FrancophonIA/ELRC3.0 huggingface dataset:
English: This trial evaluated patients who did not tolerate at least two statins (at least one at the lowest approved dose), In these patients, musculo-skeletal adverse events occurred at a lower rate in the alirocumab group (32.5%) as compared to the atorvastatin group (46.0%) (HR= 0.61 [95% CI, 0.38 to 0.99]), and a lower percentage of patients in the alirocumab group (15.9%) discontinued study treatment due to musculo-skeletal adverse events as compared to the atorvastatin group (22.2%).
Maltese: F'dawn il-pazjenti, każijiet muskoluskeletriċi avversi seħħew b'rata aktar baxxa fil-grupp ta' alirocumab (32.5%) meta mqabbla mal-grupp ta' atorvastatin group (46.0%) (HR= 0.61 [95% CI, 0.38 sa 0.99]), u persentaġġ iktar baxx ta' pazjenti fil-grupp ta' alirocumab (15.9%) waqqfu t-trattament tal-istudju minħabba każijiet muskoluskeletriċi avversi meta mqabbla mal-grupp ta' atorvastatin (22.2%).
English: ALTERNATIVE (N=248)
Maltese: TERMINU FITTUL (N=2310)
English: Conversely, gain-of-function mutations in the PCSK9 gene have been identified in patients with increased LDL-C levels and a clinical diagnosis of familial hypercholesterolaemia.
Maltese: Kuntrarju ta' dan, ġew identifikati mutazzjonijiet ta' kisba ta' funzjoni fil-ġene PCSK9 f'pazjenti b'żieda fillivelli ta' LDL-C u dijanjosi klinika ta' iperkolesterolemija fil-familja.
English: In a multicenter, double-blind, placebo-controlled, 14 week study, 13 patients with heterozygous familial hypercholesterolaemia (heFH) due to gain-of-function mutations in the PCSK9 gene were randomised to receive either alirocumab 150 mg Q2W or placebo.
Maltese: heterozygous familial hypercholesterolaemia) minħabba mutazzjonijiet ta' kisba ta' funzjoni fil-ġene PCSK9 intgħażlu b'mod arbitrarju biex jew jirċievu alirocumab 150 mg Q2W jew inkella jirċievu plaċebo.
English: No difference in the safety profile was observed between the two doses (75 mg and 150 mg) used in the phase 3 program.
Maltese: Ma kienet osservata l-ebda differenza fil-profil ta' sigurtà bejn iż-żewġ dożi (75 mg u 150 mg) użati fil programm ta' fażi 3.
English: Each pre-filled pen contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 150 mg alirocumab f'soluzzjoni ta' 1 ml (150 mg/ml).
English: MACE-plus defined as a composite of: coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization b
Maltese: Avveniment maġġuri CHD definit bħala: mewt minħabba CHD, MI mhux fatali e Avveniment kardjovaskulari definit kif ġej: mewt minħabba CV ,kwalunkwe avveniment CHD li mhuwiex fatali, u puplesija iskemika li mhijiex fatali f Sinifikanza nominali
English: Among the subgroup of patients up-titrated at week 12, an additional 22.8% mean reduction in LDL-C was achieved at week 24.
Maltese: Fost is-sottogrupp ta' pazjenti titrati 'l fuq f'ġimgħa 12, inkisbet medja ta' tnaqqis addizzjonali ta' 22.8% fl-LDL-C f'ġimgħa 24.
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -55.8% (95% CI: -60.0%, -51.6%; p-value: ˂ 0.0001).
Maltese: F'ġimgħa 24, il-medja tad-differenza fit-trattament mill-plaċebo fil-persentaġġ ta' bidla fl-LDL-C mill-linja bażi kienet -55.8% (95% CI: -60.0%, -51.6%; valur p: ˂ 0.0001).
English: Each pre-filled pen contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Maltese: Kull pinna mimlija għal-lest fiha 75 mg alirocumab f'soluzzjoni ta' 1 ml (75 mg/ml).
English: At week 12, 82.1% of patients in the alirocumab group reached an LDL-C ˂70 mg/dL (˂1.81 mmol/L) compared to 7.2% of patients in the placebo group.
Maltese: F'ġimgħa 12, 82.1% tal pazjenti fil-grupp ta' alirocumab laħqu LDL-C ˂70 mg/dL (˂1.81 mmol/L) meta mqabbla ma' 7.2% tal pazjenti fil-grupp tal-plaċebo.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu.
English: Difference versus ezetimibe was statistically significant at week 24 for all lipids/ lipoproteins except for TG, and Apo A-1.
Maltese: Id-differeza versus ezetimibe kienet sinifikanti b'mod statistiku f'ġimgħa 24 għallipidi/lipoproteini kollha ħlief għal TG, u Apo A-1.
English: Praluent 75 mg solution for injection in pre-filled pen Praluent 150 mg solution for injection in pre-filled pen Praluent 75 mg solution for injection in pre-filled syringe Praluent 150 mg solution for injection in pre-filled syringe
Maltese: Praluent 75 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Praluent 150 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Praluent 75 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Praluent 150 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: The LONG TERM study included 17.7% heFH patients, 34.6% with type 2 diabetes mellitus, and 68.6% with a history of coronary heart disease.
Maltese: L-istudju LONG TERM kien jinkludi 17.7% pazjenti heFH, 34.6% b'dijabete mellitus tat-tip 2, u 68.6% bi storja ta' mard koronarju tal-qalb.
English: Each pre-filled syringe contains 75 mg alirocumab in 1 ml solution (75 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 75 mg alirocumab f'soluzzjoni ta' 1 ml (75 mg/ml).
English: Alirocumab is expected to degrade to small peptides and individual amino acids.
Maltese: Alirocumab huwa mistenni li jitkisser f'peptides żgħar u amino aċidi individwali.
English: The efficacy of alirocumab was investigated in ten phase 3 trials (five placebo-controlled and five ezetimibe-controlled studies), involving 5296 randomised patients with hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, with 3188 patients randomised to alirocumab.
Maltese: L-effikaċja ta' alirocumab ġiet investigata f'għaxar provi ta' fażi 3 (f'ħames studji kkontrollati bi plaċebo u ħames studji kkontrollati b'ezetimibe), li kienu jinvolvu 5,296 pazjent magħżula b'mod arbitrarju b'iperkolesterolemija (eteroziguża fil-familja u mhux fil-familja) jew dislipidemija mħallta, bi 3,188 pazjent magħżula b'mod arbitrarju biex jieħdu alirocumab.
English: Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL (≥1.81 mmol/L) or ≥100 mg/dL (≥2.59 mmol/L), depending on their level of CV risk.
Maltese: Titrazzjoni 'l fuq tad-doża ta' alirocumab sa 150 mg Q2W seħħet f'ġimgħa 12 f'pazjenti b'LDL-C ≥70 mg/dL (≥1.81 mmol/L) jew ≥100 mg/dL (≥2.59 mmol/L), skont il-livell ta' riskju CV tagħhom.
English: General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies (see section 4.8).
Maltese: Fi studji kliniċi ġew irrappurtati reazzjonijiet allerġiċi ġenerali, inkluż ħakk, kif ukoll reazzjonijiet allerġiċi rari u xi drabi serji bħal sensittività eċċessiva, ekżema b'forma tixbah munita, urtikarja, u vaskulite minn sensittività eċċessiva (ara taqsima 4.8).
English: Praluent is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Maltese: Praluent huwa indikat fl-adulti b'mard kardjovaskulari aterosklerotiku stabbilit sabiex inaqqas ir-riskju kardjovaskulari billi jbaxxi l-livelli ta' LDL-C, bħala żjieda mal-korrezzjoni ta' fatturi ta' riskji oħra:
English: LDLR is the primary receptor that clears circulating LDL, therefore the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-C. By inhibiting the binding of PCSK9 to LDLR, alirocumab increases the number of LDLRs available to clear LDL, thereby lowering LDL-C levels.
Maltese: LDLR huwa r-riċettur primarju li jneħħi l-LDL li jiċċirkola, għalhekk it-tnaqqis fil-livelli ta' LDLR permezz ta' PCSK9 iwassal għal livelli ogħla ta' LDL-C fid-demm.
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily in addition to their existing statin therapy.
Maltese: Ilpazjenti rċevew alirocumab 75 mg Q2W jew ezetimibe 10 mg darba kuljum miżjuda mat-terapija ta' statin li kellhom diġà.
English: Among the subgroup of patients up-titrated at week 12, an additional 15.7% mean reduction in LDL-C was achieved at week 24.
Maltese: Fost is-sottogruppi ta' pazjenti titrati 'l fuq f'ġimgħa 12, inkisbet medja ta' tnaqqis addizzjonali ta' 15.7% fl-LDL-C f'ġimgħa 24.
English: CHD event defined as: major CHD event d, unstable angina requiring hospitalization, ischemia-driven coronary revascularization procedure d
Maltese: Avveniment CHD definit bħala: avveniment maġġuri ta' major CHD d, anġina li mhijiex stabbli li tkun teħtieġ rikoverar l-isptar, proċedura ta' vaskularazzjoni koronarja mill-ġdid minħabba iskemija d
English: Dose up-titration of alirocumab to 150 mg Q2W occurred at week 12 in patients with LDL-C ≥70 mg/dL (≥1.81 mmol/L).
Maltese: Titrazzjoni 'l fuq tad-doża ta' alirocumab sa 150 mg Q2W seħħet f'ġimgħa 12 f'pazjenti b'LDL-C ≥70 mg/dL (≥1.81 mmol/L).
English: In patients treated beyond 12 weeks, the dose was adjusted to 150 mg Q2W in 19 (14.7%) of 129 patients in the alirocumab 300 mg Q4W arm.
Maltese: Q2W f'19 (14.7%) minn 129 pazjent fil-fergħa ta' alirocumab 300 mg Q4W.
English: EU/1/15/1031/010 1 pre-filled syringe EU/1/15/1031/011 2 pre-filled syringes EU/1/15/1031/012 6 pre-filled syringes
Maltese: EU/1/15/1031/010 siringa 1 mimlija għal-lest EU/1/15/1031/011 2 siringi mimlija għal-lest EU/1/15/1031/012 6 siringi mimlija għal-lest
English: 75 mg/ml solution for injection
Maltese: 75 mg/ml soluzzjoni għall-injezzjoni
English: EU/1/15/1031/004 1 pre-filled syringe EU/1/15/1031/005 2 pre-filled syringes EU/1/15/1031/006 6 pre-filled syringes
Maltese: EU/1/15/1031/004 siringa 1 mimlija għal-lest EU/1/15/1031/005 2 siringi mimlija għal-lest EU/1/15/1031/006 6 siringi mimlija għal-lest
English: Subcutaneous use.
Maltese: sustanza speċifika fil-ġisem).
English: In the ODYSSEY OUTCOMES study, in which the starting alirocumab dose was 75 mg Q2W and the dose was increased to 150 mg Q2W if the patient's LDL-C was not <50 mg/dL (1.29 mmol/L), 54.8% of patients with baseline LDL-C <100 mg/dL and 24.2% of patients with baseline LDL-C ≥100 mg/dL treated with alirocumab had two consecutive values of LDL-C <25 mg/dL (<0.65 mmol/L).
Maltese: Fl-istudju EFFETTI ODYSSEY, fejn id-doża ta' alirocumab fil-bidu kienet ta' 75 mg Q2W u d-doża żdiedet għal 150 mg Q2W jekk l-LDL-C tal-pazjent ma kienx <50 mg/dL (1.29 mmol/L ), 54.8% tal-pazjenti b'livell ta' LDL-C fil-linja bażi ta' <100 mg/dL u 24.2% tal-pazjenti b'livell ta'
English: Urticaria, eczema nummular
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: At week 12 (before up-titration), 34.9% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Maltese: F'ġimgħa 12 (qabel titrazzjoni 'l fuq), 34.9% tal-pazjenti laħqu LDL-C ta' ˂70 mg/dL (˂1.81 mmol/L) meta mqabbla ma' 0% fil-grupp ta' ezetimibe.
English: Elderly
Maltese: ieħor.
English: Maternal toxicity was not evident in pregnant monkeys at systemic exposures that were 81 times the human exposure at the 150 mg Q2W dose.
Maltese: Tossiċità tal-omm ma kinitx evidenti f'xadini tqal b'esponimenti sistemiċi li kienu 81 darba l-esponiment tal-bniedem bid-doża ta' 150 mg Q2W dose.
English: At week 12 (before up-titration), 50.2% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0.6% in the placebo group.
Maltese: F'ġimgħa 12 (qabel it-titrazzjoni 'l fuq), 50.2% tal-pazjenti laħqu LDL-C ta' ˂70 mg/dL (˂1.81 mmol/L) meta mqabbel ma' 0.6% fil-grupp ta' plaċebo.
English: Neutralising antibody (NAb) responses were observed in 0.5% of patients treated with alirocumab and in <0.1% of patients treated with placebo.
Maltese: Rispons ta' antikorpi li jinnewtralizzaw (NAb) ġie osservat f'0.5% ta' pazjenti ttrattati b'alirocumab u f'<0.
English: In the five placebo-controlled trials in patients on a maximally tolerated dose of statin (n=3752), the discontinuation rate due to musculo-skeletal adverse events was 0.4% in the alirocumab group and 0.5% in the placebo group.
Maltese: Fil-ħames provi kkontrollati bi plaċebo f'pazjenti fuq l-ogħla doża ttollerata ta' statin (n=3,752), ir-rata ta' waqfien minħabba każijiet muskoluskeletriċi avversi kienet 0.4% fil-grupp ta' alirocumab group u 0.5% fil-grupp ta' plaċebo.
English: The discontinuation rate due to injection site reactions was 0.7% in the 300 mg once every 4 weeks treatment group and 0% in the placebo group.
Maltese: Ir-rata ta' twaqqif mit-trattament minħabba r-reazzjonijiet fis-sit tal-injezzjoni kienet ta' 0.7 % fil-grupp ta' trattament ta' 300 mg darba kull 4 ġimgħat u ta' 0% fil-grupp ta' plaċebo.
English: Renal impairment
Maltese: Planġer aħdar
English: Alirocumab is a fully human IgG1 monoclonal antibody that binds with high affinity and specificity to proprotein convertase subtilisin kexin type 9 (PCSK9).
Maltese: IgG1 kompletament uman li jintrabat b'affinità u speċifiċità kbira mal-proproteina convertase subtilisin kexin tat-tip 9 (PCSK9). PCSK9 jintrabat mar-riċetturi tal-lipoproteini b'densità baxxa (LDLR - low-density lipoprotein receptors) fuq is-superfiċje tal-epatoċiti biex jgħin id diżintegrazzjoni ta' LDLR ġol-fwied.
English: 1 pre-filled syringe 2 pre-filled syringes 6 pre-filled syringes
Maltese: Soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest siringa 1 mimlija għal-lest 2 siringi mimlijin għal-lest 6 siringi mimlijin għal-lest
English: Among the subgroup of patients up-titrated at week 12, an additional 3.6% mean reduction in LDL-C was achieved at week 24.
Maltese: Fost is-sottogrupp ta' pazjenti titrati 'l fuq f'ġimgħa 12, inkisbet medja ta' tnaqqis addizzjonali ta' 3.6% fl-LDL-C f'ġimgħa 24.
English: 1, 2, or 6 pre-filled pens.
Maltese: Daqs tal-pakkett: 1, 2, jew 6 pinen mimlija għal-lest .
English: For allergic reactions that may occur while taking Praluent, see section 4.
Maltese: Għal reazzjonijiet allerġiċi li jistgħu jseħħu waqt li tkun qed tieħu Praluent, ara taqsima 4.
English: There were no adverse effects on surrogate markers of fertility (e.g. estrous cyclicity, testicular volume, ejaculate volume, sperm motility, or total sperm count per ejaculate) in monkeys, and no alirocumab-related anatomic pathology or histopathology findings in reproductive tissues in any rat or monkey toxicology study.
Maltese: Ma kien hemm l-ebda effetti avversi fuq il-markaturi ta' sostituzzjoni tal-fertilità (eż. iċ-ċikliċità tal-perjodu meta l-mammali nisa jkunu miftuħin għas-sess, il-volum tat-testikoli, il-volum tas-semen maħruġ mill-ġisem, motilità tal-isperma, jew l-għadd totali tal-isperma għal kull ħruġ tas-semen mill-ġisem) fix-xadini, u ma kien hemm l-ebda sejbiet anatomiċi ta' patoloġija jew istopatoloġija fit-tessuti riproduttivi marbuta ma'
English: • If the window does not turn completely yellow, call sanofi-aventis for help.
Maltese: • Jekk it-tieqa ma tiġix kompletament safra, ċempel lil sanofi-aventis għall-għajnuna.
English: Praluent is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: - in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, - alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
Maltese: - flimkien mal-ogħla doża ttollerata ta' statin bi jew mingħajr terapiji oħra ta' tnaqqis fil-livelli tal lipidi jew, - waħdu jew flimkien ma' terapiji oħra ta' tnaqqis fil-livelli tal-lipidi f'pazjenti li ma jittollerawx listatins jew li għalihom l-istatin huwa konraindikat.
English: At week 12 (before dose adjustment), 77.3% of patients treated with alirocumab 300 mg Q4W reached an LDL-C of ˂70 mg/dL as compared to 9.3% in the placebo group.
Maltese: Fit-12-il ġimgħa (qabel l-aġġustament fiddoża), 77.3% tal-pazjenti ttrattati b'alirocumab 300 mg Q4W laħqu LDL-C ta' ˂70 mg/dL meta mqabbel ma' 9.3% fil-grupp ta' plaċebo.
English: Table 1 - Adverse Reactions reported in patients treated with alirocumab in controlled studies and post-marketing use
Maltese: Tabella 1 - Reazzjonijiet Avversi rrappurtati f'pazjenti ttrattati b'alirocumab f'studji kkontrollati u waqt l-użu wara li l-prodott tqiegħed fis-suq
English: -74.2 mg/dL (-1.92 mmol/L);
Maltese: c-74.2 mg/dL (-1.92 mmol/L); d -71.1 mg/dL (-1.84 mmol/mL); e -90.
English: In the ODYSSEY OUTCOMES trial, 5.5% of patients treated with alirocumab 75 mg and/or 150 mg every 2 weeks (Q2W) had anti-drug antibodies (ADA) detected after initiating treatment compared with 1.6% of patients treated with placebo, most of these were transient responses.
Maltese: ODYSSEY, 5.5% tal-pazjenti ttrattati b'alirocumab 75 mg u/jew 150 mg kull ġimgħatejn (Q2W) instab li kellhom antikorpi kontra l-mediċina (ADA) wara li bdew it-trattament meta mqabbel ma' 1.6% ta' pazjenti ttrattati bi plaċebo, fil-parti l-kbira tiegħu dan ir-rispons kien tranżitorju.
English: In the cardiovascular outcomes study (ODYSSEY OUTCOMES), injection site reactions also occurred more frequently in alirocumab-treated patients than in placebo-treated patients (3.8% alirocumab versus 2.1% placebo).
Maltese: ODYSSEY), ir-reazzjonijiet fis-sit tal-injezzjoni wkoll seħħew b'mod aktar frekwenti f'pazjenti ttrattati b'alirocumab milli f'pazjenti ttrattati bi plaċebo (3.8% alirocumab kontra 2.1% plaċebo).
English: At week 12 (before dose adjustment), 65.2% of patients treated with alirocumab 300 mg Q4W reached an LDL-C of ˂70 mg/dL as compared to 2.8% in the placebo group.
Maltese: Fit-12-il ġimgħa (qabel laġġustament fid-doża), 65.2% tal-pazjenti ttrattati b'alirocumab 300 mg Q4W laħqu LDL-C ta' ˂70 mg/dL meta mqabbel ma' 2.8% fil-grupp ta' plaċebo.
English: Or
Maltese: Non
English: In ten phase 3 controlled trials, involving patients with primary hypercholesterolemia and mixed dyslipidaemia, the most common adverse reactions were local injection site reactions, upper respiratory tract signs and symptoms, and pruritus.
Maltese: F'għaxar provi kkontrollati ta' fażi 3, li involvew pazjenti b'iperkolesterolemija primarja jew dislipidemija mħallta, l-aktar reazzjonijiet avversi komuni kienu reazzjonijiet lokali fis-sit tal-injezzjoni, sinjali u sintomi fil-parti ta' fuq tal-apparat tan-nifs, u prurite.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Praluent in all subsets of the paediatric population in the treatment of mixed dyslipidaemia (see section 4.2 for information on paediatric use).
Maltese: Praluent f'kull sett tal-popolazzjoni pedjatrika fit-trattament ta' dislipidemija mħallta (ara taqsima 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Patients received either alirocumab 300 mg Q4W, alirocumab 75 mg Q2W, or placebo in addition to their existing lipid-modifying therapy (statin, non-statin therapy or diet alone).
Maltese: Il-pazjenti rċevew jew alirocumab 300 mg Q4W, alirocumab 75 mg Q2W, jew plaċebo flimkien mat-terapija li diġà kellhom li timmodifika l-lipidi (statin, terapija mingħajr statin jew dieta waħida).
English: ODYSSEY OUTCOMES study
Maltese: TWISSIJA(IET) SPEĊJALI
English: Based on a population pharmacokinetic analysis, race had no impact on alirocumab pharmacokinetics.
Maltese: Abbażi ta' analiżi farmakokinetika ta' popolazzjoni, ir-razza ma kellha l-ebda impatt fuq il-farmakokinetika ta' alirocumab.
English: Specific metabolism studies were not conducted, because alirocumab is a protein.
Maltese: Ma sarux studji speċifiċi dwar il-metaboliżmu, minħabba li alirocumab huwa proteina.
English: Pre-filled pen 75 mg:
Maltese: Pinna mimlija għal-lest 75 mg:
English: At week 24, the mean treatment difference from placebo in LDL-C percent change from baseline was -45.9% (95% CI: -52.5%, -39.3%; p-value: ˂0.0001).
Maltese: F'ġimgħa 24, il-medja tad-differenza tat-trattament mill-plaċebo fil-persentaġġ ta' bidla fl-LDL-C mill-linja bażi kienet -45.9% (95% CI: -52.5%, -39.3%; valur p: ˂0.
English: In both cohorts, the difference vs placebo was statistically significant at week 24 for all lipid parameters, except for Apo A-1 in the subgroup of patients on background statin.
Maltese: Fiż-żewġ gruppi, id-differenza kontra plaċebo kienet statistikament sinifikanti fl-24 ġimgħa għall-parametri kollha tal-lipidi, ħlief għal Apo A-1 fis-sottogrupp ta' pazjenti li diġà kienu qed jieħdu xi statin.
English: There were no significant differences observed in safety and efficacy with increasing age.
Maltese: Ma kienu osservati l-ebda differenzi sinifikanti fis-sigurtà u l-effikaċja ma' żieda fl-età.
English: EU/1/15/1031/007 1 pre-filled pen EU/1/15/1031/008 2 pre-filled pens EU/1/15/1031/009 6 pre-filled pens
Maltese: EU/1/15/1031/007 pinna 1 mimlija għal-lest EU/1/15/1031/008 2 pinen mimlija għal-lest EU//1/15/1031/009 6 pinen mimlija għal-lest
English: Patients received either alirocumab 75 mg Q2W or ezetimibe 10 mg once daily.
Maltese: Il-pazjenti rċivew alirocumab 75 mg Q2W jew ezetimibe
English: A third multicenter, double-blind, placebo-controlled 18-month study included 106 heFH patients on a maximally tolerated dose of statin, with or without other lipid-modifying therapies, and a baseline LDL-C ≥160 mg/dL (≥4.14 mmol/L).
Maltese: L-istudju HIGH FH|It-tielet studju ta' 18-il xahar, b'ħafna ċentri, ikkontrollat bi plaċebo, fejn la l-investigatur u lanqas il pazjenti ma kienu jafu liema sustanza qed tintuża kien jinkludi 106 pazjenti heFH fuq l-ogħla doża ttollerata ta' statin, b'terapiji oħra li jimmodifikaw il-lipidi jew mingħajrhom, u linja bażi ta' LDL-C ≥160 mg/dL (≥4.14 mmol/L).
English: a g h i
Maltese: M'għandekx
English: Grey plunger
Maltese: Planġer griż
English: -90.8 mg/dL (-2.35 mmol/L);
Maltese: 8 mg/dL (-2.35 mmol/L); f -50.3 mg/dL (1.30 mmol/L);
English: At week 12 (before up-titration), 57.7% of patients reached an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) as compared to 0% in the ezetimibe group.
Maltese: F'ġimgħa 12 (qabel titrazzjoni 'l fuq), 57.7% tal-pazjenti laħqu LDL-C ta' ˂70 mg/dL (≥1.81 mmol/L) meta mqabbel ma' 0% fil-grupp ta'
English: Steady state was reached after 2 to 3 doses with an accumulation ratio up to a maximum of about 2-fold.
Maltese: 2 jew 3 dożi bi proporzjon ta' akkumulazzjoni sa massimu ta' madwar darbtejn.
English: INFORMATION IN BRAILLE
Maltese: Għatu tallabra
English: A significantly higher proportion of patients achieved an LDL-C of ˂70 mg/dL (˂1.81 mmol/L) in the alirocumab group as compared to placebo or ezetimibe at week 12 and week 24.
Maltese: ˂70 mg/dL (˂1.81 mmol/L) fil-grupp ta' alirocumab meta mqabbel ma' plaċebo jew ezetimibe fil-ġimgħa 12
English: Two elimination phases were observed for alirocumab.
Maltese: Kienu osservati żewġ fażijiet ta' eliminazzjoni għal alirocumab.
English: Patients up-titrated to 150 mg Q2W had a higher mean baseline LDL-C.
Maltese: Pazjenti titrati 'l fuq għal 150 mg Q2W kellhom medja ogħla ta' LDL-C fil-linja bażi.
English: The distribution of body weight and age, two covariates impacting alirocumab exposure, were different among renal function categories and most likely explain the observed pharmacokinetic differences.
Maltese: Id-distribuzzjoni tal-piż tal-ġisem u l-età, żewġ kovarjati li jaffettwaw l-esponiment għal alirocumab, kienu differenti fost il-kategoriji ta' funzjoni tal-kliewi u x'aktarx li l-aktar jispjegaw iddifferenzi farmakokinetiċi osservati.
English: After subcutaneous administration of 50 mg to 300 mg alirocumab, median times to maximum serum concentration (tmax) were 3-7 days.
Maltese: Wara għoti ta' 50 mg sa 300 mg alirocumab taħt il-ġilda, il-medjan tal-ħinijiet biex tintlaħaq l-ogħla konċentrazzjoni fis-serum (tmax) kien minn 3-7 ijiem.
English: Although no safety issues were observed in patients over 75 years of age, data are limited in this age group.
Maltese: Għalkemm ma ġew osservati l-ebda problemi ta' sigurtà f'pazjenti li kellhom aktar minn 75 sena, id-dejta f'dan il-grupp ta' età hija limitata.