FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people): vomiting, diarrhoea, indigestion, abdominal pain, abnormal stools, feeling sick, bloating, headache, raised levels of triglycerides (fats) in your blood.
Maltese: Komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): rimettar, dijarea, indiġestjoni, uġigħ addominali, ippurgar anormali, tħossok imdardar, nefħa, uġigħ ta' ras, livelli għolja ta' triglycerides (xaħmijiet) fid-demm tiegħek.
English: Specific clinical interaction studies with colesevelam and vitamin K have not been performed.
Maltese: Ma sarux studji speċifiċi ta' interazzjoni klinika bejn colesevelam u vitamina K.
English: The effect of 3.8 g Cholestagel plus 10 mg ezetimibe versus 10 mg ezetimibe alone on LDL-C levels was assessed in a multicentre, randomised, double-blind, placebo-controlled, parallel-group study in 86 patients with primary hypercholesterolaemia over a 6-week treatment period.
Maltese: L-effett ta' 3.8 g ta' Cholestagel flimkien ma' 10 mg ta' ezetimibe kontra 10 mg ta' ezetimibe waħdu fuq il-livelli ta' LDL-C kien evalwat fi studju multiċentriku (multi-centred), li fih il-pazjenti ntgħażlu b'mod każwali (randomised), double-blind, ikkontrollat bil-plaċebo, tat-tip grupp parallel li sar fuq 86 pazjent bi iperkolesterolemija primarja fuq perjodu ta' kura ta' 6 ġimgħat.
English: • Thyroid replacement therapy (medicines, such as thyroxine or levothyroxine, used to treat low thyroid hormone levels)
Maltese: • Terapija minnflok it-tirojde (mediċini bħal thyroxine jew levothyroxine li jintużaw biex jikkuraw livelli baxxi ta' l-ormoni tat-tirojde).
English: Uncommon: Dysphagia
Maltese: Komuni: Disfaġja
English: This causes an increased demand for cholesterol in the liver cells, resulting in the dual effects of increasing transcription and activity of the cholesterol biosynthetic enzyme, hydroxymethyl-glutaryl-coenzyme A (HMG-CoA) reductase, and increasing the number of hepatic low-density lipoprotein receptors.
Maltese: Dan jikkaġuna żieda fil-bżonn tal-kolesterol fiċ-ċelluli tal-fwied, li jirriżulta fiż-żewġ effetti ta' żieda fit-transkrizzjoni u l-attività ta' l-enżima bijosintetika tal-kolesterol, hydroxymethyl-glutanyl-coenzyme A (HMG-CoA) reductase, u jżid in-numru ta' riċetturi ta' lipoproteini tal-fwied ta' densità baxxa.
English: Iron oxide black (E172) Hypromellose (E464) Propylene glycol
Maltese: Hypromellose (E464) Propylene glycol
English: In a 6 week study 129 patients with mixed hyperlipidaemia were randomised to fenofibrate 160 mg plus 3.8 g Cholestagel or fenofibrate alone.
Maltese: Fi studju li dam 6 ġimgħat, 129 pazjent b'iperlipidimja mħallta kienu randomised għal fenofibrate 160 mg flimkien ma' 3.8 g Cholestagel jew fenofibrate waħdu.
English: Common: Serum triglycerides increased Uncommon :Serum transaminases increased
Maltese: Mhux komuni: Żieda fit-transaminase fis-serum
English: Cholestagel 625 mg film-coated tablets Colesevelam
Maltese: Cholestagel 625 mg pilloli miksijin b'rita Colesevelam
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 imma l-ebda rakkomandazzjoni dwar il pożoloġija ma tista' tingħata.
English: Each tablet contains 625 mg colesevelam.
Maltese: Kull pillola fiha 625 mg ta' colesevelam.
English: Since Cholestagel is not absorbed, the risk of systemic toxicity is low.
Maltese: Peress li Cholestagel mhux assorbit, ir-riskju ta' tossiċità sistemika hu baxx.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Qalba tal-pillola:
English: Combination therapy:
Maltese: Kategorija farmakoterapewtika:
English: For statin-naïve patients on monotherapy, Cholestagel resulted in a statistically significant LDL-C reduction of 12% at 3.8 g/day and 7% at 1.9 g/day, versus a 1% reduction in the placebo group (see section 4.2).
Maltese: Għal pazjenti li qatt ma ġew ikkurati fil-passat bi statins li kienu qed jingħataw b'Cholestagel waħdu, dan irriżulta fi tnaqqis statistikament sinifikanti f'LDL-C ta' 12% f'doża ta' 3.8 g/kuljum u 7% f'doża ta' 1.9 g/kuljum, kontra tnaqqis ta' 1% fil-grupp tal-plaċebo (ara sezzjoni
English: • Anti-epileptic medicines (medicines, such as phenytoin, used to treat epilepsy).
Maltese: • Mediċini anti-epilettiċi (mediċini bħal phenytoin li jintużaw għall-kura ta' l-epilessija).
English: Cholestagel can also be used in combination with ezetimibe, with or without a statin, in adult patients with primary hypercholesterolaemia, including patients with familial hypercholesterolaemia (see section 5.1).
Maltese: Cholestagel jista' jintuża wkoll flimkien ma' ezetimibe, bi jew mingħajr statin, f'pazjenti adulti bi iperkolesterolemija primarja, li jinkludu pazjenti b'iperkolesterolemija familjali (ara sezzjoni 5.1).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: In the paediatric population, the safety and efficacy of 1.9 or 3.8 g/day Cholestagel was assessed in an 8 week multi-centre, randomised, double-blind, placebo-controlled study in 194 boys and postmenarchal girls, aged 10-17 years, with heterozygous FH on a stable dose of statins (47 patients, 24%) or treatment-naïve to lipid-lowering therapy (147 patients, 76%).
Maltese: Fil-popolazzjoni pedjatrika, is-sigurtà u l-effikaċja ta' 1.9 jew 3.8 g/kuljum ta' Cholestagel kienu evalwati fi studju li dam 8 ġimgħat, multiċentriku, li fih il-pazjenti ntgħażlu b'mod każwali, double-blind, u kkontrollat bil-plaċebo, li sar fuq 194 subien u bniet wara li kellhom l-ewwel menstrwazzjoni, li kellhom 10-17-il sena, b'heterozygous FH fuq doża stabbli ta' statins (47 pazjent, 24%) jew li qatt ma kienu ġew ikkurati fil-passat b'terapija li tbaxxi l-lipidi (147 pazjent,
English: The mechanism of action for the activity of colesevelam, the active substance in Cholestagel, has been evaluated in several in vitro and in vivo studies.
Maltese: Il-mekkaniżmu ta' azzjoni ta' l-attività ta' colesevelam, is-sustanza attiva f'Cholestagel, ġew evalwati f'numru ta' studji in vitro u in vivo.
English: In an interaction study in healthy volunteers, co-administration of Cholestagel and ciclosporin significantly reduced the AUC0-inf and Cmax of ciclosporin by 34% by 44%, respectively.
Maltese: Ciclosporin Fi studju dwar l-interazzjoni f'voluntiera b'saħħithom, l-għoti flimkien ta' Cholestagel u ciclosporin naqqas b'mod sinifikanti l-AUC0-inf u s-Cmax ta' ciclosporin b'34% u 44%,
English: Anticoagulant therapy
Maltese: Terapija kontra l-koagulazzjoni
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam (as hydrochloride).
Maltese: Kull pillola fiha 625 mg colesevelam (bħala hydrochloride).
English: Cholestagel decreased the Cmax and AUC of sustained-release verapamil by approximately 31% and 11%, respectively.
Maltese: Cholestagel naqqas Cmax u l-AUC ta' verapamil, li jintreħa bil-mod, b'madwar 31% u 11%, rispettivament.
English: For all patients, Cholestagel resulted in a statistically significant LDL-C reduction of 11% at 3.8 g/day and 4% at 1.9 g/day, versus a 3% increase in the placebo group.
Maltese: 11% f'doża ta' 3.8 g/kuljum u 4% f'doża ta' 1.9 g/kuljum, kontra żieda ta' 3% fil-grupp talplaċebo.
English: 180 tablets (1 X 180)
Maltese: (2 x 50) u 180 (1 x 180) pilloli.
English: The most frequently occurring adverse reactions are flatulence and constipation, found within the gastrointestinal disorders system organ class.
Maltese: L-iktar reazzjonijiet avversi li jseħħu b'mod frekwenti huma gass u stitikezza, li jinsabu fil-klassi tal-organi tas-sistema tad-disturbi gastrointestinali.
English: During therapy, the cholesterol-lowering diet should be continued, and serum total-C, LDL-C and triglyceride levels should be determined periodically during treatment to confirm favourable initial and adequate long-term responses.
Maltese: Matul terapija, id-dieta li tnaqqas il-kolesterol għandha titkompla, u l-livelli ta' serum total-C, LDL-C u triglycerides għandhom jiġu stabbiliti perjodikament matul il-kura biex jiġu kkonfermati r-risponsi favorevoli inizjali u adegwati fit-tul.
English: Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract.
Maltese: F'każ ta' doża eċċessiva, il-ħsara prinċipali potenzjali hija mblukkar tas-sistema gastrointestinali.
English: Danmark Sanofi A/S Tlf: +45 45 16 70 00
Maltese: Tlf: +45 45 16 70 00
English: Constipation
Maltese: Tqala
English: The safety and efficacy of Cholestagel in patients with dysphagia, swallowing disorders, severe gastrointestinal motility disorders, inflammatory bowel disease, liver failure or major gastrointestinal tract surgery have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cholestagel f'pazjenti li jbatu mill-disfaġja, li jsibuha bi tqila biex jibilgħu, problemi serji fil-motilità gastrointestinali, mard ta' infjamazzjoni fl-imsaren, insuffiċjenza tal-fwied, jew operazzjoni kbira tas-sistema gastrointestinali, ma ġewx stabbiliti.
English: HDL-C and hsCRP levels were also not significantly different compared to placebo at 12 weeks.
Maltese: Il livelli ta' HDL-C u hsCRP ukoll ma kinux differenti b'mod sinifikanti meta mqabbla mal-plaċebo wara 12-il ġimgħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/268/001-004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/03/268/001-004
English: Cholestagel in combination with statins and in combination with ezetimibe was well tolerated and the adverse reactions observed were consistent with the known safety profile of statins or ezetimibe alone.
Maltese: Meta ngħataw Cholestagel flimkien ma' statins u flimkien ma' ezetimibe kien ittollerat tajjeb u r reazzjonijiet avversi osservati kienu konsistenti mal-profil magħruf tas-sigurtà ta' statins jew ezetimibe waħidhom.
English: Package sizes are: 24 tablets (1 X 24)
Maltese: Id-daqsijiet tal-pakkett huma 24 (1 x 24), 100
English: Not known (frequency cannot be estimated from the available data): blockage of the intestines (which can increase among patients with a history of blockage of the intestines or intestinal removal).
Maltese: Mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli): l-imblokkar tal-intestini
English: Printing ink:
Maltese: Kisja tar-rita:
English: Effects on triglyceride levels
Maltese: Effetti fuq il-livelli tat-trigliċeridi
English: A total of 85% of the patients were on either atorvastatin (50% of whom received 80 mg dose) or rosuvastatin (72% of whom received 40 mg dose).
Maltese: Total ta' 85% talpazjenti kienu qed jieħdu jew atorvastatin (li 50% minnhom irċivew doża ta' 80 mg) jew rosuvastatin (li 72% minnhom irċivew doża ta' 40 mg). Cholestagel irriżulta fi tnaqqis statistikament sinifikanti ta' LDL-C ta' 11% u 11% wara 6 u 12-il ġimgħa vs żieda ta' 7% u 1%
English: Therefore advice is given to closely monitor ciclosporin blood concentrations (see also section 4.4).
Maltese: Għalhekk, għandu jingħata parir biex il-konċentrazjonijiet ta' ciclosporin fid-demm jiġu mmonitorjati mill-qrib (ara wkoll sezzjoni 4.4).
English: The LDL-C lowering mechanism of bile acid sequestrants has been previously established as follows: As the bile acid pool becomes depleted, the hepatic enzyme, cholesterol 7--hydroxylase, is upregulated, which increases the conversion of cholesterol to bile acids.
Maltese: Hekk kif l-ammont ta' aċidu tal-bili jonqos sew, l-enżima epatika, cholesterol 7-α-hydroxylase, jiżdied, li jżid il-konverżjoni tal-kolesterol f'aċidi tal-bili.
English: NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets
Maltese: Informazzjoni għall-utent Cholestagel 625 mg pilloli miksija b'rita
English: Fertility
Maltese: Stitikezza
English: Off-white, capsule-shaped film-coated tablets imprinted with “C625” on one side.
Maltese: Pilloli off-wajt, miksijin b'rita, forma ta' kapsula, li għandhom stampat C625 fuq naħa waħda.
English: OUTER CARTON AND BOTTLE LABEL (24, 100 AND 180 TABLETS) WITH CARTON BOTTLE LABEL (180 TABLETS) WITHOUT CARTON
Maltese: KARTUNA TA' BARRA U T-TIKKETTA TAL-FLIXKUN (24, 100 U 180 PILLOLA) BIL
English: The safety and efficacy of Cholestagel in children aged 0 to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Cholestagel fit-tfal minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
English: In general
Maltese: U LUŻU
English: The addition of Cholestagel 3.8 g daily to maximally-tolerated statin and ezetimibe therapy was assessed in a multi-centre, randomised, double-blind, placebo-controlled study in 86 patients with familial hypercholesterolaemia.
Maltese: Iż-żieda ta' Cholestagel 3.8 g kuljum ma' terapija bi statin fid-doża massima ttollerata u ezetimibe kienet evalwata fi studju multiċentriku, li fih il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollat bil-plaċebo, li sar fuq 86 pazjent b'iperkolesterolemija familjali.
English: These studies have demonstrated that colesevelam binds bile acids, including glycocholic acid, the major bile acid in humans.
Maltese: Dawn l-istudji wrew li colesevelam jorbot l-aċidi tal-bili, inkluż glycocholic acid, l-aċidu principali tal-bili fin-nies.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached..
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: INFORMATION IN BRAILLE Cholestagel
Maltese: Jekk tinsa tieħu Cholestagel
English: For patients on ciclosporin starting or stopping Cholestagel or patients on Cholestagel with a need to start ciclosporin: Cholestagel reduces the bioavailability of ciclosporin (see also section 4.5).
Maltese: Għal pazjenti li qed jieħdu ciclosporin li ser jibdew jew iwaqqfu Cholestagel, jew pazjenti li qed jieħdu Cholestagel li jeħtieġu jibdew ciclosporin: Cholestagel inaqqas il-bijodisponibilità ta' ciclosporin (ara wkoll sezzjoni 4.5).
English: Therefore glimepiride should be administered at least 4 hours prior to colesevelam.
Maltese: Għalhekk glimepiride għandu jingħata mill-inqas 4 sigħat qabel colesevelam.
English: Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated.
Maltese: Cholestagel waħdu jintuża bħala terapija aġġuntiva mad-dieta għat-tnaqqis ta' livell għoli ta' total-kolesterol u LDL-C f‘pazjenti adulti li għandhom iperkolesterolimja primarja,f'każi fejn statin mhux meqjus li jgħodd għalihom jew li mhux ittolerat sewwa.
English: The maximum recommended dose is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets taken once per day with a meal.
Maltese: Id-doża massima rrakkomandata hi ta' 6 pilloli kuljum meħuda bħala 3 pilloli darbtejn kuljum ma' l-ikel jew 6 pilloli meħuda darba kuljum ma' l-ikla.
English: Propylene glycol
Maltese: pioglitazone, repaglinide jew glyburide).
English: A concomitant increase in very low density lipoprotein synthesis can occur.
Maltese: Żjieda konkomitanti fis-sinteżi ta' lipoproteini ta' densità baxxa tista' tiġri.
English: The risk of constipation should especially be considered in patients with coronary heart disease and angina pectoris.
Maltese: Ir-riskju ta' l-istitikezza għandu aktar ikun meqjus fil-każ ta' pazjenti li jbatu minn mard koronjaru tal-qalb u angina pectoris.
English: In an interaction study in healthy volunteers, Cholestagel reduced the Cmax of norethindrone as well as the AUC and Cmax of ethinylestradiol when administered simultaneously with the oral contraceptive pill.
Maltese: Pillola kontraċettiva orali Fi studju dwar l-interazzjoni f'voluntiera b'saħħithom, Cholestagel naqqas is-Cmax ta' norethindrone kif ukoll l-AUC u s-Cmax ta' ethinylestradiol meta ngħata fl-istess ħin mal-pillola kontraċettiva orali.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: Id-daqsijiet tal-pakkett huma:
English: Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 00
Maltese: Tlf: + 47 67 10 71 00
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: It is important to ensure that Cholestagel is administered at least 4 hours after the oral contraceptive pill to minimise the risk of any interaction (see also section 4.5).
Maltese: Hu importanti li tiżgura li Cholestagel jingħata mill-inqas 4 sigħat wara l-pillola kontraċettiva orali biex timminimizza r-riskju ta' kwalunkwe interazzjoni (ara wkoll sezzjoni 4.5).
English: No interaction was observed when Cholestagel was administered four hours after glyburide.
Maltese: Ma kienet osservata l-ebda interazzjoni meta Cholestagel ingħata erba' sigħat wara glyburide.
English: Description of selected adverse events
Maltese: Deskrizzjoni ta' avvenimenti avversi magħżula
English: Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam The Netherlands
Maltese: 1105 BP Amsterdam L-Olanda
English: • Antidiabetic medications (medicines used to treat diabetes, such as metformin extended-release (ER) tablets, glimepiride, glipizide, pioglitazone, repaglinide or glyburide).
Maltese: diabetes mellitus li mhix ikkontrollata tajjeb, ipotirojdiżmu, sindromu nefrotiku, disproteinimji, mard li jinvolvi sadd fil-fwied, terapija oħra farmakoloġika, alkoħoliżmu) huma kkunsidrati, dawn għandhom ikunu ddijanjostikati u kkurati kif suppost.
English: In addition, based on theoretical grounds Cholestagel should be administered at least 4 hours after ciclosporin in order to further minimise the risks related to the concomitant administration of ciclosporin and Cholestagel.
Maltese: Flimkien ma' dan, ibbażat fuq raġunijiet teoretiċi, Cholestagel għandu jingħata mill-inqas 4 sigħat wara ciclosporin sabiex jitnaqqsu aktar ir-riskji marbuta mal-għoti fl-istess ħin ta' ciclosporin u Cholestagel.
English: No interaction was observed when Cholestagel and pioglitazone were administered simultaneously in healthy volunteers
Maltese: Ma kienet osservata l-ebda interazzjoni meta Cholestagel u pioglitazone ingħataw fl-istess ħin f'voluntiera b'saħħithom.
English: Cholestagel can affect the bioavailability of the oral contraceptive pill when administered simultaneously.
Maltese: Kontraċettivi orali Cholestagel jista' jaffettwa l-bijodisponibilità tal-pillola kontraċettiva orali meta jingħata fl-istess ħin.
English: Monitoring of the clinical effects of treatment with ursodeoxycholic acid should be considered.
Maltese: Għandu jiġi kkunsidrat il-monitoraġġ ta' effetti kliniċi ta' kura b'ursodeoxycholic acid.
English: Cholestagel predominantly binds hydrophobic bile acids.
Maltese: Cholestagel, primarjament jwaħħal aċidi idrofobiċi tal-bila.
English: Co-administration of Cholestagel and repaglinide had no effect on the AUC and caused a 19% reduction in the Cmax of repaglinide, the clinical significance of which is unknown.
Maltese: L-għoti flimkien ta' Cholestagel u repaglinide ma kellu l-ebda effett fuq l-AUC u kkawża tnaqqis ta' 19% fis-Cmax ta' repaglinide.
English: These compensatory effects result in increased clearance of LDL-C from the blood, resulting in decreased serum LDL-C levels.
Maltese: Dawn l-effetti li jikkumpensaw iwasslu għal tneħħija akbar ta' LDL-C mid demm, li jwassal għal-livelli aktar baxxi ta' LDL-C fis-serum.
English: • Periodic Safety Update Reports
Maltese: * ara s-sezzjoni hawn taħt għal aktar informazzjoni
English: Co-administration of colesevelam and metformin extended-release (ER) tablets increases the exposure of metformin.
Maltese: It-teħid flimkien ta' colesevelam u pilloli ta' metformin li jerħu l-mediċina b'mod imtawwal (pilloli ER-extended release) iżid l-espożizzjoni ta' metformin.
English: A study conducted in rats did not result in any differences in reproductive parameters between the groups that might imply reproductive effects attributable to colesevelam.
Maltese: Studju li sar fuq il-firien ma rriżulta fl-ebda differenzi fil-parametri riproduttivi bejn il-gruppi li jistgħu jimplikaw effetti riproduttivi attribwibbli għal colesevelam.
English: PHARMACEUTICAL FORM AND CONTENTS 24 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: The recommended starting dose of Cholestagel is 6 tablets per day taken as 3 tablets twice per day with meals or 6 tablets once per day with a meal.
Maltese: Id-doża rrakkomandata tal-bidu ta' Cholestagel hi ta' 6 pilloli kuljum meħuda bħala 3 pilloli li jittieħdu darbtejn kuljum ma' l-ikel jew 6 pilloli darba kuljum ma' l-ikla.
English: - Cholestagel may be prescribed on its own in addition to a diet low in fat and cholesterol when treatment with a statin (a class of cholesterol-lowering medicines that work in the liver) is inappropriate or not well tolerated.
Maltese: - Cholestagel għandu mnejn jingħata bir-riċetta tat-tabib waħdu flimkien ma' dieta li hi baxxa fix-xaħam u l-kolesterol meta l-kura bi statin (klassi ta' mediċini li jbaxxu l-kolesterol li jaħdmu fil-fwied) ma tgħoddx jew ma tkunx ittolerata tajjeb.
English: This includes any possible side effects not listed in this leaflet.
Maltese: Mhux mistenni li jkun hemm effetti oħra partikolari.
English: Reductions were also seen for non-HDL-C, Total-C and Apo B. A small 5%, non-significant increase in triglycerides was noted.
Maltese: It-tnaqqis kien osservat ukoll għal non-HDL-C, Total-C u Apo B.
English: Cholestagel resulted in a statistically significant LDL-C reduction of 11% and 11% at 6 and 12 weeks vs an increase of 7% and 1% in the placebo group; mean baseline levels were 3.75 mmol/L and 3.86 mmol/L, respectively.
Maltese: fil-grupp tal-plaċebo; il-medja tal-livelli fil-linja bażi kienu 3.75 mmol/L u 3.86 mmol/L,
English: Κύπρος sanofi-aventis Cyprus Ltd. Τηλ: +357 22 871600
Maltese: Τηλ: +357 22 871600
English: • Anticoagulant therapy (medicines, such as warfarin, used to thin blood).
Maltese: • Terapija kontra l-koaġulazzjoni tad-demm (mediċini, bħal warfarin, li jintuża biex iraqqaq id-demm).
English: In these patients, monitoring vitamin A, D and E levels and assessing vitamin K status through the measurement of coagulation parameters is recommended and the vitamins should be supplemented if necessary.
Maltese: Fil-każ ta' dawn il-pazjenti, il-monitoraġġ tal-livelli tal-vitamina A, D u E u l-assessjar ta' l-istatus tal-vitamina K permezz tal-kejl tal-parametri ta'
English: Uncommon (may affect up to 1 in 100 people): muscle pain, raised levels of liver enzymes in your blood, difficulty in swallowing.
Maltese: Mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): uġigħ fil-muskoli, livelli għolja ta' enzimi tal-fwied fid-demm tiegħek, diffikultà biex tibla'.
English: No interaction was observed when Cholestagel was administered one hour after repaglinide.
Maltese: Ma kienet osservata l-ebda interazzjoni meta Cholestagel ingħata siegħa wara repaglinide.
English: Cholestagel did not induce any clinically significant reduction in the absorption of vitamins A, D, E or K during clinical studies of up to one year.
Maltese: Cholestagel ma ġiegħelx l-ebda tnaqqis sinifikanti kliniku fl-assorbiment tal-vitamini A,D, E jew K
English: The recommended dose for Cholestagel, when used with a statin or ezetimibe or both together, is 4 to 6 tablets a day by mouth.
Maltese: Id-doża rakkomandata ta' Cholestagel, meta jintuża ma' statin jew ezetimibe jew it-tnejn flimkien, hi ta' 4 sa 6 pilloli kuljum meħuda mill-ħalq.