FrancophonIA/ELRC3.0 huggingface dataset:
English: Reproduction toxicity studies showed slight treatment-related decreases in mean maternal weight gain and foetal body weight, slight increases in pup mortality, and increased incidence of supernumerary rib and incomplete ossification of the sternebra in the foetus were observed in rats at systemic exposure levels at least 513 times the human exposure based on the AUC of the recommended daily human dose.
Maltese: Studji ta' l-effett tossiku fuq is-sistema riproduttiva wrew tnaqqis żgħir relatat mattrattament fiż-żieda medja fil-piż ta' l-omm u l-piż tal-ġisem tal-fetu, żidiet żgħar fil-mortalità talfrieħ, u inċidenza akbar ta' kustilja żejda u ossifikazzjoni inkompleta ta' l-isternebra fil-fetu kienu osservati fil-firien f'livelli ta' esponiment sistemiku ta' mill-anqas 513-il darba l-esponiment uman ibbażat fuq l-AUC tad-doża ta' kuljum rakkomandata għall-bnedmin.
English: In clinical trials, over 5,700 patients received Pelzont alone or with an HMG-CoA reductase inhibitor.
Maltese: Fi provi kliniċi, aktar minn 5,700 pazjent irċevew Pelzont waħdu jew ma' inibitur HMG-CoA
English: Not known: vesicular or vesiculobullous rash
Maltese: Mhux magħruf: raxx vesikulari jew vesikulobulluż
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 July 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 3 ta' Lulju 2008
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, l aċidu nikotiniku jista' jagħti wkoll reazzjonijiet pożittivi foloz ma' soluzzjoni tas-sulfat kupriku (reaġent ta' Benedict).
English: • you have low levels of phosphorus.
Maltese: • jekk għandek livelli baxxi ta' fosfru.
English: LDL cholesterol, fatty substances called triglycerides and apo B (a part of LDL) in the blood;
Maltese: kolesterol totali, kolesterol LDL, sustanzi xaħmija msejħa trigliċeridi u apo B (parti mil-LDL)
English: - Keep this leaflet.
Maltese: Perċentwal ta' Pazjenti
English: Effect on uric acid
Maltese: Acetylsalicylic acid:
English: • blistering rash.
Maltese: • raxx bl-infafet.
English: The apparent terminal half-life (t1/2) following a 40 mg dose of laropiprant administered as two modified-release tablets of nicotinic acid/laropiprant with food was approximately 17 hours.
Maltese: Il-half-life terminali apparenti (t1/2) wara doża ta' 40 mg laropiprant mogħtija bħala żewġ pilloli ta' l-aċidu nikotiniku/laropiprant li jerħu l-mediċina b'mod modifikat ma' l-ikel kienet ta' madwar 17-il siegħa.
English: Additional adverse reactions reported with other nicotinic acid medical products Additional adverse reactions that have been reported with other nicotinic acid medicinal products (with or without a statin) in post-marketing use or in clinical trials include the following:
Maltese: Reazzjonijiet avversi addizzjonali rrappurtati bi prodotti mediċinali ta' aċidu nikotiniku oħrajn Reazzjonijiet avversi addizzjonali li ġew irrapportati bi prodotti mediċinali ta' aċidu nikotiniku oħrajn (bi jew mingħajr statin) waqt l-użu ta' wara t-tqegħid fis-suq jew fi provi kliniċi jinkludu li ġejjin:
English: In a multicentre, double-blind, 24-week placebo-controlled study, patients taking Pelzont (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 Pelzont (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: Laropiprant is metabolised primarily via acyl glucuronidation, with a smaller component of oxidative metabolism, followed by excretion of the glucuronide into faeces (via bile) and urine.
Maltese: Laropiprant huwa metabolizzat prinċipalment permezz ta' acyl glucuronidation, b'komponent iżgħar ta' metaboliżmu ossidattiv, segwit mill-eskrezzjoni tal-glucuronide fl-ippurgar (permezz tal-bile) u lawrina.
English: Pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-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: Common: abdominal pain; diarrhoea; dyspepsia; nausea; vomiting Rare: mouth oedema; eructation; peptic ulcer
Maltese: Komuni: uġigħ fl-addome; dijarea; dispepsja; tqalligħ; rimettar Rari: edima fil-ħalq; tifwiq; ulċera fl-istonku Distturbi fil-fwied u fil-marrara Mhux magħruf: suffejra Disturbi fil-ġilda u fit-tessuti ta'
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 Pelzont 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 Pelzont bi jew mingħajr statin.
English: • Uncontrolled hypothyroidism
Maltese: • Ipotirojdiżmu mhux ikkontrollat
English: Prolongation of collagen-induced platelet aggregation was observed in subjects taking multiple doses of 300 mg or greater (see section 5.1).
Maltese: Kienet osservata aggregazzjoni tal-plejtlits indotta mill-collagen imtawla f'individwi li ħadu bosta dożi ta' 300 mg jew aktar (ara sezzjoni 5.1).
English: Nicotinic acid: see sections 4.3 and 4.4.
Maltese: (ara sezzjonijiet 4.3 u 4.4.)
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' mill anqas 153 u 438 darba l-esponiment uman ibbażat fuq l-AUC tad-doża ta' kuljum rakkomandata għall-bnedmin.
English: Clopidogrel: In a clinical study, there was no meaningful effect of laropiprant on the inhibition of ADP-induced platelet aggregation by clopidogrel, but there was a modest increase in the inhibition of collagen-induced platelet aggregation by clopidogrel.
Maltese: Fi studju kliniku, ma kien hemm ebda effett sinifikanti ta' laropiprant fuq l-inibizzjoni ta' aggregazzjoni tal-plejtlits indotti mill-ADP bi clopidogrel, iżda kien hemm żieda modesta fl inibizzjoni ta' aggregazzjoni tal-plejtlits indotta mill-collagen bi clopidogrel.
English: Caution should be exercised in patients with pre-disposing factors for rhabdomyolysis.
Maltese: Għandha tintuża kawtela f'pazjenti b'fatturi ta' pre-dispożizzjoni għal rhabdomyolysis.
English: • low blood pressure
Maltese: Health) Limited
English: No nicotinic acid-related adverse effects on fertility were observed in male and female rats up to exposure levels approximately 391 times the human AUC of nicotinic acid based on the AUC of the recommended daily human dose.
Maltese: Ebda effett avvers relatat ma' aċidu nikotiniku dwar il-fertilità ma ġie osservat f'firien irġiel u nisa sa livelli ta' espożizzjoni ta' madwar 391 darba l-AUC uman ta' aċidu nikotiniku ibbażat fuq l-AUC taddoża umana ta' kuljum rakkomandata.
English: Laropiprant is not a substrate of human P-gp, and therefore other inhibitors of CYP3A4 and/or P-gp are also not expected to have a clinically meaningful impact on the pharmacokinetics of laropiprant.
Maltese: Laropiprant mhux substrat tal-P-gp umana, u għalhekk inibituri oħra ta' CYP3A4 u/jew P-gp ukoll mhumiex mistennija li jkollhom impatt kliniku sinifikanti fuq il-farmakokinetika ta' laropiprant.
English: As with other nicotinic acid medicinal products, Pelzont (2,000 mg/40 mg) was associated with small reductions in platelet count (see section 4.8).
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, Pelzont (2,000 mg/40 mg) ġie assoċjat ma' tnaqqis żgħir fl-għadd tal-plejtlits (ara sezzjoni 4.8).
English: As with other nicotinic acid medicinal products, Pelzont (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, Pelzont (2,000 mg/40 mg) ġie assoċjat ma' żidiet żgħar fil-livelli ta' l-aċidu uriku (ara sezzjoni 4.8).
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 fil plażma mal-ħin (AUC0-last) ta' madwar 58.0 μM·hr u konċentrazzjoni massima medja fil-plażma (Cmax) ta' madwar 20.2 μM.
English: Capsule-shaped, white to off-white tablet, with “552” debossed on one side.
Maltese: Pillola bajda għal offwajt, għamla ta' kapsula, li għandha “552” ibbuzzat fuq naħa waħda.
English: Effects of laropiprant on other medicinal products
Maltese: Effetti ta' laropiprant fuq prodotti mediċinali oħra
English: • Previous history of muscular toxicity with a statin or fibrate
Maltese: • Storja preċedent ta' tossiċità muskolari bi statin jew fibrat • Abbuż mill-alkoħol.
English: What Pelzont 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: Nicotinic acid causes a relative shift in the distribution of LDL subclasses from small, dense (most atherogenic) LDL particles to larger LDL particles.
Maltese: L-aċidu nikotiniku jikkawża ċaqliq relattiv fid-distribuzzjoni tas-sottokategoriji ta' LDL minn partikoli żgħar u densi (l-aktar ateroġeniċi) għal partikoli LDL akbar.
English: Pelzont is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Maltese: Pelzont jintuża flimkien ma' dieta u eżerċizzju f'pazjenti adulti b'iperkolesterolimja primarja jew dislipidimja mħallta:
English: In the second pathway, glycine is conjugated with nicotinic acid to form nicotinuric acid (NUA).
Maltese: Fit-tieni passaġġ, il-gliċina tingħaqad ma' l-aċidu nikotiniku biex tifforma l-aċidu nikotinuriku (NUA).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Pelzont in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Maltese: Pelzont f'kull sett tal-popolazzjoni pedjatrika b'iperkolesterolimja familjali omozigota (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: • generalised swelling
Maltese: • ġilda xotta
English: Aluminium/Aluminium blister with push-through lidding containing 7 modified-release tablets.
Maltese: Folja ta' l-Aluminju/Aluminju b'għeluq push-through li fiha 7 pilloli li jerħu l-mediċina b'mod modifikat.
English: In healthy subjects receiving Pelzont, pretreatment with acetylsalicylic acid 325 mg had no additional beneficial effects in reducing nicotinic acid-induced flushing symptoms compared to Pelzont alone (see section 4.8).
Maltese: F'individwi b'saħħithom li rċevew Pelzont, 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' Pelzont waħdu (ara sezzjoni 4.8).
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', bħall colestyramine.
English: Like LDL, cholesterol-enriched triglyceride-rich lipoproteins, including VLDL, intermediate-density lipoproteins (IDL), and remnants, can also promote atherosclerosis.
Maltese: Bħal-LDL, il-lipoproteini rikki fit-trigliċeridi miżjuda bil-kolesterol, fosthom il-VLDL, il-lipoproteini ta' densità intermedja (IDL), u l-fdalijiet jistgħu wkoll jippromwovu l-aterosklerosi.
English: The most commonly reported adverse reactions from the subjects who received this higher dose were consistent with a high dose of nicotinic acid and included: flushing, headache, pruritus, nausea, dizziness, vomiting, diarrhoea, epigastric and abdominal pain/discomfort, and back pain.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni mill-persuni li rċevew din id-doża ogħla kienu konsistenti ma' doża għolja ta' aċidu nikotiniku u kienu jinkludu: fawra, uġigħ ta' ras, ħakk, dardir, sturdament, rimettar, dijarea, uġigħ/skonfort epigastriku u addominali, u wġigħ fid-dahar.
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 Pelzont 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' Pelzont kuljum.
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 is sottogruppi kollha tal-pazjenti eżaminati.
English: Similar treatment-related changes were observed in rabbit foetuses but in the presence of maternal toxicity at exposure levels approximately 629 times the human AUC of nicotinic acid at the recommended daily human dose.
Maltese: Tibdiliet relatati mal-kura simili ġew osservati f'feti tal-fniek iżda fil-preżenza ta' tossiċità maternali f'livelli ta' espożizzjoni ta' madwar 629 drabi l-AUC uman ta' aċidu nikotiniku fid-doża umana ta' kuljum rakkomandata.
English: The mean absolute bioavailability of laropiprant is approximately 71 % following a 40 mg dose when administered as two modified-release tablets of nicotinic acid/laropiprant after an overnight fast.
Maltese: Il-bijodisponibilità assoluta medja ta' laropiprant hija ta' madwar 71 % wara doża ta' 40 mg meta mogħtija bħala żewġ pilloli ta' l-aċidu nikotiniku/laropiprant li jerħu l-mediċina b'mod modifikat wara sawma ta' lejl.
English: Tel: + 386 1 5204201 msd_slovenia@merck.com
Maltese: Tel.: +421 2 58282010 msd_sk@merck.com
English: Patients switching from less than 2,000 mg of prolonged-release nicotinic acid should initiate therapy at the starting dose of 1,000 mg/20 mg and advance to the 2,000 mg/40 mg maintenance dose after four weeks.
Maltese: Il-pazjenti li jaqilbu minn anqas minn 2,000 mg ta' aċidu nikotiniku li jerħi l-mediċina bil-mod għandhom jibdew it-terapija bid-doża tal-bidu ta' 1,000 mg/20 mg u javvanzaw għal doża ta' manteniment ta' 2,000 mg/40 mg wara erba' ġimgħat.
English: • flushing (which usually includes redness of the skin, feeling warm, itching, or tingling, particularly in the head, neck, chest and upper back).
Maltese: • fawra (li ġeneralment tinkludi ħmura tal-ġilda, sensazzjoni ta' sħana, ħakk, jew tingiż,
English: Rare: rhinitis
Maltese: Komuni: uġigħ ta' ras; parestesija
English: After four weeks, it is recommended that patients be advanced to the maintenance dose of 2,000 mg/40 mg taken as two modified-release tablets (1,000 mg/20 mg each) once daily.
Maltese: Wara erba' ġimgħat, huwa rakkomandat li l-pazjenti jitmexxew għaddoża ta' manteniment ta' 2,000 mg/40 mg meħuda bħala żewġ pilloli li jerħu l-mediċini b'mod modifikat (1,000 mg/20 mg kull waħda) darba kuljum.
English: The medicine comes as a modified-release tablet.
Maltese: Pillola li terħi l-mediċina b'mod modifikat.
English: UAB Merck Sharp & Dohme Tel. +370 5 278 02 47 msd_lietuva@merck.com
Maltese: +370 5 278 02 47 msd_lietuva@merck.com
English: 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.
Maltese: Pazjenti b'dislipidimja mħallta kkombinata għandhom livelli għoljin ta' kolesterol LDL ‘ħażin' u trigliċeridi (tip ta' xaħam), u livelli baxxi ta' kolesterol HDL ‘tajjeb' fid-demm.
English: • Active peptic ulcer disease.
Maltese: • Mard attiv ta' l-ulċera peptika.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/460/012
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/460/012
English: Common: erythema; pruritus; rash; urticaria Uncommon: dry skin; macular rash Rare: acanthosis nigricans; hyperpigmentation; sweating (night or cold sweat)
Maltese: Komuni: eritema; ħakk; raxx; urtikarja Mhux komuni: ġilda xotta; raxx makulari
English: • abdominal pain
Maltese: • imnieħer inixxi
English: EU/1/08/460/013
Maltese: EU/1/08/460/009 EU/1/08/460/010
English: Adjustment of diet and/or hypoglycaemic therapy may be necessary.
Maltese: Jista' jkun hemm bżonn ta' aġġustament fid-dieta u/jew fit-terapija ipoglikemika.
English: Merck, Sharp & Dohme Ltd. Shotton Lane
Maltese: Merck, Sharp & Dohme Ltd.
English: However, the plasma concentration of a metabolite of midazolam, 1'-hydroxymidazolam, was increased approximately 2-fold with multiple doses of laropiprant.
Maltese: Madankollu, il-konċentrazzjonijiet fil-plażma ta' metabolit ta' midazolam, 1'-hydroxymidazolam, żdiedu b'madwar darbtejn b'diversi dożi ta' laropiprant.
English: In these studies, the percentage of patients taking Pelzont, 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 Pelzont, 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: Pharmacotherapeutic group: Lipid modifying agents, nicotinic acid and derivatives, ATC code: C10AD52.
Maltese: Madankollu, l-aċidu nikotiniku, li huwa component ta' Pelzont, jgħaddi għal ġol-ħalib tas-sider.
English: In a multicentre, double-blind, 12-week factorial study, Pelzont 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Pelzont 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: għal 4 ġimgħat, naqqas b'mod sinifikanti l-LDL-C (-44.2%, -37.4%, -8.2% rispettivament), it-TG (25.8%, -15.
English: Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 msd_sk@merck.com
Maltese: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 5204201 msd_slovenia@merck.com
English: However, cases of severe hepatic toxicity, including fulminant hepatic necrosis, have occurred in patients who have switched from immediate-release nicotinic acid to long-acting nicotinic acid at equivalent doses.
Maltese: Effetti farmakodinamiċi Laropiprant ġie muri li huwa effettiv biex inaqqas is-sintomi ta' fawra indotti mill-aċidu nikotiniku.
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: 65 darba anqas affinità għad-DP1 meta mqabbel ma' laropiprant; għaldaqstant, mhuwiex mistenni li jikkontribwixxi għall-attività DP1 globali ta' laropiprant.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattożju, iddefiċjenza ta' Lapp lactase jew assorbiment ħażin tal-glukożju-galattożju m'għandhomx jieħdu din ilmediċina.
English: Mice in this study received approximately 9 to 13 times a human nicotinic acid dose of 2,000 mg/day as determined on a mg/m2 basis.
Maltese: Ilġrieden f'dan l-istudju rċevew madwar 9 sa 13-il darba d-doża umana ta' 2,000 mg/kuljum ta' aċidu nikotiniku kif stabbilita fuq bażi ta' mg/m2.
English: • Renal impairment
Maltese: Laropiprant irtirat
English: • muscle weakness
Maltese: • Indeboliment tal-kliewi
English: There is no change in the oral bioavailability of nicotinic acid with age.
Maltese: M'hemm ebda tibdil fil-bijodisponibilità orali ta' l-aċidu nikotiniku ma' l-età.
English: The glycine conjugation pathway is not saturated across the clinically relevant dose range, based on the dose-proportional increase in the plasma concentrations of NUA from 1,000 mg to 2,000 mg.
Maltese: Il-passaġġ fejn tingħaqad il-gliċina ma jiġix saturat tul il-medda ta' dożi klinikament rilevanti, fuq il-bażi taż-żieda proporzjonali mad-doża fil-konċentrazzjoni ta' NUA fil-plażma minn 1,000 mg għal 2,000 mg.
English: Studies in animals have shown foetal developmental toxicity at high doses of nicotinic acid (see section 5.3).
Maltese: Studji f'annimali wrew tossiċità fl-iżvilupp tal-fetu f'dożi għoljin ta' aċidu nikotiniku (ara sezzjoni 5.3).
English: Midazolam: Multiple doses of laropiprant 40 mg did not affect the pharmacokinetics of midazolam, a sensitive CYP3A4 substrate.
Maltese: Dożi multipli ta' laropiprant 40 mg ma affettwawx il-farmakokinetika ta' midazolam,
English: • vitamins or supplements that contain nicotinic acid.
Maltese: • vitamini jew supplimenti li fihom l-aċidu nikotiniku.
English: Increases in serum alanine aminotransferase (ALT) levels were observed in all dog studies, at systemic exposure levels at least 14 times the human exposure based on the AUC of the recommended daily human dose.
Maltese: Fl-istudji kollha fuq il-kelb kienu osservati żidiet fil-livelli ta' alanine aminotransferase fis-serum (ALT), f'livelli ta' esponiment sistemiku ta' mill-anqas 14-il darba l-esponiment uman ibbażat fuq id doża ta' kuljum rakkomandata għall-bniedem.
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 Pelzont 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 Pelzont jingħata > siegħa qabel jew > 4 sigħat wara l-għoti ta' sekwestrant ta' l-aċidu biljari.
English: Because nicotinic acid and its metabolites are excreted through the kidneys, Pelzont should be used with caution in patients with renal dysfunction.
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, Pelzont kien assoċjat ma' tnaqqis żgħir fillivelli ta' fosfru.