FrancophonIA/ELRC3.0 huggingface dataset:
English: ● a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patientyears), p=0.0034
Danish: ● en signifikant reduktion i den absolutte risiko for enhver diabetesrelateret komplikation i metformin-gruppen (29,8 hændelser/1.000 patientår) versus diæt alene (43,3 hændelser/1.000 patientår), p=0,0023, og versus de samlede grupper, der fik monoterapi med et sulfonylurinstof eller insulin (40,1 hændelser/1.000 patientår), p=0,0034
English: Mūkusalas iela 101
Danish: Mūkusalas iela 101 Rīga, LV-1004
English: Canagliflozin 100 mg once daily as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Danish: I dualbehandling med metformin gav canagliflozin 100 mg en gang dagligt samme reduktioner i HbA1c fra baseline, og 300 mg en gang dagligt gav reduktioner i HbA1c, som var resultaterne for glimepirid overlegne (p<0,05), hvilket påviste canagliflozins non-inferioritet.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Brug af anden medicin sammen med Vokanamet Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
Danish: n Middelændringer (%) fra baseline i serumphosphat var henholdsvis 3,6 % og 5,1 % for canagliflozin 100 mg og
English: Other side effects when taking canagliflozin alone: Very common
Danish: Andre bivirkninger, der er set ved behandling med canagliflozin alene: Meget almindelige (kan berøre flere end 1 ud af 10 personer)
English: ● Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Danish: ● Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: • Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Danish: ● Vokanamet 50 mg/850 mg filmovertrukne tabletter er lyserøde, kapselformede, 20 mm lange tabletter præget med “CM” på den ene side og “358” på den anden side
English: In this pooled analysis, patients on loop diuretics, patients with a baseline eGFR 30 mL/min/1.73 m2 to
Danish: I denne poolede analyse sås generelt en større incidens af disse bivirkninger hos patienter, der fik loop-diuretika, patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 ved baseline og patienter ≥ 75 år.
English: ● a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Danish: ● en signifikant reduktion i den absolutte risiko for samlet mortalitet: metformin (13,5 hændelser/1.000 patientår) versus diæt alene (20,6 hændelser/1.000 patientår), p=0,011, og versus de samlede grupper, der fik monoterapi med et sulfonylurinstof eller insulin 18,9 hændelser/1.000 patientår (p=0,021)
English: The tablet is beige, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “551” on the other side.
Danish: En beige, kapselformet tablet, 21 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “551” på den anden side.
English: compared to 1.5% for placebo.
Danish: 300 mg sammenlignet med 1,5 % for placebo.
English: 50 mg twice daily (N=93)
Danish: 50 mg to gange dagligt (N=93)
English: • bone fracture
Danish: ● knoglebrud
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Danish: ● Vokanamet 150 mg/1.000 mg filmovertrukne tabletter er lilla, kapselformede, 22 mm lange tabletter præget med “CM” på den ene side og “611” på den anden side
English: Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Danish: k Middelændringer (%) fra baseline i kreatinin var 2,8 % og 4,0 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 1,5 % for placebo.
English: 150 mg twice daily (N = 93)
Danish: 150 mg to gange dagligt (N=93)
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Danish: j Middelændringer fra baseline i hæmatokrit var 2,4 % og 2,5 % for henholdsvis canagliflozin 100 mg og 300 mg sammenlignet med 0,0 % for placebo.
English: • Moderate and severe renal impairment (patients with eGFR < 60 mL/min/1.73 m2 or
Danish: ● Diabetisk ketoacidose, praecoma diabeticum ● Moderat til svært nedsat nyrefunktion (patienter med eGFR < 60 ml/min/1,73 m2 eller
English: i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and
Danish: totalkolesterol 3,4 % og 5,2 % versus 0,9 %; HDL-kolesterol 9,4 % og 10,3 % versus 4,0 %; LDL-kolesterol 5,7 % og
English: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Danish: ● Vokanamet 150 mg/850 mg filmovertrukne tabletter er lysegule, kapselformede, 21 mm lange tabletter præget med “CM” på den ene side og “418” på den anden side
English: The tablet is pink, capsule-shaped, 20 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “358” on the other side.
Danish: En lyserød, kapselformet tablet, 20 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “358” på den anden side.
English: In patients where DKA is suspected or diagnosed, treatment with Vokanamet should be discontinued immediately.
Danish: Vokanamet skal straks seponeres hos patienter med formodet eller verificeret DKA.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Danish: Titandioxid (E171) Jernoxid rød (E172) Jernoxid sort (E172)
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/850 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Vokanamet 150 mg/850 mg filmovertrukne tabletter
English: • constipation
Danish: ● forstoppelse
English: • rash or red skin - this may be itchy and include raised bumps, oozing fluid or blisters.
Danish: ● udslæt eller hudrødme, som kan være ledsaget af kløe og omfatte hævede områder i huden,
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/1000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Vokanamet 50 mg/1000 mg filmovertrukne tabletter
English: The tablet is purple, capsule-shaped, 22 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “611” on the other side.
Danish: En lilla, kapselformet tablet, 22 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “611” på den anden side.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 50 mg/850 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Vokanamet 50 mg/850 mg filmovertrukne tabletter
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Danish: CrCl 30 til < 60 ml/min ved baseline var incidensen 4,8 % for canagliflozin 100 mg en gang dagligt og 8,1 % for canagliflozin 300 mg en gang dagligt sammenlignet med 2,6 % i kontrolgruppen.
English: NAME OF THE MEDICINAL PRODUCT Vokanamet 150 mg/1000 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Vokanamet 150 mg/1000 mg filmovertrukne tabletter
English: The tablet is light yellow, capsule-shaped, 21 mm in length, immediate-release, film-coated, and debossed with “CM” on one side and “418” on the other side.
Danish: En lysegul, kapselformet tablet, 21 mm lang, med konventionel (umiddelbar) udløsning, filmovertrukket og præget med “CM” på den ene side og “418” på den anden side.
English: (E171), iron oxide yellow (E172), and iron oxide red (E172).
Danish: (E171), jernoxid gul (E172) og jernoxid rød (E172).
English: (E171), iron oxide red (E172) and iron oxide black (E172).
Danish: (E171), jernoxid rød (E172) og jernoxid sort (E172).
English: Titanium dioxide (E171)) Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Titandioxid (E171) Jernoxid gul (E172) Jernoxid rød (E172)
English: Baseline (mean) in kg % change from baseline (adjusted mean) -2.5
Danish: Baseline (middelværdi) i kg Procentvis ændring fra baseline (justeret middelværdi) Forskel ift.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Danish: Titandioxid (E171) Jernoxid gul (E172)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 850 mg metforminhydrochlorid.
English: If you take more Vokanamet than you should If you take more of this medicine than you should, talk to a doctor straight away.
Danish: Kontakt straks lægen, skadestuen eller apoteket, hvis du har taget mere af dette lægemiddel, end der står i denne information, eller mere end lægen har foreskrevet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 50 mg canagliflozin og 1000 mg metforminhydrochlorid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 850 mg metforminhydrochlorid.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin, and 1000 mg of metformin hydrochloride.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En tablet indeholder canagliflozinhemihydrat svarende til 150 mg canagliflozin og 1000 mg metforminhydrochlorid.
English: ● Moderate and severe renal impairment (patients with eGFR < 60 mL/min/1.73 m2 or
Danish: Hos patienter med eGFR 30 ml/min/1,73 m2 til < 60 ml/min/1,73 m2 eller
English: Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Danish: m Middelændringer (%) fra baseline i serumkalium var henholdsvis 0,5 % og 1,0 % for canagliflozin 100 mg og 300 mg sammenlignet med 0,6 % for placebo.
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body.
Danish: (diuretika), da Vokanamet også sænker blodtrykket, da det fjerner for meget væske i kroppen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/010 (20 tablets) EU/1/14/918/011 (60 tablets) EU/1/14/918/012 (180 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/918/010 (20 tabletter)
English: Rīga, LV-1004 Tel: +371 678 93561
Danish: Tel: +371 678 93561
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/918/007 (20 tabletter)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/918/001 (20 tabletter)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/918/004 (20 tabletter)
English: • vaginal yeast infection.
Danish: ● svampeinfektion i skeden.
English: Macrogol (3350) Polyvinyl alcohol Talc
Danish: 50 mg/850 mg Macrogol (3350) Polyvinylalkohol Talcum
English: Prevention of bone complications
Danish: Forebyggelse af knoglekomplikationer
English: For 31 patients their disease got worse during treatment.
Danish: Hos 31 patienter blev sygdommen forværret under behandlingen.
English: Xgeva received a marketing authorisation valid throughout the EU on 13 July 2011.
Danish: Xgeva fik en markedsføringstilladelse med gyldighed i hele EU den 13. juli 2011.
English: Further information on Xgeva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Yderligere information om Xgeva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Of the remainder, 84 were able to have less extensive surgery than previously planned.
Danish: Af de resterende kunne de 84 nøjes med en mindre omfattende operation end planlagt.
English: A response to treatment was defined as elimination of at least 90% of the giant cells or no progression of the condition after 25 weeks of treatment.
Danish: Virkningen af behandlingen blev defineret som udryddelse af mindst 90 % af kæmpecellerne eller ingen fremadskriden af sygdommen efter 25 ugers behandling.
English: Other information about Xgeva
Danish: Andre oplysninger om Xgeva
English: As for all medicines, data on the use of Xgeva are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Xgeva løbende overvåget.
English: This reduces the loss of bone, making fractures and other serious bone complications less likely.
Danish: Dette reducerer knogletabet og gør knoglebrud og andre alvorlige knoglekomplikationer mindre sandsynlige.
English: Patients should take calcium and vitamin D supplements while being treated with Xgeva.
Danish: Patienterne skal tage calcium- og D-vitamintilskud, mens de behandles med Xgeva.
English: What measures are being taken to ensure the safe and effective use of Xgeva?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Xgeva?
English: Xgeva can only be obtained with a prescription.
Danish: Xgeva udleveres kun efter recept.
English: An overview of Xgeva and why it is authorised in the EU
Danish: En oversigt over Xgeva, og hvorfor det er godkendt i EU
English: In patients with giant cell tumour of bone, 120 mg is injected under the skin once a week for 3 weeks, and then once every 4 weeks.
Danish: Hos patienter med kæmpecelletumor i knogler indsprøjtes 120 mg under huden én gang om ugen i 3 uger, derefter én gang hver 4. uge.
English: For more information about using Xgeva, see the package leaflet or contact a doctor or pharmacist.
Danish: For mere information om brug af Xgeva, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
English: Xgeva contains the active substance denosumab.
Danish: Xgeva indeholder det aktive stof denosumab.
English: This protein activates osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Danish: Dette protein er med til at aktivere osteoklaster, der er de celler i kroppen, som medvirker ved nedbrydningen af knoglevæv.
English: In patients with giant cell tumour of bone, Xgeva was effective in controlling the disease.
Danish: Hos patienter med kæmpecelletumor i knoglerne var Xgeva effektivt til at kontrollere sygdommen.
English: By attaching to RANKL and blocking it, denosumab reduces the formation and activity of the osteoclasts.
Danish: Ved at binde sig til og blokere RANKL reducerer denosumab dannelsen og funktionen af osteoklaster.
English: The first study involved 2,046 patients with breast cancer and the second study involved 1,901 men with prostate cancer which did not respond to hormonal treatment.
Danish: Det første studie omfattede 2.046 patienter med brystkræft, det andet studie omfattede 1.901 mænd med prostatacancer, som ikke reagerede på hormonbehandling.
English: It is used in patients who cannot be treated by surgery or in whom surgery is likely to cause complications.
Danish: Det anvendes hos patienter, der ikke kan behandles med operation, eller hos hvem en operation vil medføre komplikationer.
English: What is Xgeva and what is it used for?
Danish: Hvad er Xgeva, og hvad anvendes det til?
English: Side effects reported with Xgeva are carefully evaluated and any necessary action taken to protect patients.
Danish: Indberettede bivirkninger ved Xgeva vurderes omhyggeligt, og der træffes de nødvendige forholdsregler for at beskytte patienterne.
English: The cells in giant cell tumour of bone are also activated via RANKL, and treatment with denosumab prevents them from growing and breaking down bone, allowing normal bone to replace the tumour.
Danish: Også cellerne i kæmpecelletumorer i knoglerne aktiveres via RANKL, og behandling med denosumab forhindrer dem i at vokse og nedbryde knoglen, så tumoren kan erstattes af normalt knoglevæv.
English: In the second study which involved 507 patients treatment with Xgeva prevented surgery in about half (109 of 225) of the group in whom surgery would have resulted in complications.
Danish: I det andet studie, der omfattede 507 patienter, blev det ved behandling med Xgeva muligt at undgå at operere patienten i omkring halvdelen (109 af 225) af den gruppe, hvor operation ville have medført komplikationer.
English: About 20% of patients were able to have complete surgical removal of the cancer.
Danish: Hos ca. 20 % af patienterne kunne kræften fjernes fuldstændigt ved operation.
English: The Agency noted that there is a need for an effective treatment for bone disease in advanced cancer, particularly for patients with kidney problems since currently available treatments can be toxic for the kidneys.
Danish: Agenturet bemærkede, at der er behov for en ny effektiv behandling af knoglelidelser ved fremskreden kræft, særligt til patienter med nyreproblemer, da de nuværende behandlingsmuligheder kan være giftige for nyrerne.
English: For patients with giant cell tumour of bone the possibility of complete surgical removal of the tumour after treatment and the reduction in extent of the surgery in some patients were considered clinically important.
Danish: For patienter med kæmpecelletumorer blev muligheden for fuldstændig bortoperation af tumoren efter behandlingen og mindsket omfang af den nødvendige operation hos nogle patienter anset for klinisk vigtig.
English: The active substance in Xgeva, denosumab, is a monoclonal antibody which has been designed to recognise and attach to a protein called RANKL.
Danish: Det aktive stof i Xgeva, denosumab, er et monoklonalt antistof, der er udformet, så det genkender og bindes til et protein kaldet RANKL.
English: The first study involved 37 patients, 86 % of whom responded to treatment with Xgeva.
Danish: Det første studie omfattede 37 patienter, hvoraf behandling med Xgeva virkede hos 86 %.
English: In another study involving 1,718 patients with newly diagnosed multiple myeloma, Xgeva was as effective as zoledronic acid in delaying the patients' first skeletal-related event.
Danish: I et andet studie med 1.718 patienter med nydiagnosticeret multipelt myelom var Xgeva lige så effektivt som zoledronsyre til at forsinke patienternes første knoglerelaterede hændelse.
English: All the studies looked at the risk of patients having a first ‘skeletal-related event' (such as a fracture, pressure on the spinal cord or the need for radiotherapy or surgery to the bone) during the study period by measuring how long it took for this event to happen.
Danish: I alle studierne så man på patienternes risiko for at opleve en første "knoglerelateret hændelse" (f.eks. knoglebrud, tryk på rygmarven eller behov for strålebehandling eller operation af knoglen) i studieperioden ved at måle, hvor længe det tog, inden en sådan hændelse indtraf.
English: Why is Xgeva authorised in the EU?
Danish: Hvorfor blev Xgeva godkendt i EU?
English: The company that markets Xgeva will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they have symptoms.
Danish: Virksomheden, som markedsfører Xgeva, skal desuden udarbejde et patientkort med oplysninger om risikoen for osteonekrose i kæben og en instruks til patienter om at kontakte deres læge, hvis de får symptomer.
English: The third study involved 1,776 patients with advanced solid tumours in various parts of the body or with multiple myeloma (a cancer of the bone marrow).
Danish: Det tredje studie omfattede 1.776 patienter med fremskredne organtumorer i forskellige dele af kroppen, eller med multipelt myelom (kræft i knoglemarven).
English: Two main studies looked at the effect of Xgeva in adults or full-grown adolescents with giant cell tumour of bone that was unsuitable for surgery or in whom surgery would have resulted in severe complications like amputation of a limb.
Danish: To hovedstudier vedrørte virkningen af Xgeva hos voksne og fuldt udvoksede unge med kæmpecelletumorer i knoglerne, der var uegnede til operation, eller hos hvem operation ville medføre svære komplikationer som f.eks. amputation.
English: What are the risks associated with Xgeva?
Danish: Hvilke risici er der forbundet med Xgeva?
English: It is available as a solution for injection under the skin.
Danish: Det fås som injektionsvæske, opløsning, til indsprøjtning under huden.
English: Xgeva must not be used in patients with wounds from dental or mouth surgery have not yet healed, or in people with severe, untreated hypocalcaemia.
Danish: Xgeva må ikke anvendes hos patienter, hos hvem sår fra tand- eller mundkirurgi ikke er helet fuldstændigt, eller hos personer med alvorlig ubehandlet hypocalcæmi).
English: The Agency considered that Xgeva was effective in preventing bone-related events and was less toxic to the kidneys and easier to use than existing treatments.
Danish: Agenturet fandt, at Xgeva havde vist sig effektivt til forebyggelse af knoglerelaterede hændelser og var mindre giftigt for nyrerne og lettere at bruge end eksisterende behandlinger.
English: Xgeva was compared with zoledronic acid (another medicine used to prevent bone complications) in four main studies in patients with different types of cancer which had spread to the bone.
Danish: Xgeva blev sammenlignet med zoledronsyre (et andet lægemiddel, der anvendes til at forebygge knoglekomplikationer) i fire hovedstudier hos patienter med forskellige typer kræft, som havde bredt sig til knoglerne.
English: The most common side effects with Xgeva (seen in more than 1 patient in 10) are hypocalcaemia (low levels of calcium in the blood), pain in the muscles and bones, dyspnoea (difficulty breathing) and diarrhoea.
Danish: De hyppigste bivirkninger med Xgeva (som forekommer hos mere end 1 ud af 10 patienter) er lavt calciumindhold i blodet (hypocalcæmi), smerter i muskler og knogler, vejrtrækningsbesvær (dyspnø) og diarré.
English: The Agency considered that the benefits of Xgeva in giant cell tumour of bone were greater than the risks, and recommended that it be authorised for use in the EU.
Danish: Agenturet fandt, at fordelene ved Xgeva til kæmpecelletumor i knogler var større end risiciene, og anbefalede, at det blev godkendt til brug i EU.
English: Treatment of giant cell tumour of bone
Danish: Behandling af kæmpecelletumor i knoglerne