FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: 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.
English: Trevaclyn is indicated for the treatment of dyslipidaemia, particularly in adult patients with combined mixed dyslipidaemia (characterised by elevated levels of LDL-cholesterol and triglycerides and low HDL-cholesterol) and in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial).
Maltese: Trevaclyn huwa indikat għat-trattament tad-dislipidemija, b'mod partikolari f'pazjenti adulti li għandhom dislipidemija mħallta kkombinata (ikkaratterizzata minn livelli għolja ta' LDL-kolesterol u trigliċeridi u HDL-kolesterol baxx) u f'pazjenti adulti b'iperkolesterolemija primarja (eterozigote familjali u mhux familjali).
English: Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Maltese: 2 Perċentwal ta' pazjenti b'Sintomi Moderati jew Aktar ta' Fwawar Matul il-Ġimgħat 1-32
English: Nicotinic acid showed no mutagenic effects in the in vitro assays.
Maltese: L-aċidu nikotiniku ma wera ebda effetti mutaġeniċi flassaġġi in vitro.
English: Merck Sharp & Dohme s.r.o.
Maltese: Česká republika Merck Sharp & Dohme s.r.o.
English: Race has no clinically meaningful effect on the pharmacokinetics of nicotinic acid (prolonged-release formulation) based on pharmacokinetic data including subjects of Hispanic, White, Black, and Native American racial groups.
Maltese: Ir-razza ma għandha l-ebda effett kliniku sinifikanti fuq il-farmakokinetika ta' l-aċidu nikotiniku (formulazzjoni li terħi lmediċina bil-mod) fuq il-bażi ta' informazzjoni farmakokinetika li kienet tinkludi individwi ta' gruppi razzjali Ispaniċi, Bojod, Suwed, u Amerikani Nattivi.
English: Acetylsalicylic acid and clopidogrel: In a clinical study in dyslipidaemic patients receiving both acetylsalicylic acid (81 mg) and clopidogrel (75 mg), laropiprant induced transient (4 hours post-dose) inhibition of platelet function in vivo (as evaluated by bleeding time and platelet aggregation studies), but had little effect across the dosing interval.
Maltese: Fi studju kliniku f'pazjenti dislipidimiċi li kienu qed jirċievu kemm acetylsalicylic acid (81 mg) kif ukoll clopidogrel (75 mg), laropiprant ikkawża inibizzjoni temporanja (4 sigħat wara d-doża) tal-funzjoni tal-plejtlits in vivo (hekk kif evalwat minn studji dwar il-ħin ta' kemm iddum il-fsada u t-twaħħil tal-plejtlits), iżda ftit li xejn kellu effett tul l-intervall bejn id-dożi.
English: As with other nicotinic acid medicinal products, elevations in fasting glucose (a median increase of approximately 4 mg/dL), and uric acid (mean change from baseline of +14.7 %), and reductions in platelet counts (a mean change from baseline of -14.0 %) were reported in controlled clinical studies with Trevaclyn (2,000 mg/40 mg) (see section 4.4).
Maltese: 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 talplejtlits (bidla medja mil-linja bażi ta' -14.0 %) ġew irrapportati fi provi kliniċi kkontrollati ma' Trevaclyn (2,000 mg/40 mg) (ara sezzjoni 4.4).
English: • burning sensation
Maltese: Sensazzjoni ta' sħana
English: Caution should be used when Trevaclyn is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Maltese: Għandha tintuża attenzjoni meta Trevaclyn jingħata fl-istess ħin ma' prodotti mediċinali li jiġu metabolizzati primarjament minn UGT2B4 jew UGT2B7, per eżempju zidovudine.
English: Pharmacokinetic steady state is achieved within 2 days of once-daily dosing of laropiprant, with minimal accumulation in AUC (approximately 1.3-fold) and Cmax (approximately 1.1-fold).
Maltese: Stat farmakokinetiku fiss jinkiseb fi żmien jumejn ta' dożaġġ darba kuljum ta' laropiprant, b'akkumulazzjoni minima fl-AUC (madwar 1.3 darbiet) u fil-Cmax (madwar 1.1 darbiet).
English: • dizziness
Maltese: Dispneja.
English: Trevaclyn contains lactose.
Maltese: Trevaclyn fih tip ta' zokkor imsejjaħ lactose.
English: 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.
Maltese: 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.
English: ●Trevaclyn (1000 mg/20 mg to 2000 mg/40 mg at week 5) ▲Nicotinic acid (prolonged-release 1000 mg to 2000 mg at week 5)
Maltese: ●Trevaclyn (1,000 mg/20 mg għal 2,000 mg/40 mg f'Ġimgħa 5) ▲Aċidu nikotiniku (rilaxx bil-mod 1,000 mg għal 2,000 mg f'Ġimgħa 5) ○Plaċebo *Jinkludi pazjenti b'sintomi moderati, severa, jew estremi ta' fawra †Avvanzament tad-doża f'Ġimgħa 5
English: • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1..
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/458/012
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/458/012
English: Laropiprant: Consistent with the characteristics of a medicinal product that is primarily cleared by metabolism, moderate hepatic disease has a significant impact on laropiprant pharmacokinetics, with an increase in AUC and Cmax of approximately 2.8- and 2.2-fold respectively.
Maltese: Konsistenti mal-karatteristiċi ta' prodott mediċinali li jitneħħa primarjament bilmetaboliżmu, mard tal-fwied moderat għandu impatt sinifikanti fuq il-farmakokinetika ta' laropiprant, b'żieda fl-AUC u l-Cmax ta' madwar 2.8 u 2.2 darbiet rispettivament.
English: Other medicines and Trevaclyn
Maltese: Mediċini oħra u Trevaclyn
English: EU/1/08/458/014 32 x 1modified-release tablets
Maltese: EU/1/08/458/005
English: NAME OF THE MEDICINAL PRODUCT Trevaclyn 1000 mg/20 mg modified-release tablets Nicotinic acid/laropiprant
Maltese: TAL-PRODOTT MEDIĊINALI Trevacyln 1,000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat Nicotinic acid/laropiprant
English: Trevaclyn 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Maltese: Trevaclyn 1,000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat aċidu nikotiniku/laropiprant
English: 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.
Maltese: 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.
English: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Maltese: Uġigħ addominali, edema fil-ħalq, tifwiq, ulċera peptika.
English: • Renal impairment
Maltese: Disturbi vaskulari
English: As with other nicotinic acid medicinal products, Trevaclyn (2,000 mg/40 mg) was associated with small increases in uric acid levels (see section 4.8).
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, Trevaclyn (2,000 mg/40 mg) ġie assoċjat ma' tnaqqis żgħir fl-għadd tal-plejtlits (ara sezzjoni 4.8).
English: In a multicentre, double-blind, 12-week factorial study, Trevaclyn 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Trevaclyn 1,000 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).
Maltese: Fi studju fattorjali, multi-ċentri, double-blind, ta' 12-il ġimgħa, Trevaclyn 1,000 mg/20 mg mogħti flistess 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), itTG (-25.8%, -15.
English: In vitro studies have shown that the acyl glucuronide conjugate of laropiprant had at least a 65-fold reduced affinity for DP1 as compared to laropiprant; thus, it is not expected to contribute to the overall DP1 activity of laropiprant.
Maltese: Studji in vitro wrew li l-acyl glucuronide conjugate ta' laropiprant kellu mill-anqas 65 darba anqas affinità għad-DP1 meta mqabbel ma' laropiprant; għaldaqstant, mhuwiex mistenni li jikkontribwixxi għall-attività DP1 globali ta' laropiprant.
English: Laropiprant was not teratogenic in rats or in rabbits at systemic exposure levels at least 153 and 438 times the human exposure based on the AUC of the recommended daily human dose.
Maltese: Laropiprant ma kienx teratoġeniku fil-firien jew fil-fniek f'livelli ta' esponiment sistemiku ta' millanqas 153 u 438 darba l-esponiment uman ibbażat fuq l-AUC tad-doża ta' kuljum rakkomandata għallbnedmin.
English: Medicinal product /laboratory test interactions: In urine glucose tests, nicotinic acid may also give false-positive reactions with cupric sulfate solution (Benedict's reagent).
Maltese: F'testijiet tal-glukożju fl-awrina, laċidu nikotiniku jista' jagħti wkoll reazzjonijiet pożittivi foloz ma' soluzzjoni tas-sulfat kupriku (reaġent ta' Benedict).
English: Because the risk of myopathy with statins is dose-related, the use of Trevaclyn with simvastatin 80 mg or ezetimibe/simvastatin 10/80 mg is not recommended in Chinese patients.
Maltese: Minħabba li r-riskju ta' mijopatija bi statins huwa relatat mad-doża, l-użu ta' Trevaclyn ma' simvastatin 80 mg jew ma' ezetimibe/simvastatin 10/80 mg mhuwiex rakkomandat f'pazjenti Ċiniżi.
English: Trevaclyn is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Maltese: Trevaclyn jintuża flimkien ma' dieta u eżerċizzju f'pazjenti adulti b'iperkolesterolimja primarja jew dislipidimja mħallta:
English: Trevaclyn to two tablets a day.
Maltese: Reazzjonijiet avversi totali bi Trevaclyn
English: 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).
Maltese: F'individwi b'saħħithom li rċevew Trevaclyn, it-trattament ta' qabel bl-acetylsalicylic acid 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).
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Pjan ta' Farmakoviġilanza jew l-attivitajiet ta' minimizzazzjoni tar-riskju;
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trevaclyn in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji bi Trevaclyn f'pazjenti pedjatriċi minn 7-18-il sena f'iperkolesterolimja familjali eterozigota (ara sezzjoni 4.2 għal informazzjoni dwar użu pedjatriku).
English: Flushing
Maltese: Frekwenza
English: In a multicentre, double-blind, 24-week placebo-controlled study, patients taking Trevaclyn (2,000 mg/40 mg) with or without a statin, when compared to placebo, had significantly decreased LDL-C (-18.9 % vs. -0.5 %), TG (-21.7 % vs. 3.6 %), LDL-C:HDL-C (-28.9 % vs. 2.3 %), non-HDL-C (-19.0 % vs. 0.8 %), apo B (-16.4 % vs. 2.5 %), TC (-9.2 % vs. -0.6 %), Lp(a) (-17.6 % vs. 1.1 %), and TC:HDL-C (-21.2 % vs. 1.9 %) and also had significantly increased HDL-C (18.8 % vs. -1.2 %), and apo A-I (11.2 % vs. 4.3 %) as measured by percent change from baseline.
Maltese: Fi studju b'aktar minn ċentru wieħed, double blind, ikkontrollat bi plaċebo ta' 24 ġimgħa, pazjenti li ħadu Trevaclyn (2,000 mg/40 mg) bi jew mingħajr statin, meta mqabbla ma' plaċebo, kellhom tnaqqis sinifikanti fl-LDL-C (-18.9 % vs. -0.5 %), TG (-21.7 % vs. 3.6 %), LDL-C:HDL-C (-28.9 % vs.
English: What Trevaclyn 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.
Maltese: Kull pillola li terħi l-mediċina b'mod modifikat hija pillola bajda għal offwajt, forma ta' kapsula, li għandha “552” ibbuzzat fuq naħa waħda.
English: Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Maltese: Astenja, kesħa, edema fil-wiċċ, edema ġeneralizzata, uġigħ, edema periferali.
English: Rare: rhinitis
Maltese: • nefħa fix-xufftejn
English: Following a 2,000 mg dose of nicotinic acid administered orally as two modified-release tablets of nicotinic acid/laropiprant with food, nicotinic acid was absorbed with a median time to peak plasma concentration (Tmax) of 4 hours, a mean area under the plasma concentration-time curve (AUC0-last) of approximately 58.0 μM·hr and a mean peak plasma concentration (Cmax) of approximately 20.2 μM.
Maltese: Wara doża ta' 2,000 mg ta' aċidu nikotiniku mogħtija mill-ħalq bħala żewġ pilloli li jerħu l-mediċina b'mod modifikat ta' l-aċidu nikotiniku/laropiprant ma' l-ikel, l-aċidu nikotiniku b'ħin medjan sa logħla konċentrazzjoni fil-plażma (Tmax) ta' 4 sigħat, arja medja taħt il-kurva tal-konċentrazzjoni filplażma mal-ħin (AUC0-last) ta' madwar 58.0 μM·hr u konċentrazzjoni massima medja fil-plażma (Cmax) ta' madwar 20.2 μM.
English: Trevaclyn contains lactose
Maltese: Kif jidher Trevaclyn u l-kontenut tal-pakkett
English: In clinical trials, over 5,700 patients received Trevaclyn alone or with an HMG-CoA reductase inhibitor.
Maltese: Fi provi kliniċi, aktar minn 2,500 pazjent irċevew Trevaclyn waħdu jew ma' inibitur HMG-CoA reductase.
English: Like other lipid-lowering therapies, nicotinic acid medicinal products have been associated with abnormal liver function tests (see section 4.8).
Maltese: Bħal terapiji oħra li jbaxxu l-lipidi, il-prodotti mediċinali ta' l-aċidu nikotiniku ġew assoċjati ma' testijiet abnormali tal-funzjoni tal-fwied (ara sezzjoni 4.8).
English: Pack sizes of 14, 28, 56; 168 modified-release tablets and 32 x 1modified-release tablets in a perforated unit dose blister.
Maltese: Pakketti ta' 14, 28, 56, 168 pillola li terħi l-mediċina b'mod modifikat u 32 x 1 pillola li terħi l-mediċina b'mod modifikat f'folja ta' doża waħda perforata.
English: cora.greece.gragcm@merck.com
Maltese: Τηλ: +3 0210 98 97 300 cora.greece.gragcm@merck.com
English: When driving vehicles or operating machines, it should be taken into account that dizziness has been reported (see section 4.8).
Maltese: Meta wieħed isuq vetturi jew iħaddem magni, irid iżomm f'moħħu li ġew irrappurtati każi ta' sturdament (ara sezzjoni 4.8).
English: In general, the between-group treatment effects on all lipid parameters were consistent across all patient subgroups examined.
Maltese: B'mod ġenerali, l-effetti tat-trattament bejn il-gruppi fuq il-parametri kollha tal-lipidi kienu konsistenti tul issottogruppi kollha tal-pazjenti eżaminati.
English: • If you are switching from a medicine containing 2,000 mg or more of a prolonged-release nicotinic acid, your doctor can start you with two tablets of Trevaclyn a day.
Maltese: • Jekk qed taqleb minn mediċina li fiha 2,000 mg jew aktar ta' aċidu nikotiniku li jintreħa bilmod, it-tabib tiegħek jista' jibdik fuq żewġ pilloli ta' Trevaclyn kuljum.
English: Daily doses greater than 2,000 mg/40 mg have not been studied and therefore are not recommended.
Maltese: Dożi akbar minn 2,000 mg/40 mg kuljum ma ġewx studjati u għalhekk mhumiex rakkomandati.
English: • medicines used to lower cholesterol called ‘bile acid sequestrants', such as colestyramine.
Maltese: • mediċini użati biex ibaxxu l-kolesterol imsejħa ‘sekwestranti ta' l-aċidu biljari', bħallcolestyramine.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Indeboliment tat-tolleranza għall-glukows, gotta.
English: 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.
Maltese: 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.
English: Nicotinic acid inhibits release of free fatty acids (FFA) from adipose tissue, which may contribute to the reduced plasma LDL-C, TC, VLDL-C, apo B, TG, and Lp(a), as well as elevated HDL-C, and apo A-I, all of which are associated with lower cardiovascular risk.
Maltese: L-aċidu nikotiniku jimpedixxi r-rilaxx ta' aċidi grassi ħielsa (FFA - free fatty acids) mit-tessut xaħmi, li jista' jikkontribwixxi għat-tnaqqis fl-LDL-C, TC, VLDL-C, apo B, TG, u Lp(a) fil-plażma, kif ukoll għaż-żieda fl-HDL-C, u l-apo A-I, li kollha huma assoċjati ma' riskju kardjovaskulari aktar baxx.
English: • Avoid drinking alcohol or hot drinks or eating spicy foods near the time you take your dose of Trevaclyn.
Maltese: • Evita li tixrob alkoħol jew xarbiet sħan jew li tiekol ikel pikkanti qrib il-ħin meta għandek tieħu Trevaclyn.
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Maltese: Acanthosis nigricans, ġilda xotta, pigmentazzjoni eċċessiva, raxx makulari, għaraq (bil-lejl jew kiesaħ), raxx vesikulari jew vesikulobulluż.
English: The reduction in flushing symptoms (assessed by patient questionnaires) was correlated with a reduction in nicotinic acid-induced vasodilatation (assessed by measurements of skin blood flow).
Maltese: Ittnaqqis fis-sintomi ta' fawra (evalwati mill-kwestjonarji fil-pazjenti) kien korrelat ma' tnaqqis filvażodilatazzjoni indotta mill-aċidu nikotiniku (evalwata bil-kejl tal-fluss tad-demm fil-ġilda).
English: Effect on skeletal muscle
Maltese: .8 Effetti mhux mixtieqa
English: In patients continuing in the first study (24 weeks), the frequency of moderate or greater flushing in patients treated with Trevaclyn 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).
Maltese: Fil-pazjenti li komplew fl-ewwel studju (24 ġimgħa), il-frekwenza ta' fawra moderata jew akbar f'pazjenti trattati bi Trevaclyn naqset jew avviċinat dik tal-pazjenti li rċevew plaċebo (ara Figura 1), filwaqt li fil-pazjenti trattati bl-aċidu nikotiniku (formulazzjoni li terħi lmediċina bil-mod) il-frekwenza tal-fwawar baqgħet kostanti (wara Ġimgħa 6).
English: Age had no clinically meaningful effect on the pharmacokinetics of laropiprant.
Maltese: Is-sess talpersuna ma kellu ebda effett kliniku sinifikanti fuq il-farmakokinetika ta' laropiprant.
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Trevaclyn should be used with caution in patients with renal dysfunction.
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, Trevaclyn kien assoċjat ma' tnaqqis żgħir fillivelli ta' fosfru.
English: A multicenter, randomized, double-blind, placebo-controlled 32-week study to assess the effects of withdrawal of laropiprant showed that dyslipidaemic patients in whom laropiprant was withdrawn after 20 weeks on Trevaclyn experienced significantly more flushing than patients who continued taking Trevaclyn in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Maltese: Studju ta' 32 ġimgħa, b'ħafna ċentri, randomised, double-blind, ikkontrollat bil-plaċebo, biex jevalwa l-effetti ta' twaqqif ta' laropiprant wera li pazjenti dislipidemiċi fejn laropitant twaqqaf wara li kienu ilhom 20 ġimgħa fuq Trevaclyn kellhom b'mod sinifikanti aktar fwawar minn pazjenti li komplew jieħdu Trevaclyn bħala numru ta' ġranet fil-ġimgħa bi fwawar moderati jew aktar, p< 0.001, Figura 2.
English: Effects of other medicinal products on nicotinic acid Bile acid sequestrants: 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.
Maltese: Effetti ta' prodotti mediċinali oħra fuq l-aċidu nikotiniku Sekwestranti ta' l-aċidu biljari: 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' laċidu biljari.
English: • palpitation (feeling your heartbeat)
Maltese: Reazzjoni ta' sensittività eċċessiva (ara taħt)
English: Pregnancy and breast-feeding
Maltese: Disfunzjoni tal-fwied
English: Renal dysfunction
Maltese: Laropiprant irtirat
English: There is no difference in the oral bioavailability of nicotinic acid in men and women receiving Trevaclyn.
Maltese: M'hemmx differenza fil-bijodisponibilità orali ta' l-aċidu nikotiniku fl-irġiel u n-nisa li jirċievu Trevaclyn.
English: It is unknown whether there is an increased risk of myopathy in other Asian patients treated with Trevaclyn co-administered with simvastatin or ezetimibe/simvastatin.
Maltese: F'każ ta' doża eċċessiva, huwa raġonevoli li jintużaw il-miżuri sintomatiċi u supportivi tas-soltu.
English: Tecnifar - Indústria Técnica Farmacêutica, S.A. Tel: +351 210 330 700 farmalerta@tecnifar.pt
Maltese: 330 700 farmalerta@tecnifar.pt
English: • you have gout.
Maltese: • qtugħ ta' nifs
English: Diet and other non-pharmacological treatments (e.g. exercise, weight reduction) should be continued during therapy with Trevaclyn.
Maltese: Dieti u trattamenti oħra mhux farmakoloġiċi (eż. eżerċizzju, tnaqqis fil-piż) għandhom jitkomplew matul it-terapija bi Trevaclyn.
English: Marked and persistent increases of serum transaminases have been reported infrequently (see section 4.4).
Maltese: Żidiet ċari u persistenti tat-transaminases fis-serum ġew irrappurtati b'mod mhux frekwenti (ara sezzjoni 4.4).
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Maltese: Xokk anafilattiku, anġjoedema, sensittività eċċessiva tat-tip I. Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: • blistering rash
Maltese: • għaraq kiesaħ
English: In the second study (16 weeks) where acetylsalicylic acid was allowed, patients taking Trevaclyn 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 2,000 mg titration) (p< 0.001).
Maltese: Fit-tieni studju (16-il ġimgħa) fejn kien permess l-acetylsalicylic acid, il-pazjenti li ħadu Trevaclyn 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 2,000 mg fuq tnax-il ġimgħa)
English: • stomach ulcer
Maltese: Sess tal-persuna