FrancophonIA/ELRC3.0 huggingface dataset:
English: It contains the active substance firocoxib.
Maltese: Fih is-sustanza attiva firocoxib.
English: The full EPAR for Equioxx can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Equioxx:
Maltese: Informazzjoni oħra dwar Equioxx:
English: The active substance in Equioxx, firocoxib, is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the group of medicines called ‘cyclo-oygenase-s (COX-2) inhibitors' (or Coxibs).
Maltese: Is-sustanza attiva f'Equioxx, il-firocoxib, hija mediċina antinfjammatorja mhux sterojdali (NSAID) li tappartjeni għall-grupp ta' mediċini msejħa 'inibituri taċ-ċiklossiġenażi-2 (COX2)' (jew Coxibs).
English: This is a summary of the European public assessment report (EPAR) for Equioxx.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Equioxx.
English: Why is Equioxx approved?
Maltese: Għaliex ġie approvat Equioxx?
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in the inflammation process.
Maltese: Din timblokka l-enzima COX-2, bir-riżultat li jkun hemm tnaqqis fil-produzzjoni tal-prostaglandini, sustanzi li huma involuti fil-proċess ta' infjammazzjoni.
English: This authorisation was based on the authorisation granted to Previcox in 2004 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Previcox fl-2004 (‘kunsens infurmat').
English: What are the risks associated with Equioxx?
Maltese: X'inhuma r-riskji assoċjati ma' Equioxx?
English: Equioxx is available as a solution for injection, an oral paste and chewable tablets.
Maltese: Equioxx jiġi bħala soluzzjoni għall-injezzjoni, pejst orali u pilloli li jintmagħdu.
English: This summary was last updated in December 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Diċembru 2016
English: By reducing the production of prostaglandins, Equioxx helps reduce the responses of inflammation, including pain.
Maltese: Bit-tnaqqis fil-produzzjoni tal-prostaglandini, Equioxx jgħin fit-tnaqqis tar-risponsi tal-infjammazzjoni, inkluż l-uġigħ.
English: The European Commission granted a marketing authorisation valid throughout the EU for Equioxx on 25 June 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Equioxx fil-25 ta' Ġunju 2008.
English: Equioxx oral paste and Equioxx solution for injection have been studied in a laboratory and found to be bioequivalent.
Maltese: Il-pejst orali Equioxx u s-soluzzjoni għal injezzjoni Equioxx ġew studjati f'laboratorju u nstab li kienu bijoekwivalenti.
English: The dose depends on the bodyweight of the animal except for the tablets which are for horses of 450 to 600 kg bodyweight and where the dose is one tablet.
Maltese: Id-doża tiddependi mill-piż tal-ġisem tal-annimal minbarra għall-pilloli li huma għal żwiemel li għandhom piż tal-ġisem bejn 450 u 600 kg u fejn id-doża hija ta' pillola waħda.
English: Two forms of a medicine are bioequivalent when they produce the same levels of active substance in the body.
Maltese: Żewġ forom ta' mediċina huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Equioxx is a medicine used in horses to relieve pain and inflammation in the joints caused by osteoarthritis (a long-term disease causing damage and pain in the joints) and to reduce the lameness that is associated with the disease.
Maltese: Equioxx huwa mediċina użata fi żwiemel għas-soljev ta' wġigħ u infjammazzjoni fil-ġogi kkawżati minn osteoartrite (marda fit-tul li tikkawża ħsara u wġigħ fil-ġogi) u għat-tnaqqis taz-zappip li huwa assoċjat mal-marda.
English: The studies showed that Equioxx oral paste given daily for 14 days was as effective as the comparator medicines.
Maltese: L-istudji wrew li l-pejst orali Equioxx mogħti kuljum għal 14-il jum kien effettiv daqs il-mediċini komparaturi.
English: Similarly Equioxx oral paste and Equioxx chewable tablets have been shown to be bioequivalent.
Maltese: B'mod simili ntwera li l-pejst orali Equioxx u l-pilloli li jintmagħdu Equioxx kienu bijoekwivalenti.
English: The most common side effects with Equioxx (which may affect up to 1 in 100 horses) are salivation and lip and tongue swelling associated with the mouth sores.
Maltese: L-effetti sekondarji l-aktar komuni b'Equioxx (li jistgħu jaffettwaw sa żiemel 1 f'100) huma rieq u nefħa tax-xofftejn u tal-ilsien assoċjati mas-selħiet tal-ħalq.
English: One study in the USA compared Equioxx to another NSAID medicine, phenylbutazone, and the second study in Europe compared Equioxx to the NSAID
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u l-kondizzjonijiet ta' użu tagħha.
English: The withdrawal period for meat from horses treated with Equioxx is 26 days.
Maltese: Il-perjodu ta' tiżmim għal-laħam minn żwiemel ikkurati b'Equioxx huwa ta' 26 jum.
English: For the full list of all side effects reported with Equioxx and the full list of restrictions, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Equioxx u għal-lista sħiħa ta' restrizzjonijiet ara l-fuljett ta tagħrif.
English: Equioxx must not be used at the same time as corticosteroid medicines or other NSAIDs.
Maltese: Equioxx m'għandux jintuża fl-istess ħin ta' mediċini kortikosterojdi jew NSAIDs oħra.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Equioxx, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u l-fuljett ta' tagħrif ġiet inkluża informazzjoni rigward is-sigurtà għal Equioxx, inklużi l-prekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u mis-sidien tal-annimali jew dawk li jieħdu ħsiebhom.
English: How does Equioxx work?
Maltese: Kif jintuża Equioxx?
English: The full EPAR for Thorinane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Thorinane is a ‘biosimilar medicine'.
Maltese: Thorinane huwa "mediċina bijosimili".
English: Other information about Thorinane
Maltese: Informazzjoni oħra dwar Thorinane
English: The reference medicine for Thorinane is Clexane.
Maltese: Ilmediċina ta' referenza għal Thorinane hija Clexane.
English: The most common side effect with Thorinane (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Thorinane to prevent blood clots during surgery.
Maltese: L-effetti sekondarju l-aktar komuni b'Thorinane (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma emorraġija (fsada); seħħet fsada serja f'madwar 4 persuni minn kull 100 li ngħataw Thorinane biex jiġu evitati l-emboli tad-demm waqt kirurġija.
English: Extensive laboratory studies comparing Thorinane with Clexane have shown that Thorinane is highly similar to Clexane in terms of structure, purity and biological activity.
Maltese: Studji estensivi fil-laboratorju li jqabblu Thorinane ma' Clexane urew li Thorinane huwa simili ħafna għal Clexane f'termini ta' struttura, purità u attività bijoloġika.
English: Why is Thorinane approved?
Maltese: Għaliex ġie approvat Thorinane?
English: This is a summary of the European public assessment report (EPAR) for Thorinane.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Thorinane.
English: The active substance in Thorinane, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Maltese: Is-sustanza attiva f'Thorinane, enoxaparin, hija waħda minn grupp ta' mediċini antikoagulanti msejjaħ "eparina ta' piż molekulari baxx".
English: The active substance in Thorinane is enoxaparin sodium.
Maltese: Is-sustanza attiva f'Thorinane hija enoxaparin sodium.
English: What are the risks associated with Thorinane?
Maltese: X'inhuma r-riskji assoċjati ma' Thorinane?
English: It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood.
Maltese: Dan normalment jingħata bħala injezzjoni taħt il-ġilda għalkemm fil-kura ta' tip ta' attakk tal-qalb imsejjaħ infart mijokardijaku b'elevazzjoni tas-segment ST (STEMI) akut l-ewwel jingħata bħala injezzjoni filvina, u sabiex jiġu evitati emboli fil-magni tal-emodijaliżi dan jiġi injettat direttament fit-tubu li jġorr id-demm.
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
Maltese: • biex jikkura kundizzjonijiet assoċjati ma' emboli tad-demm bħal trombożi profonda fil-vini (fejn lembolu jifforma f'vina profonda, normalment fis-sieq)
English: This means that Thorinane is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Thorinane huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-"mediċina ta' referenza") li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: Thorinane is an anticoagulant medicine (a medicine to prevent blood clots).
Maltese: Thorinane huwa mediċina antikoagulanti (mediċina biex tipprevjeni emboli tad-demm).
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;
Maltese: • biex jipprevjeni tromboemboliżmu (emboli tad-demm li jiffurmaw ġol-vini, li jfixklu l-fluss taddemm), speċjalment f'pazjenti li jkunu qed jiġu operati jew li jkunu jinsabu f'riskju akbar ta' emboli minħabba li jkunu ilhom għal żmien twil fis-sodda minħabba l-mard;
English: The safety profiles of the two medicines were also considered similar, based on laboratory testing.
Maltese: Il-profili ta' sigurtà taż-żewġ mediċini ukoll tqiesu simili, skont l-ittestjar tal-laboratorju.
English: In the treatment of unstable angina and heart attack Thorinane is given with aspirin (acetylsalicylic acid).
Maltese: Fil-kura ta' anġina instabbli u attakk tal-qalb Thorinane jingħata ma' aspirina (aċidu aċetilsaliċiliku).
English: For the full list of all side effects reported with Thorinane, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Thorinane, ara l-fuljett ta' tagħrif.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Maltese: Għalhekk, il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) qies li m'hemm l-ebda differenza klinikament sinifikanti bejn Thorinane u Clexane f'termini tal-effikaċja u sigurtà u kien tal-fehma li, għal Clexane, il-benefiċċju huwa akbar mir-riskju identifikat.
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Maltese: • biex jikkura anġina instabbli (tip sever ta' uġigħ fis-sider kkawżat minn problemi fil-fluss tad-demm
English: Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood's clotting factors and helps prevent blood from clotting inside the body.
Maltese: Enoxaparin iżid l-effett ta' antitrombin III, sustanza naturali li tikkontrollla l-fatturi tal-għaqid tad-demm u tgħin tipprevjeni biex id-demm ma jagħqadx fil-ġisem.
English: What measures are being taken to ensure the safe and effective use of Thorinane?
Maltese: X'miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Thorinane?
English: In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).
Maltese: Barra minn hekk, il-livelli miżjuda ta' enzimi tal-fwied fid-demm (sinjal ta' problemi possibbli fil-fwied) huma komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10).
English: Thorinane must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Maltese: Thorinane m'għandux jintuża f'pazjenti bi fsada kbira eżistenti, b'disturbi severi ta' emboli tad-demm, jew b'kundizzjonijiet li jżidu r-riskju ta', jew jiffurmaw, fsada, bħal ulċeri fl-istonku jew puplesija.
English: When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart.
Maltese: Meta l-emboli tad-demm jiffurmaw fil-vini u fl-arterji dawn jistgħu jirrestrinġu l-fluss tad-demm għallorgani, inkluż il-qalb.
English: Studies have shown that Thorinane has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Maltese: L-istudji wrew li Thorinane għandu struttura u attività bijoloġika simili ħafna għal Clexane u għandu listess effett fuq fatturi ta' emboli tad-demm.
English: • Age > 70 years
Maltese: • Età > 70 sena
English: A. Φ B.E.E.
Maltese: MSD. A. Φ B.E.E.
English: ○Placebo
Maltese: ○ Plaċebo
English: INFORMATION IN BRAILLE Pelzont
Maltese: INFORMAZZJONI BIL-BRAILLE Pelzont
English: Nicotinic acid: see section 4.4.
Maltese: L-aċidu nikotiniku: ara sezzjoni 4.4.
English: 1'-hydroxymidazolam is metabolised predominantly by uridine diphosphate-glucuronosyltransferases (UGT) 2B4 and 2B7.
Maltese: 1'-hydroxymidazolam huwa metabolizzat prinċipalment mill-uridine diphosphateglucuronosyltransferases (UGT) 2B4 u 2B7.
English: • zidovudine, a medicine used for HIV.
Maltese: • zidovudine, mediċina użata għall-HIV.
English: • Personal or familial history of hereditary muscular disorders
Maltese: • Storja personali jew familjari ta' disturbi muskolari ereditarji
English: Hypophosphatemia
Maltese: Ipofosfatemja
English: Мерк Шарп и Доум България ЕООД Тел.
Maltese: България Мерк Шарп и Доум България ЕООД
English: Uncommon: gout Rare: impaired glucose tolerance
Maltese: Mhux komuni: gotta Rari: indeboliment fit-tolleranza għall-glucose
English: The first pathway results in the formation of nicotinamide adenine dinucleotide (NAD) and nicotinamide.
Maltese: nicotinamide adenine dinucleotide (NAD) u nicotinamide.
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Maltese: Fih lactose monohydrate.
English: PVC/Aclar blisters: 2 years.
Maltese: PVC/Aclar Folji:
English: Northumberland NE23 3JU United Kingdom
Maltese: Northumberland NE23 3JU Ir-Renju Unit
English: • The other ingredients are: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, and magnesium stearate.
Maltese: • Is-sustanzi l-oħra huma: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, u magnesium stearate.
English: The oxidative metabolism of laropiprant is catalysed primarily by CYP3A4, whereas several UGT isoforms (1A1, 1A3, 1A9 and 2B7) catalysed the acyl glucuronidation.
Maltese: Ilmetaboliżmu ossidattiv ta' laropiprant huwa katalizzat prinċipalment minn CYP3A4, filwaqt li diversi isoformi UGT (1A1, 1A3, 1A9 and 2B7) ikkatalizzaw l-acyl glucuronidation.
English: Laropiprant is a potent and selective antagonist of DP1.
Maltese: Laropiprant huwa antagonist qawwi u selettiv tad-DP1.
English: • decreased glucose (sugar) tolerance
Maltese: • tnaqqis fit-tolleranza għall-glucose (zokkor) • ansjetà
English: Effects of other medicinal products on laropiprant
Maltese: Effetti ta' prodotti mediċinali oħra fuq laropiprant
English: Nicotinic acid
Maltese: Nicotinic acid/laropiprant
English: Respiratory, thoracic, and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Disturbi gastro-intestinali
English: • clopidogrel and acetylsalicylic acid (ASA), medicines to help prevent harmful blood clots.
Maltese: • clopidogrel u acetylsalicylic acid (ASA), mediċini li jgħinu fil-prevenzjoni ta' emboli perikolużi.
English: Aluminium/Aluminium blisters: 18 months.
Maltese: 2 snin Aluminju/folji ta' aluminju: 18-il xahar.
English: • pruritus (itching)
Maltese: • prurite (ħakk)
English: ●Pelzont (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: ●Pelzont (1,000 mg/20 mg għal 2,000 mg/40 mg f'Ġimgħa 5)
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' l isoenzimi CYP 3A4, 2C9, 2C8 u l-glikoproteina-P umana (P-gp).
English: In diabetic patients a median increase in HbA1c of 0.2 % was observed (where modification of hypoglycaemic therapy was allowed).
Maltese: F'pazjenti bid-dijabete, ġiet osservata żieda medja filHbA1c ta' 0.2 % (fejn modifika ta' terapija ipoglimika kienet permessa).
English: In urine, the primary component is the acyl glucuronide conjugate (64 % of radioactivity) with smaller contributions from the parent compound (5 %).
Maltese: Fl-awrina, il-komponent primarju huwa l-acyl glucuronide conjugate (64 % tar-radjuattività) b'kontribuzzjonijiet iżgħar mill-kompost oriġinali (5 %).
English: Pelzont (2000 mg/40 mg) co-administered with simvastatin when compared with simvastatin alone or Pelzont (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: 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:
English: Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Maltese: Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir-Renju Unit
English: Other medicinal products: Co-administration of laropiprant 40 mg with midazolam increased the AUC0-∞ and Cmax of 1'-hydroxymidazolam, a midazolam metabolite, by 98 % and 59 %, respectively.
Maltese: Prodotti mediċinali oħra: L-għoti fl-istess ħin ta' laropiprant 40 mg ma' midazolam żied l-AUC0-∞ u l-Cmax ta' 1'-hydroxymidazolam, metabolit ta' midazolam, bi 98 % u 59 %, rispettivament.
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 % tar radjuattività) fl-ippurgar huwa laropiprant (inkluża s-sustanza attiva mhux assorbita u/jew il-konjugat idrolizzat ta' l-aċidu glukoroniku).
English: The combination has not been tested in reproductive toxicity studies.
Maltese: Ilkombinazzjoni ma ġietx ittestjata fi studji tat-tossiċità riproduttiva.
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),
English: Side effects of Pelzont are:
Maltese: L-effetti sekondarji ta' Pelzont huma:
English: • skin disorder with dark velvety plaques called acanthosis nigricans
Maltese: • disturb fil-ġilda bi qxur skur bellusi imsejjaħ acanthosis nigricans
English: In in vitro studies, laropiprant did not inhibit CYP1A2, CYP2B6, CYP2C19, CYP2D6, or CYP2E1-mediated reactions.
Maltese: Fi studji in vitro, laropiprant ma impediex reazzjonijiet medjati minn CYP1A2, CYP2B6, CYP2C19, CYP2D6, jew CYP2E1.
English: In in vitro studies, nicotinic acid and its metabolites did not inhibit CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4-mediated reactions or UGT1A1-mediated 3-glucuronidation of estradiol.
Maltese: Fi studji in vitro, l-aċidu nikotiniku u l-metaboliti tiegħu ma waqqfux reazzjonijiet medjati b'CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, jew CYP3A4 jew 3-glucuronidation medjat b'UGT1A1 ta' estradiol.
English: Pelzont with food, drink and alcohol
Maltese: Pelzont ma' ikel, xorb u alkoħol
English: Pelzont has not been studied in children and adolescents who are under 18 years of age.
Maltese: Pelzont ma ġiex studjat fi tfal u adoloxxenti ta' taħt it-18-il sena.
English: Each modified-release tablet contains 128.4 mg of lactose monohydrate.
Maltese: Kull pillola li terħi l-mediċina b'mod modifikat fiha 128.4 mg ta' lactose monohydrate.
English: • medicines used to lower cholesterol called ‘statins'.
Maltese: • mediċini użati biex ibaxxu l-kolesterol imsejħa ‘statins'.
English: Patients receiving Pelzont, 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] (pravastatin, fluvastatin, rosuvastatin, lovastatin)), li 9 % minnhom kienu qegħdin jieħdu wkoll ezetimibe [10 mg].
English: • to raise levels of ‘good' cholesterol (HDL cholesterol) and apo A-I (a part of HDL).
Maltese: • biex jgħolli l-livelli tal-kolesterol ‘tajjeb' (kolesterol HDL) u apo A-I (parti mill-HDL).
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: Komuni: żieda fil-livelli tal-ALT u/jew l-AST (konsekuttivi, ≥ 3 X ULN), glucose fl-istat sajjem (ara taħt) Mhux komuni: żieda fil-livelli ta' CK (≥ 10 X ULN), LDH, uric acid (ara taħt)
English: ▲ Pelzont  nicotinic acid (laropiprant withdrawn at Week 21)
Maltese: ● Pelzont ▲ Pelzont  nicotinic acid (laropiprant twaqqaf f'Ġimgħa 21)
English: Clinical and in vitro studies support the conclusion that laropiprant is a mild to moderate inhibitor of UGT2B4/UGT2B7.
Maltese: Studji kliniċi u in vitro jsostnu l-konklużjoni li laropiprant huwa inibitur ħafif għal moderat ta' UGT2B4/UGT2B7.