FrancophonIA/ELRC3.0 huggingface dataset:
English: Keep the needle pointing up and press the dose button until 0 mg lines up with the pointer.
Danish: Hold stadig pennen lodret med nålen opad, og tryk på dosisknappen, indtil der står 0 mg ud for markøren.
English: Turn the dose selector until your needed dose lines up with the pointer (0.6 mg, 1.2 mg or 1.8 mg).
Danish: Drej dosisvælgeren, indtil den ønskede dosis er ud for markøren (0,6 mg, 1,2 mg eller 1,8 mg).
English: Pancreatitis
Danish: Pankreatitis
English: Thus, when blood glucose is high, insulin secretion is stimulated and glucagon secretion is inhibited.
Danish: Når glucoseniveauet i blodet er højt, stimuleres insulinsekretionen således, mens glukagonsekretionen hæmmes.
English: The reductions in HbA1c and superiority vs sitagliptin observed after 26 weeks of liraglutide treatment (1.2 mg and 1.8 mg) were sustained after 52 weeks of treatment (-1.29% and -1.51% vs -0.88%, p<0.0001).
Danish: Reduktionerne i HbA1c og fordelen af liraglutid i forhold til sitagliptin, observeret efter 26 ugers behandling (1,2 mg og 1,8 mg), blev opretholdt efter 52 ugers behandling (-1,29% og -1,51% versus -0,88%, p<0,0001).
English: Glimepiride 8 mg/day 248 8.23
Danish: Glimepirid 8 mg/day 248 8,23
English: Switching patients from exenatide to liraglutide after 26 weeks of treatment resulted in an additional and statistically significant reduction in HbA1c (-0.32%, 95% CI: -0.41 to -0.24) at week 40, but a formal control group was not available.
Danish: Skift af patienter fra exenatid til liraglutid efter 26 ugers behandling resulterede i en yderligere og statistisk signifikant reduktion af HbA1c (-0,32%, 95% CI: -0,41 til -0,24) i uge 40, men en formel kontrolgruppe var ikke tilgængelig.
English: Victoza should not be used during pregnancy because it is not known if it may harm your unborn child.
Danish: Fortæl det til lægen, hvis du er gravid, tror du er gravid eller forsøger at blive det. Victoza må ikke bruges under graviditet, da det er ukendt, om det kan skade dit ufødte barn.
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-liraglutide antibodies following treatment with liraglutide.
Danish: Patienter kan udvikle anti-liraglutid-antistoffer efter behandling med liraglutid, hvilket er konsistent med de potentielt immunogene egenskaber ved lægemidler indeholdende proteiner eller peptider.
English: Anaphylactic reactions
Danish: Anafylaktiske reaktioner
English: Switching patients from sitagliptin to liraglutide after 52 weeks of treatment resulted in additional and statistically significant reduction in HbA1c (-0.24% and -0.45%, 95% CI: -0.41 to -0.07 and -0.67 to -0.23) at week 78, but a formal control group was not available.
Danish: Skift af patienter fra sitagliptin til liraglutid efter 52 ugers behandling resulterede i en yderligere og statistisk signifikant reduktion i HbA1c (-0,24% og -0,45%, 95% CI: -0,41% til -0,07 og -0,67 til -0,23) ved uge 78, men en formel kontrolgruppe var ikke tilgængelig.
English: Liraglutide monotherapy for 52 weeks resulted in statistically significant and sustained reductions in HbA1c compared with glimepiride 8 mg (-0.84% for 1.2 mg, -1.14% for 1.8 mg vs -0.51% for comparator) in patients previously treated with either diet and exercise or OAD monotherapy at no more than half-maximal dose (Table 2).
Danish: 52 ugers monoterapi med liraglutid resulterede i statistisk signifikante og vedvarende reduktioner i HbA1c sammenlignet med glimepirid 8 mg (-0,84% for 1,2 mg, -1,14% for 1,8 mg versus -0,51% for komparator) hos patienter, som tidligere blev behandlet med enten kost og motion eller monoterapi med orale antidiabetika, hvor dosis ikke var mere end halvdelen af den maksimale dosis (Tabel 2).
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg lægen, apotekspersonalet eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: Each pen contains 3 ml of solution, delivering 30 doses of 0.6 mg, 15 doses of 1.2 mg or 10 doses of 1.8 mg.
Danish: Hver pen indeholder 3 ml injektionsvæske, opløsning, der giver 30 doser på 0,6 mg, 15 doser på 1,2 mg eller 10 doser på 1,8 mg.
English: • Do not share your pen or needles with anyone else.
Danish: • Del aldrig pennen med andre.
English: Therefore, no dose adjustment of atorvastatin is required when given with liraglutide.
Danish: Justering af atorvastatindosis er derfor ikke nødvendig ved administration sammen med liraglutid.
English: When the needle is covered, carefully push the outer needle cap completely on. Then unscrew the needle.
Danish: Når nålen er skjult, skal du forsigtigt trykke den ydre nålehætte helt på.
English: Package leaflet: Information for the user Victoza 6 mg/ml solution for injection in pre-filled pen
Danish: Indlægsseddel: Information til brugeren Victoza 6 mg/ml injektionsvæske, opløsning i fyldt pen
English: Conversely, during hypoglycaemia liraglutide diminishes insulin secretion and does not impair glucagon secretion.
Danish: Omvendt mindsker liraglutid insulinsekretionen under hypoglykæmi uden at hæmme glukagonsekretionen.
English: In the LEADER trial, the frequency of acute pancreatitis confirmed by adjudication was 0.4% for liraglutide and 0.5% for placebo, respectively (see sections 4.4 and 5.1).
Danish: I LEADER-studiet var hyppigheden af akut pankreatitis, der blev bekræftet ved ekstern ekspertvurdering, henholdsvis 0,4% for liraglutid og 0,5% for placebo (se pkt.
English: Hepatic impairment
Danish: Hovedpine Svimmelhed
English: Hold the pen with the needle pointing up.
Danish: Hold pennen lodret med nålen opad.
English: - If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er du i tvivl, så spørg lægen, apotekspersonalet eller sygeplejersken.
English: Turn the dose selector until the flow check symbol lines up with the pointer.
Danish: Drej dosisvælgeren, indtil klargøringssymbolet er ud for markøren.
English: A severe form of constipation with additional symptoms such as stomach ache, bloating, vomiting etc.
Danish: En alvorlig form for forstoppelse med yderligere symptomer, såsom mavesmerter, oppustet mave, opkastning mm.
English: In a 52-week clinical trial, the addition of insulin detemir to liraglutide 1.8 mg and metformin in patients not achieving glycaemic targets on liraglutide and metformin alone resulted in a HbA1c decrease from baseline of 0.54%, compared to 0.20% in the liraglutide 1.8 mg and metformin control group.
Danish: I et 52 ugers klinisk studie blev insulin detemir givet i tillæg til liraglutid 1,8 mg og metformin til patienter, som ikke opnåede glykæmisk kontrol med liraglutid og metformin alene, hvilket resulterede i en reduktion af HbA1C i forhold til baseline på 0,54% versus 0,20% i liraglutid 1,8 mg + metforminkontrolgruppen.
English: (CrCL 30-59 ml/min, see section 5.1) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
Danish: 5.1) 26% reduceret eksponering for liraglutid i et 26 ugers klinisk studie sammenlignet med separate studier, der inkluderede patienter med type 2-diabetes med normal nyrefunktion eller let nedsat nyrefunktion.
English: Lisinopril median tmax was delayed from 6 h to 8 h with liraglutide.
Danish: Medianværdien for tmax for lisinopril sammen med liraglutid blev forsinket fra 6 timer til 8 timer.
English: • Allergic reactions like pruritus (itching) and urticaria (a type of skin rash)
Danish: • Allergiske reaktioner, såsom kløe og nældefeber (en form for hududslæt)
English: Other medicines and Victoza
Danish: Brug af anden medicin sammen med Victoza
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Danish: For forsøgsresultater vedrørende kombinationer, virkning på glykæmisk kontrol og kardiovaskulære hændelser og de undersøgte populationer henvises til pkt.
English: These trials included 3,978 exposed patients with type 2 diabetes mellitus (2,501 patients treated with liraglutide), 53.7% men and 46.3% women, 797 patients (508 treated with liraglutide) were ≥65 years of age and 113 patients (66 treated with liraglutide) were ≥75 years of age.
Danish: Studierne omfattede 3.978 eksponerede patienter med type 2-diabetes mellitus (2.501 patienter behandlet med liraglutid), 53,7% mænd og 46,3% kvinder.
English: Grounds for the variation to the terms of the marketing authorisation
Danish: Begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne
English: This medicine contains less than 1 mmol sodium (23 mg) per dose.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentlige 'natriumfrit'.
English: • Your doctor may tell you to further increase the dose to 1.8 mg once a day, if your blood glucose is not adequately controlled with a dose of 1.2 mg.
Danish: • Din læge vil muligvis bede dig om igen at øge dosis til 1,8 mg én gang dagligt, hvis en dosis på
English: Neonatal growth was reduced in rats while exposed to Victoza, and persisted in the post-weaning period in the high dose group.
Danish: Den neonatale vækst blev reduceret hos rotter, der blev eksponeret for Victoza.
English: CI: confidence interval
Danish: CI: konfidensinterval
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelige: kan forekomme hos flere end 1 ud af 10 personer
English: 1 ml contains 6 mg of liraglutide.
Danish: 1 ml indeholder 6 mg liraglutid.
English: • Cases of inflammation of the pancreas (pancreatitis).
Danish: • Betændelse i bugspytkirtlen (pankreatitis).
English: In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with insulin degludec in combination with metformin achieved a target HbA1c <7% and the remaining patients continued in a
Danish: I et 104 ugers klinisk studie opnåede 57% af de patienter med type 2-diabetes, der blev behandlet med insulin degludec i kombination med metfomin, et target HbA1c på <7%, og de resterende patienter fortsatte i et 26 ugers åbent studie og blev randomiseret til at tilføje liraglutid eller en enkelt dosis insulin aspart (i forbindelse med hovedmåltidet).
English: Glimepiride 4 mg/day 242 8.4
Danish: Glimepirid 4 mg/dag 242 8,4
English: Hypoglycaemia Anorexia
Danish: Hypoglykæmi Anoreksi Nedsat appetit
English: Turn the dose selector in either direction until 0.6 mg or 1.2 mg lines up with the pointer.
Danish: Drej dosisvælgeren frem eller tilbage indtil 0,6 mg eller 1,2 mg er ud for markøren.
English: Select your dose Always check that the pointer lines up with 0 mg.
Danish: Indstilling af dosis Kontrollér altid, at der står 0 mg ud for markøren.
English: Keep away from the freezer compartment.
Danish: Må ikke opbevares tæt på køleelementet.
English: Subcutaneous use
Danish: Subkutan anvendelse
English: If you use more Victoza than you should, talk to your doctor straight away.
Danish: Hvis du har brugt for meget Victoza, skal du straks opsøge din læge.
English: Fatigue Injection site reactions
Danish: Træthed Reaktioner på injektionsstedet
English: General disorders and administration site conditions
Danish: Almene symptomer og reaktioner på administrationsstedet
English: Injection site reactions
Danish: Reaktioner på injektionsstedet
English: • Glycaemic control
Danish: • Glykæmisk kontrol Monoterapi
English: Gastrointestinal adverse reactions
Danish: Gastrointestinale bivirkninger
English: • Constipation
Danish: • Forkølelse
English: (74.2% vs 45.5%, p<0.0001), as well as the HbA1c target below or equal 6.5% (54.6% vs 26.2%, p<0.0001).
Danish: Signifikant flere patienter opnåede HbA1c under 7% med liraglutid sammenlignet med lixisenatid (74,2% versus 45,5%, p<0,0001), lige så vel som HbA1c target under eller lig med 6,5% (54,6% versus 26,2%, p<0,0001).
English: One pre-filled pen contains 18 mg liraglutide in 3 ml.
Danish: Én fyldt pen indeholder 18 mg liraglutid i 3 ml.
English: In animal studies, peripheral administration of liraglutide led to uptake in specific brain regions involved in regulation of appetite, where liraglutide via specific activation of the GLP-1 receptor (GLP-1R) increased key satiety and decreased key hunger signals, thereby leading to lower body weight.
Danish: Liraglutid forstærkede væsentlige mæthedssignaler og svækkede væsentlige sultsignaler, via specifik aktivering af GLP-1-receptoren (GLP-1R), hvilket fører til nedsat legemsvægt.
English: • oral antidiabetics (such as metformin, pioglitazone, sulfonylurea, sodium-glucose cotransporter
Danish: • lægemidler mod diabetes i tabletform (såsom metformin, pioglitazon, sulfonylurinstof, natrium glucose co-transporter-2-hæmmer (SGLT2i)) og/eller insulin.
English: Very rare: may affect up to 1 in 10,000 people
Danish: Meget sjældne: kan forekomme hos op til 1 ud af 10.000 personer
English: Signs and symptoms of dehydration, including renal impairment and acute renal failure, have been reported in patients treated with liraglutide.
Danish: Hos patienter behandlet med liraglutid er tegn og symptomer på dehydrering, inklusive nedsat nyrefunktion og akut nyresvigt, blevet indrapporteret.
English: Liraglutide reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake, GLP-1 is a physiological regulator of appetite and food intake, but the exact mechanism of action is not entirely clear.
Danish: GLP-1 er en fysiologisk regulator af appetit og fødeindtagelse, men den eksakte virkningsmekanisme er ikke fuldstændigt klarlagt.
English: In a double-blind study comparing the efficacy and safety of Victoza 1.8 mg versus placebo as add-on to metformin ± insulin in adolescents and children aged 10 years and above with type 2 diabetes, Victoza was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.06, [-1.65, 0.46]).
Danish: I et dobbeltblindet studie, hvor virkningen og sikkerheden af Victoza 1,8 mg versus placebo, som tillægsbehandling til metformin ± insulin hos unge og børn i alderen 10 år og derover med type-2 diabetes, blev sammenlignet, var Victoza bedre end placebobehandling til at reducere HbA1C efter 26 uger (-1,06, [-1,65; 0,46]).
English: Delayed gastric emptying
Danish: Forsinket ventrikeltømning
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg once daily and exenatide 10 mcg twice daily in patients inadequately controlled on metformin and/or sulfonylurea therapy (mean HbA1c 8.3%), liraglutide was statistically superior to exenatide treatment in reducing HbA1c after 26 weeks (-1.12% vs -0.79%; estimated treatment difference: -0.33; 95% CI: -0.47 to -0.18).
Danish: I et åbent studie, der sammenligner virkningen og sikkerheden af 1,8 mg liraglutid én gang dagligt og 10 mikrogram exenatid to gange dagligt hos patienter, der er utilstrækkeligt kontrolleret med metformin og/eller sulfonylurinstof (middel-HbA1c 8,3%), var liraglutid statistisk bedre end exenatid til at reducere HbA1c efter 26 uger (-1,12% versus -0,79%; estimeret behandlingsforskel: -0,33; 95% CI -0,47 til -0,18).
English: Add-on to metformin (2,000 mg/day) + glimepiride (4 mg/day) Liraglutide 1.8 mg 230 8.3
Danish: Tillægsbehandling til metformin (2.000 mg/dag) + glimepirid (4 mg/dag) Liraglutid 1,8 mg
English: Rare: may affect up to 1 in 1,000 people
Danish: Sjældne: kan forekomme hos op til 1 ud af 1.000 personer
English: 1 ml solution for injection contains 6 mg liraglutide.
Danish: 1 ml injektionsvæske, opløsning, indeholder 6 mg liraglutid.
English: 1 ml of solution contains 6 mg of liraglutide*.
Danish: 1 ml opløsning indeholder 6 mg liraglutid*.
English: • Gallstones
Danish: • Galdesten
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevar dette lægemiddel utilgængeligt for børn.
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: kan forekomme hos op til 1 ud af 10 personer
English: In an open label trial comparing the efficacy and safety of liraglutide (1.2 mg and 1.8 mg) and sitagliptin (a DPP-4 inhibitor, 100 mg) in patients inadequately controlled on metformin therapy (mean HbA1c 8.5%), liraglutide at both doses was statistically superior to sitagliptin treatment in reducing HbA1c after 26 weeks (-1.24%, -1.50% vs -0.90%, p<0.0001).
Danish: I et åbent studie, der sammenligner virkningen og sikkerheden af liraglutid (1,2 mg og 1,8 mg) og sitagliptin (en DPP-4 inhibitor, 100 mg) hos patienter, der er utilstrækkeligt kontrolleret med metformin (middel HbA1c 8,5%), var liraglutid ved begge doser statistisk bedre end sitagliptin til at reducere HbA1c efter 26 ugers behandling (-1,24%, -1,50% versus -0,90%, p<0,0001).
English: Add-on to metformin (2,000 mg/day) + rosiglitazone (4 mg twice daily) Liraglutide 1.2 mg 177 8.48
Danish: Tillægsbehandling til metformin (2.000 mg/dag) + rosiglitazon (4 mg to gange dagligt) Liraglutid 1,2 mg
English: 1all patients; 2previous OAD monotherapy; 3previous diet treated patients 5Victoza add-on to SGLT2i was investigated at all approved doses of SGLT2i 4the dosing of insulin glargine was open-labelled and was applied according to Guideline for titration of insulin glargine.
Danish: Placebo *Superioritet (p<0,01) versus aktiv komparator; **Superioritet (p<0,0001) versus aktiv komparator; ***Superioritet (p<0,001) versus aktiv komparator; †Non-inferioritet (p<0,0001) versus aktiv komparator 1alle patienter; 2tidligere monoterapi med orale antidiabetika; 3patienter tidligere behandlet med kost 5Victoza tillægsbehandling til SGLT2i blev undersøgt for alle godkendte doseringer af SGLT2i 4doseringen af insulin glargin var åben, og blev foretaget i henhold til Vejledning for titrering af insulin glargin.
English: Inject the dose.
Danish: Injicér den valgte dosis.
English: Pull off the pen cap.
Danish: Træk penhætten af.
English: Monotherapy
Danish: Monoterapi
English: In a double-blind trial comparing the efficacy and safety of liraglutide 1.8 mg versus placebo as addon to insulin and/or OAD in patients with type 2 diabetes and moderate renal impairment, liraglutide was superior to placebo treatment in reducing HbA1c after 26 weeks (-1.05% vs -0.38%).
Danish: I et dobbeltblindet studie, der sammenlignede virkningen og sikkerheden af liraglutid 1,8 mg, som tillægsbehandling til insulin og/eller orale antidiabetika hos patienter med type 2-diabetes og moderat nedsat nyrefunktion, versus placebo var liraglutid bedre end placebo til at reducere HbA1c efter 26 uger (-1,05% versus -0,38%).
English: In an open label trial comparing the efficacy and safety of liraglutide 1.8 mg with lixisenatide 20 mcg in 404 patients inadequately controlled on metformin therapy (mean HbA1c 8.4%), liraglutide was superior to lixisenatide in reducing HbA1c after 26 weeks of treatment (-1.83% vs -1.21%, p<0.0001).
Danish: I et åbent studie, der sammenligner virkningen og sikkerheden af 1,8 mg liraglutid med 20 mikrogram lixisenatid hos 404 patienter, der er utilstrækkeligt kontrollerede med meformin (middel-HbA1c 8,4%), var liraglutid bedre end lixisenatid til at reducere HbA1c efter 26 ugers behandling (-1,83% versus1,21%, p<0,0001).
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: kan forekomme hos op til 1 ud af 100 personer
English: • Indigestion
Danish: • Fordøjelsesbesvær
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING 15.
English: Liraglutide did not change the overall exposure of griseofulvin following administration of a single dose of griseofulvin 500 mg. Griseofulvin Cmax increased by 37% while median tmax did not change.
Danish: Liraglutid ændrede ikke den overordnede eksponering for griseofulvin efter administration af én dosis på 500 mg griseofulvin.
English: • Headache
Danish: • Hovedpine
English: The absorption of liraglutide following subcutaneous administration is slow, reaching maximum concentration 8-12 hours post dosing.
Danish: Maksimal koncentration nås 8-12 timer efter dosisadministration.
English: Digoxin median tmax was delayed from 1 h to 1.5 h. No adjustment of digoxin dose is required based on these results.
Danish: Medianværdien for tmax for digoxin blev forsinket fra 1 time til 1,5 time.
English: One pre-filled pen contains 18 mg liraglutide
Danish: Én fyldt pen indeholder 18 mg liraglutid
English: Excipients
Danish: Udslæt
English: One pre-filled pen contains 18 mg liraglutide.
Danish: Én fyldt pen indeholder 18 mg liraglutid.
English: Breast-feeding
Danish: Tandpine
English: Special populations
Danish: Særlige patientgrupper
English: Victoza 6 mg/ml solution for injection in pre-filled pen
Danish: Victoza 6 mg/ml injektionsvæske, opløsning i fyldt pen
English: How to use Victoza
Danish: Sådan skal du bruge Victoza
English: Liraglutide 1.8 mg 203 8.00
Danish: Liraglutid 1,8 mg
English: What Victoza is and what it is used for What you need to know before you use Victoza How to use Victoza
Danish: Det skal du vide, før du begynder at bruge Victoza Sådan skal du bruge Victoza Bivirkninger
English: • Dizziness
Danish: • Svimmelhed
English: Victoza 6 mg/ml solution for injection in pre-filled pen Liraglutide
Danish: Victoza 6 mg/ml injektionsvæske, opløsning i fyldt pen Liraglutid
English: Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Danish: For at undgå stikuheld og krydsinfektion skal omsorgspersoner være meget forsigtige ved håndtering af brugte nåle.
English: • Inflamed gallbladder
Danish: • Fasteplasmaglucose
English: Add-on to glimepiride (4 mg/day)
Danish: Tillægsbehandling til glimepirid (4 mg/dag) Liraglutid 1,2 mg
English: • Abdominal discomfort
Danish: • Ubehag i maven
English: • Periodic Safety Update Reports
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Nausea Diarrhoea
Danish: Mave-tarm-kanalen Kvalme Diarré
English: Liraglutide 1.2 mg 228 8.5
Danish: Liraglutid 1,2 mg
English: • Toothache
Danish: • Tandpine
English: Your pen comes with 18 mg of liraglutide.
Danish: Pennen indeholder 18 mg liraglutid ved levering.
English: • Beta-cell function
Danish: • Betacellefunktion
English: This summary was last updated in 03-2012.
Danish: Dette sammendrag blev sidst ajourført i 03-2012.
English: This means that it is similar to a ‘reference medicine' containing the same active substance, but available at a new strength in addition to existing strengths.
Danish: Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men at det leveres i en ny styrke foruden de eksisterende styrker.
English: The full EPAR for Capecitabine Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Capecitabine Accord findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Capecitabine Accord on 20 April 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Capecitabine Accord den 20. april 2012.
English: For other types of cancer, treatment is stopped if the disease gets worse or the patient cannot tolerate the treatment.
Danish: Ved andre kræftformer standses behandlingen, hvis sygdommen bliver værre, eller hvis patienten ikke kan tåle behandlingen.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de frembringer samme mængde aktivt stof i kroppen.
English: Capecitabine Accord tablets should be swallowed with water within the 30 minutes after a meal.
Danish: Capecitabine Accord tabletter skal tages med vand inden for 30 minutter efter et måltid.
English: The full EPAR for the reference medicine can also be found on the Agency's website.
Danish: Den fuldstændige EPAR for referencelægemidlet findes ligeledes på agenturets websted.