FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 60 mg of daclatasvir (as dihydrochloride).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 60 mg daclatasvir (som dihydrochlorid).
English: Daklinza 60 mg film-coated tablets
Danish: Daklinza 60 mg filmovertrukne tabletter
English: ↑ Daclatasvir ↔ Fluconazole
Danish: ↔ Fluconazol
English: Relapse**
Danish: ↔ Lopinavir*
English: CYP3A4 inhibition by ketoconazole
Danish: Ketoconazols hæmning af CYP3A4
English: What Daklinza is and what it is used for What you need to know before you take Daklinza How to take Daklinza
Danish: Det skal du vide, før du begynder at tage Daklinza Sådan skal du tage Daklinza Bivirkninger
English: Fainting
Danish: Amning
English: ↔ Daclatasvir ↔ Enfuvirtide
Danish: ↔ Enfuvirtid
English: ↔ Tacrolimus AUC: 1.00 (0.88, 1.13) Cmax: 1.05 (0.90, 1.23)
Danish: AUC: 1,00 (0,88; 1,13) Cmax: 1,05 (0,90 ; 1,23)
English: For detailed recommendations regarding pregnancy and contraception, refer to the Summary of Product Characteristics for ribavirin and peginterferon alfa.
Danish: Se produktresuméet for ribavirin og peginterferon alfa for oplysninger om graviditet og prævention.
English: ↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
Danish: AUC: 0,87 (0,83; 0,92) Cmax: 0,95 (0,88; 1,04)
English: Proton pump inhibitors Omeprazole 40 mg once daily (daclatasvir 60 mg single dose)
Danish: Protonpumpehæmmere Omeprazol 40 mg en gang dagligt (daclatasvir 60 mg enkeltdosis)
English: HCV genotype:
Danish: HCV-genotype: 1a
English: ↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
Danish: AUC: 0,90 (0,73; 1,11) Cmax: 0,97 (0,80; 1,17) Cmin: 0,98 (0,67; 1,44)
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Danish: Daklinza + sofosbuvir +/- ribavirin i 24 uger (se pkt.
English: CYP3A4 induction by rifampicin
Danish: Rifampicins induktion af CYP3A4
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 90 mg tabletter daclatasvir
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 30 mg tabletter daclatasvir
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with ketoconazole or other strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt, når det administreres sammen med ketoconazol eller andre potente CYP3A4-hæmmere.
English: Inhibition of P-gp and BCRP by daclatasvir
Danish: Daclatasvirs hæmning af P-gp og BCRP
English: No dose adjustment of Daklinza or dolutegravir is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller dolutegravir.
English: Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Danish: - Hvis HCV-RNA er ikke-detekterbart ved både behandlingsuge 4 og 12, bør alle 3 komponenter i regimet fortsætte i i alt 24 uger.
English: Expected due to CYP3A4 inhibition by boceprevir:
Danish: Forventes på grund af boceprevirs hæmning af CYP3A4:
English: Expected due to CYP3A4 inhibition by the antibacterial:
Danish: Forventes på grund af det antibakterielle middels hæmning af CYP3A4:
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 60 mg tabletter daclatasvir
English: Cirrhosis was determined by liver biopsy (METAVIR F4) for 14 patients, FibroScan >14.6 kPa for
Danish: ** Cirrose blev konstateret ved hjælp af leverbiopsi (METAVIR F4) hos 14 patienter, FibroScan >14,6 kPa hos 11 patienter eller FibroTest score ≥0,75 og aspartataminotransferase (ASAT): indeks for trombocytratio (APRI) >2 hos 7 patienter.
English: Expected due to CYP3A4 inhibition by cobicistat:
Danish: Forventes på grund af cobicistats hæmning af CYP3A4:
English: Retreatment with daclatasvir
Danish: Genbehandling med daclatasvir
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg film-coated tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 30 mg filmovertrukne tabletter daclatasvir
English: 12 weeks therapy
Danish: 12 ugers behandling
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg film-coated tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 90 mg filmovertrukne tabletter daclatasvir
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg film-coated tablets daclatasvir
Danish: LÆGEMIDLETS NAVN Daklinza 60 mg filmovertrukne tabletter daclatasvir
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) Tenofovir disoproxil fumarate 300 mg once daily (daclatasvir 60 mg once daily)
Danish: Tenofovir disoproxilfumarat 300 mg en gang dagligt (daclatasvir 60 mg en gang dagligt)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with cobicistat or other strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt, når det administreres sammen med cobicistat eller andre potente CYP3A4-hæmmere.
English: No cirrhosis**
Danish: SVR12 Uden cirrose**
English: ↑ Buprenorphine
Danish: ↑ Dabigatranetexilat
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with boceprevir or other strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt ved samtidig administration med boceprevir eller andre potente CYP3A4-hæmmere.
English: Coadministration of Daklinza with St. John's wort or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Danish: Samtidig administration af Daklinza og perikon eller andre potente CYP3A4-induktorer er kontraindiceret (se pkt.4.3).
English: No dose adjustment of Daklinza or the NRTI is required.
Danish: Dosisjustering er ikke nødvendig for Daklinza eller NRTI.
English: Expected due to CYP3A4 inhibition by the antifungal:
Danish: Forventes på grund af antiepileptikas induktion af CYP3A4:
English: Vascular disorders common hot flush
Danish: Vaskulære sygdomme almindelig hedeture
English: Expected due to CYP3A4 induction by the antimycobacterial:
Danish: Forventes på grund af antimykobakterielle midlers induktion af CYP3A4:
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz 600 mg once daily (daclatasvir 60 mg once daily/120 mg once daily)
Danish: Efavirenz 600 mg en gang dagligt (daclatasvir 60 mg en gang dagligt/120 mg en gang dagligt)
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with telaprevir or other strong inhibitors of CYP3A4.
Danish: Dosis af Daklinza bør reduceres til 30 mg en gang dagligt ved samtidig administration af telaprevir eller andre potente CYP3A4-hæmmere.
English: Relapse
Danish: Recidiv
English: If you have any questions about your medicines, please ask your doctor or pharmacist.
Danish: Spørg lægen eller apotekspersonalet, hvis du har spørgsmål om din medicin.
English: HCV RNA undetectable SVR12*
Danish: HCV-RNA ikke-detekterbart
English: If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Danish: Kontakt lægen eller apotekspersonalet, hvis du er i tvivl om oplysningerne i indlægssedlerne.
English: All patients Cirrhosis
Danish: Alle patienter Cirrose
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Danish: Forventes på grund af calciumantagonistens hæmning af CYP3A4:
English: CYP3A4 inhibition by telaprevir
Danish: Telaprevir hæmmer CYP3A4
English: Tablet core
Danish: ↔ Tacrolimus
English: Expected due to CYP3A4 induction by the anticonvulsant:
Danish: Forventes på grund perikons induktion af CYP3A4:
English: CP A CP B CP C Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Genotype 6 ND: Not determined * 2 patients had detectable HCV RNA at end of treatment; 1 of these patients achieved SVR.
Danish: ND: Ikke fastlagt * 2 patienter havde detekterbart HCV-RNA ved afslutning af behandlingen; 1 af disse patienter nåede SVR.
English: Pharmaceutical Form
Danish: Lægemiddelform Administration
English: MA (EU) number
Danish: MF (EU)-nummer Særnavn Navn
English: Invented name Strength
Danish: Styrke
English: Route of administration Immediate Packaging Pack size
Danish: Pakningsstørrelse
English: Packaging Content (concentration)
Danish: Emballage Indhold (koncentration)
English: Withdrawal Period
Danish: Tilbageholdelse stid
English: Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per doses
Danish: Tørstof og solvens til injektionsvæsk e, suspension
English: Route of administration
Danish: Indgivelses -vej
English: Attenuated feline panleucopenia virus (PLI IV): at least 3.5 log 10 CCID50 per dose FeLV recombinant canarypox virus (vCP97): at least 7.2 log 10
Danish: Tørstof og solvens til injektionsvæske, suspension
English: Strength harmaceutical Form
Danish: Lægemiddelform
English: 90 (3 x 30) tablets
Danish: 90 (3 x 30) tabletter
English: Packaging Package size l t o r
Danish: Emballage Pakningsstørrelse r l
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform
English: This summary was last updated in 08-2012.
Danish: Dette sammendrag blev sidst ajourført i 08-2012.
English: It is used in addition to diet and exercise in the following ways:
Danish: Det anvendes som supplement til diæt og motion på følgende måder:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xelevia on 21 March 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Xelevia den 21. marts 2007.
English: The full EPAR for Xelevia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Xelevia findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Xelevia.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Xelevia.
English: Other information about Xelevia
Danish: Andre oplysninger om Xelevia
English: Xelevia is taken at a dose of 100 mg once a day.
Danish: Xelevia tages i en dosis a 100 mg én gang dagligt.
English: EPAR summary for the public sitagliptin
Danish: EPAR - sammendrag for offentligheden sitagliptin
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 Xelevia.
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 anvendelsesbetingelserne for Xelevia.
English: Xelevia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Danish: Xelevia havde større effekt end placebo, når det blev taget alene eller i kombination med andre lægemidler mod diabetes.
English: For more information about treatment with Xelevia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Xelevia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Xelevia is a medicine that contains the active substance sitagliptin.
Danish: Xelevia er et lægemiddel, der indeholder det aktive stof sitagliptin.
English: In patients with moderately or severely reduced kidney function the dose of Xelevia should be reduced.
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion skal dosis af Xelevia nedsættes.
English: The CHMP decided that Xelevia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Xelevia opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: Serious side effects reported with Xelevia (generally seen in more than 5% of patients) include pancreatitis (inflammation of the pancreas) and hypersensitivity (allergic reactions).
Danish: Alvorlige indberettede bivirkninger ved Xelevia (som generelt optræder hos mere end 5 % af patienterne) omfatter pankreatitis (betændelse i bugspytkirtlen) og overfølsomhed (allergiske reaktioner).
English: The active substance in Xelevia, sitagliptin, is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Danish: Det aktive stof i Xelevia, sitagliptin, er en dipeptidylpeptidase-4 (DPP-4)-hæmmer.
English: What is the risk associated with Xelevia?
Danish: Hvilken risiko er der forbundet med Xelevia?
English: • two studies compared Xelevia with other antidiabetes medicines.
Danish: • I to undersøgelser sammenlignedes Xelevia med andre lægemidler mod diabetes.
English: Xelevia must not be used in people who are hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Danish: Xelevia må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for sitagliptin eller andre af indholdsstofferne.
English: Xelevia was studied in nine studies, involving almost 6,000 patients with type 2 diabetes whose blood glucose levels were not adequately controlled:
Danish: Xelevia blev undersøgt i ni undersøgelser, som omfattede næsten 6 000 patienter med type 2diabetes, hvis blodglukoseniveauer ikke var tilstrækkeligt reguleret:
English: Sitagliptin does not work when the blood glucose is low.
Danish: Sitagliptin virker ikke, når blodsukkeret er lavt.
English: In all of the studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Danish: I alle undersøgelserne var det primære effektmål ændringen i blodets koncentration af et stof kaldet glykosyleret hæmoglobin (HbA1c), der viser, hvor godt blodsukkeret er kontrolleret.
English: If Xelevia is taken with a sulphonylurea or insulin, the dose of the sulphonylurea or insulin may need to be lowered to reduce the risk of hypoglycaemia (low blood sugar levels).
Danish: Hvis Xelevia tages sammen med et sulfonylurinstof eller insulin, er det muligvis nødvendigt at nedsætte dosis af sulfonylurinstoffet for at mindske risikoen for hypoglykæmi (lave blodsukkerniveauer).
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets koncentration af glukose, eller hvor kroppen ikke kan udnytte insulin tilstrækkeligt effektivt.
English: What is Xelevia?
Danish: Hvad er Xelevia?
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Danish: Sitagliptin reducerer også den mængde glukose, der produceres af leveren, ved at øge insulinkoncentrationerne og mindske koncentrationerne af hormonet glukagon.
English: Xelevia is used in patients with type 2 diabetes to improve the control of blood glucose (sugar) levels.
Danish: Xelevia anvendes til patienter med type 2-diabetes til at forbedre reguleringen af blodglukoseniveauerne (sukker).
English: In contrast, they rose by 0.12% and 0.18%, respectively, in the patients taking placebo.
Danish: Til gengæld steg de med henholdsvis 0,12 % og 0,18 % hos patienter, der tog placebo.
English: By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Danish: Ved at øge koncentrationerne af inkretinhormoner i blodet stimulerer sitagliptin bugspytkirtlen til at producere mere insulin, når blodglukoseniveauerne er høje.
English: In the studies comparing Xelevia with other medicines, the effectiveness of adding Xelevia to metformin was similar to that of adding glipizide.
Danish: I de undersøgelser, hvor Xelevia blev sammenlignet med andre lægemidler, svarede effekten af at tilføje Xelevia til metformin til effekten af at tilføje glipizid.
English: When taken on their own, Xelevia and metformin produced similar reductions in HbA1c levels, but the effectiveness of Xelevia seemed to be slightly lower than that of metformin.
Danish: Når de blev taget hver for sig, bevirkede Xelevia og metformin tilsvarende fald i HbA1c-niveauer, men effekten af Xelevia var tilsyneladende en anelse lavere end effekten af metformin.
English: • three additional studies compared Xelevia with placebo when they were added to other antidiabetes medicines: glimepiride (another sulphonylurea), with or without metformin, in 441 patients; the combination of metformin and rosiglitazone (a PPAR-gamma agonist) in 278 patients; and a stable dose of insulin, with or without metformin, in 641 patients.
Danish: • I tre yderligere undersøgelser blev Xelevia sammenlignet med placebo, når disse blev anvendt som tillægsbehandling til andre lægemidler mod diabetes: glimepirid (et andet sulfonylurinstof), med eller uden metformin, hos 441 patienter, en kombination af metformin og rosiglitazon (en PPARgamma-agonist) hos 278 patienter og en stabil dosis insulin, med eller uden metformin, hos 641 patienter.
English: • on its own, in patients who are not satisfactorily controlled on diet and exercise and in whom metformin (an antidiabetes medicine) is not suitable;
Danish: • alene hos patienter, som ikke reguleres tilfredsstillende med diæt og motion, og hos hvem metformin (et lægemiddel mod diabetes) ikke er egnet
English: In patients taking Xelevia on its own, HbA1c levels fell from around 8.0% at the start of the studies by 0.48% after 18 weeks and 0.61% after 24 weeks.
Danish: Hos patienter, som fik Xelevia alene, faldt HbA1c-niveauerne fra ca. 8,0 % i starten af undersøgelserne med 0,48 % efter 18 uger og med 0,61 % efter 24 uger.
English: Why has Xelevia been approved?
Danish: Hvorfor blev Xelevia godkendt?
English: For the full list of all side effects reported with Xelevia, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Xelevia fremgår af indlægssedlen.
English: • in combination with insulin, with or without metformin, in patients who are not satisfactorily controlled on a stable dose of insulin.
Danish: • i kombination med insulin med eller uden metformin hos patienter, som ikke reguleres tilfredsstillende med en fast dosis insulin.
English: One study compared Xelevia with glipizide (a sulphonylurea), when they were used as an add-on to metformin in 1,172 patients.
Danish: I en undersøgelse sammenlignedes Xelevia med glipizid (et sulfonylurinstof), hvor de blev anvendt som en tillægsbehandling til metformin hos 1 172 patienter.
English: The other study compared Xelevia with metformin, used on their own, in 1,058 patients;
Danish: I den anden undersøgelse sammenlignedes Xelevia med metformin anvendt hver for sig hos 1 058 patienter.
English: Finally, they were reduced by 0.59% in patients adding Xelevia to insulin (with or without metformin), compared with a fall of 0.03% in those adding placebo.
Danish: Niveauerne blev endelig reduceret med 0,59 % hos patienter, som fik tilføjet Xelevia til insulin (med eller uden metformin), sammenlignet med et fald på 0,03 % hos dem, der fik tilføjet placebo.
English: What is Xelevia used for?
Danish: Hvad anvendes Xelevia til?
English: • in combination with metformin or a PPAR-gamma agonist (a type of antidiabetes medicine) such as a thiazolidinedione, in patients who are not satisfactorily controlled on metformin or the PPAR-gamma agonist used on its own;
Danish: • i kombination med metformin eller en PPAR-gammaagonist (en type lægemiddel mod diabetes) såsom et thiazolidindion hos patienter, som ikke reguleres tilfredsstillende med metformin eller PPAR-gammaagonisten anvendt alene
English: • in combination with both metformin, and a sulphonylurea or a PPAR-gamma agonist, in patients who are not satisfactorily controlled on the two medicines;
Danish: • i kombination med både metformin og et sulfonylurinstof eller en PPAR-gammaagonist hos patienter, som ikke reguleres tilfredsstillende med de to lægemidler
English: Hypoglycaemia has been reported in combination with a sulphonylurea in 4.7-13.8% of patients and with insulin in 9.6% of patients.
Danish: Hypoglykæmi blev indberettet hos 4,7 til 13,8 % af patienterne, der fik Xelevia i kombination med et sulfonylurinstof, og hos 9,6 % af patienterne, som fik Xelevia med insulin.
English: • in combination with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled with a sulphonylurea used on its own and in whom metformin is not suitable;
Danish: • i kombination med et sulfonylurinstof (en anden type lægemiddel mod diabetes) hos patienter, som ikke reguleres tilfredsstillende med et sulfonylurinstof alene, og hos hvem metformin ikke er egnet
English: HbA1c levels were reduced by 1.03% after 18 weeks in patients adding Xelevia to metformin and rosiglitazone, compared with a fall of 0.31% in those adding placebo.
Danish: HbA1c-niveauerne blev reduceret med 1,03 % efter 18 uger hos patienter, som fik tilføjet Xelevia til metformin og rosiglitazon sammenlignet med et fald på 0,31 % hos dem, som fik tilføjet placebo.
English: How has Xelevia been studied?
Danish: Hvordan blev Xelevia undersøgt?
English: In the additional studies, adding Xelevia to glimepiride (with or without metformin) led to a reduction in HbA1c levels of 0.45% after 24 weeks, compared with an increase of 0.28% in those adding placebo.
Danish: I de yderligere undersøgelser bevirkede tilføjelsen af Xelevia til glimepirid (med eller uden metformin) et fald i HbA1c-niveauerne på 0,45 % efter 24 uger sammenlignet med en stigning på 0,28 % hos dem, som fik tilføjet placebo.
English: What benefit has Xelevia shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xelevia?
English: • four of the studies compared Xelevia with placebo (a dummy treatment): Xelevia or placebo were used on their own in two studies involving 1,262 patients, as an add-on to metformin in one study involving 701 patients, and as an add-on to pioglitazone (a PPAR-gamma agonist) in one study involving 353 patients;
Danish: Xelevia eller placebo blev anvendt hver for sig i to undersøgelser, der omfattede 1 262 patienter, som en tillægsbehandling til metformin i en undersøgelse, der omfattede 701 patienter, og som tillægsbehandling til pioglitazon (en PPAR-gammaagonist) i en undersøgelse, der omfattede 353 patienter.
English: How is Xelevia used?
Danish: Hvordan anvendes Xelevia?
English: When added to pioglitazone, Xelevia reduced HbA1c levels by 0.85% after 24 weeks, compared with a fall of 0.15% in the patients adding placebo.
Danish: Ved at tilføje Xelevia til pioglitazon reduceredes HbA1cniveauerne med 0,85 % efter 24 uger sammenlignet med et fald på 0,15 % hos patienter, som fik tilføjet placebo.
English: HbA1c levels by 0.67% after 24 weeks, compared with a fall of 0.02% in the patients adding placebo.
Danish: Ved at tilføje Xelevia til metformin reduceredes HbA1c-niveauerne med 0,67 % efter 24 uger sammenlignet med et fald på 0,02 % hos patienter, som fik tilføjet placebo.
English: How does Xelevia work?
Danish: Hvordan virker Xelevia?
English: There is no evidence that such an interaction would be harmful.
Danish: Der er intet, som tyder på, at en sådan interaktion vil være skadelig.
English: Equipment that you need
Danish: Udstyr du skal bruge
English: If there are particles in it, you must not use it.
Danish: Hvis der er partikler i, må du ikke bruge den.
English: Therefore, your doctor may decide that you should not use this medicine.
Danish: Derfor vil lægen måske beslutte, at du ikke må bruge dette lægemiddel.
English: For safety reasons:  Do not grasp the plunger.
Danish: Af sikkerhedsmæssige grunde:  Hold ikke på stemplet.