FrancophonIA/ELRC3.0 huggingface dataset:
English: A substantial reduction of LDL-C was observed throughout the study, with achieved median LDL-C ranges of 0.8 to 0.9 mmol/L at each assessment; 25% of patients achieved a LDL-C concentration less than 0.5 mmol/L.
Maltese: Tnaqqis sostanzjali ta' LDL-C kien osservat matul l-istudju, b'firxa medjana ta' LDL-C milħuqa ta' 0.8 sa 0.9 mmol/L f'kull valutazzjoni; 25% tal-pazjenti kisbu konċentrazzjoni ta' LDL-C ta' inqas minn 0.5 mmol/L.
English: Fourteen adolescent patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia have been included in clinical trials.
Maltese: Erbatax-il pazjent adolexxenti b'età ta' ≥ 12 sa < 18-il sena b'iperkolesterolemija familjali omozigota ġew inklużi filprovi kliniċi.
English: LAPLACE-2 was an international, multicentre, double-blind, randomised, 12-week study in 1,896 patients with primary hypercholesterolaemia or mixed dyslipidaemia who were randomised to receive Repatha in combination with statins (rosuvastatin, simvastatin or atorvastatin).
Maltese: LAPLACE-2 kien studju internazzjonali, multiċentriku, double-blind, randomised ta' 12-il ġimgħa fuq 1,896 pazjent b'iperkolesterolemija primarja jew dislipidemija mħallta li kienu randomised biex jirċievu Repatha flimkien ma' statins (rosuvastatin, simvastatin jew atorvastatin).
English: No dose adjustment is necessary in patients with mild to moderate renal impairment, see section 4.4 for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment ħafif sa moderat tal-kliewi, ara sezzjoni 4.4 għal pazjenti b'indeboliment sever tal-kliewi (eGFR < 30 mL/min/1.73 m2).
English: Repatha 420 mg solution for injection in cartridge Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Maltese: Repatha 420 mg soluzzjoni għall-injezzjoni fi skartoċċ Kull skartoċċ fih 420 mg ta' evolocumab fi 3.5 mL ta' soluzzjoni (120 mg/mL).
English: Reduction in LDL-C from baseline at week 52 compared with placebo was consistent across background lipidlowering therapies optimised for LDL-C and cardiovascular risk.
Maltese: Tnaqqis fl-LDL-C mil-linja bażi f'ġimgħa 52 meta mqabbel mal-plaċebo kien konsistenti ma' terapiji fl-isfond li jbaxxu l-lipidi ottimizzati għal LDL-C u riskju kardjovaskulari.
English: Treatment effects were maintained as demonstrated by reduction in LDL-C from week 12 to week 104 in the open-label extension.
Maltese: L-effetti tat-trattament inżammu kif muri permezz ta' tnaqqis fl-LDL-C minn ġimgħa 12 sa ġimgħa 104 fl-estensjoni open label.
English: Pack sizes of one cartridge/automated mini-doser or multipack of three (3x1) cartridges/automated mini-dosers.
Maltese: Daqs tal-pakkett ta' skartoċċ wieħed/mini-doser awtomatizzat jew pakkett multiplu ta' tliet (3x1) skrataċ/mini-dosers awtomatizzati.
English: b 2-sided log-rank test stratified by randomisation stratification factors collected via IVRS.
Maltese: b test log-rank fuq żewġ naħat stratifikat bil-fatturi ta' stratifikazzjoni ta' randomisation miġbura permezz ta' IVRS.
English: Following repeat subcutaneous administration of 140 mg every 2 weeks, the 12-week trough concentrations were 147% higher and 70% lower in patients of 69 kg and 93 kg respectively, than that of the typical 81 kg subject.
Maltese: Wara għoti ripetut taħt il-ġilda ta' 140 mg kull ġimagħtejn, il-konċentrazzjonijiet laktar baxxi wara 12-il ġimgħa kienu 147 % ogħla u 70 % aktar baxxi f'pazjenti ta' 69 kg u 93 kg rispettivament, minn dawk ta' individwu tipiku li jiżen 81 kg.
English: Changes in unbound PCSK9 and serum lipoproteins were reversible upon discontinuation of Repatha.
Maltese: Bidliet f'PCSK9 mhux marbut u fil-lipoproteini fis-serum kienu riversibbli mal-waqfien ta' Repatha.
English: Window Medicine
Maltese: IL-PRODOTT MEDIĊINALI
English: L When the blue light flashes, the automated mini-doser is ready.
Maltese: L Meta d-dawl iteptep blu, il-mini-doser awtomatizzat huwa lest.
English: Myocardial infarction (fatal/non-fatal)
Maltese: Mewt kardjovaskulari Mortalità minn kull kawża Infart mijokardijaku (fatali/mhux fatali)
English: Effect of Repatha on LDL-C in patients with severe familial hypercholesterolaemia (non-HoFH) - mean percent change from baseline to OLE week 216 (and associated 95% CI)
Maltese: Effett ta' Repatha fuq LDL-C f'pazjenti b'iperkolesterolemija familjali severa (nonHoFH) - bidla perċentwali medja mil-linja bażi sa ġimgħa 216 ta' OLE (u Cl ta' 95 % assoċjat)
English: Repatha significantly reduced the risk of cardiovascular events defined as the composite of time to first CV death, MI, stroke, coronary revascularisation, or hospitalisation for unstable angina (see table 8); the Kaplan-Meier curves for the primary and key secondary composite endpoints separated at approximately 5 months (see figure 1 for the MACE three year Kaplan-Meier curve).
Maltese: Repatha naqqas b'mod sinifikanti r-riskju ta' avvenimenti kardjovaskulari definiti bħala kompost ta' żmien sal-ewwel mewt CV, MI, puplesija, rivaskularizzazzjoni tal-koronarji, jew dħul l-isptar għal anġina instabbli (ara tabella 8); il-kurvi Kaplan-Meier għall-punti finali komposti primarji u sekondarji ewlenin separati b'madwar 5 xhur (ara figura 1 għall-kurva Kaplan-Meier ta' MACE ta' tliet snin).
English: Subcutaneous regimens of 140 mg every 2 weeks and 420 mg once monthly were equivalent in average LDL-C lowering (mean of weeks 10 and 12) resulting in -72 to -57% from baseline compared with placebo.
Maltese: Korsijiet ta' injezzjonijiet taħt il-ġilda ta' 140 mg kull ġimagħtejn u 420 mg darba fix-xahar kienu ekwivalenti fit-tnaqqis medju tal-LDL-C (medja ta' ġimgħat 10 u 12) li rriżultaw fi tnaqqis ta' -72 sa57 % mil-linja bażi meta mqabbel mal-plaċebo.
English: • for adults with primary hypercholesterolaemia and mixed dyslipidaemia the dose is either 140 mg every two weeks or 420 mg once monthly.
Maltese: • għall-adulti b'iperkolesterolemija primarja u dislipidemija mħallta, id-doża hija 140 mg kull ġimagħtejn jew 420 mg darba fix-xahar.
English: Clear tray
Maltese: Trej trasparenti
English: OLE Week 96 (n = 180)
Maltese: Ġimgħa 9 6 ta' OLE (n = 180)
English: Repatha significantly reduced LDL-C compared with ezetimibe (p < 0.001).
Maltese: Repatha naqqas l-LDL-C b'mod sinifikanti meta mqabbel ma' ezetimibe (p < 0.001).
English: • Clear tray containing the automated mini-doser and cartridge
Maltese: • It-trej trasparenti li fih il-mini-doser awtomatizzat u l-iskartoċċ
English: This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Maltese: Din iż-żieda fit-tneħħija hija parzjalment medjata minn statins li jżidu l-konċentrazzjoni ta' Proprotein Convertase Subtilisin/Kexin Tip 9 (PCSK9) li ma kellux impatt ħażin fuq l-effett farmakodinamiku ta' evolocumab fuq il-lipidi.
English: Key: QM = once monthly, a nominal p value < 0.001 when compared with placebo, b p value < 0.001 when compared with placebo.
Maltese: Tifsira: QM = darba kull xhar, a valur nominali p < 0.001 meta mqabbel mal-plaċebo, b valur p < 0.001 meta mqabbel mal-plaċebo.
English: Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
Maltese: Repatha huwa indikat f'adulti b'mard kardjovaskulari aterosklerotiku stabbilit (infart mijokardijaku, puplesija jew marda tal-arterji periferali), biex inaqqas ir-riskju kardjovaskulari billi jbaxxi l-livelli ta' LDL-C, bħala żieda mal-korrezzjoni ta' fatturi oħra ta' riskju:
English: Repatha is composed solely of amino acids and carbohydrates as native immunoglobulin and is unlikely to be eliminated via hepatic metabolic mechanisms.
Maltese: Repatha huwa kompost biss minn aċidi amminiċi u karboidrati bħala immunoglobulina indiġena u x'aktarx ma jistax jiġi eliminat permezz ta' mekkaniżmi metaboliċi tal-fwied.
English: Repatha is a human IgG2 monoclonal antibody produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Maltese: IgG2 magħmul bl-użu ta' teknoloġija tat-tfassil tad-DNA f'ċelluli tal-ovarju tal-ħamster Ċiniż (CHO - Chinese hamster ovary).
English: In clinical trials, Repatha reduced unbound PCSK9, LDL-C, TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 in patients with primary hypercholesterolaemia and mixed dyslipidaemia.
Maltese: Fi provi kliniċi, Repatha naqqas PCSK9, LDL-C, TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG u Lp(a) mhux marbuta u żied HDL-C u ApoA1 f'pazjenti b'iperkolesterolemija primarja u dislipidemija mħallta.
English: In patients with primary hypercholesterolaemia or mixed dyslipidaemia on high dose statin, the systemic exposure of evolocumab was slightly lower than in subjects on low-to-moderate dose statin (the ratio of AUClast 0.74 [90% CI 0.29; 1.9]).
Maltese: F'pazjenti b'iperkolesterolemija primarja jew dislipidemija mħallta li qegħdin jieħdu doża għolja ta' statin, l-esponiment sistemiku għal evolocumab kien ftit inqas minn dak għal individwi fuq doża baxxa sa moderata ta' statin (il-proporzjon ta' AUCl-aħħar 0.74 [CI ta' 90 % 0.29; 1.9]).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each cartridge contains 420 mg of evolocumab in 3.5 mL of solution (120 mg/mL).
Maltese: Kull skartoċċ fih 420 mg ta' evolocumab fi 3.5 mL ta' soluzzjoni (120 mg/mL).
English: Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over The initial recommended dose is 420 mg once monthly.
Maltese: Iperkolesterolemija familjali omozigota f'adulti u adolexxenti ta' età minn 12-il sena 'l fuq Id-doża rakkomandata tal-bidu hija ta' 420 mg darba fix-xahar.
English: Coronary revascularisation
Maltese: Rivaskularizzazzjoni tal-koronarji
English: Repatha 420 mg once monthly, as an adjunct to other lipid-lowering therapies (e.g., statins, bile-acid sequestrants), significantly reduced LDL-C and ApoB at week 12 compared with placebo (p < 0.001) (table 6).
Maltese: Repatha 420 mg darba fix-xahar, bħala żieda ma' terapiji oħra li jbaxxu l-lipidi (eż., statins, sekwestranti tal-aċidu tal-bili), naqqas l-LDL-C u l-ApoB b'mod sinifikanti f'ġimgħa 12 meta mqabbel ma' plaċebo (p < 0.001) (tabella 6).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment ‘ħieles mis-sodium'.
English: Repatha is a medicine that lowers levels of 'bad' cholesterol, a type of fat, in the blood.
Maltese: Repatha huwa mediċina li tnaqqas il-livelli ta' kolesterol ‘ħażin', tip ta' xaħam, fid-demm.
English: Hypercholesterolaemia and mixed dyslipidaemia
Maltese: Iperkolesterolemija u dislipidemija mħallta
English: LDL-C reduction of approximately 55% to 75% was achieved with Repatha as early as week 1 and maintained during long-term therapy.
Maltese: Tnaqqis fl-LDL-C ta' madwar 55 % sa 75 % inkiseb permezz ta' Repatha sa mill-ewwel ġimgħa talgħoti u nżamm matul terapija fit-tul.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 from baseline to week 52 in OSLER and to week 48 in OSLER-2 compared with control (nominal p < 0.001).
Maltese: Repatha naqqas TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG u Lp(a), u żied HDL-C u ApoA1 b'mod sinifikanti mil-linja bażi sa ġimgħa 52 f'OSLER u sa ġimgħa 48 f'OSLER-2 meta mqabbel malkontroll (p nominali < 0.001).
English: Single 140 mg subcutaneous doses of Repatha were studied in 8 patients with mild hepatic impairment, 8 patients with moderate hepatic impairment and 8 healthy subjects.
Maltese: Dożi singoli ta' Repatha ta' 140 mg taħt il-ġilda ġew studjati fi 8 pazjenti b'indeboliment ħafif talfwied, 8 pazjenti b'indeboliment moderat tal-fwied u 8 individwi f'saħħithom.
English: Fourteen patients aged ≥ 12 to < 18 years with homozygous familial hypercholesterolaemia were included in clinical studies.
Maltese: Erbatax-il pazjent b'età ta' ≥ 12-il sena sa < 18-il sena b'iperkolesterolemija familjali omozigota kienu inklużi fl-istudji kliniċi.
English: Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation.
Maltese: Evolocumab jeħel b'mod selettiv ma' PCSK9 u jipprevjeni PCSK9 li jkun qiegħed jiċċirkola milli jeħel mar-riċettur tal-lipoproteini ta' densità baxxa (LDLR - low density lipoprotein receptor) fuq ilwiċċ taċ-ċelluli tal-fwied, u b'hekk tiġi evitata d-degradazzjoni ta' LDLR medjata minn PCSK9. Żieda fil-livelli ta' LDLR fil-fwied twassal għal tnaqqis assoċjat tal-kolesterol LDL (LDL-C - LDLcholesterol) fis-serum.
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at week 12 and week 52 compared with control (nominal p < 0.001).
Maltese: Repatha 420 mg darba fix-xahar naqqas l-LDL-C b'mod sinifikanti mil-linja bażi f'ġimgħa 12 u ġimgħa 52 meta mqabbel mal-kontroll (p nominali < 0.001).
English: Apart from a reduced T-cell Dependent Antibody Response in cynomolgus monkeys immunised with keyhole limpet haemocyanin (KLH) after 3 months of treatment with evolocumab, no adverse effects were observed in hamsters (up to 3 months) and cynomolgus monkeys (up to 6 months) at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Maltese: Apparti minn tnaqqis fir-Rispons tal-Antikorpi Dipendenti fuq iċ-ċelluli T f'xadini cynomolgus imlaqqma b'keyhole limpet haemocyanin (KLH) wara 3 xhur ta' trattament b'evolocumab, ma ġie osservat l-ebda effett avvers fil-ħamsters (sa 3 xhur) u f'xadini cynomolgus (sa 6 xhur) b'esponimenti ferm ogħla minn dawk f'pazjenti li jkunu qegħdin jieħdu evolocumab 420 mg darba fix-xahar.
English: Flashing Warning Light beep-beep-beep-beep-beep
Maltese: Dawl Iteptep beep-beep-beep
English: Other medicines and Repatha
Maltese: Mediċini oħra u Repatha
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: Step 3: Inject A Hold the PINCH.
Maltese: Pass 3: Injetta A Żomm il-QARSA.
English: The treatment effect was consistent across all subgroups (including age, type of disease, baseline LDL-C, baseline statin intensity, ezetimibe use, and diabetes) and was driven by a reduction in the risk of myocardial infarction, stroke and coronary revascularisation; no significant difference was seen on cardiovascular or all-cause mortality however the study was not designed to detect such a difference.
Maltese: L-effett tat-trattament kien konsistenti fis-sottogruppi kollha (inklużi l-età, tip ta' mard, LDL-C fil-linja bażi, intensità ta' statins fil-linja bażi, użu ta' ezetimibe u dijabete) u kien immexxi minn tnaqqis fir-riskju ta' infart mijokardijaku, puplesija u rivaskularizzazzjoni tal-koronarji; ma kienet osservata l-ebda differenza sinifikanti fil-mortalità kardjovaskulari jew minn kull kawża, madankollu l-istudju ma kienx iddisinjat biex tiġi osservata differenza bħal din.
English: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh class A).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment ħafif tal-fwied (Child-Pugh klassi A).
English: • The automated mini-doser and cartridge must be kept in the refrigerator (2ºC - 8ºC).
Maltese: • Il-mini-doser awtomatizzat u l-iskartoċċ għandhom jinżammu fil-friġġ (2ºC - 8ºC).
English: Clinical efficacy in primary hypercholesterolaemia and mixed dyslipidaemia
Maltese: Effikaċja klinika f'iperkolesterolemija primarja u dislipidemija mħallta
English: The review of all reported hypersensitivity reactions revealed a clear evidence of different clinical presentations of hypersensitivity associated with evolocumab.
Maltese: L-eżami mill-ġdid tar-reazzjonijiet ta' sensittività eċċessiva rrappurtati kollha żvela evidenza ċara ta' preżentazzjonijiet kliniċi differenti ta' sensittività eċċessiva assoċjati ma' evolocumab.
English: The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha.
Maltese: Il-preżenza ta' antikorpi li jorbtu kontra evolocumab ma kellha l-ebda impatt fuq il-profil farmakokinetiku, ir-rispons kliniku, jew is-sigurtà ta' Repatha.
English: Upper respiratory tract infection
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq
English: After reaching room temperature, all injections should be given within a 30 minute period.
Maltese: Wara li tilħaq it-temperatura tal-kamra, l-injezzjonijiet kollha għandhom jingħataw fi żmien 30 minuta.
English: 3 SureClick pre-filled pens.
Maltese: 3 pinen mimlija għal-lest SureClick.
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection in pre-filled syringe Repatha 140 mg solution for injection in pre-filled pen Repatha 420 mg solution for injection in cartridge
Maltese: Repatha 140 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Repatha 140 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Repatha 420 mg soluzzjoni għall-injezzjoni fi skartoċċ
English: Despite the very low levels of LDL-C achieved, no new safety issues were observed (see section 4.8); the frequencies of new onset diabetes and cognitive events were comparable in patients who achieved LDL-C levels < 0.65 mmol/L and those with higher LDL-C.
Maltese: Minkejja l-livelli baxxi ħafna ta' LDL-C miksuba, ma kinux osservati problemi ġodda ta' sigurtà (ara sezzjoni 4.8); il-frekwenzi ta' dijabete u avvenimenti konoxxittivi osservati għall-ewwel darba kienu komparabbli f'pazjenti li kisbu livelli ta' LDL-C < 0.65 mmol/L u dawk b'livell ta' LDL-C ogħla.
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo (p < 0.001).
Maltese: Repatha naqqas l-LDL-C b'mod sinifikanti mil-linja bażi sa medja ta' ġimgħat 10 u 12 meta mqabbel mal-plaċebo (p < 0.001).
English: Combination with a statin and statin with other lipid-lowering therapies
Maltese: Kombinazzjoni ma' statin u ma' statin flimkien ma' terapiji oħra li jbaxxu l-lipidi
English: Plunger rod
Maltese: Mhux korrett
English: A single subcutaneous administration of Repatha 140 mg or 420 mg resulted in maximum suppression of circulating unbound PCSK9 by 4 hours followed by a reduction in LDL-C reaching a mean nadir in response by 14 and 21 days, respectively.
Maltese: L-għoti ta' injezzjoni waħda taħt il-ġilda ta' Repatha 140 mg jew 420 mg wasslet għal soppressjoni massima ta' PCSK9 mhux marbut, li jkun qiegħed jiċċirkola wara 4 sigħat segwit minn tnaqqis f'LDL-C li jilħaq il-medja tal-aktar punt baxx fir-rispons wara 14 u 21 ġurnata, rispettivament.
English: There is limited experience with Repatha in patients with severe renal impairment (see section 4.4).
Maltese: Hemm esperjenza limitata b'Repatha f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 4.4).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 420 mg injection evolocumab
Maltese: U MNEJN GĦANDU JINGĦATA Repatha 420 mg injezzjoni evolocumab
English: Stretch method for belly
Maltese: Il-metodu tal-ġbid
English: Run a finger around the adhesive edges to secure it.
Maltese: Agħmel stikka jekk ikun hemm bżonn.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA (I) Kull siringa mimlija għal-lest fiha 140 mg ta' evolocumab f'1 mL ta' soluzzjoni.
English: Atherosclerotic regression was observed in 64.3% (95% CI 59.6, 68.7) and 47.3% (95% CI 42.6, 52.0) of patients who received Repatha or placebo respectively when measured by PAV.
Maltese: Rigressjoni aterosklerotika kienet osservata f'64.3% (CI ta' 95% 59.6, 68.7) u 47.
English: However, baseline PCSK9 levels and the degree and time course of PCSK9 neutralisation were found to be similar between patients with mild or moderate hepatic impairment and healthy volunteers.
Maltese: Madankollu, livelli ta' PCSK9 fil-linja bażi u l-livell u t-tul taż-żmien għal newtralizzazzjoni ta' PCSK9 instabu li huma simili fost pazjenti b'indeboliment ħafif jew moderat talfwied u voluntiera f'saħħithom.
English: Statin intolerant patients
Maltese: Pazjenti intolleranti għal statins
English: It is normal to see a drop of medicine at the end of the needle.
Maltese: Huwa normali li tara qatra tal-mediċina fit-tarf tal-labra.
English: Animal studies did not show any effects on fertility endpoints at area under the concentration time curve (AUC) exposure levels much higher than in patients receiving evolocumab at 420 mg once monthly (see section 5.3).
Maltese: Studji fuq l-annimali ma wrewx effetti fuq punti finali tal-fertilità f'livelli ta' esponiment skont l-erja taħt il-kurva taż-żmien meta mqabbel mal-konċentrazzjoni (AUC - area under the concentration time curve) li kienu ferm ogħla minn dawk f'pazjenti li jirċievu evolocumab b'doża ta' 420 mg darba fix-xahar (ara sezzjoni 5.3).
English: You can use:
Maltese: Iċċekkja li:
English: Medicine Always hold the pre-filled syringe by the syringe barrel.
Maltese: TUŻAX mediċina li jkun fadal fis-siringa użata.
English: The mutagenic potential of evolocumab has not been evaluated.
Maltese: Il-potenzjal mutaġeniku ta' evolocumab ma ġiex evalwat.
English: Key: Q2W = once every 2 weeks, QM = once monthly, HMD = Primary hypercholesterolaemia and mixed dyslipidaemia; HeFH = Heterozygous familial hypercholesterolaemia; a p value < 0.05 when compared with placebo.
Maltese: Q2W = darba kull ġimagħtejn, QM = darba kull xahar, HMD = Iperkolesterolemija primarja u dislipidemija mħallta;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON AUTOMATED MINI-DOSER (with blue box)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KARTUNA TA' PAKKETT MULTIPLU TA' MINI-DOSER AWTOMATIZZAT (b'kaxxa blu)
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 at week 52 compared with placebo (p < 0.001) (table 4).
Maltese: Repatha naqqsas TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG u Lp(a), u żied HDL-C u ApoA1 b'mod sinifikanti f'ġimgħa 52 meta mqabbel mal-plaċebo (p < 0.001) (tabella 4).
English: It is normal to see a drop of liquid at the end of the needle or yellow safety guard.
Maltese: Huwa normali li tara taqtira likwidu fit-tarf tal-labra jew fil-protezzjoni tas-sigurtà safra.
English: Treatment effects of Repatha compared with placebo in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to week 52 (%, 95% CI)
Maltese: Effetti tat-trattament b'Repatha meta mqabbel mal-plaċebo f'pazjenti b'iperkolesterolemija primarja u dislipidemija mħallta - bidla perċentwali medja mil-linja bażi sa ġimgħa 52 (%, CI ta' 95 %)
English: Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Maltese: Kull pinna mimlija għal-lest SureClick fiha 140 mg ta' evolocumab f'1 mL ta' soluzzjoni.
English: Each cartridge contains 420 mg of evolocumab in 3.5 mL
Maltese: Kull skartoċċ fih 420 mg ta' evolocumab fi 3.5 mL ta'
English: Repatha 420 mg solution for injection in cartridge evolocumab
Maltese: Repatha 420 mg soluzzjoni għall-injezzjoni fi skartoċċ evolocumab
English: • for adults with established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems) the dose is either 140 mg every two weeks or 420 mg once monthly.
Maltese: • għall-adulti b'mard kardjovaskulari aterosklerotiku stabbilit (storja ta' attakk tal-qalb, puplesija jew problemi fil-vini u/jew fl-arterji) id-doża hija 140 mg kull ġimagħtejn jew 420 mg darba fix-xahar.
English: • Flu-like symptoms
Maltese: TAS-SIMBOLI
English: Dry natural rubber
Maltese: Lastku naturali niexef
English: Grab here
Maltese: Proporzjon ta'