qanastek/EMEA-V3 huggingface dataset:
There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Tredaptive.
M’ hemmx differenza fil- bijodisponibilità orali ta ’ l- aċidu nikotiniku fl- irġiel u n- nisa li jirċievu Tredaptive.
Women have a modest increase in plasma concentrations of nicotinuric acid and nicotinic acid compared to men.
In- nisa kellhom żieda modesta fil - konċentrazzjonijiet ta ’ aċidu nikotinuriku u aċidu nikotiniku fil- plażma meta mqabbel ma ’ l- irġiel.
Paediatric Tredaptive:
Pedjatriċi Tredaptive:
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.
Tredaptive Fi studji li m’ humiex kliniċi, effetti dehru biss wara esponimenti meqjusa ferm aktar għolja mill - massimu ta ’ l- esponimenti fil- bnedmin, li juru ftit li xejn rilevanza ma ’ l- użu fil- bnedmin.
Tredaptive 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Tredaptive 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat Aċidu nikotiniku/ laropiprant
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
EU/ 1/ 08/ 459/ 009 14- il pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 010 28 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 011 56 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 013 168 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 014 32 x 1 pillola li terħi l- mediċina b’ mod modifikat
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
EU/ 1/ 08/ 459/ 001 14- il pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 002 28 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 003 56 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 004 84 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 005 98 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 006 168 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 007 196 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 008 49 x1 pillola li terħi l- mediċina b’ mod modifikat EU/ 1/ 08/ 459/ 012 196 (2 pakketti ta ’ 98) pillola li terħi l- mediċina b’ mod modifikat
Tredaptive 1000 mg/ 20 mg modified-release tablets Nicotinic acid/ laropiprant
Tredaptive 1000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat Nicotinic acid/ laropiprant
Tredaptive 1000 mg/ 20 mg modified-release tablets nicotinic acid/ laropiprant
Tredaptive 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat aċidu nikotiniku/ laropiprant
What Tredaptive is and what it is used for 2.
X’ inhu Tredaptive u għaliex jintuża 2.
Before you take Tredaptive 3.
Qabel ma tieħu Tredaptive 3.
How to take Tredaptive 4.
Kif għandek tieħu Tredaptive 4.
How to store Tredaptive 6.
Kif taħżen Tredaptive 6.
WHAT TREDAPTIVE IS AND WHAT IT IS USED FOR
X’ INHU TREDAPTIVE U GĦALIEX JINTUŻA
The name of your medicine is Tredaptive.
L- isem tal- mediċina tiegħek huwa Tredaptive.
Tredaptive is used in addition to diet • to lower your ‘ bad’ cholesterol level.
Tredaptive jintuża mad- dieta: • biex ibaxxi l- livell tal- kolesterol ‘ ħażin ’ tiegħek.
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.
Il- kolesterol HDL huwa xi kultant imsejjaħ kolesterol ‘ tajjeb ’ minħabba li jżomm lill- kolesterol ‘ ħażin ’ milli jinġema ’ fl- arterji u minħabba li jipproteġi kontra l- mard tal- qalb.
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 jintuża jekk għandek bżonnittejjeb il- livelli tal- kolesterol u tax- xaħam fid- demm tiegħek (iperkolesterolemija primarja (eterozigota familjali u mhux familjali) jew dislipidemija mħallta): • meta ma tistax tikkontrolla l- livelli tal- kolesterol tiegħek bi statin (kategorija ta ’ mediċini li jbaxxu l- kolesterol li taħdem fil- fwied); • meta ma tistax tittollera statin jew meta statin ma jkunx rakkomandat għalik.
Tredaptive can be used by itself or with other medicines to treat cholesterol problems.
Tredaptive jista ’ jintuża waħdu jew ma ’ mediċini oħra li jittrattaw problemi tal- kolesterol.
BEFORE YOU TAKE TREDAPTIVE
QABEL MA TIEĦU Tredaptive
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.
Tiħux Tredaptive • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- aċidu nikotiniku, għal laropiprant, jew għal xi sustanzi oħra ta ’ Tredaptive (elenkati f’ sezzjoni 6). • jekk bħalissa għandek problemi bil- fwied. • jekk għandek ulċera fl- istonku tiegħek. • jekk għandek fsada arterjali.
Do not take Tredaptive if any of the above apply to you.
Tiħux Tredaptive jekk xi waħda minn dawn ta ’ hawn fuq tgħodd għalik.
If you are not sure, talk to your doctor or pharmacist before taking Tredaptive.
Jekk m’ intix ċert, kellem lit - tabib jew lill- ispiżjar tiegħek qabel tieħu Tredaptive.
Take special care with Tredaptive Tell your doctor about all of your medical conditions.
Oqgħod attent ħafna bi Tredaptive Għid lit- tabib tiegħek dwar il- kundizzjonijiet mediċi tiegħek kollha.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Tredaptive.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Tredaptive.
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.
Testijiet tad- demm u monitoraġġ • Ara lit- tabib tiegħek regolarment biex tiċċekkja l- livelli tal- kolesterol LDL (ħażin) u HDL (tajjeb) u l- livell tat- trigliċeridi tiegħek. • It- tabib tiegħek għandu jagħmillek test tad- demm qabel ma tibda tieħu Tredaptive biex jiċċekkja
Children and adolescents Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Tfal u adoloxxenti Tredaptive ma ġiex studjat fi tfal u adoloxxenti ta ’ taħt it- 18- il sena.
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.
B’ mod partikolari, għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu xi ħaġa minn dawn li ġejjin: • mediċini użati biex ibaxxu l- pressjoni tad- demm. • mediċini użati biex ibaxxu l- kolesterol imsejħa ‘ statins ’, kategorija ta ’ mediċini li taħdem fil - fwied. • mediċini użati biex ibaxxu l- kolesterol imsejħa ‘ sekwestranti ta ’ l- aċidu biljari ’, bħall - colestyramine. • zidovudine, mediċina użata għall- HIV. • midazolam, mediċina biex traqqdek qabel xi proċeduri mediċi. • vitamini jew supplimenti li fihom l- aċidu nikotiniku. • clopidogrel, mediċina li tgħin fil- prevenzjoni ta ’ emboli perikolużi.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Tredaptive.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu 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.
Meta tieħu Tredaptive ma ’ l- ikel u max- xorb • Ħu Tredaptive ma ’ l- ikel. • Biex tbaxxi ċ- ċans tiegħek ta ’ fwawar, evita li tixrob alkoħol jew xorb jaħraq qrib il- ħin li tieħu d- doża tiegħek ta ’ Tredaptive. • Huwa importanti li ssegwi l- parir mogħti f’ sezzjoni 3 Kif għandek tieħu Tredaptive.
Pregnancy and breast-feeding Talk with your doctor before taking Tredaptive if: • You are pregnant or plan to become pregnant.
Tqala u treddigħ Tkellem mat- tabib tiegħek qabel tieħu Tredaptive jekk: • Inti tqila jew qiegħda tippjana biex tinqabad tqila.
It is not known if Tredaptive will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Mhux magħruf jekk Tredaptive jagħmilx ħsara lit- tarbija mhux imwielda tiegħek. • Qiegħda tredda ’ jew qiegħda tippjana li tredda ’.
It is not known if Tredaptive will pass into your breast milk.
Mhux magħruf jekk Tredaptive jgħaddix għal ġol- ħalib tas- sider tiegħek.
However, nicotinic acid a component of Tredaptive does pass into breast milk.
Madankollu, l- aċidu nikotiniku, li huwa component ta ’ Tredaptive, jgħaddi għal ġol- ħalib tas- sider.
Your doctor will decide if Tredaptive is right for you.
It- tabib tiegħek jiddeċiedi jekk Tredaptive hux tajjeb għalik.
34 Driving and using machines The effects of Tredaptive on the ability to drive and use machines have not been studied.
Sewqan u tħaddim ta ’ magni L- effetti ta ’ Tredaptive fuq il- ħila li ssuq u tħaddem magni għadu ma ġiex studjat.
However, some people get dizzy after taking Tredaptive.
Madankollu, xi nies jistordu wara li jieħdu Tredaptive.
If you get dizzy, you should avoid driving or operating machines after taking Tredaptive.
Jekk tistordi, inti għandek tevita li ssuq jew tħaddem magni wara li tieħu Tredaptive.
Important information about some of the ingredients of Tredaptive Tredaptive contains a sugar called lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Tredaptive Tredaptive fih tip ta ’ zokkor imsejjaħ lattożju.
HOW TO TAKE TREDAPTIVE
KIF GĦANDEK TIEĦU TREDAPTIVE
Always take Tredaptive exactly as your doctor has told you.
Dejjem għandek tieħu Tredaptive skond il- parir tat- tabib.
How to take • Take Tredaptive once a day, in the evening or at bedtime. • Take Tredaptive with food. • Swallow each tablet whole.
Kif għandek tieħdu • Ħu Tredaptive darba kuljum, filgħaxija jew qabel torqod. • Ħu Tredaptive ma ’ l- ikel. • Ibla ’ kull pillola sħiħa.
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.
Sabiex il- mediċina tiegħek taħdem kif suppost, m’ għandekx taqsam, tkisser, tfarrak, jew tomgħod il- pillola qabel ma tiblagħha. • Evita li tixrob alkoħol jew xarbiet sħan qrib il- ħin meta għandek tieħu Tredaptive.
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.
Dan għandu jnaqqas iċ- ċans ta ’ fawra (fawra tal- ġilda, sensazzjoni ta ’ sħana, ħakk, jew tingiż, speċjalment f’ rasek, għonqok, sidrek u l- parti ta ’ fuq ta ’ dahrek). • It- teħid ta ’ aspirina qabel tieħu Tredaptive ma jnaqqasx il- fwawar tiegħek aktar milli tieħu Tredaptive waħdu.
Therefore, taking aspirin to reduce flushing symptoms is not necessary.
Għalhekk, m’ hemmx bżonn li tieħu aspirina biex tnaqqas is- sintomi tal - fwawar.
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.
Jekk tieħu Tredaptive aktar milli suppost • Fil- każ ta ’ doża eċċessiva, ġew irrapportati l- episodji avversi li ġejjin: fwawar, uġigħ ta ’ ras, prurite (ħakk), dardir, sturdament, rimettar, dijarrea, uġigħ addominali/ skumdità u uġigħ fid- dahar. • Jekk tieħu aktar milli suppost, kellem tabib jew spiżjar immedjatament.
If you forget to take Tredaptive • If you miss a dose, do not take an extra dose.
Jekk tinsa tieħu Tredaptive • Jekk tinsa tieħu doża, tiħux doża żejda.
However, if you do not take Tredaptive for 7 or more days in a row, talk to your doctor before restarting Tredaptive.
Madankollu, jekk ma tiħux Tredaptive għal sebat ijiem jew aktar konsekuttivi, kellem lit- tabib tiegħek qabel terġa ’ tibda Tredaptive.
If you stop taking Tredaptive Do not stop taking Tredaptive without talking to your doctor.
Jekk tieqaf tieħu Tredaptive Tiqafx tieħu Tredaptive mingħajr ma tkellem lit- tabib tiegħek.
Like all medicines, Tredaptive can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Tredaptive jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects of Tredaptive are:
L- effetti sekondarji ta ’ Tredaptive huma:
If flushing occurs, symptoms are generally most noticeable at first and usually lessen over time.
Jekk ikun hemm fawra, is- sintomi normalment jidhru l- aktar fil- bidu u ġeneralment jonqsu mal- ħin.
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.
• nefħa fil- wiċċ, xufftejn, ilsien, u/ jew gerżuma li tista ’ tikkawża diffikultà fit- teħid tan- nifs jew biex tibla ’ (anġjoedema, li jista ’ jkollha bżonn trattament mill- ewwel) • ħass ħażin • qtugħ ta ’ nifs • telf tal- kontroll fuq l- awrina u l- ippurgar • għaraq kiesaħ • rogħda • kesħa • pressjoni tad- demm aktar għolja • nefħa fix- xufftejn • sensazzjoni ta ’ ħruq • raxx mal- ġisem kollu • uġigħ fil- ġogi • nefħa fis- saqajn • taħbita tal- qalb mgħaġġla
HOW TO STORE TREDAPTIVE
KIF TAĦŻEN TREDAPTIVE
Do not use Tredaptive after the expiry date (EXP) which is stated on the carton and the blister.
Tużax Tredaptive wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna u l- folja.
What Tredaptive contains • The active substances are nicotinic acid and laropiprant.
X’ fih Tredaptive • Is- sustanzi attivi huma l- aċidu nikotiniku u laropiprant.
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.
33 Id- dehra ta ’ Tredaptive u l- kontenuti tal- pakkett Kull pillola li terħi l- mediċina b’ mod modifikat hija pillola bajda għal offwajt, forma ta ’ kapsula, li għandha “ 552 ” ibbuzzat fuq naħa waħda.
Opaque PVC/ Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.
Folja opaka tal- PVC/ Aclar mgħottija b’ aluminju push- through f’ pakketti ta ’ 14, 28, 56, 84, 98, 168 196 pillola li terħi l- mediċina b’ mod modifikat, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) pillola li jerħu l- mediċina b’ mod modifikat u 49 x 1 pillola li terħi l- mediċina b’ mod modifikat f’ folja unit dose perforata.
Eesti Merck Sharp & Dohme OÜ Tel: +372 613 9750 msdeesti@merck. com
34 Eesti Österreich Merck Sharp & Dohme OÜ Tel +372 613 9750 msdeesti@ merck. com
This leaflet was last approved in {MM/ YYYY}.
35 Dan il- fuljett kien approvat l- aħħar f ’ {XX/ SSSS}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /.
What is Trevaclyn?
X’ inhu Trevaclyn?
Trevaclyn is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Trevaclyn huwa mediċina li fiha żewġ sustanzi attivi: l- aċidu nikotiniku (magħruf ukoll bħala niacin jew vitamina B3) u laropiprant.
What is Trevaclyn used for?
Għalxiex jintuża Trevaclyn?
Trevaclyn is used in addition to diet and exercise in patients with dyslipidaemia (abnormally high levels of fat in the blood), particularly ‘ combined mixed dyslipidaemia’ and ‘ primary hypercholesterolaemia’.
Trevaclyn jintuża flimkien mad- dieta u l- eżerċizzju f’ pazjenti b’ dislipidemija (livelli għoljin b’ mod anormali ta ’ xaħam fid- demm), b’ mod partikolari ‘ dislipidemija mħallta kombinata ’ u ‘ livell għoli primarju ta ’ kolesterol ’.
Patients with combined mixed dyslipidaemia have high blood levels of ‘ bad’ LDL cholesterol and triglycerides (a type of fat), and low levels of ‘ good’ HDL cholesterol.
Il- pazjenti b’ dislipidemja mħallta kombinata jkollhom livelli għoljin ta ’ kolesterol LDL ‘ ħażin ’ u ta ’ triġliċeridi (tip ta ’ xaħam), u livelli baxxi ta ’ kolesterol HDL ‘ tajjeb ’ fid - demm.
Primary means that the hypercholesterolaemia does not have any identifiable cause.
Primajru jfisser li l- livell għoli ta ’ kolesterol ma jkollux kawża identifikabbli.
Trevaclyn is normally given together with a statin (the standard medicine used to reduce cholesterol) when the effectiveness of a statin taken alone is inadequate.
Trevaclyn normalment jingħata flimkien ma ’ statin (il- mediċina standard użata għat- tnaqqis tal - kolesterol) meta l- effikaċja ta ’ statin meħud waħdu ma jkunx adegwat.
Trevaclyn is used on its own only in patients who cannot take statins.
Trevaclyn jintuża waħdu biss f’ pazjenti li ma jkunux jistgħu jieħdu statins.
How is Trevaclyn used?
Kif jintuża Trevaclyn?
The starting dose of Trevaclyn is one tablet once a day for four weeks, after which the dose is increased to two tablets once a day.
Wara d- doża tiżdied għal żewġ pilloli darba kuljum.
The tablets must be swallowed whole, and should not be split, broken, crushed or chewed.
Il- pilloli għandhom jinbelgħu sħaħ, u m’ għandhomx jinqasmu, jitkissru, jitfarrku jew jintmagħdu.
Trevaclyn 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.
Trevaclyn mhux rakkomandat għall- użu fi tfal ta ’ inqas minn 18- il sena minħabba nuqqas ta ’ tagħrif dwar is- sigurtà u l- effikaċja tiegħu f’ dan il- grupp.
How does Trevaclyn work?
Kif jaħdem Trevaclyn?
The two active substances in Trevaclyn, nicotinic acid and laropiprant, have different modes of action.
Iż- żewġ sustanzi attivi fi Trevaclyn, l- aċidu nikotiniku u laropiprant, għandhom modi differenti ta ’ azzjoni.
It was first used as a medicine to modify blood fat levels in the mid-1950s, but its use has been limited because of its side effects, particularly flushing (reddening of the skin).
F’ nofs is- snin ħamsin, kien jintuża bħala mediċina biex jibdel il- livelli tax- xaħam fid- demm, iżda l- użu tiegħu kien limitat minħabba l- effetti sekondarji, b’ mod partikolari l- ħmura fil- ġilda tal- wiċċ.
When the receptors are blocked, PGD2 cannot dilate the vessels in the skin, reducing the frequency and intensity of flushing.
Meta r- riċetturi jiġu mblukkati, il- PGD2 ma jkunx jista ’ jwessa ’ l- arterji u l- vini fil- ġilda, u jnaqqas il- frekwenza u l - intensità tal- ħmura fil- wiċċ.
In Trevaclyn tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Fil- pilloli ta ’ Trevaclyn, laropiprant jinsab f’ wieħed mis- saffi, u s- saff l- ieħor fih l- aċidu nikotiniku.
How has Trevaclyn been studied?
Kif ġie studjat Trevaclyn?
The effects of Trevaclyn were first tested in experimental models before being studied in humans.
L- effetti ta ’ Trevaclyn għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Trevaclyn was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Trevaclyn ġie studjat f’ erba ’ studji ewlenin b’ livelli għoljin ta ’ kolesterol fid- demm jew b’ dislipidemja mħallta.
Two studies looked at the effectiveness of Trevaclyn in modifying blood fat levels.
Żewġ studji ħarsu lejn l- effikaċja ta ’ Trevaclyn fil- modifikazzjoni tal- livelli tax- xaħam fid- demm.
The first study compared the effectiveness of Trevaclyn with that of nicotinic acid alone or placebo (a dummy treatment) in reducing the levels of LDL cholesterol in a total of 1,613 patients.
L - ewwel studju qabbel l- effikaċja ta ’ Trevaclyn ma ’ dik ta ’ l- aċidu nikotiniku jew plaċebo (trattament finta) fit- tnaqqis tal- livelli ta ’ kolesterol LDL f’ total ta ’ 1, 613- il pazjent.
The second study compared the combination of Trevaclyn and simvastatin (a statin) with Trevaclyn alone or simvastatin alone in 1,398 patients.
It- tieni studju qabbel il- kombinazzjoni ta ’ Trevaclyn u simvastatin (statin) ma ’ Trevaclyn waħdu jew simvastatin waħdu f’ 1, 398 pazjent.
They included a total of 2,349 patients who were taking either Trevaclyn or nicotinic acid.
F’ dawn b’ kollox ħadu sehem 2, 349 pazjent li kienu qegħdin jieħdu Trevaclyn jew aċidu nikotiniku.
What benefit has Trevaclyn shown during the studies?
Liema benefiċċju wera Trevaclyn waqt l- istudji mwettqa?
Trevaclyn was effective in reducing the blood levels of LDL cholesterol.
Trevaclyn kien effikaċi fit- tnaqqis tal- livelli ta ’ kolesterol LDL fid- demm.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Trevaclyn, compared with 1% in those taking placebo.
Fl- ewwel studju, il- livelli ta ’ kolesterol LDL tnaqqsu b’ 19% fil- pazjenti li kienu qed jieħdu Trevaclyn, meta mqabbla ma ’ 1% f’ dawk li kienu qed jieħdu plaċebo.
The second study showed that the LDL cholesterol levels were further reduced when Trevaclyn was taken with simvastatin (48% reduction), compared with Trevaclyn alone (17% reduction) or simvastatin alone (37% reduction).
It- tieni studju wera li l- livelli ta ’ kolesterol LDL tnaqqsu iktar meta Trevaclyn ittieħed flimkien ma ’ simvastatin (tnaqqis ta ’ 48%), milli meta Trevaclyn ittieħed waħdu (tnaqqis ta ’ 17%) jew ma ’ simvastatin waħdu (tnaqqis ta ’ 37%).
In the first and third studies, fewer patients taking Trevaclyn reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Fl- ewwel u t- tielet studju, inqas pazjenti li kienu qegħdin jieħdu Trevaclyn rrappurtaw ħmura fil- wiċċ moderata, severa jew estrema meta mqabbla ma ’ pazjenti li kienu qed jieħdu l- aċidu nikotiniku biss.
In the fourth study, flushing was seen on fewer days in patients taking Trevaclyn than in those taking nicotinic acid alone.
Fir- raba ’ studju, il- ħmura fil- wiċċ dehret f’ inqas jiem fil- pazjenti li kienu qegħdin jieħdu Trevaclyn milli f’ dawk li kienu qegħdin jieħdu aċidu nikotiniku waħdu.
What is the risk associated with Trevaclyn?
X’ inhu r- riskju assoċjat ma ’ Trevaclyn?
The most common side effect with Trevaclyn (seen in more than 1 patient in 10) is flushing.
L- iktar effetti sekondarji komuni bi Trevaclyn (li deher f’ iktar minn pazjent wieħed minn kull 10) huwa l- ħmura fil- wiċċ.
For the full list of all side effects reported with Trevaclyn, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtata bi Trevaclyn, ara l - Fuljett ta ’ Tagħrif.
Trevaclyn should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Trevaclyn m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi żżejjed għall- aċidu nikotiniku, laropiprant jew għal xi sustanza oħra tiegħu.
It should also not be used in patients who have problems with their liver, an active stomach ulcer or bleeding from an artery.
Lanqas ma għandu jintuża f’ pazjenti bi problemi fil - fwied, b’ ulċera attiva fl- istonku jew bi fsada minn arterja.
Why has Trevaclyn been approved?
Għaliex ġie approvat Trevaclyn?
The Committee for Medicinal Products for Human Use (CHMP) decided that Trevaclyn’ s benefits are greater than its risks for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia and in patients with primary hypercholesterolaemia.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Trevaclyn huma ikbar mir- riskji tiegħu għat- trattament tad- dislipidemija, b’ mod partikolari f’ pazjenti b’ dislipidemija mħallta kombinata u f‘ pazjenti b’ livell għoli primarju ta ’ kolesterol fid- demm.
The Committee recommended that Trevaclyn be given marketing authorisation.
Il - Kumitat irrakkomanda li Trevaclyn jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Trevaclyn:
Informazzjoni oħra dwar Trevaclyn:
The European Commission granted a marketing authorisation valid throughout the European Union for Trevaclyn to Merck Sharp & Dohme Ltd. on 3 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Trevaclyn lil Merck Sharp & Dohme Ltd. fl- 3 ta ’ Lulju 2008.
The full EPAR for Trevaclyn can be found here.
2/ 3 L- EPAR sħiħ għal Trevaclyn jista ’ jinstab hawn.
This summary was last updated in 05-2008.
Dan is- sommarju ġie aġġornat l- aħħar fi 05- 2008.
Trevaclyn 1000 mg/ 20 mg modified-release tablets.
Trevaclyn 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat.
Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Trevaclyn huwa indikat għat- trattament tad- dislipidemija, b’ mod partikolari f’ pazjenti li għandhom dislipidemija mħallta kkombinata (ikkaratterizzata minn livelli għolja ta ’ LDL- kolesterol u trigliċeridi u HDL- kolesterol baxx) u f’ pazjenti b’ iperkolesterolemija primarja (eterozigote familjali u mhux familjali).
Trevaclyn should be used in patients in combination with HMG-CoA reductase inhibitors (statins), when the cholesterol lowering effect of HMG-CoA reductase inhibitor monotherapy is inadequate.
Trevaclyn għandu jintuża fil- pazjenti flimkien ma ’ inibituri HMG- CoA reductase (statins), meta l - effett tat- tbaxxija tal- kolesterol ta ’ monoterapija b’ inibitur HMG- CoA reductase ma jkunx adegwat.
Diet and other non-pharmacological treatments (e. g. exercise, weight reduction) should be continued during therapy with Trevaclyn.
Dieti u trattamenti oħra mhux farmakoloġiċi (eż. eżerċizzju, tnaqqis fil- piż) għandhom jitkomplew matul it- terapija bi Trevaclyn.
If Trevaclyn is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Jekk Trevaclyn ma jitteħidx għal inqas minn 7 ijiem konsekuttivi, il- pazjenti jistgħu jerġgħu jibdew it - terapija bl- aħħar doża mogħtija.
If Trevaclyn is missed for 7 or more consecutive days, therapy should be resumed at the 1000 mg/ 20 mg dose for 1 week, before advancing to the maintenance dose of 2000 mg/ 40 mg.
Jekk Trevaclyn ma jitteħidx għal 7 ijiem konsekuttivi jew aktar, il - bidu mill- ġdid tat- terapija għandu jsir bid- doża ta ’ 1, 000 mg/ 20 mg għal ġimgħa, qabel ma wieħed jgħaddi għad- doża ta ’ manteniment ta ’ 2000 mg/ 40 mg.
2 Those patients switching from 2000 mg or more of prolonged-release nicotinic acid can initiate Trevaclyn at the 2000 mg/ 40 mg dose.
Dawk il- pazjenti li jaqilbu minn 2000 mg jew aktar ta ’ aċidu nikotiniku li jerħi l- mediċina bil- mod jistgħu jibdew Trevaclyn bid- doża ta ’ 2000 mg/ 40 mg.
For patients switching from immediate-release nicotinic acid to Trevaclyn, therapy should be initiated at the 1000 mg/ 20 mg dose and advanced to the 2000 mg/ 40 mg maintenance dose after four weeks.
Fil- każ tal- pazjenti li jaqilbu minn aċidu nikotiniku ta ’ rilaxx immedjat għal Trevaclyn, it- terapija għandha 2 tinbeda bid- doża ta ’ 1, 000 mg/ 20 mg u tgħaddi għad- doża ta ’ manteniment ta ’ 2000 mg/ 40 mg wara erba ’ ġimgħat.
Use in paediatric patients Safety and effectiveness of Trevaclyn in paediatric patients have not been established.
Użu f’ pazjenti pedjatriċi Is- sigurtà u l- effikaċja ta ’ Trevaclyn ma ġietx stabbilita f’ pazjenti pedjatriċi.
Use in patients with hepatic or renal insufficiency Use of Trevaclyn in patients with hepatic or renal insufficiency has not been studied.
Użu f’ pazjenti b’ insuffiċjenza tal- fwied jew tal- kliewi L- użu ta ’ Trevaclyn f’ pazjenti b’ insuffiċjenza tal- fwied jew tal- kliewi ma ġiex studjat.
Like other nicotinic acid medicinal products, Trevaclyn is contraindicated in patients with significant or unexplained hepatic dysfunction.
Bħal prodotti mediċinali oħra ta ’ l- aċidu nikotiniku, Trevaclyn huwa kontra- indikat f’ pazjenti li għandhom disfunzjoni tal- fwied sinifikanti jew mhux spjegata.
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Trevaclyn.
Terapija konkomitanti L- aċidu aċetilsaliċiliku ma jipprovdi l- ebda tnaqqis addizzjonali tal- fawra aktar minn dik miksuba bi Trevaclyn.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant (see section 4.5).
Minħabba li l- għoti fl- istess ħin ta ’ sekwestranti ta ’ l- aċidu biljari jista ’ jnaqqas il- bijodisponibilità ta ’ prodotti mediċinali aċidużi bħall- aċidu nikotiniku, huwa rakkomandat li Trevaclyn jingħata > siegħa qabel jew > 4 sigħat wara l- għoti ta ’ sekwestrant ta ’ l- aċidu biljari (ara sezzjoni 4. 5).
When Trevaclyn is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Meta Trevaclyn jingħata fl- istess ħin ma ’ statin, jekk jogħġbok irreferi għas- Sommarju tal - Karatteristiċi tal- Prodott ta ’ dak il- prodott mediċinali partikolari.
Hepatic effects Switching from immediate-release (crystalline) nicotinic acid to Trevaclyn has not been studied.
Effetti fuq il- fwied Il- qlib minn aċidu nikotiniku (kristallin) ta ’ rilaxx immedjat għal Trevaclyn ma ġiex studjat.
Therefore, patients switching from immediate-release nicotinic acid to Trevaclyn should be initiated at the 1000 mg/ 20 mg dose.
Għalhekk, il- pazjenti li jaqilbu minn aċidu nikotiniku ta ’ rilaxx immedjat għal Trevaclyn għandhom jinbdew bid- doża ta ’ 1, 000 mg/ 20 mg.
Trevaclyn should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Trevaclyn għandu jintuża b’ kawtela f’ pazjenti li jikkunsmaw kwantitajiet sostanzjali ta ’ alkoħol u/ jew li għandhom storja passata ta ’ mard tal- fwied.
Should an increase in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥ 3 X ULN persist, reduction of dose or withdrawal of Trevaclyn is recommended.
Jekk żieda fl- alanine aminotransferase (ALT) jew fl- aspartate aminotransferase (AST) ta ’ ≥ 3 X ULN tippersisti, huwa rakkomandat tnaqqis fid- doża jew twaqqif ta ’ Trevaclyn.
Physicians contemplating combined therapy with statins and Trevaclyn should carefully weigh the potential benefits and risks and should carefully monitor patients for any signs and symptoms of muscle pain, tenderness, or weakness, particularly during the initial months of therapy and when the dose of either medicinal product is increased.
It- tobba li jikkunsidraw terapija kkombinata bl- istatins u Trevaclyn għandhom iqisu bil- għaqal il - vantaġġi u r- riskji potenzjali u għandhom jimmonitorjaw sewwa l- pazjenti għal kwalunkwe sinjali u sintomi ta ’ uġigħ, sensittività, jew dgħjufija fil- muskoli, b’ mod partikolari matul l- ewwel xhur tat - terapija u meta d- doża ta ’ xi wieħed mill- prodotti mediċinali tiżdied.
If muscle pain, weakness or cramps occur while a patient is receiving Trevaclyn with a statin, their CK levels should be measured.
Jekk iseħħ uġigħ muskolari, dgħjufija jew bugħawwieġ waqt li pazjent ikun qiegħed jirċievi Trevaclyn bi statin, għandhom jitkejlu l- livelli CK tagħhom.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Trevaclyn should be used with caution in patients with renal dysfunction.
Disfunzjoni tal- fwied Minħabba li l- aċidu nikotiniku u l- metaboliti tiegħu jitneħħew mill- kliewi, Trevaclyn għandu jintuża b’ kawtela f’ pazjenti li jkollhom disfunzjoni tal- kliewi.
4 Acute coronary syndrome As with other nicotinic acid medicinal products, caution should be used when Trevaclyn is used in patients with unstable angina or in the acute phase of an MI, particularly when such patients are also receiving vasoactive medicinal products such as nitrates, calcium channel blockers, or adrenergic blocking agents.
Sindrome koronarju akut Bħal fi prodotti mediċinali ta ’ l- aċidu nikotiniku oħrajn, għandha tintuża kawtela meta Trevaclyn jintuża f’ pazjenti b’ anġina instabbli jew fil- fażi akuta ta ’ MI, b’ mod partikolari meta dawn il- pazjenti jkunu qegħdin jirċievu wkoll prodotti mediċinali vasoattivi bħal nitrati, imblokkaturi tal- kanali tal - kalċju, jew sustanzi ta ’ imblokk adrenerġiċi.
Haematologic effects As with other nicotinic acid medicinal products, Trevaclyn (2000 mg/ 40 mg) was associated with small reductions in platelet count (see section 4.8).
Effetti ematoloġiċi Bħal fi prodotti mediċinali ta ’ l- aċidu nikotiniku oħrajn, Trevaclyn (2000 mg/ 40 mg) ġie assoċjat ma ’ tnaqqis żgħir fl- għadd tal- plejtlits (ara sezzjoni 4. 8).
Effect on uric acid As with other nicotinic acid medicinal products, Trevaclyn (2000 mg/ 40 mg) was associated with small increases in uric acid levels (see section 4.8).
Effett fuq l- aċidu uriku Bħal fi prodotti mediċinali ta ’ l- aċidu nikotiniku oħrajn, Trevaclyn (2000 mg/ 40 mg) ġie assoċjat ma ’ żidiet żgħar fil- livelli ta ’ l- aċidu uriku (ara sezzjoni 4. 8).
Therefore, Trevaclyn should be used with caution in patients with or predisposed to gout.
Għalhekk, Trevaclyn għandu jintuża b’ kawtela f’ pazjenti bil- gotta jew predisposti għaliha.
Hypophosphatemia As with other nicotinic acid medicinal products, Trevaclyn was associated with small decreases in phosphorus levels.
4 Ipofosfatemja Bħal fi prodotti mediċinali ta ’ l- aċidu nikotiniku oħrajn, Trevaclyn kien assoċjat ma ’ tnaqqis żgħir fil - livelli ta ’ fosfru.
Excipient Trevaclyn contains lactose.
Sustanza mhux attiva Trevaclyn fih il- lattożju.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Trevaclyn.
Użu simultanju ta ’ alkoħol jew xorb sħun jista ’ jkabbar l- effetti ta ’ fawra u għalhekk dawn għandhom jiġu evitati mal- ħin ta ’ inġestjoni ta ’ Trevaclyn.
The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
L- interazzjoni farmakokinetika ta ’ Trevaclyn ma ’ l- istatins ġiet studjata biss b’ simvastatin (ara sezzjoni 4. 4).
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Trevaclyn be administered > 1 hour before or > 4 hours after administration of a bile acid sequestrant.
Minħabba li l- għoti fl- istess ħin ta ’ sekwestranti ta ’ l- aċidu biljari jista ’ jnaqqas il- bijodisponibilità ta ’ prodotti mediċinali aċidużi bħall- aċidu nikotiniku, huwa rakkomandat li Trevaclyn jingħata > siegħa qabel jew > 4 sigħat wara l- għoti ta ’ sekwestrant ta ’ l - aċidu biljari.
Vitamins or other nutritional supplements containing (≥ 50 mg/ day) of nicotinic acid (or nicotinamide) have not been studied with Trevaclyn.
Vitamini jew supplimenti nutrizzjonali oħra li fihom (≥ 50 mg/ ġurnata) ta ’ aċidu nikotiniku (jew nicotinamide) ma ġewx studjati ma ’ Trevaclyn.
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Trevaclyn.
It- tobba għandhom jikkunsidraw l- ammont ta ’ aċidu nikotiniku meħud mill- vitamini u s- supplimenti nutrizzjonali meta jordnaw Trevaclyn.
Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Għandha tintuża attenzjoni meta Trevaclyn jingħata fl- istess ħin ma ’ prodotti mediċinali li jiġu metabolizzati primarjament minn UGT2B4 jew UGT2B7, per eżempju zidovudine.
Pregnancy Trevaclyn There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Tqala Trevaclyn M’ hemm ebda informazzjoni dwar l- użu kombinat ta ’ l- aċidu nikotiniku u laropiprant f’ nisa tqal.
Therefore, Trevaclyn should not be used during pregnancy unless clearly necessary.
Għalhekk Trevaclyn m’ għandux jintuża waqt it- tqala jekk ma jkunx hemm bżonn ċar.
Lactation Trevaclyn No studies in lactating animals have been conducted with Trevaclyn.
Treddigħ Trevaclyn Ma sarux studji bi Trevaclyn fuq bhejjem ireddgħu.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy should be made taking into account the benefit of breast-feeding to the child and the benefit of Trevaclyn to the woman.
Deċiżjoni dwar jekk jitkompliex/ jitwaqqaf it - treddigħ jew jekk titkompliex/ titwaqqaf it- terapija għandha ssir billi jiġi kkunsidrat il- benefiċċju tat - treddigħ għat- tarbija u l- benefiċċju ta ’ Trevaclyn għall- mara.
4.8 Undesirable effects In clinical trials, over 2500 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
Fi provi kliniċi, aktar minn 2500 pazjent irċevew Trevaclyn waħdu jew ma ’ inibitur HMG- CoA reductase.
Flushing Flushing is the most common adverse reaction of Trevaclyn.
Fawra Il- fawra hija l- aktar reazzjoni avversa komuni ta ’ Trevaclyn.
In a pool of four active- or placebo-controlled clinical trials (N=2548), flushing was reported by the investigator as a possibly, probably, or definitely treatment-related adverse reaction in 12.3% of patients taking Trevaclyn.
Fi grupp ta ’ erba ’ provi kliniċi attivi jew ikkontrollati bil- plaċebo (N=2548), il- fawra kienet irrappurtata mill- investigatur bħala reazzjoni avversa possibbli, probabbli, jew definittivament marbuta mal- kura fi 12. 3% tal- pazjenti li ħadu Trevaclyn.
In these studies, the percentage of patients taking Trevaclyn, nicotinic acid (pooled prolonged-release formulations) or pooled placebo/ simvastatin who discontinued due to any flushing-related symptom (redness, warmth, itching and tingling) was 7.2%, 16.6%, and 0.4%, respectively.
F’ dawn l- istudji, il - perċentwali ta ’ pazjenti li kienu qegħdin jieħdu Trevaclyn, aċidu nikotiniku (formulazzjonijiet li jerħu l- mediċina bil- mod miġburin f’ daqqa) jew plaċebo/ simvastatin miġburin f’ daqqa li ma komplewx it - trattament minħabba xi sintomu relatat mal- fawra (fawra, sħana, ħakk u tingiż) kien ta ’ 7. 2%, 16. 6%, u 0. 4%, rispettivament.
Discontinuations due to other specific adverse reactions among patients taking Trevaclyn were infrequent (< 1%).
Il- każijiet ta ’ twaqqif tal- kura minħabba reazzjonijiet avversi speċifiċi oħra fost il- pazjenti li kienu qegħdin jieħdu Trevaclyn ma kinux frekwenti (< 1%)
7 Overall adverse reactions with Trevaclyn In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Trevaclyn in ≥ 1% of patients treated with Trevaclyn alone (n=947) or co-administered with statin (n=1601) and clinically meaningful adverse reactions (< 1%), for up to one year are listed below.
Reazzjonijiet avversi totali bi Trevaclyn Minbarra l- fawra, ir- reazzjonijiet kliniċi avversi rrappurtati mill- investigaturi bħala possibbilment, probabbilment, jew definittivament relatati ma ’ Trevaclyn f’ ≥1% tal- pazjenti trattati bi Trevaclyn waħdu (n=947) jew mogħti fl- istess ħin ma ’ statin (n=1601) u reazzjonijiet avversi li klinikament huma sinifikattivi (< 1%), sa sena huma elenkati hawn taħt.
In controlled clinical studies, the incidence of clinically important elevations in serum transaminases (ALT and/ or AST ≥ 3 X ULN, consecutive) was 1.0% for patients treated with Trevaclyn with or without a statin.
Fl- istudji kliniċi kkontrollati, l- inċidenza taż- żidiet kliniċi importanti fit- transaminases fis- serum (ALT u/ jew AST ≥ 3 X ULN, konsekuttivi) kienet ta ’ 1. 0% għall- pazjenti trattati bi Trevaclyn bi jew mingħajr statin.
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Trevaclyn with or without a statin (see section 4.4).
Żidiet kliniċi importanti ta ’ CK (≥ 10 X ULN) dehru f’ 0. 3% tal- pazjenti trattati bi Trevaclyn bi jew mingħajr statin (ara sezzjoni 4. 4).
8 controlled clinical studies with Trevaclyn (2000 mg/ 40 mg) (see section 4.4).
Bħal bi prodotti mediċinali oħra ta ’ l- aċidu nikotiniku, żidiet fil- glukożju tas- sawm (żieda medja ta ’ madwar 4 mg/ dL), u aċidu uriku (bidla medja mil- linja bażi ta ’ +14. 7%), u tnaqqis fl- għadd tal - plejtlits (bidla medja mil- linja bażi ta ’ - 14. 0%) ġew irrapportati fi provi kliniċi kkontrollati ma ’ Trevaclyn (2000 mg/ 40 mg) (ara sezzjoni 4. 4).
Nicotinic acid-related adverse reactions The following nicotinic acid-related adverse reactions have been seen in clinical trials or post-marketing experience with other nicotinic acid medicinal products at unknown frequency or in clinical trials with Trevaclyn (or the nicotinic acid component of Trevaclyn) in < 1% of the patients treated:
Reazzjonijiet avversi relatati ma ’ l- aċidu nikotiniku Ir- reazzjonijiet avversi li ġejjin relatati ma ’ l- aċidu nikotiniku dehru fi provi kliniċi jew fl- esperjenza ta ’ wara t- tqegħid fis- suq ma ’ prodotti mediċinali oħra ta ’ l- aċidu nikotiniku fi frekwenza magħrufa jew fi provi kliniċi ma ’ Trevaclyn (jew il- komponent ta ’ l- aċidu nikotiniku ta ’ Trevaclyn) < 1% tal - pazjenti ttrattati:
Trevaclyn In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Trevaclyn F’ każ ta ’ doża eċċessiva, huwa raġonevoli li jintużaw il- miżuri sintomatiċi u supportivi tas- soltu.
Cases of overdose have been reported; the maximum dose of Trevaclyn taken was 5000 mg/ 100 mg.
Ġew irrappurtati każi ta ’ doża eċċessiva; l- akbar doża ta ’ Trevaclyn li ttieħdet kienet 5000 mg/ 100 mg.
Nicotinic acid lowers the levels of low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), very low density lipoprotein cholesterol (VLDL-C), apolipoprotein B (apo B, the major LDL protein), triglycerides (TG), and lipoprotein(a) (Lp(a), a modified LDL particle) and elevates the levels of high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-I (apo A-I, the major protein component of HDL).
Trevaclyn fih l- aċidu nikotiniku, li f’ dożi terapewtiċi huwa sustanza li timmodifika l- lipidi, u laropiprant, antagonist selettiv b’ saħħtu tar- riċettur tal- prostaglandin D2 (PGD2) sottotip 1 (DP1). L - aċidu nikotiniku jbaxxi l- livelli tal- kolesterol ta ’ lipoproteini ta ’ densità baxxa (LDL- C), tal- kolesterol totali (TC), tal- kolesterol ta ’ lipoproteini ta ’ densità baxxa ħafna (VLDL- C), ta ’ l- apolipoproteina B (apo B, il- proteina LDL prinċipali), tat- trigliċeridi (TG), u tal- lipoproteina( a) (Lp( a), partikula LDL modifikata) u jgħolli l- livelli tal- kolesterol ta ’ lipoproteini ta ’ densità għolja (HDL- C) u ta ’ l - apolipoproteina A- I (apo A- I, il- komponent prinċipali ta ’ proteina ta ’ l- HDL).
In healthy subjects receiving Trevaclyn, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Trevaclyn alone (see section 4.8).
F’ individwi b’ saħħithom li rċevew Trevaclyn, it- trattament ta ’ qabel bl- aċidu aċetilsaliċiliku 325 mg ma kellu ebda effetti benefiċi addizzjonali fit- tnaqqis tas- sintomi ta ’ fawra indotti mill- aċidu nikotiniku meta mqabbel ma ’ Trevaclyn waħdu (ara sezzjoni 4. 8).
Clinical studies Effect on lipids Trevaclyn was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Studji kliniċi Effetti fuq il- lipidi Trevaclyn kien effikaċji b’ mod konsistenti fis- subpopolazzjonijiet ta ’ pazjenti prespeċifikati kollha definiti permezz tar- razza, is- sess, il- livelli bażiċi ta ’ LDL- C, HDL- C u TG, jew l- età u l- istejtus tad - dijabete.
Patients taking Trevaclyn (2000 mg/ 40 mg) with or without a statin, versus placebo, had significantly decreased LDL-C (-18.9% vs. -0.5%), TG (-21.7% vs.
Il- pazjenti li ħadu Trevaclyn (2000 mg/ 40 mg) bi jew mingħajr statin, kontra l- plaċebo, kellhom tnaqqis sinifikanti fl- LDL- C (- 18. 9% vs. - 0. 5%), TG (- 21. 7% vs.
Patients receiving Trevaclyn, 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].
Il- pazjenti li kienu qegħdin jirċievu Trevaclyn, aċidu nikotiniku (formulazzjoni li terħi l- mediċina bil- mod), jew plaċebo kienu qegħdin jieħdu wkoll statins (29% atorvastatin [5- 80 mg], 54% simvastatin [10- 80 mg], 17% statins oħra [2. 5- 180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), li 9% minnhom kienu qegħdin jieħdu wkoll ezetimibe [10 mg].
The effect on lipids was similar whether Trevaclyn was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
L- effett fuq il- lipidi kien simili kemm jekk Trevaclyn ingħata bħala monoterapija kif ukoll jekk żdied ma ’ terapija kontinwa bl- istatins bi jew mingħajr ezetimibe.
In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1000 mg/ 20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 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).
Fi studju fattorjali, multi- ċentri, double- blind, ta ’ 12- il ġimgħa, Trevaclyn 1, 000 mg/ 20 mg mogħti fl - istess ħin ma ’ simvastatin, meta mqabbel ma ’ simvastatin waħdu jew Trevaclyn 1, 000 mg/ 20 mg waħdu, għal 4 ġimgħat, naqqas b’ mod sinifikanti l- LDL- C (- 44. 2%, - 37. 4%, - 8. 2% rispettivament), it - TG (- 25. 8%, - 15. 7%, - 18. 7% rispettivament), it- TC (- 27. 9%, - 25. 8%, - 4. 9% rispettivament) u żied b’ mod sinifikanti l- HDL- C (19. 2%, 4. 2%, 12. 5% rispettivament).