FrancophonIA/ELRC3.0 huggingface dataset:
English: The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure.
Maltese: L-informazzjoni ppreżentata kkonċernat 173 mill-293 Awtorizzazzjoni għat-Tqegħid fis-Suq involuti f'din il-proċedura ta' referenza.
English: The Committee confirmed that a withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin as a single active substance.
Maltese: Il-Kumitat ikkonferma li għandu jiġi stabbilit perjodu ta' rtirar ta' 49 jum għall-prodotti injettabbli kollha kkonċernati għallbhejjem tal-ifrat li fihom ivermektina bħala sustanza attiva unika.
English: Therefore, the Committee adopted by written procedure an opinion on 5 June 2009 recommending the variation the existing Marketing Authorisations in line with the proposed amendments of the Summary of Product Characteristics, labelling and package leaflet.
Maltese: Għaldaqstant, fil-5 ta' Ġunju 2009 permezz ta' proċedura bil-miktub il-Kumitat adotta opinjoni li fiha jirrakkomanda l-varjazzjoni talAwtorizzazzjoni għat-Tqegħid fis-Suq attwali konformi mal-emendi proposti lis-Sommarju talKaratteristiċi tal-Prodott, lit-tikketta u lill-fuljett ta' tagħrif.
English: The withdrawal period of 49 days for cattle would also apply to all concerned injectable products containing ivermectin in combination with closantel as a second active substance.
Maltese: Il-perjodu ta' rtirar ta' 49 jum għallbhejjem tal-ifrat għandu japplika wkoll għall-prodotti injettabbli kollha kkonċernati li fihom ivermektina f'kombinazzjoni ma' closantel bħala sustanza attiva oħra.
English: Based on the evaluation of the currently available data and the rapporteurs' assessment, the CVMP considered that a single withdrawal period of 49 days should be established for all concerned injectable products for cattle containing ivermectin.
Maltese: Abbażi tal-evalwazzjoni tad-dejta attwalment disponibbli u tal-valutazzjoni tar-relaturi, is-CVMP kkunsidra li għandu jiġi stabbilit perjodu ta' rtirar uniku ta' 49 jum għall-prodotti injettabbli kollha kkonċernati li fihom ivermektina għall-bhejjem tal-ifrat.
English: The referral procedure started on 16 January 2008.
Maltese: Il-proċedura ta' referenza bdiet fis-16 ta' Jannar 2008.
English: On 17 September 2008 the CVMP considered that there were still issues with regard to some products which needed further clarification and therefore the Committee requested the relevant Marketing Authorisation Holders to address the outstanding issues in writing.
Maltese: Fis-17 ta' Settembru 2008 s-CVMP qies li kien għad fadal kwistjonijiet fir-rigward ta' xi prodotti li ħtieġu kjarifika ulterjuri u għaldaqstant il-Kumitat talab lid-Detenturi tal-Awtorizzazzjoni għatTqegħid fis-Suq rilevanti biex jindirizzaw bil-miktub il-kwistjonijiet pendenti.
English: Therefore, the Committee adopted an opinion on 11 February 2009 recommending the variation of the existing Marketing Authorisations in accordance with the recommended amendments to the Summary of Product Characteristics.
Maltese: Għaldaqstant, il-Kumitat adotta opinjoni fil11 ta' Frar 2009 li fiha rrakkomanda l-varjazzjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq eżistenti f'konformità mal-emendi rakkomandati lis-Sommarju tal-Karatteristiċi tal-Prodott.
English: The final opinion was converted into a Decision by the European Commission on 1 October 2009.
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fl-1 ta' Ottubru 2009 .
English: National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases.
Maltese: Ingħataw Awtorizzazzjonijiet Nazzjonali għat-Tqegħid fis-Suq tal-prodotti mediċinali veterinarji injettabbli li fihom ivermektina għall-użu fil-bhejjem tal-ifrat fl-Istati Membri kollha tal-Unjoni Ewropea permezz ta' proċeduri ta' awtorizzazzjoni differenti (proċeduri ta' rikonoxximent reċiproku u proċeduri nazzjonali) u skont diversi bażijiet ġuridiċi.
English: The CVMP was requested to give its opinion on the matter.
Maltese: Is-CVMP ntalab jagħti l-opinjoni tiegħu dwar il-kwistjoni.
English: The full EPAR for Nuedexta 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: This is a summary of the European public assessment report (EPAR) for Nuedexta.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nuedexta.
English: • with ‘prolonged QT interval' (a disruption of the electrical activity of the heart);
Maltese: • b'“intervall ta' QT imtawwal” (tfixkil fl-attività elettrika tal-qalb);
English: Nuedexta is a medicine that contains two active substances, dextromethorphan and quinidine.
Maltese: Nuedexta huwa mediċina li fiha żewġ sustanzi attivi, dextromethorphan u quinidine.
English: After 12 weeks of treatment with Nuedexta, the CNS-LS score decreased by 8.2 points, compared with a decrease of 5.7 points for placebo.
Maltese: Wara 12-il ġimgħa ta' kura b'Nuedexta, il-punteġġ CNS LS naqas bi 8.2 punti, meta mqabbel ma' tnaqqis ta' 5.7 punti għall-plaċebo.
English: Serious side effects reported include muscle spasticity (excessive stiffness of muscles), respiratory depression (inhibition of breathing) and decreased oxygen saturation (lower-than-normal levels of oxygen) in the blood.
Maltese: Effetti sekondarji serji li kienu rrappurtati jinkludu spastiċità tal-muskoli (ebusija eċċessiva tal-muskoli), depressjoni respiratorja (inibizzjoni ta' teħid tan-nifs) u nuqqas ta' saturazzjoni ta' ossiġnu (livelli aktar baxxi minn dak normali ta' ossiġnu) fid-demm.
English: Nuedexta is available as capsules (15 mg or 23 mg dextromethorphan and 9 mg quinidine) and can only be obtained with a prescription.
Maltese: Nuedexta jiġi bħala kapsuli (dextromethorphan ta' 15 mg jew 23 mg u quinidine ta' 9 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: It is used to treat the symptoms of pseudobulbar affect (PBA) in adults.
Maltese: Jintuża biex jiġu kkurati s-sintomi ta' effett psewdobulbari (PBA) fl-adulti.
English: This summary was last updated in 07-2013.
Maltese: Is-sommarju ġie aġġornat l-aħħar fi: 07-2013.
English: • with a history suggestive of torsades de pointes ventricular tachycardia (abnormal heart rhythms);
Maltese: • bi storja li tissuġġerixxi takikardija ventrikulari ta' torsades de pointes (ritmu tal-qalb anormali);
English: Other information about Nuedexta
Maltese: Informazzjoni oħra dwar Nuedexta
English: • who are taking or have taken within the last 14 days medicines for depression called monoamine oxidase inhibitors (MAOI).
Maltese: • li qegħdin jieħdu jew li matul l-aħħar 14-il jum ħadu mediċini kontra d-dipressjoni msejħa inibituri tal-ossidażi tal-monoamina (MAOI).
English: The most common side effects with Nuedexta (which may affect up to 1 in 10 people) are diarrhoea, nausea (feeling sick), dizziness, headache, somnolence (sleepiness) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Nuedexta (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma dijarea, dardir (tħossok ma tiflaħx), sturdament, uġigħ ta' ras, somnolenza (ngħas) u għeja.
English: Nuedexta has been studied in one main study involving 326 patients with PBA due to multiple sclerosis or amyotrophic lateral sclerosis.
Maltese: Nuedexta ġie studjat fi studju ewlieni wieħed li involva lil 326 pazjent b'PBA minħabba sklerożi multipla jew sklerożi laterali amijotrofika.
English: • who are already being treated with the medicines quinidine, quinine or mefloquine or who have previously developed certain serious problems such as thrombocytopenia (low platelet counts) due to the use of these medicines;
Maltese: • li diġà qegħdin jiġu trattati bil-mediċini quinidine, quinine jew mefloquine jew li qabel kienu żviluppaw ċerti problemi serji bħal tromboċitopenija (għadd baxx ta' plejtlits) minħabba l-użu ta' dawn il-mediċini;
English: Although the exact way dextromethorphan works in PBA is unclear, it attaches to several different nerve cell receptors in the brain such as NMDA receptors and sigma-1 receptors for the neurotransmitter glutamate as well as receptors for the neurotransmitter serotonin.
Maltese: Għalkemm il-mod eżatt li bih taħdem dextromethorphan fil-PBA mhuwiex ċar, din teħel ma' diversi riċetturi differenti ta' ċelloli tan-nervituri fil-moħħ bħal riċetturi NMDA u riċetturi sigma-1 għannewrotrasmettitur tal-glutamat kif ukoll riċetturi għan-newrotrasmettitur tas-serotonina.
English: Why has Nuedexta been approved?
Maltese: Għal xiex ġie approvat Nuedexta?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nuedexta on 24 June 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Nuedexta Fl-24 ta' Ġunju 2013.
English: The CHMP concluded that Nuedexta is effective in treating the symptoms of PBA based on the studies in patients with PBA caused by multiple sclerosis and amyotrophic lateral sclerosis.
Maltese: IsCHMP ikkonkluda li Nuedexta huwa effettiv fil-kura tas-sintomi tal-PBA abbażi tal-istudji f'pazjenti b'PBA kkawżata minn sklerożi multipla u sklerożi laterali amijotrofika.
English: Treatment with Nuedexta was effective in reducing patients' PBA episodes which were reduced by nearly 50% more than in patients treated with placebo.
Maltese: Il-kura b'Nuedexta kienet effettiva fit-tnaqqis tal-episodji ta' PBA tal-pazjenti li raw tnaqqis ta' kważi 50 % aktar mill-pazjenti kkurati bi plaċebo.
English: What is the risk associated with Nuedexta?
Maltese: X'inhuma r-riskji assoċjati ma' Nuedexta?
English: How does Nuedexta work?
Maltese: Kif jintuża Nuedexta?
English: A risk management plan has been developed to ensure that Nuedexta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Nuedexta jintuża bl-aktar mod sigur possibbli.
English: Since these neurotransmitters are involved in the control of emotions, dextromethorphan helps to normalise its activity in the brain, reducing the symptoms of PBA.
Maltese: Peress li dawn in-newrotrasmettituri huma involuti fil-kontroll tal-emozzjonijiet, dextromethorphan jgħin jinnormalizza l-attività tiegħu fil-moħħ, billi tnaqqas is-sintomi tal-PBA.
English: • who are taking the medicine thioridazine used for mental illness;
Maltese: • li qegħdin jieħdu l-mediċina tijoridażina użata għall-mard mentali;
English: The main safety issues were considered manageable and adequately addressed by risk minimisation measures.
Maltese: Il-kwistjonijiet ewlenin ta' sigurtà kienu kkunsidrati maniġġabbli u indirizzati b'mod xieraq permezz ta' miżuri ta' minimizzazzjoni tar-riskju.
English: The study also measured the change in the patients' symptoms, assessed in several ways including using a standard scale (called a CNS-LS score which ranges from 7 to 35).
Maltese: L-istudju kejjel ukoll il-bidla fis-sintomi tal-pazjenti, li ġiet ivvalutata b'diversi modi inkluż l-użu ta' skala standard (imsejħa punteġġ CNS LS li tvarja minn 7 sa 35).
English: In patients whose response is inadequate after four weeks, the higher strength capsule (23mg/9mg) may be used twice a day.
Maltese: F'pazjenti li ma wiġbux b'mod xieraq wara erba' ġimgħat, il-kapsula aktar b'saħħitha (23mg/9mg) tista' tintuża darbtejn kuljum.
English: In addition, the company that makes Nuedexta must ensure that all healthcare professionals who are expected to use Nuedexta receive an information pack and a patient alert card with key safety information.
Maltese: Barra minn hekk, il-kumpanija li timmanifattura Nuedexta għandha tiżgura li l-professjonisti kollha talkura tas-saħħa li huma mistennija li jużaw Nuedexta jirċievu pakkett ta' tagħrif u karta għat-twissija tal-pazjent b'informazzjoni ewlenija dwar is-sigurtà.
English: What measures are being taken to ensure the safe use of Nuedexta?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Nuedexta?
English: Regarding its safety, the CHMP decided that dextromethorphan and quinidine have been marketed as medicines for a number of years and their safety and interactions with other medicines are relatively well known.
Maltese: Rigward is-sigurtà tiegħu, is-CHMP iddeċieda li dextromethorphan u quinidine ilhom imqiegħda fis-suq bħala mediċini għal numru ta' snin u s-sigurtà u l-interazzjonijiet tagħhom ma' mediċini oħra huma magħrufa relattivament tajjeb.
English: • with or at high risk of complete AV block (a type of heart rhythm disorder);
Maltese: • b'riskju għoli jew li jinsabu f'riskju għoli ta' blokk AV komplut (tip ta' disturb fir-rittmu tal-qalb);
English: 1 g/vial
Maltese: 1 g/kunjett
English: Amoxil Syrup SucroseFree /Dye-Free 250mg/5ml
Maltese: Amoxil Syrup Sucrose-Free /DyeFree 250mg/5ml
English: SmithKline Beecham Limited, 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Maltese: SmithKline Beecham Limited, 980 Great West Road Brentford
English: 266 Kifisias Avenue 152 32 Halandri Greece
Maltese: GlaxoSmithKline a.e.b.e. 266 Kifisias Avenue 152 32 Halandri Greece
English: Clamoxyl 1g comprimidos 1 g
Maltese: Clamoxyl 1g comprimidos
English: Amoxicilline Biogaran 500 mg Capsule
Maltese: Amoxicilline Biogaran 500 mg Kapsula
English: 500 mg Capsule
Maltese: 500 mg Kapsula
English: GlaxoSmithKline (Ireland) Ltd
Maltese: GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham
English: Amoxil Vials for Injection 1 g
Maltese: Amoxil Vials for Injection
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, Marketing Authorisation Holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn għandu jingħata, Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl-Istati Membri
English: Intravenous
Maltese: Ġol-vini
English: Powder for solution for injection or infusion
Maltese: Trab għal soluzzjoni għal injezzjoni or infusion
English: Amoxil Capsules 500mg 500 mg Capsule
Maltese: Amoxil Capsules 500mg
English: Amoxil 500 mg kapsulas 500 mg Capsule
Maltese: Amoxil 500 mg kapsulas
English: Clamoxyl 500 mg cápsulas 500 mg Capsule, hard
Maltese: Clamoxyl 500 mg cápsulas
English: 500 mg Capsule, hard
Maltese: 500 mg Kapsula, iebsa
English: Intravenous/ Intramuscular
Maltese: Ġol-vini / Ġol-muskoli
English: Intramuscular
Maltese: Ġol-muskoli
English: United Kingdom250 mg Capsule
Maltese: 250 mg Kapsula
English: Apo B decreased by 12%.
Maltese: Apo B naqas bi 12%.
English: 24 tablets
Maltese: 24 pillola
English: Vistor hf.
Maltese: Ísland Vistor hf.
English: Date of first authorisation: 10 March 2004 Date of latest renewal: 12 March 2009
Maltese: Data tal-aħħar tiġdid: 12 ta' Marzu 2009
English: Very rare: Pancreatitis
Maltese: Rari ħafna: Pankreatite
English: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland
Maltese: Genzyme Ireland Ltd., IDA Industrial Park, Old Kilmeaden Road, Waterford, L-Irlanda
English: Interaction with ciclosporin
Maltese: Interazzjoni ma' ciclosporin
English: The reporting rate is classified as 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) and not known (cannot be estimated from the available data).
Maltese: Ir-rata ta' rappurtaġġ hi kklassifikata bħala 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) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
English: • Ciclosporin (a medicine used to suppress the immune system).
Maltese: • Ciclosporin (mediċina li tintuża biex trażżan is-sistema immuni).
English: The maximum recommended dose is 7 tablets per day.
Maltese: Id-doża massima rrakkomandata hi 7 pilloli kuljum.
English: In interaction studies in healthy volunteers, Cholestagel had no effect on the bioavailability of digoxin, metoprolol, quinidine, valproic acid, and warfarin.
Maltese: Skond studju ta' interazzjoni f'voluntiera b'saħħithom, Cholestagel ma kellu l-ebda effett fuq il-bijodisponibiltà ta' digoxin, metoprolol, quinidine, valproic acid, u warfarin.
English: Doses in excess of the maximum recommended dose (4.5 g per day (7 tablets)) have not been tested.
Maltese: Ma sarux testijiet b'dożi ta' iktar mid-doża massima rakkomandata (4.5 g kuljum (7 pilloli)).
English: - The active substance is colesevelam (as hydrochloride).
Maltese: - Is-sustanza attiva hi colesevelam (bħala hydrochloride).
English: Gastrointestinal symptoms could occur.
Maltese: Jista' jkun hemm sintomi gastrointestinali.
English: Cholestagel is not absorbed from the gastrointestinal tract.
Maltese: Cholestagel mhux assorbit mis-sistema gastrointestinali.
English: Very common: Flatulence*, constipation* Common: Vomiting, diarrhoea*, dyspepsia*, abdominal pain, abnormal stools, nausea, abdominal distension
Maltese: Komuni ħafna: Gass*, stitikezza* Komuni: rimettar, dijarea*, dispepsja*, uġigħ addominali, ippurgar anormali, nawseja, nefħa addominali
English: Not known: Intestinal obstruction*,** Musculoskeletal and connective tissue disorders Uncommon: Myalgia
Maltese: Mhux magħruf: Ostruzzjoni intestinali*,** Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Multi-centre, randomised, double-blind, placebo-controlled studies in 487 patients demonstrated an additive reduction of 8 to 16% in LDL-C when 2.3 to 3.8 g Cholestagel and a statin (atorvastatin, lovastatin or simvastatin) were administered at the same time.
Maltese: Studji multi-centred, randomised, double-blind, ikkontrollati bil-plaċebo li kienu jinvolvu 487 pazjent urew tnaqqis addizzjonali ta' bejn 8% u 16% f'LDL-C meta bejn 2.3 g u 3.8 g Cholestagel u statin (atorvastatin, lovastatin jew simvastatin) ngħataw flimkien.
English: Microcrystalline cellulose (E460) Silica colloidal anhydrous Magnesium stearate Purified water
Maltese: Microcrystalline cellulose (E460) Silica colloidal anhydrous Magnesium stearate Ilma ppurifikat
English: Pack sizes are 24 (1 x 24), 100 (2 x 50) and 180 (1 x 180) tablets.
Maltese: 24 pillola (1 X 24) 100 pillola (2 X 50) 180 pillola (1 X 180)
English: 625 mg
Maltese: Cholestagel 625 mg
English: Tel. aus dem Ausland: +49 69 305 21 131
Maltese: Tel.: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131
English: Cellulose (E460), microcrystalline Silica, colloidal anhydrous Magnesium stearate Water, purified
Maltese: Cellulose (E460), microcrystalline Silica, colloidal anhydrous
English: Pharmacotherapeutic group: Lipid modifying agent, bile acid sequestrants, ATC code: C10A C 04
Maltese: Kodiċi ATC: C10A C 04
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Bowel or biliary obstruction
Maltese: • Sensittivita' eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Cholestagel contains the active substance colesevelam (as hydrochloride).
Maltese: Cholestagel fih is-sustanza attiva colesevelam (bħala hydrochloride).
English: 180 tablets with carton
Maltese: 180 pillola bil-kartuna
English: Triglycerides in the Cholestagel group increased by 19% and 13% at 6 and 12 weeks vs an increase of 6% and 13% in the placebo group, but the increases were not significantly different.
Maltese: Triglycerides fil-grupp ta' Cholestagel żdiedu b'19% u 13% wara 6 u 12-il ġimgħa vs żieda ta' 6% u 13% fil-grupp tal-plaċebo, iżda ż-żidiet ma kinux differenti b'mod sinifikanti.
English: Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
Maltese: Cholestagel mogħti flimkien ma' inibitur ta' 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMGCoA) reductase (statin) jintuża bħala terapija aġġuntiva mad-dieta biex jipprovdi tnaqqis addizzjonali fil-livelli tal- kolesterol b'lipoproteina ta' densità baxxa (LDL-C) f'pazjenti adulti li għandhom iperkolesterolimja li mhix ikkontrollata b'mod adekwat permezz ta' statin waħdu.
English: Marketing authorisation holder Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, the Netherlands
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, L-Olanda
English: INSTRUCTIONS ON USE 16.
Maltese: Tel: 800.
English: The fenofibrate plus Cholestagel group (64 patients) demonstrated a 10% reduction on LDL-C levels versus 2% increase for the fenofibrate group
Maltese: Il-grupp li ngħata fenofibrate flimkien ma' Cholestagel (64 pazjent) wera tnaqqis ta' 10% fil-livelli ta' LDL-C kontra żieda ta' 2% għall-grupp ta' fenofibrate (65 pazjent).
English: In comparison, in patients given placebo, LDL-C, Total-C, HDL-C and Apo-B were unchanged, while triglycerides increased 5%.
Maltese: Meta ġew mqabblin ma' pazjenti li ngħataw il-plaċebo, LDL-C, Total-C, HDL-C u Apo-B baqgħu l-istess, waqt li t-trigliċeridi żdiedu b'5%.
English: Co-administration of Cholestagel and glyburide (also known as glibenclamide) caused a decrease in the AUC0-inf and Cmax of glyburide by 32% and 47%, respectively.
Maltese: L-għoti flimkien ta' Cholestagel u glyburide (magħruf ukoll bħala glibenclamide) ikkawża tnaqqis fl-AUC0-inf u s-Cmax ta' glyburide bi 32% u 47%, rispettivament.
English: In addition, Total-C decreased 7 to 10%, HDL-C increased 3% and triglycerides increased 9 to 10%.
Maltese: Barra minn dan, Total-C naqas minn 7% sa 10%, HDL-C żdid b'3% u ttrigliċeridi żdiedu minn 9% sa 10%.
English: Package sizes are: 180 tablets (1 X 180)
Maltese: Id-daqsijiet tal-pakkett huma: 180 pillola (1 X 180)
English: The combination of ezetimibe 10 mg and Cholestagel 3.8 g daily therapy in the absence of a statin resulted in a significant combined effect for LDL-C lowering by 32% demonstrating an additional effect of 11% LDL-C lowering with Cholestagel and ezetimibe compared to ezetimibe alone.
Maltese: Terapija kuljum b'kumbinazzjoni ta' ezetimibe 10 mg u Cholestagel 3.8 g fl-assenza ta' statin irriżultat f'effett kombinat sinifikanti għat-tnaqqis ta' LDL-C bi 32% u wriet effett addizzjonali ta' tnaqqis ta' 11% ta' LDL-C b'Cholestagel u ezetimibe meta mqabbel ma' ezetimibe waħdu.
English: In a clinical study Cholestagel did not affect the faecal excretion of endogenous (hydrophilic) ursodeoxycholic acid.
Maltese: Fi studju kliniku Cholestagel ma affettwax it-tneħħija fl-ippurgar ta' ursodeoxycholic acid endoġenu (idrofiliku).
English: Other medicines and Cholestagel
Maltese: Mediċini oħra u Cholestagel
English: Very rare (may affect up to 1 in 10,000 people): inflammation of the pancreas.
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000): infjammazzjoni tal-frixa.
English: • Ursodeoxycholic acid (a medicine used to dissolve gallstones or treat specific chronic liver diseases).
Maltese: • Ursodeoxycholic acid (mediċina li tintuża biex tħoll ġebel fil-marrara jew tikkura mard speċifiku kroniku tal-fwied).
English: • Verapamil or olmesartan (medicines used to treat high blood pressure).
Maltese: • Verapamil jew olmesartan (mediċini li jintużaw biex tikkura l-pressjoni għolja tad demm).