FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking factor Xa, the medicine reduces the levels of thrombin in the blood and this reduces the risk of blood clots forming in blood vessels.
Maltese: Billi timblokka l-fattur Xa, il-mediċina tnaqqas il-livelli ta' trombina fid-demm u dan inaqqas ir-riskju li jiffurmaw emboli tad-demm fil-vażi.
English: This was considered an important concern given that the medicine was expected to be used in patients with serious underlying conditions for whom any episode of bleeding could have serious consequences, and Dexxience's long persistence in the body could complicate management of bleeding.
Maltese: Barra minn hekk, il-pazjenti li ġew ikkurati b'Dexxience kellhom aktar episodji ta' fsada minn dawk li ġew ikkurati bil-mediċina komparatur.
English: These patients may be at high risk of blood clots because of reduced mobility during their hospital treatment as well as other underlying conditions that increase the risk.
Maltese: Dawn il-pazjenti jistgħu jkunu f'riskju għoli ta' emboli tad-demm minħabba mobilità mnaqqsa waqt il-kura tagħhom l-isptar, kif ukoll kondizzjonijiet sottostanti oħra li jżidu r-riskju.
English: EMA/783154/2015 EMEA/H/C/004072
Maltese: EMEA/H/C/004072
English: The full EPAR and risk management plan summary for Pemetrexed Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Pemetrexed Accord jistgħu jinstabu fissit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Pemetrexed Accord is a ‘generic medicine'.
Maltese: Pemetrexed Accord huwa ‘mediċina ġenerika'.
English: Pemetrexed Accord contains the active substance pemetrexed.
Maltese: Pemetrexed Accord fih is-sustanza attiva pemetrexed.
English: Pemetrexed Accord pemetrexed
Maltese: Aktar informazzjoni dwar Pemetrexed Accord
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Accord.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Accord.
English: Pemetrexed Accord is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Accord huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers talpulmun:
English: The active substance in Pemetrexed Accord, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Accord, il-pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qed jiddividu ruħhom, bħaċ-ċelloli tal-kanċer) li jagħmlu parti mill-grupp tal‘antimetaboliti'.
English: Why is Pemetrexed Accord approved?
Maltese: Għaliex ġie approvat Pemetrexed Accord?
English: Pemetrexed Accord is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Pemetrexed Accord huwa disponibbli bħala trab li jsir f'soluzzjoni għal infużjoni (dripp) ġol-vina.
English: No additional studies were needed as Pemetrexed Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: L-ebda studju addizzjonali ma kien meħtieġ minħabba li Pemetrexed Accord huwa mediċina ġenerika li tingħata permezz ta' infużjoni u li fiha l-istess sustanza attiva bħal tal-mediċina ta' referenza, Alimta.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Accord.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jirċievu injezzjonijiet ta' vitamina
English: Because Pemetrexed Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Pemetrexed Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusin listess bħal dawk tal-mediċina ta' referenza.
English: When Pemetrexed Accord is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Accord jingħata ma' ċisplatina, mediċina ‘antiemetika' (biex tipprevjeni r-rimettar) u fluwidi (biex jipprevjenu d-diżidratazzjoni) għandhom jingħataw ukoll qabel jew wara d-doża ta' ċisplatina.
English: This means that Pemetrexed Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Pemetrexed Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem ta' Alimta.
English: How is Pemetrexed Accord used?
Maltese: Kif jaħdem Pemetrexed Accord?
English: A risk management plan has been developed to ensure that Pemetrexed Accord is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Pemetrexed Accord jintuża bl-aktar mod sigur possibbli.
English: Type (formulation)
Maltese: Tip (formulazzjoni)
English: linear (intra-articular)
Maltese: lineari (intra-artikulari)
English: Product
Maltese: Prodott
English: The review of gadolinium contrast agents was initiated on 17 March 2016 at the request of the European Commission, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' aġenti ta' kuntrast ta' gadolinju nbdiet fis-17 ta' Marzu 2016 fuq talba tal-Kummissjoni Ewropea, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: This review covers agents containing the following active substances: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide and gadoxetic acid.
Maltese: Din ir-reviżjoni tkopri aġenti li fihom is-sustanzi attivi li ġejjin: gadobenic acid, gadobutrol, gadodiamide, gadopentetic acid, gadoteric acid, gadoteridol, gadoversetamide u gadoxetic acid.
English: Artirem / Dotarem (gadoteric acid) macrocyclic (intra-articular) maintain Gadovist (gadobutrol)
Maltese: Artirem / Dotarem (gadoteric acid) makroċikliku (intra-artikulari) jinżamm Gadovist (gadobutrol)
English: Artirem / Dotarem (gadoteric acid) macrocyclic (i.v.)
Maltese: Artirem / Dotarem (gadoteric acid) makroċikliku (ġol-vini)
English: • All macrocyclic agents reviewed - gadobutrol, gadoteric acid and gadoteridol - also remain available.
Maltese: • L-aġenti makroċikliċi riveduti kollha - gadobutrol, gadoteric acid and gadoteridol - ukoll għadhom disponibbli.
English: Once injected, gadolinium interacts with the water molecules.
Maltese: Ladarba jiġi injettat, il-gadolinju jinteraġixxi mal-molekuli talilma.
English: OptiMARK (gadoversetamide) is the only gadolinium contrast agent that was authorised centrally via EMA in the EU.
Maltese: OptiMARK (gadoversetamide) huwa l-uniku aġent ta' kuntrast ta' gadolinju li ġie awtorizzat b'mod ċentrali permezz tal-EMA fl-UE.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations in March 2017.
Maltese: Ir-reviżjoni saret l-ewwel mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini li jintużaw millbniedem, li għamel sett ta' rakkomandazzjonijiet f'Marzu 2017.
English: On 20 July 2017, the European Medicines Agency (EMA) concluded its review of gadolinium contrast agents, confirming recommendations to restrict the use of some linear gadolinium agents used in MRI body scans and to suspend the authorisations of others.
Maltese: Fl-20 ta' Lulju 2017, l-Aġenzija Ewropea għall-Mediċini (EMA) ikkonkludiet ir-reviżjoni tagħha dwar aġenti ta' kuntrast ta' gadolinju, li kkonfermat rakkomandazzjonijiet biex jiġi ristrett l-użu ta' xi aġenti lineari ta' gadolinju użati fi skens MRI tal-ġisem u biex jiġu sospiżi l-awtorizzazzjonijiet ta' oħrajn.
English: • Data on stability, as well as in vitro and non-clinical studies, show that linear gadolinium agents release gadolinium from the ligand molecules to a greater extent than macrocyclic agents.
Maltese: • Data dwar l-istabbiltà, kif ukoll studji in vitro u mhux kliniċi, juru li aġenti ta' kuntrast ta' gadolinju lineari jirrilaxxaw gadolinium mill-molekuli ligandi sa limitu akbar mill-aġenti makroċikliċi.
English: • Healthcare professionals in the EU will be sent a letter with information about EMA's review of gadolinium contrast agents.
Maltese: • Il-professjonisti tal-kura tas-saħħa fl-UE sejrin jintbagħtu ittra b'informazzjoni dwar ir-reviżjoni talEMA ta' aġenti ta' kuntrast ta' gadolinju.
English: • Two intravenous linear agents - gadoxetic acid and gadobenic acid - remain available as these agents undergo hepatic uptake, and can be used for imaging poorly vascularised hepatic lesions, especially in delayed phase imaging, that cannot be adequately studied with other agents.
Maltese: • Żewġ aġenti lineari ġol-vini - gadoxetic acid and gadobenic acid - għadhom disponibbli peress li dawn l-aġenti jgħaddu minn teħid epatiku, u jistgħu jintużaw għal immaġni ta' leżjonijiet epatiċi vaskularizzati ħażin, speċjalment f'immaġni b'fażi mdewma, li ma jistgħux jiġu studjati b'mod adegwat b'aġenti oħra.
English: The final stage of the review procedure was the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Maltese: L-istadju finali tal-proċedura ta' reviżjoni kien l-adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE.
English: All other intravenous linear products (gadodiamide, gadopentetic acid and gadoversetamide) should be suspended in the EU.
Maltese: Il-prodotti lineari ġol-vini l-oħrajn kollha (gadodiamide, gadopentetic acid u gadoversetamide) għandhom jiġu sospiżi fl-UE.
English: Another class of gadolinium agents known as macrocyclic agents (gadobutrol, gadoteric acid and gadoteridol) are more stable and have a lower propensity to release gadolinium than linear agents.
Maltese: Klassi oħra ta' aġenti ta' gadolinju magħrufa wkoll bħala aġenti makroċikliċi (gadobutrol, gadoteric acid u gadoteridol) huma aktar stabbli u għandhom propensità aktar baxxa li jirrilaxxaw il-gadolinju minn aġenti lineari.
English: The final recommendations have been sent to the European Commission, which issued a final legally binding decision applicable in all EU Member States.
Maltese: Ir-rakkomandazzjonijiet finali ntbagħtu lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE.
English: • Gadolinium deposition in the brain has been confirmed by mass spectrometry and increases in signal intensity in brain tissue.
Maltese: • Id-depożitu ta' gadolinju fil-moħħ ġie kkonfermat minn spettrometrija ta' massa u żidiet fl-intensità tas-sinjal fit-tessut tal-moħħ.
English: The suspensions or restrictions on linear agents can be lifted if the companies concerned provide evidence of new benefits in an identified patient group that outweigh the risk of brain deposition or if the companies can modify their products so they do not release gadolinium significantly or cause its retention in tissues.
Maltese: Dawn il-prodotti jistgħu jibqgħu jintużaw fl-indikazzjonijiet attwali tagħhom iżda fid-dożi l-aktar baxxi li jistgħu jtejbu l-immaġni konsiderevolment u biss meta skens tal-ġisem mhux imtejba ma jkunux xierqa.
English: There is currently no evidence that gadolinium deposition in the brain has caused any harm to patients; however EMA has recommended restrictions and suspensions for some intravenous linear agents in order to prevent any risks that could potentially be associated with gadolinium brain deposition.
Maltese: Attwalment m'hemm l-ebda evidenza li d-depożitu ta' gadolinju fil-moħħ ikkawża xi ħsara lill-pazjenti; madankollu l-EMA rrakkomandat restrizzjonijiet u sospensjonijiet għal xi aġenti lineari ġol-vini sabiex tipprevjeni xi riskji li jistgħu potenzjalment jiġu assoċjati ma' depożitu ta' gadolinju fil-moħħ.
English: The full EPAR for Bortezomib Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Bortezomib Hospira jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Bortezomib Hospira is a ‘generic medicine'.
Maltese: Bortezomib Hospira huwa ‘mediċina ġenerika'.
English: For mantle cell lymphoma, Bortezomib Hospira is used in combination with rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: Għal limfoma taċ-ċelloli mantle, Bortezomib Hospira jintuża flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone.
English: The active substance in Bortezomib Hospira, bortezomib, is a proteasome inhibitor.
Maltese: Is-sustanza attiva f'Bortezomib Hospira, il-bortezomib, hija inibitur ta' proteasome.
English: When given into a vein, the solution is injected through a catheter (a thin sterile tube).
Maltese: Meta tingħata fil-vina, issoluzzjoni tiġi injettata minn ġo katiter (tubu sterili rqiq).
English: Bortezomib Hospira bortezomib
Maltese: Informazzjoni oħra dwar Bortezomib Hospira
English: The company provided data from the published literature on bortezomib.
Maltese: Il-kumpanija pprovdiet data minn dokumentazzjoni ppubblikata dwar bortezomib.
English: This is a summary of the European public assessment report (EPAR) for Bortezomib Hospira.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bortezomib Hospira.
English: Cancer cells are more sensitive than normal cells to the effects of proteasome inhibitors like bortezomib.
Maltese: Iċ-ċelloli tal-kanċer huma iżjed sensittivi miċ-ċelloli normali għall-effetti tal-inibituri tal-proteasome bħal bortezomib.
English: This means that Bortezomib Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU) called Velcade.
Maltese: Dan ifisser li Bortezomib Hospira huwa simili għall"mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) li tissejjaħ Velcade.
English: Bortezomib Hospira is a cancer medicine used to treat multiple myeloma, a blood cancer, in the following groups of patients:
Maltese: Bortezomib Hospira huwa mediċina kontra l-kanċer li tintuża għall-kura ta' majeloma multipla, kanċer fid-demm, fil-gruppi ta' pazjenti li ġejjin:
English: Why is Bortezomib Hospira approved?
Maltese: Għaliex ġie approvat Bortezomib Hospira?
English: In these patients, Bortezomib Hospira is used in combination with melphalan and prednisone;
Maltese: F'dawn il-pazjenti, Bortezomib Hospira jintuża flimkien ma' melphalan u prednisone;
English: No additional studies were needed as Bortezomib Hospira is a generic medicine that is given by injection and contains the same active substance as the reference medicine, Velcade.
Maltese: Ma kien meħtieġ lebda studju addizzjonali peress li Bortezomib Hospira huwa mediċina ġenerika mogħtija permezz ta' injezzjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Velcade.
English: Bortezomib Hospira is available in vials as a 3.5 mg powder to be made up into a solution for injection into a vein or under the skin.
Maltese: Bortezomib Hospira jiġi f'kunjetti bħala trab ta' 3.5 mg biex isir f'soluzzjoni għall-injezzjoni fil-vina jew taħt il-ġilda.
English: How has Bortezomib Hospira been studied?
Maltese: Kif ġie studjat Bortezomib Hospira?
English: Because Bortezomib Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Bortezomib Hospira huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee recommended that Bortezomib Hospira be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Bortezomib Hospira jkun approvat għall-użu fl-UE.
English: The company that markets Bortezomib Hospira will supply educational material to healthcare professionals on making up and giving the injection, calculating the dose, and prescribing and giving the correct treatment for patients receiving blood stem-cell transplantation.
Maltese: Il-kumpanija li tpoġġi Bortezomib Hospira fis-suq sejra tipprovdi materjal edukattiv lill-professjonisti fil-qasam tal-kura tas-saħħa dwar il-preparazzjoni u l-għoti tal-injezzjoni, il-kalkolu tad-doża, u lpreskrizzjoni u l-għoti tal-kura korretta għall-pazjenti li qed jirċievu trapjant taċ-ċelloli staminali taddemm.
English: What are the benefits and risks of Bortezomib Hospira?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Bortezomib Hospira?
English: How does Bortezomib Hospira work?
Maltese: Kif jaħdem Bortezomib Hospira?
English: At least 72 hours must pass between two doses of Bortezomib Hospira.
Maltese: Iridu jkunu għaddew minn tal-inqas 72 siegħa qabel ma tingħata doża oħra ta' Bortezomib Hospira.
English: (See section 6.6)
Maltese: (Ara taqsima 6.6).
English: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine France
Maltese: SANOFI CHIMIE 9 Quai Jules Guesde 94403 Vitry-sur-Seine Franza
English: Placebo N=9462
Maltese: Plaċebo N=9462
English: Number of events
Maltese: Numru ta' avvenimenti
English: Hazard ratio (95% CI) p-value
Maltese: Proporzjon ta' periklu (95% CI) p-value
English: Evaluation of Cardiovascular (CV) events
Maltese: Evalwazzjoni ta' avvenimenti Kardjovaskulari (CV)
English: Immunogenicity/ Anti-drug-antibodies (ADA)
Maltese: Immunoġeniċità/Antikorpi kontra l-mediċina (ADA - Anti-drug-antibodies)
English: Primary endpoint (MACEplus a)
Maltese: Punt finali primarju (MACE-plusa)
English: Praluent blocks a protein called PCSK9.
Maltese: Praluent jimblokka proteina msejħa PCSK9.
English: Hazard Ratio: 0.85 95% CI (0.78, 0.93)
Maltese: 95% CI (0.78, 0.93)
English: Placebo Alirocumab
Maltese: Plaċebo Alirocumab
English: For pre-filled pens Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
Maltese: Sanofi-Aventis Deutschland GmbH Industriepark Hoechst Brüningstraße 50
English: COMBO II (N=707)
Maltese: COMBO II (N=707) ALTERNATIVE (N=248)
English: Table 3: Efficacy of Alirocumab in ODYSSEY OUTCOMES (Overall Population)
Maltese: Tabella 3: L-Effikaċja ta' Alirocumab f'EFFETTI ODYSSEY (Popolazzjoni Totali)
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara taqsima 6.1.
English: Figure 1 Primary Composite Endpoint Cumulative Incidence Over 4 Years in ODYSSEY OUTCOMES
Maltese: Figura 1 L-Inċidenza Kumulattiva tal-Punt finali Primarju Kompost Fuq 4 Snin f'EFFETTI ODYSSEY
English: Clinical efficacy and safety in prevention of cardiovascular events
Maltese: Effikaċja klinika u sigurtà fil-prevenzjoni ta' avvenimenti kardjovaskulari
English: Date of first authorisation: 23 September 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 23 Settembru 2015
English: FH I and FH II studies
Maltese: FH I u FH II
English: Difference versus ezetimibe was statistically significant at week 24 for LDL-C, Total-C, Non-HDL-C, Apo B, and Lp(a).
Maltese: Id-differenza versus ezetimibe kienet sinifikanti b'mod statistiku f'ġimgħa 24 għal LDL-C, Total-C, Non-HDL-C, Apo B, u Lp(a).
English: Apo B Total-C Lp(a) TG
Maltese: Apo B 1.2 Total-C -0.3 Lp(a)
English: Manufacturer Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait France
Maltese: Sanofi Winthrop Industrie 1051 Boulevard Industriel 76580 Le Trait Franza
English: A multicentre, double-blind, placebo-controlled trial included 18,924 adult patients (9462 alirocumab; 9462 placebo) followed for up to 5 years.
Maltese: Prova kkontrollata bil-plaċebo, double-blind, u multiċentrika kienet tinkludi 18,924 pazjent adult (9462 alirocumab; 9462 plaċebo) li ġew segwiti sa 5 snin.
English: • itching (pruritus).
Maltese: • ħakk (prurite).
English: Blue cap
Maltese: Għatu blu
English: Hazard ratios were calculated posthoc; for all CV events, HR=0.91 (95% CI, 0.62 to 1.34); for MACE-plus, HR=0.52 (95% CI, 0.31 to 0.90).
Maltese: Proporzjonijiet ta' periklu kienu kkalkulati post-hoc; għall avvenimenti CV kollha, HR=0.91 (95% CI, 0.62 sa 1.34); għal MACE plus, HR=0.52 (95% CI, 0.31 sa
English: • the Praluent syringe
Maltese: • is-siringa Praluent
English: Excipients: histidine, sucrose, polysorbate 20, water for injections.
Maltese: Eċċipjenti: histidine, sucrose, polysorbate 20, ilma għall-injezzjonijiet.
English: • a puncture-resistant container (see Step B, 6).
Maltese: • kontenitur li ma jistax jittaqqab (ara Pass B, 6).
English: Effects of other medicinal products on alirocumab
Maltese: L-effetti ta' prodotti mediċinali oħra fuq alirocumab
English: Consequently, the frequency of these adverse events is qualified as "not known".
Maltese: Għaldaqstant, il-frekwenza ta' dawn l-avvenimenti avversi tikkwalifika bħala “mhux magħrufa”.
English: A total of 99.5% of patients were followed for survival until the end of the trial.
Maltese: Total ta' 99.5% tal-pazjenti ġew segwiti għal sopravivenza sal-aħħar tal-prova..
English: Alirocumab also reduced triglycerides (TG), and increased high-density lipoprotein cholesterol (HDL-C) and apolipoprotein A-1 (Apo A-1) as compared to placebo.
Maltese: Alirocumab naqqas ukoll it-trigliċeridi (TG - trigycerides), u żied il-kolesterol ta' lipoproteina ta' densità baxxa (HDL-C - high-density lipoprotein cholesterol) u l apolipoproteina A-1 (Apo A-1) meta mqabbel mal-plaċebo.
English: Combination therapy with a statin
Maltese: Terapija flimkien ma' statin
English: (75 milligrams per ml) or 150 milligrams (150 milligrams per ml) of alirocumab.
Maltese: (75 milligramma f'kull ml) jew 150 milligramma (150 milligramma f'kull ml) ta' alirocumab.
English: LDL-C values <25 mg/dL (<0.65 mmol/L)
Maltese: Valuri LDL-C <25 mg/dL (<0.65 mmol/L)
English: • a puncture-resistant container (see Step B, 8).
Maltese: • kontenitur li ma jistax jittaqqab (ara Pass B, 8).
English: This did not translate into a clinically meaningful difference in LDL-C lowering.
Maltese: Dan ma nbidilx f'differenza sinifikanti b'mod kliniku fit-tnaqqis ta' LDL-C.
English: • Praluent contains the active substance alirocumab.
Maltese: • Praluent fih is-sustanza attiva alirocumab.
English: CHD Event c
Maltese: Avveniment CHDc
English: Praluent 150 mg injection alirocumab
Maltese: Praluent 150 mg injezzjoni alirocumab
English: The LDLR also binds triglyceride-rich VLDL remnant lipoproteins and intermediate-density lipoprotein (IDL).
Maltese: densità intermedja (IDL - intermediate-density lipoprotein).
English: The index ACS event was a myocardial infarction in 83.2% of patients (34.6% STEMI, 48.6% NSTEMI) and an episode of unstable angina in 16.8% of patients.
Maltese: L-avveniment indiċi ACS kien infart mijokardijaku f'83.2% ta' pazjenti (34.6% STEMI, 48.6% NSTEMI) u episodjju ta' anġina li mhijiex stabbli f'16.8% ta' pazjenti.
English: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2) (see section 5.2).
Maltese: Fi studji kliniċi, kien hemm rappreżentazzjoni limitata ta' pazjenti b'indeboliment sever tal-kliewi (ddefinit bħala eGFR < 30 mL/min/1.73 m2) (ara taqsima 5.2).
English: LDL-C (ITT)
Maltese: LDL-C (ITT)a
English: 150 mg/ml 1 ml
Maltese: INDIVIDWALI 150 mg/ml
English: Praluent 75 mg injection alirocumab
Maltese: Praluent 75 mg injezzjoni alirocumab
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara taqsima 4.8 dwar kif għandhom jiġu rappurtati reazzjonijiet avversi.
English: Approximately 2615 (27.7%) of 9451 patients treated with alirocumab required dose adjustment to 150 mg Q2W.
Maltese: Madwar 2615 (27.7%) minn 9451 pazjent ittrattati b'alirocumab kellhom bżonn aġġustament fid-doża għal 150 mg Q2W.
English: Alirocumab binds to PCSK9.
Maltese: PCSK9.
English: The safety profile in ODYSSEY OUTCOMES was consistent with the overall safety profile described in the phase 3 controlled trials.
Maltese: ODYSSEY huwa konsistenti mal-rofil ta' sigurtà in ġenerali deskritt fil-provi kkontrollati ta' fażi 3.