FrancophonIA/ELRC3.0 huggingface dataset:
English: Atorvastatin also significantly reduced mean TC by 34.1% (pravastatin: -18.4%, p<0.0001), mean TG levels by 20% (pravastatin: -6.8%, p<0.0009), and mean apolipoprotein B by 39.1% (pravastatin: -22.0%, p<0.0001).
Maltese: Atorvastatin naqqas ukoll b'mod sinifikanti t-TC medju bi 34.1% (pravastatin: -18.4%, p<0.0001), illivelli medji ta' TG b'20% (pravastatin: -6.8%, p<0.0009), u l-alipoproteina B medja b'39.1% (pravastatin: -22.0%, p<0.0001).
English: In the atorvastatin group, LDL-C was reduced to a mean of 2.04 mmol/L ± 0.8 (78.9 mg/dl ± 30) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 28) and in the pravastatin group, LDL-C was reduced to a mean of 2.85 mmol/l ± 0.7 (110 mg/dl ± 26) from baseline 3.89 mmol/l ± 0.7 (150 mg/dl ± 26) (p<0.0001).
Maltese: Fil-grupp li ħa atorvastatin, LDL-C tnaqqas għal medja ta' 2.04 mmol/L ± 0.8 (78.9 mg/dl ± 30) mil-linja bażi 3.89 mmol/l ± 0.7 (150 mg/dl ± 28) u fil-grupp li ħa pravastatin, LDL-C tnaqqas għal medja ta' 2.85 mmol/l ± 0.7 (110 mg/dl ± 26) mil-linja bażi 3.89 mmol/l ± 0.7 (150 mg/dl ± 26) (p<0.0001).
English: ^ Total atorvastatin equivalent activity
Maltese: ^ Attività ekwivalenti għal atorvastatin totali.
English: Hypercholesterolaemia
Maltese: Iperkolesterolemija
English: Reproductive system and breast disorders Very rare: gynecomastia.
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Rari ħafna: ginekomastja.
English: Overall and cardiovascular mortality were numerically higher in the female patients (38 vs. 30 and 17 vs. 12), but this was not statistically significant.
Maltese: Il-mortalità globali u kardjovaskulari kienu numerikament ogħla fil-pazjenti nisa (38 vs. 30 u 17 vs. 12), iżda dan ma kienx statistikament sinifikanti.
English: Mean volume of distribution of atorvastatin is approximately 381 l. Atorvastatin is ≥ 98% bound to plasma proteins.
Maltese: Il-volum medju ta' distribuzzjoni ta' atorvastatin huwa madwar 381 l.  98% ta' atorvastatin jeħel malproteini tal-plażma.
English: Atorvastatin increased mean HDL-C by 2.9% (pravastatin: +5.6%, p=NS).
Maltese: Atorvastatin żied il-HDL-C bi 2.9% (pravastatin:
English: Skeletal muscle effects
Maltese: Effetti muskolu-skeletriċi
English: In patients with SLCO1B1 polymorphism there is a risk of increased exposure of atorvastatin, which may lead to an increased risk of rhabdomyolysis (see section 4.4).
Maltese: Fil-pazjenti li jkollhom polimorfiżmu SLCO1B1, hemm riskju ta' esponiment akbar ta' atorvastatin, li jista' jwassal għal riskju akbar ta' rabdomijolisi (ara sezzjoni 4.4).
English: Cimetidine 300 mg QID, 2 weeks
Maltese: Cimetidine 300 mg QID, ġimagħtejn
English: Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received.
Maltese: Waslu rapporti rari ta' anomaliji konġenitali wara espożizzjoni fl-utru ta' inibituri reductase ta' HMG-CoA.
English: Patients were 60% male, 21-92 years of age (average age 63 years), and had an average baseline LDL of 133 mg/dL (3.4 mmol/L).
Maltese: Il-pazjenti kienu 60% rġiel, età minn 21-92 sena (età medja ta' 63 sena), u kellhom LDL bażiku medju ta' 133 mg/dL (3.4 mmol/L).
English: Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin Atorvastatin
Maltese: Tabella 1: Effett ta' prodotti mediċinali mogħtija apparti l-farmakokinetiċi ta' atorvastatin
English: Atorvastatin 80 mg reduced the risk of the primary endpoint of fatal or non-fatal stroke by 15% (HR 0.85; 95% CI, 0.72-1.00; p=0.05 or 0.84; 95% CI, 0.71-0.99; p=0.03 after adjustment for baseline factors) compared to placebo.
Maltese: Atorvastatin 80 mg naqqas ir-riskju tal-endpoint primarju ta' puplesija fatali jew mhux fatali bi 15% (HR 0.85; 95% CI, 0.72-1.00; p=0.05 jew 0.84; 95% CI, 0.71-0.99; p=0.03 wara aġġustament għall-fatturi bażiċi) meta pparagunat mal-plaċebo.
English: The dose of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily (see section 5.1).
Maltese: Id-doża ta' atrovastatin f'pazjenti b'iperkolesterolemija omozigota familjali hija ta' 10 sa 80 mg kuljum (ara sezzjoni 5.1).
English: Co-administration of potent CYP3A4 inhibitors (e.g. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.) should be avoided if possible.
Maltese: Jekk ikun possibbli, il-koamministrazzjoni ta' inibituri ta' CYP3A4 qawwijin (eż. ciclosporin, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole u inibituri tal-HIV inkluż ritonavir, lopinavir, atazanavir, indinavir, darunavir, eċċ.) għandha tiġi evitata.
English: In rats, there is evidence of placental transfer.
Maltese: Fil-firien, hemm evidenza ta' trasferiment għal ġol-plaċenta.
English: Total mortality and cardiovascular mortality were not significantly reduced (185 vs. 212 events, p=0.17 and 74 vs. 82 events, p=0.51).
Maltese: Il-mortalità totali u l-mortalità kardjovaskulari ma tnaqqsux b'mod sinifikanti (185 vs. 212-il episodju, p=0.17 u 74 vs.
English: Clinical Recommendation#
Maltese: Rakkomandazzjoni Klinika#
English: Inhibitors of transport proteins (e.g. ciclosporin) can increase the systemic exposure of atorvastatin (see Table 1).
Maltese: L-inibituri tal-proteini tal-ġarr (eż. ciclosporin) jistgħu jżidu l-espożizzjoni sistemika ta' atorvastatin (ara Tabella 1).
English: In this randomised, double- blind, multicenter, controlled clinical trial, IVUS was performed at baseline and at 18 months in 502 patients.
Maltese: F'din il-prova klinika randomizzata, double blind, multiċentri, ikkontrollata, l-IVUS saret fil-linja bażi u wara 18-il xahar f'502 pazjenti.
English: 1Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Maltese: 1Ibbażat fuq id-differenza fir-rati krudi ta' episodji li seħħew tul segwitu medju ta' 3.9 snin.
English: HOSPITAL PACK LABEL
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Rare: affects 1 to 10 users in 10,000:
Maltese: Rari: jaffettwa minn 1 sa 10 utenti minn kull 10,000:
English: Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Maltese: Seħħew elevazzjonijiet klinikament importanti (> 3 darbiet iktar mill-limitu normali) fis-serum transaminases f'0.8% tal-pazjenti fuq {ISEM
English: Fosamprenavir 700 mg BID/ Ritonavir 100 mg BID, 14 days
Maltese: Fosamprenavir 700 mg BID/ Ritonavir 100 mg BID, 14-il jum
English: In the atorvastatin group (n=253), there was no progression of atherosclerosis.
Maltese: Fil-grupp li ħa atorvastatin (n=253), ma kienx hemm progressjoni tal-aterosklerożi.
English: Approximately 70% of circulating inhibitory activity for HMG-CoA reductase is attributed to active metabolites.
Maltese: Madwar 70% tal-attività inibitorja ta' ċirkolazzjoni għal HMG-CoA reductase hija attribwita għal metaboliti attivi.
English: Heterozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija eterozigota familjali
English: Co-administration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Maltese: TAL-PRODOTT} ma' kontraċettiv orali ġab żidiet fil-konċentrazzjonijiet tal-plażma ta' norethindrone u ethinyl oestradiol.
English: Diltiazem 240 mg OD, 28 days 40 mg, SD ↑ 51% After initiation or following dose adjustments of diltiazem, appropriate clinical monitoring of these patients is recommended.
Maltese: Diltiazem 240 mg OD, 28 jum 40 mg SD ↑ 51% Wara l-bidu jew wara laġġustamenti tad-doża ta' diltiazem, huwa rrakkomandat monitoraġġ kliniku ta' dawn ilpazjenti.
English: The effect of atorvastatin on fatal and non-fatal coronary heart disease was assessed in a randomized, double-blind, placebo-controlled study, the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
Maltese: L-effett ta' atorvastatin fuq il-mard tal-qalb koronarju fatali u mhux fatali ġie evalwat bi studju doubleblind, randomizzat, ikkontrollat bi plaċebo, l-Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA).
English: Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicinal products that may increase the plasma concentration of atorvastatin such as potent inhibitors of CYP3A4 or transport proteins (e.g. ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole and HIV protease inhibitors including ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc).
Maltese: Ir-riskju ta' rhabdomyolysis huwa miżjud meta atrovastatin jingħata fl-istess ħin ma' ċerti prodotti mediċinali li jistgħu jżidu l-konċentrazzjoni tal-plażma ta' atrovastatin bħal pereżempju inibituri qawwija ta' CYP3A4 jew proteini tal-ġarr (eż. ciclosporine, telithromycin, clarithromycin, delavirdine, stiripentol, ketoconazole, voriconazole, itraconazole, posaconazole u inibituri ta' protease tal-HIV inkluż ritonavir, lopinavir, atazanavir, indinavir, darunavir, eċċ).
English: CHD = coronary heart disease; MI = myocardial infarction.
Maltese: MI = infart mijokardijaku.
English: Table 2: Effect of atorvastatin on the pharmacokinetics of co-administered medicinal products
Maltese: Tabella 2: Effetti ta' atorvastatin fuq il-farmakokinetiċi ta' prodotti mediċinali mogħtijin flimkien Prodott mediċinal ko-amministrat
English: Fosamprenavir 1400 mg BID, 14 days
Maltese: Fosamprenavir 1400 mg BID, 14-il jum
English: In a post-hoc analysis, atorvastatin 80 mg reduced the incidence of ischemic stroke (218/2365, 9.2% vs. 274/2366, 11.6%, p=0.01) and increased the incidence of hemorrhagic stroke (55/2365, 2.3% vs. 33/2366, 1.4%, p=0.02) compared to placebo.
Maltese: F'analiżi post-hoc, atorvastatin 80 mg naqqas l-inċidenza ta' puplesija iskemika (218/2365, 9.2% vs. 274/2366, 11.6%, p=0.01) u żied l-inċidenza ta' puplesija emorraġika (55/2365, 2.3% vs.
English: Change in AUC&
Maltese: Bidla flAUC&
English: Common: liver function test abnormal, blood creatine kinase increased.
Maltese: Komuni: test tal-funzjoni tal-fwied anormali, żieda ta' creatine kinase fid-demm.
English: The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with atenolol (HR 0.83 (0.59-1.17), p=0.287).
Maltese: L-endpoint primarju (CRD fatali u MI mhux fatali) naqas b'mod sinifikanti b'atorvastatin fil-pazjenti ttrattati b'amlodipine (HR 0.47 (0.32-0.69), p=0.00008), iżda mhux b'dawk ittrattati b'atenolol (HR 0.83 (0.59-1.17), p=0.287).
English: Atorvastatin was administered at doses up to 80 mg/day.
Maltese: Atorvastatin ingħata f'dożi sa 80 mg/jum.
English: After oral administration, atorvastatin film-coated tablets are 95% to 99% bioavailable compared to the oral solution.
Maltese: Wara għoti mill-ħalq, il-pilloli miksijin b'rita atorvastatin huma 95% sa 99% bijodisponibbli meta mqabbla mas-soluzzjoni orali.
English: Metabolism and nutrition disorders Common: hyperglycaemia.
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni: ipergliċemija.
English: 40 mg OD for 22 days
Maltese: 40 mg OD għal 22 jum
English: All cause mortality was 10.9% (77/708) for atorvastatin versus 9.1% (64/701) for placebo in the subgroup of patients with prior lacunar infarct.
Maltese: għal atorvastatin kontra 9.1% (64/701) għall-plaċebo fis-sottogrupp ta' pazjenti b'infart lakunari preċedenti.
English: In this leaflet:
Maltese: TAL-PRODOTT}:
English: The risk of myopathy may also be increased with the concomitant use of gemfibrozil and other fibric acid derivates, erythromycin, niacin and ezetimibe.
Maltese: Ir-riskju ta' mijopatija jista' wkoll jiżdied bl-użu fl-istess ħin ta' gemfibrozil u ta' derivattivi oħrajn ta' fibric acid, erythromycin, niacin u ezetimibe.
English: Germany, Hungary, Italy, Latvia, Lithuania,
Maltese: Awstrija, Bulgarija, Repubblika Ċeka, Estonja, Ġermanja, Ungerija, Italja, Latvja, Litwania, Polonja, Rumanija, Slovakja, Slovenja
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior hemorrhagic stroke (7/45 for atorvastatin versus 2/48 for placebo; HR 4.06; 95% CI, 0.84-19.57), and the risk of ischemic stroke was similar between groups (3/45 for atorvastatin versus 2/48 for placebo; HR 1.64; 95% CI, 0.27-9.82).
Maltese: • Ir-riskju ta' puplesija emorraġika żdied fil-pazjenti li daħlu fl-istudju b'puplesija emorraġika preċedenti (7/45 għal atorvastatin kontra 2/48 għall-plaċebo; HR 4.06; 95% CI, 0.84-19.57), u rriskju ta' puplesija iskemika kien simili bejn il-gruppi (3/45 għal atorvastatin kontra 2/48 għallplaċebo;
English: Increase is indicated as “↑”, decrease as “↓”
Maltese: Żieda hija indikata bħala “↑”, tnaqqis bħala “↓”
English: ↑ 5.9 fold
Maltese: .9 Doża eċċessiva
English: Due to the dual interaction mechanism of rifampin, (cytochrome P450 3A induction and inhibition of hepatocyte uptake transporter OATP1B1), simultaneous co-administration of atorvastatin with rifampin is recommended, as delayed administration of atorvastatin after administration of rifampin has been associated with a significant reduction in atorvastatin plasma concentrations.
Maltese: Minħabba l-mekkaniżmu ta' interazzjoni doppja ta' rifampin, (l-induzzjoni ta' cytochrome P450 3A u l-inibizzjoni tat-trasportatur tat-teħid ta' hepatocyte OATP1B1), hija rrakkomandata l-koamministrazzjoni simultanja ta' atorvastatin ma' rifampin , billi l-amministrazzjoni ittardjata ta' atorvastatin wara l-amministrazzjoni ta' rifampin ġiet assoċjata ma' tnaqqis sinifikanti filkonċentrazzjonijiet ta' atorvastatin fil-plażma.
English: Hungary
Maltese: Ungerija
English: A favourable trend was observed regarding the mortality rate (82 deaths in the placebo group vs. 61 deaths in the atorvastatin group, p=0.0592).
Maltese: Kienet osservata xejra favorevoli fir-rigward tar-rata ta' mortalità (82 mewt fil-grupp li ħa plaċebo vs. 61 mewt fil-grupp li ħa atorvastatin, p=0.0592).
English: Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137).
Maltese: Il-pazjenti ġew ittrattati b'terapija kontra l-pressjoni għolja (reġim ibbażat fuq amlodipine jew fuq atenolol) u atorvastatin 10 mg kuljum (n=5,168) jew plaċebo (n=5,137).
English: Patients were treated with either atorvastatin 10 mg daily (n=1,428) or placebo (n=1,410) for a median follow-up of 3.9 years.
Maltese: Il-pazjenti ġew ittrattati jew b'atorvastatin 10 mg kuljum (n=1,428) jew plaċebo (n=1,410) għal segwitu medju ta' 3.9 snin.
English: {PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Maltese: TAL-PRODOTT} hu indikat bħala żieda mad-dieta għat-tnaqqis tal-kolesterol totali elevat (totalC), kolesterol-LDL (LDL-C), apolipoproteina B, u trigliċeridi f'pazjenti b'iperkolesterolemija primarja inkluż il-kolesterolemija familjali (varjant eterozigota) jew iperlipidemija kkombinata (mħallta)
English: Please note the following:
Maltese: TAL-PRODOTT} aktar milli suppost:
English: 80 mg OD for 15 days
Maltese: 80 mg OD għal 15-il jum
English: There was a 36.4% mean reduction in CRP in the atorvastatin group compared to a 5.2% reduction in the pravastatin group (p<0.0001).
Maltese: Kien hemm tnaqqis medju ta' 36.4% fil-CRP fil-grupp li ħa atorvastain meta mqabbel ma' tnaqqis ta' 5.2% fil-grupp li ħa pravastatin (p<0.
English: Uncommon: urticaria, skin rash, pruritus, alopecia.
Maltese: Mhux komuni: urtikarja, raxx tal-ġilda, ħakk, alopeċja.
English: Rare: myopathy, myositis, rhabdomyolysis, tendonopathy, sometimes complicated by rupture.
Maltese: Rari: mijopatija, mijosite, rhabdomyolysis, tendonopatija (xi drabi jiċċarrat).
English: Immune system disorders Common: allergic reactions.
Maltese: Disturbi fis-sistema immuni Komuni: reazzjonijiet allerġiċi.
English: Creatine kinase measurement
Maltese: Kejl tal-creatine kinase
English: • Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4).
Maltese: • Każijiet eċċezzjonali ta' mard interstizjali tal-pulmun, b'mod speċjali bit-terapija fit-tul (ara sezzjoni 4.4).
English: No adjustment of dose is required (see section 4.4).
Maltese: TAL-PRODOTT} jitwaqqaf (ara sezzjoni 4.8).
English: Event
Maltese: Episodju
English: Homozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija omozigota familjali
English: The use of ezetimibe alone is associated with muscle related events, including rhabdomyolysis.
Maltese: L-użu ta' ezetimibe waħdu, kultant huwa assoċjat ma' avvenimenti relatati mal-muskoli, inkluż rhabdomyolysis.
English: Potent CYP3A4 inhibitors have been shown to lead to markedly increased concentrations of atorvastatin (see Table 1 and specific information below).
Maltese: Inibituri ta' CYP3A4 qawwijin ġew innotati li jwasslu għal konċentrazzjonijiet ogħla b'mod sostanzjali ta' atorvastatin (ara Tabella 1 u l-informazzjoni speċifika hawn taħt).
English: Large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites).
Maltese: Kwantitajiet kbar ta' meraq tal-grejpfrut (aktar minn 1.2 l kuljum għal 5 ijiem) żied l-AUC ta' atrovastatin bi 2.5 darbiet u AUC ta' (atorvastatin jew metaboliti) attivi.
English: [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I- Biex timtela mill-pajjiż partikolari] {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: In the primary prevention trials the dose was 10 mg/day.
Maltese: Fil-provi primarji ta' prevenzjoni, id-doża kienet ta' 10 mg/kuljum.
English: Polymorphism in the gene encoding OATP1B1 (SLCO1B1 c.521CC) is associated with a 2.4-fold higher atorvastatin exposure (AUC) than in individuals without this genotype variant (c.521TT).
Maltese: Ilpolimorfiżmu fil-ġene ta' kodifikazzjoni OATP1B1 (SLCO1B1 c.521CC) huwa assoċjat ma' esponiment 2.4 darbiet ogħla ta' atorvastatin (AUC) milli f'individwi li m'għandhomx dan il-varjant ta' ġenotip (c.521TT).
English: − Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, etc.
Maltese: Mediċini użati għall-kura tal-HIV eż. ritonavir, lopinavir, atazanavir, indinavir, darunavir, eċċ. Mediċini oħrajn magħrufin li jinteraġixxu ma' {ISEM
English: Atorvastatin is eliminated primarily in bile following hepatic and/or extrahepatic metabolism.
Maltese: Atorvastatin jitneħħa prinċipalment mill-marrara wara metaboliżmu epatiku u/jew extra-epatiku.
English: The median percent change, from baseline, in total atheroma volume (the primary study criteria) was0.4% (p=0.98) in the atorvastatin group and +2.7% (p=0.001) in the pravastatin group (n=249).
Maltese: Il-bidla perċentwali medja, mil-linja bażi, fil-volum ta' ateroma (il-kriterji primarji tal-istudju) kienet0.4% (p=0.98) fil-grupp li ħa atorvastatin u +2.7% (p=0.001) fil-grupp li ħa pravastatin (n=249).
English: All patients had at least 1 of the following risk factors: hypertension, current smoking, retinopathy, microalbuminuria or macroalbuminuria.
Maltese: Il-pazjenti kollha kellhom mill-anqas 1 mill-fatturi ta' riskju li ġejjin: pressjoni għolja, tipjip preżenti, retinopatija, mikroalbuminurja jew makroalbuminurja.
English: Fenofibrate 160 mg OD, 7 days
Maltese: 160 mg OD, 7t ijiem
English: Moderate CYP3A4 inhibitors (e.g. erythromycin, diltiazem, verapamil and fluconazole) may increase plasma concentrations of atorvastatin (see Table 1).. An increased risk of myopathy has been observed with the use of erythromycin in combination with statins.
Maltese: Inibituri ta' CYP3A4 moderati (eż. erythromycin, diltiazem, verapamil u fluconazole) jistgħu iżidu lkonċentrazzjonijiet tal-plażma ta' atorvastatin (ara Tabella 1).
English: Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially lifethreatening condition characterised by markedly elevated creatine kinase (CK) levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Maltese: Atrovastatin, bħal inibituri reductase ta' HMG-CoA oħrajn, jista', f'okkażjonijiet rari, jaffettwa il-muskolu skeletali u jikkawża mijalġja, majosite u mijopatija li jistgħu isiru rhabdomyolysis, kundizzjoni li tista' tkun ta' theddida għall-ħajja kkaratterizzata minn livelli ta' creatine kinase (CK) notevolment elevati (> 10 darbiet l-ULN), myoglobinaemia u myoglobinuria li jistgħu jwasslu għal indeboliment renali.
English: The half-life of inhibitory activity for HMG-CoA reductase is approximately 20 to 30 hours due to the contribution of active metabolites.
Maltese: Il-half-life talattività inibitorja għal HMG-CoA reductase hija madwar 20 sa 30 siegħa minħabba l-kontribut ta' metaboliti attivi.
English: 80 mg OD for 8 days
Maltese: 80 mg OD għal 8t ijiem darbiet
English: Blood and lymphatic system disorders Rare: thrombocytopenia.
Maltese: Disturbi tad-demm u tas-sistema limfatika Rari: tromboċitopenija.
English: Darunavir 300 mg BID/ Ritonavir 100 mg BID, 9 days
Maltese: Darunavir 300 mg BID/ Ritonavir 100 mg BID, 9t ijiem
English: • The risk of hemorrhagic stroke was increased in patients who entered the study with prior lacunar infarct (20/708 for atorvastatin versus 4/701 for placebo; HR 4.99; 95% CI, 1.71-14.61), but the risk of ischemic stroke was also decreased in these patients (79/708 for atorvastatin versus 102/701 for placebo; HR 0.76; 95% CI, 0.57-1.02).
Maltese: • Ir-riskju ta' puplesija emorraġika żdied fil-pazjenti li daħlu fl-istudju b'infart lakunari preċedenti (20/708 għal atorvastatin kontra 4/701 għall-plaċebo; HR 4.99; 95% CI, 1.71-14.61), iżda r-riskju ta' puplesija iskemika naqas ukoll f'dawn il-pazjenti (79/708 għal atorvastatin kontra 102/701 għallplaċebo;
English: Elevated serum creatine kinase (CK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Maltese: Seħħew livelli elevati ta' serum creatine kinase (CK) aktar minn 3 darbiet mill-ogħla limitu tan-normal fi 2.5 % tal-pazjenti fuq {ISEM
English: − Other medicines known to interact with {PRODUCT NAME} include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller)
Maltese: TAL-PRODOTT} jinkludu ezetimibe (li jnaqqas il-kolesterol), warfarin (li jnaqqas l-emboli tad-demm), kontraċettivi orali, stiripentol (mediċina kontra l-konvulżjonijiet għall-epilessija), cimetidine (li jintuża għall-ħruq ta' stonku u ulċeri peptiċi), phenazone (mediċina kontra l-uġigħ) u anti-aċidi (prodotti kontra l-indiġestjoni li fihom l-aluminju jew il-manjeżju)
English: The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/or hepatic first-pass metabolism
Maltese: Id-disponibbiltà sistemika baxxa hija attribwita għat-tneħħija presistemika fil-mukuża gastro-intestinali u/jew il-metaboliżmu epatiku tal-ewwel passaġġ.
English: Interaction studies with atorvastatin and fusidic acid have not been conducted.
Maltese: Ma sarux studji ta' interazzjoni b'atorvastatin u fusidic acid.
English: * Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Maltese: * Fih komponent wieħed jew aktar li jinibixxi CYP3A4 u jista' jżid il-konċentrazzjonijiet talplażma ta' prodotti mediċinali metabolizzati b'CYP3A4.
English: 80 mg OD for 10 days
Maltese: 80 mg OD għal 10t ijiem