af lipase CTCAE Grad 3 eller 4 forekom hos 11 % og 9 % af patienterne i sorafenib-gruppen i henholdsvis studie 1 (renalcellekarcinom) og studie 3 (hepatocellulært karcinom) sammenlignet med 7 % og 9 % af patienterne i placebogruppen.
English: What Nexavar is and what it is used for
Danish: Nexavar kan påvirke, hvordan
English: Renal and urinary disorders renal failure proteinuria nephrotic syndrome
Danish: Nyrer og urinveje nyresvigt proteinuri nefrotisk syndrom
English: In vitro, sorafenib inhibited glucuronidation via UGT1A1 and UGT1A9.
Danish: Sorafenib hæmmede glukuronidering via UGT1A1 og UGT1A9 in vitro.
English: Nexavar is also used to treat kidney cancer (advanced renal cell carcinoma) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable.
Danish: Nexavar bruges, når standardbehandling ikke har hjulpet til at stoppe Deres sygdom, eller når den ikke anses for at være den bedste løsning.
English: Some medicines may affect Nexavar, or be affected by it. Tell your doctor or pharmacist if you are taking, have recently taken or might take anything in this list or any other medicines, including medicines obtained without a prescription: - Rifampicin, Neomycin or other medicines used to treat infections (antibiotics) - St John's wort, a herbal treatment for depression - Phenytoin, carbamazepine or phenobarbital, treatments for epilepsy and other conditions - Dexamethasone, a corticosteroid used for various conditions - Warfarin or phenprocoumon, anticoagulants used to prevent blood clots - Doxorubicin, capecitabine, docetaxel, paclitaxel and irinotecan, which are cancer treatments - Digoxin, a treatment for mild to moderate heart failure
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler: - Rifampicin, neomycin eller andre lægemidler mod infektioner (antibiotika) - Perikon, et naturlægemiddel mod depression - Phenytoin, carbamazepin eller phenobarbital, lægemidler mod epilepsi og andre sygdomme - Dexamethason, et kortikosteroid mod forskellige tilstande - Warfarin eller phenprocoumon, blodfortyndende medicin til forebyggelse af blodpropper - Doxorubicin, capecitabin, docetaxel, paclitaxel og irinotecan, som er andre lægemidler mod kræft
English: Investigations weight decreased increased amylase increased lipase transient increase in transaminases transient increase in blood alkaline phosphatase
Danish: Undersøgelser vægttab forhøjet amylase forhøjet lipase forbigående stigning i aminotransferaser forbigående stigning i basisk fosfatase i blodet unormal INR unormalt protrombinniveau * Bivirkningerne kan være livstruende eller letale.
English: Each film-coated tablet contains 200 mg sorafenib (as tosylate).
Danish: Hver filmovertrukket tablet indeholder 200 mg sorafenib (som tosylat).
English: Combination with other anti-neoplastic agents
Danish: Kombination med andre antineoplastiske lægemidler
English: Hepatobiliary disorders increase in bilirubin and jaundice, cholecystitis, cholangitis drug induced hepatitis*
Danish: Lever og galdeveje stigning i bilirubin og gulsot cholecystitis cholangitis
English: Each film-coated tablet contains 200 mg of sorafenib (as tosylate).
Danish: Hver filmovertrukken tablet indeholder 200 mg sorafenib (som tosylat).
English: Co-administration of neomycin, a non-systemic antimicrobial agent used to eradicate gastrointestinal flora, interferes with the enterohepatic recycling of sorafenib (see section 5.2, Metabolism and Elimination), resulting in decreased sorafenib exposure.
Danish: Samtidig indgift af neomycin, et ikke-systemisk, antimikrobielt stof, der anvendes til at eradikere bakteriefloraen i mave og tarm, påvirker sorafenibs enterohepatiske recirkulation (se pkt.
English: Sorafenib therapy should be discontinued (see section 4.8).
Danish: Behandlingen med sorafenib skal seponeres (se pkt.
English: MedDRA. ° Cases have been reported in the post marketing setting.
Danish: ° Der er set tilfælde efter markedsføringen.
English: Nexavar 200 mg tablets sorafenib
Danish: Nexavar 200 mg tabletter sorafenib
English: In study 3 (see section 5.1) the incidence of treatmentemergent cardiac ischaemia/infarction events was 2.7 % in sorafenib patients compared with 1.3 % in the placebo group.
Danish: 5.1), var forekomsten af tilfælde med hjerteiskæmi/hjerteinfarkt 2.7 % hos sorafenib-patienterne sammenlignet med 1.3 % hos placebogruppen.
English: Drug-drug interactions
Danish: Lægemiddelsinteraktioner
English: CTCAE grade 3 hypocalcaemia occurred in 6.8% of sorafenib treated patients and 1.9% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia occurred in 3.4% of sorafenib treated patients and 1.0% of patients in the placebo group.
Danish: I de fleste rapporter var hypokalcæmi af lav grad. CTCAE grad 3 hypokalcæmi opstod hos 6,8 % af de sorafenibbehandlede patienter og hos 1,9 % af placebopatienterne, og CTCAE grad 4 hypokalcæmi opstod hos 3,4 % af de sorafenibbehandlede patienter og hos 1,0 % af placebopatienterne.
English: No data is available on patients with Child Pugh C (severe) hepatic impairment.
Danish: Der findes ingen tilgængelige data vedrørende patienter med Child-Pugh C (svært) nedsat leverfunktion.
English: Information about excipients
Danish: Information om hjælpestoffer
English: Because sorafenib could harm infant growth and development (see section 5.3), women must not breast-feed during sorafenib treatment.
Danish: Da sorafenib kan skade barnets vækst og udvikling (se pkt.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05 Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and antiangiogenic properties in vitro and in vivo.
Danish: Farmakoterapeutisk klassifikation: Proteinkinase-hæmmere, andre antineoplastiske lægemidler, ATCkode: L01XE05.
English: In clinical studies sorafenib has been administered with a variety of other anti-neoplastic agents at their commonly used dosing regimens including gemcitabine, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabine, doxorubicin, irinotecan, docetaxel and cyclophosphamide.
Danish: Disse inkluderer gemcitabin, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabin, doxorubicin, irinotecan, docetaxel og cyclophosphamid.
English: Nexavar 200 mg film-coated tablets
Danish: Nexavar 200 mg filmovertrukne tabletter
English: Posology adjustments
Danish: Dosisjustering
English: Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Danish: Patienter med risiko for nedsat nyrefunktion bør overvåges med hensyn til væske- og elektrolytbalance.
English: Not known: frequency cannot be estimated from the available data - impaired brain function that can be associated with e.g. drowsiness, behavioural changes, or confusion (encephalopathy) - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Danish: Ikke kendt kan ikke estimeres ud fra tilgængelige data - forstyrrelser i hjernen, der kan give f.eks. døsighed, adfærdsændringer eller forvirring
English: How to store Nexavar
Danish: Sådan skal De tage Nexavar
English: Common:
Danish: Filmovertræk:
English: Nexavar 200 mg film-coated tablets sorafenib
Danish: Nexavar 200 mg filmovertrukne tabletter sorafenib
English: In a randomised, placebo-controlled, double-blind study (study 1, see section 5.1) the incidence of treatment-emergent cardiac ischaemia/infarction events was higher in the sorafenib group (4.9 %) compared with the placebo group (0.4 %).
Danish: 5.1) var forekomsten af tilfælde med hjerteiskæmi/hjerteinfarkt, som opstod som følge af behandling, større i sorafenibgruppen (4,9 %) sammenlignet med placebogruppen (0,4 %).
English: If you take more Nexavar than you should
Danish: Hvis De har taget for meget Nexavar
English: may affect more than 1 in 10 people - diarrhoea - feeling sick (nausea) - feeling weak or tired (fatigue) - pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain) - hair loss (alopecia) - flushed or painful palms or soles (hand foot skin reaction) - itching or rash - throwing up (vomiting) - bleeding (including bleeding in the brain, gut wall and respiratory tract; haemorrhage) - high blood pressure, or increases in blood pressure (hypertension) - infections - loss of appetite (anorexia) - constipation - joint pain (arthralgia) - fever - weight loss - dry skin
Danish: - hårtab (alopeci) - røde eller smertefulde håndflader og fodsåler (hånd-fod-hud-reaktion) - kløe og udslæt - opkastning - blødning (inklusive blødning i hjernen, tarmvæggen og luftvejene; hæmoragi) - højt blodtryk eller blodtryksstigning (hypertension) - infektioner - appetitløshed - forstoppelse - ledsmerter (artralgi) - feber - vægttab - tør hud
English: What Nexavar is and what it is used for What you need to know before you take Nexavar How to take Nexavar
Danish: Det skal De vide, før De begynder at tage Nexavar Sådan skal De tage Nexavar Bivirkninger