natgillin/translations-raw huggingface dataset:
For at nå vedligeholdelsesdosis må doserne maksimalt øges med 50-100 mg hver eller hver anden uge, indtil den optimale respons er opnået 
To achieve maintenance, doses may be increased by maximum of 50 - 100 mg every one to two weeks until optimal response is achieved
Natriumstivelsesglycolat (type A) Povidon K30 
Low-substituted hydroxypropyl cellulose Aluminium magnesium silicate Sodium starch glycolate (Type A) Povidone K30
Lamictal Dispersible 25mg Starter-Pack Add-on 
Lamictal Dispersible 25mg Starter-Pack Add-on 25 mg Dispersible Tablet
200 mg/dag (fordelt på to doser) 
200 mg/day (two divided doses)
50 mg/dag (én gang dagligt eller fordelt på to doser) 
50 mg/day (once a day or two divided doses)
Hos patienter, der tager lægemidler, hvor den farmakokinetiske interaktion med lamotrigin ikke kendes på nuværende tidspunkt (se pkt. 
In patients taking medicinal products where the pharmacokinetic interaction with lamotrigine is currently not known (see section 4.5), the treatment regimen as recommended for lamotrigine with concurrent valproate, should be used.
- Spørg lægen eller på apoteket, hvis der er mere, du vil vide. 
Check with your doctor or pharmacist if you're not sure.
21 dispergible tabletter / tyggetabletter 
21 dispersible/chewable tablets
Pakninger med 10, 14, 30, 42, 50, 56, 60, 90, 100 eller 200 dispergible tabletter / tyggetabletter. 
Packs of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 dispersible/chewable tablets.
Der findes startpakninger med 21 eller 42 tabletter til de første uger af behandlingen, hvor dosis langsomt øges. 
Starter packs containing 21 or 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
50 dispergible tabletter / tyggetabletter 
50 dispersible/chewable tablets
Î Spørg lægen til råds om, hvordan du skal fortsætte behandlingen. 
If you have missed taking a dose of Lamictal: Î Ask your doctor for advice on how to start taking it again.
56 dispergible tabletter / tyggetabletter 
56 dispersible/chewable tablets
Hver Lamictal 2 mg dispergibel tablet / tyggetabletindeholder 2 mg lamotrigin. 
Each Lamictal 2 mg dispersible/chewable tablet contains 2 mg lamotrigine.
Hver pakning med blistere indeholder 14, 21, 30, 42, 50, 56 eller 100 tabletter. 
Each pack contains blisters of 14, 21, 30, 42, 50, 56 or 100 tablets.
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter. 
Lamictal and associated names (see Annex I) 25 mg tablets.
100 mg/dag (én gang dagligt eller fordelt på to doser) 
100 mg/day (once a day or two divided doses)
Hver pakning med blistere indeholder 10, 14, 30, 42, 50, 56, 60, 90, 100 eller 200 tabletter. 
Each pack contains blisters of 10, 14, 30, 42, 50, 56, 60, 90, 100 or 200 tablets.
Hver Lamictal 100 mg dispergibel tablet / tyggetabletindeholder 100 mg lamotrigin. 
Each Lamictal 100 mg dispersible/chewable tablet contains 100 mg lamotrigine.
90 dispergible tabletter / tyggetabletter 
90 dispersible/chewable tablets
Under kliniske forsøg vedrørende bipolar sygdom: Meget almindelig: 
Nervous system disorders During bipolar disorder clinical trials: Very common:
14 dispergible tabletter / tyggetabletter 
14 dispersible/chewable tablets
Hver Lamictal 200 mg dispergibel tablet / tyggetabletindeholder 200 mg lamotrigin. 
Each Lamictal 200 mg dispersible/chewable tablet contains 200 mg lamotrigine.
Lamictal og tilknyttede navne (se bilag I) 100 mg tabletter. 
Lamictal and associated names (see Annex I) 100 mg tablets.
Hver Lamictal 5 mg dispergibel tablet / tyggetabletindeholder 5 mg lamotrigin. 
Each Lamictal 5 mg dispersible/chewable tablet contains 5 mg lamotrigine.
Der er ikke foretaget undersøgelser af interaktionen mellem andre perorale kontraceptiva eller hormonsubstitutionsbehandlinger og lamotrigin. 
The interaction between other oral contraceptive or HRT treatments and lamotrigine have not been studied, though they may similarly affect lamotrigine pharmacokinetic parameters.
30 dispergible tabletter / tyggetabletter 
30 dispersible/chewable tablets
Under kliniske forsøg med monoterapi: Meget almindelig: 
Nervous system disorders During monotherapy clinical trials: Very common:
Der findes også startpakninger med 21 eller 42 tabletter til de første uger af behandlingen, hvor dosis langsomt øges. 
Starter packs containing 21 or 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - udfyldes nationalt] 
MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
100 dispergible tabletter / tyggetabletter 
100 dispersible/chewable tablets
For at nå vedligeholdelsesdosis må doserne maksimalt øges med 0,6 mg/kg hver eller hver anden uge, indtil den optimale respons er opnået, og vedligeholdelsesdosis må maksimalt være 200 mg/dag Hos patienter, der tager lægemidler, hvor den farmakokinetiske interaktion med lamotrigin ikke kendes på nuværende tidspunkt (se pkt. 
To achieve maintenance, doses may be increased by maximum of 0.3 mg/kg every one to two weeks until optimal response is achieved, with a maximum maintenance dose of 200 mg/day Adjunctive therapy WITHOUT valproate and WITH inducers of lamotrigine glucuronidation (see section 4.5): This dosage regimen should be used without valproate but with:
Lamictal og tilknyttede navne (se bilag I) 200 mg tabletter. 
Lamictal and associated names (see Annex I) 200 mg tablets.
Under kliniske forsøg vedrørende bipolar sygdom: Almindelig: 
Gastrointestinal disorders During bipolar disorder clinical trials: Common:
Hver pakning med blistere indeholder 14, 30, 42, 56, 90 eller 100 tabletter. 
Each pack contains blisters of 14, 30, 42, 56, 90 or 100 tablets.
1-10 mg/kg/dag (én gang dagligt eller fordelt på to doser) 
1 − 10 mg/kg/day (once a day or two divided doses)
0,3 mg/kg/dag (én gang dagligt eller fordelt på to doser) 
0.3 mg/kg/day (once a day or two divided doses)
60 dispergible tabletter / tyggetabletter 
60 dispersible/chewable tablets
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 200 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 200 mg lamotrigine
Der findes startpakninger med 42 tabletter til de første uger af behandlingen, hvor dosis langsomt øges. 
Starter packs containing 42 tablets are available for use during the first few weeks of treatment when the dose is being slowly increased.
De er påtrykt 'GS CL5' på den ene side og '25' på den anden side. 
They are marked ‘GSCL5' on one side; and ‘25' on the other.
Hver Lamictal 25 mg dispergibel tablet / tyggetabletindeholder 25 mg lamotrigin. 
Each Lamictal 25 mg dispersible/chewable tablet contains 25 mg lamotrigine.
10 dispergible tabletter / tyggetabletter 
10 dispersible/chewable tablets
GlaxoSmithKline ehf Thverholt 14 
Thverholt 14
Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter. 
Lamictal and associated names (see Annex I) 50 mg tablets.
Lavere vedligeholdelsesdoser kan være effektive hos patienter med signifikant nedsat nyrefunktion (se pkt. 
For patients with end-stage renal failure, initial doses of lamotrigine should be based on patients' concomitant medicinal products; reduced maintenance doses may be effective for patients with significant renal functional impairment (see sections 4.4 and 5.2).
Hver pakning med blistere indeholder 30, 50, 56, 60, 90 eller 100 tabletter. 
Each pack contains blisters of 30, 50, 56, 60, 90 or 100 tablets.
0,6 mg/kg/dag (én gang dagligt eller fordelt på to doser) 
0.6 mg/kg/day (once a day or two divided doses)
Lamictal 25 mg disperzibilne/žvečljive tablete 
Lamictal 25 mg disperzibilne/žvečljive tablete 25 mg Dispersible/Chewable Tablet
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 100 mg lamotrigine
1-5 mg/kg/dag (én gang dagligt eller fordelt på to doser) 
1 − 5 mg/kg/day (once a day or two divided doses)
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 25 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 25 mg lamotrigine
Smerter, rygsmerter. 
pain, back pain.
Lamictal 200 mg disperzibilne/žvečljive tablete 
Lamictal 200 mg disperzibilne/žvečljive tablete 200 mg Dispersible/Chewable Tablet
Der findes også startpakninger med 42 tabletter til de første uger af behandlingen, hvor dosis langsomt øges. 
Starter packs containing 42 tablets are also available for use during the first few weeks of treatment when the dose is being slowly increased.
Før du tager Lamictal, skal du fortælle lægen: - om du har problemer med nyrerne - om du nogensinde har fået udslæt, mens du har taget lamotrigin eller andre lægemidler til behandling af epilepsi - om du allerede tager medicin, der indeholder lamotrigin. 
• if you have ever developed a rash when you've taken lamotrigine or other medicines for epilepsy
2 mg dispergible tabletter / tyggetabletter: 
2 mg dispersible/chewable tablets:
Lamictal 200 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner. 
Lamictal 200 mg dispersible/chewable tablets are square with rounded corners.
100 mg dispergible tabletter / tyggetabletter: 
100 mg dispersible/chewable tablets:
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CL7" på den ene side og "100" på den anden side. 
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL7” on one side and “100” on the other.
200 mg dispergible tabletter / tyggetabletter: 
200 mg dispersible/chewable tablets:
GlaxoSmithKline UK 
GlaxoSmithKline ehf.
Hver pakning med blistere indeholder 10, 30, 50, 56, 60, 90, 100 eller 200 tabletter. 
Each pack contains blisters of 10, 30, 50, 56, 60, 90, 100 or 200 tablets.
Lamictal 25 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner. 
Lamictal 25 mg dispersible/chewable tablets are square with rounded corners.
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE7" på den ene side og "200" på den anden side. 
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE7” on one side and “200” on the other.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each tablet contains 50 mg lamotrigine
25 mg dispergible tabletter / tyggetabletter: 
25 mg dispersible/chewable tablets:
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE1" på den ene side og "50" på den anden side. 
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE1” on one side and “50” on the other.
Lamictal 100 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner. 
Lamictal 100 mg dispersible/chewable tablets are square with rounded corners.
5 mg dispergible tabletter / tyggetabletter: 
5 mg dispersible/chewable tablets:
Hver Lamictal 50 mg dispergibel tablet / tyggetabletindeholder 50 mg lamotrigin. 
Each Lamictal 50 mg dispersible/chewable tablet contains 50 mg lamotrigine.
Lamictal 50 mg dispergible tabletter / tyggetabletter er kvadratiske med afrundede hjørner. 
Lamictal 50 mg dispersible/chewable tablets are square with rounded corners.
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EC7" på den ene side og "25" på den anden side. 
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEC7” on one side and “25” on the other.
Lamictal 100 mg disperzibilne/žvečljive tablete 
Lamictal 100 mg disperzibilne/žvečljive tablete 100 mg Dispersible/Chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets.
Lamictal 5 mg disperzibilne/žvečljive tablete 
Lamictal 5 mg disperzibilne/žvečljive tablete 5 mg Dispersible/Chewable Tablet
50 mg dispergible tabletter / tyggetabletter: 
50 mg dispersible/chewable tablets:
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets.
Lever og galdeveje Meget sjælden: 
Immune system disorders Very rare:
Lamictal 50 mg disperzibilne/žvečljive tablete 
Lamictal 50 mg disperzibilne/žvečljive tablete 50 mg Dispersible/Chewable Tablet
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CX7" på den ene side og "50" på den anden side. 
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCX7” on one side and “50” on the other.
Lamictal og tilknyttede navne (se bilag I) 100 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lys, gulligbrun, multifacetslebet, superellipseformet tablet påtrykt "GS EE5" på den ene side og "100" på den anden side. 
Pale, yellowish-brown, multifaceted, super-elliptical tablet, marked “GSEE5” on one side and “100” on the other.
Lamictal og tilknyttede navne (se bilag I) 200 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 100 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 100 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 2 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets.
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS CL5" på den ene side og "25" på den anden side. 
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSCL5” on one side “25” on the other.
200 mg Dispergible / tyggetabletter 
200 mg Dispersible/Chewable Tablets
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 200 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 200 mg lamotrigine
Hvid til offwhite, multifacetslebet, superellipseformet tablet med solbærlugt påtrykt "GS EC5" på den ene side og "200" på den anden side. 
White to off-white multi-faceted, super-elliptical, tablet with a blackcurrant odour, marked “GSEC5” on one side and “200” on the other.
Lamictal og tilknyttede navne (se bilag I) 25 mg tabletter [Se bilag 1 - udfyldes nationalt] Lamotrigin 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 25 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 25 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets.
100 mg Dispergible eller tyggetabletter 
100 mg Dispersible or chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 100 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter. 
Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 5 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 5 mg lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 2 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 2 mg lamotrigine
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 200 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver dispergibel tablet / tyggetablet indeholder 50 mg lamotrigin 
STATEMENT OF ACTIVE SUBSTANCE Each dispersible/chewable tablet contains 50 mg lamotrigine
200 mg Dispergible eller tyggetabletter 
200 mg Dispersible or chewable Tablet
Lamictal og tilknyttede navne (se bilag I) 50 mg tabletter [Se bilag I - udfyldes nationalt] Lamotrigin 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 25 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal og tilknyttede navne (se bilag I) 2 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 2 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Lamictal 5mglösliche Tabletten 
Lamictal 5mg - lösliche Tabletten
2 mg Dispergible / tyggetabletter 
2 mg Dispersible/Chewable Tablets
100 mg Dispergible / tyggetabletter 
100 mg Dispersible/Chewable Tablet
5 mg Dispergible eller tyggetabletter 
5 mg Dispersible or chewable Tablet
Lamictal dispergible tabletter / tyggetabletter indeholder: 
What Lamictal tablets contain
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter [Se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 50 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
Vedligeholdelsesdosen af lamotrigin skal i de fleste tilfælde reduceres med op til 50 % (se pkt. 
Stopping hormonal contraceptives in patients already taking maintenance doses of lamotrigine and NOT taking inducers of lamotrigine glucuronidation The maintenance dose of lamotrigine will in most cases need to be decreased by as much as 50% (see sections 4.4 and 4.5).
Hvis du vil have yderligere oplysninger om Lamictal, skal du henvende dig til den lokale repræsentant: 
Take special care with Lamictal Your doctor needs to know before you take Lamictal:
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter [se bilag I - udfyldes nationalt] 
NAME OF THE MEDICINAL PRODUCT Lamictal and associated names (see Annex I) 5 mg dispersible/chewable tablets [See Annex I - To be completed nationally] Lamotrigine
25 mg Dispergible eller tyggetabletter 
25 mg Dispersible or chewable Tablet
Oversigt over indlægssedlen: 
To make a liquid medicine:
50 mg Dispergible / tyggetabletter 
50 mg Dispersible/Chewable Tablets
Medbring denne indlægsseddel og/eller pakningen, hvis du har mulighed for det. 
If possible, show them the Lamictal packet.
50 mg Dispergible eller tyggetabletter 
50 mg Dispersible or chewable Tablet
Derfor kan metaboliseringen af folat blive påvirket ved længerevarende behandling (se pkt. 
Lamotrigine has a slight inhibitory effect on dihydrofolic acid reductase, hence there is a possibility of interference with folate metabolism during long-term therapy (see section 4.6).
2 mg Opløselige tabletter 
2 mg Soluble Tablet
Tilføjelse af valproat (hæmmer af lamotrigin-glukuronidering - se pkt. 
Addition of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
Seponering af valproat (hæmmer af lamotrigin-glukuronidering - se pkt. 
Withdrawal of valproate (inhibitor of lamotrigine glucuronidation - see section 4.5), depending on original dose of lamotrigine:
5 mg Dispergible / tyggetabletter 
5 mg Dispersible/Chewable Tablet
5 mg Opløselige tabletter 
5 mg Soluble Tablet
Andre oplysninger om Tredaptive: 
Other information about Tredaptive:
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tredaptive. 
The Committee recommended that Tredaptive be given marketing authorisation.
Startdosis for Tredaptive er én tablet én gang dagligt i fire uger, hvorefter dosis øges til to tabletter én gang dagligt. 
The starting dose of Tredaptive is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tredaptive til Merck Sharp & Dohme Ltd. 
The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Den fuldstændige EPAR for Tredaptive findes her. 
The full EPAR for Tredaptive can be found here.
Virkningerne af Tredaptive blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker. 
The effects of Tredaptive were first tested in experimental models before being studied in humans.
Tredaptive anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning hos denne aldersgruppe. 
Tredaptive is not recommended for use in children under 18 years of age because of a lack of information on its safety and effectiveness in this group.
EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) TREDAPTIVE EPAR - sammendrag for offentligheden 
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) TREDAPTIVE EPAR summary for the public
Tredaptive anvendes alene hos patienter, der ikke tåler statiner. 
Tredaptive is used on its own only in patients who cannot take statins.
Den mest almindelige bivirkning ved Tredaptive (som optræder hos flere end 1 ud af 10 patienter) er flushing. 
The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
De omfattede i alt 2 349 patienter, som tog enten Tredaptive eller nikotinsyre. 
They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
Tredaptive anvendes normalt sammen med et statin (standard kolesterolsænkende lægemiddel), når virkningen af et statin alene er utilstrækkelig. 
Tredaptive is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Den anden undersøgelse viste, at indholdet af LDL-kolesterol blev yderligere sænket, når Tredaptive blev givet sammen med simvastatin (48 % reduktion) sammenlignet med Tredaptive alene (17 % reduktion) eller simvastatin alene (37 % reduktion). 
The second study showed that the LDL cholesterol levels were further reduced when Tredaptive was taken with simvastatin (48% reduction), compared with Tredaptive alone (17% reduction) or simvastatin alone (37% reduction).
Den anden undersøgelse sammenlignede kombinationen af Tredaptive og simvastatin (et statin) med Tredaptive alene eller simvastatin alene hos 1 398 patienter. 
The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
De to aktive stoffer i Tredaptive, nikotinsyre og laropiprant, har forskellige virkemåder. 
The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Den fuldstændige liste over alle de indberettede bivirkninger ved Tredaptive fremgår af indlægssedlen. 
For the full list of all side effects reported with Tredaptive, see the Package Leaflet.
Hvilken risiko er der forbundet med Tredaptive? 
What is the risk associated with Tredaptive?
Tredaptive er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3-vitamin) og laropiprant. 
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.