FrancophonIA/ELRC3.0 huggingface dataset:
English: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o a fibrate (e.g. fenofibrate, gemfibrozil) o a statin (e.g. simvastatin, atorvastatin)
Maltese:  danazol (ormon magħmul mill-bniedem użat għall-kura ta' endometrijożi)  ciclosporin (mediċina li spiss tintuża f'pazjenti ta' trapjant tal-organi)  itraconazole, ketoconazole, fluconazole jew posaconazole (mediċini għal infezzjonijiet fungali)  Inibituri tal-protease tal-HIV bħal indinavir, nelfinavir, ritonavir u saquinavir (mediċini użati għal infezzjoni tal-HIV u AIDS)  glecaprevir jew pibrentasvir (jintużaw għall-kura ta' infezzjoni bil-virus tal-epatite Ċ)  erythromycin, clarithromycin, jew telithromycin (mediċini għal infezzjonijiet batterjali)  nefazodone (mediċina għad-depressjoni)  fibrat (eż. fenofibrate, gemfibrozil)  statin (eż. simvastatin, atorvastatin)
English: Concomitant administration of amiodarone, verapamil, amlodipine or diltiazem (see section 4.5) 4.4 Special warnings and precautions for use
Maltese: • L-għoti konkomittanti ta' amiodarone, verapamil, amlodipine jew diltiazem (ara sezzjoni 4.5)
English: • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia
Maltese: • Pankreatite kronika jew akuta bl-eċċezzjoni ta' pankreatite akuta minħabba ipertrigliċeridimja severa
English: Do not take Cholib:
Maltese: Kisja ta' barra:
English: Reduced function of transport proteins
Maltese: Funzjoni mnaqqsa ta' proteini tat-trasport
English: How to take Cholib
Maltese: X'fih Cholib
English: Galepharma Ltd. Tel: +356-21-22 14 22
Maltese: Tel: +356-21-22 14 22
English: Rhabdomyolysis with or without renal failure (see section 4.4),
Maltese: Rabdomijolisi bi jew mingħajr insuffiċjenza renali (ara sezzjoni 4.4),
English: The tablets are provided in carton boxes with blisters containing 10, 30 or 90 tablets.
Maltese: Il-pilloli jiġu f'kaxex tal-kartun b'folji li fihom 10, 30 jew 90 pillola.
English: • If you have moderate or severe kidney problems
Maltese: • Għandek problemi moderati jew severi bil-kliewi
English: Do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
Maltese: Tiħux fusidic acid (mediċina għal infezzjonijiet batterjali) waqt li tkun qed tieħu din il-mediċina.
English: Cholelithiasis uncommo n
Maltese: Is-sustanzi l-oħra huma:
English: Fenofibrate is a mild to moderate inhibitor of CYP 2C9 and a weak inhibitor of CYP 2C19 and CYP 2A6.
Maltese: Fenofibrate u simvastatin mhumiex inibituri ta' CYP 2D6, CYP 2E1, jew CYP 1A2. Fenofibrate huwa inibitur minn ħafif sa moderat ta' CYP 2C9 u inibitur dgħajjef ta CYP 2C19 u CYP 2A6.
English: Cholib is used in adults at high risk of problems like heart attack and stroke who have high blood levels of 2 types of fats (triglycerides and LDL cholesterol).
Maltese: Cholib jintuża fl-adulti b'riskju għoli ta' problemi bħal attakk tal-qalb u puplesija li għandhom livelli għoljin fid-demm ta' 2 tipi ta' xaħam (trigliċeridi u kolesterol LDL).
English: Myopathy ** In a clinical trial, myopathy occurred commonly in patients treated with simvastatin 80 mg/day compared to patients treated with 20 mg/day (1.0% vs 0.02%, respectively).
Maltese: Mijopatija ** Fi prova klinika, mijopatija seħħet b'mod komuni f'pazjenti li rċevew kura b'simvastatin 80 mg/kuljum meta mqabbla ma' pazjenti li rċevew kura b'20 mg/kuljum (1.0% kontra 0.02%, rispettivament).
English: Some cases of reversible paradoxical reduction of HDL-C have been reported during concomitant administration of fenofibrate and glitazones.
Maltese: Xi każijiet ta' tnaqqis paradossali riversibbli tal-HDL-C ġew irrapportati matul l-għoti konkomittanti ta' fenofibrate u glitazones.
English: Adverse reactions observed with the co-administration of fenofibrate and simvastatin (Cholib)
Maltese: Reazzjonijiet avversi osservati bl-għoti flimkien ta' fenofibrate u simvastatin (Cholib)
English: The risk of myopathy is increased by high levels of HMG CoA reductase inhibitory activity in plasma (i.e., elevated simvastatin and simvastatin acid plasma levels), which may be due, in part, to interacting drugs that interfere with simvastatin metabolism and/or transporter pathways (see section
Maltese: Ir-riskju ta' mijopatija jiżdied minn livelli għoljin ta' attività inibitorja ta' HMG CoA reductase filplażma (i.e. livelli għoljin ta' simvastatin u simvastatin acid fil-plażma), li jista' jkun dovut, parzjalment, minħabba mediċini li jinteraġixxu u b'hekk jinterferixxu mal-metaboliżmu ta' simvastatin u/jew mal-passaġġi tat-trasportatur (ara sezzjoni 4.5).
English: Additional information on the individual active substances of the fixed dose combination Additional adverse reactions associated with the use of medicinal products containing simvastatin or fenofibrate observed in clinical trials and postmarketing experience that may potentially occur with Cholib are listed below.
Maltese: Informazzjoni addizzjonali dwar is-sustanzi attivi individwali fil-kombinazzjoni tad-doża fissa Reazzjonijiet avversi addizzjonali assoċjati mal-użu ta' prodotti mediċinali li fihom simvastatin jew fenofibrate osservati fi provi kliniċi u fl-esperjenza wara t-tqegħid fis-suq li potenzjalment jistgħu jseħħu b'Cholib huma elenkati hawn taħt.
English: Avoid with Cholib unless clinical benefit outweigh the risk
Maltese: Evita t-teħid ma' Cholib sakemm il-benefiċċju kliniku ma jegħlibx ir-riskju.
English: Non-HDL-C (mmol/L)
Maltese: Mhux-HDL-C (mmol/l)
English: The primary efficacy criterion was superiority of the combination fenofibrate 145 and simvastatin 40 mg versus simvastatin 40 mg on TG and LDL-C decrease and HDL-C increase at 12 weeks.
Maltese: Il-kriterju tal-effikaċja primarja kien is-superjorità tal-kombinazzjoni fenofibrate 145 u simvastatin 40 mg meta mqabbel ma' simvastatin 40 mg fuq TG u tnaqqis tal-LDL-C u żieda tal-HDL-C wara 12-il ġimgħa.
English: Of these, 2,474 subjects were randomized for 24 weeks treatment, 1,237 subjects received fenofibrate and simvastatin co-administration and 1,230 subjects received statin monotherapy all administered in the evening.
Maltese: Minn dawn, 2,474 individwu magħżula kif ġie ġie, tpoġġew fuq kura ta' 24 ġimgħa, 1,237 individwu rċivew l-għoti flimkien ta' fenofibrate u simvastatin u 1,230 individwu rċivew monoterapija bi statin ilkoll mogħtija filgħaxija.
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax of the active metabolites, fenofibric acid and simvastatin acid, of the fixed dose combination Cholib 145 mg/20 mg tablet and the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Maltese: Il-proporzjonijiet tal-medja ġeometrika u 90% CIs għat-tqabbil tal-AUC, AUC(0-t) u Cmax tal-metaboliti attivi, fenofibric acid u simvastatin acid, kienu simili wara l-għoti tal-kombinazzjoni tad-doża fissa tal-pillola Cholib 145 mg/20 mg u l-għoti flimkien tal-pilloli separati ta' 145 mg fenofibrate u 20 mg simvastatin kif użati fil-programm kliniku, kienu lkoll fi ħdan l-intervall ta' bijoekwivalenza ta' 80-125%.
English: Alu/Alu blisters
Maltese: Qabel il-kura
English: Pancreatitis * In the FIELD study, a randomised placebo-controlled trial performed in 9795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p=0.031).
Maltese: Pankreatite * Fl-istudju FIELD, prova randomized ikkontrollata bi plaċebo li saret fuq 9795 pazjent bid-dijabete mellitus tat-tip 2, kienet osservata żieda statistikament sinifikanti f'każijiet ta' pankreatite f'pazjenti li kienu qed jirċievu fenofibrate kontra pazjenti li kienu qed jirċievu plaċebo (0.8% kontra 0.5%; p=0.031).
English: The geometric mean ratios and 90% CIs for the comparison of AUC, AUC(0-t) and Cmax for fenofibric acid, simvastatin and simvastatin acid of the fixed dose combination Cholib 145 mg/40 mg tablet and the co-administration of the separate 145 mg fenofibrate and 40 mg simvastatin tablets as used in the clinical program, were all within the 80-125% bioequivalence interval.
Maltese: Il-proporzjonijiet tal-medja ġeometrika u 90% CIs għat-tqabbil tal-AUC, AUC(0-t) u Cmax għal fenofibric acid, simvastatin u simvastatin acid tal-kombinazzjoni tad-doża fissa tal-pillola Cholib 145 mg/40 mg u l-għoti flimkien tal-pilloli separati ta' 145 mg fenofibrate u 40 mg simvastatin kif użati fil-programm kliniku, kienu lkoll fi ħdan l-intervall ta' bijoekwivalenza ta' 80-125%.
English: 0504 pravastatin 40 mg pravastatin 40 mg simvastatin 20 mg pravastatin 40 mg simvastatin 40 mg
Maltese: 0504 pravastatin 40 m g pravastatin 40 m g simvastatin 20 mg pravastatin 40 m g simvastatin 40 mg
English: Reversible effects on fertility have been observed in animals (see section 5.3).
Maltese: Effetti riversibbli fuq il-fertilità ġew osservati fl-annimali (ara sezzjoni 5.3).
English: Cholib must not be co-administered with fusidic acid.
Maltese: Cholib ma għandux jingħata flimkien ma' fusidic acid.
English: As this medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Minħabba li dan il-prodott mediċinali fih il-lactose, pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, defiċjenza ta' Lapp lactase jew malassorbiment ta' glucose-galactose ma għandhomx jieħdu dan il-prodott mediċinali.
English: Cholib is indicated as adjunctive therapy to diet and exercise in high cardiovascular risk adult patients with mixed dyslipidaemia to reduce triglycerides and increase HDL-C levels when LDL-C levels are adequately controlled with the corresponding dose of simvastatin monotherapy.
Maltese: Cholib huwa indikat bħala terapija addizzjonali mad-dieta u l-eżerċizzju f'pazjenti adulti b'dislipidemija mħallta b'riskju kardjovaskulari għoli biex inaqqas it-trigliċeridi u jżid il-livelli tal-HDL-C meta l-livelli tal-LDL-C jkunu ikkontrollati b'mod adegwat bid-doża korrespondenti ta' monoterapija ta' simvastatin.
English: Through activation of PPAR, fenofibrate activates lipoprotein lipase production and reduces production of apoprotein CIII.
Maltese: Permezz tal-attivazzjoni ta' PPARα, fenofibrate jattiva l-produzzjoni ta' lipoprotein lipase u jnaqqas il-produzzjoni tal-apoproteina CIII.
English: Treatment should be interrupted when creatinine level is 50% above the upper limit of normal.
Maltese: Il-kura għandha tiġi interrotta meta l-livell tal-kreatinina jkun 50% ogħla mil-limitu ta' fuq tan-normal.
English: This was not significantly different from the 29% (90% CI 22%-35%) reduction in AUC of SVA observed when co-administration was 12 hours apart: simvastatin 40 mg in the evening and fenofibrate 145 mg in the morning.
Maltese: Dan ma kienx ferm differenti mit-tnaqqis ta' 29% (90% CI 22%-35%) fl-AUC ta' SVA osservat meta l-għoti flimkien kien 12-il siegħa minn xulxin: simvastatin 40 mg filgħaxija u fenofibrate 145 mg filgħodu.
English: The increased risk of venous thrombotic events may be related to the increased homocysteine level, a risk factor for thrombosis and other unidentified factors.
Maltese: Iż-żieda fir-riskju ta' avvenimenti trombotiċi fil-vini tista' tkun relatata maż-żieda fil-livell ta' homocysteine, fattur tar-riskju għal trombożi u fatturi oħra mhux identifikati.
English: • Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen
Maltese: • Fotoallerġija magħrufa jew reazzjoni fototossika matul kura b'fibrati jew b'ketoprofen
English: • you drink large amounts of alcohol (more than 21 units (210 mL) a week of pure alcohol)
Maltese: • tixrob ammonti kbar ta' alkoħol (aktar minn 21 unità (210 mL) fil-ġimgħa ta' alkoħol pur)
English: HDL-C levels are frequently increased.
Maltese: Livelli ta' HDL-C jiżdiedu b'mod frekwenti.
English: Secondary causes of hyperlipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment (like oral oestrogens), alcoholism should be adequately treated, before Cholib therapy is considered and patients should be placed on a standard cholesterol and triglycerides-lowering diet which should be continued during treatment.
Maltese: Kawżi sekondarji ta' iperlipidemija, bħad-dijabete mellitus tat-tip 2 li mhijiex ikkontrollata, ipotirojdiżmu, sindromu nefrotiku, dysproteinemia, mard tal-fwied ostruttiv, kura farmakoloġika (bħal estroġeni orali), alkoħoliżmu għandhom jiġi ikkurati b'mod adegwat, qabel ma tiġi kkunsidrata terapija b'Cholib u l-pazjenti għandhom jitqiegħdu fuq dieta standard li tbaxxi l-kolesterol u t-trigliċeridi li għandha titkompla waqt il-kura.
English: Statin monotherapy
Maltese: Monoterapija bi statin
English: rare unkown
Maltese: Tqabbil tal-Kuri
English: The liver is the primary site of action of the active form.
Maltese: Il-fwied huwa s-sit ewlieni ta' azzjoni tal-forma attiva.
English: • gallstones
Maltese: • stitikezza
English: One film-coated tablet contains 145 mg of fenofibrate and 20 mg of simvastatin.
Maltese: Kull pillola fiha 145 mg ta' fenofibrate u 20 mg ta' simvastatin.
English: • increase in “urea” - produced by the kidneys - shown in tests
Maltese: • żieda fl-“urea” - prodott mill-kliewi - murija fit-testijiet
English: • If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o glecaprevir or pibrentasvir (used to treat hepatitis C virus infection) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression)
Maltese: • Inti diġà qed tieħu dawn il-mediċini li ġejjin:  danazol (ormon magħmul mill-bniedem użat għall-kura ta' endometrijożi)  ciclosporin (mediċina li spiss tintuża f'pazjenti ta' trapjant tal-organi)  itraconazole, ketoconazole, fluconazole jew posaconazole (mediċini għal infezzjonijiet fungali)  Inibituri tal-protease tal-HIV bħal indinavir, nelfinavir, ritonavir u saquinavir (mediċini użati għal infezzjoni bl-HIV u AIDS)  glecaprevir jew pibrentasvir (jintużaw għall-kura ta' infezzjoni bil-virus tal-epatite Ċ)  erythromycin, clarithromycin, jew telithromycin (mediċini għal infezzjonijiet batterjali)  nefazodone (mediċina għad-depressjoni)
English: • severe allergic skin rash with blisters
Maltese: • raxx allerġiku sever tal-ġilda bi bżieżaq
English: • increase in “glycosylated haemoglobin” and blood glucose levels - markers for blood glucose control in diabetes mellitus - shown in tests
Maltese: • żieda fil-“glycosylated haemoglobin” u l-livelli ta' glukożju fid-demm - markaturi ta' kontroll tal-glukożju fid-demm fid-dijabete mellitus - murija fit-testijiet
English: • Alcohol abuse
Maltese: • Abbuż tal-alkoħol
English: As a result of these changes the ratios of TC to HDL-C and LDL-C to HDL-C are reduced.
Maltese: Tibdil Perċentwal fit-TG, LDL-C u HDL-C mil-Linja
English: • If you are already taking the following medicines: o danazol (a man-made hormone used to treat endometriosis) o ciclosporin (a medicine often used in organ transplant patients) o itraconazole, ketoconazole, fluconazole or posaconazole (medicines for fungal infections) o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used for HIV infection and AIDS) o erythromycin, clarithromycin, or telithromycin (medicines for bacterial infections) o nefazodone (a medicine for depression) o amiodarone (a medicine for an irregular heartbeat) or verapamil (a medicine for high blood pressure, chest pain associated with heart disease, or other heart conditions) o hepatitis C antiviral agents such as elbasvir, grazoprevir, glecaprevir or pibrentasvir (used to treat hepatitis C virus infection)
Maltese: • Inti diġà qed tieħu dawn il-mediċini li ġejjin:  danazol (ormon magħmul mill-bniedem użat għall-kura ta' endometrijożi)  ciclosporin (mediċina li spiss tintuża f'pazjenti ta' trapjant tal-organi)  itraconazole, ketoconazole, fluconazole jew posaconazole (mediċini għal infezzjonijiet fungali)  Inibituri tal-protease tal-HIV bħal indinavir, nelfinavir, ritonavir u saquinavir (mediċini użati għal infezzjoni bl-HIV u AIDS)  erythromycin, clarithromycin, jew telithromycin (mediċini għal infezzjonijiet batterjali)  nefazodone (mediċina għad-depressjoni)  amiodarone (mediċina għal taħbit tal-qalb irregolari) jew verapamil (mediċina għal pressjoni tad-demm għolja, uġigħ fis-sider assoċjat ma' mard tal-qalb, jew kundizzjonijiet tal-qalb oħrajn)  aġenti antivirali tal-epatite Ċ bħal elbasvir, grazoprevir, glecaprevir jew pibrentasvir (jintużaw għall-kura ta' infezzjoni bil-virus tal-epatite Ċ)
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 33 00
Maltese: Mylan Healthcare Sp. z o.o. Tel: +48 22 546 64 00
English: Reversible ulcers and erosions in the gastro-intestinal tract occurred in dogs treated during 3 months at exposures approximately 7-fold the clinical AUC.
Maltese: Ulċeri u erożjonijiet riversibbli fil-passaġġ gastro-intestinali seħħew fil-klieb li rċevew kura fuq 3 xhur f'espożizzjonijiet madwar 7 darbiet l-AUC klinika.
English: Reduced function of hepatic OATP transport proteins can increase the systemic exposure of simvastatin and increase the risk of myopathy and rhabdomyolysis.
Maltese: Funzjoni mnaqqsa tal-proteini tat-trasport OATP epatiċi tista' żżid l-espożizzjoni sistemika ta' simvastatin u żżid ir-riskju ta' mijopatija u ta' rabdomijoliżi.
English: Cholib: Cholib contains fenofibrate and simvastatin, which have different modes of action as described above.
Maltese: Cholib: Cholib fih fenofibrate u simvastatin, li għandhom modi differenti ta' azzjoni kif deskritt hawn fuq.
English: The film-coated tablet (tablet) is a, oval, biconvex, brick red coloured 19.3 x 9.3 mm tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Maltese: Il-pillola miksija b'rita (pillola) hija pillola ovali, bikonvessa, ta' lewn aħmar bħall-brikks, 19,3 x 9,3 mm bix-xifer ġej għat-tond u mnaqqxa b'145/40 fuq naħa waħda u l-logo ta' Abbott fuq in-naħa l-oħra.
English: In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite of fenofibrate, toxicity for the skeletal muscles (particularly those rich in type I -slow oxidative- myofibres) and cardiac degeneration, anemia and decreased body weight were seen at exposure levels ≥50- fold the human exposure for the skeletal toxicity and >15 fold for the cardiomyotoxicity.
Maltese: Fi studju mhux kliniku li dam għaddej tliet xhur fuq firien b'fenofibric acid li ttieħed b'mod orali, il-metabolit attiv ta' fenofibrate, tossiċità għall-muskoli skeletali (partikularment dawk b'ammont kbir ta' mijofibri tat-tip I u b'ossidazzjoni baxxa) u deġenerazzjoni kardijaka, anemija u tnaqqis fil-piż tal-ġisem dehru f'livelli ta' espożizzjoni ta' ≥50 darba l-espożizzjoni umana għat-tossiċità skeletali u > 15-il darba għall-kardjomijotossiċità.
English: Maximum plasma concentrations (Cmax) of fenofibrate occur within 2 to 4 hours after oral administration.
Maltese: Il-konċentrazzjonijiet massimi fil-plasma (Cmax) ta' fenofibrate jseħħu fi żmien 2 sa 4 sigħat wara l-għoti orali.
English: One film-coated tablet contains 145 mg of fenofibrate and 40 mg of simvastatin.
Maltese: Kull pillola fiha 145 mg ta' fenofibrate u 40 mg ta' simvastatin.
English: • you are taking hepatitis C antiviral agents such as elbasvir or grazoprevir (used to treat hepatitis
Maltese: • inti qed tieħu aġenti antivirali tal-epatite Ċ bħal elbasvir jew grazoprevir (jintużaw għall-kura ta' infezzjoni bil-virus talepatite Ċ)
English: Hepatobiliary disorders Transaminases increased common
Maltese: Żieda fit-transaminase komuni
English: Maternal treatment with simvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis.
Maltese: Kura materna b'simvastatin tista' tnaqqas il-livelli ta' mevalonate fil-fetu li huwa prekursur tal-bijosintesi tal-kolesterol.
English: Oval, biconvex, brick red coloured, 19.3 x 9.3 mm film-coated tablet with bevelled edges and the inscription 145/40 on one side and the Abbott logo on the other side.
Maltese: Pillola ovali, bikonvessa, ta' lewn aħmar bħall-brikks, 19.3 x 9.3 mm miksija b'rita b'xifer ġej għat-tond u mnaqqxa b'145/40 fuq naħa waħda u l-logo ta' Abbott fuq in-naħa l-oħra.
English: België/Belgique/Belgien Mylan EPD sprl-bvba
Maltese: Suomi/Finland Mylan Finland Oy Puh/Tel:
English: Hepatic disorders
Maltese: Disturbi epatiċi
English: The geometric mean ratios and 90% CIs for the comparison of plasma exposure (AUC and AUC(0-t)) to simvastatin after administration of the fixed dose combination Cholib 145 mg/20 mg tablet and after co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program, were within the 80-125% bioequivalence interval.
Maltese: Il-proporzjonijiet tal-medja ġeometrika u 90% CIs għat-tqabbil tal-espożizzjoni fil-plasma (AUC u AUC(0-t)) għal simvastatin wara l-għoti tal-kombinazzjoni tad-doża fissa tal-pillola Cholib 145 mg/20 mg u wara l-għoti flimkien tal-pilloli separati ta' 145 mg fenofibrate u 20 mg simvastatin kif użati fil-programm kliniku, kienu fi ħdan l-intervall ta' bijoekwivalenza ta' 80-125%
English: The usual dose is recommended, except for decreased renal function with estimated glomerular filtration rate < 60 mL/min/1.73 m where Cholib is contraindicated
Maltese: Id-doża tas-soltu hija rakkomandata, ħlief għal tnaqqis fil-funzjoni renali b'rata stmata ta' filtrazzjoni glomerulari ta' < 60 mL/min/1.73 m fejn
English: BGP Products UAB Tel: +370 52 051 288
Maltese: Tel: +370 52 051 288
English: Drugs or herbal products that inhibit certain enzymes (e.g. CYP3A4) and/or transporter (e.g. OATP1B) pathways may increase simvastatin and simvastatin acid plasma concentrations and may lead to an increased risk of myopathy/rhabdomyolysis.
Maltese: Mediċini jew prodotti li ġejjin mill-ħxejjex li jinibixxu ċerti enzimi (eż. CYP3A4) u/jew il-passaġġi tat-trasportaturi (e.ż OATP1B), jistgħu jżidu l-konċentrazzjonijiet ta' simvastatin u ta' simvastatin acid fil-plażma, u jwasslu għal żieda akbar fir-riskju ta' mijopatija/rabdomijolisi.
English: This is because on rare occasions, there have been cases of serious muscle problems including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
Maltese: Dan minħabba li f'okkażjonijiet rari, kien hemm każijiet ta' problemi serji fil-muskoli inkluż deterjorament tal-muskoli li jirriżulta fi ħsara fil-kliewi, u kien hemm każijiet rari ta' mwiet.
English: Concomitant administration of diltiazem and simvastatin caused a 2.7-fold increase in exposure of simvastatin acid, presumable due to inhibition of CYP 3A4.
Maltese: L-għoti konkomittanti ta' diltiazem u simvastatin ikkawża żieda ta' 2.7 darbiet fl-espożizzjoni għal simvastatin acid, x'aktarx minħabba l-inibizzjoni ta' CYP 3A4.
English: (See sections 4.4 and 4.5.)
Maltese: (Ara sezzjonijiet 4.4 u 4.5)
English: • If you are allergic to peanut, arachis oil, soya lecithin or related substances
Maltese: • Inti allerġiku għal karawett, żejt tal-arakis, leċitina tas-soja jew sustanza relatata
English: Whether fenofibrate had an effect on other active metabolites of simvastatin was not investigated.
Maltese: Il-fatt jekk fenofibrate kellux effett fuq metaboliti attivi oħrajn ta' simvastatin ma ġiex investigat.
English: Simva 40
Maltese: Ara sezzjoni 4.