FrancophonIA/ELRC3.0 huggingface dataset:
English: Having noted the BSWP assessment, the CHMP concluded that there are serious concerns regarding the appropriateness of the statistical methodology used for the pooled analyses, mainly because they have been based on fixed effects models in the presence of evident heterogeneity but in particular because the main grounds for the refusal of the evidence relate to the lack of compliance with the key criteria detailed in the CHMP Points to consider document (CPMP/EWP/2330/99).
Maltese: Wara li nnota l-evalwazzjoni tal-BSWP, is-CHMP ikkonkluda li kien hemm tħassib serju dwar l-adegwatezza tal-metodoloġija statistika użata għall-analiżi miġbura, prinċipalment minħabba li kienet ibbażata fuq mudelli b'effetti fissi fil-preżenza ta' eteroġeneità evidenti iżda b'mod partikolari minħabba li r-raġunijiet ewlenin għar-rifjut tal-evidenza huma relatati man-nuqqas ta' konformità mal-kriterji ewlenin dettaljati fid-dokument Punti li Jridu Jiġu Kkunsidrati mis-CHMP (CPMP/EWP/2330/99).
English: • Central-reticular level - An imbalance between supraspinal facilitatory and inhibitory control can also lead to an enhanced reflex activity and an increased muscle tone.
Maltese: • Livell ċentroretikulari - Żbilanċ bejn il-kontroll faċilitatorju u inibitorju supraspinali jista' jwassal ukoll għal attività mtejba tar-riflessi u żieda fit-ton tal-muskoli.
English: Treatment of obliterative vascular diseases as well as syndromes due to impaired vascular innervation
Maltese: Trattament ta' mard kif ukoll sindromi vaskolari obliterattivi minħabba innervazzjoni vaskolari indebolita
English: • Central-spinal level - tolperisone reduces the increased mono- and polysynaptic reflex activity in a dose-dependent manner to the physiological level.
Maltese: • Livell ċentrospinali - tolperisone inaqqas l-attività miżjuda tar-riflessi mono u polisinattiċi b'mod li jiddependi mid-doża sal-livell fiżjoloġiku.
English: The CHMP has considered the totality of the available data on the safety and efficacy of tolperisone.
Maltese: Is-CHMP ikkunsidra d-dejta kollha disponibbli dwar is-sigurtà u l-effikaċja ta' tolperisone.
English: It possesses high affinity for nervous tissue, reaching the highest concentrations in the brain stem, spinal cord and peripheral nerve tissue.
Maltese: Huwa għandu affinità kbira għat-tessuti tan-nervituri, u jilħaq l-ogħla konċentrazzjonijiet fiz-zokk enċefaliku tal-moħħ, is-sinsla tad-dahar u t-tessuti tan-nervituri periferali.
English: • The Committee also concluded that, in the absence of relevant data to support the efficacy in the dosing recommendations approved, the potential benefit of tolperisone-containing parenteral formulations is outweighed by the identified risk of hypersensitivity.
Maltese: • Il-Kumitat ikkonkluda wkoll li, fin-nuqqas ta' dejta rilevanti li tappoġġja l-effikaċja firrakkomandazzjonijiet approvati tad-dożaġġ, il-benefiċċju potenzjali ta' formulazzjonijiet parenterali li fihom tolperisone huwa megħlub mir-riskju identifikat ta' ipersensittività.
English: The only studies that exist are of observational nature, were conducted in a heterogeneous population and contain extremely limited information.
Maltese: L-uniċi studji li jeżistu huma ta' xorta osservazzjonali, u saru f'popolazzjoni eteroġenea u fihom informazzjoni tassew limitata.
English: Hypotheses include structural similarity to the local anaesthetic lidocaine, so the risk for cross-reactions needs to be consistently described in the product information.
Maltese: L-ipoteżijiet jinkludu xebh strutturali mal-anestetiku lokali lidocaine, u għalhekk hemm bżonn ir-riskju ta' reazzjonijiet ma' prodotti oħrajn jiġi deskritt b'mod konsistenti fl-informazzjoni dwar il-prodott.
English: The chemical structure of tolperisone is similar to that of lidocaine and, similarly to lidocaine, tolperisone has membrane stabilising effects.
Maltese: L-istruttura kimika ta' tolperisone hija simili għal dik ta' lidocaine u, b'mod simili għal lidocaine, tolperisone għandu effetti ta' stabbilizzazzjoni tal-membrani.
English: The Struck 2002 study failed to demonstrate a significant improvement in the primary endpoint, and the two secondary parameters for which a statistically significant improvement could be seen are subjective, and not considered clinically meaningful given that they were not accompanied by commensurate improvements in clinically relevant parameters such as pain intensity, pain at movement and motility.
Maltese: L-istudju Struck 2002 naqas milli juri titjib sinifikanti fil-punt aħħari primarju, u ż-żewġ parametri sekondarji li għalihom deher titjib statistikament sinifikanti huma suġġettivi, u mhux meqjusa klinikament sinifikanti peress li dawn ma kinux akkumpanjati minn titjib proporzjonat f'parametri klinikament rilevanti bħal-intensità tal-uġigħ, uġigħ maċ-ċaqliq u l-motilità.
English: As a result, the CHMP considered that none of the provided pooled analyses could be considered as supportive to demonstrate the efficacy of tolperisone in the “treatment of muscular hypertonicity and muscle spasms associated with locomotor diseases” indication, nor in the proposed restricted indication.
Maltese: Bħala riżultat, is-CHMP ikkunsidra li l-ebda waħda mill-analiżi miġbura pprovduta ma tista' titqies li tappoġġa t-turija tal-effikaċja ta' tolperisone fl-indikazzjoni għat"trattament ta' ipertoniċità muskolari u ta' spażmi muskolari assoċjati ma' mard lokomotorju", u lanqas fl-indikazzjoni ristretta proposta.
English: The product information should also be updated so that all products contain consistent and updated information on interactions, effects on ability to drive and use machines, the effect of food on bioavailability, influence of renal or hepatic function and adverse reactions.
Maltese: L-informazzjoni dwar il-prodott għandha tkun aġġornata wkoll sabiex il-prodotti kollha jkun fihom informazzjoni konsistenti u aġġornata dwar l-interazzjonijiet, l-effetti fuq il-kapaċità biex wieħed isuq jew iħaddem magni, leffett tal-ikel fuq il-bijodisponibbiltà, l-influwenza tal-funzjoni renali jew epatika u r-reazzjonijiet avversi.
English: It is well known that the safety profile of a product may vary depending on the formulation.
Maltese: Huwa magħruf sew li l-profil ta' sigurtà ta' prodott jista' jvarja skont il-formulazzjoni.
English: In both studies, tolperisone is given to a very heterogeneous population as part of a rehabilitation program, so it is not possible to isolate the effect of tolperisone from the effect of other interventions and therefore this data does not support the evidence of efficacy in this particular indication.
Maltese: Fiż-żewġ studji, tolperisone ingħata lil popolazzjoni eteroġenea ħafna bħala parti minn programm ta' rijabilitazzjoni, u għalhekk mhuwiex possibbli li wieħed jiżola l-effett ta' tolperisone mill-effett ta' intervenzjonijiet oħra u għaldaqstant, din id-dejta ma tappoġġjax l-evidenza tal-effikaċja f'din l-indikazzjoni partikolari.
English: The only double-blind, placebo-controlled studies identified where parenteral tolperisone was used and that have acceptable methodological standards were conducted in indications where efficacy has not been demonstrated, that have never been approved for the product or included only a very small number of patients in the indication of interest.. No data was submitted in support of the dosing recommendations.
Maltese: L-uniċi studji ta' għama doppja (double-blind) u kkontrollati bi plaċebo identifikati li fihom intuża tolperisone parenterali u li għandhom standards ta' metodoloġija aċċettabbli saru f'indikazzjonijiet fejn ma ntwerietx l-effikaċja, li qatt ma ġew approvati għall-prodott jew kienu jinkludu biss għadd żgħir ħafna ta' pazjenti flindikazzjoni ta' interess.
English: The CHMP also noted the MAH proposal to conduct a clinical study to collect additional evidence of the efficacy of tolperisone in the proposed restricted low back pain indication, as a post-referral commitment, as well as the related draft study synopsis.
Maltese: Is-CHMP innota wkoll il-proposta tad-detentur talawtorizzazzjoni għat-tqegħid fis-suq biex iwettaq studju kliniku biex jiġbor evidenza addizzjonali taleffikaċja ta' tolperisone fl-indikazzjoni ristretta proposta ta' uġigħ fil-parti t'isfel tad-dahar, bħala impenn wara r-riferiment, kif ukoll is-sinopsi relatat dwar l-abbozz tal-istudju.
English: This effect is well demonstrated in several animal models.
Maltese: Proċedura ta' eżami mill-ġdid
English: EMA/785026/2012
Maltese: EMA/670858/2012 EMEA/H/C/001173
English: The full EPAR for Clopidogrel ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Clopidogrel ratiopharm jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The standard dose of Clopidogrel ratiopharm is one 75 mg tablet once a day.
Maltese: Id-doża standard ta' Clopidogrel ratiopharm hija pillola waħda ta' 75 mg darba kuljum.
English: Clopidogrel ratiopharm is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel ratiopharm huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: The CHMP concluded that, in accordance with EU requirements, Clopidogrel ratiopharm has been shown to have comparable quality and to be bioequivalent to Plavix.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Clopidogrel ratiopharm wera li għandu kwalità kumparabbli ma' Plavix u li huwa bijoekwivalenti għalih.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel ratiopharm.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Clopidogrel ratiopharm.
English: The active substance in Clopidogrel ratiopharm, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Clopidogrel ratiopharm, klopidogrel, hi inibitur tal-aggregazzjoni tal-pjastrini.
English: Other information about Clopidogrel ratiopharm
Maltese: Informazzjoni oħra dwar Clopidogrel ratiopharm
English: Clopidogrel ratiopharm is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Maltese: Clopidogrel ratiopharm jintuża f'adulti biex jipprevjeni każijiet aterotrombotiċi (problemi li jirriżultaw minn demm magħqud u t-twebbis tal-arterji).
English: This means that Clopidogrel ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Maltese: Clopidogrel ratiopharm huwa ‘mediċina ġenerika' Dan ifisser li Clopidogrel ratiopharm huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Plavix.
English: Because Clopidogrel ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Peress li Clopidogrel ratiopharm huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċini ta' referenza.
English: Because Clopidogrel ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Maltese: Billi Clopidogrel ratiopharm huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Plavix.
English: What are the benefits and risks of Clopidogrel ratiopharm?
Maltese: X'inhuma l-benefiċċju u r-riskji ta' Clopidogrel ratiopharm?
English: Clopidogrel ratiopharm is a ‘generic medicine'.
Maltese: Clopidogrel ratiopharm jista' jingħata lill-gruppi ta' pazjenti li ġejjin:
English: How is Clopidogrel ratiopharm used?
Maltese: X'inhu Clopidogrel ratiopharm?
English: How has Clopidogrel ratiopharm been studied?
Maltese: Kif ġie studjat Clopidogrel ratiopharm?
English: The Committee recommended that Clopidogrel ratiopharm be given marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Clopidogrel ratiopharm jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: INFORMATION IN BRAILLE Trevaclyn
Maltese: INFORMAZZJONI BIL-BRAILLE Trevaclyn
English: Nicotinic acid
Maltese: Acetylsalicylic acid:
English: ▲ Trevaclyn  nicotinic acid (laropiprant withdrawn at Week 21)
Maltese: ● Pelzont ▲ Pelzont Æ nicotinic acid (laropiprant irtirat f'Ġimgħa 21)
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: Laċidu nikotiniku jbaxxi l-livelli tal-kolesterol ta' lipoproteini ta' densità baxxa (LDL-C), tal-kolesterol totali (TC), tal-kolesterol ta' lipoproteini ta' densità baxxa ħafna (VLDL-C), ta' l-apolipoproteina B (apo B, il-proteina LDL prinċipali), tat-trigliċeridi (TG), u tal-lipoproteina(a) (Lp(a), partikula LDL modifikata) u jgħolli l-livelli tal-kolesterol ta' lipoproteini ta' densità għolja (HDL-C) u ta' l apolipoproteina A-I (apo A-I, il-komponent prinċipali ta' proteina ta' l-HDL).
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-carboxamide (2PY).
English: Trevaclyn with food, drink and alcohol
Maltese: Trevaclyn ma' ikel, xorb u alkoħol
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltrali u tal-connective tissue:
English: • Previous history of muscular toxicity with a statin or fibrate
Maltese: • Storja preċedent ta' tossiċità muskolari bi statin jew fibrat
English: EU/1/08/458/001 14 modified-release tablets EU/1/08/458/002 28 modified-release tablets EU/1/08/458/003 56 modified-release tablets EU/1/08/458/004 84 modified-release tablets EU/1/08/458/005 98 modified-release tablets EU/1/08/458/006 168 modified-release tablets EU/1/08/458/007 196 modified-release tablets EU/1/08/458/008 49 x 1 modified-release tablets EU/1/08/458/012 196 (2 packs of 98) modified-release tablets
Maltese: EU/1/08/458/001 14 -il pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/002 28 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/003 56 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/004 84 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/005 98 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/006 168 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/007 196 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/008 49 x1 pillola li terħi l-mediċina b'mod modifikat EU/1/08/458/012 196 (2 pakketti ta' 98) pillola li terħi l-mediċina b'mod modifikat
English: Nicotinic acid is less than 20 % bound to serum proteins.
Maltese: L-aċidu nikotiniku jeħel anqas minn 20 % mal-proteini tas-serum.
English: Side effects of Trevaclyn are:
Maltese: L-effetti sekondarji ta' Trevaclyn huma:
English: Based on these data, laropiprant is not expected to cause interactions with substrates of CYP isozymes 3A4, 2C9, 2C8 and human P-glycoprotein (P-gp).
Maltese: Fuq il-bażi ta' din l-informazzjoni, laropiprant mhux mistenni li jikkawża interazzjonijiet ma' substrati ta' lisoenzimi CYP 3A4, 2C9, 2C8 u l-glikoproteina-P umana (P-gp).
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: anġjoedema, 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, eruzzjoni tal-mediċina, artralġja, nefħa fis-sieq, u takikardija.
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 ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1,000 sa < 1/100), Rari (≥ 1/10,000 sa < 1/1,000), Rari ħafna (< 1/10,000).
English: Trevaclyn (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Trevaclyn (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: Trevaclyn 2,000 mg/40 mg mogħti flimkien ma' simvastatin, meta mqabbel ma' simvastatin waħdu jew ma' Trevaclyn 2,000 mg/40 mg waħdu għal 12-il ġimgħa, naqqas b'mod sinjifikanti LDL-C (-47.9 %, -37.0 %, -17.0 % rispettivament), TG(-33.3 %, -14.7 %, -21.6 % rispettivament), apo B (-41.0 %, -28.8 %, -17.1 % rispettivament), u TC (-29.6 %, -24.9 %, 9.1 % rispettivament), kif ukoll LDL-C:HDL-C (-57.1 %, -39.8 %, -31.2 % rispettivament), non-HDL-C (-45.8 %, -33.4 %, -18.1 % rispettivament), u TC:HDLC (-43.0 %, -28,0 %, -24.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 July 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 3 ta' Lulju 2008
English: The pharmacokinetic interaction of Trevaclyn with statins has been studied only with simvastatin (see section 4.4).
Maltese: L-interazzjoni farmakokinetika ta' Trevaclyn ma' l-istatins ġiet studjata biss b'simvastatin (ara sezzjoni 4.4).
English: EU/1/08/458/001 EU/1/08/458/002 EU/1/08/458/003 EU/1/08/458/004 EU/1/08/458/005 EU/1/08/458/006 EU/1/08/458/007 EU/1/08/458/008 EU/1/08/458/009 EU/1/08/458/010 EU/1/08/458/011 EU/1/08/458/012 EU/1/08/458/013 EU/1/08/458/014
Maltese: EU/1/08/458/006 EU/1/08/458/007 EU/1/08/458/008 EU/1/08/458/009 EU/1/08/458/010
English: Patients receiving Trevaclyn, 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: Il-pazjenti li kienu qegħdin jirċievu Trevaclyn, aċidu nikotiniku (formulazzjoni li terħi l-mediċina bil-mod), jew plaċebo kienu qegħdin jieħdu wkoll statins (29 % atorvastatin [5-80 mg], 54 % simvastatin [10-80 mg], 17 % statins oħra [2.5-180 mg] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), li 9 % minnhom kienu qegħdin jieħdu wkoll ezetimibe [10 mg].
English: Trevaclyn has not been studied in children and adolescents who are under 18 years of age.
Maltese: Trevaclyn ma ġiex studjat fi tfal u adoloxxenti ta' taħt it-18-il sena.
English: The first pathway results in the formation of nicotinamide adenine dinucleotide (NAD) and nicotinamide.
Maltese: L-ewwel passaġġ jirriżulta fil-formazzjoni ta' nicotinamide adenine dinucleotide (NAD) u nicotinamide.
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 168 modified-release tablets 32 x 1modified-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: Further analysis showed Trevaclyn (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 Trevaclyn 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: 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 llivell tal-lipidi ta' aċidu nikotiniku (≥1,000 mg/kuljum) u inibituri HMG-CoA reductase (statins) (ara sezzjoni 4.8).
English: Pharmacotherapeutic group: Lipid modifying agents, nicotinic acid and derivatives, ATC code: C10AD52.
Maltese: Sustanzi li jimmodifikaw il-lipidi, aċidu nikotiniku u derivattivi, Kodiċi ATC:
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Clinically important elevations of CK (≥ 10 X ULN) were seen in 0.3 % of the patients treated with Trevaclyn 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 Trevaclyn bi jew mingħajr statin (ara sezzjoni 4.4).
English: Common: elevations in ALT and/or AST (consecutive, ≥ 3 X ULN), fasting glucose (see below) Uncommon: elevations in CK (≥ 10 X ULN), LDH, uric acid (see
Maltese: Żidiet fl-ALT u/jew fl-AST (konsekuttivi, ≥ 3 X ULN), glukows tas-sawm, aċidu uriku (ara taħt)
English: Trevaclyn 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: Trevaclyn 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 a pool of four active- or placebo-controlled clinical trials (N=4,747, n=2,548 taking Trevaclyn), flushing was reported in 12.3 % of patients taking Trevaclyn.
Maltese: Fi grupp ta' erba' provi kliniċi attivi jew ikkontrollati bil-plaċebo (N=4,747, n=2,548 li ħadu Trevaclyn), il-fawra kienet irrappurtata mill-investigatur bħala reazzjoni avversa possibbli, probabbli, jew definittivament marbuta mal-kura fi 12.3 % tal-pazjenti li ħadu Trevaclyn.
English: Eye disorders: Cystoid macular oedema, toxic amblyopia.
Maltese: Edema makulari taċ-ċistojde, amblijopija tossika.
English: How to store Trevaclyn
Maltese: Tiħux Trevaclyn
English: Supplements containing nicotinic acid: Vitamins or other nutritional supplements containing (≥ 50 mg/day) of nicotinic acid (or nicotinamide) have not been studied with Trevaclyn.
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' Trevaclyn.
English: Trevaclyn 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: Trevaclyn 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.