FrancophonIA/ELRC3.0 huggingface dataset:
English: It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining, which pump acid into the stomach.
Maltese: Taħdem billi timblokka 'pompi tal-protons', proteini li jinsabu f'ċelloli speċjalizzati fir-rita tal-istonku, li jippumpjaw laċidu għal ġewwa l-istonku.
English: It is available as tablets (20 mg) which are gastro-resistant (the contents pass through the stomach without being broken down until they reach the intestine).
Maltese: Jiġi bħala pilloli (20 mg) li huma gastroreżistenti (il-kontenut jgħaddi mill-istonku mingħajr ma' jinkiser sakemm jasal fl-intestini).
English: For the full list of all side effects reported with Nexium Control, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtata b'Nexium Control, ara l-fuljett ta' tagħrif.
English: How is Nexium Control used?
Maltese: Kif jintuża Nexium Control?
English: The patients were treated for 4 weeks.
Maltese: Il-pazjenti ġew ikkurati għal 4 ġimgħat.
English: This summary was last updated in 08-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08/2013.
English: By blocking the pumps, esomeprazole reduces acid production, thereby relieving the symptoms of acid reflux.
Maltese: Billi jimblokka l-pompi, esomeprazole jnaqqas il-produzzjoni tal-aċidu, b'hekk iserraħ is-sintomi tar-rifluss tal-aċidi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nexium Control's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Nexium Control jisbqu r-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: It is used in adults for the short-term treatment of reflux symptoms (sometimes called acid reflux), such as heartburn and acid regurgitation.
Maltese: Jintuża fl-adulti għall-kura għal perjodu ta' żmien qasir ta' sintomi ta' rifluss (xi kultant imsejjaħ rifluss tal-aċidu), bħal ħruq ta' stonku u rigurġitazzjoni tal-aċidi.
English: Nexium Control can be obtained without a prescription.
Maltese: Nexium Control jista' jinkiseb mingħajr riċetta ta' tabib.
English: Receptor type α (PPARα).
Maltese: Activated Receptor type α (PPARα).
English: Mean (%)± SEb
Maltese: Medja (%)± SEb
English: Diabetes mellitus aggravated, Obesity
Maltese: Diabetes mellitus aggravata, Obeżità
English: Indigo carmine Black iron oxide Titanium dioxide Yellow iron oxide
Maltese: Indigo carmine Iron oxide iswed Titanium dioxide Iron oxide isfar
English: Pruritus, urticaria
Maltese: Prurite, urtikarja
English: (see sections 4.2 and 5.2).
Maltese: (ara sezzjonijiet 4.2 u 5.2).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 April 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 ta' April 2011
English: • Hypersensitivity.
Maltese: • Sensittività eċċessiva.
English: Synapsis Bulgaria Ltd
Maltese: Synapsis Bulgaria Ltd Teл.:
English: Thromboembolism (pulmonary embolism, deep vein thrombosis)*
Maltese: Tromboemboliżmu (emboliżmu pulmonari, trombożi profonda tal vini)*
English: 68.71% respectively.
Maltese: 28% rispettivament.
English: Paediatric population (< 18 years old)
Maltese: Popolazzjoni pedjatrika (< 18-il sena)
English: Interactions relevant to fenofibrate
Maltese: Interazzjonijiet relevanti għal fenofibrate
English: Tel. +32 (2) 411 48 28 Fax.
Maltese: +32 (2) 411 48 28 Fax.
English: Venothromboembolic events
Maltese: Avvenimenti Venotromboemboliċi
English: • Obesity.
Maltese: • Obeżità.
English: EU/1/11/679/007 14 hard capsules EU/1/11/679/004 30 hard capsules EU/1/11/679/005 60 hard capsules EU/1/11/679/006 90 hard capsules
Maltese: EU/1/11/679/007 14 kapsula iebsa EU/1/11/679/004 30 kapsula iebsa EU/1/11/679/005 60 kapsula iebsa EU/1/11/679/006 90 kapsula iebsa
English: In clinical trials, over 1,566 patients received Pravafenix.
Maltese: Fi provi kliniċi, aktar minn 1,566 pazjent irċevew Pravafenix.
English: Mean (%)± SEb p-valuec
Maltese: Medja (%)± SEb valur-P
English: 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).
Maltese: 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
English: In a similar study with clarithromycin a statistically significant increase in AUC (110%) and Cmax (127%) was observed.
Maltese: Fi studju simili bi clarithromycin, ġiet osservata żieda statistikament sinifikanti fl-AUC (110%) u fis-Cmax (127%).
English: Interactions relevant to pravastatin
Maltese: Interazzjonijiet relevanti ma' pravastatin
English: 14 hard capsules 30 hard capsules 60 hard capsules 90 hard capsules
Maltese: 14 kapsula iebsa 30 kapsula iebsa 60 kapsula iebsa 90 kapsula iebsa
English: A-II and of HDL cholesterol.
Maltese: Apoproteini A-I, A-II u tal-kolesterol HDL.
English: Fatigue and vertigo
Maltese: Għejja u vertigo
English: Also see section 4.4
Maltese: Ara wkoll sezzjoni 4.4.
English: The volume of distribution is about 0.5 l/kg.
Maltese: Il-volum ta' distribuzzjoni huwa madwar 0.5 l/kg.
English: INFORMATION IN BRAILLE Pravafenix
Maltese: INFORMAZZJONI BIL-BRAILLE Pravafenix
English: B-6900 Marche en Famenne
Maltese: Marche en Famenne
English: Sodium hydrogen carbonate Lauroyl macrogolglycerides Type 1500 Hydroxypropylcellulose Macrogol 20 000
Maltese: Sodium hydrogen carbonate Lauroyl macrogolglycerides Tip 1500
English: - Children and adolescents (age below 18 years).
Maltese: − Tfal u adoloxxenti (età taħt it-18-il sena).
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 (PPARα).
Maltese: Fenofibrate huwa derivattiv tal-aċidu fibriku li l-effetti tiegħu ta' modifikazzjoni tal-lipidi rrapportati fil-bniedem huma medjati bl-attivazzjoni tal-Peroxisome Proliferator Activated Receptor type alpha (PPARα).
English: Teл.
Maltese: Tel.
English: Pravafenix is contraindicated in moderate to severe renal impairment (section 4.3).
Maltese: Pravafenix huwa kontra-indikat f'indeboliment renali moderat għal sever (sezzjoni 4.3).
English: Alopecia, photosensitivity reactions
Maltese: Alopeċja, reazzjonijiet ta'
English: of fenofibric acid (point estimate) is of 30.94%, 10.9% and
Maltese: u Cmax tal-aċidu fenofibriku (stima tal-punt) huwa ta' 30.94%, 10.9% u 68.71% rispettivament.
English: The systemic clearance of pravastatin is 0.81 l/h/kg and the renal clearance is 0.38 l/h/kg indicating tubular secretion.
Maltese: It-tneħħija sistemika ta' pravastatin hija 0.81 l/h/kg u t-tneħħija mill-kliewi hija 0.38 l/h/kg li tindika sekrezzjoni tubulari.
English: Pravastatin is administered orally in the active form.
Maltese: Pravastatin jingħata b'mod orali fil-forma attiva.
English: Lactose monohydrate Cellulose microcrystalline Ascorbyl palmitate
Maltese: - kontenut tal-kapsula: lattożju monoidrat, cellulose microcrystalline, ascorbyl palmitate,
English: Muscle disorder (e.g. myositis, muscular weakness)
Maltese: Disturbi tal-muskoli (eż. mijożite, dgħjufija muskolari)
English: System organ class
Maltese: Sistema ta' klassifika tal-organi
English: System Organ Class
Maltese: Sistema ta' Klassifika tal-Organi
English: 90 hard capsules
Maltese: U 90 KAPSULA IEBSA
English: HDL-C (mg/dl)
Maltese: Kolesterol HDL (mg/dl)
English: - Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia (see section 4.4).
Maltese: − Pankreatite kronika jew akuta bl-eċċezzjoni ta' pankreatite akuta minħabba ipertrigliċeridemija severa (ara sezzjoni 4.4).
English: In one of two interaction studies with pravastatin and erythromycin a statistically significant increase in the area under the curve (AUC) (70%) and Cmax (121%) of pravastatin was observed.
Maltese: F'wieħed miż-żewġ studji ta' interazzjoni bi pravastatin u erythromycin ġiet osservata żieda statistikament sinifikanti fiż-żona ta' taħt il-kurva (AUC) (70%) u Cmax (121%) ta' pravastatin.
English: - You are under 18 years old.
Maltese: Tiħux Pravafenix jekk għandek inqas minn 18-il sena.
English: Each hard capsule contains 19 mg of lactose.
Maltese: Kull kapsula iebsa fiha 19 mg ta' lattożju.
English: Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Maltese: Artralġija, uġigħ fid-dahar, żieda fil-creatine phosphokinase fid demm, spażmi tal-muskoli, uġigħ muskuloskeletali, mijalġija,
English: Apo B (g/L)
Maltese: NUMRU(I)
English: Pravastatin is a competitive inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate-limiting step in cholesterol biosynthesis, and produces its lipid-lowering effect in two ways.
Maltese: Pravastatin huwa inibitur kompetittiv ta' 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, l-enzima li tikkatalizza l-istadju bikri ta' limitazzjoni tar-rata fil-bijosinteżi tal-kolesterol, u tipproduċi l-effett tagħha ta' tnaqqis tal-lipidi b'żewġ modi.
English: The risk of muscle toxicity is increased when a fibrate and a 3-hydroxy-3-methyl-glutarylCoenzyme A (HMG-CoA) reductase inhibitor are administered together.
Maltese: Ir-riskju tat-tossiċità tal-muskolu huwa miżjud meta fibrat u 3-hydroxy-3-methyl-glutarylCoenzyme A (HMG-CoA) inibitur ta' reductase jingħataw flimkien.
English: The respective effects of pravastatin and fenofibrate are complementary.
Maltese: L-effetti rispettivi ta' pravastatin u fenofibrate huma kumplimentari.
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 interazzjoni statistikament sinifikanti bejn it-trattament u s-sess tal-persuna (p = 0.01) li jindika benefiċju potenzjali tat-trattament tat-terapija kombinata fl-irġiel (p=0.037) iżda riskju potenzjalment ogħla għar-riżultat primarju finnisa ttrattati b'terapija kombinata mqabbla ma' monoterapija b'simvastatin (p=0.069).
English: Vision disturbance (including blurred vision and diplopia)
Maltese: Disturbi fil-viżta (inkluż viżta mċajpra u diplopja)
English: Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Maltese: Sustanzi li jimmodifikaw il-lipidi, inibituri ta' HMG CoA reductase f'kombinazzjoni ma' sustanzi oħra li jimmodifikaw il-lipidi, Kodiċi ATC: C10BA03
English: Immune-mediated necrotizing myopathy (see section 4.4).
Maltese: Mijopatija li tinnekrotizza medjata mis-sistema immunitarja (ara sezzjoni 4.4)
English: In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, < 5 times the ULN) was 1.92% for patients treated with Pravafenix.
Maltese: Fi studji kliniċi, l-inċidenza ta' żidiet importanti fi creatine phosphokinase (CK ≥ 3 darbiet il-ULN, < 5 darbiet il-ULN) kienet 1.92% għal pazjenti kkurati bi Pravafenix.
English: - Fusidic acid: do not take fusidic acid (a medicine for bacterial infections) while using this medicine.
Maltese: - Fusidic acid: m'għandekx tieħu aċidu fusidiku (mediċina għal infezzjoni batterika) waqt li qed tuża din il-mediċina.
English: Firstly, with the reversible and specific competitive inhibition of HMG-CoA reductase, it effects modest reduction in the synthesis of intracellular cholesterol.
Maltese: L-ewwel, bl-inibizzjoni kompetittiva reversibbli u speċifika ta' HMG-CoA reductase, huwa jwettaq tnaqqis modest fis-sinteżi tal-kolesterol intraċellulari.
English: The overall effect is a decrease in the ratio of low and very low-density lipoproteins to high-density lipoproteins.
Maltese: L-effett globali huwa tnaqqis fil-proporzjon ta' lipoproteini ta' densità baxxa u baxxa ħafna għal-lipoproteini ta' densità għolja.
English: Abnormal urination (including dysuria, frequency, nocturia)
Maltese: (inkluż disurja, frekwenza,
English: Adverse reaction (fenofibrate)
Maltese: Reazzjoni avversa (fenofibrate)
English: Fenofibrate Fenofibric acid is strongly bound to plasma albumin (more than 99%).
Maltese: L-aċidu fenofibriku jeħel ħafna mal-albumina tal-plażma (aktar minn 99%).
English: Frequency categories are based on information available from pravastatin and fenofibrate Summary of Product characteristics available in the EU.
Maltese: Ilkategoriji tal-frekwenzi huma bbażati fuq l-informazzjoni disponibbli minn pravastatin u fenofibrate Sommarju tal-Karatteristiċi tal-Prodott disponibbli fl-UE.
English: Opaque white HDPE bottles containing 14, 30, 60 and 90 hard capsules.
Maltese: Fliexken tal-HDPE bojod opaki li fihom 14, 30, 60 u 90 kapsula iebsa.
English: Laboratoires SMB s.a. rue de la Pastorale, 26-28 B-1080 Brussels Belgium
Maltese: Laboratoires SMB s.a. rue de la Pastorale, 26-28
English: Hepatic pain, gammaglutamyl transferase increased.
Maltese: Uġigħ fil-fwied, żieda fit-transferase tal-gammaglutamyl.
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% 48/4,900 patients) versus fenofibrate 1.4% (67/4,895); p=0.074.
Maltese: Fl-istudju fil-QASAM, ġiet irrapportata żieda statistikament sinifikanti ta' emboliżmu pulmonari (0.7% fil-grupp tal-plaċebo kontra 1.1% fil-grupp tal-fenofibrate; p=0.022) u żieda statitstikament mhux sinifikanti fi trombożi profonda tal-vini (plaċebo 1.0% 48/4,900 pazjenti) kontra fenofibrate 1.4% (67/4,895); p=0.074.
English: - capsule shell: gelatine, indigo carmine (E132), black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172).
Maltese: povidone, sodium starch glycolate, magnesium stearate, talc, triacetin, sodium hydrogen carbonate, lauroyl macrogolglycerides, hydroxypropylcellulose, macrogol 20 000. - qoxra tal-kapsula: ġelatina, indigo carmine (E132), iron oxide iswed (E172), titanium dioxide (E171), iron oxide isfar (E172).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001-007
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/679/001-007
English: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
Maltese: SMB Technology s.a. rue du Parc Industriel 39
English: Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, < 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Maltese: Żidiet klinikamenti importanti fi creatine phosphokinase (CK ≥ 5 darbiet il-ULN, < 10 darbiet il-ULN mingħajr sintomi muskolari) intwerew f'0.38% tal-pazjenti kkurati bi Pravafenix.
English: Fusidic acid
Maltese: Aċidu fusidiku
English: - Keep this leaflet.
Maltese: mijożite, polimijożite.
English: Pravastatin is not metabolised to a clinically significant extent by the cytochrome P450 system.
Maltese: Prodotti mediċinali metabolizzati minn cytochrome P450 Pravastatin mhuwiex metabolizzat għal ammont klinikament sinifikanti bis-sistema ta' cytochrome
English: Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
Maltese: Żieda klinikament importanti (CK ≥ 10 darbiet il-ULN mingħajr sintomi muskolari) dehret f'0.06% tal-pazjenti kkurati bi Pravafenix.
English: In vitro and in vivo genetic toxicology studies have shown no evidence of mutagenic potential.
Maltese: Studji in vitro u in vivo dwar it-tossikoloġija ġenetika ma wrew l-ebda evidenza ta' potenzjal mutaġeniku.
English: On average, 34% of the orally administered dose is absorbed, with an absolute bioavailability of 17%.
Maltese: Bħala medja, tiġi assorbita 34% tad-doża mogħtija b'mod orali, b'bijodisponibilità assoluta ta' 17%.
English: Renal and urinary disorders:
Maltese: Disturbi fil-kliewi u fissistema urinarja:
English: The capsules are supplied in Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60, or 90 capsules, and in opaque white plastic bottles containing either 14, 30, 60 or 90 capsules.
Maltese: Il-kapsuli jiġu f'pakketti ta' folji tal-Polyamide-AluminjuPVC/aluminju li jkun fihom 30, 60, jew 90 kapsula, u fi fliexken tal-plastik bojod opaki li fihom 14, 30, 60 jew 90 kapsula.
English: - Moderate to severe renal impairment (defined as an estimated creatinine clearance < 60 ml/min).
Maltese: − Indeboliment renali moderat għal sever (definit bħala tneħħija tal-kreatinina stmata < 60 ml/min).
English: Dizziness, headache, paraesthesia
Maltese: Sturdament, uġigħ ta' ras, paraesteżija
English: Each hard capsule contains 40 mg pravastatin sodium and 160 mg fenofibrate.
Maltese: Kull kapsula iebsa fiha 40 mg pravastatin sodium u 160 mg fenofibrate.
English: About 50% of circulating pravastatin is bound to plasma proteins.
Maltese: Madwar 50% ta' pravastatin fiċ-ċirkolazzjoni jeħel mal-proteini tal-plażma.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
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 li jinkludi rabdomajlosi jista' jiżdied bl-għoti fl-istess waqt ta' fusidic acid sistemiku ma' statins.
English: In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
Maltese: Kemm f'individwi b'saħħithom kif ukoll fil-pazjenti b'iperkolesterolemija, pravastatin ibaxxi l-valuri tal-lipidi li ġejjin: il-kolesterol totali, il-kolesterol LDL, l-apolipoproteina B, il-kolesterol VLDL u ttrigliċeridi; filwaqt li jogħlew il-kolesterol HDL u l-apolipoproteina A.
English: No specific antidote is known.
Maltese: Ebda antidotu speċifiku ma huwa magħruf.
English: Peripheral polyneuropathy
Maltese: Polinewropatija periferali
English: In mice, a 2-year carcinogenicity study with pravastatin demonstrates at doses of 250 and 500 mg/kg/day (> 310 times the maximum human mg/kg dose), statistically significant increases in the incidence of hepatocellular carcinomas in males and females, and lung adenomas in females only.
Maltese: Fil-ġrieden, studju ta' sentejn dwar il karċinoġeniċità bi pravastatin juri f'dożi ta' 250 u 500 mg/kg/ġurnata (> 310 darbiet id-doża massima mg/kg fil-bniedem), żidiet statistikament sinifikanti fl-inċidenza ta' karċinomi epatoċellulari fl-irġiel u n-nisa, u ta' adenomi fil-pulmun fin-nisa biss.
English: Polyamide-Aluminium-PVC/aluminium blister packs containing 30, 60 and 90 hard capsules.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pakketti tal-folji tal-polyamide-Aluminju-PVC/aluminju li fihom 30, 60 u 90 kapsula iebsa.
English: There is no relevant use of Pravafenix in the paediatric population (< 18 years old) for the indication of mixed dyslipidaemia (see section 4.3).
Maltese: Ma hemmx użu relevanti ta' Pravafenix fil-popolazzjoni pedjatrika (< 18-il sena) għall-indikazzjoni ta' dislipidemija mħallta (ara sezzjoni 4.3).
English: In clinical studies, the incidence of important elevations in serum transaminases (ALT
Maltese: Żidiet klinikamenti importanti fi transaminases tas-serum (ALT u/jew AST ≥ 5 darbiet il
English: 30 hard capsules
Maltese: 14 kapsula iebsa 30 kapsula iebsa
English: After intravenous administration, 47% of the dose is eliminated by the renal excretion and 53% by biliary excretion and biotransformation.
Maltese: Wara għoti fil-vini, 47% tad-doża titneħħa permezz tal-eskrezzjoni renali u 53% permezz taleskrezzjoni biljari u bijotrasformazzjoni.
English: The effects of Pravafenix 40 mg/160 mg were confirmed in a similar multicenter, 64-week trial including a 12 week randomized, double-blind phase in a study performed in the USA and comparing Pravafenix 40 mg/160 mg to Fenofibrate 160 mg monotherapy and Pravastatin 40 mg monotherapy in patients with mixed dyslipidaemia.
Maltese: L-effetti ta' Pravafenix 40 mg/160 mg ġew ikkonfermati fi prova b'aktar minn ċentru wieħed simili ta' 64 ġimgħa li kienet tinkludi fażi double-blind, randomizzata, ta' 12-il ġimgħa mwettqa fl-USA u li qabblet Pravafenix 40 mg/160 mg ma' monoterapija b'Fenofibrate 160 mg u monoterapija bi Pravastatin 40 mg f'pazjenti b'dislipidemija mħallta.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Maltese: Ir-rekwiżiti tar- rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tadDirettiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Possible side effects reported with some statins (same type of cholesterol-lowering medicines as pravastatin)
Maltese: Effetti sekondarji possibbli rraportati b'xi statins (l-istess tip ta' mediċini li jbaxxa l-livell tal kolesterol bħal pravastatin)
English: Pravafenix is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance < 60 ml/min) (see section 4.3.)
Maltese: Pravafenix huwa kontra-indikat f'pazjenti li jkollhom indeboliment renali moderat għal sever (definit bħala tneħħija tal-kreatinina < 60 ml/min) (ara sezzjoni 4.3.)
English: The decreased in AUCt, AUC∞ and Cmax
Maltese: It-tnaqqis fl-AUCt, AUC∞
English: Apo A1 (g/L)
Maltese: TG (mg/dl) TC (mg/dl) Apo A1 (g/L) Apo B (g/L) Apo B/Apo A1 Fibrinogen (g/L)
English: • Breathing problems including persistent cough/or shortness of breath or fever.
Maltese: • Diffikultajiet respiratorji, inklużi sogħla persistenti/jew qtugħ ta' nifs jew deni.
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: It-terapija ta' fenofibrate flimkien ma' simvastatin ma wrietx kwalunkwe differenzi sinifikanti meta mqabbla mal monoterapija b'simvastatin fir-riżultat primarju kompost ta' infart mijokardijaku mhux fatali, puplesija mhux fatali, u mewt kardjovasklari (proporzjon ta' periklu [HR, hazard ratio] 0.92, 95% CI 0.79-1.08, p = 0.
English: It contains two active substances: pravastatin and fenofibrate.
Maltese: Fiha żewġ sustanzi attivi: pravastatina u fenofibrate.
English: Pravastatin must not be co-administered with systemic fusidic acid.
Maltese: Pravastarin m'għandux jiġi mogħti flimkien ma' fusidic acid sistemiku.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: − Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Therefore the fixed dose combination (Pravafenix) could not be considered interchangeable with the free co-administration of fenofibrate and pravastatin mono-component drug products.
Maltese: Għalhekk il-kombinazzjoni ta' doża fissa (Pravafenix) ma tistax titqies bħala interkambjabbli malkoamministrazzjoni libera ta' prodotti mediċinali b'fenofibrate u pravastatin bħala monokomponenti.
English: The major degradation product of pravastatin is the 3-αhydroxy isomeric metabolite.
Maltese: Il-prodott prinċipali tad-degradazzjoni ta' pravastatin huwa lmetabolit isomeriku 3-α-hydroxy.