FrancophonIA/ELRC3.0 huggingface dataset:
English: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Danish: Synjardy 12,5 mg/1000 mg filmovertrukne tabletter Mørk brunlig lilla, oval, bikonveks filmovertrukket tablet på 21,1 mm x 9,7 mm, præget med “S12” og Boehringer Ingelheim logo på den ene side og “1000” på den anden side.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: HbA1c (%) Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - KARTON SOM DEL AF MULTIPAKNING UDEN BLUE BOX5 mg/1000 mg
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg tablets empagliflozin/metformin HCL
Danish: LÆGEMIDLETS NAVN Synjardy 12,5 mg/1000 mg tabletter empagliflozin/metformin HCl
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 12.5 mg/1,000 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE MULTIPAKNING - KARTON SOM DEL AF MULTIPAKNING UDEN BLUE BOX12,5 mg/1000 mg
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Den populationsfarmakokinetiske analyse viste, at alder ikke havde nogen klinisk betydende virkning på empagliflozins farmakokinetik.
English: Yellowish white, oval, biconvex film coated tablets debossed with “S5” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Danish: Gullig, oval, bikonveks, filmovertrukket tablet på 19,2 mm x 9,4 mm, præget med “S5” og Boehringer Ingelheim logo på den ene side og “850” på den anden side.
English: Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy
Danish: Bivirkninger af empagliflozin monoterapi.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Synjardy 5 mg/850 mg filmovertrukne tabletter empagliflozin/metforminhydrochlorid
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Synjardy 5 mg/1000 mg filmovertrukne tabletter empagliflozin/metforminhydrochlorid
English: Pinkish white, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “850” on the other side (tablet length: 19.2 mm, tablet width: 9.4 mm).
Danish: Synjardy 12,5 mg/850 mg filmovertrukne tabletter Svagt pink, oval, bikonveks filmovertrukket tablet på 19,2 mm x 9,4 mm, præget med “S12” og Boehringer Ingelheim logo på den ene side og “850” på den anden side.
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: HbA1c (%) i uge 78 Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: HbA1c (%) at week 52 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: HbA1c (%) i uge 52 Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Danish: HbA1c (%) i uge 18 Baseline (middelværdi) Ændring fra baseline Forskel til placebo (97,5 % CI)
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Synjardy 12,5 mg/850 mg filmovertrukne tabletter empagliflozin/metforminhydrochlorid
English: Placebo empagliflozin
Danish: Met = metformin; empa = empagliflozin
English: • abnormalities in liver function tests, inflammation of the liver (hepatitis)
Danish: • Unormal leverfunktion, leverbetændelse
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Danish: LÆGEMIDLETS NAVN Synjardy 12,5 mg/1.000 mg filmovertrukne tabletter empagliflozin/metforminhydrochlorid
English: EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets
Danish: EU/1/15/1003/001 10 filmovertrukne tabletter EU/1/15/1003/002 14 filmovertrukne tabletter EU/1/15/1003/003 30 filmovertrukne tabletter EU/1/15/1003/004 56 filmovertrukne tabletter EU/1/15/1003/005 60 filmovertrukne tabletter EU/1/15/1003/037 90 filmovertrukne tabletter EU/1/15/1003/006 100 filmovertrukne tabletter
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, genital tract infections and increased urination (see description of selected side effects).
Danish: urinvejsinfektioner, genitale infektioner og øget vandladning (se beskrivelse af udvalgte bivirkninger) var de hyppigst rapporterede bivirkninger.
English: EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets
Danish: EU/1/15/1003/019 10 filmovertrukne tabletter EU/1/15/1003/020 14 filmovertrukne tabletter EU/1/15/1003/021 30 filmovertrukne tabletter EU/1/15/1003/022 56 filmovertrukne tabletter EU/1/15/1003/023 60 filmovertrukne tabletter EU/1/15/1003/039 90 filmovertrukne tabletter EU/1/15/1003/024 100 filmovertrukne tabletter
English: EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets
Danish: EU/1/15/1003/028 10 filmovertrukne tabletter EU/1/15/1003/029 14 filmovertrukne tabletter EU/1/15/1003/030 30 filmovertrukne tabletter EU/1/15/1003/031 56 filmovertrukne tabletter EU/1/15/1003/032 60 filmovertrukne tabletter EU/1/15/1003/040 90 filmovertrukne tabletter EU/1/15/1003/033 100 filmovertrukne tabletter
English: Therapeutic experience in patients aged 85 years and older is limited.
Danish: Den kliniske erfaring med empagliflozin til patienter på 85 år og derover er begrænset, og behandling af denne population bør ikke indledes (se pkt.
English: EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets
Danish: EU/1/15/1003/010 10 filmovertrukne tabletter EU/1/15/1003/011 14 filmovertrukne tabletter EU/1/15/1003/012 30 filmovertrukne tabletter EU/1/15/1003/013 56 filmovertrukne tabletter EU/1/15/1003/014 60 filmovertrukne tabletter EU/1/15/1003/038 90 filmovertrukne tabletter EU/1/15/1003/015 100 filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1003/034 120 (2 x 60 x 1) filmovertrukne tabletter EU/1/15/1003/035 180 (2 x 90 x 1) filmovertrukne tabletter EU/1/15/1003/036 200 (2 x 100 x 1) filmovertrukne tabletter
English: Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating and change in vision, and may affect your ability to drive and use machines.
Danish: Hvis du tager Synjardy i kombination med lægemidler, der kaldes for sulfonylurinstoffer, eller med insulin, kan dit blodsukker blive for lavt (hypoglykæmi).
English: Subgroup analysis of full analysis set (FAS) for patients on additional background of metforminCompleters using last observation carried forward (LOCF) prior to glycaemic rescue therapy mean adjusted for baseline value * p-value <0.0001 ** p-value ≤0.025
Danish: Undergruppeanalyse af det fuldstændige analysedatasæt (FAS) for patienter, der også fik metformin, ved brug af sidste observation føres videre (LOCF) før blodglucoseregulerende behovsbehandling.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1003/025 120 (2 x 60 x 1) filmovertrukne tabletter EU/1/15/1003/026 180 (2 x 90 x 1) filmovertrukne tabletter EU/1/15/1003/027 200 (2 x 100 x 1) filmovertrukne tabletter
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Danish: Tel: +39 055 42571
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1003/016 120 (2 x 60 x 1) filmovertrukne tabletter EU/1/15/1003/017 180 (2 x 90 x 1) filmovertrukne tabletter EU/1/15/1003/018 200 ( 2 x 100 x 1) filmovertrukne tabletter
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1003/007 120 (2 x 60 x 1) filmovertrukne tabletter EU/1/15/1003/008 180 (2 x 90 x 1) filmovertrukne tabletter EU/1/15/1003/009 200 ( 2 x 100 x 1) filmovertrukne tabletter)
English: Symptoms of lactic acidosis include:
Danish: Andre bivirkninger omfatter:
English: • vomiting
Danish: • Nældefeber
English: Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Danish: Empagliflozin skal straks seponeres hos patienter med formodet eller verificeret diabetisk ketoacidose.
English: 90 (3 x 30) tablets (multipack)
Danish: 90 (3 x 30) tabletter (multipakning)
English: MA (EU) number (Invented) name
Danish: MA (EU)-nummer (Sær)navn
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administrationsvej Indre emballage
English: The application was withdrawn in the Netherlands and United Kingdom.
Danish: Ansøgningen blev trukket tilbage i Nederlandene og Det Forenede Kongerige.
English: Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Danish: Portugal og Tyskland fremsendte begrundelserne for uenigheden til EMEA den 15. december 2004.
English: 21 February 2006 EMEA/CHMP/373061/2005
Danish: 21. februar 2006 EMEA/CHMP/373061/2005
English: The Reference Member State was Finland and the Concerned Member States were Austria, Belgium, Denmark, Germany, Italy, Luxembourg, the Netherlands, Portugal, Sweden and United Kingdom.
Danish: Referencemedlemsstaten var Finland og de berørte medlemsstater var Østrig, Belgien, Danmark, Tyskland, Italien, Luxembourg, Nederlandene, Portugal, Sverige og Det Forende Kongerige.
English: The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 21. februar 2006.
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Danish: De berørte medlemsstater har ikke kunnet nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: A Mutual Recognition Procedure was started on 16 September 2004.
Danish: En gensidig anerkendelsesprocedure blev indledt den 16. september 2004.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2005.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 20. juli 2005.
English: During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Lansoprazol-ratiopharm.
Danish: På sit møde i september 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet er gunstigt for Lansoprazol
English: Lansoprazol-ratiopharm (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Danish: Lansoprazol-ratiopharm (lansoprazol) er en protonpumpehæmmer, som hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gastrisk ulcus, reflux øsofagitis, gastro-øsofageal reflukssygdom, behandling og profylakse af NSAID-relaterede gastriske og duodenale ulcera, Zollinger-Ellisons syndrom og i kombination med passende antibakterielle behandlingsregimener til udryddelse af Helicobacter pylori og forebyggelse af recidiv af peptiske ulcera hos patienter med H. pylori-relaterede ulcera.
English: In particular, the data of the bioequivalence of the 2x15 mg capsules and the 30 mg capsules, and the possible need for a reduced dose of lansoprazole in this therapeutic indication.
Danish: Navnlig dataene for bioækvivalensen af 2x15 mg kapsler og 30 mg kapsler og det mulige behov for en reduceret dosis lansoprazol til denne terapeutiske indikation.
English: The applicant should provide clinical data to support the use of 15 mg capsules for Helicobacter pylori eradication.
Danish: Ansøgeren bør fremlægge kliniske data til støtte for anvendelsen af 15 mg kapsler til udryddelse af Helicobacter pylori.
English: A Marketing Authorisation for Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Danish: Der er tidligere udstedt en markedsføringstilladelse for Lansoprazol-ratiopharm (15 mg og 30 mg) til ratiopharm GmbH i Finland.
English: For the 15 mg dosage form the therapeutic indication “Helicobacter pylori eradication” is not approved for the reference medicinal product marketed in Portugal.
Danish: For 15 mg doseringsformen er den terapeutiske indikation ”udryddelse af Helicobacter pylori” ikke godkendt for referencelægemidlet, der markedsføres i Portugal.
English: The SPC of the reference product in Germany contains specific doses and dosing schedules for the combinations of lansoprazole and antibiotics recommended for eradication of Helicobacter pylori.
Danish: Produktresuméet for referenceproduktet i Tyskland indeholder specifikke doser og doseringsplaner for de kombinationer af lansoprazol og antibiotika, der anbefales til udryddelse af Helicobacter pylori.
English: Significant differences in comparison to the reference product have been identified with regard to the indication section of the SPCs.
Danish: Der er identificeret væsentlige forskelle i forhold til referenceproduktet i afsnittet om indikationen i produktresuméerne.
English: Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Danish: CHMP godkendte ændringerne af afsnit 4.2 (dosering og indgivelsesmåde) og præciserede den anbefalede dosering for antibiotika i overensstemmelse med ”punkter, der bør overvejes vedrørende ordlyden af Helicobacter pylori-eradikationsbehandlingen i de forskellige afsnit af produktresuméet” og vedtog en positiv udtalelse den 15. september 2005.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Lansoprazol-ratiopharm 15 mg og 30 mg
English: Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Danish: Der er identificeret væsentlige forskelle i forhold til referenceproduktet i afsnittet om dosering i produktresuméerne.
English: Somavert received a marketing authorisation valid throughout the EU on 13 November 2002.
Danish: Somavert fik en markedsføringstilladelse med gyldighed i hele EU den 13. november 2002.
English: The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Danish: Virkningen blev målt ved at sammenligne niveauerne af insulinlignende vækstfaktor I (IGF-I) før og ved afslutningen af studiet.
English: The doctor should check the response every four to six weeks and adjust the dose if needed.
Danish: Lægen skal kontrollere patientens respons hver fjerde til sjette uge og om nødvendigt justere dosis.
English: The maximum dose is 30 mg per day.
Danish: Den maksimale dosis er 30 mg daglig.
English: Further information on Somavert can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Somavert.
Danish: Yderligere information om Somavert findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Somavert.
English: The majority of side effects were mild to moderate and of limited duration.
Danish: Størstedelen af bivirkningerne var lette eller moderate og af begrænset varighed.
English: IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Danish: IGF-I-niveauerne var normale ved studiets afslutning (i uge 12) hos henholdsvis 38,5 %, 75 % og 82 % af de patienter, der blev behandlet med 10, 15 eller 20 mg/dag af Somavert, sammenlignet med 9,7 % hos de patienter, der fik placebo.
English: As for all medicines, data on the use of Somavert are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Somavert løbende overvåget.
English: If levels are too high, the doctor may decide not to begin or to stop treatment with Somavert.
Danish: Hvis niveauet er for højt, kan lægen beslutte enten ikke at begynde eller at stoppe behandlingen med Somavert.
English: Following this, Somavert is given as an injection of 10 mg once a day.
Danish: Herefter indgives Somavert som en injektion på 10 mg én gang dagligt.
English: The patient first receives a starting dose of 80 mg under medical supervision.
Danish: Patienten får først en startdosis på 80 mg under lægeovervågning.
English: Other information about Somavert
Danish: Andre oplysninger om Somavert
English: Somavert lowered IGF-I levels at all of the doses tested.
Danish: Somavert sænkede IGF-I-niveauerne ved alle de afprøvede doser.
English: Somavert contains the active substance pegvisomant.
Danish: Somavert indeholder det aktive stof pegvisomant.
English: The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Danish: De hyppigste bivirkninger ved Somavert (som optræder hos mere end 1 ud af 10 personer) var hovedpine, diarré og ledsmerter.
English: The European Medicines Agency decided that Somavert's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Somavert opvejer risiciene, og det kan godkendes til anvendelse i EU.
English: An overview of Somavert and why it is authorised in the EU
Danish: En oversigt over Somavert, og hvorfor det er godkendt i EU
English: IGF-I is regulated by human growth hormone and causes growth in the body.
Danish: IGF-I reguleres af menneskeligt væksthormon og bevirker vækst i kroppen.
English: Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Danish: Bivirkninger rapporteret for Somavert vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
English: What measures are being taken to ensure the safe and effective use of Somavert?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Somavert?
English: Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Danish: Derefter fik de 10, 15 eller 20 mg Somavert pr. dag eller placebo.
English: Growth hormone promotes growth during childhood and adolescence.
Danish: Væksthormon fremmer væksten i barndommen og under opvæksten.
English: For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Somavert, se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: The patient or caregiver can inject Somavert after being trained by a doctor or a nurse.
Danish: Patienten eller behandleren kan injicere Somavert efter at være blevet instrueret heri af en læge eller sygeplejerske.
English: Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Danish: Somavert blev undersøgt i et 12-ugers studie med 112 patienter med akromegali.
English: Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Danish: Patienterne fik en startdosis på 80 mg Somavert eller placebo (en uvirksom behandling).
English: By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
Danish: Ved at blokere disse receptorer forhindrer Somavert væksthormonet i at have nogen effekt, hvilket forhindrer den uønskede vækst og andre lidelser, der ses ved akromegali.
English: Why is Somavert authorised in the EU?
Danish: Hvorfor blev Somavert godkendt i EU?
English: What is Somavert and what is it used for?
Danish: Hvad er Somavert, og hvad anvendes det til?
English: Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Danish: Somavert anvendes til patienter, som ikke har responderet tilstrækkeligt på kirurgi og/eller stråleterapi og på behandling med somatostatinanaloger (en anden type lægemidler til behandling af akromegali).
English: Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood.
Danish: Patienten bør før og under behandlingen med Somavert få foretaget prøver for at måle niveauet af leverenzymer i blodet.
English: What are the risks associated with Somavert?
Danish: Hvilke risici er der forbundet med Somavert?
English: The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
Danish: Det aktive stof i Somavert, pegvisomant, ligner i høj grad menneskeligt væksthormon, men det er udviklet således, at det blokerer de receptorer, som væksthormonet normalt binder sig til.
English: Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly.
Danish: Somavert udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af akromegali.