natgillin/translations-raw huggingface dataset:
Coronary Drug Project, en fem - årig undersøgelse, der afsluttedes i 1975, viste, at nicotinsyre havde en statistisk signifikant positivindvirkning på reduktionen af nonfatale, tilbagevendende myokardieinfarkter (MI) hos mænd i alderen 30- 64 år med MI i anamnesen.
The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
4. 8).
In healthy subjects receiving Tredaptive, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Tredaptive alone (see section 4.8).
Kliniske undersøgelser Indvirkning på lipider Tredaptive var konsekvent effektivt på tværs af alle på forhånd specificerede patientundergrupper i henhold til race, køn, LDL- C, HDL- C og TG ved baseline, alder og diabetesstatus.
Clinical studies Effect on lipids Tredaptive was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Patienter, der tager Tredaptive (2. 000 mg/ 40 mg) med eller uden statin, versus placebo, havde signifikant nedsat LDL- C (- 18, 9% versus - 0, 5%), TG (- 21, 7% versus 3, 6%), LDL- C: HDL- C (- 28, 9% versus 2, 3%), non- HDL- C (- 19, 0% versus 0, 8%) apo- B (- 16, 4% versus 2, 5%), TC (- 9, 2% versus - 0, 6%), Lp( a) (- 17, 6% versus 1, 1%) og TC: HDL- C (- 21, 2% versus 1, 9%) og havde også signifikant øget HDL- C (18, 8% versus - 1, 2%) og apo- A- I (11, 2% versus 4, 3%) målt som ændring i procent i forhold til baseline.
1.1%), and TC: HDL-C (-21.2% vs.
Patienter, der fik MK524A, nicotinsyre (depotformulering) eller placebo, tog også statiner (29% atorvastatin [5- 80 mg], 54% simvastatin [10- 80 mg], 17% andre statiner [2, 5- 180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), hvoraf 9% også tog ezetimibe [10 mg].
Patients receiving Tredaptive, nicotinic acid (prolonged-released formulation), or placebo were also taking statins (29% atorvastatin [5-80 mg], 54% simvastatin [10-80 mg], 17% other statins [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), of which 9% were also taking ezetimibe [10 mg].
Placebojusteret respons for LDL- C, HDL- C og TG forekom højere hos kvinder end hos mænd og forekom højere hos ældre patienter (≥ 65 år) end hos yngre patienter (< 65 år).
The placebo-adjusted LDL-C, HDL-C and TG responses appeared greater among women compared to men and appeared greater among elderly patients (≥ 65 years) compared to younger patients (< 65 years).
I en multicenter, dobbeltblindet 12- ugers faktoriel undersøgelse reducerede Tredaptive 1. 000 mg/ 20 mg og simvastatin signifikant LDL- C (henholdsvis - 44, 2%, - 37, 4% og - 8, 2%), TG (henholdsvis - 25, 8%, - 15, 7% og - 18, 7%), TC (henholdsvis - 27, 9%, - 25, 8% og - 4, 9%), når det blev sammenlignet med simvastatin alene eller Tredaptive 1. 000 mg/ 20 alene i 4 uger.
In a multicentre, double-blind, 12-week factorial study, Tredaptive 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Tredaptive 1000 mg/ 20 mg alone, for 4 weeks, significantly lowered LDL-C (-44.2%, -37.4%, -8.2% respectively), TG (-25.8%, -15.7%, -18.7% respectively), TC (-27.9%, -25.8%, -4.9% respectively) and significantly increased HDL-C (19.2%, 4.2%, 12.5% respectively).
HDL- C øgedes signifikant (henholdsvis 19, 2%, 4, 2% og 12, 5%).
Tredaptive (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone or Tredaptive (2000 mg/ 40 mg) alone for 12 weeks, significantly lowered LDL-C (-47.9%, -37.0%, -17.0% respectively), TG (-33.3%, -14.7%, -21.6% respectively), apo B
Sammenlignet med simvastatin alene eller Tredaptive (2. 000 mg/ 40 mg) alene i 12 uger sænkede Tredaptive (2. 000 mg/ 40 mg) sammen med simvastatin LDL- C (henholdsvis - 47, 9%, - 37, 0%, - 17, 0%), TG (henholdsvis - 33, 3%, - 14, 7%, - 21, 6%), apo B (henholdsvis - 41, 0%, - 28, 8%, - 17, 1%) og TC (henholdsvis - 29, 6%, - 24, 9%, 9, 1%) samt LDL- C: HDL- C (henholdsvis - 57, 1%, - 39, 8%, - 31, 2%), non- HDL- C (henholdsvis - 45, 8%, - 33, 4%, - 18, 1%) og TC: HDL- C (henholdsvis - 43, 0%, - 28, 0%, - 24, 9%) signifikant og øgede HDL- C signifikant (henholdsvis 27, 5%, 6, 0%, 23, 4%).
11 (-41.0%, -28.8%, -17.1% respectively), and TC (-29.6%, -24.9%, -9.1% respectively), as well as LDL-C: HDL-C (-57.1%, -39.8%, -31.2% respectively), non-HDL-C (-45.8%, -33.4%, -18.1% respectively), and TC: HDL-C (-43.0%, -28.0%, -24.9% respectively), and significantly increased HDL-C (27.5%, 6.0%, 23.4% respectively).
Yderligere analyse viste, at Tredaptive (2. 000 mg/ 40 mg) administreret sammen med simvastatin i sammenligning med simvastatin alene øgede apo- A- I signifikant (henholdsvis 8, 6%, 2, 3%) og reducerede Lp( a) signifikant (henholdsvis - 19, 8%, 0, 0%).
Further analysis showed Tredaptive (2000 mg/ 40 mg) co-administered with simvastatin when compared with simvastatin alone significantly increased apo A-I (8.6%, 2.3% respectively) and significantly decreased Lp(a) (-19.8%, 0.0% respectively).
Flushing I to store kliniske undersøgelser, hvor patientrapporterede flushing- symptomer blev målt, oplevede de patienter, der tog Tredaptive, mindre flushing end de patienter, der tog nicotinsyre (depotformuleringer).
Flushing In two large clinical trials measuring patient-reported flushing symptoms, patients taking Tredaptive experienced less flushing than those taking nicotinic acid (prolonged-release formulations).
Men hos de patienter, der blev behandlet med nicotinsyre (depotformulering) forblev hyppigheden af flushing konstant (efter uge 6).
In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Tredaptive declined and approached that of patients receiving placebo (see Figure 1), whereas in patients treated with nicotinic acid (prolonged-release formulation) the flushing frequency remained constant (after Week 6).
● Tredaptive (1. 000 mg/ 20 mg til 2. 000 mg/ 40 mg ved uge 5) ▲Nicotinsyre (depotformulering 1. 000mg to 2. 000 mg ved uge 5) ○Placebo * Inkluderer patienter med moderate, svære eller ekstreme flushing- symptomer † Øgning af dosis ved uge 5
● Tredaptive (1000 mg/ 20 mg to 2000 mg/ 40 mg at week 5) ▲ Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5) ○ Placebo *Includes patients with moderate, severe, or extreme flushing symptoms † Dose advancement at Week 5
I den anden undersøgelse (16 uger), hvor acetylsalicylsyre var tilladt, oplevede de patienter, der fik Tredaptive, signifikant færre dage pr. uge med moderat eller mere udbredt flushing sammenlignet med nicotinsyre (taget som depotformulering med multi- step titrering fra 500 mg til 2. 000 mg over 12 uger) (p < 0, 001).
In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Tredaptive experienced significantly fewer days per week with moderate or greater flushing compared to nicotinic acid (prolonged-release formulation taken as a 12-week multi-step 500 mg to 2000 mg titration) (p < 0.001).
1, 6 µM.
Laropiprant Following a 40 mg dose of laropiprant administered orally as two modified-release tablets of nicotinic acid/ laropiprant with food, laropiprant is rapidly absorbed with a median Tmax of 1 hour, a mean AUC0-∞ of approximately 13 μ M·hr, and a mean Cmax of approximately 1.6 μ M.
11 Nicotinsyre Nicotinsyre er bundet mindre end 20% til serumproteiner.
Distribution Nicotinic acid Nicotinic acid is less than 20% bound to serum proteins.
Patientkarakteristika Nyreinsufficiens Tredaptive:
Characteristics in patients Renal insufficiency Tredaptive:
Leverinsufficiens Tredaptive:
Hepatic insufficiency Tredaptive:
Børn Tredaptive:
Paediatric Tredaptive:
Tredaptive I prækliniske undersøgelser sås kun effekt ved eksponeringer, der blev anset for at være tilstrækkeligt over den maksimale eksponering for mennesker, hvilket tyder på ringe relevans for brugen til mennesker.
Tredaptive Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure, indicating little relevance to human use.
Hypromellose (E464) Silica, kolloid vandfri (E551) Natriumstearylfumarat Hydroxypropylcellulose (E463)
Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
EU/ 1/ 08/ 459/ 001 EU/ 1/ 08/ 459/ 002 EU/ 1/ 08/ 459/ 003 EU/ 1/ 08/ 459/ 004 EU/ 1/ 08/ 459/ 005 EU/ 1/ 08/ 459/ 006 EU/ 1/ 08/ 459/ 007 EU/ 1/ 08/ 459/ 008 EU/ 1/ 08/ 459/ 009
EU/ 1/ 08/ 459/ 001 EU/ 1/ 08/ 459/ 002 EU/ 1/ 08/ 459/ 003 EU/ 1/ 08/ 459/ 004 EU/ 1/ 08/ 459/ 005 EU/ 1/ 08/ 459/ 006 EU/ 1/ 08/ 459/ 007
15 EU/ 1/ 08/ 459/ 010 EU/ 1/ 08/ 459/ 011 EU/ 1/ 08/ 459/ 012 EU/ 1/ 08/ 459/ 013 EU/ 1/ 08/ 459/ 014
17 EU/ 1/ 08/ 459/ 008 EU/ 1/ 08/ 459/ 009 EU/ 1/ 08/ 459/ 010 EU/ 1/ 08/ 459/ 011 EU/ 1/ 08/ 459/ 012 EU/ 1/ 08/ 459/ 013 EU/ 1/ 08/ 459/ 014
Tredaptive 1. 000 mg/ 20 mg tabletter med modificeret udløsning Nicotinsyre/ laropiprant
Tredaptive 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
EU/ 1/ 08/ 459/ 009 14 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 010 28 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 011 56 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 013 168 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 014 32 x 1 tabletter med modificeret udløsning
EU/ 1/ 08/ 459/ 009 14 modified-release tablets EU/ 1/ 08/ 459/ 010 28 modified-release tablets EU/ 1/ 08/ 459/ 011 56 modified-release tablets EU/ 1/ 08/ 459/ 013 168 modified-release tablets EU/ 1/ 08/ 459/ 014 32 x 1 modified-release tablets
14 tabletter med modificeret udløsning 28 tabletter med modificeret udløsning 56 tabletter med modificeret udløsning 84 tabletter med modificeret udløsning 98 tabletter med modificeret udløsning 168 tabletter med modificeret udløsning 196 tabletter med modificeret udløsning Multipakning indeholdende 196 (2 pakninger à 98) tabletter med modificeret udløsning 49 x 1 tabletter med modificeret udløsning
14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 84 modified-release tablets 98 modified-release tablets 168 modified-release tablets 196 modified-release tablets Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
EU/ 1/ 08/ 459/ 001 14 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 002 28 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 00356 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 004 84 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 005 98 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 006 168 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 007 196 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 008 49 x 1 tabletter med modificeret udløsning EU/ 1/ 08/ 459/ 012 196 (2 pakninger à 98) tabletter med modificeret udløsning
EU/ 1/ 08/ 459/ 001 14 modified-release tablets EU/ 1/ 08/ 459/ 002 28 modified-release tablets EU/ 1/ 08/ 459/ 003 56 modified-release tablets EU/ 1/ 08/ 459/ 004 84 modified-release tablets EU/ 1/ 08/ 459/ 005 98 modified-release tablets EU/ 1/ 08/ 459/ 006 168 modified-release tablets EU/ 1/ 08/ 459/ 007 196 modified-release tablets EU/ 1/ 08/ 459/ 008 49 x 1 modified-release tablets EU/ 1/ 08/ 459/ 012 196 (2 packs of 98) modified-release tablets
25 Merck Sharp & Dohme Ltd.
Merck Sharp & Dohme Ltd.
Tredaptive 1. 000 mg/ 20 mg tabletter med modificeret udløsning nicotinsyre/ laropiprant
Tredaptive 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
De kan få brug for at læse den igen. • Spørg lægen eller på apoteket, hvis der er mere, De vil vide. • Lægen har ordineret Tredaptive til Dem personligt.
- If you have any further questions, ask your doctor or pharmacist.
Tredaptives virkning og hvad De skal bruge det til 2.
What Tredaptive is and what it is used for 2.
Det skal De vide, før De begynder at tage Tredaptive 3.
Before you take Tredaptive 3.
Sådan skal De tage Tredaptive 4.
How to take Tredaptive 4.
Sådan opbevarer De Tredaptive 6.
How to store Tredaptive 6.
TREDAPTIVES VIRKNING OG HVAD DE SKAL BRUGE DET TIL
WHAT TREDAPTIVE IS AND WHAT IT IS USED FOR
Tredaptive bruges som tillæg til diæt for at: • sænke det "dårlige" kolesterol.
Tredaptive is used in addition to diet • to lower your ‘ bad’ cholesterol level.
HDL- kolesterol kaldes ofte det "gode" kolesterol, fordi det er med til at forhindre det "dårlige" kolesterol i at tilstoppe blodårerne, og fordi det beskytter mod hjertesygdom.
HDL cholesterol is often called ‘ good’ cholesterol because it helps keep the ‘ bad’ cholesterol from building up in the arteries and because it protects against heart disease.
Forbedre indholdet af kolesterol og fedt i blodet (primær hyperkolesterolæmi (heterozygot familiær og ikke- familiær) eller blandet dyslipidæmi, dvs. ændringer i blodets indhold af fedtstoffer): • når mængden af kolesterol ikke kan kontrolleres ved hjælp af et statin (en gruppe af kolesterolsænkende lægemidler, der virker i leveren). • når De ikke kan tåle et statin, eller når De ikke bør få et statin.
Tredaptive is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia): • when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver); • when you cannot tolerate a statin or when a statin is not recommended for you.
Tredaptive kan bruges alene eller sammen med anden medicin til at behandle kolesterolproblemer.
Tredaptive can be used by itself or with other medicines to treat cholesterol problems.
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE TREDAPTIVE
BEFORE YOU TAKE TREDAPTIVE
Tag ikke Tredaptive hvis: • De er overfølsom (allergisk) over for nicotinsyre, laropiprant eller et af de øvrige indholdsstoffer i Tredaptive (nævnt i afsnit 6). • De har leverproblemer. • De har mavesår. • De har pulsåreblødning.
Do not take Tredaptive if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Tredaptive (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Vær ekstra forsigtig med at tage Tredaptive Fortæl lægen om Deres helbredstilstand.
Take special care with Tredaptive Tell your doctor about all of your medical conditions.
Hvis De er i tvivl om noget af ovenstående passer på Dem, skal De tale med lægen eller apoteket, før De tager Tredaptive.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tredaptive.
Blodprøver og kontrol • Gå regelmæssigt til lægen for at få kontrolleret Deres LDL (det "dårlige" kolesterol) og HDL (det "gode" kolesterol) samt indholdet af triglycerider i blodet. • Lægen bør tage en blodprøve, før De begynder at tage Tredaptive for at kontrollere, hvor godt Deres lever virker. • Lægen vil måske også tage blodprøver af og til, efter De er begyndt at tage Tredaptive for at kontrollere, hvor godt Deres lever virker, og om der er andre bivirkninger.
Blood tests and monitoring • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. • Your doctor should do a blood test before you start taking Tredaptive to check how well your liver is working. • Your doctor may also want you to periodically have blood tests after you start taking Tredaptive, to check how well your liver is working and for other side effects.
30 Børn og unge Tredaptive er ikke undersøgt hos børn og unge under 18 år.
Children and adolescents Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Det er særlig vigtigt for lægen eller apoteket at vide, om De tager følgende: • Medicin til at sænke blodtrykket. • Medicin til at sænke kolesterolet kaldet "statiner", som er en gruppe af lægemidler, der virker i leveren. • Medicin til at sænke kolesterolet kaldet "galdesyrebindende lægemidler", f. eks. colestyramin. • Zidovudin, medicin der bruges til HIV. • Midazolam, medicin der bruges til at gøre Dem søvnig før lægelige indgreb. • Vitaminer eller kosttilskud, som indeholder nicotinsyre. • Clopidogrel, medicin som forebygger blodpropper.
In particular, tell your doctor or pharmacist if you are taking any of the following: • medicines used to lower blood pressure. • medicines used to lower cholesterol called ‘ statins’, a class of medicine that works in the liver. • medicines used to lower cholesterol called ‘ bile acid sequestrants’, such as colestyramine. • zidovudine, a medicine used for HIV. • midazolam, a medicine to make you sleepy before some medical procedures. • vitamins or supplements that contain nicotinic acid. • clopidogrel, a medicine to help prevent harmful blood clots.
Brug af Tredaptive sammen med mad og drikke • Tag Tredaptive sammen med mad. • For at mindske risikoen for rødmen bør De undgå at drikke alkohol eller varme drikke tæt på det tidspunkt, hvor De tager Deres dosis Tredaptive. • Det er vigtigt, at De følger vejledningen i afsnit 3 Sådan skal De tage Tredaptive.
Taking Tredaptive with food and drink • Take Tredaptive with food. • To lower your chance of flushing, avoid drinking alcohol or hot drinks near the time you take your dose of Tredaptive. • It is important to follow the advice given in section 3 How to take Tredaptive.
Graviditet og amning Tal med lægen, før De tager Tredaptive hvis: • De er gravid eller planlægger at blive gravid.
Pregnancy and breast-feeding Talk with your doctor before taking Tredaptive if: • You are pregnant or plan to become pregnant.
Det er ukendt, om Tredaptive kan skade Deres ufødte barn. • De ammer eller planlægger at amme.
It is not known if Tredaptive will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Trafik - og arbejdssikkerhed Der er ikke foretaget undersøgelser af Tredaptives virkningen på evnen til at køre bil eller betjene maskiner.
34 Driving and using machines The effects of Tredaptive on the ability to drive and use machines have not been studied.
Nogle mennesker kan dog føle sig svimle, efter de har taget Tredaptive.
However, some people get dizzy after taking Tredaptive.
Vigtig information om nogle af de øvrige indholdsstoffer i Tredaptive Tredaptive indeholder et sukkerstof, der kaldes lactose.
Important information about some of the ingredients of Tredaptive Tredaptive contains a sugar called lactose.
SÅDAN SKAL DE TAGE TREDAPTIVE
HOW TO TAKE TREDAPTIVE
Tag altid Tredaptive nøjagtigt efter lægens anvisning.
Always take Tredaptive exactly as your doctor has told you.
31 • Tag Tredaptive én gang dagligt, om aftenen eller ved sengetid. • Tag Tredaptive sammen med mad. • Slug tabletten hel.
How to take • Take Tredaptive once a day, in the evening or at bedtime. • Take Tredaptive with food. • Swallow each tablet whole.
For at Deres medicin skal virke efter hensigten, må De ikke dele, bryde, knuse eller tygge tabletten, før De sluger den. • Undgå at drikke alkohol eller varme drikke tæt på det tidspunkt, hvor De tager Tredaptive.
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it. • Avoid drinking alcohol or hot drinks near the time you take your dose of Tredaptive.
Dette vil nedsætte risikoen for rødmen (rødme af huden, varmefølelse, kløe eller prikkende fornemmelse, især i hovedet, på halsen, brystet og den øverste del af ryggen). • At tage aspirin før De tager Tredaptive vil ikke mindske Deres rødmen mere, end hvis De tager Tredaptive alene.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back). • Taking aspirin before you take Tredaptive does not reduce your flushing more than taking Tredaptive alone.
Rødmen, hovedpine, kløe, kvalme, svimmelhed, opkastning, diarré, mavesmerter/ mavegener samt smerter i ryggen. • Hvis De har taget mere, end De skulle, skal De straks kontakte lægen eller apoteket.
If you take more Tredaptive than you should • In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/ discomfort, and back pain. • If you take more than you should, talk to a doctor or pharmacist straight away.
Hvis De har glemt at tage Tredaptive • Hvis De glemmer en dosis, skal De ikke tage en ekstra dosis.
If you forget to take Tredaptive • If you miss a dose, do not take an extra dose.
Hvis De holder op med at tage Tredaptive De må ikke holde op med at tage Tredaptive uden at tale med lægen.
If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor.
Tredaptive kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Tredaptive can cause side effects, although not everybody gets them.
Ikke almindelige (forekommer hos færre end 1 ud af 100 patienter) Desuden er en eller flere af følgende symptomer set som del af en allergisk reaktion over for Tredaptive. •
Uncommon (affects less than 1 in 100 patients) In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Tredaptive. • swelling of the face, lips, tongue, and/ or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away) • fainting • shortness of breath • loss of control over urine and stool • cold sweats • shivering • chills • increased blood pressure • swelling of the lips • burning sensation • whole body rash • joint pain • swelling of the legs • rapid heart rate.
SÅDAN OPBEVARER DE TREDAPTIVE
HOW TO STORE TREDAPTIVE
Brug ikke Tredaptive efter den udløbsdato, der står på pakning og blister.
Do not use Tredaptive after the expiry date (EXP) which is stated on the carton and the blister.
Nicotinsyre og laropiprant.
What Tredaptive contains • The active substances are nicotinic acid and laropiprant.
Tredaptives udseende og pakningsstørrelser Hver tablet med modificeret udløsning er kapselformet, hvid til off- white, med "552" præget på den ene side.
What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Aluminium/ aluminium blister med push- through folie i pakningsstørrelser à 14, 28, 56, 168 tabletter med modificeret udløsning og 32 x 1 tabletter med modificeret udløsning i perforeret enkeltdosisblister.
Aluminium/ Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
33 Indehaver af markedsføringstilladelsen Merck Sharp & Dohme Ltd.
Marketing Authorisation Holder Merck Sharp & Dohme Ltd.
Hvis De vil have yderligere oplysninger om Tredaptive, skal De henvende Dem til den lokale repræsentant:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tel: +43 (0) 1 26 044 msd- medizin@ merck. com
Österreich Merck Sharp & Dohme GmbH Tel: +43 (0) 1 26 044 msd-medizin@merck. com
34 France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@ msd- france. com
France Laboratoires Merck Sharp & Dohme – Chibret Tél: +33 (0) 1 47 54 87 00 contact@msd-france. com
De kan finde yderligere information om Tredaptive på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/.
Trevaclyn er et lægemiddel, der indeholder de to aktive stoffer nikotinsyre (også kendt som niacin eller B3- vitamin) og laropiprant.
Trevaclyn is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.