FrancophonIA/ELRC3.0 huggingface dataset:
English: HDL-C Apo A-1
Maltese: u Apo A-1.
English: Local injection site reactions, including erythema/redness, itching, swelling, and pain/tenderness, were reported in 6.1% of patients treated with alirocumab versus 4.1% in the control group (receiving placebo injections).
Maltese: Reazzjonijiet lokali fil-post tal-injezzjoni, inkluż eritema/ħmura, ħakk, nefħa, u uġigħ/sensittività, kienu rrappurtati f'6.1% tal-pazjenti ttrattati b'alirocumab versus 4.1% fil-grupp ta' kontroll (li kienu qed jirċievu injezzjonijiet ta' plaċebo).
English: COMBO I study
Maltese: L-istudju COMBO I
English: Alirocumab also results in reductions in lipoprotein (a) [Lp(a)], which is a form of LDL that is bound to apolipoprotein (a).
Maltese: lipoprotein (a)], li hija forma ta' LDL li jintrabat mal-apolipoproteina (a).
English: Hypersensitivity, hypersensitivity vasculitis
Maltese: vaskulite minn sensittività eċċessiva
English: Mean baseline LDL-C was 151.5 mg/dL (3.90 mmol/L).
Maltese: Il-medja tal-LDL-C fil-linja bażi kienet 151.5 mg/dL (3.90 mmol/L).
English: A multicenter, double-blind, placebo-controlled, 48 week study included 540 patients on a maximally tolerated dose of a statin, with or without other lipid-modifying therapy (308 in the alirocumab 300 mg Q4W group, 76 in the alirocumab 75 mg Q2W group, and 156 in the placebo group), and 252 patients not treated with a statin (144 in the alirocumab 300 mg Q4W group, 37 in the alirocumab 75 mg Q2W group, and 71 in the placebo group).
Maltese: Studju multiċentriku, double-blind, ikkontrollat bil-plaċebo u li dam 48 ġimgħa kien jinkludi 540 pazjent fuq l-ogħla doża ttollerata ta' statin u li kellhom jew ma kellhomx terapija oħra li timmodifika l-lipidi (308 fil grupp ta' alirocumab 300 mg Q4W, 76 fil-grupp ta' alirocumab 75 mg Q2W, u 156 fil-grupp ta' plaċebo), u 252 pazjent li ma kinux ittrattati bi statin (144 fil-grupp ta' alirocumab 300 mg Q4W, 37 fil-grupp ta' alirocumab 75 mg Q2W, u 71 fil-grupp ta' plaċebo).
English: • The active substance is alirocumab.
Maltese: • Is-sustanza attiva hija alirocumab.
English: 150 mg/ml solution for injection:
Maltese: 150 mg/ml soluzzjoni għall-injezzjoni:
English: • Praluent is a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Maltese: • Praluent huwa antikorp monoklonali (tip ta' proteina speċjalizzata magħmula biex taqbad ma' sustanza speċifika fil-ġisem).
English: Store unused syringes in the refrigerator at 2°C to 8°C.
Maltese: Taħżen is-siringi mhux użati fil-friġg f'temperatura ta' 2°C sa 8°C.
English: • PCSK9 is a protein secreted by liver cells.
Maltese: • PCSK9 hija proteina li tiġi magħmula u tintreħa miċ-ċelluli tal-fwied.
English: Pharmacokinetic/pharmacodynamic relationship(s)
Maltese: Relazzjoni(jiet) farmakokientiċi/farmakodinamiċi
English: In the cardiovascular outcomes study (ODYSSEY OUTCOMES), general allergic reactions were similar in alirocumab-treated patients and placebo-treated patients (7.9% alirocumab, 7.8% placebo).
Maltese: ODYSSEY), ir-reazzjonijiet allerġiċi ġenerali kienu simili f'pa f'pazjenti ttrattati b'alirocumab u f'pazjenti ttrattati bi plaċebo (7.9% alirocumab, 7.8% plaċebo).
English: Local injection site reactions were reported overall at a frequency of 16.6% in the 300 mg once every 4 weeks treatment group and 7.9% in the placebo group.
Maltese: Bħala total, reazzjonijiet lokali fis-sit tal-injezzjoni ġew irrapportati b'frekwenza ta' 16.6 % fil-grupp ta' trattament ta' 300 mg darba kull 4 ġimgħat u 7.9 % fil grupp ta' plaċebo.
English: In the cardiovascular outcomes controlled study, 2505 patients (26.5%) treated with Praluent were ≥65 years of age and 493 patients (5.2%) treated with Praluent were ≥75 years of age.
Maltese: Fl istudju kkontrollat dwar l-effetti kardjovaskulari, 2505 pazjenti (26.5%) ittrattati bi Praluent kellhom età ta' ≥65 sena u 493 pazjent (5.2%) ittrattati bi Praluent kellhom età ta' ≥75 sena.
English: Praluent 150 mg
Maltese: 150 milligramma.
English: • Adults with high cholesterol levels in their blood and with cardiovascular disease to reduce cardiovascular risk.
Maltese: • Adulti b'livelli għolja ta' kolesterol fid-demm tagħhom u b'mard kardjovaskulari sabiex inaqqas ir riskju kardjovaskulari.
English: CHOICE I study
Maltese: L-istudju CHOICE I
English:  Let the syringe warm up at room temperature for 30 to 40 minutes.
Maltese:  Ħalli l-pinna tilħaq it-temperatura tal-kamra għal bejn 30 u 40 minuta.
English: EU/1/15/1031/001 EU/1/15/1031/002 EU/1/15/1031/003 EU/1/15/1031/004 EU/1/15/1031/005 EU/1/15/1031/006 EU/1/15/1031/007 EU/1/15/1031/008 EU/1/15/1031/009 EU/1/15/1031/010 EU/1/15/1031/011 EU/1/15/1031/012
Maltese: EU/1/15/1031/006 EU/1/15/1031/007 EU/1/15/1031/008 EU/1/15/1031/009 EU/1/15/1031/010
English: 75 mg/ml 1 ml
Maltese: INDIVIDWALI 75 mg/ml
English: Placebo-controlled phase 3 studies (on background statin) in patients with heterozygous familial hypercholesterolaemia (heFH)
Maltese: Studji ta' fażi 3 ikkontrollati bi plaċebo (fuq statin fl-isfond) f'pazjenti b'iperkolesterolemija eteroziguża fil familja (heFH - heterozygous familial hypercholesterolaemia)
English: Keep this leaflet.
Maltese: Għatu tal labra
English: The difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C and Apo B.
Maltese: għal LDL-C, Total-C, Non-HDL-C u Apo B.
English: • You can inject into your:
Maltese: • Tista' tinjetta:
English: In general, administration of alirocumab also resulted in a statistically significant greater percent reduction in total cholesterol (Total-C), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), and lipoprotein (a) [Lp(a)] as compared to placebo/ ezetimibe, whether or not patients were concomitantly being treated with a statin.
Maltese: B'mod ġenerali, l-għoti ta' alirocumab wassal ukoll għal persentaġġ ta' tnaqqis sinifikanti b'mod statistiku akbar fil-kolesterol totali (Total-C - total cholesterol), kolesterol b'lipoproteina mhux ta' densità għolja (non-HDL-C - non-high-density lipoprotein cholesterol), apolipoproteina B (Apo B), u lipoproteina (a) [Lp(a)] meta mqabbel ma' plaċebo/ ezetimibe, kemm jekk il-pazjenti kienu qed jiġu ttrattati bi statin fl-istess ħin kif ukoll jekk le.
English: • Adults with high cholesterol levels in their blood (hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
Maltese: • Adulti b'livelli għolja ta' kolesterol fid-demm tagħhom (iperkolesterolemija, [eteroziguża fil-familja u mhux fil-familja] jew dislipidemija mħallta).
English: For detailed results see Table 2.
Maltese: Għal riżultati ddettaljati ara Tabella 2 taħt.
English: A reduction of all-cause mortality was also observed, with only nominal statistical significance by hierarchical testing (HR 0.85, 95% CI: 0.73, 0.98).
Maltese: Ġie wkoll osservat tnaqqis fil-mortalità minn kwalunkwe kawża, b'sinifikanza statistika nominali biss permezz ta' ttestjar ġerarkiku (HR 0.85, 95% CI: 0.73, 0.98).
English: Population pharmacokinetic analyses showed that alirocumab exposure (AUC0-14d) at steady state at both the 75 and 150 mg Q2W dosing regimen was increased by 22%-35%, and 49%-50% in patients with mild and moderate renal impairment, respectively, compared to patients with normal renal function.
Maltese: Analiżi farmakokinetiċi ta' popolazzjoni urew li l-esponiment għal alirocumab (AUC0-14d) fl-istat fiss kemm bl-iskeda ta' għoti ta' dożi ta' 75 kif ukoll 150 mg Q2W żdied bi 22%-35%, u 49%-50% f'pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi, rispettivament, meta mqabbel ma' pazjenti b'funzjoni normali tal-kliewi.
English: In pre-specified final analyses of the LONG TERM study, treatment-emergent CV events confirmed by adjudication occurred in 72 of 1550 (4.6%) patients in the alirocumab group and in 40 of 788 (5.1%) patients in the placebo group; MACE-plus confirmed by adjudication were reported in 27 of 1550 (1.7%) patients in the alirocumab group and 26 of 788 (3.3%) patients in the placebo group.
Maltese: F'analiżi finali speċifikati minn qabel tal-istudju LONG TERM, avvenimenti CV li jfiġġu minħabba t trattament ikkonfermati permezz ta' aġġudikazzjoni seħħew fi 72 minn 1,550 (4.6%) pazjent fil-grupp ta' alirocumab u f'40 minn 788 (5.1%) pazjent fil-grupp ta' plaċebo; MACE plus ikkonfermati permezz ta' aġġudikazzjoni kienu rrappurtati f'27 minn 1,550 (1.7%) pazjent fil-grupp ta' alirocumab u f'26 minn 788 (3.3%) pazjent fil-grupp ta' plaċebo.
English: FHI and FHII (N=732)
Maltese: FHI u FHII (N=732) FH għolja(N=106) COMBO I (N=311)
English: • the Praluent pen
Maltese: • il-pinna Praluent
English: Mechanism of action
Maltese: darba biss
English: * including mainly oropharyngeal pain, rhinorrhea, sneezing ** including erythema/redness, itching, swelling, pain/tenderness
Maltese: * jinkludu l-aktar uġigħ fil-ħalq u fil-farinġi, rinorrea, għatis ** jinkludu eritema/ħmura, ħakk, nefħa, uġigħ/sensittività
English: Established atherosclerotic cardiovascular disease
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: When co-administered with a statin, the median apparent half-life of alirocumab was 12 days.
Maltese: Meta ngħata flimkien ma' statin, il-medjan tal-half-life apparenti ta' alirocumab kien ta' 12-il jum.
English: Therefore, alirocumab treatment can produce reductions in these remnant lipoproteins as evidenced by its reductions in apolipoprotein B (Apo B), non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TG).
Maltese: Għalhekk, trattament b'alirocumab jista' jipproduċi tnaqqis f'dan il-fdal tal-lipoproteini kif jixhed it-tnaqqis tiegħu ta' apolipoproteina B (Apo B), kolesterol b'lipoproteina mhux ta' densità għolja (non-HDL-C - non-high-density lipoprotein cholesterol) u trigliċeridi (TG - triglycerides).
English: 1 ml solution in a siliconised Type 1 clear glass syringe, equipped with a stainless steel staked needle, a styrene-butadiene rubber soft needle shield, and an ethylene tetrafluoroethylene -coated bromobutyl rubber plunger stopper.
Maltese: Siringa ta' 1 ml silikonizzata tal-ħġieg tat-Tip 1 ċar, mgħammra b'labra tal-azzar inossidabbli immanifatturata ħaġa waħda mas-siringa, għatu tal-labra artab tal-gomma styrene-butadiene, u bi planġer b'tarf tal-gomma bromobutyl miksija b'ethylene tetrafluoroethylene.
English: Grey button
Maltese: Buttuna griża
English: Frequency categories are defined as: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
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 (<1/10,000) u mhux magħrufa (ma tistax tittieħed stima mid-dejta disponibbli).
English: In the phase 3 primary hypercholesterolemia and mixed dyslipidaemia controlled studies, 1158 patients (34.7%) treated with Praluent were ≥65 years of age and 241 patients (7.2%) treated with Praluent were ≥75 years of age.
Maltese: Fi studji kkontrollati ta' fażi 3 ta' iperkolesterolemija u dislipidemija mħallta, 1,158 pazjent (34.7%) trattati bi Praluent kellhom età ta' ≥65 sena u 241 pazjent (7.2%) trattati bi Praluent kellhom età ta' ≥75 sena.
English: 1, 2, or 6 pre-filled syringes.
Maltese: 1, 2, jew 6 siringi mimlija għal-lest.
English: Alirocumab significantly reduced the risk for the primary composite endpoint of the time to first occurrence of Major Adverse Cardiovascular Events (MACE-plus) consisting of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, or unstable angina (UA) requiring hospitalization (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.0003).
Maltese: Alirocumab naqqas b'mod sinifikanti r-riskju għall-punt finali primarju kompost taż-żmien sabiex seħħ l ewwel Avveniment Maġġuri Avvers Kardjovaskulari (MACE plus) li jikkonsisti minn mewt minħabba mard koronarju tal-qalb (CHD), infart mijokardijaku (MI), puplesija iskemika kemm fatali u mhux fatali, jew anġina li mhijiex stabbli li tkun teħtieġ rikoverar l-isptar (HR 0.85, 95% CI: 0.78, 0.93; p-value=0.
English: (See picture).
Maltese: (Ara l-istampa).
English: All-cause mortality in phase 3 studies was 0.6% (20 of 3182 patients) in the alirocumab group and 0.9% (17 of 1792 patients) in the control group.
Maltese: Fi studji ta' fażi 3, mortalità minn kull kawża kienet 0.6% (20 minn 3,182 pazjent) fil-grupp ta' alirocumab u 0.9% (17 minn 1,792 pazjent) fil-grupp ta' kontroll.
English: The mean LDL-C value at baseline was 92.4 mg/dL (2.39 mmol/L).
Maltese: Il-medja tal-valur ta' LDL-C fil-linja bażi kien ta' 92.4 mg/dL (2.39 mmol/L).
English: In pre-specified analyses of pooled phase 3 studies, treatment-emergent CV events confirmed by adjudication, consisting of coronary heart disease (CHD) death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalisation, congestive heart failure hospitalisation, and revascularisation, were reported in 110 (3.5%) patients in the alirocumab group and 53 (3.0%) patients in the control group (placebo or active control) with HR=1.08 (95% CI, 0.78 to 1.50).
Maltese: F'analiżi speċifikata minn qabel ta' ġabra ta' studji ta' fażi 3, avvenimenti CV li jfiġġu minħabba t trattament ikkonfermati b'aġġudikazzjoni, li jikkonsistu f'mewt minn mard koronarju tal-qalb (CHDcoronary heart disease), infart mijokardijaku, puplesija iskemika, anġina mhux stabbli li tkun teħtieġ rikoverar l-isptar, rikoverar l-isptar minħabba insuffiċjenza konġestiva tal-qalb, u vaskularizzazzjoni millġdid, ġew irrappurtati f'110 (3.5%) pazjenti fil-grupp ta' alirocumab u 53 (3.0%) pazjent fil-grupp ta' kontroll (plaċebo jew kontroll attiv) b'HR=1.08 (95% CI, 0.78 sa 1.50).
English: Ballycummin
Maltese: Il-Ġermanja
English: • Your injection is complete, when the window has turned completely yellow, you may hear a second click.
Maltese: • L-injezzjoni tiegħek tkun lesta, meta t-tieqa tiġi kompletament safra, jista' jkun li inti tisma' klikk oħra.
English: Limited data are available in patients with severe renal impairment (see section 5.2).
Maltese: Hija disponibbli dejta limitata f'pazjenti b'indeboliment sever tal-kliewi (ara taqsima 5.2).
English: Compared to alirocumab monotherapy, the exposure to alirocumab is about 40%, 15%, and 35% lower when used concomitantly with statins, ezetimibe, and fenofibrate, respectively.
Maltese: Meta mqabbel ma' monoterapija b'alirocumab, l-esponiment għal alirocumab huwa madwar 40%, 15%, u 35% aktar baxx meta jintuża flimkien ma' statins, ezetimibe, u fenofibrate, rispettivament.
English: At week 24, the mean treatment difference for alirocumab 300 mg Q4W/150 mg Q2W from placebo in LDL-C percent change from baseline was -58.7% (97.5% CI: -65.0%, -52.4%; p-value: ˂ 0.0001).
Maltese: Fl-24 ġimgħa, il-medja ta' differenza fit-trattament bejn alirocumab 300 mg Q4W/150 mg Q2W u plaċebo f'bidla perċentwali f'LDL-C mil-linja bażi kienet ta' -58.7 % (97.5% CI: -65.0%, -52.4%; p-value: ˂ 0.0001).
English: Do not
Maltese: JIS.
English: Difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins.
Maltese: Id-differenza versus il-plaċebo kienet sinifikanti b'mod statistiku f'ġimgħa 24 għall-lipidi/lipoproteini kollha.
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 web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti għas-sottomissjoni 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 kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see section 5.2).
Maltese: Pazjenti b'indeboliment sever tal-fwied (Child-Pugh Ċ) ma ġewx studjati (ara taqsima 5.2).
English: Reduction in LDL-C was seen across age, gender, body mass index (BMI), race, baseline LDL-C levels, patients with heFH and non-heFH, patients with mixed dyslipidaemia, and diabetic patients.
Maltese: Tnaqqis fl-LDL-C deher fuq firxa ta' etajiet, sess tal-persuni, indiċi tal-massa tal-ġisem (BMI - body mass index), razez, livelli ta' LDL-C fil-linja bażi, pazjenti b'heFH u mhux heFH, pazjenti b'dislipidemija mħallta u pazjenti dijabetiċi.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: SYRINGE LABEL - 150 mg
Maltese: TIKKETTA TAS-SIRINGA - 150 mg
English: For patients who had their dose adjusted to 150 mg Q2W and who had two consecutive LDL-C values below 25 mg/dL (0.65 mmol/L), down-titration from 150 mg Q2W to 75 mg Q2W was performed.
Maltese: 25 mg/dL (0.65 mmol/L), kellhom id-doża mniżżla minn 150 mg Q2W għal 75 mg Q2W.
English: Number of patients Mean Baseline LDL-C in mg/dL (mmol/L) Week 12
Maltese: Numru ta' pazjenti Medja ta' LDL-C fil-Linja Bażi f'mg/dl (mmol/L)
English: • The other ingredients are histidine, sucrose, polysorbate 20 and water for injection.
Maltese: • Is-sustanzi l-oħra huma histidine, sucrose, polysorbate 20 u ilma għall-injezzjoni.
English: Clinical efficacy and safety in primary hypercholesterolaemia and mixed dyslipidaemia
Maltese: 4.1 Indikazzjonijiet terapewtiċi Iperkolesterolemija primarja u dislipidemija mħallta
English: Persistent ADA responses were observed in 0.7% of patients treated with alirocumab and 0.4% of patients treated with placebo.
Maltese: Rispons permanenti ta' ADA kien osservat f'0.7% ta' pazjenti ttrattati b'alirocumab u f'0.4% ta' pazjenti ttrattati bi plaċebo.
English: PEN LABEL - 75 mg
Maltese: TIKKETTA TAL-PINNA - 75 mg
English: PEN LABEL - 150 mg
Maltese: TIKKETTA TAL-PINNA - 150 mg
English: Overall, 71.6% of patients were categorized at high or very high CV risk and not at their LDL-C target.
Maltese: B'mod ġenerali, 71.6% tal-pazjenti ġew ikkategorizzati f'riskju ta'kardjovaskulari għoli jew għoli ħafna u li ma kinux fil-mira tagħhom ta' LDL-C.
English: Praluent 75 mg
Maltese: 75 milligramma.
English: The Kaplan-Meier estimates of the cumulative incidence of the primary endpoint for the overall patient population over time are presented in Figure 1.
Maltese: L-istimi Kaplan-Meier tal-inċidenza kumulattiva tal-punt finali primarju għall-popolazzjoni totali ta' pazjenti maż-żmien huma ppreżentati f'Figura 1.
English: At month 2, if additional LDL-C lowering was required based on pre-specified LDL-C criteria (LDL-C ≥50 mg/dL or 1.29 mmol/dL), alirocumab was adjusted to 150 mg Q2W.
Maltese: (LDL-C ≥50 mg/dL jew 1.29 mmol/dL), alirocumab kien aġġustat għal 150 mg Q2W.
English: Praluent is not recommended for children and adolescents under 18 years old.
Maltese: Praluent mhuwiex rrakkomandat għal tfal u adolexxenti ta' taħt it-18-il sena.
English: • If you see any blood, press a cotton ball or gauze on the site until the bleeding stops.
Maltese: • Tiġbidx it-tapp il-blu 'il barra sa ma tkun lest biex tinjetta.
English: SYRINGE LABEL - 75 mg
Maltese: TIKKETTA TAS-SIRINGA - 75 mg
English: The difference versus placebo was statistically significant at week 24 for all lipids/ lipoproteins except TG and Apo A-1.
Maltese: Iddifferenza versus il-plaċebo kienet sinifikanti b'mod statistiku f'ġimgħa 24 għall-lipidi/lipoproteini kollha ħlief TG u Apo A-1.
English: Monoclonal antibodies are proteins that recognise and bind to other unique proteins.
Maltese: Antikorpi monoklonali huma proteini li jagħrfu u jintrabtu ma' proteini uniċi oħra.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fit taqsima 6.1.
English: Body weight was identified as one significant covariate in the final population PK model impacting alirocumab pharmacokinetics.
Maltese: Il-piż tal-ġisem ġie identifikat bħala kovarjat sinifikanti wieħed fil-mudell PK finali ta' popolazzjoni li jaffettwa l-farmakokinetika ta' alirocumab.
English: The % LDL-C reduction at week 24 corresponds to a mean absolute change of:
Maltese: Il-% ta' tnaqqis fl-LDL-C f'ġimgħa 24 jaqbel mal-medja tal-bidla assoluta ta':
English: The discontinuation rate due to local injection site reactions was comparable between the two groups (0.2% in the alirocumab group versus 0.3% in the control group).
Maltese: Ir-rata ta' waqfien minħabba reazzjonijiet lokali fil-post tal-injezzjoni kien kumparabbli bejn iż-żewġ gruppi (0.2% fil-grupp ta' alirocumab versus 0.3% fil-grupp ta' kontroll).
English: Alirocumab is a recombinant IgG1 antibody, therefore it is expected to cross the placental barrier (see section 5.3).
Maltese: Alirocumab huwa antikorp IgG1 rikombinanti, għalhekk huwa mistenni li jgħaddi minn ġol-plaċenta (ara taqsima 5.3).
English: The dose was up-titrated to 150 mg Q2W in 32 (16.8%) patients treated beyond 12 weeks.
Maltese: 150 mg Q2W fi 32 (16.8%) pazjent ittrattati għal iktar minn 12 il-ġimgħa.
English: Syringe body
Maltese: Sess tal-Persuna
English: If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated (see section 4.3).
Maltese: Jekk iseħħu sinjali u sintomi ta' reazzjonijiet allerġiċi serji, ittrattament bi Praluent għandu jitwaqqaf u għandu jinbeda trattament xieraq għas-sintomi (ara taqsima 4.3).
English: Three of the ten studies were conducted exclusively in patients with heterozygous familial hypercholesterolaemia (heFH).
Maltese: Tlieta mill-għaxar studji saru esklussivament f'pazjenti b'iperkolesterolemija eteroziguża fil-familja (heFH - heterozygous familial hypercholesterolaemia).
English: Each pre-filled syringe contains 150 mg alirocumab in 1 ml solution (150 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 150 mg alirocumab f'soluzzjoni ta' 1 ml (150 mg/ml).
English: Alirocumab also significantly reduced the following composite endpoints: risk of CHD event; major CHD event; cardiovascular event; and the composite of all-cause mortality, non-fatal MI, and non-fatal ischemic stroke.
Maltese: Alirocumab naqqas b'mod sinifikanti wkoll il-punti finali komposti li ġejjin: ir-riskju ta' avveniment CHD ; avveniment maġġuri CHD ; avveniment kardjovaskulari; u l-avvenimenti kollha flimkien ta' mortalità minn kwalunkwe kawża, MI li ma kinitx fatali, u puplesija iskemika li ma kinitx fatali.
English: In a pool of controlled studies using a 75 mg every 2 week (Q2W) starting dose and in which the dose was increased to 150 mg Q2W if the patient's LDL-C was not <70 mg/dL or < 100 mg/dL (1.81 mmol/L or 2.59 mmol/L), 29.3% of patients with baseline LDL-C <100 mg/dL and 5.0% 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: F'ġabra ta' studji kkontrollati fejn intużat doża fil-bidu ta' 75 mg kull ġimgħatejn (Q2W) u fejn id-doża żdiedet għal 150 mg Q2W jekk l-LDL-C tal-pazjent ma kienx <70 mg/dL jew < 100 mg/dL (1.81 mmol/L or 2.59 mmol/L), 29.3% tal-pazjenti b'livell ta' LDL-C fil-linja bażi ta' <100 mg/dL u 5.0% tal-pazjenti b'livell ta' LDL-C fil-linja bażi ta' ≥100 mg/dL ittrattati b'alirocumab kellhom żewġ valuri konsekuttivi ta' LDL-C
English: LDL-C (on treatment)
Maltese: LDL-C (fuq ittrattament)