FrancophonIA/ELRC3.0 huggingface dataset:
English: The corresponding risk is 0.3% in patients having the most common genotype (TT) (See section
Maltese: Ir-riskju korrespondenti huwa ta' 0.3% f'pazjenti li għandhom l-aktar ġenotip komuni (TT) (Ara sezzjoni 5.2).
English: Fenofibrate plus simvastatin therapy did not show any significant differences compared to simvastatin monotherapy in the composite primary outcome of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death (hazard ratio [HR] 0.92, 95% CI 0.79-1.08, p = 0.32; absolute risk reduction: 0.74%).
Maltese: Terapija ta' fenofibrate flimkien ma' simvastatin ma wriet l-ebda differenza sinifikanti meta mqabbla ma' monoterapija b'simvastatin fir-riżultat primarju kompost ta' infart mijokardijaku mhux fatali, puplesija mhux fatali, u mwiet kardjovaskulari (proporzjon tal-periklu [HR] 0.92, 95% CI 0.79-1.08, p=0.32; tnaqqis assolut tar-riskju: 0.74%).
English: Common
Maltese: komuni
English: Musculoskeletal, connective tissue disorders
Maltese: Disturbi muskolu-skeletriċ i u tat-tessuti konnettivi
English: One film-coated tablet contains, 194.7 mg of lactose (as monohydrate), 145 mg of sucrose and 0.8 mg of lecithin (derived from soya bean (E322)).
Maltese: Kull pillola miksija b'rita fiha, 194.7 mg ta' lactose (bħala monoidrat), 145 mg ta' sucrose u 0.8 mg ta' leċitina (derivata mill-fażola tas-soja (E322)).
English: In elderly patients, the fenofibric acid apparent total plasma clearance is not modified.
Maltese: F'pazjenti anzjani, it-tneħħija totali apparenti ta' fenofibric acid mill-plasma ma tiġix modifikata.
English: The geomean maximum plasma level (Cmax) of the inactive parent simvastatin was 2.7 ng/mL for the fixed dose combination Cholib 145 mg/20 mg tablet and 3.9 ng/mL for the co-administration of the separate 145 mg fenofibrate and 20 mg simvastatin tablets as used in the clinical program.
Maltese: Il-livell massimu ġeomedju fil-plasma (Cmax) tas-sustanza primarja inattiva simvastatin kien 2.7 ng/mL għad-doża fissa tal-pillola Cholib 145 mg/20 mg ta' kombinazzjoni u 3.9 ng/mL għall-għoti flimkien tal-pilloli separati ta' 145 mg fenofibrate u 20 mg simvastatin kif użati fil-programm kliniku.
English: In a pooled analysis of these four trials, the rate of discontinuation due to treatment emergent adverse reactions was 5.0% (51 subjects on 1012) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/20 mg per day and 1.8% (4 subjects on 225) after 12 weeks of treatment with fenofibrate and simvastatin 145 mg/40 mg per day.
Maltese: F'analiżi miġbura ta' dawn l-erba' provi, ir-rata ta' twaqqif minħabba reazzjonijiet avversi tal-kura kienet ta' 5.0% (51 individwu minn 1012) wara 12-il ġimgħa ta' kura b'fenofibrate u simvastatin 145 mg/20 mg kuljum u ta' 1.8% (4 individwi minn 225) wara 12-il ġimgħa ta' kura b'fenofibrate u simvastatin 145 mg/40 mg kuljum.
English: The mean exposure (AUC) of the main active metabolite, simvastatin acid is 120% in heterozygote carriers (CT) of the C allele and 221% in homozygote (CC) carriers relative to that of patients who have the most common genotype (TT).
Maltese: Lespożizzjoni medja (AUC) tal-metabolit attiv prinċipali, simvastatin acid hija 120% f'trasportaturi eterożigoti (CT) ta' C-allele u 221% f'trasportaturi omożigoti (CC) meta mqabbla ma' dik ta' pazjenti li kellhom il-ġenotip l-aktar komuni (TT).
English: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of ciclosporin with simvastatin.
Maltese: Ir-riskju ta' mijopatija/rabdomijolisi jiżdied bl-għoti konkomittanti ta' ciclosporin ma' simvastatin.
English: Following an oral dose of radioactive simvastatin to man, 13% of the radioactivity was excreted in the urine and 60% in the faeces within 96 hours.
Maltese: Wara doża orali ta' simvastatin radjuattiv lill-bnedmin, 13% tar-radjoattività ġiet eliminata fl-awrina u 60% fl-ippurgar fi żmien 96 siegħa.
English: Embryotoxic effects were observed at doses in the range of maternal toxicity.
Maltese: Effetti embrijotossiċi kienu osservati f'dożi fil-firxa ta' tossiċità materna.
English: CYP 3A4 inhibitors: fluconazole, verapamil, or diltiazem (see sections 4.3 and 4.4).
Maltese: Għandha tiġi eżerċitata l-kawtela meta Cholib jiġi kkombinat ma' inibituri inqas qawwija ta' CYP 3A4: fluconazole, verapamil, jew diltiazem (ara sezzjonijiet 4.3 u 4.4).
English: Memory impairment/Memory loss rare
Maltese: Indeboliment fil-memorja/Telf tal-memorja rari
English: Simvastatin is an inactive lactone which is readily hydrolyzed in vivo to the corresponding beta-hydroxyacid, a potent inhibitor of HMG-CoA reductase.
Maltese: Simvastatin huwa lactone inattiv li jiġi faċilment idrolizzat in vivo għal beta-hydroxyacid korrispondenti, inibitur qawwi ta' HMG-CoA reductase.
English: Renal function Cholib is contraindicated in moderate to severe renal impairment (see section 4.3).
Maltese: Cholib huwa kontraindikat f'indeboliment renali minn moderat għal sever (ara sezzjoni 4.3).
English: Mean plasma half-life: the plasma elimination half-life of fenofibric acid is approximately 20 hours.
Maltese: Il-medja tal-half-life fil-plasma: il-half-life tal-eliminazzjoni ta' fenofibric acid fil-plasma hija ta' madwar 20 siegħa.
English: Cholib must not be given to children and adolescents (age below 18 years).
Maltese: Cholib ma għandux jingħata lil tfal u adolexxenti (li jkollhom inqas minn 18-il sena).
English: This medicine contains less than 1 mmol sodium (23 mg) per one tablet, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: One film-coated tablet contains 160.1 mg of lactose (as monohydrate), 145 mg of sucrose, 0.7 mg of lecithin (derived from soya bean (E322)) and 0.17 mg of sunset yellow FCF (E110).
Maltese: Kull pillola miksija b'rita fiha 160.1 mg ta' lactose (bħala monoidrat), 145 mg ta' sucrose, 0.7 mg ta' leċitina (derivata mill-fażola tas-soja (E322)) u 0.17 mg ta' sunset yellow FCF (E110).
English: Once a stable INR has been documented, it can be monitored at the intervals usually recommended for patients on those oral anticoagulants.
Maltese: Ladarba jiġi dokumentat INR stabbli, jista' jiġi mmonitorjat fl-intervalli normalment rakkomandati għal pazjenti fuq dawk l-antikoagulanti orali.
English: Thromboembolism * In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% [32/4900 patients] in the placebo group versus 1.1% [53/4895 patients] in the fenofibrate group; p = 0.022) and a statistically non-significant increase in deep vein thromboses (placebo: 1.0% [48/4900 patients] versus fenofibrate 1.4% [67/4895 patients]; p=0.074).
Maltese: Tromboemboliżmu * Fl- istudju FIELD, kienet irrapportata żieda statistikament sinifikanti fl-inċidenza ta' emboliżmu pulmonari (0.7% [32/4900 pazjent] fil-grupp tal-plaċebo kontra 1.1% [53/4895 pazjent] fil-grupp ta' fenofibrate; p=0.022) u żieda mhux statistikament sinifikanti f'trombożi profonda fil-vini (plaċebo: 1.0% [48/4900 pazjent] kontra fenofibrate 1.4% [67/4895 pazjent]; p=0.074).
English: However reversible hypospermia and testicular vacuolation and immaturity of the ovaries were observed in a repeat-dose toxicity study with fenofibric acid in young dogs.
Maltese: Madankollu kienu osservati ipospermja u vakulazzjoni testikulari riversibbli u immaturità tal-ovarji fi studji ta' tossiċità b'dożi ripetuti b'fenofibric acid fil-klieb żgħar.
English: At 12 weeks and 24 weeks the combination of fenofibrate 145 mg and simvastatin 40 mg (F145/S40) showed superiority over simvastatin 40 mg (S40) for TG reduction and HDL-C increase.
Maltese: Wara 12-il ġimgħa u 24 ġimgħa, il-kombinazzjoni ta' fenofibrate 145 u simvastatin 40 mg (F145/S40) uriet superjorità fuq simvastatin 40 mg (S40) għal tnaqqis tat-TG u żieda tal-HDL-C.
English: Mylan Healthcare Sp. z o.o.
Maltese: Mylan Healthcare B.V.
English: The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic fusidic acid with statins.
Maltese: Ir-riskju ta' mijopatija inkluż rabdomijaliżi jista' jiżdied bl-għoti fl-istess ħin ta' fusidic acid sistemiku ma' statins.
English: Therapy with Cholib should be temporarily stopped a few days prior to elective major surgery and when any major medical or surgical condition supervenes.
Maltese: Terapija b'Cholib għandha titwaqqaf temporanjament ftit ġranet qabel kirurġija elettiva maġġuri u meta tinqala' xi kundizzjoni medika jew kirurġika maġġuri.
English: Fenofibrate is not a substrate for CYP 3A4.
Maltese: Fenofibrate mhuwiex substrat għal CYP 3A4.
English: In addition, they both raise levels of “good” cholesterol (HDL cholesterol).
Maltese: Barra minn hekk, it-tnejn iżidu l-livelli ta' kolesterol it-“tajjeb” (kolesterol HDL).
English: Glycosylated haemoglobin increased not known
Maltese: Żieda fil-glycosylated haemoglobin mhux magħrufa
English: Simvastatin has been shown to reduce both normal and elevated LDL-C concentrations.
Maltese: Intwera li simvastatin jnaqqas kemm konċentrazzjonijiet normali u elevati tal-LDL-C.
English: Other statins and fibrates
Maltese: Statins u fibrati oħra
English: Diabetes mellitus ****Diabetes mellitus: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Maltese: Dijabete mellitus **** Dijabete mellitus: Pazjenti li qegħdin f'riskju (glukosju waqt is-sawm ta' 5.6 sa 6.9 mmol/L, BMI > 30 kg/m2, trigliċeridi elevati, pressjoni għolja) għandhom jiġu mmonitorjati kemm klinikament kif ukoll biokimikament skont linji gwida nazzjonali.
English: Inhibitors of Breast Cancer Resistant Protein (BCRP) Concomitant administration of medicinal products that are inhibitors of BCRP, including products containing elbasvir or grazoprevir, may lead to increased plasma concentrations of simvastatin and an increased risk of myopathy (see sections 4.2 and 4.4).
Maltese: L-għoti fl-istess ħin ta' prodotti mediċinali li huma inibituri tal-BCRP, inkluż prodotti li fihom elbasvir jew grazoprevir, jista' jwassal għall-żieda fil-konċentrazzjonijiet fil-plażma ta' simvastatin u riskju miżjud ta' mijopatija (ara sezzjonijiet 4.2 u 4.4).
English: The repeated administration of simvastatin 40 or 80 mg, the highest dose registered, did not affect the plasma levels of fenofibric acid at steady state.
Maltese: L-għoti ripetut ta' simvastatin 40 jew 80 mg, l-ogħla doża reġistrata, ma affettwax il-livelli tal-plasma ta' fenofibric acid fi stat fiss.
English: • Hypersensitivity to the active substances, peanut, soya or to any of the excipients listed in section 6.1 (see also section 4.4)
Maltese: • Sensittività eċċessiva għas-sustanzi attivi, karawett, soja jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1 (ara wkoll sezzjoni 4.4)
English: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30 kg/m2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Maltese: Pazjenti f'riskju (glukosju waqt is-sawm ta' 5.6 sa 6.9 mmol/L, BMI > 30 kg/m2, trigliċeridi elevati, pressjoni għolja) għandhom jiġu mmonitorjati kemm klinikament kif ukoll bioklinikament skont linji gwida nazzjonali.
English: The protein binding of simvastatin and its active metabolite is > 95%.
Maltese: L-irbit ta' simvastatin u l-metabolit attiv tiegħu mal-proteini huwa ta' > 95%.
English: Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway.
Maltese: Gemfibrozil iżid l-AUC ta' simvastatin acid b'1.9 darbiet, possibbilment minħabba l-inibizzjoni tal-passaġġ ta' glukuronidazzjoni.
English: • Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase elevation above 5 times the upper limit of normal (ULN) under previous statin treatment (see section 4.4)
Maltese: • Passat mediku personali ta' mijopatija u/jew rabdomijolisi b'statins u/jew fibrati jew żieda kkonfermata fil-creatine phosphokinase ta' aktar minn 5 darbiet l-ogħla limitu tan-normal (ULN) taħt kura preċedenti b'statin (ara sezzjoni 4.4)
English: The active substances are fenofibrate and simvastatin.
Maltese: Is-sustanzi attivi huma fenofibrate u simvastatin.
English: Cholib 145 mg/40 mg tablets fenofibrate/simvastatin
Maltese: Cholib 145 mg/40 mg pilloli fenofibrate/simvastatin
English: • colchicine (a medicine used to treat gout)
Maltese: • colchicine (mediċina użata biex tikkura l-gotta)
English: Prescribing recommendations for interacting substances are summarised in the table below (see also sections 4.2 and 4.3).
Maltese: Ir-rakkomandazzjonijiet tal-preskrizzjoni għal sustanzi li jinteraġixxu huma mqassra fit-tabella hawn taħt (ara wkoll sezzjonijiet 4.2 u 4.3).
English: The availability of the beta-hydroxyacid to the systemic circulation following an oral dose of simvastatin was found to be less than 5% of the dose.
Maltese: Id-disponibbiltà tal-beta-hydroxyacid għaċ-ċirkolazzjoni sistemika wara doża orali ta' simvastatin instabet li kienet inqas minn 5% tad-doża.
English: Avoid when taking Cholib
Maltese: Evita waqt it-teħid ta' Cholib
English: Multiple mechanisms may contribute to potential interactions with HMG Co-A reductase inhibitors.
Maltese: Mekkaniżmi multipli jistgħu jikkontribwixxu għal interazzjonijiet potenzjali ma' inibituri ta' HMG Co-A reductase.
English: In the larger study a reduction of 21% (90% CI 14%-27%) in AUC of SVA was observed after repeated co-administration of simvastatin 40 mg and fenofibrate 145 mg in the evening.
Maltese: Fl-istudju l-kbir, tnaqqis ta' 21% (90% CI 14%-27%) fl-AUC ta' SVA ġie osservat wara ko-amministrazzjoni ripetuta ta' simvastatin 40 mg u fenofibrate 145 mg filgħaxija.
English: In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p=0.022) and a statistically non significant increase in deep vein thrombosis (placebo 1.0% 48/4900 patients) versus fenofibrate 1.4% (67/4895); p=0.074.
Maltese: Fl-istudju FIELD, kienet irrapportata żieda statistikament sinifikanti fl-inċidenza ta' emboliżmu pulmonari (0.7% fil-grupp tal-plaċebo kontra 1.1% fil-grupp ta' fenofibrate; p=0.022) u żieda mhux statistikament sinifikanti fi trombożi profonda fil-vini (plaċebo 1.0% 48/4900 pazjent) kontra fenofibrate 1.4% (67/4895); p=0.074.
English: • pioglitazone (a particular class of medicines to treat diabetes)
Maltese: • pioglitazone (klassi partikolari ta' mediċini għall-kura tad-dijabete)
English: Cholib 145 mg/20 mg tablets fenofibrate/simvastatin
Maltese: Cholib 145 mg/20 mg pilloli fenofibrate/simvastatin
English: • increase in “creatine phosphokinase” - produced by the muscle - shown in tests
Maltese: • żieda fil-“creatine phosphokinase” - prodott mill-muskolu - murija fit-testijiet
English: Βαρνάβας Χατζηπαναγής Λτδ (Varnavas Hadjipanayis Ltd) Τηλ: +357 22207700
Maltese: Βαρνάβας Χατζηπαναγής Λτδ (Varnavas Hadjipanayis Ltd)
English: • Elderly ≥ 65 years
Maltese: • Anzjani ≥ 65 sena
English: Studies on mutagenicity of fenofibrate have been negative.
Maltese: Studji dwar il-mutaġeniċità ta' fenofibrate kienu negattivi.
English: Cholib therapy has not been associated with bleeding in patients not taking anticoagulants.
Maltese: Terapija b'Cholib ma ġietx assoċjata ma' fsada f'pazjenti li ma kinux qed jieħdu antikoagulanti.
English: Skeletal muscle toxicity, including rare cases of rhabdomyolysis with or without renal failure, has been reported with administration of lipid-lowering substances like fibrates and statins.
Maltese: Tossiċità fil-muskoli skeletali, inkluż każijiet rari ta' rabdomijolisi bi jew mingħajr insuffiċjenza renali, ġiet irrapportata bl-għoti ta' sustanzi li jbaxxu l-lipidi bħal fibrati u statins.
English: The most commonly reported adverse drug reactions (ADRs) during Cholib therapy are increased blood creatinine, upper respiratory tract infection, increased platelet count, gastroenteritis and increased alanine- aminotransferase.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADRs) li ġew irrapportati b'mod komuni matul terapija b'Cholib huma żieda fil-kreatinina fid-demm, infezzjoni fl-apparat respiratorju ta' fuq, żieda fl-għadd tal-plejtlits, gastroenterite u żieda fl-alanine- aminotransferase.
English: Severe cutaneous reactions (e.g erythema multiforme,
Maltese: Reazzjonijiet severi tal-ġilda (eż. eritema multiformi, sindromu ta'
English: In one study the AUC of the simvastatin acid (SVA), a major active metabolite of simvastatin, was reduced by 42% (90% CI 24%-56%) when a single dose of 40 mg simvastatin was combined with repeated administration of fenofibrate 160 mg.
Maltese: Fi studju wieħed, l-AUC ta' simvastatin acid (SVA), metabolit attiv maġġuri ta' simvastatin, tnaqqset bi 42% (90% CI 24%-56%) meta doża waħda ta' simvastatin 40 mg ingħatat ma' għotja ripetuta ta' fenofibrate 160 mg.
English: Cases of myopathy/rhabdomyolysis have been associated with concomitant administration of statins and niacin (nicotinic acid) at lipid-modifying doses (≥ 1 g/day), knowing that niacin and statins can cause myopathy when given alone.
Maltese: Każijiet ta' mijopatija/rabdomijolisi kienu assoċjati mal-għoti konkomittanti ta' statins u niacin (nicotinic acid) f'dożi li jimmodifikaw il-lipidi (≥ 1 g/kuljum), bl-għarfien li niacin u statins jistgħu jikkawżaw mijopatija meta jingħataw weħidhom.
English: In addition, simvastatin moderately increases HDL-C and reduces plasma TG.
Maltese: Barra minn hekk, simvastatin iżid b'mod moderat l-HDL-C u jnaqqas it-TG fil-plasma.
English: Pancreatitis has been reported in patients taking fenofibrate (see sections 4.3 and 4.8).
Maltese: Il-pankreatite ġiet irrapportata f'pazjenti li kienu qed jieħdu fenofibrate (ara sezzjonijiet 4.3 u 4.8).
English: • digestive disturbances (stomach pain, nausea, vomiting, diarrhoea and flatulence)
Maltese: • disturbi diġestivi (uġigħ fl-istonku, dardir, rimettar, dijarea u gass)
English: The risk of muscle toxicity may be increased if Cholib is administered with another fibrate, statin, niacin, fusidic acid or other specific concomitant substances (for specific interactions see section 4.5).
Maltese: Ir-riskju ta' tossiċità fil-muskoli jista' jiżdied jekk Cholib jingħata ma' fibrat ieħor, statin, niacin, fusidic acid jew sustanzi speċifiċi oħra konkomittanti (għal interazzjonijiet speċifiċi ara sezzjoni 4.5).
English: Patients receiving co-administration of Cholib and drugs metabolised by CYP 2C19, CYP 2A6, or especially CYP 2C9 with a narrow therapeutic index should be carefully monitored and, if necessary, dose adjustment of these drugs is recommended.
Maltese: Pazjenti li jkunu qed jirċievu l-għoti ta' Cholib flimkien ma' mediċini metabolizzati permezz ta' CYP 2C19, CYP 2A6, jew speċjalment CYP 2C9 b'indiċi terapewtiku dejjaq għandhom jiġu mmonitorjati bir-reqqa u, jekk ikun hemm il-ħtieġa, l-aġġustament tad-doża ta' dawn il-mediċini hija rakkomandata.
English: Based on the results of the SEARCH trial, homozygote C allele carriers (also called CC) treated with 80 mg have a 15% risk of myopathy within one year, while the risk in heterozygote C allele carriers (CT) is 1.5%.
Maltese: Abbażi tar-riżultati tal-prova SEARCH, it-trasportaturi C allele omożigotiċi (imsejħin ukoll CC) ikkurati bi 80 mg għandhom 15% riskju ta' mijopatija fi żmien sena, filwaqt li r-riskju f'trasportaturi C allele eterożigotiċi (CT) huwa ta' 1.5%.
English: This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
Maltese: Din l-enzima tikkatalizza l-konverżjoni ta' HMG-CoA f'mevalonate, pass bikri u li jillimita r-rata tal-bijosintesi tal-kolesterol.
English: The use of micronised fenofibrate and NanoCrystal® technology for the formulation of the fenofibrate 145 mg tablet enhances its absorption.
Maltese: L-użu ta' fenofibrate mikronizzat u teknoloġija ta' NanoCrystal għall-formolazzjoni tal-pillola ta' 145 mg fenofibrate jtejjeb l-assorbiment tiegħu.
English: The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with simvastatin.
Maltese: Ir-riskju ta' mijopatija u rabdomijolisi jiżdied bl-għoti konkomittanti ta' danazol ma' simvastatin.
English: *Treatment Comparison consists of the difference between the LS-means for Feno 145 + Simva 40 an d Simva 40, as well as the corresponding 95% CI.
Maltese: *Tqabbil tal-Kuri jikkonsisti mid-differenzi bejn il-Medji ta' LS għal Feno 145 + Simva 40 u Simva 40, kif ukoll 95% CI korrespondenti.
English: Therefore, the co-administration of Cholib with danazol is contraindicated (see section 4.3).
Maltese: Cholib huwa kontraindikat (ara sezzjoni 4.3).
English: Blood creatinine increased (see sections 4.3 and 4.4)
Maltese: Żieda fil-kreatinina fid-demm (ara sezzjonijiet 4.3 u 4.4)
English: Nervous system disorders Headache uncommon
Maltese: Disturbi fis-sistema nervuża
English: Contraindicated with Cholib 145 mg/40 mg
Maltese: Kontraindikat ma' Cholib 145 mg/40 mg
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Maltese: L-effett ġenerali huwa tnaqqis fil-proporzjon ta' lipoproteini ta' densità baxxa u baxxa ħafna għal lipoproteini ta' densità għolja.
English: 10 film-coated tablets 30 film-coated tablets 90 film coated tablets
Maltese: 10 pilloli miksijin b'rita 30 pillola miksijin b'rita 90 pillola miksija b'rita
English: Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if aspartate aminotransferase (AST) or also known as serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) or also known as serum glutamic pyruvic transaminase (SGPT) levels increase to more than 3 times the upper limit of the normal range.
Maltese: Għandha tingħata attenzjoni lil pazjenti li jiżviluppaw żieda fil-livelli tat-transaminase u t-terapija għandha titwaqqaf jekk il-livelli ta' aspartate aminotransferase (AST), magħruf ukoll bħala serum glutamic oxaloacetic transaminase (SGOT) u ta' alanine aminotransferase (ALT) jew magħruf ukoll bħala serum glutamic pyruvic transaminase (SGPT) jiżdiedu aktar minn 3 darbiet l-ogħla livell tal-firxa normali.
English: Cholib is contraindicated in patients with moderate to severe renal insufficiency whose estimated glomerular filtration rate is < 60 mL/min/1.73 m
Maltese: Cholib huwa kontraindikat f'pazjenti b'insuffiċjenza renali minn moderata għal severa b'rata stmata ta' filtrazzjoni glomerulari ta' < 60 mL/min/1.73 m
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: • feeling exhausted (astenia)
Maltese: • tħossok eżawrit/a (astenia)
English: • Concomitant administration of glecaprevir, pibrentasvir, elbasvir or grazoprevir (see section
Maltese: • L-għoti konkomitanti ta' glecaprevir, pibrentasvir, elbasvir jew grazoprevir (ara sezzjoni 4.5)