qanastek/EMEA-V3 huggingface dataset:
What Trazec is and what it is used for 2.
X’ inhu Trazec u għalxiex jintuża 2.
Before you take Trazec 3.
Qabel ma tieħu Trazec 3.
How to take Trazec 4.
Kif għandek tieħu Trazec 4.
How to store Trazec 6.
Kif taħżen Trazec 6.
WHAT TRAZEC IS AND WHAT IT IS USED FOR
X’ INHU TRAZEC U GĦALXIEX JINTUŻA
Trazec is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).
Trazec hija mediċina biex tbaxxi z- zokkor fid- demm (glucose), li tittieħed mill- ħalq (dawn il- mediċini huma magħrufin ukoll bħala anti- dijabetiċi li jittieħdu mill- ħalq).
Trazec works by stimulating the pancreas to produce insulin more quickly.
Trazec jaħdem billi jistimula l- frixa biex tibda tgħamel l- insulina iżjed malajr.
Your doctor will prescribe Trazec together with another oral anti-diabetic containing metformin.
It- tabib tiegħek ser jordnalek Trazec flimkien ma ’ mediċina anti- dijabetika oħra li tittieħed mill- ħalq, li fiha metformin.
Trazec tablets start to act quickly after you take them and are eliminated from the body rapidly.
Il- pilloli Trazec jibdew jaħdmu malajr wara li tieħodhom u huma mneħħija mill- ġisem fi żmien qasir.
BEFORE YOU TAKE TRAZEC
QABEL MA TIEĦU TRAZEC
Do not take Trazec
Tieħux Trazec
- if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Trazec.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal nateglinide jew sustanzi oħra ta ’
Talk to your doctor if you have any further questions or you think that any of these may apply to you.
Itlob għall- parir tat- tabib tiegħek jekk għandek iżjed mistoqsijiet jew taħseb li kwalunkwe minn dawn japplikaw għalik.
37 Take special care with Trazec People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia).
40 Oqgħod attent ħafna bi Trazec Nies bid- dijabete xi kultant ikollhom sintomi ta` livell baxx ta ’ zokkor fid- demm (imsejjħa anke ipogliċemija).
Medicines, including Trazec, may also produce symptoms of low blood sugar.
Mediċini, inkluż Trazec, jistgħu anke jikkawżaw sintomi ta ’ livell baxx ta ’ zokkor fid - demm.
The amount of Trazec that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
L- ammont ta ’ Trazec li jkollok bżonn jista ’ jinbidel jekk qed tieħu mediċini oħra għaliex dawn jistgħu jgħollu jew ibaxxu l- livelli ta ’ zokkor fid- demm.
Food, drink and exercise Take Trazec before meals (see section 3, “ How to take Trazec”).
Ikel, xorb u eżerċizzju Ħu Trazec qabel l- ikel (ara sezzjoni 3 “ Kif għandek tieħu Trazec ”).
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Trazec.
41 L- Alkoħol jista ’ jiżbilanċja l- kontroll taz- zokkor fid- demm għalhekk qed tiġi imwissi tkellem lit- tabib tiegħek fuq ix- xorb ta ’ l- alkoħol waqt li qed tieħu Trazec.
Trazec and older people Trazec can be used by people over 65 years of age.
Trazec u l- Anzjani Starllix jista ’ jintuża f ’ nies li għandhom iżjed minn 65 sena.
38 Trazec and children and adolescents Trazec is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Trazec u tfal u adolexxenti Trazec mhuwiex rakkomandat għal tfal u adolexxenti (taħt it- 18- il sena) minħabba li l- effetti fuq dan il- grupp ta ’ din l- età ma ġiex studjat.
Pregnancy and breast-feeding Do not take Trazec if you are pregnant or planning to become pregnant.
Tqala u treddigħ Trazec m’ għandux jintuża jekk int ħriġt tqila jew qed tippjana li toħroġ tqila.
Do not breast-feed during treatment with Trazec.
Treddax waqt il- kura bi Trazec
Important information about some of the ingredients of Trazec Trazec tablets contain lactose monohydrate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Trazec Il- pilloli Trazec fihom lactose monohydrate.
HOW TO TAKE TRAZEC
KIF GĦANDEK TUŻA TRAZEC
Always take Trazec exactly as your doctor has told you.
Dejjem għandek tieħu Trazec skond il- parir tat- tabib.
When to take Trazec Take Trazec before the three main meals, usually:
Meta għandek tieħu Trazec Ħu Trazec qabel it- tlett ikliet prinċipali, ġeneralment:
It is best to take it right before a main meal but you can take it up to 30 minutes before.
L- aħjar li tieħu Trazec qabel- ikla prinċipali iżda tista ’ tieħu d- doża sa 30 minuta qabel.
If you miss a meal, skip that dose of Trazec and wait until your next meal.
Jekk titlef ikla, aqbeż id- doża ta ’ Trazec u stenna sa l - ikla li jkun imissek.
How much to take Take Trazec as your doctor told you to.
Kemm għandek tieħu Ħu Trazec kif qallek it- tabib tiegħek.
The usual dose of Trazec to start with is 60 mg before the three main meals.
Id- doża ta ’ Trazec li ssoltu tingħata biex tibda hija ta ’ 60 mg qabel it- tlett ikliet prinċipali.
How long to take Trazec Take Trazec daily until your doctor tells you to stop.
42 Ħu Trazec kuljum sakemm jgħidlek tieqaf it- tabib tiegħek.
If you take more Trazec than you should If you have accidentally taken too many tablets, talk to a doctor straight away.
Jekk tieħu Trazec aktar milli suppost Jekk bi żball ħadt wisq pilloli, kellem lit- tabib tiegħek minnufih.
If you forget to take Trazec If you forget to take a tablet simply take the next one before your next meal.
Jekk tinsa tieħu Trazec Jekk tinsa tieħu pillola ħu dik li jmiss qabel l- ikla li jmissek.
Do not take a double dose of Trazec to make up for the one that you missed.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Trazec can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Trazec jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects caused by Trazec are usually mild to moderate.
L - effetti sekondarji ikkawżati minn Trazec huma ġeneralment ħfief għal moderati.
HOW TO STORE TRAZEC
KIF TAĦŻEN TRAZEC
Do not use Trazec after the expiry date stated on the carton after EXP.
M’ għandekx tuża Trazec wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Do not use any Trazec pack that is damaged or shows signs of tampering.
M’ għandekx tuża l- pakkett ta ’ Trazec jekk tara li huwa danneġġat jew jidher li ġie imbagħbas.
What Trazec contains
X’ Fih Trazec
What Trazec looks like and contents of the pack Trazec 60 mg film-coated tablets are pink, round tablets with “ NVR” marked on one side and “ TS” on the other.
Id- Dehra ta ’ Trazec u l- kontenuti tal- pakkett Trazec 60 mg pilloli miksijin b’ rita huma roża, tondi b ’ “ NVR ” immarkata fuq naħa u “ TS ” fuq l- oħra.
Trazec 120 mg film-coated tablets are yellow, ovaloid tablets with “ NVR” marked on one side and “ TSL” on the other.
Trazec 120 mg pilloli miksijin b’ rita huma sofor, b’ għamla ovali b ’ “ NVR ” immarkata fuq naħa u “ TSL ” fuq l- oħra.
Trazec 180 mg film-coated tablets are red, ovaloid tablets with “ NVR” marked on one side and “ TSX” on the other.
Trazec 180 mg pilloli miksijin b’ rita huma ħomor, b’ għamla ovali b ’ “ NVR ” immarkata fuq naħa u “ TSX ” fuq l- oħra.
Each blister pack contains 12, 60, 84, 120 or 360 tablets.
Kull pakkett ta ’ folji fih 12, 60, 84, 120 jew 360 pillola.
What is Tredaptive?
X’ inhu Tredaptive?
Tredaptive is a medicine containing two active substances: nicotinic acid (also known as niacin or vitamin B3) and laropiprant.
Tredaptive huwa mediċina li fiha żewġ sustanzi attivi: l- aċidu nikotiniku (magħruf ukoll bħala niacin jew vitamina B3) u laropiprant.
It is available as modified-release tablets. ‘ Modified-release ’ means that the two active substances are released at different rates from the tablet over a few hours.
Jiġi bħala pilloli ta ’ rilaxx modifikat. ‘ Rilaxx modifikat ’ ifisser li ż - żewġ sustanzi attivi jiġu rilaxxati b’ rati differenti mill- pillola fuq perjodu ta ’ ftit sigħat.
What is Tredaptive used for?
Għalxiex jintuża Tredaptive?
Tredaptive 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’.
Tredaptive jintuża flimkien mad- dieta u l- eżerċizzju f’ pazjenti b’ dislipidemija (livelli għoljin b’ mod mhux normali 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’ dislipidemija mħallta kombinata jkollhom livelli għoljin ta ’ kolesterol LDL ‘ ħażin ’ u ta ’ trigliċeridi (tip ta ’ xaħam), u livelli baxxi ta ’ kolesterol HDL ‘ tajjeb ’ fid - demm.
Primary hypercholesterolaemia is when the levels of cholesterol in the blood are high.
Il- livell ta ’ kolesterol għoli primarju jseħħ meta l- livelli ta ’ kolesterol fid- demm ikunu għoljin.
Primary means that the hypercholesterolaemia does not have any identifiable cause.
Primarju jfisser li l- livell għoli ta ’ kolesterol ma jkollux kawża identifikabbli.
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.
Tredaptive normalment jingħata flimkien ma ’ statin (il- mediċina standard użata għat- tnaqqis tal - kolesterol) meta l- effikaċja ta ’ statin meħud waħdu ma jkunx adegwat.
Tredaptive is used on its own only in patients who cannot take statins.
Tredaptive jintuża waħdu biss f’ pazjenti li ma jkunux jistgħu jieħdu statins.
How is Tredaptive used?
Kif jintuża Tredaptive?
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.
Wara, id- doża tiżdied għal żewġ pilloli darba kuljum.
It is taken by mouth, with food, in the evening or before going to bed.
Tittieħed oralment, ma ’ l- ikel filgħaxija jew qabel l- irqad.
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.
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.
Tredaptive 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.
It should be used with caution in patients who have problems with their kidneys and should not be used in patients with liver problems.
Għandu jintuża b’ kawtela f’ pazjenti li jkollhom problemi fil- kliewi u m’ għandux jintuża f’ pazjenti bil- problemi fil- fwied.
How does Tredaptive work?
Kif jaħdem Tredaptive?
The two active substances in Tredaptive, nicotinic acid and laropiprant, have different modes of action.
Iż- żewġ sustanzi attivi fi Tredaptive, l- aċidu nikotiniku u laropiprant, għandhom modi differenti ta ’ azzjoni.
Nicotinic acid is a naturally occurring substance that is used in low doses as a vitamin.
L- aċidu nikotiniku huwa sustanza naturali li tintuża f’ dożi baxxi bħala vitamina.
In higher doses, it reduces the levels of fat in the blood via a mechanism that is not fully understood.
F’ dożi ogħla, inaqqas il- livelli ta ’ xaħam fid- demm b’ mekkaniżmu li għadu mhux mifhum għal kollox.
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).
Intuża għall- ewwel darba f’ nofs is- snin ħamsin 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.
Flushing due to nicotinic acid is thought to occur because of the release of a substance called ‘ prostaglandin D2’ (PGD2) from cells in the skin, which dilates (widens) the blood vessels in the skin.
Huwa maħsub li l- ħmura fil- wiċċ minħabba l- aċidu nikotiniku sseħħ minħabba r- rilaxx ta ’ sustanza magħrufa bħala ‘ prostaglandin D2 ’ (PGD2) minn ċelloli fil- ġilda, li twessa ’ l- arterji u l- vini fil- ġilda.
When the receptors are blocked, PGD2 cannot dilate the vessels in the skin, reducing the frequency and intensity of flushing.
Meta r- riċetturi jiġu imblukkati, 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 Tredaptive tablets, laropiprant is in one of the layers, and the other layer contains nicotinic acid.
Fil- pilloli ta ’ Tredaptive, laropiprant jinsab f’ wieħed mis- saffi, u s- saff l- ieħor fih l- aċidu nikotiniku.
When the patient takes the tablet, laropiprant is released first into the bloodstream and blocks the PGD2 receptors.
Meta l- pazjent jieħu l- pillola, laropiprant jiġi rilaxxat l- ewwel fiċ- ċirkolazzjoni tad- demm u jimblokka r- riċetturi tal- PGD2.
The nicotinic acid is released more slowly from the other layer and has its effect as a fat-modifying agent.
L- aċidu nikotiniku jiġi rilaxxat iktar bil- mod mis- saff l- ieħor u għandu l- effett tiegħu bħala sustanza li timmodifika x- xaħam.
How has Tredaptive been studied?
Kif ġie studjat Tredaptive?
The effects of Tredaptive were first tested in experimental models before being studied in humans.
L- effetti ta ’ Tredaptive għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Tredaptive was studied in four main studies in patients with hypercholesterolaemia or mixed dyslipidaemia.
Tredaptive ġie studjat f’ erba ’ studji ewlenin b’ livelli għoljin ta ’ kolesterol fid- demm jew b’ dislipidemija mħallta.
Two studies looked at the effectiveness of Tredaptive in modifying blood fat levels.
Żewġ studji ħarsu lejn l- effikaċja ta ’ Tredaptive fil- modifikazzjoni tal- livelli tax- xaħam fid- demm.
The first study compared the effectiveness of Tredaptive 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 ’ Tredaptive ma ’ dik ta ’ l- aċidu nikotiniku waħdu jew plaċebo (trattament finta) fit- tnaqqis tal- livelli ta ’ kolesterol LDL f’ total ta ’ 1, 613- il pazjent.
This study also looked at the symptoms of flushing using a specially designed questionnaire.
Dan l- istudju ħares ukoll lejn is- sintomi tal- ħmura fil- wiċċ bl- użu ta ’ kwestjonarju mfassal apposta.
The second study compared the combination of Tredaptive and simvastatin (a statin) with Tredaptive alone or simvastatin alone in 1,398 patients.
It- tieni studju qabbel il- kombinazzjoni ta ’ Tredaptive u simvastatin (statin) ma ’ Tredaptive waħdu jew simvastatin waħdu f’ 1, 398 pazjent.
The main measure of effectiveness was the change in the blood levels of LDL cholesterol after 12 weeks.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kien it- tibdil fil- livelli fid - demm ta ’ kolesterol LDL wara 12- il ġimgħa.
The third and fourth studies looked at the effectiveness of laropiprant in reducing the flushing caused by nicotinic acid.
It- tielet u r- raba ’ studji ħarsu lejn l- effikaċja ta ’ laropiprant fit- tnaqqis fil- ħmura fil- wiċċ ikkawżata mill- aċidu nikotiniku.
They included a total of 2,349 patients who were taking either Tredaptive or nicotinic acid.
F’ dawn b’ kollox ħadu sehem 2, 349 pazjent li kienu qegħdin jieħdu Tredaptive jew aċidu nikotiniku.
Flushing was measured using the flushing symptom questionnaire.
Il- ħmura fil- wiċċ tkejlet bl- użu ta ’ kwestjonarju dwar is- sintomi tal- ħmura fil - wiċċ.
What benefit has Tredaptive shown during the studies?
Liema benefiċċju wera Tredaptive waqt l- istudji mwettqa?
Tredaptive was effective in reducing the blood levels of LDL cholesterol.
Tredaptive kien effettiv fit- tnaqqis tal- livelli ta ’ kolesterol LDL fid- demm.
In the first study, LDL cholesterol levels were reduced by 19% in patients taking Tredaptive, compared with 1% in those taking placebo.
Fl- ewwel studju, il- livelli ta ’ kolesterol LDL tnaqqsu b’ 19% fil- pazjenti li kienu qed jieħdu Tredaptive, meta mqabbla ma ’ 1% f’ dawk li kienu qed jieħdu plaċebo.
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).
It- tieni studju wera li l- livelli ta ’ kolesterol LDL tnaqqsu iktar meta Tredaptive ittieħed flimkien ma ’ simvastatin (tnaqqis ta ’ 48%), milli meta Tredaptive ittieħed waħdu (tnaqqis ta ’ 17%) jew ma ’ simvastatin waħdu (tnaqqis ta ’ 37%).
Adding laropiprant to nicotinic acid reduced the symptoms of flushing caused by nicotinic acid.
Iż- żieda ta ’ laropiprant ma ’ l- aċidu nikotoniku naqset is- sintomi tal- ħmura fil- wiċċ ikkawżata mill - aċidu nikotiniku.
In the first and third studies, fewer patients taking Tredaptive reported moderate, severe or extreme flushing than patients taking nicotinic acid alone.
Fl- ewwel u t- tielet studji, inqas pazjenti li kienu qegħdin jieħdu Tredaptive 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 Tredaptive than in those taking nicotinic acid alone.
Fir- raba ’ studju, il- ħmura fil- wiċċ dehret f’ inqas jiem fil- pazjenti li kienu qegħdin jieħdu Tredaptive milli f’ dawk li kienu qegħdin jieħdu aċidu nikotiniku waħdu.
What is the risk associated with Tredaptive?
X’ inhu r- riskju assoċjat ma ’ Tredaptive?
The most common side effect with Tredaptive (seen in more than 1 patient in 10) is flushing.
L- iktar effett sekondarju komuni bi Tredaptive (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 Tredaptive, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtata bi Tredaptive, ara l - Fuljett ta ’ Tagħrif.
Tredaptive should not be used in people who may be hypersensitive (allergic) to nicotinic acid, laropiprant or any of the other ingredients.
Tredaptive m’ għandux jintuża f’ persuni li jistgħu jkunu sensittivi żżejjed (allerġiċi) 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 Tredaptive been approved?
Għaliex ġie approvat Tredaptive?
The Committee for Medicinal Products for Human Use (CHMP) decided that Tredaptive’ 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 għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Tredaptive 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 Tredaptive be given marketing authorisation.
Il - Kumitat irrakkomanda li Tredaptive jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Tredaptive:
Informazzjoni oħra dwar Tredaptive:
The European Commission granted a marketing authorisation valid throughout the European Union for Tredaptive to Merck Sharp & Dohme Ltd. on 3 July 2008.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Tredaptive lil Merck Sharp & Dohme Ltd. fl- 3 ta ’ Lulju 2008.
The full EPAR for Tredaptive can be found here.
2/ 3 L- EPAR sħiħ għal Tredaptive jista ’ jiġi kkonsultat hawn.
EU Number
Daqs tal - Numru ta ’ l- EU
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/ 010 EU/ 1/ 08/ 459/ 011 EU/ 1/ 08/ 459/ 012 EU/ 1/ 08/ 459/ 013 EU/ 1/ 08/ 459/ 014
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
Tredaptive 1000 mg/ 20 mg modified-release tablets.
Tredaptive 1, 000 mg/ 20 mg pilloli li jerħu l- mediċina b’ mod modifikat.
Capsule-shaped, white to off-white tablet, with “ 552” debossed on one side.
Pillola bajda għal offwajt, għamla ta ’ kapsula, li għandha “ 552 ” ibbuzzat fuq naħa waħda.
Tredaptive 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).
Tredaptive 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).
Tredaptive 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.
Tredaptive 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 Tredaptive.
Dieti u trattamenti oħra mhux farmakoloġiċi (eż. eżerċizzju, tnaqqis fil- piż) għandhom jitkomplew matul it- terapija bi Tredaptive.
If Tredaptive is missed for less than 7 consecutive days, patients can resume therapy at the last administered dose.
Jekk Tredaptive ma jitteħidx għal inqas minn 7 ijiem konsekuttivi, il- pazjenti jistgħu jerġgħu jibdew it- terapija bl- aħħar doża mogħtija.
If Tredaptive 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 Tredaptive 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 Tredaptive 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 Tredaptive bid- doża ta ’ 2000 mg/ 40 mg.
For patients switching from immediate-release nicotinic acid to Tredaptive, 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 Tredaptive, it- terapija 2 għandha 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 Tredaptive in paediatric patients have not been established.
Użu f’ pazjenti pedjatriċi Is- sigurtà u l- effikaċja ta ’ Tredaptive ma ġietx stabbilita f’ pazjenti pedjatriċi.
Use in patients with hepatic or renal insufficiency Use of Tredaptive in patients with hepatic or renal insufficiency has not been studied.
Użu f’ pazjenti b’ insuffiċjenza tal- fwied jew tal- kliewi L- użu ta ’ Tredaptive f’ pazjenti b’ insuffiċjenza tal- fwied jew tal- kliewi ma ġiex studjat.
Like other nicotinic acid medicinal products, Tredaptive is contraindicated in patients with significant or unexplained hepatic dysfunction.
Bħal prodotti mediċinali oħra ta ’ l- aċidu nikotiniku, Tredaptive huwa kontra- indikat f’ pazjenti li għandhom disfunzjoni tal- fwied sinifikanti jew mhux spjegata.
It should be used with caution in patients with renal insufficiency, because nicotinic acid and its metabolites are primarily excreted by the kidneys (see sections 4.3, 4.4 and 5.2).
Huwa għandu jintuża b’ kawtela f’ pazjenti b’ insuffiċjenza tal- kliewi, minħabba li l- aċidu nikotiniku u l- metaboliti tiegħu jitneħħew primarjament mill- kliewi (ara sezzjonijiet 4. 3, 4. 4 u 5. 2).
Concomitant therapy Acetylsalicylic acid provides no additional reduction of flushing beyond that achieved by Tredaptive.
Terapija konkomitanti L- aċidu aċetilsaliċiliku ma jipprovdi l- ebda tnaqqis addizzjonali tal- fawra aktar minn dik miksuba bi Tredaptive.
Because co-administration of bile acid sequestrants may reduce the bioavailability of acidic medicinal products such as nicotinic acid, it is recommended that Tredaptive 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 Tredaptive jingħata > siegħa qabel jew > 4 sigħat wara l- għoti ta ’ sekwestrant ta ’ l- aċidu biljari (ara sezzjoni 4. 5).
When Tredaptive is co-administered with a statin, please refer to the Summary of Product Characteristics for that particular medicinal product.
Meta Tredaptive 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 Tredaptive has not been studied.
Effetti fuq il- fwied Il- qlib minn aċidu nikotiniku (kristallin) ta ’ rilaxx immedjat għal Tredaptive ma ġiex studjat.
3 patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Madankollu, seħħew każijiet ta ’ tossiċità epatika severa, fosthom nekrosi epatika fulminanti, f’ pazjenti li qalbu minn aċidu nikotiniku ta ’ rilaxx immedjat għal aċidu nikotiniku li jaħdem fit- tul b’ dożi ekwivalenti.
Therefore, patients switching from immediate-release nicotinic acid to Tredaptive should be initiated at the 1000 mg/ 20 mg dose.
Għalhekk, il- pazjenti li jaqilbu minn aċidu nikotiniku ta ’ rilaxx immedjat għal Tredaptive għandhom jinbdew bid- doża ta ’ 1, 000 mg/ 20 mg.
Tredaptive should be used with caution in patients who consume substantial quantities of alcohol and/ or have a past history of liver disease.
Tredaptive 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 Tredaptive 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 ’ Tredaptive.
Physicians contemplating combined therapy with statins and Tredaptive 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 Tredaptive 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 Tredaptive with a statin, their CK levels should be measured.
Jekk iseħħ uġigħ muskolari, dgħjufija jew bugħawwieġ waqt li pazjent ikun qiegħed jirċievi Tredaptive bi statin, għandhom jitkejlu l- livelli CK tagħhom.
Renal dysfunction Because nicotinic acid and its metabolites are excreted through the kidneys, Tredaptive 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, Tredaptive 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 Tredaptive 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 Tredaptive 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, Tredaptive (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, Tredaptive (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, Tredaptive (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, Tredaptive (2000 mg/ 40 mg) ġie assoċjat ma ’ żidiet żgħar fil- livelli ta ’ l- aċidu uriku (ara sezzjoni 4. 8).
Therefore, Tredaptive should be used with caution in patients with or predisposed to gout.
Għalhekk, Tredaptive għandu jintuża b’ kawtela f’ pazjenti bil- gotta jew predisposti għaliha.
Hypophosphatemia As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
4 Ipofosfatemja Bħal fi prodotti mediċinali ta ’ l- aċidu nikotiniku oħrajn, Tredaptive kien assoċjat ma ’ tnaqqis żgħir fil - livelli ta ’ fosfru.
Excipient Tredaptive contains lactose.
Sustanza mhux attiva Tredaptive fih il- lattożju.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- galattożju, id - defiċjenza ta ’ Lapp lactase jew assorbiment ħażin tal- glukożju- galattożju m’ għandhomx jieħdu din il - mediċina.
Simultaneous use of alcohol or hot drinks can enhance the effects of flushing and should therefore be avoided around the time of ingestion of Tredaptive.
Użu simultanju ta ’ alkoħol jew xorb sħun jista ’ jkabbar l- effetti ta ’ fawra u għalhekk dawn għandhom jiġu evitati mal- ħin ta ’ inġestjoni ta ’ Tredaptive.
The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
L- interazzjoni farmakokinetika ta ’ Tredaptive 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 Tredaptive 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 Tredaptive 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 Tredaptive.
Vitamini jew supplimenti nutrizzjonali oħra li fihom (≥ 50 mg/ ġurnata) ta ’ aċidu nikotiniku (jew nicotinamide) ma ġewx studjati ma ’ Tredaptive.
Physicians should consider the nicotinic acid intake from vitamins and nutritional supplements when prescribing Tredaptive.
It- tobba għandhom jikkunsidraw l- ammont ta ’ aċidu nikotiniku meħud mill- vitamini u s- supplimenti nutrizzjonali meta jordnaw Tredaptive.
1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
5 glucuronosyltransferases (UGT) 2B4 u 2B7.
Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/ UGT2B7.
Studji kliniċi u in vitro jsostnu l- konklużjoni li laropiprant huwa inibitur ħafif għal moderat ta ’ UGT2B4/ UGT2B7.
Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Għandha tintuża attenzjoni meta Tredaptive jingħata fl- istess ħin ma ’ prodotti mediċinali li jiġu metabolizzati primarjament minn UGT2B4 jew UGT2B7, per eżempju zidovudine.
Pregnancy Tredaptive There are no data from the combined use of nicotinic acid and laropiprant in pregnant women.
Tqala Tredaptive M’ hemm ebda informazzjoni dwar l- użu kombinat ta ’ l- aċidu nikotiniku u laropiprant f’ nisa tqal.
Therefore, Tredaptive should not be used during pregnancy unless clearly necessary.
Għalhekk Tredaptive m’ għandux jintuża waqt it- tqala jekk ma jkunx hemm bżonn ċar.
Lactation Tredaptive No studies in lactating animals have been conducted with Tredaptive.
Treddigħ Tredaptive Ma sarux studji bi Tredaptive 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 Tredaptive 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 ’ Tredaptive għall- mara.
4.8 Undesirable effects In clinical trials, over 2500 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
Fi provi kliniċi, aktar minn 2500 pazjent irċevew Tredaptive waħdu jew ma ’ inibitur HMG- CoA reductase.
Flushing Flushing is the most common adverse reaction of Tredaptive.
Fawra Il- fawra hija l- aktar reazzjoni avversa komuni ta ’ Tredaptive.
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 Tredaptive.
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 Tredaptive.
In these studies, the percentage of patients taking Tredaptive, 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 Tredaptive, 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 Tredaptive were infrequent (< 1%).
Il- każijiet ta ’ twaqqif tal- kura minħabba reazzjonijiet avversi speċifiċi oħra fost il- pazjenti li kienu qegħdin jieħdu Tredaptive ma kinux frekwenti (< 1%)
7 Overall adverse reactions with Tredaptive In addition to flushing, clinical adverse reactions reported by the investigators as possibly, probably, or definitely related to Tredaptive in ≥ 1% of patients treated with Tredaptive 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 Tredaptive Minbarra l- fawra, ir- reazzjonijiet kliniċi avversi rrappurtati mill- investigaturi bħala possibbilment, probabbilment, jew definittivament relatati ma ’ Tredaptive f’ ≥1% tal- pazjenti trattati bi Tredaptive 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 Tredaptive 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 Tredaptive bi jew mingħajr statin.
These elevations were generally asymptomatic and returned to baseline after discontinuation of therapy or with continued treatment.
Dawn iż- żidiet ġeneralment kienu bla sintomi u reġgħu lura għal - linja bażi wara t- twaqqif tat- terapija jew bi trattament li ssokta.
Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3% of the patients treated with Tredaptive 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 Tredaptive bi jew mingħajr statin (ara sezzjoni 4. 4).
8 controlled clinical studies with Tredaptive (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 ’ Tredaptive (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 Tredaptive (or the nicotinic acid component of Tredaptive) 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 ’ Tredaptive (jew il- komponent ta ’ l- aċidu nikotiniku ta ’ Tredaptive) < 1% tal - pazjenti ttrattati:
Tredaptive In the event of an overdose, it is reasonable to employ the usual symptomatic and supportive measures.
Tredaptive 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 Tredaptive taken was 5000 mg/ 100 mg.
Ġew irrappurtati każi ta ’ doża eċċessiva; l- akbar doża ta ’ Tredaptive 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).
Tredaptive 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 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).
F’ individwi b’ saħħithom li rċevew Tredaptive, 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 ’ Tredaptive waħdu (ara sezzjoni 4. 8).
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.
Studji kliniċi Effetti fuq il- lipidi Tredaptive 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 Tredaptive (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 Tredaptive (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 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].
Il- pazjenti li kienu qegħdin jirċievu Tredaptive, 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 Tredaptive was given as monotherapy or was added to ongoing statin therapy with or without ezetimibe.
L- effett fuq il- lipidi kien simili kemm jekk Tredaptive 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, 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).
Fi studju fattorjali, multi- ċentri, double- blind, ta ’ 12- il ġimgħa, Tredaptive 1, 000 mg/ 20 mg mogħti fl - istess ħin ma ’ simvastatin, meta mqabbel ma ’ simvastatin waħdu jew Tredaptive 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).
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
Tredaptive 2, 000 mg/ 40 mg mogħti flimkien ma ’ simvastatin, meta mqabbel ma ’ simvastatin waħdu jew ma ’ Tredaptive 2, 000 mg/ 40 mg waħdu għal 12- il ġimgħa, naqqas b’ mod sinjifikanti LDL- C (- 47. 9%, - 37. 0%, - 17. 0% rispettivament), TG (- 33. 3%, - 14. 7%, - 21. 6% rispettivament), apo B (- 41. 0%, - 28. 8%, - 17. 1% rispettivament), u TC (- 29. 6%, - 24. 9%, 9. 1% rispettivament), kif ukoll LDL- C: HDL- C (- 57. 1%, - 39. 8%, - 31. 2% rispettivament), non- HDL- C (- 45. 8%, - 33. 4%, - 18. 1% rispettivament), u TC: HDL - C (- 43. 0%, - 28, 0%, - 24. 9% rispettivament), u żied b’ mod sinjifikanti HDL- C (27. 5%, 6. 0%, 23. 4% rispettivament).
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).
Analiżi addizzjonali wriet li Tredaptive 2000 mg/ 40 mg mogħti fl- istess ħin ma ’ simvastatin meta mqabbel ma ’ simvastatin waħdu żied b’ mod sinifikanti l- apo A- I (8. 6%, 2. 3% rispettivament) u naqqas b’ mod sinifikanti l- Lp( a) (- 19. 8%, 0. 0% rispettivament).
Efficacy and safety of Tredaptive in combination with simvastatin > 40 mg were not included in this study.
L- effikaċja u s - sigurtà ta ’ Tredaptive f’ kombinazzjoni ma ’ simvastatin > 40 mg ma kinux inklużi f’ dan l- istudju.
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).
10 Fwawar F’ żewġ provi kliniċi kbar li kejlu s- sintomi ta ’ fawra rrappurtati mill- pazjenti stess, il- pazjenti li ħadu Tredaptive esperjenzaw anqas fawra minn dawk li ħadu l- aċidu nikotiniku (formulazzjonijiet li jerħu l - mediċina bil- mod).
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).
Fil- pazjenti li komplew fl- ewwel studju (24 ġimgħa), il- frekwenza ta ’ fawra moderata jew akbar f’ pazjenti trattati bi Tredaptive naqset jew avviċinat dik tal- pazjenti li rċevew plaċebo (ara Figura 1), filwaqt li fil- pazjenti trattati bl- aċidu nikotiniku (formulazzjoni li terħi l - mediċina bil- mod) il- frekwenza tal- fwawar baqgħet kostanti (wara Ġimgħa 6).
Flushing efficacy of laropiprant has not been established past 24 weeks.
Ammont medju ta ’ ġranet fil- ġimgħa b’ sintomi moderati jew akbar * ta ’ fawra minn ġimgħa 1- 24 2 Number of Days per Week
● 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
●Tredaptive (1, 000 mg/ 20 mg għal 2000 mg/ 40 mg f’ Ġimgħa 5) ▲Aċidu nikotiniku (rilaxx bil- mod 1000 mg għal 2000 mg f’ Ġimgħa 5) ○Plaċebo * Jinkludi pazjenti b’ sintomi moderati, severa, jew estremi ta ’ fawra † Avvanzament tad- doża f’ Ġimgħa 5
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).
Fit- tieni studju (16- il ġimgħa) fejn kien permess l- aċidu aċetilsaliċiliku, il- pazjenti li ħadu Tredaptive esperjenzaw ġranet konsiderevolment inqas fil- ġimgħa b’ fawra moderata jew akbar meta mqabbel ma ’ l- aċidu nikotiniku (formulazzjoni li terħi l- mediċina bil- mod meħuda bħala titrazzjoni multi- step ta ’ 500 mg għal 2000 mg fuq tnax- il ġimgħa) (p < 0. 001).
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.
Laropiprant Wara doża ta ’ 40 mg ta ’ laropiprant mogħtija mill- ħalq bħala żewġ pilloli ta ’ l- aċidu nikotiniku/ laropiprant li jerħu l- mediċina b’ mod modifikat ma ’ l- ikel, laropiprant jiġi assorbit malajr b’ Tmax medjan ta ’ siegħa, AUC0- ∞ medju ta ’ madwar 13 μM· hr, u Cmax medju ta ’ madwar 1. 6 μM.
Characteristics in patients Renal insufficiency Tredaptive:
Karatteristiċi fil- pazjenti Insuffiċjenza tal- kliewi Tredaptive:
Hepatic insufficiency Tredaptive:
Insuffiċjenza tal- fwied Tredaptive: