FrancophonIA/ELRC3.0 huggingface dataset:
English: Discontinuation of efavirenz/emtricitabine/tenofovir disoproxil therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4).
Maltese: Jekk Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jitwaqqaf f'pazjenti ko-infettati b'HIV u HBV, dawn il-pazjenti għandhom jiġu sorveljati mill-qrib għal taħrix tal-epatite (ara sezzjoni 4.4).
English: Antimycobacterials Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
Maltese: Rifabutin/Efavirenz (300 mg q.d./600 mg q.d.)
English: It is recommended that Efavirenz/Emtricitabine/Tenofovir disoproxil Krka be taken on an empty stomach since food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 4.8).
Maltese: Huwa rakkomandat li Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jittieħed fuq stonku vojt peress li l-ikel jista' jżid l-esponiment ta' efavirenz u jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjonijiet 4.4 u 4.8).
English: Prior PI-based regimen (N=34)
Maltese: Reġim ibbażat fuq il-PI filpassat (N=34)
English: If Efavirenz/Emtricitabine /Tenofovir disoproxil Krka is used with nephrotoxic medicinal products, renal function should be closely monitored according to the recommended schedule.
Maltese: Jekk Efavirenz/Emtricitabine/Tenofovir disoproxil Krka jintuża ma' prodotti mediċinali nefrotossiċi, il-funzjoni renali għandha tiġi monitorata mill-qrib skont l-iskeda rakkomandata.
English: Table 2: Adverse reactions associated with efavirenz/emtricitabine/tenofovir disoproxil listed by the component(s) of efavirenz/emtricitabine/tenofovir disoproxil to which the adverse reactions are attributable
Maltese: Tabella 2: Reazzjonijiet avversi assoċjati ma' efavirenz/emtricitabine/tenofovir disoproxil elenkati skont il-komponent(i) ta' efavirenz/emtricitabine/tenofovir disoproxil li għalihom irreazzjonijiet avversi huma attribwibbli
English: elevated serum AST and/or elevated serum ALT, hyperbilirubinaemia
Maltese: AST fis-serum għolja u/jew ALT fis-serum għolja, iperbilirubinimja transaminases miżjuda
English: Atazanavir/ritonavir/Efavirenz (400 mg q.d./200 mg q.d./600 mg q.d., all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg q.d./200 mg q.d./600 mg q.d., kollha mogħtija mal-ikel)
English: Vigabatrin/Efavirenz
Maltese: Acenocoumarol/Efavirenz
English: Other medicines used for HIV infection: The following protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or ritonavir boosted atazanavir or saquinavir.
Maltese: L-impedituri protease li ġejjin: darunavir, indinavir, lopinavir/ritonavir, ritonavir, jew atazanavir jew saquinavir imqawwija b'ritonavir.
English: Clinically significant interactions have not been found and would not be expected since the NRTIs are metabolised via a different route than efavirenz and would be unlikely to compete for the same metabolic enzymes and elimination pathways.
Maltese: Ma nstabux u m'għandhomx ikunu mistennija interazzjonijiet kliniċi sinifikanti billi l-NRTIs jiġu metabolizzati permezz ta' rotta differenti minn efavirenz u mhumiex probabbli li jikkompetu għallistess enzimi metaboliċi u mogħdijiet ta' tneħħija.
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Krka is and what it is used for What you need to know before you take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Krka Possible side effects
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka m'għandux jintuża waqt it-tqala ħlief meta jkun hemm bżonn speċifiku tat-trattament b'efavirenz/emtricitabine/tenofovir disoproxil minћabba lkundizzjoni klinika tal-mara.
English: Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and didanosine is not recommended (see section 4.4 and Table 1).
Maltese: L-għoti fl-istess ħin ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka u didanosine m'huwiex rakkomandat (ara sezzjoni 4.4 u Tabella 1).
English: Management
Maltese: Reżistenza
English: Medicines used to treat fungal infections (antifungals): Itraconazole or posaconazole.
Maltese: - Mediċini użati biex jittrattaw infezzjonijiet fungali (antifungali):
English: Administration of efavirenz capsules with a high fat meal increased the mean AUC and Cmax of efavirenz by 28% and 79%, respectively, compared to administration in a fasted state.
Maltese: Għoti ta' pilloli ta' efavirenz ma' ikla b'ħafna xaħam żied l-AUC medju u Cmax ta' efavirenz bi 28% u b'79%, rispettivament, meta mqabbla tal-għoti fi stat ta' sawm.
English: A reliable method of barrier contraception must be used in addition to hormonal contraceptives (see section 4.6).
Maltese: Għandu jintu¿a metodu affidabbli ta' kontraċezzjoni tat-tip barriera flimkien malkontraċettivi ormonali (ara sezzjoni 4.6).
English: Darunavir/ritonavir/Emtricitabine Interaction not studied.
Maltese: Darunavir/ritonavir/Emtricitabine L-interazzjoni ma ġietx studjata.
English: Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: Clarithromycin, rifabutin, rifampicin.
Maltese: Clarithromycin, rifabutin, rifampicin.
English: Co-administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka and sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir is not recommended since plasma concentrations of velpatasvir and voxilaprevir are expected to decrease following co-administration with efavirenz leading to reduced therapeutic effect of sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir (see section
Maltese: L-għoti flimkien ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka ma' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir mhux rakkomandat peress li l-konċentrazzjonijiet fil-plażma ta' velpatasvir u voxilaprevir huma mistennija li jonqsu wara għoti flimkien ma' efavirenz li jwasslu għal effett terapewtiku mnaqqas ta' sofosbuvir/velpatasvir jew sofosbuvir/velpatasvir/voxilaprevir (ara sezzjoni 4.5).
English: The administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka with food may increase efavirenz exposure and may lead to an increase in the frequency of adverse reactions (see sections 4.4 and 5.2).
Maltese: L-għoti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka mal-ikel jista' jżid l-esponiment għal efavirenz u jwassal għal żieda fil-frekwenza ta' reazzjonijiet avversi (ara sezzjonijiet 4.4 u 5.2).
English: Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours.
Maltese: Wara għoti orali, il-half-life ta' eliminazzjoni ta' emtricitabine hija madwar 10 sigħat.
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
Maltese: Maraviroc/Efavirenz (100 mg b.i.d./600 mg q.d.)
English: Discontinuation of efavirenz/emtricitabine/tenofovir disoproxil therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Maltese: It-twaqqif ta' terapija b'efavirenz/emtricitabine/tenofovir disoproxil f'pazjenti ko-infettati bl-HIV u l-HBV jista' jkun assoċjat ma' taħrix tal-epatite sever u akut.
English: Gabapentin/Efavirenz
Maltese: Warfarin/Efavirenz
English: The safety and efficacy of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka in children under the age of 18 years have not been established (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka fit-tfal taħt l-età ta' 18-il sena ma ġewx determinati s'issa (ara sezzjoni 5.2).
English: Rashes may be caused by Efavirenz/Emtricitabine/Tenofovir disoproxil Krka.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka).
English: Patients with a history of psychiatric disorders appear to be at greater risk of serious psychiatric adverse reactions listed in the efavirenz column of Table 2.
Maltese: Pazjenti bi storja ta' disturbi psikjatriċi jidhru li huma f'riskju akbar ta' reazzjonijiet avversi psikjatriċi serji elenkati fil-kolonna ta' efavirenz f'Tabella 2.
English: What Efavirenz/Emtricitabine/Tenofovir disoproxil Krka contains - The active substances are efavirenz, emtricitabine and tenofovir disoproxil.
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil Krka huwa kumbinazzjoni ta' doża-fissa ta' efavirenz, emtricitabine u tenofovir disoproxil.
English: There have also been post-marketing reports of severe depression, death by suicide, delusions psychosis-like behaviour, and catatonia.
Maltese: Kien hemm ukoll rapporti wara t-tqegħid fis-suq tal-prodott ta' depressjoni severa, mewt permezz ta' suwiċidju, delużjonijiet, imġiba tixbah il-psikożi, u katatonja.
English: Sofosbuvir/Velpatasvir/Voxilaprevi r (400 mg/100 mg/100 mg q.d.)
Maltese: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg q.d.) + Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
English: Efavirenz/emtricitabine/tenofovir disoproxil was administered on an empty stomach (see section 4.2).
Maltese: Efavirenz/Emtricitabine/Tenofovir disoproxil ngħata fuq stonku vojt (ara sezzjoni 4.2).
English: nephritis
Maltese: Treddigħ
English: Atazanavir/ritonavir/Efavirenz (400 mg q.d./100 mg q.d./600 mg q.d., all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg q.d./100 mg q.d./600 mg q.d., kollha mogħtija mal-ikel)
English: Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Krka prior to initiation of their first antiretroviral treatment regimen (see sections 4.4 and 5.1).
Maltese: Il-pazjenti ma jridux ikunu esperjenzaw falliment viroloġiku fuq xi terapija antiretrovirali preċedenti u jrid ikun magħruf li ma kellhomx forom tal-virus b'mutazzjonijiet li jagħtu reżistenza sinifikanti għal xi wieħed mit-tliet komponenti kontenuti f'Efavirenz/Emtricitabine/Tenofovir disoproxil Krka qabel ma jinbeda l-ewwel reġim ta' trattament antiretrovirali tagħhom (ara sezzjoni 4.4 u 5.1).
English: Tenofovir is primarily excreted by the kidneys by both filtration and an active tubular transport system with approximately 70 to 80% of the dose excreted unchanged in urine following intravenous administration.
Maltese: Tenofovir jiġi eliminat prinċipalment mill-kilwa kemm permezz ta' filtrazzjoni kif ukoll mis-sistema ta' trasport tubulari attiv b'bejn wieħed u ieħor b'70 sa 80% tad-doża eliminata mhux mibdula flawrina wara għoti ġol-vini.
English: */100 mg b.i.d./600 mg q.d.)
Maltese: 3 ijiem/600 mg q.d.)
English: Medicines used to prevent organ transplant rejection (also called immunosuppressants), such as cyclosporine, sirolimus or tacrolimus.
Maltese: - Mediċini użati għall-prevenzjoni tar-rifjut tat-trapjant ta' organu (imsejħa wkoll immunosoppressanti) bħal cyclosporine, sirolimus jew tacrolimus.
English: ANTICOAGULANTS Warfarin/Efavirenz Acenocoumarol/Efavirenz
Maltese: Vigabatrin/Efavirenz Gabapentin/Efavirenz
English: The administration of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka with food may increase efavirenz exposure (see section 5.2) and may lead to an increase in frequency of adverse reactions (see section 4.8).
Maltese: L-għoti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka mal-ikel jista' jżid l-esponiment għal efavirenz (ara sezzjoni 5.2) u jista' jwassal għal żieda fil-frekwenza tar-reazzjonijiet avversi (ara sezzjoni 4.8).
English: Cmax: ↓ 45% (↓ 25 to ↓ 59) (CYP3A4 induction)
Maltese: AUC: ↓ 52% (↓ 33 għal ↓ 66) Cmax: ↓ 45% (↓ 25 għal ↓ 59) (Induzzjoni ta' CYP3A4)
English: Co-administration with voriconazole.
Maltese: Voriconazole:
English: Uncommon suicide attempt
Maltese: Komuni ħafna astenja
English: Pharmacokinetic studies have not been performed with efavirenz/emtricitabine/tenofovir disoproxil in infants and children under 18 years of age (see section 4.2).
Maltese: Għadhom ma sarux studji farmakokinetiċi b'efavirenz/mmtricitabine/tenofovir disoproxil fuq trabi u tfal taħt l-età ta' 18-il sena (ara sezzjoni 4.2).
English: If your doctor decides to stop one of the components of Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, you may be given efavirenz, emtricitabine and/or tenofovir disoproxil separately or with other medicines for the treatment of your HIV infection.
Maltese: Jekk it-tabib tiegħek jiddeċiedi li jwaqqaf wieħed mill-komponenti ta' Efavirenz/Emtricitabine/Tenofovir disoproxil Krka, tista' tingħata efavirenz, emtricitabine u/jew tenofovir disoproxil separatament jew ma' mediċini oħra għat-trattament tal-infezzjoni tal-HIV tiegħek.
English: Clarithromycin/Tenofovir disoproxil
Maltese: Rosuvastatin/Tenofovir disoproxil
English: Findings in the rat and monkey studies indicated that there was a substance-related decrease in intestinal absorption of phosphate with potential secondary reduction in BMD.
Maltese: Sejbiet fl-istudji fuq il-firien u x-xadini indikaw li kien hemm tnaqqis konness mas-sustanza fl-assorbiment intestinali ta' phosphate b'potenzjali ta' tnaqqis sekondarju fil-BMD.
English: allergic reactions disturbances of coordination and balance feeling worried or depressed difficulty sleeping, abnormal dreams, difficulty concentrating, drowsiness pain, stomach pain problems with digestion resulting in discomfort after meals, feeling bloated, wind (flatulence) loss of appetite tiredness itching changes in skin colour including darkening of the skin in patches often starting on hands and soles of feet
Maltese: reazzjonijiet allerġiċi disturbi tal-koordinazzjoni u tal-bilanċ tħossok ansjuż jew depress diffikultà fl-irqad, holm anormali, diffikultà fil-konċentrazzjoni, ħedla uġigħ, uġigħ fl-istonku problemi bid-diġestjoni li jirriżultaw fi dwejjaq wara l-ikel, tħossok minfuħ, gass (flatulenza) telf ta' aptit għeja ħakk tibdil fil-kulur tal-ġilda inkluż swidija tal-ġilda fi rqajja' ta' spiss jibdew fuq l-idejn u l-qigħan tas-saqajn
English: Further information on Repatha can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Repatha contains the active substance evolocumab.
Maltese: Repatha fih is-sustanza attiva evolocumab.
English: Repatha received a marketing authorisation valid throughout the EU on 17 July 2015.
Maltese: Repatha rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-17 ta' Lulju 2015.
English: Other information about Repatha
Maltese: Informazzjoni oħra dwar Repatha
English: It is used to reduce blood fat levels in patients with primary hypercholesterolaemia (high blood cholesterol levels caused by a genetic abnormality), homozygous familial hypercholesterolaemia (a severe form of high blood cholesterol inherited from both parents) and mixed dyslipidaemia (abnormal levels of different fats, including cholesterol).
Maltese: Dan jintuża biex inaqqas il-livelli ta' xaħam fid-demm f'pazjenti b'iperkolesterolemija primarja (livelli ta' kolesterol għoli fid-demm ikkawżati minn anormalità ġenetika), iperkolesterolemija omożigotika familjali (forma severa ta' kolesterol għoli fid-demm li tintiret miż-żewġ ġenituri) u dislipidemija mħallta (livelli anormali ta' xaħmijiet differenti, inkluż kolesterol).
English: In the Repatha group, less than 10% (1,344 of 13,784 patients) had a cardiovascular event (meaning death, heart attack, stroke, hospitalization or surgery due to problems with the blood flow to the heart) during the study compared with just over 11% in the placebo group (1,563 of 13,780 patients).
Maltese: Fil-grupp ta' Repatha, inqas minn 10 % (1,344 mit-13,784 pazjent) kellhom avveniment kardjovaskulari (li jfisser mewt, attakk tal-qalb, puplesija, dħul fl-isptar jew kirurġija minħabba problemi bil-fluss tad-demm lejn il-qalb) waqt l-istudju meta mqabbel ma' ftit aktar minn 11 % biss filgrupp tal-plaċebo (1,563 mit-13,780 pazjent).
English: Repatha is available as a solution for injection in pre-filled syringes (140 mg), pre-filled pens (140 mg) and cartridges (420 mg).
Maltese: Repatha jiġi bħala soluzzjoni għall-injezzjoni f'siringi mimlijin għal-lest (140 mg), pinen mimlijin għallest (140 mg) u kartriġis (420 mg).
English: In primary hypercholesterolaemia and mixed dyslipidaemia, Repatha was studied in 9 main studies involving around 7,400 adult patients, including patients with heterozygous familial disease.
Maltese: F'iperkolesterolemija primarja u dislipidemija mħallta, Repatha ġie studjat f'9 studji ewlenin li involvew madwar 7,400 pazjent adult, inklużi pazjenti b'mard eterożigotiku familjali.
English: Repatha was studied in more than 27,500 patients with a history of established cardiovascular disease.
Maltese: Repatha ġie studjat f'aktar minn 27,500 pazjent bi storja ta' mard kardjovaskulari stabbilit.
English: What are the risks associated with Repatha?
Maltese: X'inhuma r-riskji assoċjati ma' Repatha?
English: The most common side effects with Repatha (which may affect up to 1 in 100 people) are nasopharyngitis (inflammation of the nose and throat), upper respiratory tract infection (nose and throat infection), back pain, joint pain, flu and reactions at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Repatha (li jistgħu jaffettwaw sa 1 minn kull 100) huma nażofarinġite (infjammazzjoni tal-imnieħer u l-griżmejn), infezzjoni tal-apparat respiratorju ta' fuq (infezzjoni tal-imnieħer u tal-griżmejn), uġigħ fid-dahar, uġigħ fil-ġogi, influwenza u reazzjonijiet fis-sit tal-injezzjoni.
English: These studies found a substantial reduction in blood levels of LDL-cholesterol (around 60 to 70% more than placebo, and of around 40% more than ezetimibe) from week 10 to week 12 of the study and at the end of 12 weeks.
Maltese: Dawn l-istudji sabu tnaqqis sostanzjali fillivelli ta' kolesterol-LDL fid-demm (madwar 60 sa 70% aktar mill-plaċebo, u madwar 40% aktar minn ezetimibe) minn ġimgħa 10 sa ġimgħa 12 u fl-aħħar tat-12-il ġimgħa.
English: For adults and children aged 12 years and above with homozygous familial hypercholesterolaemia, the initial recommended dose is 420 mg once a month.
Maltese: Għal adulti u tfal li għandhom 12-il sena u aktar b'iperkolesterolemija omożigotika familjali, id-doża rakkomandata inizjali hija ta' 420 mg darba fix-xahar.
English: With regard to safety, the Agency noted an acceptable safety profile and did not identify any substantial safety issue.
Maltese: Fir-rigward tas-sigurtà, l-Aġenzija nnutat profil tas-sigurtà aċċettabbli u ma identifikat ebda kwistjoni ta' sigurtà sostanzjali.
English: In homozygous familial hypercholesterolaemia, Repatha was studied in 2 main studies involving 155 patients, which included 14 children older than 12 years.
Maltese: F'iperkolesterolemija omożigotika familjali, Repatha ġie studjat f'2 studji ewlenin li involvew 155 pazjent, li kienu jinkludu 14-il wild li għandhom aktar minn 12-il sena.
English: One of these studies showed that Repatha given together with other fat-lowering medicines reduced fat levels in the blood after 12 weeks of treatment (around 15 to 32% more than placebo given on top of other fat-lowering medicines).
Maltese: Wieħed minn dawn l-istudji wera li Repatha mogħti flimkien ma' mediċini oħra li jnaqqsu x-xaħam naqqas il-livelli ta' xaħam fiddemm wara 12-il ġimgħa ta' kura (madwar 15 sa 32% aktar minn plaċebo mogħti bħala żieda ma' mediċini oħra li jnaqqsu x-xaħam).
English: The Agency noted that across all studies in patients with primary hypercholesterolaemia and mixed dyslipidaemia, Repatha showed an important reduction in LDLcholesterol levels, which is a known risk factor for cardiovascular disease.
Maltese: L-Aġenzija nnutat li fl-istudji kollha f'pazjenti b'iperkolesterolemija primarja u dislipidemija mħallta, Repatha wera tnaqqis importanti fil-livelli ta' kolesterol-LDL, li huwa fattur ta' riskju magħruf għal mard kardjovaskulari.
English: The recommended dose for adults with primary hypercholesterolaemia, mixed dyslipidaemia and atherosclerotic heart disease is either 140 mg every two weeks or 420 mg (the contents of three prefilled syringes or one cartridge) once a month.
Maltese: Id-doża rakkomandata għall-adulti b'iperkolesterolemija primarja, dislipidemija mħallta u mard tal-qalb aterosklerotiku hija jew ta' 140 mg kull ġimagħtejn jew 420 mg (il-kontenut ta' tliet siringi mimlijin minn għal-lest jew kartriġ wieħed) darba fix-xahar.
English: The active substance in Repatha, evolocumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to an enzyme called ‘PCSK9'.
Maltese: Is-sustanza attiva f'Repatha, evolocumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex tagħraf u teħel ma' enzima msejħa “PCSK9”. Din l-enzima teħel mar-riċetturi tal-kolesterol fuq il-wiċċ taċ-ċelloli tal-fwied u tikkawża l-assorbiment u t-tkissir ta' dawn ir-riċetturi ġewwa ċ-ċelloli.
English: What measures are being taken to ensure the safe and effective use of Repatha?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Repatha?
English: Some of the studies looked at Repatha taken on its own, while others studied Repatha in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins.
Maltese: Uħud mill-istudji ħarsu lejn Repatha meta jittieħed waħdu, filwaqt li oħrajn studjaw Repatha flimkien ma' mediċini oħra li jnaqqsu x-xaħam, inklużi pazjenti fuq id-dożi rakkomandati massimi ta' statini.
English: For the full list of side effects and restrictions with Repatha, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Repatha, ara l-fuljett ta' tagħrif.
English: In patients with atherosclerotic heart disease, Repatha reduced the number of cardiovascular events, in particular heart attacks and strokes.
Maltese: F'pazjenti b'mard tal-qalb aterosklerotiku, Repatha naqqas in-numru ta' avvenimenti kardjovaskulari, b'mod partikolari l-attakki tal-qalb u l-puplesiji.
English: Some studies compared Repatha with placebo (a dummy treatment) and others to another medicine (ezetimibe).
Maltese: Xi studji qabblu Repatha malplaċebo (kura finta) u oħrajn ma' mediċina oħra (ezetimibe).
English: It is also used to reduce the risk of heart problems in patients with atherosclerosis (thickened arterial walls) who have had a heart attack, stroke or other problems of the circulatory system (atherosclerotic heart disease).
Maltese: Dan jintuża wkoll biex inaqqas ir-riskju ta' problemi tal-qalb f'pazjenti b'aterosklerożi (ħitan arterjali aktar ħoxnin) li kellhom attakk tal-qalb, puplesija jew problemi oħra tas-sistema ċirkolatorja (mard talqalb aterosklerotiku).
English: By attaching and blocking PCSK9, Repatha prevents the receptors from being broken down and therefore increases their numbers on the cell surface, where they can attach to LDL-cholesterol and remove it from the bloodstream.
Maltese: Billi jeħel ma' PCSK9 u jimblokkah, Repatha jipprevjeni r-riċetturi milli jitkissru u għaldaqstant iżid in-numru tagħhom fuq il-wiċċ taċ-ċellola, fejn dawn jistgħu jeħlu mal-kolesterol-LDL u jneħħuh mill-fluss taddemm.
English: In this population, including some children above 12 years, Repatha showed a consistent reduction in LDLcholesterol levels beyond what can be achieved with existing fat-lowering medicines.
Maltese: F'din il-popolazzjoni, inkluż xi tfal li għandhom aktar minn 12-il sena, Repatha wera tnaqqis konsistenti fil-livelli ta' kolesterol-LDL aktar minn dak li jista' jinkiseb b'mediċini eżistenti li jnaqqsu x-xaħam.
English: How does Repatha work?
Maltese: Kif jaħdem Repatha?
English: Pharmaceutical form
Maltese: Qawwa Għamla farmaċewtika
English: Pack size
Maltese: 1 siringa
English: Content (concentration)
Maltese: Il-pakkett li jmiss mal-prodott Kontenut (konċentrazzjoni)
English: Primula root EMA/424238/2016
Maltese: 20 ta' Settembru 2016 EMA/424238/2016
English: Primula veris L. and/or Primula elatior (L.) Hill, radix
Maltese: Primula veris L. u/jew Primula elatior (L.) Hill, radix
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom20 September 2016 EMA/424238/2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom