FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH also provided responses to a request from the CHMP to discuss the merits and feasibility of any risk minimisation measures which could be introduced in order to improve the benefit/risk of the Quixil spray application.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda wkoll tweġibiet għal talba mis-CHMP biex jiddiskuti l-merti u l-fattibbiltà ta' kwalunkwe miżura ta' minimizzazzjoni tar-riskju li tista' tiġi introdotta sabiex jitjieb il-benefiċċju/riskju tal-applikazzjoni ta' Quixil bħala sprej.
English: Regarding the clinical use of the product, the CHMP was of the opinion, based on the last case of air embolism that was reported during an endoscopy procedure, where the surgeon has limited visibility of the tissue surface that the use of Quixil by spray application should only be considered if it is possible to accurately judge the spraying distance.
Maltese: Dwar l-użu kliniku tal-prodott, is-CHMP kien tal-opinjoni, abbażi tal-aħħar każ ta' emboliżmu tal-arja li kien irrapportat matul proċedura ta' endoskopija, fejn il-kirurgu għandu viżibilità limitata tal-wiċċ tat-tessut li l-użu ta' Quixil bl-applikazzjoni bħala sprej għandu jiġi kkunsidrat biss jekk ikun possibbli li d-distanza tal-isprejjar tiġi ġġudikata b'mod preċiż.
English: Based on the above, the European Commission initiated a procedure under Article 20 of Regulation (EC) No 726/2004 on 21 May 2012, requesting the CHMP to assess the above concerns and their impact on the benefit-risk for Evicel, to give its opinion on measures necessary to ensure the safe and effective use of Evicel and on whether the marketing authorisation for this product should be maintained, varied, suspended or withdrawn.
Maltese: Abbażi ta' dan ta' hawn fuq, il-Kummissjoni Ewropea nidiet proċedura skont l-Artikolu 20 tarRegolament (KE) Nru 726/2004 fil-21 ta' Mejju 2012, u fiha talbet lis-CHMP jivvaluta t-tħassib imsemmi hawn fuq u l-impatt tiegħu fuq il-benefiċċju-riskju għal Evicel.
English: They were of the opinion that CO2 should be used instead of air as a safety precaution because of the markedly lower risk of gas embolism due to the high solubility of CO2 in the blood.
Maltese: Kienu tal-opinjoni li bħala prekawzjoni ta' sigurtà għandu jintuża CO2 minflok arja minħabba r-riskju ferm aktar baxx ta' emboliżmu tal-gass minħabba ssolubbilità għolja ta' CO2 fid-demm.
English: INFORMATION IN BRAILLE Tredaptive
Maltese: INFORMAZZJONI BIL-BRAILLE Tredaptive
English: Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460) Croscarmellose sodium Lactose monohydrate Magnesium stearate
Maltese: Hypromellose (E464) Colloidal anhydrous silica (E551) Sodium stearyl fumarate Hydroxypropylcellulose (E463) Microcrystalline cellulose (E460)
English: ●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)
Maltese: ●Tredaptive (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)
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, substrat sensittiv ta' CYP3A4.
English: EU/1/08/459/001 14 modified-release tablets EU/1/08/459/002 28 modified-release tablets EU/1/08/459/003 56 modified-release tablets EU/1/08/459/004 84 modified-release tablets EU/1/08/459/005 98 modified-release tablets EU/1/08/459/006 168 modified-release tablets EU/1/08/459/007 196 modified-release tablets EU/1/08/459/008 49 x 1 modified-release tablets EU/1/08/459/012 196 (2 packs of 98) modified-release tablets
Maltese: EU/1/08/459/004 84 pillola li terħi l-mediċina b'mod modifikat EU/1/08/459/005 98 pillola li terħi l-mediċina b'mod modifikat EU/1/08/459/006 168 pillola li terħi l-mediċina b'mod modifikat EU/1/08/459/007 196 pillola li terħi l-mediċina b'mod modifikat EU/1/08/459/008 49 x1 pillola li terħi l-mediċina b'mod modifikat EU/1/08/459/012 196 (2 pakketti ta' 98) pillola li terħi l-mediċina b'mod modifikat
English: The frequencies of adverse reactions are ranked according to the following: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000), Not known (cannot be estimated from the available data).
Maltese: Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1,000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1,000),
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: 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
English: The major component (73 % of radioactivity) in faeces is laropiprant (comprising unabsorbed active substance and/or hydrolysed glucuronic acid conjugate).
Maltese: Il-komponent prinċipali (73 % tarradjuattività) fl-ippurgar huwa laropiprant (inkluża s-sustanza attiva mhux assorbita u/jew il-konjugat idrolizzat ta' l-aċidu glukoroniku).
English: EU/1/08/459/014 32 x 1 modified-release tablets
Maltese: EU/1/08/459/014 32 x 1 pillola li terħi l-mediċina b'mod modifikat
English: Side effects of Tredaptive are:
Maltese: L-effetti sekondarji ta' Tredaptive huma:
English: 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
Maltese: 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
English: Tredaptive with food, drink and alcohol
Maltese: Tredaptive ma' ikel, xorb u alkoħol
English: How to take Tredaptive
Maltese: Tiħux Tredaptive
English: 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].
Maltese: (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % statins oħra [2.5-180 mg]
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: 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 (-41.0 %, -28.8 %, -17.1 % respectively), and TC (-29.6 %, -24.9 %, -9.1 % respectively), as well as LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % respectively), non-HDL-C (-45.8 %, -33.4 %, -18.1 % respectively), and TC:HDL-C (-43.0 %, -28.0 %, -24.9 % respectively), and significantly increased HDL-C (27.5 %, 6.0 %, 23.4 % respectively).
Maltese: 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
English: The pharmacokinetic interaction of Tredaptive with statins has been studied only with simvastatin (see section 4.4).
Maltese: L-interazzjoni farmakokinetika ta' Tredaptive ma' l-istatins ġiet studjata biss b'simvastatin (ara sezzjoni 4.4).
English: ▲ Tredaptive  nicotinic acid (laropiprant withdrawn at Week 21)
Maltese: ● Tredaptive ▲ Tredaptive  nicotinic acid (laropiprant twaqqaf f'Ġimgħa 21)
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Tredaptive.
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' Tredaptive.
English: 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).
Maltese: 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).
English: • you are over 70 years old.
Maltese: • jekk għandek aktar minn 70 sena.
English: Nicotinic acid was not teratogenic in rats and rabbits up to exposure levels approximately 253 and 104 times the human AUC of nicotinic acid at the recommended daily human dose, respectively.
Maltese: Aċidu nikotiniku ma kienx teratoġeniku f'firien u fniek sa livelli ta' espożizzjoni ta' madwar 253 u 104 darba l-AUC uman ta' aċidu nikotiniku fid-doża umana ta' kuljum rakkomandata, rispettivament.
English: Tredaptive 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: 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).
English: In clinical trials, over 5,700 patients received Tredaptive alone or with an HMG-CoA reductase inhibitor.
Maltese: Fi provi kliniċi, aktar minn 5,700 pazjent irċevew Tredaptive waħdu jew ma' inibitur HMG-CoA
English: 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.
Maltese: 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 taddijabete.
English: Each tablet contains 1,000 mg nicotinic acid and 20 mg laropiprant.
Maltese: Kull pillola fiha 1,000 mg aċidu nikotiniku u 20 mg laropiprant.
English: 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 ).
Maltese: (8.6 %, 2.3 % rispettivament) u naqqas b'mod sinifikanti l-Lp(a) (-19.8 %, 0.0 % rispettivament).
English: Tredaptive 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: Tredaptive 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: 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 lmediċina b'mod modifikat u 32 x 1 pillola li terħi l-mediċina b'mod modifikat f'folja ta' doża waħda perforata.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tredaptive in paediatric patients from 7-18 years old in heterozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Maltese: Tredaptive f'pazjenti pedjatriċi minn 7-18-il sena f'iperkolesterolimja familjali eterozigota (ara sezzjoni 4.2 għal informazzjoni dwar użu pedjatriku).
English: In a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Tredaptive), flushing was reported in 12.3 % of patients taking Tredaptive.
Maltese: (N=4,747, n=2,548 li ħadu Tredaptive), il-fawra kienet irrappurtata fi 12.3 % tal-pazjenti li ħadu
English: In a multicentre, double-blind, 12-week factorial study, Tredaptive 1,000 mg/20 mg co-administered with simvastatin, when compared with simvastatin alone or Tredaptive 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, Tredaptive 1,000 mg/20 mg mogħti flistess 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), itTG (-25.8%, -15.
English: The name of your medicine is Tredaptive.
Maltese: Mediċini oħra u Tredaptive
English: Caution should be used when Tredaptive is co-administered with medicinal products metabolised predominantly by UGT2B4 or UGT2B7, for instance zidovudine.
Maltese: Għandha tintuża attenzjoni meta Tredaptive jingħata fl-istess ħin ma' prodotti mediċinali li jiġu metabolizzati primarjament minn UGT2B4 jew UGT2B7, per eżempju zidovudine.
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 Tredaptive (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'
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/459/012
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/08/459/012
English: 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.
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' Tredaptive.
English: Tredaptive contains lactose.
Maltese: Tredaptive fih tip ta' zokkor imsejjaħ lactose.
English: Tredaptive 1,000 mg/20 mg modified-release tablets nicotinic acid/laropiprant
Maltese: Tredaptive 1,000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat Aċidu nikotiniku/laropiprant
English: In a multicentre, double-blind, 24-week placebo-controlled study, patients taking Tredaptive (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 Tredaptive (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: 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,
English: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/discomfort, and back pain.
Maltese: fwawar, uġigħ ta' ras, prurite (ħakk), dardir, sturdament, rimettar, dijarrea, uġigħ addominali/skumdità u uġigħ fid-dahar.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (for Alu/Alu blister)
Maltese: KARTUNA TA' BARRA (għal folja Alu/Alu)
English: • blistering rash
Maltese: • ġilda xotta
English: 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).
Maltese: F'individwi b'saħħithom li rċevew Tredaptive, 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' Tredaptive waħdu (ara sezzjoni 4.8).
English: As with other nicotinic acid medicinal products, Tredaptive (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, Tredaptive (2,000 mg/40 mg) ġie assoċjat ma' żidiet żgħar fil-livelli ta' l-aċidu uriku (ara sezzjoni 4.8).
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 flinibizzjoni ta' aggregazzjoni tal-plejtlits indotta mill-collagen bi clopidogrel.
English: Tredaptive is used in addition to diet and exercise in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia:
Maltese: Tredaptive jintuża flimkien ma' dieta u eżerċizzju f'pazjenti adulti b'iperkolesterolimja primarja jew dislipidimja mħallta:
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 Tredaptive 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
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 Tredaptive 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' Tredaptive kuljum.
English: As with other nicotinic acid medicinal products, Tredaptive was associated with small decreases in phosphorus levels.
Maltese: Bħal fi prodotti mediċinali ta' l-aċidu nikotiniku oħrajn, Tredaptive kien assoċjat ma' tnaqqis żgħir fil-livelli ta' fosfru.
English: What Tredaptive looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “552” debossed on one side.
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: As with other nicotinic acid medicinal products, Tredaptive (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, Tredaptive (2,000 mg/40 mg) ġie assoċjat ma' tnaqqis żgħir fl-għadd tal-plejtlits (ara sezzjoni 4.8).
English: Therefore, laropiprant is not an inducer or inhibitor of CYP3A4.
Maltese: Għalhekk, laropiprant mhuwiex induttur jew inibitur ta' CYP3A4.
English: Uncommon (may affect up to 1 in 100 people) • gout
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Tredaptive in all subsets of the paediatric population in homozygous familial hypercholesterolaemia (see section 4.2 for information on paediatric use).
Maltese: Tredaptive f'kull sett tal-popolazzjoni pedjatrika b'iperkolesterolimja familjali omozigota (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: NAME OF THE MEDICINAL PRODUCT Tredaptive 1000 mg/20 mg modified-release tablets Nicotinic acid/laropiprant
Maltese: Tredaptive 1000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat Aċidu nikotiniku/laropiprant
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)
English: NAME OF THE MEDICINAL PRODUCT Tredaptive 1,000 mg/20 mg modified-release tablets Nicotinic acid/laropiprant
Maltese: Tredaptive 1,000 mg/20 mg pilloli li jerħu l-mediċina b'mod modifikat aċidu nikotiniku/laropiprant
English: 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.
Maltese: 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.
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: 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: 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: It tnaqqis 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: Tredaptive has not been studied in children and adolescents who are under 18 years of age.
Maltese: Tredaptive ma ġiex studjat fi tfal u adoloxxenti ta' taħt it-18-il sena.