FrancophonIA/ELRC3.0 huggingface dataset:
English: Up to 99% of patients treated with either dose of Repatha achieved an LDL-C of < 2.6 mmol/L and up to 95% achieved an LDL-C < 1.8 mmol/L at the mean of weeks 10 and 12.
Maltese: Sa 99% tal-pazjenti ttrattati b'waħda middożi ta' Repatha kisbu LDL-C ta' < 2.6 mmol/L u sa 95% kisbu LDL-C ta' < 1.8 mmol/L fil-medja ta' ġimgħat 10 u 12.
English: Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency in table 1 below using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Maltese: Reazzjonijiet avversi rrappurtati matul studji kliniċi pivitali u kkontrollati, u rappurtar spontanju, huma murija skont il-klassi tas-sistemi u tal-organi u l-frekwenza f'tabella 1 hawn taħt bl-użu talkonvenzjoni li ġejja: 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) u rari ħafna (< 1/10,000).
English: A total of 1,324 patients enrolled in OSLER.
Maltese: Total ta' 1,324 pazjent irreġistraw f'OSLER.
English: Repatha contains the active substance evolocumab, a monoclonal antibody (a type of specialised protein designed to attach to a target substance in the body).
Maltese: Repatha fih is-sustanza attiva evolocumab, antikorp monoklonali (tip ta' proteina speċjalizzata maħsuba biex teħel ma' sustanza mmirata fil-ġisem).
English: Severe FH (non-HoFH) (N = 194) Key: OLE = open-label extension, N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific scheduled visit (n) in the severe familial hypercholesterolaemia (non-HoFH) final analysis set.
Maltese: OLE = estensjoni open label, N (n) = Numru ta' pazjenti li setgħu jiġu evalwati (N) u pazjenti b'valuri ta' LDL osservati matul vista speċifika skedata (n) fis-sett tal-analiżi finali ta' iperkolesterolemija familjali severa (non-HoFH).
English: TC/ HDL-C Ratio
Maltese: TC/ HDL-C
English: (statin intolerant)
Maltese: (intolleranti għal statins)
English: OLE Week 96
Maltese: Ġimgħa 96 ta' OLE
English: It is given: together with a statin or other cholesterol lowering medication, if the maximum dose of a statin does not lower levels of cholesterol sufficiently.
Maltese: Jingħata: flimkien ma' statin jew ma' mediċina oħra li tnaqqas il-kolesterol, jekk id-doża massima ta' statin ma tbaxxix il-livelli tal-kolesterol b'mod suffiċjenti.
English: Over 99% of patients were on moderate to high intensity statin and at least one other cardiovascular medicine such as anti-platelet agents, beta blockers, ACE inhibitors, or angiotensin receptor blockers; median (Q1, Q3) baseline LDL-C was 2.4 mmol/L (2.1, 2.8).
Maltese: Aktar minn 99% tal-pazjenti kienu fuq statins ta' intensità moderata sa għolja u mill-inqas mediċina kardjovaskulari waħda oħra bħal sustanzi kontra l-plejtlits, imblokkaturi tar-riċetturi beta, inibituri ta' ACE jew imblokkaturi tar-riċetturi ta' angiotensin; LDL-C medjan (Q1, Q3) fil-linja bażi kien 2.4 mmol/L (2.1, 2.8).
English: OLE Week 192
Maltese: Ġimgħa 192 ta' OLE
English: Homozygous familial hypercholesterolaemia
Maltese: Iperkolesterolemija familjali omozigota
English: OLE Week 216 (n = 96)
Maltese: Ġimgħa 216 ta' OLE (n = 96)
English: The relative risk of the MACE composite (CV death, MI, or stroke) was significantly reduced by 20%.
Maltese: Irriskju relattiv tal-kompost ta' MACE (mewt CV, MI, jew puplesija) kien imnaqqas b'mod sinifikanti b'20%.
English: OLE Week 12
Maltese: Ġimgħa 1 2 ta' OLE
English: TAUSSIG was a multicentre, open-label, 5-year extension study to assess the long-term safety and efficacy of Repatha, as an adjunct to other lipid-lowering therapies, in patients with severe familial hypercholesterolaemia (FH), including homozygous familial hypercholesterolaemia.
Maltese: TAUSSIG kien studju open label, multiċentriku ta' estensjoni ta' 5 snin biex jevalwa s-sigurtà u leffikaċja fit-tul ta' Repatha, bħala żieda ma' terapiji oħra li jbaxxu l-lipidi, f'pazjenti b'iperkolesterolemija familjali severa (FH), inkluża iperkolesterolemija familjali omozigota.
English: When measured by TAV, atherosclerotic regression was observed in 61.5% (95% CI 56.7, 66.0) and 48.9% (95% CI 44.2, 53.7) of patients who received Repatha or placebo respectively.
Maltese: Meta mkejla b'TAV, rigressjoni aterosklerotika kienet osservata f'61.5% (CI ta' 95% 56.7, 66.0) u 48.9% (CI ta' 95% 44.2, 53.7) tal-pazjenti li rċevew Repatha jew plaċebo rispettivament.
English: Step 1: Prepare
Maltese: Pass 1: Ipprepara
English: • Alcohol wipes.
Maltese: • Imsielaħ tal-alkoħol.
English: OLE Week 192 (n = 147)
Maltese: Ġimgħa 192 ta' OLE (n = 147)
English: What Repatha contains - The active substance is evolocumab.
Maltese: X'fih Repatha - Is-sustanza attiva hi evolocumab.
English: Reductions in LDL-C and changes in other lipid parameters in 14 adolescent patients (aged ≥ 12 to < 18 years) with homozygous familial hypercholesterolaemia are comparable to those in the overall population of patients with homozygous familial hypercholesterolaemia.
Maltese: Tnaqqis fl-LDL-C u bidliet f'parametri oħra tal-lipidi f'14il pazjent adolexxenti (b'età ta' ≥ 12 sa < 18-il sena) b'iperkolesterolemija familjali omozigota huwa komparabbli ma' dak fil-popolazzjoni globali ta' pazjenti b'iperkolesterolemija familjali omozigota.
English: OLE Week 12 (n = 191)
Maltese: Ġimgħa 12 ta' OLE (n = 191)
English: OLE Week 36
Maltese: Ġimgħa 36 ta' OLE
English: Patients at Risk
Maltese: Pazjenti f'Riskju
English: RUTHERFORD-2 was an international, multicentre, double-blind, randomised, placebo-controlled, 12-week study in 329 patients with heterozygous familial hypercholesterolaemia on lipid-lowering therapies.
Maltese: RUTHERFORD-2 kien studju internazzjonali, multiċentriku, double-blind, randomised u kkontrollat bi plaċebo ta' 12-il ġimgħa, ta' 329 pazjent b'iperkolesterolemija familjali eterozigota fuq terapiji li jbaxxu l-lipidi.
English: Repatha has not been studied in patients with severe hepatic impairment (Child-Pugh class C) (see section 4.4).
Maltese: Repatha ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (Child-Pugh klassi C) (ara sezzjoni 4.4).
English: The Repatha Outcomes Study (FOURIER) was a randomised, event-driven, double-blind study of 27,564 subjects, aged between 40 and 86 years (mean age 62.5 years), with established atherosclerotic CV disease; 81% had a prior MI event, 19% had a prior stroke event and 13% had peripheral arterial disease.
Maltese: L-Istudju tar-Riżultati ta' Repatha (FOURIER) kien studju randomised, immexxi mill-avvenimenti u double-blind ta' 27,564 individwu, ta' età bejn 40 u 86 sena (età medja ta' 62.5 snin), b'mard CV aterosklerotiku stabbilit; 81% kellhom avveniment ta' MI preċedenti, 19% kellhom avveniment ta' puplesija preċedenti u 13% kellhom marda tal-arterji periferali.
English: ApoB/ ApoA 1 ratio
Maltese: Proporzjon ta' ApoB/ ApoA1
English: OLE Week 24 (n = 191)
Maltese: Ġimgħa 24 ta' OLE (n = 191)
English: During injection, keep the automated mini-doser a minimum of 10 cm (4 inches) away from other electronics such as mobile phones.
Maltese: Waqt l-injezzjoni, żomm il-mini-doser awtomatizzat minimu ta' 10 cm (4 pulzieri) 'il bogħod minn apparat elettroniku ieħor bħal telefons ċellulari.
English: OLE Week 24
Maltese: Ġimgħa 24 ta' OLE
English: Administration of single subcutaneous dose of 140 mg resulted in a Cmax mean (SD) of 13.0 (10.4) μg/mL and AUClast mean (SD) of 96.5 (78.7) day•μg/mL.
Maltese: taħt il-ġilda ta' 140 mg wassal għal Cmax medja (SD) ta' 13.0 (10.4) μg/mL u AUCl-aħħar medja (SD) ta' 96.5 (78.7) jum•μg/mL.
English: Repatha 420 mg solution for injection in cartridge EU/1/15/1016/006 - 1 cartridge with co-packed automated mini-doser EU/1/15/1016/007 - 3 (3x1) cartridges with co-packed automated mini-dosers (multipack)
Maltese: EU/1/15/1016/005 - 6 (3x2) pinen mimlija għal-lest (pakkett multiplu) Repatha 420 mg soluzzjoni għall-injezzjoni fi skartoċċ EU/1/15/1016/006 - skartoċċ wieħed ippakkjat flimkien ma' mini-doser awtomatizzat EU/1/15/1016/007 - 3 (3x1) skrataċ ippakkjati flimkien ma' mini-dosers awtomatizzati (pakkett multiplu)
English: Component of a multi-pack, can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: The long-term safety of sustained very low levels of LDL-C (i.e. < 0.65 mmol/L [< 25 mg/dL]) has not yet been established.
Maltese: Is-sigurtà fit-tul ta' livelli baxxi ħafna sostnuti ta' LDL-C (jiġifieri < 0.65 mmol/L [< 25 mg/dL]) għadha ma ġietx stabbilita.
English: TESLA was an international, multicentre, double-blind, randomised, placebo-controlled 12-week study in 49 homozygous familial hypercholesterolaemia patients aged 12 to 65 years.
Maltese: TESLA kien studju internazzjonali, multiċentriku, double-blind, randomised, ikkontrollat bi plaċebo ta' 12-il ġimgħa fuq 49 pazjent b'iperkolesterolemija familjali omozigota ta' età minn 12 sa 65 sena.
English: The pharmacokinetic interaction between statins and evolocumab was evaluated in the Repatha clinical trials.
Maltese: L-interazzjoni farmakokinetika bejn statins u evolocumab kienet evalwata fil-provi kliniċi dwar Repatha.
English: RUTHERFO RD-2
Maltese: RUTHERFORD-2
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 C) ma ġewx studjati (ara sezzjoni 5.2).
English: OLE Week 144 (n = 180)
Maltese: Ġimgħa 144 ta' OLE (n = 180)
English: The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population.
Maltese: Il-profil tas-sigurtà filpopolazzjoni b'iperkolesterolemija familjali omozigota kien konsistenti ma' dak muri fil-popolazzjoni b'iperkolesterolemija primarja u dislipidemija mħallta.
English: • Flu (high temperature, sore throat, runny nose, cough and chills)
Maltese: • Influwenza (temperatura għolja, griżmejn juġgħu, imnieħer inixxi, sogħla u bard)
English: Repatha was effective in all subgroups relative to placebo and ezetimibe, with no notable differences observed between subgroups, such as age, race, gender, region, body-mass index, National Cholesterol Education Program risk, current smoking status, baseline coronary heart disease (CHD) risk factors, family history of premature CHD, glucose tolerance status, (i.e. diabetes mellitus type 2, metabolic syndrome, or neither), hypertension, statin dose and intensity, unbound baseline PCSK9, baseline LDL-C and baseline TG.
Maltese: Repatha kien effettiv fis-sottogruppi kollha meta mqabbel mal-plaċebo u ma' ezetimibe, bl-ebda differenza notevoli osservata bejn sottogruppi, bħall-età, razza, sess, reġjun, indiċi tal-massa tal-ġisem, ir-riskju talProgramm Nazzjonali tal-Edukazzjoni dwar il-Kolesterol, l-istat attwali ta' tipjip, fatturi ta' riskju fillinja bażi ta' marda tal-koronarji tal-qalb (CHD - coronary heart disease), storja familjari ta' CHD prematura, l-istat tat-tolleranza tal-glukożju, (jiġifieri, dijabete mellitus tat-tip 2, sindrome metabolika, jew l-ebda minn dawn), pressjoni għolja, id-doża u l-intensità ta' statin, PCSK9 mhux marbut fil-linja bażi, LDL-C fil-linja bażi u TG fil-linja bażi.
English: Automated mini-doser Plastic cover
Maltese: Mini-doser awtomatizzat Għatu tal-plastik
English: Available data demonstrate that there are no clinically meaningful differences between the safety profiles of patients with LDL-C levels < 0.65 mmol/L and those with higher LDL-C, see section 4.8.
Maltese: Dejta disponibbli turi li ma hemm l-ebda differenzi klinikament sinifikanti bejn il-profili tas-sigurtà ta' pazjenti b'livelli ta' LDL-C < 0.65 mmol/L u dawk b'livelli aktar għoljin ta' LDL-C, ara sezzjoni 4.8.
English: OLE Week 48 (n = 187)
Maltese: Ġimgħa 48 ta' OLE (n = 187)
English: The effects of Repatha 420 mg once monthly on atherosclerotic disease burden, as measured by intravascular ultrasound (IVUS), were evaluated in a 78-week double-blind, randomised, placebo controlled study in 968 patients with coronary artery disease on a stable background of optimal statin therapy.
Maltese: L-effetti ta' Repatha 420 mg darba fix-xahar fuq il-piż tal-marda aterosklerotika, kif imkejjel permezz ta' ultrasound intravaskulari (IVUS - intravascular ultrasound), ġew evalwati fi studju double-blind, randomised, ikkontrollat bil-plaċebo ta' 78 ġimgħa f'968 pazjent b'marda tal-arterji koronarji f'ambjent stabbli ta' terapija ottimali ta' statins.
English: In 80-85% of all primary hyperlipidaemia patients treated with either dose, Repatha demonstrated a ≥ 50% reduction in LDL-C at the mean of weeks 10 and 12.
Maltese: Fi 80-85% tal-pazjenti kollha b'iperlipidemija primarja ttrattati b'waħda mid-dożi, Repatha wera tnaqqis ta' ≥ 50% fl-LDL-C fil-medja ta' ġimgħat 10 u 12.
English: 1 cartridge and automated mini-doser.
Maltese: Skartoċċ wieħed u mini-doser awtomatizzat.
English: Following a single 420 mg Repatha intravenous dose, the mean (SD) steady-state volume of distribution was estimated to be 3.3 (0.5) L, suggesting evolocumab has limited tissue distribution.
Maltese: Wara doża waħda ta' 420 mg Repatha ġol-vini, il-volum ta' distribuzzjoni medju (SD) fi stat fiss kien stmat bħala 3.3 (0.5) L, li jissuġġerixxi li evolocumab għandu distribuzzjoni limitata fit-tessuti.
English: A 3.5 mL solution in a single use cartridge made from cyclic olefin polymer with elastomer septum and piston as product-contact materials, and a resin cap.
Maltese: 3.5 mL ta' soluzzjoni fi skartoċċ li jintuża darba magħmul minn cyclic olefin polymer b'elastomer septum u pistun bħala materjali ta' kuntatt mal-prodott, u għatu tar-resin.
English: MACE+ (composite of MACE, coronary revascularisation, or hospitalisation for unstable angina) MACE (composite of CV death, MI, or stroke)
Maltese: MACE+ (kompost ta' MACE, rivaskularizzazzjoni tal-koronarji, jew dħul l-isptar minħabba anġina instabbli) MACE (kompost ta' mewt CV, MI, jew puplesija)
English: Medicine Syringe barrel
Maltese: Mediċina Tubu ċilindriku tas-siringa
English: Long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) (table 5).
Maltese: Użu fit-tul ta' Repatha wera effett sostnut tat-trattament kif muri minn tnaqqis fl-LDL-C f'pazjenti b'iperkolesterolemija familjali severa (non-HoFH) (tabella 5).
English: Key: HoFH = homozygous familial hypercholesterolaemia, QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo.
Maltese: HoFH = iperkolesterolemija familjali omozigota, QM = darba kull xahar, a valur nominali p < 0.001 meta mqabbel ma' plaċebo, b valur p < 0.001 mata mqabbel ma' plaċebo.
English: The exposure to evolocumab was found to be approximately 40-50% lower compared to healthy subjects.
Maltese: L-esponiment għal evolocumab instab li kien bejn wieħed u ieħor 40-50 % aktar baxx meta mqabbel ma' individwi f'saħħithom.
English: MARKETING AUTHORISATION NUMBER(S) Repatha 140 mg solution for injection in pre-filled syringe EU/1/15/1016/001 - 1 pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen EU/1/15/1016/002 - 1 pre-filled pen EU/1/15/1016/003 - 2 pre-filled pens EU/1/15/1016/004 - 3 pre-filled pens EU/1/15/1016/005 - 6 (3x2) pre-filled pens (multipack)
Maltese: Repatha 140 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/15/1016/002 - pinna mimlija għal-lest waħda EU/1/15/1016/003 - 2 pinen mimlija għal-lest
English: Population pharmacokinetic analysis indicated no appreciable differences in evolocumab serum concentrations in hypercholesterolaemic patients (nonfamilial hypercholesterolaemia or familial hypercholesterolaemia) taking concomitant statins.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ma indikat l-ebda differenzi apprezzabbli fil-konċentrazzjonijiet ta' evolocumab fis-serum f'pazjenti iperkolesterolemiċi (iperkolesterolemija mhux familjali jew iperkolesterolemija familjali) li kienu qegħdin jieħdu statins konkomitanti.
English: Administration of single subcutaneous dose 420 mg resulted in a Cmax mean (SD) of 46.0 (17.2) μg/mL and AUClast mean (SD) of 842 (333) day•μg/mL.
Maltese: L-għoti ta' doża waħda taħt il-ġilda ta' 420 mg wassal għal Cmax medja (SD) ta' 46.0 (17.2) μg/mL u AUCl-aħħar medja (SD) ta' 842 (333) jum•μg/mL.
English: N (n) = Number of evaluable patients (N) and patients with observed LDL values at specific schedule visit (n) in the HoFH final analysis set.
Maltese: N (n) = Numru ta' pazjenti li setgħu jiġu evalwati (N) u pazjenti b'valuri ta' LDL osservati matul vista speċifika skedata (n) fis-sett tal-analiżi finali ta' HoFH.
English: There are limited data available on the use of Repatha in the paediatric population.
Maltese: Hemm dejta limitata disponibbli dwar l-użu ta' Repatha fil-popolazzjoni pedjatrika.
English: Key: Q2W = once every 2 weeks, QM = once monthly, HMD = Primary hypercholesterolaemia and mixed dyslipidaemia, a p value < 0.05 when compared with ezetimibe, b p value < 0.001 when compared with ezetimibe, c nominal p value < 0.001 when compared with ezetimibe.
Maltese: Q2W = darba kull ġimagħtejn, QM = darba kull xahar, HMD = Iperkolesterolemija primarja u dislipidemija mħallta, a valur p < 0.05 meta mqabbel ma' ezetimibe, b valur p < 0.001 meta mqabbel ma' ezetimibe.
English: DESCARTES was an international, multicentre, double-blind, randomised, placebo-controlled, 52-week study in 901 patients with hyperlipidaemia who received diet alone, atorvastatin, or a combination of atorvastatin and ezetimibe.
Maltese: DESCARTES kien studju internazzjonali, multiċentriku, double-blind, randomised, u kkontrollat bilplaċebo ta' 52 ġimgħa fuq 901 pazjent b'iperlipidemija li rċevew dieta waħedha, atorvastatin, jew kombinazzjoni ta' atorvastatin u ezetimibe.
English: GAUSS-2 was an international, multicentre, double-blind, randomised, ezetimibe-controlled, 12-week study in 307 patients who were statin-intolerant or unable to tolerate an effective dose of a statin.
Maltese: GAUSS-2 kien studju internazzjonali, multiċentriku, double-blind, randomised, ikkontrollot b'ezetimibe ta' 12-il ġimgħa fuq 307 pazjenti li kienu intolleranti għal statins jew li ma setgħux jittolleraw doża effettiva ta' statin.
English: Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Maltese: Repatha huwa indikat f'adulti u adolexxenti ta' età minn 12-il sena 'il fuq li jbatu minn iperkolesterolemija familjali omozigota flimkien ma' terapiji oħra li jbaxxu l-lipidi.
English: Patient Population (N)
Maltese: Popolazzjoni ta' Pazjenti (N)
English: OLE Week 36 (n = 187)
Maltese: Ġimgħa 36 ta' OLE (n = 187)
English: Treatment of homozygous familial hypercholesterolaemia
Maltese: Trattament ta' iperkolesterolemija familjali omozigota
English: In TAUSSIG, long-term use of Repatha demonstrated a sustained treatment effect as evidenced by reduction of LDL-C of approximately 20% to 30% in patients with homozygous familial hypercholesterolaemia not on apheresis and approximately 10% to 30% in patients with homozygous familial hypercholesterolaemia on apheresis (table 7).
Maltese: Fi TAUSSIG, użu fit-tul ta' Repatha wera effett sostnut tat-trattament kif muri minn tnaqqis fl-LDL-C ta' madwar 20 % sa 30 % f'pazjenti b'iperkolesterolemija familjali omozigota li ma kinux qegħdin jagħmlu aferesi u ta' madwar 10 % sa 30 % f'pazjenti b'iperkolesterolemija familjali omozigota li kienu qegħdin jagħmlu aferesi (tabella 7).
English: • for adults or adolescents with homozygous familial hypercholesterolaemia the recommended starting dose is 420 mg once monthly.
Maltese: • għall-adulti jew adolexxenti b'iperkolesterolemija familjali omozigota d-doża rakkomandata talbidu hija 420 mg darba fix-xahar.
English: No difference in safety was observed between adolescent and adult patients with homozygous familial hypercholesterolaemia.
Maltese: Ma kienet osservata l-ebda differenza fis-sigurtà bejn pazjenti adolexxenti u adulti b'iperkolesterolemija familjali omozigota.
English: It is recommended that 12 and 13 year olds are supervised by an adult when they are using the automated mini-doser.
Maltese: Huwa rakkomandat li persuni ta' 12 u 13-il sena jiġu ssorveljati minn adult meta jużaw il-mini-doser awtomatizzat.
English: An approximate two to three-fold accumulation was observed in trough serum concentrations (Cmin (SD) 7.21 (6.6)) following 140 mg doses every 2 weeks or following 420 mg doses administered monthly (Cmin (SD) 11.2 (10.8)), and serum trough concentrations approached steady-state by 12 weeks of dosing.
Maltese: Kienet osservata akkumulazzjoni ta' madwar darbtejn sa tliet darbiet fil-konċentrazzjonijiet l-aktar baxxi fis-serum (Cmin (SD) 7.21 (6.6)) wara dożi ta' 140 mg kull ġimagħtejn jew wara dożi ta' 420 mg mogħtija kull xahar (Cmin (SD) 11.2 (10.8)), u l-konċentrazzjonijiet l-aktar baxxi fis-serum avviċinaw stat fiss wara12-il ġimgħa ta' dożaġġ.
English: INFORMATION IN BRAILLE Repatha 140 syringe
Maltese: INFORMAZZJONI BIL-BRAILLE Siringa ta' Repatha 140
English: Repatha 140 mg solution for injection in pre-filled syringe evolocumab
Maltese: Repatha 140 mg soluzzjoni għall-injezzjoni evolocumab
English: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Maltese: Repatha huwa indikat f'adulti b'iperkolesterolemija primarja (eterozigota familjali u mhux familjali) jew dislipidemija mħallta, bħala żieda mad-dieta:
English: Repatha significantly reduced LDL-C from baseline at week 12 and week 48 compared with control (nominal p < 0.001).
Maltese: Repatha naqqas LDL-C b'mod sinifikanti mil-linja bażi f'ġimgħa 12 u ġimgħa 48 meta mqabbel mal-kontroll (p nominali < 0.001).
English: Multipack: 6 (3 packs of 2) single use SureClick pre-filled pens.
Maltese: 6 (3 pakketti ta' 2) pinen mimlija għal-lest SureClick li jintużaw darba.
English: MENDEL-2 was an international, multicentre, double-blind, randomised, placebo and ezetimibecontrolled, 12-week study of Repatha in 614 patients with primary hypercholesterolaemia and mixed dyslipidaemia.
Maltese: MENDEL-2 kien studju internazzjonali, multiċentriku, double-blind, randomised, ikkontrollot bi plaċebo u b'ezetimibe ta' 12-il ġimgħa ta' Repatha f'614-il pazjent b'iperkolesterolemija primarja u dislipidemija mħallta.
English: There is limited experience with Repatha in paediatric patients.
Maltese: Hemm esperjenza limitata b'Repatha f'pazjenti pedjatriċi.
English: Marketing Authorisation Holder Amgen Europe B.V.
Maltese: FIS-SUQ Amgen Europe B.V.
English: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Repatha tested positive for binding antibody development.
Maltese: Fi studji kliniċi, 0.3% tal-pazjenti (48 minn 17,992 pazjent) ittrattati b'mill-inqas doża waħda ta' Repatha nstabu pożittivi għal żvilupp ta' antikorpi li jorbtu.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C from baseline to mean of weeks 10 and 12 as compared to placebo for the rosuvastatin and simvastatin groups (p < 0.05) and significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), compared with placebo and ezetimibe for the atorvastatin group (p < 0.001) (see tables 2 and 3).
Maltese: Repatha naqqas TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG u Lp(a) u żied HDL-C b'mod sinifikanti mil-linja bażi sa medja ta' ġimgħat 10 u 12 meta mqabbel mal-plaċebo għall-gruppi ta' rosuvastatin u simvastatin (p < 0.05) u naqqas TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 u Lp(a) b'mod sinifikanti, meta mqabbel mal-plaċebo u ma' ezetimibe għall-grupp ta' atorvastatin (p < 0.001) (ara tabelli 2 u 3).