FrancophonIA/ELRC3.0 huggingface dataset:
English: Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (comprised of cellulose, microcrystalline and silica, colloidal anhydrous), ascorbic acid (E300).
Maltese: Butylhydroxyanisole (E320), lactose monohydrate, sodium laurilsulfate, starch, pregelatinised (maize), docusate sodium, sucrose, citric acid monohydrate (E330), hypromellose (E464), crospovidone (E1202), magnesium stearate (E572), silicified microcrystalline cellulose (magħmul minn cellulose, microcrystalline u silica, colloidal anhydrous), ascorbic acid (E300).
English: Anaemia rare
Maltese: Anemija rari
English: Carriers of the SLCO1B1 gene c.521T>C allele have lower OATP1B1 activity.
Maltese: Trasportaturi tal-ġene SLCO1B1 c.521T>C allele għandhom attività OATP1B1 iktar baxxa.
English: Lecithin (derived from soya bean (E322)) Xanthan gum (E415)
Maltese: Lecithin (derivata mill-fażola tas-soja (E322)) Xanthan gum (E415)
English: Fenofibric acid is not eliminated by hemodialysis.
Maltese: Fenofibric acid ma jiġix eliminat bl-emodijaliżi.
English: Following an intravenous injection of the beta-hydroxyacid metabolite, its half-life averaged 1.9 hours.
Maltese: Wara injezzjoni tal-metabolit beta-hydroxyacid ġol-vina, il-half-life tiegħu kellu medja ta' 1.9 sigħat.
English: Interactions relevant to monotherapies Inhibitors of CYP 3A4
Maltese: Interazzjonijiet rilevanti għal monoterapiji Inibituri ta' CYP 3A4
English: Contains: lactose, sucrose, lecithin (derived from soya bean (E322)), sunset yellow FCF (E110).
Maltese: Fih: lactose, sucrose, lecithin (miksub mil-fażola tas-soja (E322)), sunset yellow FCF (E110).
English: Immune-mediated necrotizing myopathy (IMNM)
Maltese: Mijopatija li tinnekrotizza medjata mis-sistema immunitarja (IMNM)
English: • If you are under 18 years of age
Maltese: • Għandek inqas minn 18-il sena
English: Adverse reactions (simvastatin)
Maltese: Reazzjonijiet avversi (simvastatin)
English: The major metabolites of simvastatin present in human plasma are the beta-hydroxyacid and four additional active metabolites.
Maltese: Il-metaboliti maġġuri ta' simvastatin preżenti fil-plasma umana huma l-beta-hydroxyacid u erba' metaboliti attivi addizzjonali.
English: • Hypoalbuminaemia
Maltese: • Ipoalbuminemija
English: Statin 6 weeks run-in
Maltese: Run-in ta' 6 ġimgħat ta' Statin
English: Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are mediated via activation of Peroxisome Proliferator Activated Receptor type alpha (PPAR).
Maltese: Fenofibrate huwa derivat ta' fibric acid li l-effetti tiegħu ta' modifikazzjoni tal-lipidi rapportati fil-bnedmin huma medjati permezz tal-attivazzjoni ta' Peroxisome Proliferator Activated Receptor type alpha (PPARα).
English: España Mylan pharmaceuticals S.L.
Maltese: España Mylan pharmaceuticals
English: Week 0 to Week 12
Maltese: Ġimgħa 0 sa Ġimgħa 12
English: Cholib contains soya lecithin.
Maltese: Cholib fih leċitina tas-soja.
English: • Personal or familial history of hereditary muscular disorders
Maltese: • Passat mediku personali jew familjari ta' disturbi muskolari ereditarji
English: Week 12 to Week 24
Maltese: Ġimgħa 12 sa Ġimgħa 24
English: Tendinopathy Immune-mediated necrotizing myopathy (see section 4.4)
Maltese: Mijopatija li tinnekrotizza medjata mis-sistema immunitarja (ara sezzjoni 4.4)
English: Other medicines and Cholib:
Maltese: Mediċini oħra u Cholib:
English: Severe cutaneous reactions (e.g erythema multiforme, Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.)
Maltese: Reazzjonijiet severi tal-ġilda (eż. eritema multiformi, sindromu ta' Stevens-Johnson, nekroliżi epidermali tossika, eċċ.)
English: • Previous history of muscular toxicity with a statin or a fibrate
Maltese: • Passat mediku preċedenti ta' tossiċità muskolari b'statin jew b'fibrat
English: Statin type and dose used:
Maltese: It-tip ta' statin u d-doża użata:
English: % Change Mean (SD)
Maltese: % Tibdil Medju (SD)
English: • rifampicin (a medicine used to treat tuberculosis)
Maltese: • rifampicin (mediċina użata biex tikkura t-tuberkulożi)
English: EU/1/13/866/003-004 EU/1/13/866/006
Maltese: EU/1/13/866/006
English: In normal volunteers, the plasma exposure to simvastatin acid was decreased by 93% with concomitant administration of rifampicin.
Maltese: F'voluntiera normali, l-espożizzjoni ta' simvastatin acid fil-plasma naqset bi 93% bl-għoti konkomittanti ta' rifampicin.
English: In a clinical trial, myopathy was reported in 6% of patients receiving simvastatin 80 mg and amiodarone, versus 0.4% in patients on simvastatin 80 mg only.
Maltese: Fi prova klinika, kienet irrapporta mijopatija f'6% tal-pazjenti li kienu qed jirċievu simvastatin 80 mg u amiodarone, kontra 0.4% f'pazjenti fuq simvastatin 80 mg biss.
English: Contains: lactose, sucrose, lecithin (derived from soya bean (E322))
Maltese: Fih: lactose, sucrose, lecithin (miksub mil-fażola tas-soja (E322))
English: Frequenc y
Maltese: Frekwenz a
English: • increase in “alkaline phosphatase” - produced by the bile system - shown in tests
Maltese: • żieda fl-“alkaline phosphatase” - prodotta mis-sistema biljari - murija fit-testijiet
English: Date of first authorisation: 26 August 2013 Date of latest renewal: 16 May 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 26ta' Awissu 2013
English: Cholib The respective effects of simvastatin and fenofibrate are complementary.
Maltese: Cholib L-effetti rispettivi ta' simvastatin u fenofibrate huma kumplimentari.
English: Simvastatin, which is an inactive lactone, is hydrolyzed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy - 3 methylglutaryl CoA reductase).
Maltese: Simvastatin, li huwa lactone inattiv, jiġi idrolizzat fil-fwied fil-forma attiva korrispondenti ta' beta-hydroxyacid li għandha attività qawwija fl-inibizzjoni ta' HMG-CoA reductase (3 hydroxy - 3 methylglutaryl CoA reductase).
English: The frequencies of adverse reactions are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi ta' reazzjonijiet avversi huma elenkati skont dawn li ġejjin: 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 jistax jiġi stmat mid-dejta disponibbli).
English: Photosensitivity reactions rare
Maltese: Sensittività eċċessiva rari
English: Amiodarone, amlodipine, diltiazem and verapamil The risk of myopathy and rhabdomyolysis is increased by concomitant use of amiodarone, amlodipine, diltiazem or verapamil with simvastatin 40 mg per day.
Maltese: Ir-riskju ta' mijopatija u rabdomijolisi jiżdied bl-użu konkomittanti ta' amiodarone, amlodipine, diltiazem jew verapamil ma' simvastatin 40 mg kuljum.
English: Creatine kinase measurement
Maltese: Kejl ta' Creatine kinase
English: In the other study [Bergman et al, 2004] repeated co-administration of both simvastatin 80 mg and fenofibrate 160 mg led to a reduction in the AUC of the SVA of 36% (90% CI 30%-42%).
Maltese: Fl-istudju l-ieħor [Bergman et al, 2004] l-għoti ripetut ta' simvastatin 80 mg u flimkien ma' fenofibrate 160 mg wassal għal tnaqqis fl-AUC tal-SVA ta' 36% (90% CI 30%-42%).
English: Ireland Mylan IRE Healthcare Ltd
Maltese: Mylan IRE Healthcare Ltd Tel: +44
English: HIV protease inhibitors (e.g. nelfinavir) Nefazodone
Maltese: Inibituri tal-protease tal-HIV (eż. nelfinavir)
English: The combination F145/S40 showed superiority over S40 for LDL-C reduction only at 24 weeks from a non-significant additional 1.2% reduction of LDL-C at 12 weeks to a statistically significant 7.2% reduction at 24 weeks.
Maltese: Il-kombinazzjoni F145/S40 uriet superjorità fuq S40 għal tnaqqis ta' LDL-C biss f'24 ġimgħa minn tnaqqis ta' 1.2% addizzjonali mhux sinifikanti ta' LDL-C wara 12-il ġimgħa għal tnaqqis statistikament sinifikanti ta' 7.2% wara 24 ġimgħa.
English: Pharmacotherapeutic group: Lipid modifying substances, HMG-CoA reductase inhibitors in combination with other lipid modifying substances, ATC code: C10BA04
Maltese: Sustanzi li jimmodifikaw il-lipidi, Inibituri ta' HMG-CoA reductase f'kombinazzjoni ma' sustanzi oħra li jimmodifikaw il-lipidi, Kodiċi ATC: C10BA04
English: Blood homocysteine level increased (see section 4.4)*****
Maltese: Investigazzjonijiet Żieda fil-livell ta' homocysteine fid-demm (ara sezzjoni 4.4)*****
English: Constipation, dyspepsia rare
Maltese: Stitikezza, dispepsja rari
English: Upper respiratory tract infection, Gastroenteritis
Maltese: Infezzjoni fil-passaġġ respiratorju ta' fuq, Gastroenterite komuni
English: In patients with SLCO1B1 polymorphism there is a risk of increased exposure of simvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4).
Maltese: F'pazjenti bil-polimorfiżmu SLCO1B1, hemm riskju ta' espożizzjoni miżjuda ta' simvastatin, u dan jista' jwassal għal riskju miżjud ta' rabdomijoliżi (ara sezzjoni 4.4).
English: F145/S40 demonstrated statistically significant superiority on all parameters except on ApoA1 increase.
Maltese: F145/S40 wera superjorità statistikament sinifikanti fuq il-parametri kollha għajr fuq żieda ta' ApoA1.
English: Response to therapy should be monitored by determination of serum lipid values (total cholesterol (TC), LDL-C, triglycerides (TG)).
Maltese: Ir-rispons għat-terapija għandu jiġi mmonitorjat permezz tad-determinazzjoni tal-figuri tal-lipidi fis-serum (kolesterol totali (TC), LDL-C, trigliċeridi (TG)).
English: EU/1/13/866/001 10 film-coated tablets EU/1/13/866/002 30 film-coated tablets EU/1/13/866/005 90 film coated tablets
Maltese: EU/1/13/866/001 10 pilloli miksijin b'rita EU/1/13/866/002 30 pillola miksija b'rita EU/1/13/866/005 90 pillola miksija b'rita
English: Pack sizes: 10, 30 and 90 film-coated tablets.
Maltese: Daqsijiet tal-pakkett: 10, 30 u 90 pilloli miksijin b'rita.
English: Fenofibrate is mainly excreted in the form of fenofibric acid and its glucuronide conjugate.
Maltese: Fenofibrate jiġi prinċipalment eliminat fil-forma ta' fenofibric acid u l-konjugat glukuronid tiegħu.
English: Simvastatin is a substrate of the Breast Cancer Resistant Protein (BCRP) efflux transporter.
Maltese: Simvastatin huwa sottostrat tat-trasportatur tal-effluss tal-Proteina ta' Reżistenza għall-Kanċer tasSider (BCRP, Breast Cancer Resistant Protein).
English: Grapefruit juice inhibits CYP 3A4.
Maltese: Il-meraq tal-grejpfrut jinibixxi s-CYP 3A4.
English: Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy.
Maltese: Inibituri qawwija taċ-ċitokromju P450 3A4 jżidu r-riskju ta' mijopatija u rabdomijolisi billi jżidu l-konċentrazzjoni tal-attività inibitorja ta' HMG-CoA reductase fil-plasma matul terapija b'simvastatin.
English: Effects on the pharmacokinetics of other medicinal products Fenofibrate and simvastatin are not CYP 3A4 inhibitors or inducers.
Maltese: Effetti fuq il-farmakokinetika ta' prodotti mediċinali oħra Fenofibrate u simvastatin mhumiex inibituri jew indutturi ta' CYP 3A4.
English: EU/1/13/866/003 10 film-coated tablets EU/1/13/866/004 30 film-coated tablets EU/1/13/866/006 90 film coated tablets
Maltese: EU/1/13/866/003 10 pilloli miksijin b'rita EU/1/13/866/004 30 pillola miksija b'rita EU/I/13/866/006 90 pillola miksija b'rita
English: Hepatitis/jaundice Hepatic failure very rare
Maltese: Epatite/suffejra Insuffiċjenza epatika rari ħafna
English: • increase in “gamma-glutamyltransferase” - produced by the liver - shown in tests
Maltese: • żieda fil-“gamma glutamyltransferase” - prodott mill-fwied - murija fit-testijiet
English: Combination with itraconazole, ketoconazole, posaconazole, HIV protease inhibitors (e.g. nelfinavir), erythromycin, clarithromycin, telithromycin and nefazodone is contraindicated (see section 4.3).
Maltese: Il-kombinazzjoni ma' itraconazole, ketoconazole, posaconazole, inibituri tal-protease tal-HIV (eż. nelfinavir), erythromycin, clarithromycin, telithromycin u nefazodone hija kontraindikata (ara sezzjoni 4.3).
English: Another prespecified subgroup analysis identified a statistically significant treatment-by-gender interaction (p=0.01) indicating a possible treatment benefit of combination therapy in men (p=0.037) but a potentially higher risk for the primary outcome in women treated with combination therapy compared to simvastatin monotherapy (p=0.069).
Maltese: Analiżi oħra ta' sottogrupp speċifikat minn qabel identifikat kura statistikament sinifikanti skont l-interazzjoni tas-sess (p=0.01) li tindika benefiċċju possibbli tal-kura ta' terapija kkombinata fl-irġiel (p=0.037) imma riskju potenzjalment ogħla għar-riżultat primarju fin-nisa li rċevew kura b'terapija kkombinata meta mqabbla ma' monoterapija b'simvastatin (p=0.069).
English: Patients carrying the SLCO1B1 gene allele (c.521T>C) coding for a less active OATP1B1 protein have an increased systemic exposure of simvastatin and increased risk of myopathy.
Maltese: Pazjenti li jġorru l-kodifikazzjoni tal-allele tal-ġene SLCO1B1 (c.521T>C) għal proteina OATP1B1 inqas attiva għandhom espożizzjoni sistemika miżjuda ta' simvastatin u riskju miżjud ta' mijopatija.
English: The combination of fenofibrate 145 mg with simvastatin 20 mg demonstrated statistically significant superiority on apoA1 increase and fibrinogen decrease compared to simvastatin 40 mg.
Maltese: Il-kombinazzjoni ta' fenofibrate 145 mg ma' simvastatin 20 mg uriet superjorità statistikament sinifikanti fuq żieda tal-apoA1 u tnaqqis ta' fibrinogen meta mqabbel ma' simvastatin 40 mg.
English: No hepatic microsomal metabolism is involved.
Maltese: Ma hemm l-ebda metaboliżmu mikrosomali epatiku nvolut.
English: • erectile dysfunction
Maltese: • disfunzjoni erettili
English: This medicinal product contains sunset yellow FCF (E110) that may cause allergic reactions.
Maltese: Dan il-prodott mediċinali fih sunset yellow FCF (E110) li jista' jikkawża reazzjonijiet allerġiċi.
English: Hypersensitivity syndrome *** An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, erythrocyte sedimentation rate (ESR) increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea and malaise.
Maltese: Sindromu ta' sensittività eċċessiva *** Is-sindromu apparenti ta' sensittività eċċessiva ġie rrapportat b'mod rari li kien jinkludi xi wħud mill-karatteristiċi li ġejjin: angjoedema, sindromu bħal-lupus, polymyalgia rewmatika, dermatomyositis, vaskulite, tromboċitopenja, eosinofilja, żieda fir-rata ta' sedimentazzjoni tal-eritroċiti (ESR), artrite u artralġja, urtikarja, fotosensittività, deni, fwawar, dispneja u telqa.
English: Poly (vinyl alcohol), partially hydrolysed (E1203), titanium dioxide (E171), talc (E553b), lecithin (derived from soya bean (E322)), xanthan gum (E415), iron oxide red (E172).
Maltese: Poly (vinyl alcohol), partially hydrolysed, titanium dioxide (E171), talc (E553b), lecithin (miksuba minn fażola tas-soja (E322)), xanthan gum (E415), iron oxide red (E172).
English: The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of simvastatin with potent inhibitors of (CYP) 3A4 (see section 4.5).
Maltese: Ir-riskju ta' mijopatija u rabdomijolisi jiżdied b'mod sinifikanti bl-użu konkomittanti ta' simvastatin ma' inibituri qawwija ta' (CYP) 3A4 (ara sezzjoni 4.5).
English: • you are due to have an operation.
Maltese: • se ssirlek xi operazzjoni.
English: Lipid parameter (mmol/L)
Maltese: Parametru tal-lipidi (mmol/L)
English: Cutaneous hypersensitivity (e.g.
Maltese: Sensittività eċċessiva fil-ġilda(eż.
English: Paresthesia, dizziness, peripheral neuropathy rare
Maltese: Parestesija, sturdament, newropatija periferali rari
English: Fibrinogen (g/L) *Treatment Comparison: difference between the LS Means for Feno 145 + Simva 20 and Simva 40, as well as the associated 95% confidence interval
Maltese: Fibrinogen (g/l) * Tqabbil tal-Kuri: id-differenza bejn il-Medji ta' LS għal Feno 145 + Simva 20 u Simva 40, kif ukoll l-intervall ta' fiduċja ta' 95% assoċjat
English: Reduced function can occur as the result of inhibition by interacting medicines (eg ciclosporin) or in patients who are carriers of the SLCO1B1 c.521T>C genotype.
Maltese: Funzjoni mnaqqsa tista' sseħħ bħala konsegwenza tal-inibizzjoni minn mediċini li jinteraġixxu (eż. ciclosporin) jew f'pazjenti li huma trasportaturi tal-ġenotip SLCO1B1 c.521T>C.
English: Concomitant administration of amlodipine and simvastatin caused a 1.6-fold increase in exposure of simvastatin acid.
Maltese: L-għoti konkomittanti ta' amlodipine u simvastatin ikkawża żieda ta' 1.6 darbiet fl-espożizzjoni għal simvastatin acid.
English: Fenofibrate/Simvas tatin in combination
Maltese: Fenofibrate/ Simvastatin f'kombinazzjo ni
English: Study 0501 evaluated 2 different doses of fenofibrate-simvastatin combination compared to simvastatin 40 mg for a 24 week double-blind period.
Maltese: Studju 0501 evalwa 2 dożi differenti tal-kombinazzjoni ta' fenofibrate-simvastatin meta mqabbel ma' simvastatin 40 mg għal perjodu double-blind ta' 24 ġimgħa.
English: When symptoms indicative of hepatitis occur (e.g. jaundice, pruritus) and diagnosis is confirmed by laboratory testing, Cholib therapy should be discontinued.
Maltese: Meta jkun hemm sintomi li jindikaw epatite (eż. suffejra, ħakk) u d-dijanjosi tiġi kkonfermata minn testijiet fil-laboratorju, it-terapija b'Cholib għandha titwaqqaf.
English: Insomnia very rare
Maltese: Insomnija rari ħafna
English: Contraindicated with Cholib
Maltese: Kontraindikati ma' Cholib
English: Monitor HDL-C and stop either therapy (glitazone or Cholib) if HDL-C is too low
Maltese: Immonitorja l-HDL-C u waqqaf xi waħda mit-terapiji(glitazone jew Cholib) jekk l-HDL-C ikun baxx wisq
English: In the pre-specified subgroup of dyslipidaemic patients, defined as those in the lowest tertile of HDL-C (≤ 34 mg/dl or 0.88 mmol/L) and highest tertile of TG (≥ 204 mg/dl or 2.3 mmol/L) at baseline, fenofibrate plus simvastatin therapy demonstrated a 31% relative reduction compared to simvastatin monotherapy for the composite primary outcome (hazard ratio [HR] 0.69, 95% CI 0.49-0.97, p=0.03; absolute risk reduction: 4.95%).
Maltese: Fis-sottogrupp speċifikat minn qabel ta' pazjenti b'dislipidemija, definiti bħala dawk fl-aktar tertile baxx tal-HDL-C (≤ 34 mg/dl jew 0.88 mmol/L) u l-ogħla tertile tat-TG (≥ 204 mg/dl jew 2.3 mmol/L) fil-linja bażi, terapija b'fenofibrate flimkien ma' simvastatin wriet tnaqqis relattiv ta' 31% meta mqabbla ma' monoterapija b'simvastatin għar-riżultat primarju kompost (proporzjon tal-periklu [HR] 0.69, 95% CI 0.49-0.97, p=0.03; tnaqqis assolut tar-riskju: 4.95%).
English: EU/1/13/866/001-002 EU/1/13/866/005
Maltese: EU 1/13/866/005
English: Gastrointestinal disorders Gastrointestinal signs and symptoms (abdominal pain, nausea, vomiting, diarrhoea, flatulence)
Maltese: Sinjali u sintomi gastrointestinali (uġigħ addominali, dardir, rimettar, dijarea, gass)
English: Cholib contains two different active substances: fenofibrate (belongs to the group called ‘fibrates') and simvastatin (belongs to the group called ‘statins').
Maltese: Cholib fih żewġ sustanzi attivi differenti: fenofibrate (li jappartjeni għall-grupp imsejjaħ ‘fibrati') u simvastatin (li jappartjeni għall-grupp imsejjaħ ‘statins').
English: Cholib contains sunset yellow FCF (E110) that may cause allergic reactions.
Maltese: Cholib fih sunset yellow FCF (E110) li jista' jikkawża reazzjonijiet allerġiċi.
English: During four double blind clinical trials of 24-week duration 1,237 patients have received treatment with co-administered fenofibrate and simvastatin.
Maltese: Matul erba' provi kliniċi double blind li damu għaddejjin 24 ġimgħa 1,237 pazjent irċievew kura bl-għoti flimkien ta' fenofibrate u simvastatin.
English: ANCOVA (analysis of covariance) of Percent Change in TC, non-HDL-C, ApoAI, ApoB, ApoB/ApoAI and fibrinogen from Baseline to 24 Weeks - Full Analysis Subject Sample Parameter
Maltese: ANCOVA (analiżi ta' kovarjanza) tat-Tibdil Perċentwali fit-TC, mhux HDL-C, ApoAI, ApoB, ApoB/ApoAI u fibrinogen mil-Linja bażi għal 24 Ġimgħa - Kampjun ta' Suġġett ta' Analiżi Sħiħa
English: Diabetes Mellitus**** not known
Maltese: Dijabete mellitus****
English: Ste vens-Johnson syndrome, toxic epidermal necrolysis, etc.) Cutaneous hypersensitivity (e.g.
Maltese: Stevens-Johnson, nekroliżi epidermali tossika, eċċ.)
English: Studies with fenofibrate on lipoprotein fractions show decreases in levels of LDL and VLDL cholesterol (VLDL-C).
Maltese: Studji b'fenofibrate fuq frazzjonijiet ta' lipoproteina juru tnaqqis fil-livelli ta' kolesterol-LDL u VLDL (VLDL-C).
English: Simva 40 Simva 40 Fibrinogen* (g/L) Feno 145 + Simva 40 Simva 40 *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: Feno 145 + Simva 40 Simva 40 * Tqabbil tal-Kuri jikkonsisti mid-differenzi bejn il-Medji ta' LS għal Feno 145 + Simva 40 u Simva 40, kif ukoll is-CI ta' 95% korrespondenti.
English: After oral administration, fenofibrate is rapidly hydrolyzed by esterases to the active metabolite fenofibric acid.
Maltese: Wara l-għoti orali, fenofibrate jiġi idrolizzat malajr permezz ta' esterasi fil-metabolit attiv fenofibric acid.
English: Fenofibrate and simvastatin enhance effects of Vitamin K antagonists and may increase the risk of bleeding.
Maltese: Fenofibrate u simvastatin jżidu l-effetti ta' antagonisti tal-vitamina K u jistgħu jżidu r-riskju ta' fsada.
English: Such inhibitors include itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), and nefazodone.
Maltese: Inibituri bħal dawn jinkludu itraconazole, ketoconazole, posaconazole, erythromycin, clarithromycin, telithromycin, inibituri tal-protease tal-HIV (eż. nelfinavir), u nefazodone.
English: Blood alkaline phosphatase increased rare
Maltese: Żieda fil-livell ta' creatine phosphokinase fid-demm rari
English: Simvastatin is taken up actively into the hepatocytes by the transporter OATP1B1.
Maltese: Simvastatin jittieħed b'mod attiv fl-epatoċiti mit-trasportatur OATP1B1.
English: Study 0502 was evaluated a constant dose of fenofibrate-simvastatin combination and statin comparator throughout the 24 week double-blind period.
Maltese: Studju 0502 evalwa doża kostanti tal-kombinazzjoni fenofibrate-simvastatin u komparatur ta' statins tul il-perjodu double-blind kollu ta' 24 ġimgħa.
English: Fenofibrate Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Maltese: Studji dwar tossiċità akuta ma taw l-ebda informazzjoni rilevanti dwar it-tossiċità speċifika ta' fenofibrate.
English: Fenofibrate also has a uricosuric effect leading to reduction in uric acid levels of approximately 25%.
Maltese: Fenofibrate għandu wkoll effett urikosuriku li jwassal għal tnaqqis fil-livelli ta' uric acid ta' madwar 25%.
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving a statin in combination with fusidic acid (see section 4.5).
Maltese: Kien hemm rapporti ta' rabdomijoliżi (inkluż xi fatalitajiet) f'pazjenti li rċievew statins f'kombinazzjoni ma' fusidic acid (ara sezzjoni 4.5).
English: Overall, 7,583 subjects with mixed dyslipidemia entered a 6 week statin run-in period.
Maltese: B'kollox, 7,583 individwu b'dislipidemija mħallta daħlu f'perjodu run-in ta' 6 ġimgħat bi statin.
English: • elbasvir or grazoprevir (used to treat hepatitis C virus infection)
Maltese: • elbasvir jew grazoprevir (jintużaw għall-kura ta' infezzjoni bil-virus tal-epatite Ċ)