FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/08/460/001 14 modified-release tablets EU/1/08/460/002 28 modified-release tablets EU/1/08/460/003 56 modified-release tablets EU/1/08/460/004 84 modified-release tablets EU/1/08/460/005 98 modified-release tablets EU/1/08/460/006 168 modified-release tablets EU/1/08/460/007 196 modified-release tablets EU/1/08/460/008 49 x 1 modified-release tablets EU/1/08/460/012 196 (2 packs of 98) modified-release tablets
Maltese: EU/1/08/460/001 14 -il pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/002 28 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/003 56 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/004 84 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/005 98 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/006 168 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/007 196 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/008 49 x1 pillola li terħi l-mediċina b'mod modifikat
English: • Arterial bleeding.
Maltese: • Fsada arterjali.
English: • you have thyroid problems.
Maltese: • jekk għandek problemi bit-tirojde.
English: The pharmacokinetic interaction of Pelzont with statins has been studied only with simvastatin (see section 4.4).
Maltese: L-interazzjoni farmakokinetika ta' Pelzont ma' l-istatins ġiet studjata biss b'simvastatin (ara sezzjoni 4.4).
English: 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 a perforated unit dose blister.
Maltese: 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 terħi l-mediċina b'mod modifikat u 49 x 1 pillola li terħi l-mediċina b'mod modifikat f'folja unit dose perforata.
English: During controlled clinical trials in healthy subjects, single doses of up to 900 mg laropiprant and multiple doses up to 450 mg once daily for 10 days were generally well tolerated.
Maltese: Waqt provi kliniċi kkontrollati f'individwi b'saħħithom, dożi singoli sa 900 mg laropiprant u dożi multipli sa 450 mg darba kuljum għal 10 ijiem ġeneralment kienu ttollerati sewwa.
English: Uncommon: insomnia Rare: anxiety
Maltese: Mhux komuni: insomnja Rari: ansjetà
English: This is characterised by multiple symptoms that may include: angio-oedema, pruritus, erythema, paraesthesia, loss of consciousness, vomiting, urticaria, flushing, dyspnoea, nausea, incontinence of urine and stool, cold sweats, shivering, chills, increased blood pressure, lip swelling, burning sensation, drug eruption, arthralgia, leg swelling, and tachycardia.
Maltese: Din hija kkaratterizzata minn bosta sintomi li jistgħu jinkludu: anġjoedima, ħakk, eritema, parasteżija, telfien mis-sensi, rimettar, urtikarja, fawra, dispneja, dardir, inkontinenza ta' l-awrina u l-ippurgar, għaraq kiesaħ, rogħda, kesħa, pressjoni tad-demm aktar għolja, nefħa fix-xufftejn, sensazzjoni ta' ħruq,
English: 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).
Maltese: (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
English: An apparent hypersensitivity reaction has been reported (< 1 %).
Maltese: Kienet irrappurtata reazzjoni li apparentement kienet sensittività eċċessiva (< 1 %).
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Pelzont with or without a statin (see section 4.4).
Maltese: Żidiet kliniċi importanti ta' CK (≥ 10 X ULN) dehru f'0.3 % tal-pazjenti trattati bi Pelzont bi jew mingħajr statin (ara sezzjoni 4.4).
English: • you have kidney problems.
Maltese: • jekk għandek problemi bil-kliewi.
English: Eye disorders: Cystoid macular oedema, toxic amblyopia.
Maltese: Edima makulari taċ-ċistojde, amblijopja tossika.
English: Race had no clinically meaningful effect on the pharmacokinetics of laropiprant based on a composite analysis of pharmacokinetic data including subjects of White, Hispanic, Black, Asian, and Native American racial groups.
Maltese: Ir-razza ma kellha ebda effett kliniku sinifikanti fuq il-farmakokinetika ta' laropiprant skond analiżi komposta ta' informazzjoni farmakokinetika li kienet tinkludi individwi ta' gruppi razzjali Bojod, Ispaniċi, Suwed, Asjatiċi, u Amerikani Nattivi.
English: Nicotinic acid is less than 20 % bound to serum proteins.
Maltese: L-aċidu nikotiniku L-aċidu nikotiniku jeħel anqas minn 20 % mal-proteini tas-serum.
English: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004 EU/1/08/460/005 EU/1/08/460/006 EU/1/08/460/007 EU/1/08/460/008 EU/1/08/460/009 EU/1/08/460/010
Maltese: EU/1/08/460/001 EU/1/08/460/002 EU/1/08/460/003 EU/1/08/460/004
English: Rare cases of myopathy/rhabdomyolysis have been associated with concomitant administration of lipid-altering doses (≥ 1,000 mg/day) of nicotinic acid and HMG-CoA reductase inhibitors (statins) (see section 4.8).
Maltese: Każijiet rari ta' mijopatija/rhabdomyolysis ġew assoċjati ma' l-għoti fl-istess ħin ta' dożi li jibdlu l livell tal-lipidi ta' aċidu nikotiniku (≥1,000 mg/kuljum) u inibituri HMG-CoA reductase (statins) (ara sezzjoni 4.8).
English: Effect on lipids
Maltese: Effetti fuq il-lipidi
English: CYP3A4 Inhibitor: Clarithromycin (a potent inhibitor of CYP3A4 and P-gp) did not have a clinically meaningful effect on the pharmacokinetics of laropiprant.
Maltese: Clarithromycin (inibitur b'saħħtu ta' CYP3A4 u P-gp) ma kellux effett kliniku sinifikanti fuq il-farmakokinetika ta' laropiprant.
English: Further analysis showed Pelzont (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 ).
Maltese: Analiżi addizzjonali wriet li Pelzont 2,000 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).
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1 modified-release tablets
Maltese: 14 -il pillola li terħi l-mediċina b'mod modifikat 28 pillola li terħi l-mediċina b'mod modifikat 56 pillola li terħi l-mediċina b'mod modifikat 168 pillola li terħi l-mediċina b'mod modifikat 32 x 1 pillola li terħi l-mediċina b'mod modifikat
English: Multi-pack containing 196 (2 packs of 98) modified-release tablets 49 x 1 modified-release tablets
Maltese: Pakkett multiplu li fih 196 (2 pakketti ta' 98) pillola li terħi l-mediċina b'mod modifikat
English: Pelzont was consistently efficacious across all prespecified patient subpopulations defined by race, gender, baseline LDL-C, HDL-C and TG levels, age and diabetes status.
Maltese: Pelzont 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 taddijabete.
English: Pelzont 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: Pelzont 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: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Pelzont), flushing was reported in 12.3 % of patients taking Pelzont.
Maltese: (N=4,747, n=2,548 li ħadu Pelzont), il-fawra kienet irrappurtata fi 12.3 % tal-pazjenti li ħadu Pelzont.
English: Age has no clinically meaningful effect on pharmacokinetics of nicotinic acid (prolonged-release formulation) based on a composite analysis of subjects ages 18-65 years.
Maltese: L-età tal-persuna ma għandha ebda effett kliniku sinifikanti fuq il-farmakokinetika ta' l-aċidu nikotiniku (formulazzjoni li terħi l-mediċina bil-mod) skond analiżi komposta ta' individwi ta' bejn 18 u 65 sena.
English: In addition, an updated RMP should be submitted:
Maltese: Inibituri HMG-CoA reductase:
English: HDL is hypothesised to participate in the transport of cholesterol from tissues back to the liver, to suppress vascular inflammation associated with atherosclerosis, and to have anti-oxidative and anti-thrombotic effects.
Maltese: Huwa ipotizzat li l-HDL jipparteċipaw fit-trasport tal-kolesterol mit-tessuti lura lejn il-fwied, li jrażżnu l-infjammazzjoni vaskulari assoċjata ma' l-aterosklerosi, u li għandhom effetti anti-ossidattivi u anti-trombotiċi.
English: • midazolam, a medicine to make you sleepy before some medical procedures.
Maltese: • midazolam, mediċina biex traqqdek qabel xi proċeduri mediċi.
English: In rats, foetotoxic effects (significantly decreased foetal body weights associated with a decrease in the number of ossified sacrocaudal vertebrae and an increased incidence of foetuses with sites of incomplete ossification) were noted in the absence of any signs of maternal toxicity at exposure levels approximately 959 times the human AUC of nicotinic acid at the recommended daily human dose.
Maltese: Fil-firien, l-effetti fetotossiċi (piżijiet tal-ġisem tal-fetu ferm inqas assoċjati ma' tnaqqis fin-numru ta' vertebrati sakrokawdali ossifikati u inċidenza miżjuda ta' feti b'siti ta' ossifikazzjoni mhux sħiħa) ġew innotati fin-nuqqas ta' kwalunkwe sinjal ta' tossiċità maternali f'livelli ta' espożizzjoni ta' madwar 959 drabi l-AUC uman ta' aċidu nikotiniku fid-doża umana ta' kuljum rakkomandata.
English: EU/1/08/460/009 14 modified-release tablets EU/1/08/460/010 28 modified-release tablets EU/1/08/460/011 56 modified-release tablets EU/1/08/460/013 168 modified-release tablets EU/1/08/460/014 32 x 1 modified-release tablets
Maltese: EU/1/08/460/009 14 -il pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/010 28 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/011 56 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/013 168 pillola li terħi l-mediċina b'mod modifikat EU/1/08/460/014 32 x 1 pillola li terħi l-mediċina b'mod modifikat
English: In interaction studies, laropiprant did not have clinically significant effects on the pharmacokinetics of the following medicinal products: simvastatin, warfarin, oral contraceptives, rosiglitazone and digoxin.
Maltese: Fi studji dwar l-effett ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku tal-prodott, laropiprant ma kellu ebda effetti kliniċi sinifikanti fuq il-farmakokinetika ta' dawn il-prodotti mediċinali li ġejjin: simvastatin, warfarin, kontraċettivi orali, rosiglitazone u digoxin.
English: PHARMACEUTICAL FORM AND CONTENTS 98 modified-release tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 98 pillola li terħi l-mediċina b'mod modifikat.
English: Pelzont contains nicotinic acid, which at therapeutic doses is a lipid-modifying agent, and laropiprant, a potent, selective antagonist of the prostaglandin D2 (PGD2) receptor subtype 1 (DP1).
Maltese: Pelzont 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).
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Pelzont.
Maltese: Supplimenti li fihom l-aċidu nikotiniku: Vitamini jew supplimenti nutrizzjonali oħra li fihom (≥ 50 mg/ġurnata) ta' aċidu nikotiniku (jew nicotinamide) ma ġewx studjati ma' Pelzont.
English: Nicotinic acid showed no mutagenic effects in the in vitro assays.
Maltese: L-aċidu nikotiniku ma wera ebda effetti mutaġeniċi fl assaġġi in vitro.
English: Pelzont 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Maltese: Pelzont 1,000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat Aċidu nikotiniku/laropiprant
English: Rare: elevations in total bilirubin, amylase; reductions in phosphorus and platelet counts (see below)
Maltese: Rari: żieda fil-livelli tal-bilirubin totali u tal-amylase; tnaqqis filfosfru u fl-għadd tal-plejtlits (ara taħt)
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'
English: Uncommon: palpitations Rare: atrial fibrillation and other cardiac arrhythmias; tachycardia
Maltese: Rari: fibrillazzjoni tal-atriju u arritmiji oħrajn tal-qalb; takikardija
English: Uncommon: hypersensitivity reaction (see below) Rare: angio-oedema; type I hypersensitivity Not known: anaphylactic shock
Maltese: Mhux komuni: reazzjoni ta' sensittività eċċessiva (ara taħt) Rari: anġjoedima; sensittività eċċessiva tat-tip I
English: • laropiprant, which reduces symptoms of flushing, a common side effect of nicotinic acid.
Maltese: • laropiprant, li jnaqqas is-sintomi ta' fawra, effett sekondarju komuni ta' l-aċidu nikotiniku.
English: Laropiprant and its acyl glucuronide conjugate are the major circulating components in human plasma.
Maltese: Laropiprant u l-acyl glucuronide conjugate tiegħu huma l-komponenti prinċipali li jiċċirkolaw fil-plażma umana.
English: Nicotinic acid-induced flushing is mediated primarily by release of prostaglandin D2 (PGD2) in the skin.
Maltese: Il-fawra indotta mill-aċidu nikotiniku hija medjata primarjament mir-rilaxx tal-prostaglandin D2 (PGD2) fil-ġilda.
English: How to take Pelzont
Maltese: Tiħux Pelzont
English: Laropiprant also has affinity for the thromboxane A2 receptor (TP) (although it is substantially less potent at TP as compared to DP1).
Maltese: Laropiprant għandu affinità wkoll għar-riċettur tat-thromboxane A2 (TP) (għalkemm huwa sostanzjalment anqas b'saħħtu fit-TP meta mqabbel mad-DP1).
English: In humans, nicotinamide is further predominantly metabolised to N-methylnicotinamide (MNA) and to N-methyl-2-pyridone-5-carboxamide (2PY).
Maltese: Fil-bnedmin, nicotinamide jiġi metabolizzat aktar prinċipalment f'N-methylnicotinamide (MNA) u f'N-methyl-2-pyridone-5
English: Pelzont contains lactose.
Maltese: Pelzont fih tip ta' zokkor imsejjaħ lactose.
English: Effects of nicotinic acid on other medicinal products Antihypertensive therapy: Nicotinic acid may potentiate the effects of ganglionic blocking agents and vasoactive medicinal products such as nitrates, calcium channel blockers, and adrenergic receptor blocking agents, resulting in postural hypotension.
Maltese: L-aċidu nikotiniku jista' jqawwi l-effetti ta' sustanzi ta' imblokk ganglijoniċi u prodotti mediċinali vasoattivi bħal nitrati, imblokkaturi tal-kanali tal-kalċju, u sustanzi li jimblokkaw ir-riċetturi adrenerġiċi, li jwassal għal pressjoni baxxa posturali.
English: Other medicines and Pelzont
Maltese: Mediċini oħra u Pelzont
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: laropiprant, b'akkumulazzjoni minima fl-AUC (madwar 1.3 darbiet) u fil-Cmax (madwar 1.1 darbiet).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Pelzont in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Maltese: Pelzont f'pazjenti pedjatriċi minn 7-18-il sena f'iperkolesterolimja familjali eterozigota (ara sezzjoni 4.2 għal informazzjoni dwar użu pedjatriku).
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)
English: As with other nicotinic acid medicinal products, patients with a history of jaundice, hepato-biliary disorder or peptic ulcer should be observed closely (see sections 4.2 and 4.3).
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, pazjenti bi storja ta' suffejra, disturbi epatobiljari jew ulċera peptika għandhom jiġu osservati mill-qrib (ara sezzjonijiet 4.2 u 4.3).
English: • a sudden serious allergic reaction (anaphylactic shock).
Maltese: • reazzjoni allerġika serja f'daqqa (xokk anafilattiku).
English: Other abnormal laboratory values reported were elevations in LDH, fasting glucose, uric acid, total bilirubin, and amylase, and reductions in phosphorus and platelet counts (see section 4.4).
Maltese: fl-aċidu uriku, fil-bilirubina totali, u fl-amylase, u tnaqqis fil-fosfru u fl-għadd tal-plejtlits (ara sezzjoni 4.4).
English: • The active substances are nicotinic acid and laropiprant.
Maltese: • Is-sustanzi attivi huma l-aċidu nikotiniku u laropiprant.
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 bil metaboliżmu, 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: 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 l mediċina bil-mod) fuq il-bażi ta' informazzjoni farmakokinetika li kienet tinkludi individwi ta' gruppi razzjali Ispaniċi, Bojod, Suwed, u Amerikani Nattivi.
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: Laropiprant is highly bound (> 99 %) to plasma proteins, and its binding is independent of concentration.
Maltese: Laropiprant jeħel ħafna (>99 %) mal-proteini talplażma, u l-irbit tiegħu huwa indipendenti mill-konċentrazzjoni.
English: HMG-CoA reductase inhibitors: When simvastatin is combined with nicotinic acid, a modest increase in AUC and Cmax of simvastatin acid (the active form of simvastatin) was observed, which may be devoid of clinical relevance.
Maltese: Meta simvastatin jitħallat ma' l-aċidu nikotiniku, kienet osservata żieda modesta fl-AUC u l-Cmax ta' l-aċidu ta' simvastatin (il-forma attiva ta' simvastatin), li jista' ma jkollhiex rilevanza klinika.
English: Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant.
Maltese: Kull pillola fiha 1,000 mg aċidu nikotiniku u 20 mg laropiprant.
English: Nicotinic acid: There is no pharmacokinetic data in the elderly (≥ 65 years).
Maltese: M'hemmx dejta farmakokinetika dwar l-anzjani (≥ 65 sena).
English: • Swallow each tablet whole.
Maltese: • Ibla' kull pillola sħiħa.
English: Uncommon: chills; pain; peripheral oedema Rare: asthaenia; face oedema; generalised oedema
Maltese: Mhux komuni: tkexkix ta' bard; uġigħ; edima periferali
English: Caution should be used when Pelzont is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Maltese: Għandha tintuża attenzjoni meta Pelzont jingħata fl-istess ħin ma' prodotti mediċinali li jiġu metabolizzati primarjament minn UGT2B4 jew UGT2B7, per eżempju zidovudine.
English: Therefore, laropiprant is not an inducer or inhibitor of CYP3A4.
Maltese: substrat sensittiv ta' CYP3A4.
English: Haematologic effects
Maltese: Effetti ematoloġiċi
English: Aluminium/Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Maltese: Folja ta' l-aluminju/aluminju b'għata push-through f'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: The Coronary Drug Project, a five year study completed in 1975, showed that nicotinic acid had a statistically significant benefit in decreasing nonfatal, recurrent myocardial infarctions (MI) in men 30 to 64 years old with a history of MI.
Maltese: Il-Proġett tal-Mediċina Koronarja, studju ta' ħames snin li tlesta fl-1975, wera li l-aċidu nikotiniku kellu benefiċċju statistikament sinifikanti fit-tnaqqis ta' l-infarti mijokardijaċi (MI) rikorrenti mhux fatali f'irġiel ta' bejn 30 u 64 sena bi storja ta' MI. Għalkemm il-mortalità totali kienet simili fiż-żewġ gruppi wara ħames snin,
English: Figure 2 Percentage of Patients with Moderate or Greater Flushing Symptoms Across Weeks 1-32
Maltese: Perċentwal ta' pazjenti b'Sintomi Moderati jew Aktar ta' Fwawar Matul il-Ġimgħat 1-32
English: • you have unexplained muscle pain, muscle tenderness, or muscle weakness.
Maltese: • jekk għandek uġigħ fil-muskoli, sensittività fil-muskoli, jew dgħjufija mhux spjegata fil muskoli.
English: They may raise your risk of having heart problems.
Maltese: Jistgħu jżidu r-riskju tiegħek li tiżviluppa problemi tal-qalb.
English: Nicotinic acid medicinal products have been associated with increases of fasting blood glucose levels (see section 4.8).
Maltese: Il-prodotti mediċinali ta' l-aċidu nikotiniku ġew assoċjati ma' żidiet fil-livelli ta' glukożju fid-demm (ara sezzjoni 4.8).
English: Your total cholesterol is made up mainly of ‘bad' (LDL) and ‘good' (HDL) cholesterol.
Maltese: Il-kolesterol totali tiegħek huwa magħmul prinċipalment minn kolesterol ‘ħażin' (LDL) u ‘tajjeb' (HDL).
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 Pelzont (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'