FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if any of the following applies to you: - Liver or kidney problems - Thyroid problems - You are more than 70 years old - You have ever had muscle problems during a treatment with cholesterol-lowering medicines such as a statin or fibrate - You are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection - You or your close family members have a hereditary muscle disorder - You have alcohol problems (regularly drinking large amounts of alcohol)
Maltese: - Qed tieħu jew, fl-aħħar 7 ijiem ħadt jew ingħatajt mediċina li tissejjaħ aċidu fusidiku (mediċina għal infezzjoni batterika) - Inti jew il-membri tal-familja qrib tiegħek għandhom disturb muskolari ereditarju - Għandek problemi bl-alkoħol (tixrob regolarment ammonti kbar ta' alkoħol)
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: Ir-riskju miżjud ta' avvenimenti trombotiċi fil-vini jista' jkun relatat mażżieda tal-livell ta' homocysteine, fattur ta' riskju għal trombożi u fatturi oħrajn mhux identifikati.
English: Non-HDL-C (mg/dl)
Maltese: Kolesterol Mhux HDL (mg/dl) Kolesterol LDL (mg/dl)
English: Abiogen Pharma S.p.A. Tel: +39 050 3154 101
Maltese: Tel: +39 050 3154 101
English: The incremental benefit of Pravafenix 40 mg/160 mg on main lipid parameters versus Pravastatin 40 mg and Fenofibrate 160 mg monotherapy was also established.
Maltese: Ġie stabbilit ukoll il-vantaġġ inkrimentali ta' Pravafenix 40 mg/160 mg fuq il-parametri prinċipali tal-lipidi meta mqabbel ma' Pravastatin 40 mg u monoterapija b'Fenofibrate 160 mg.
English: • Effects on liver: raised serum transaminases.
Maltese: • Effetti fuq il-fwied: transaminażi tas-serum miżjuda.
English: Four multicenter studies with either Pravafenix 40 mg/160 mg or Pravastatin 40 mg or Simvastatin 20 mg were conducted: 3 studies included a 12 week randomized, double-blind, active controlled period with an open-label extension phase and one was a 24-week open-label study.
Maltese: Saru erba' studji b'aktar minn ċentru wieħed bi Pravafenix 40 mg/160 mg jew Pravastatin 40 mg jew Simvastatin 20 mg: 3 studji inkludew perjodu ta' 12-il ġimgħa, randomizzat, double-blind u kkontrollat bis-sustanza attiva b'fażi ta' estensjoni b'tikketta mikxufa u wieħed kien studju b'tikketta mikxufa ta' 24 ġimgħa.
English: Secondly, pravastatin inhibits LDL production by inhibiting the hepatic synthesis of VLDLcholesterol, the LDL-cholesterol precursor.
Maltese: It-tieni, pravastatin jimpedixxi l-produzzjoni ta' LDL billi jimpedixxi s-sinteżi epatika tal-kolesterol VLDL, il-prekursur tal-kolesterol LDL.
English: Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Maltese: Pravafenix 40 mg/160 mg kapsuli iebsin Pravastatin/Fenofibrate
English: • Muscle breakdown (rhabdomyolysis), some cases of tendon problems, sometimes complicated by rupture.
Maltese: • Tkissir muskolari (rhabdomyolysis), xi każi ta' problemi bit-tendini, xi kultant ikkumplikat bi qsim.
English: Abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhoea, dry mouth, dyspepsia, eructation, flatulence, nausea, abdominal discomfort, vomiting.
Maltese: Nefħa addominali, uġigħ addominali, uġigħ fil-parti ta' fuq tal addome, stitikezza, dijarrea, ħalq xott, dispepsija, tifwiq, gass,
English: Rhabdomyolysis is an acute potentially fatal condition of skeletal muscle, which may develop at any time during treatment and is characterised by massive muscle destruction associated with major increase in CK (usually > 30 or 40 times the ULN) leading to myoglobinuria.
Maltese: Rhabdomyolysis hija kundizzjoni akuta u potenzjalment fatali tal-muskoli skeletali, li tista' tiżviluppa fi kwalunkwe ħin waqt il-kura u hija kkaratterizzata minn distruzzjoni massiva talmuskoli assoċjata ma' żieda kbira fis-CK (normalment > 30 jew 40 darba l-ULN) li twassal għal mijoglobinurja.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li jkollhom problemi ereditarji rari ta' intolleranza għal galattożju, id-defiċjenza tal-Lapp lattażi jew assobiment ħażin ta' glukożju-lattożju ma għandhomx jieħdu dan il-prodott mediċinali.
English: Intersticial pneumopathies
Maltese: Pneomopatiji tal-iterstizju
English: Apoprotein C-III.
Maltese: LDL-C.
English: In rats a 2-year carcinogenicity study demonstrates at a dose of 100 mg/kg/day (125 times the maximum human mg/kg/dose) a statistically significant increase in the incidence of hepatocellular carcinomas in males only.
Maltese: Fil-firien, studju ta' sentejn dwar ir-riskju ta' kanċer f'doża ta' 100 mg/kg/ġurnata (125 darba d-doża massima mg/kg fil-bniedem) juri żieda statistikament sinifikanti fl-inċidenza ta' karċinomi epatoċellulari fl-irġiel biss.
English: Chronic toxicity studies have yielded no relevant information about specific toxicity of fenofibrate.
Maltese: Studji dwar it-tossiċità kronika ma taw l-ebda informazzjoni rilevanti dwar effett tossiku speċifiku ta' fenofibrate.
English: Pravastatin is not significantly metabolised by cytochrome P450 nor does it appear to be a substrate or an inhibitor of P-glycoprotein but rather a substrate of other transport proteins.
Maltese: Pravastatin mhuwiex metabolizzat b'mod sinifikanti minn cytochrome P450 u lanqas ma jidher li huwa substrat jew inibitur tal-glikoproteina-P iżda pjuttost substrat ta' proteini oħra tat-trasport.
English: Repeated dose studies indicate that pravastatin may induce varying degrees of hepatotoxicity and myopathy; in general, substantive effects on these tissues were only evident at doses 50 or more times the maximum human mg/kg dose.
Maltese: Studji b'dożi ripetuti jindikaw li pravastatin jista' jikkawża livelli differenti ta' tossi ċità tal-fwied u mijopatija; b'mod ġenerali, effetti sostantivi fuq dawn it-tessuti kienu evidenti biss f'dożi ta' 50 darba jew aktar id-doża massima mg/kg fil-bniedem.
English: • Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping
Maltese: • Effetti diġestivi: disturbi gastriċi jew intestinali (uġigħ addominali, dardir, rimettar, dijarrea u gass, stitikezza, ħalq xott, uġigħ fil-parti ta' fuq tal-addome b'nefħa (dispepsja), tifwiq (eruktazzjonijiet)).
English: Skin rash, Scalp/hair abnormality (including alopecia)
Maltese: Raxx fuq il-ġilda, anormamlità tal-qorriegħa/xagħar (inkluż alopeċja)
English: 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, iddefiniti bħala dawk b'tertile l-aktar baxx ta' HDL-C (≤34 mg/dl jew 0.88 mmol/L) u l-ogħla tertile ta' TG (≥204 mg/dl jew 2.3 mmol/L) fil-linja bażi, it-terapija b'fenofibrate flimkien ma' simvastatin uriet tnaqqis relattiv ta' 31% mqabbla ma' monoterapija ta' simvastatin għar-riżultat primarju kompost (proporzjon ta' periklu [HR] 0.69, 95% CI 0.49-0.97, p = 0.03 ; tnaqqis assolut tar riskju: 4.95%).
English: Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
Maltese: Informazzjoni addizzjonali dwar is-sustanzi attivi inidividwali tal-kombinazzjoni ta' doża fissa Pravafenix fih pravastatin u fenofibrate.
English: Adverse reaction (Pravastatin)
Maltese: Reazzjoni avversa (Pravastatin)
English: • Muscle and joint pain (myalgia, arthralgia), back pain, alterations in some laboratory blood tests for muscle function.
Maltese: • Uġigħ fil-muskoli u fil-ġogi (mijalġija, artralġija), uġigħ fid-dahar, alterazzjonijiet f'xi testijiet tad-demm tal-laboratorju għall-funzjoni tal-muskoli.
English: If cholelithiasis is suspected, gallbladder studies are indicated.
Maltese: Jekk ikun hemm suspett ta' cholelithiasis, jiġu indikati studji tal-bużżieqa tal-marrara.
English: General disorders:
Maltese: • Dijabete:
English: Pravafenix contains lactose
Maltese: Pravafenix fih il-lactose
English: No effect on fertility in reproductive toxicity studies have been observed with both fenofibrate and pravastatin (see section 5.3)
Maltese: Fi studji ta' tossiċità riproduttiva ma ġie osservat ebda effett fuq il-fertilità kemm b'fenofibrate kif ukoll bi pravastatin (ara sezzjoni 5.3)
English: In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.
Maltese: Fi studji ta' interazzjoni, ma ġiet osservata l-ebda differenza statistikament sinifikanti fil bijodisponibilità meta pravastatin ingħata ma' acetylsalicylic acid, antaċidi (meta mogħti siegħa qabel pravastatin), nicotinic acid jew probucol.
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Laboratoires SMB S.A.
English: EU/1/11/679/004 30 hard capsules
Maltese: EU/1/11/679/004 30 kapsula iebsa
English: The plasma concentrations are proportional to the doses administered.
Maltese: Il-konċentrazzjonijiet fil-plażma huma proporzjonali mad-dożi mogħtija.
English: The name of your medicine is Pravafenix.
Maltese: Mediċini oħra u Pravafenix
English: The absence of a significant pharmacokinetic interaction with pravastatin has been specifically demonstrated for several medicinal products, particularly those that are substrates/inhibitors of CYP3A4 e.g. diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice and CYP2C9 inhibitors (e.g. fluconazole).
Maltese: In-nuqqas ta' interazzjoni farmakokinetika sinifikanti ma' pravastatin intwera b'mod speċifiku għal bosta prodotti mediċinali, b'mod partikolari dawk li huma substrati/inibituri ta' CYP3A4 eż. diltiazem, verapamil,
English: Tél/Tel: + 32.2.411.48.28.
Maltese: Tel: + 32.2.411.
English: Your total cholesterol is made up mainly of LDL and HDL cholesterol.
Maltese: Il-kolesterol totali tiegħek huwa magħmul prinċipalment minn kolesterol LDL u kolesterol HDL.
English: The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders.
Maltese: Ir-reazzjonijiet avversi rapportati (ADRs, reported adverse reactions) l-aktar komunement matul itterapija bi Pravafenix huma żieda fit-transaminase u disturbi gastro-intestinali.
English: - Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI>30kg/m2, raised triglycerides, history of hypertension).
Maltese: Pazjenti f'riskju (glukosju fid-demm waqt is-sawm ta' 5.6 sa 6.9 mmol/l, BMI >30 kg/m2,
English: Therefore, taking into account the contra indication of pravastatin during lactation, Pravafenix is contraindicated during breastfeeding (see section 4.3).
Maltese: Għaldaqstant, meta tiġi kkunsidrata l-kontra-indikazzjoni ta' pravastatin matul it-treddigħ, Pravafenix huwa kontra-indikat matul it-treddigħ (ara sezzjoni 4.3).
English: Hs-CRP (mg/L) a Number of patients b Mean percent change (least square mean ± standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if <0.05
Maltese: 8 ġimgħat fuq Pravastatin 40 mg u 12-il ġimgħa addizzjonali bi Pravafenix 40 mg/160 mg jew Pravastatin 40 mg c Il-valur-p tal-par huwa sinifikanti jekk <0.05
English: Fenofibrate may increase cholesterol excretion into the bile, potentially leading to cholelithiasis.
Maltese: Il-fenofibrate jista' jżid it-tneħħija tal-kolesterol fil-bili, li jista' potenzjalment iwassal għal cholelithiasis.
English: • Abnormal heartbeat (palpitations), formation of blood clots in veins (deep vein thrombosis) and blockage of the lung arteries by blood clots (pulmonary embolism)
Maltese: • Taħbit tal-qalb mhux normali (palpitazzjonijiet), formazzjoni ta' emboli tad-demm fil-vini (trombożi profonda tal-vini) u mblukkar tal-arterji tal-pulmun b'emboli tad-demm (emboliżmu pulmonari).
English: There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5).
Maltese: Kien hemm rapporti ta' rhabdomajlosi (li jinkludi xi fatalitajiet) f'pazjenti li r ċevew din il-kombinazzjoni (ara sezzjoni 4.5).
English: Skeletal muscle: Marked and persistent increases of creatine phosphokinase (CK) have been reported infrequently.
Maltese: Żidiet evidenti u persistenti ta' creatine phosphokinase (CK) ġew irrapportati b'mod mhux frekwenti.
English: Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 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: Rari * Fl-istudju FIELD (studju tal-fenofibrate), prova kkontrollata bi plaċebo randomizzata mwettqa f'9,795 pazjent b'diabetes mellitus ta' tip 2, ġiet osservata żieda statistikament sinifikanti f'każi ta'
English: Both are cholesterol/lipid modifying medicines.
Maltese: Iżżewġ sustanzi huma mediċini li jimmodifikaw il-kolesterol/lipidi.
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules
Maltese: Pravafenix 40 mg/160 mg kapsuli iebsin
English: Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3).
Maltese: Ġiet irrapportata pankreatite f'pazjenti li jing ħataw fenofibrate jew pravastatin (ara sezzjoni 4.3).
English: - Gallbladder disease (see section 4.4).
Maltese: − Mard tal-bużżieqa tal-marrara (ara sezzjoni 4.4).
English: - Pregnancy and breast-feeding (see section 4.6).
Maltese: − Fertilità, tqala u treddigħ (ara sezzjoni 4.6).
English: Studies on mutagenicity of fenofibrate have been negative.
Maltese: L-istudji dwar il-mutaġeniċità ta' fenofibrate kienu negattivi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha 40 mg ta' pravastatin sodium u 160 mg ta' fenofibrate.
English: EU/1/11/679/002 60 hard capsules
Maltese: EU/1/11/679/002 60 kapsula iebsa
English: The following statements reflect the information available on the individual active substances (fenofibrate and pravastatin).
Maltese: L-istqarrijiet li ġejjin jirriflettu l-informazzjoni disponibbli dwar is-sustanzi attivi individwali (fenofibrate u pravastatin).
English: - Personal history of myopathy and/or rhabdomyolysis with statins and/or fibrates or confirmed creatine phosphokinase (CK) elevation above 5 times the ULN under previous statin treatment
Maltese: − Storja personali ta' mijopatija u/jew rhabdomyolysis bi statins u/jew fibrati jew elevazzjoni ta' creatine phosphokinase (CK) ikkonfermata, ogħla minn 5 darbiet il-ULN taħt kura minn qabel bi statin (ara sezzjoni 4.4).
English: No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
Maltese: Ma dehret ebda interazzjoni farmakokinetika klinikament sinifikanti meta fenofibrate ngħata flimkien ma' pravastatin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kapsula fiha 40 mg ta' pravastatin sodium u 160 mg ta' fenofibrate
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules pravastatin/fenofibrate
Maltese: Pravafenix 40 mg/160 mg kapsuli iebsin pravastatin/fenofibrate
English: Povidone K29-32
Maltese: Cellulose microcrystalline Ascorbyl palmitate Povidone K29-32
English: Capsule shell Gelatine
Maltese: Qoxra tal-kapsula Ġelatina
English: In the pivotal European multicenter 64-week clinical trial including 12 week randomised, doubleblind, double-dummy, 2-arm, parallel study period, 248 high vascular risk patients with mixed dyslipidaemia were randomised to one of the two treatment groups: Pravafenix 40 mg/160 mg or pravastatin 40 mg. Only patients who had not met their NCEP ATP III target LDL-C and Triglyceride goals (LDL >100 mg/dl and TG >150 mg/dl) after 8 weeks on pravastatin 40 mg (1 tablet, once daily) were randomized.
Maltese: Fil-prova klinika b'aktar minn ċentru wieħed pivotali Ewropea ta' 64 ġimgħa li kienet tinkludi perjodu parallel ta' 12-il ġimgħa ta' studju randomizzat, double-blind, double-dummy, b'żewġ gruppi, 248 pazjent b'riskju vaskulari għoli li kellhom dislipidemija mħallta ġew randomizzati għal wieħed miżżewġ gruppi ta' kura:
English: Clinical efficacy and safety
Maltese: Effikaċja klinika u sikurezza
English: Pravafenix is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the treatment of mixed hyperlipidaemia in adult patients at high cardiovascular risk to reduce triglycerides and increase HDL-C when LDL-C levels are adequately controlled while on a treatment with pravastatin 40 mg monotherapy.
Maltese: Pravafenix huwa indikat bħala żieda mad-dieta u trattament ieħor mhux farmakoloġiku (eż leżerċizzju, it-tnaqqis fil-piż) għall-kura ta' iperlipidemija mħallta f'pazjenti adulti b'riskju kardjovaskulari għoli għat-tnaqqis tat-trigliċeridi u ż-żieda fl-HDL-C meta l-livelli ta' LDL-C huma kkontrollati b'mod adegwat waqt li jkunu qed jirċievu l-kura b'monoterapija bi pravastatina 40 mg.
English: EU/1/11/679/006 90 hard capsules
Maltese: EU/1/11/679/006 90 kapsula iebsa
English: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) lipid trial was a randomized placebo-controlled study of 5,518 patients with type 2 diabetes mellitus treated with fenofibrate in addition to simvastatin.
Maltese: Il-prova bil-lipidi tal-Azzjoni għall-Kontroll tar-Riskju Kardjovaskulari fid-Dijabete (ACCORD, Action to Control Cardiovascular Risk in Diabetes) kien studju randomizzat ikkontrollat bi plaċebo ta' 5,518 pazjent b'dijabete mellitus ta' tip 2 b'fenofibrate flimkien ma' simvastatin.
English: - You have a history of muscle problems (e.g. myopathy or rhabdomyolysis) during treatment with cholesterol-controlling medicines called ‘statins' (such as simvastatin, atorvastatin, pravastatin or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).
Maltese: - Għandek storja ta' problemi fil-muskoli (eż. mijopatija jew rabdomijolisi) matul il-kura b'mediċini li jikkontrollaw il-kolesterol imsejħin ‘statins' (bħal simvastatin, atorvastatin,
English: EU/1/11/679/003 90 hard capsules
Maltese: EU/1/11/679/003 90 kapsula iebsa
English: Pravafenix contains fenofibrate and pravastatin, which have different modes of action and show additive effects in terms of reduction of serum lipid.
Maltese: Pravafenix fih fenofibrate u pravastatin, li għandhom modi differenti ta' azzjoni u juru effetti addittivi f'termini tat-tnaqqis tal-lipidi fis-serum.
English: If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment.
Maltese: Jekk it-trattament b'fusidic acid huwa meħtieġ, it-trattament b'pravastatin għandu jitwaqqaf matul ilperjodu kollu tat-trattament b'fusidic acid.
English: - Severe hepatic impairment including biliary cirrhosis or active liver disease including unexplained persistent elevations in liver function tests (including serum transaminase elevation) exceeding 3
Maltese: − Indeboliment epatiku sever li jinkludi ċirrożi biljari jew marda tal-fwied attiva, inkluż żidiet persistenti li ma jistgħux jiġu spjegati fit-testijiet tal-funzjoni tal-fwied (inkluż żieda tattransaminase fis-serum) li jkunu aktar minn tliet darbiet tal-limitu ta' fuq tan-normali (ULN) (ara sezzjoni 4.4).
English: Hepatobiliary disorders Cholelithiasis
Maltese: Tfal u adolexxenti
English: Treatment should be discontinued in case of an estimated creatinine clearance < 60 ml/min.
Maltese: Il-kura għandha titwaqqaf fil-każ ta' tneħħija tal-kreatinina stmata ta' < 60 ml/min.
English: Jaundice, fulminant hepatic necrosis
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Check with your doctor or pharmacist before taking Pravafenix if you have severe respiratory failure, e.g. you have breathing problems including, persistent non-productive cough, deterioration in general health like fatigue (tiredness), weight loss and/or shortness of breath or fever.
Maltese: Ara mat-tabib jew mal-ispiżjar tiegħek qabel tieħu Pravafenix jekk inti għandek indeboliment respiratorju serju, eż. għandek problemi bit-teħid tan-nifs inkluż, sogħla persistenti mhux produttiva, deterjorazzjoni fis-saħħa ġenerali bħal għejja, telf fil-piż u/jew qtugħ ta' nifs jew deni.
English: • Tingling and numbness (peripheral polyneuropathy).
Maltese: • Tnemnim u mewt (polinewropatija periferali) Effetti sekondarji ta' frekwenza mhux mag ħrufa (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli)
English: 60 hard capsules
Maltese: 60 kapsula iebsa 90 kapsula iebsa
English: The medicine must be discontinued because of the potential risk to the foetus.
Maltese: Il-mediċina għandha titwaqqaf minħabba r-riskju potenzjali għall-fetu.
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jista' jaffettwa sa 1 minn kull 10 persuni)
English: Swallow the capsule with water.
Maltese: Ibla' l-kapsula mal ilma.
English: • The other ingredients are: - capsule content: lactose monohydrate, cellulose microcrystalline, ascorbyl palmitate, povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000.
Maltese: • Żieda fil-kolesterol fid-demm, żieda fit-trigliċeridi fid-demm, żieda fl-LDL, żieda fil-gammaglutamyl transferase (diversi enżimi tal-fwied), uġigħ fil-fwied (uġigħ fil-muskoli addominali tal lemin ta' fuq, kemm bl-uġigħ fid-dahar u kemm mingħajru), żieda fil-piż.
English: The bioavailability of fenofibric acid is lower in fasting conditions after a single dose administration of the Fenofibrate-Pravastatin 160/40 mg combination.
Maltese: Il-bijodisponibilità tal-aċidu fenofibriku hija iżjed baxxa fuq stonku vojt wara l-għoti ta' doża waħda tal-kombinazzjoni Fenofibrate-Pravastatin 160/40 mg.
English: • Tiredness, weakness, influenza-like illness.
Maltese: • Għejja, dgħjufija, mard simili għall-influwenza.
English: Meditrina Pharmaceuticals Ltd Τηλ: +30 210 67 26 260
Maltese: Τηλ: +30 210 62 69 200
English: Diabetes Mellitus
Maltese: Dijabete Mellitus
English: Technimede Sociedade Técnico-Medicinal S.A. Tel: +351 21 041 41 00
Maltese: Tel: +351 21 041 41 00
English: (anticoagulants) - An antibiotic such as erythromycin, clarithromycin to treat infections caused by bacteria.
Maltese: - Antibijotiku bħall-erythromycin jew clarithromycin biex tikkura infezzjonijiet ikkawżati mill batterji.
English: • Memory loss
Maltese: • Telf tal-memorja
English: After absorption, 66% of pravastatin undergoes a first-pass extraction through the liver, which is the primary site of its action and the primary site of cholesterol synthesis and clearance of LDLcholesterol.
Maltese: Wara l-assorbiment, 66% ta' pravastatin jgħaddi minn tneħħija tal-ewwel passaġġ permezz tal-fwied, li huwa s-sit primarju tal-azzjoni tiegħu u s-sit primarju tas-sinteżi tal-kolesterol u t-tneħħija talkolesterol LDL.
English: Jaundice, complications of cholelithiasis (e.g cholecystitis, cholangitis, biliary colic, etc).
Maltese: - Reżini tal-aċidi tal-bili colestyramine/colestipol (mediċina biex tbaxxi l-ammont ta' kolesterol),
English: Patients at risk (fasting glucose 5.6 to 6.9 mmol/L, BMI>30kg/m 2, raised triglycerides, hypertension) should be monitored both clinically and biochemically according to national guidelines.
Maltese: (zokkor fid-demm waqt is-sawm ≥ 5.6 mmol/L, BMI>30kg/m2, trigliċeridi mgħollija, storja medika ta' pressjoni għolja) Rappurtar ta' reazzjonijiet avversi suspettati