FrancophonIA/ELRC3.0 huggingface dataset:
English: Dexdor was compared with other sedative medicines (propofol or midazolam) in two main studies involving 1,000 patients who required sedation in intensive care units.
Maltese: Dexdor tqabbel ma' mediċini sedattivi oħrajn (propofol jew midazolam) f'żewġ studji ewlenin li involvew 1,000 pazjent li kienu jeħtieġu sedazzjoni f'unitajiet tal-kura intensiva.
English: As for all medicines, data on the use of Dexdor is continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Dexdor hija ssorveljata kontinwament.
English: Midazolam treatment was not required in 40% of patients receiving the lower dose of Dexdor and 54% of those receiving the higher dose compared with 3% of patients receiving placebo.
Maltese: Kura b'midazolam ma kinitx meħtieġa f'40 % talpazjenti li rċivew id-doża aktar baxxa ta' Dexdor u 54 % ta' dawk li rċivew id-doża ogħla meta mqabbel ma' 3 % tal-pazjenti li rċivew plaċebo.
English: In the second study, 61% of patients given Dexdor maintained the required level of sedation compared with 57% of those receiving midazolam.
Maltese: Fit-tieni studju, 61 % tal-pazjenti li ngħataw Dexdor żammew il-livell meħtieġ ta' sedazzjoni meta mqabbel ma' 57 % ta' dawk li rċivew midazolam.
English: What are the risks associated with Dexdor?
Maltese: X'inhuma r-riskji assoċjati ma' Dexdor?
English: Dexdor is given by infusion (drip) into a vein using a controlled infusion device.
Maltese: Dexdor jingħata permezz ta' infużjoni (dripp) ġo vina billi jintuża apparat ta' infużjoni kkontrollata.
English: Dexdor was compared with placebo (a dummy treatment) in two main studies involving 431 patients.
Maltese: Dexdor tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew 431 pazjent.
English: Dexdor is a medicine used to sedate (calm or make sleepy) adult patients in the following settings:
Maltese: Dexdor huwa mediċina li tintuża bħala sedattiv (tikkalma jew traqqad) f'pazjenti adulti fl-ambjenti li ġejjin:
English: Midazolam treatment was not required in 53% of patients receiving Dexdor compared with 14% receiving placebo.
Maltese: Kura b'midazolam ma kinitx meħtieġa f'53 % tal-pazjenti li rċivew Dexdor meta mqabbel ma' 14 % li rċivew plaċebo.
English: Awake sedation during diagnostic or surgical procedures
Maltese: Sedazzjoni mqajma waqt proċeduri dijanjostiċi jew kirurġiċi
English: The first study involved patients undergoing surgery or a procedure under an anaesthetic block (where sensation to a part of the body is blocked).
Maltese: L-ewwel studju involva pazjenti li kienet qiegħda ssirilhom kirurġija jew proċedura taħt imblokk anestetiku (fejn sensazzjoni għal parti tal-ġisem tiġi mblukkata).
English: In the first study, 65% of patients given Dexdor maintained the required level of sedation compared with 65% of those receiving propofol.
Maltese: Fl-ewwel studju, 65 % tal-pazjenti li ngħataw Dexdor żammew il-livell meħtieġ ta' sedazzjoni meta mqabbel ma' 65 % ta' dawk li rċivew propofol.
English: Dexdor can only be obtained with a prescription and should be given by a healthcare professional skilled in managing patients in intensive care or giving anaesthetic during diagnostic or surgical procedures.
Maltese: Dexdor jista' jinkiseb biss b'riċetta ta' tabib u għandu jingħata minn professjonista fil-qasam tal-kura tas-saħħa mħarreġ fil-ġestjoni ta' pazjenti fil-kura intensiva jew fl-għoti ta' anestetiku waqt proċeduri dijanjostiċi jew kirurġiċi.
English: The most common side effects when it is used for awake sedation are low blood pressure, respiratory depression (reduced ability to breathe) and bradycardia.
Maltese: L-effetti sekondarji l-aktar komuni meta jintuża għal sedazzjoni mqajma huma pressjoni tad-demm baxxa, dipressjoni respiratorja (ħila mnaqqsa li jittieħed in-nifs) u bradikardija.
English: What measures are being taken to ensure the safe and effective use of Dexdor?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Dexdor?
English: It works by blocking receptors in the brain called alpha-2 receptors and reduces the activity of the sympathetic nervous system which is involved in controlling anxiety, arousal and sleep as well as blood pressure and heart rate.
Maltese: Din taħdem billi timblokka riċetturi fil-moħħ imsejħa riċetturi alfa-2 u tnaqqas l-attività tas-sistema nervuża simpatetika li hija involuta fil-kontroll tal-ansjetà, tat-tqanqil u tal-irqad, kif ukoll tal-pressjoni taddemm u tar-rata tat-taħbit tal-qalb.
English: How does Dexdor work?
Maltese: X'inhu Dexdor u għal xiex jintuża?
English: The studies also showed that Dexdor reduced the duration of mechanical ventilation.
Maltese: L-istudji wrew ukoll li Dexdor naqqas id-durata tal-ventilazzjoni mekkanika.
English: It is effective for awake sedation during procedures but sometimes an additional sedative medicine as well as Dexdor may be needed.
Maltese: Dan huwa effettiv għal sedazzjoni mqajma waqt il-proċeduri iżda xi drabi tista' tkun meħtieġa wkoll mediċina sedattiva addizzjonali minbarra Dexdor.
English: The most common side effects with Dexdor (which may affect more than 1 in 10 people) when it is used in intensive care are low or high blood pressure and bradycardia (slow heart rate).
Maltese: L-effetti sekondarji l-aktar komuni b'Dexdor (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) meta jintuża fil-kura intensiva huma pressjoni tad-demm baxxa jew għolja u bradikardija (rata baxxa tat-taħbit tal-qalb).
English: • before or during diagnostic or surgical procedures where the patient remains awake (awake sedation).
Maltese: • qabel jew waqt proċeduri dijanjostiċi jew kirurġiċi fejn il-pazjent jibqa' mqajjem (sedazzjoni mqajma).
English: By reducing the activity of the sympathetic nervous system, dexmedetomidine helps to make patients calm or sleepy.
Maltese: Aktar informazzjoni fuq Dexdor tinstab fis-sit elettroniku tal-Aġenzija:
English: For the full list of side effects and restrictions with Dexdor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Dexdor, ara l-fuljett ta' tagħrif.
English: A higher proportion of patients treated with Dexdor did not require additional treatment with midazolam (another sedative medicine) to maintain the desired sedation level.
Maltese: Proporzjon ogħla ta' pazjenti li ġew ikkurati b'Dexdor ma kinux jeħtieġu kura addizzjonali b'midazolam (mediċina sedattiva oħra) biex iżommu l-livell ta' sedazzjoni mixtieq.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: MPS VII is rare, and Mepsevii was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 March 2012.
Maltese: MPS VII hija rari, u Mepsevii ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil21 ta' Marzu 2012.
English: Further information on Mepsevii can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni fuq Mepsevii tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mepsevii contains the active substance vestronidase alfa.
Maltese: Mepsevii fih is-sustanza attiva vestronidase alfa.
English: Other information about Mepsevii
Maltese: Informazzjoni oħra dwar Mepsevii
English: The recommended dose for each infusion is 4 mg per kilogram of body weight.
Maltese: Id-doża rakkomandata għal kull infużjoni hija 4 mg għal kull kilogramma tal-piż tal-ġisem.
English: In a main study of 12 patients with MPS VII, patients treated with Mepsevii for 6 months had a 65% reduction in their urine levels of GAGs.
Maltese: Fi studju ewlieni ta' 12-il pazjent b'MPS VII, pazjenti kkurati b'Mepsevii għal 6 xhur kellhom tnaqqis ta' 65 % ta' GAGs fil-livelli ta' urina tagħhom.
English: What information is still awaited for Mepsevii?
Maltese: Liema informazzjoni għadha mistennija għal Mepsevii?
English: The most common side effects with Mepsevii (which may affect more than 1 in 10 people) are anaphylactic reaction (sudden, severe allergic reaction), urticaria (itchy rash) and swelling at the infusion site.
Maltese: L-effetti sekondarji l-aktar komuni b'Mepsevii (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma reazzjoni anafilattika (reazzjoni allerġika f'daqqa u severa), urtikarja (raxx bil-ħakk) u nefħa fissit tal-infużjoni.
English: Mepsevii is a medicine to treat mucopolysaccharidosis type VII (MPS VII, also known as Sly syndrome), an inherited disease caused by a lack of an enzyme needed to break down complex carbohydrates known as glycosaminoglycans (GAGs).
Maltese: Mepsevii huwa mediċina li tintuża biex tikkura mukopolisakkaridożi tat-tip VII (MPS VII, magħruf ukoll bħala sindrome ta' Sly), marda li tintiret li tiġi kkawżata minn nuqqas ta' enzima meħtieġa biex tkisser karboidrati kumplessi magħrufa bħala glikosaminoglikani (GAGs).
English: What are the risks associated with Mepsevii?
Maltese: X'inhuma r-riskji assoċjati ma' Mepsevii?
English: As for all medicines, data on the use of Mepsevii are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Mepsevii hija ssorveljata kontinwament.
English: Mepsevii is an enzyme replacement therapy that works by replacing the missing enzyme (betaglucuronidase) in patients with MPS VII, helping to break down GAGs and stopping them building up in the body.
Maltese: Mepsevii huwa terapija ta' sostituzzjoni tal-enzimi li jaħdem billi jissostitwixxi l-enzima nieqsa (betaglucuronidase) f'pazjenti b'MPS VII, billi jgħin biex ikisser GAGs u jwaqqafhom milli jakkumulaw filġisem.
English: The disease leads to build up of GAGs in the body, which causes a wide range of problems, including joint stiffness, short stature, enlarged liver and spleen, hearing loss, cataract and delays in development.
Maltese: Din il-marda twassal għal akkumulazzjoni ta' GAGs fil-ġisem, li tikkawża firxa wiesgħa ta' problemi, inklużi ebusija tal-ġogi, statura qasira, fwied u milsa mkabbra, telf tas-smigħ, katarretta u dewmien fliżvilupp.
English: Side effects reported with Mepsevii are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Mepsevii huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Mepsevii is given every two weeks as an infusion (drip) into a vein lasting 4 hours.
Maltese: Mepsevii jingħata kull ġimagħtejn bħala infużjoni (dripp) ġo vina li ddum 4 sigħat.
English: EMA decided that Mepsevii's benefits are greater than its risks and that it can be authorised for use in the EU.
Maltese: L-EMA ddeċidiet li l-benefiċċji ta' Mepsevii huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: How does Mepsevii work?
Maltese: Kif jintuża Mepsevii?
English: Mepsevii has been shown to reduce the levels of GAGs in the body and reduce or stabilise symptoms in patients with MPS VII.
Maltese: Mepsevii ntwera li jnaqqas il-livelli ta' GAGs fil-ġisem u jnaqqas jew jistabbilizza s-sintomi f'pazjenti b'MPS VII.
English: Since Mepsevii has been authorised under exceptional circumstances, the company that markets Mepsevii will conduct a study to provide data on the long-term effectiveness and safety of Mepsevii as well as on the disease itself, including its progression and development of symptoms.
Maltese: Minħabba li Mepsevii ġie awtorizzat taħt ċirkostanzi ta' eċċezzjoni, il-kumpanija li tqiegħed Mepsevii fissuq ser twettaq studju biex tipprovdi data dwar l-effikaċja u s-sigurtà fit-tul ta' Mepsevii kif ukoll dwar il-marda nnifisha, inkluż il-progressjoni tagħha u l-iżvilupp tas-sintomi.
English: Although only a limited amount of data is available from clinical studies, the European Medicines Agency took into account the life-threatening and debilitating nature of MPS VII and the lack of authorised medicines.
Maltese: Għalkemm hemm biss ammont limitat ta' data disponibbli minn studji kliniċi, l-Aġenzija Ewropea għallMediċini qieset in-natura ta' periklu għall-ħajja u debilitanti ta' MPS VII u n-nuqqas ta' mediċini awtorizzati.
English: Oral use bottle (HDPE)
Maltese: Użu orali flixkun (HDPE)
English: 500 mg Film-Coated tablet
Maltese: 500 mg Pillola miksija b'rita
English: 120 filmcoated tablets
Maltese: 120 pillola miksija b'rita
English: Invented name Strength Pharmaceutical form
Maltese: Qawwa Għamla farmaċewtika
English: Pack size
Maltese: Isem ivvintat
English: Rare: cholestasis.
Maltese: Rari: cholestasis.
English: Gemfibrozil / fibric acid derivatives
Maltese: Gemfibrozil / derivattivi tal-fibric acid
English: Oral contraceptive OD, 2 months - norethindrone 1 mg -ethinyl estradiol 35 µg
Maltese: Kontraċettiv orali OD, xahrejn - norethindrone 1 mg -ethinyl estradiol 35 µg
English: Uncommon: dizziness, paraesthesia, hypoesthesia, dysgeusia, amnesia.
Maltese: Mhux komuni: sturdament, paraesthesia, hypoesthesia, dysgeusia, amnesija.
English: Only limited data are available (see section 5.1).
Maltese: Dejta limitata biss hija disponibbli (ara sezzjoni 5.1).
English: No. of Events (Atorvastatin vs Placebo)
Maltese: Nru ta' Episodji (Atorvastatin vs Plaċebo)
English: Itraconazole 200 mg OD, 4 days
Maltese: Itraconazole 200 mg OD, 4 ijiem
English: Belgium, Cyprus, Finland, Greece, Ireland, Luxembourg, Malta, Netherlands, Norway, Sweden, UK
Maltese: Belġju, Ċipru, Finlandja, Greċja, Irlanda, Lussemburgu, Malta, Olanda, Norveġja, Svezja, Renju Unit
English: Antacid suspension of magnesium and aluminium hydroxides, 30 mL QID, 2 weeks
Maltese: Sospensjoni antaċida ta' magnesium u aluminium hydroxides, 30 mL QID, ġimagħtejn
English: Ciclosporin 5.2 mg/kg/day, stable dose
Maltese: Ciclosporin 5.2 mg/kg/jum, doża stabbli
English: {PRODUCT NAME} contains lactose.
Maltese: TAL-PRODOTT} fih il-lactose.
English: Rare: peripheral neuropathy.
Maltese: Rari: newropatija periferali.
English: When compared to pravastatin the effects of atorvastatin were statistically significant (p=0.02).
Maltese: Meta pparagunat ma' pravastatin, l-effetti ta' atorvastatin kienu statistikament sinifikanti (p=0.02).
English: ↓ 35%^ No specific recommendation.
Maltese: ↓ 35%^ L-ebda rakkomandazzjoni speċifika.
English: 100 vs. 154 389 vs. 483
Maltese: 389 vs. 483
English: Acute coronary syndrome
Maltese: Sindrome koronarju akut
English: • Sexual dysfunction.
Maltese: • Disfunzjoni sesswali.
English: The other secondary endpoints did not reach statistical significance on their own (overall: Placebo: 22.2%, Atorvastatin: 22.4%).
Maltese: L-endpoints sekondarji l-oħra ma laħqux importanza statistika waħedhom (globali: Placebo: 22.2%, Atorvastatin: 22.4%).
English: 40 mg SD ↑ 3.3 fold
Maltese: 40 mg SD ↑ 3.3 darbiet
English: The mean LDL-C was 73 mg/dL (1.9 mmol/L) during treatment with atorvastatin and 129 mg/dL (3.3 mmol/L) during treatment with placebo.
Maltese: Il-LDL-C medju kien 73 mg/dL (1.9 mmol/L) matul it-trattament b'atorvastatin u 129 mg/dL (3.3 mmol/L) matul it-trattament bi plaċebo.
English: Denmark, Greece, Iceland, Portugal, Spain
Maltese: Danimarka, Greċja, Islanda, Portugall, Spanja Zarator Finlandja
English: Pharmacotherapeutic group: Lipid modifying agents, HMG-CoA-reductase inhibitors, ATC code: C10AA05
Maltese: Aġenti li jimmodifikaw il-lipidi, inibituri reductase ta' HMG-CoA, kodiċi ATC: C10AA05
English: * Phenazone, 600 mg SD ↑ 3% No specific recommendation
Maltese: * Phenazone, 600 mg SD ↑ 3% L-ebda rakkomandazzjoni speċifika
English: Atorvastatin and dosing regimen Medicinal product/Dose (mg)
Maltese: Atorvastatin u kors ta' dożaġġ Prodott mediċinali/Doża (mg)
English: Rare: angioneurotic oedema, dermatitis bullous including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Maltese: Rari: edima anġjonewrotika, dermatite bulluża inkluż eritema multiforme, is-sindromu ta' StevensJohnson u nekrolisi epidermali tossika.
English: Atorvastatin is metabolized by cytochrome P450 3A4 to ortho- and parahydroxylated derivatives and various beta-oxidation products.
Maltese: Atorvastatin huwa mmetabolizzat miċ-ċitokromu P450 3A4 għal derivattivi ortho- u parahydroxylated u diversi prodotti ta' beta-ossidazzjoni.
English: Rare: visual disturbance.
Maltese: Rari: disturb viżiv.
English: Avoid drinking too much alcohol while taking this medicine.
Maltese: Evita li tixrob wisq alkoħol waqt li tkun qed tieħu din il-mediċina.
English: Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDLC and apolipoprotein A1 in a dose response study.
Maltese: Atorvastatin intwera li jnaqqas il-konċentrazzjonijiet ta' total-C (30% - 46%), LDL-C (41% - 61%), apolipoproteini B (34% - 50%), u trigliċeridi (14% - 33%) waqt li jipproduċi żidiet varjabbli fl-HDL-C u l-apolipoproteina A1 fi studju ta' rispons għad-doża.
English: Strokes (Fatal and non-fatal)
Maltese: Puplesiji (Fatali u mhux fatali)
English: In the MIRACL study, atorvastatin 80 mg has been evaluated in 3,086 patients (atorvastatin n=1,538; placebo n=1,548) with an acute coronary syndrome (non Q-wave MI or unstable angina).
Maltese: Fl-istudju MIRACL, atorvastatin 80 mg ġie evalwat fi 3,086 pazjent (atorvastatin n=1,538; plaċebo n=1,548) b'sindrome koronarju akut (non Q-wave MI jew anġina instabbli).
English: Clarithromycin 500 mg BID, 9 days
Maltese: Clarithromycin 500 mg BID, 9t ijiem
English: − The active substance is atorvastatin.
Maltese: Is-sustanza attiva hija atorvastatin.
English: Rifampin 600 mg OD, 5 days (doses separated)
Maltese: Rifampin 600 mg OD, 5t ijiem (dożi separati)
English: • Depression.
Maltese: • Dipressjoni.
English: − Medicines obtained without a prescription: St John's Wort
Maltese: Mediċini li jinkisbu mingħajr riċetta ta' tabib: St John's Wort
English: Erythromycin 500 mg QID, 7 days
Maltese: Erythromycin 500 mg QID, 7t ijiem
English: CYP3A4 inducers
Maltese: Inducers tas-CYP3A4
English: 40 mg on day 1, 10 mg on day 20
Maltese: 40 mg f'jum 1, 10 mg f'jum 20
English: Tipranavir 500 mg BID/ Ritonavir 200 mg BID, 8 days (days 14 to 21)
Maltese: Tipranavir 500 mg BID/ Ritonavir 200 mg BID, 8t ijiem (jiem 14 sa 21)
English: Rifampin 600 mg OD, 7 days (co-administered)
Maltese: Rifampin 600 mg OD, 7t ijiem (ko-amministrat)
English: Gemfibrozil 600 mg BID, 7 days
Maltese: Gemfibrozil 600 mg BID, 7t ijiem
English: Atorvastatin was negative for mutagenic and clastogenic potential in a battery of 4 in vitro tests and 1 in vivo assay.
Maltese: Atorvastatin kien negattiv għall-potenzjal mutaġeniku u klastoġeniku f'batterija ta' 4 testijiet in vitro u assaġġ 1 in vivo.
English: In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 Lipitor vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued due to adverse reactions compared to 4.0% of the patients on placebo.
Maltese: Fid-database ta' 16,066 (8755 Lipitor vs. 7311 plaċebo) pazjent kkurati għal perijodu medju ta' 53 ġimgħa fil-prova klinika ta' atorvastatin ikkontrollat bi plaċebo, 5.2% tal-pazjenti fuq atorvastatin ma komplewx minħabba reazzjonijiet avversi meta mqabbla ma' 4.0% tal-pazjenti fuq plaċebo.
English: Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Maltese: Atorvastatin huwa inibitur reductase ta' HMG-CoA kompetittiv u selettiv, l-enzima li tillimita r-rata responsabbli għall-konverżjoni ta' 3-hydroxy-3-methyl-glutaryl-coenzyme A għal mevalonate, prekursur tal-isteroli, inkluż il-kolesterol.
English: Possible side effects reported with some statins (medicines of the same type):
Maltese: Effetti sekondarji possibbli rrappurtati b'xi statins (mediċini tal-istess tip):
English: Saquinavir 400 mg BID/ Ritonavir (300 mg BID from days 5-7, increased to 400 mg BID on day 8), days 5-18, 30 min after atorvastatin dosing
Maltese: Saquinavir 400 mg BID/ Ritonavir (300 mg BID minn jum 5-7, jiżdied għal 400 mg BID f'jum 8), jiem 5-18, 30 min wara d-doża ta' atorvastatin
English: Nelfinavir 1250 mg BID, 14 days
Maltese: Nelfinavir 1250 mg BID, 14-il jum
English: Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Maltese: CHD fatali u MI mhux fatali Total ta' episodji kardjovaskulari u proċeduri ta' rivaskularizzazzjoni Total ta' episodji koronarji
English: OD = once daily; SD = single dose
Maltese: OD = darba kuljum; SD = doża waħda
English: The safety and tolerability profiles of the two treatment groups were comparable.
Maltese: Il-profili ta' sigurtà u tollerabilità taż-żewġ gruppi ta' trattament kienu komparabbli.
English: Atorvastatin is metabolized by cytochrome P450 3A4 (CYP3A4) and is a substrate to transport proteins e.g. the hepatic uptake transporter OATP1B1.
Maltese: Atorvastatin huwa mmetabolizzat b'cytochrome P450 3A4 (CYP3A4) u huwa substrat għall-proteini talġarr eż. it-trasportatur OATP1B1 għat-teħid mis-sistema epatika.
English: All cause mortality was 9.1% (216/2365) for atorvastatin versus 8.9% (211/2366) for placebo.
Maltese: Il-mortalità mill-kawżi kollha kienet 9.1% (216/2365) għal atorvastatin kontra 8.9% (211/2366) għall-plaċebo.
English: Estimated frequencies of reactions are ranked according to the following convention: common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (≤ 1/10,000).
Maltese: Il-frekwenzi stmati tar-reazzjonijiet huma kklassifikati skont il-konvenzjoni li ġejja: komuni ( 1/100, < 1/10); mhux komuni ( 1/1,000, < 1/100); rari ( 1/10,000, < 1/1,000); rari ħafna ( 1/10,000).
English: The absolute bioavailability of atorvastatin is approximately 12% and the systemic availability of HMGCoA reductase inhibitory activity is approximately 30%.
Maltese: Il-bijodisponibilità assoluta ta' atorvastatin hija madwar 12% u ddisponibbiltà sistemika tal-attività inibitorja ta' HMG-CoV hija madwar 30%.
English: • visual disturbance
Maltese: • disturb fil-vista
English: • hepatitis (liver inflammation)
Maltese: • epatite (infjammazzjoni tal-fwied)
English: AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
Maltese: AMI = infart mijokardijaku akut; CABG = trapjant ta' bypass tal-arterja koronarja;
English: The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of cardiovascular disease, and with LDL-C ≤4.14 mmol/l (160 mg/dl) and TG ≤6.78 mmol/l (600 mg/dl).
Maltese: L-effett ta' atorvastatin fuq il-mard kardjovaskulari fatali u mhux fatali ġie studjat ukoll fi prova randomizzata, double-blind, multiċentri, ikkontrollata bi plaċebo, il-Collaborative Atorvastatin Diabetes Study (CARDS) f'pazjenti b'dijabete tat-tip 2, età ta' 40-75 sena, mingħajr storja preċedenti ta' mard kardjovaskulari, u b'LDL-C ≤4.14 mmol/l (160 mg/dl) u TG ≤6.78 mmol/l (600 mg/dl).
English: Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA, revascularization, stroke) MI (fatal and non-fatal AMI, silent MI)
Maltese: Episodji kardjovaskulari maġġuri (AMI fatali u mhux fatali, MI sieket, mewt minn CHD akut, anġina instabbli, CABG, PTCA, rivaskularizzazzjoni, puplesija) MI (AMI fatali u mhux fatali, MI sieket)
English: Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)
Maltese: Prevenzjoni ta' Puplesija bit-Tnaqqis Aggressiv fil-Livelli tal-Kolesterol (SPARCL)