FrancophonIA/ELRC3.0 huggingface dataset:
English: Established atherosclerotic cardiovascular disease in adults The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Maltese: Id-doża rakkomandata ta' Repatha hija 140 mg kull ġimagħtejn jew 420 mg darba fix-xahar; iż-żewġ dożi huma klinikament ekwivalenti.
English: Apply a plaster if needed.
Maltese: Applika stikk jekk ikun hemm bżonn.
English: The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive.
Maltese: L-apparat għall-għoti fih batteriji tas-silver oxide-zinc u jinkludi roqgħa li teħel magħmula minn tejp tal-polyester b'kolla tal-acrylate.
English: Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see section 5.3).
Maltese: Studji fl-annimali ma jindikawx effetti diretti jew indiretti rigward l-effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Treatment effects were sustained over 1 year as demonstrated by reduction in LDL-C from week 12 to week 52.
Maltese: Effetti tat-trattament kienu sostnuti fuq sena kif muri permezz ta' tnaqqis fl-LDL-C minn ġimgħa 12 sa ġimgħa 52.
English: Injection is complete when:
Maltese: L-injezzjoni tkun lesta meta:
English: Thigh
Maltese: Xhur
English: • Adult supervision is recommended for 12 and 13 year olds while using the automated mini-doser and cartridge.
Maltese: • Superviżjoni adulta hija rakkomandata għal persuni b'età ta' 12 u 13-il sena waqt li jużaw ilmini-doser awtomatizzat u l-iskartoċċ.
English: F Inspect medicine and syringe.
Maltese: F Spezzjona l-mediċina u s-siringa.
English: Effect of Repatha on major cardiovascular events
Maltese: L-effett ta' Repatha fuq avvenimenti kardjovaskulari maġġuri
English: Population pharmacokinetic analysis of integrated data from the Repatha clinical trials did not reveal a difference in pharmacokinetics of evolocumab in patients with mild or moderate renal impairment relative to non-renally impaired patients.
Maltese: Analiżi farmakokinetika tal-popolazzjoni ta' dejta integrata mill-provi kliniċi dwar Repatha ma żvelatx differenza fil-farmakokinetika ta' evolocumab f'pazjenti b'indeboliment ħafif jew moderat tal-kliewi meta mqabbla ma' pazjenti mingħajr indeboliment tal-kliewi.
English: Syringe barrel
Maltese: Labra użata
English: • Do not shake the automated mini-doser or cartridge.
Maltese: • Terġax tuża l-mini-doser awtomatizzat u l-iskartoċċ.
English: The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex, see section 4.4).
Maltese: L-għatu tal-labra tas-siringa mimlija għal-lest huwa magħmul minn lastku naturali niexef (derivattiv tal-latex, ara sezzjoni 4.4).
English: Treatment effects of Repatha compared with ezetimibe in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to average of weeks 10 and 12 (%, 95% CI)
Maltese: Tabella 3. Effetti tat-trattament b'Repatha meta mqabbel ma' ezetimibe f'pazjenti b'iperkolesterolemija primarja u dislipidemija mħallta - bidla perċentwali medja mil-linja bażi sa medja ta' ġimgħat 10 u 12 (%, CI ta' 95 %)
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with severe familial hypercholesterolaemia (non-HoFH).
Maltese: Tibdil f'parametri oħra tal-lipidi (TC, ApoB, non-HDL-C, TC/HDL-C, u ApoB/ApoA1) ukoll wera effett sostnut tal-għoti ta' Repatha fit-tul f'pazjenti b'iperkolesterolemija familjali severa (non-HoFH).
English: Cartridge
Maltese: Korrett
English: • The grey needle cap on the Repatha pre-filled syringe is composed of dry natural rubber, which is made from latex.
Maltese: • Żomm Repatha siringa mimlija għal-lest fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: Following a single 420 mg intravenous dose, the mean (SD) systemic clearance was estimated to be 12 (2) mL/hr.
Maltese: Wara doża waħda ta' 420 mg ġol-vini, it-tneħħija sistemika medja (SD) kienet stmata bħala 12 (2) mL/siegħa.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/007
Maltese: TAL-AWTORIZZAZZJONI TAT-TQEGĦID FIS-SUQ EU/1/15/1016/007
English: Long-term efficacy in primary hypercholesterolaemia and mixed dyslipidaemia
Maltese: Iperkolesterolemija primarja u dislipidemija mħallta fl-adulti
English: • The Repatha pre-filled syringe is to be stored in the refrigerator (2ºC to 8ºC).
Maltese: • Repatha siringa mimlija għal-lest għandu jinżamm fil-friġġ (2°C sa 8°C).
English: Step 4: Finish A Discard the used pre-filled pen and orange needle cap.
Maltese: Pass 4: Lesti A Armi l-pinna mimlija għal-lest użata u l-għatu oranġjo tal-labra.
English: Medicine window Pull tabs
Maltese: Tubu ċilindriku tassiringa
English: Used syringe barrel
Maltese: Protezzjoni tassigurtà safra
English: • You hear several beeps.
Maltese: • Tisma ħafna beeps.
English: Check that:
Maltese: Tista' tuża:
English: Use a new Repatha pre-filled syringe.
Maltese: ITTEKTIKX il-labra tas-siringa.
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 mean of weeks 10 and 12 compared to placebo (p < 0.05) (see table 2).
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 medja ta' ġimgħat 10 u 12 meta mqabbel mal-plaċebo (p < 0.05) (ara tabella 2).
English: In hamsters and cynomolgus monkeys at exposures much higher than patients receiving 420 mg evolocumab once monthly, no effect on male or female fertility was observed.
Maltese: Fil-ħamsters u xadini cynomolgus b'esponimenti ħafna ogħla minn pazjenti li jkunu qegħdin jieħdu 420 mg evolocumab darba fix-xahar, ma ġie osservat l-ebda effett fuq il-fertilità maskili jew femminili.
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo for the rosuvastatin and simvastatin groups and compared with placebo and ezetimibe for the atorvastatin group (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 għall-gruppi ta' rosuvastatin u simvastatin u meta mqabbel mal-plaċebo u ma' ezetimibe għall-grupp ta' atorvastatin (p < 0.001).
English: • Do not shake the automated mini-doser and cartridge.
Maltese: • Terġax tuża l-mini-doser awtomatizzat.
English: • Injection site reactions, such as bruising, redness, bleeding, pain or swelling
Maltese: • Reazzjonijiet fil-post tal-injezzjoni, bħal tbenġil, ħmura, fsada, uġigħ jew nefħa
English: With the cap off, place the yellow end of the pre-filled pen on the skin at 90 degrees.
Maltese: Daħħal il-labra fil-ġilda billi tuża angolu ta' 45 sa 90 grad.
English: No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha at 420 mg once monthly.
Maltese: Ma kinux osservati effetti avversi fi studji fuq l-annimali b'esponimenti sa 300 darba ogħla minn dawk f'pazjenti ttrattati b'Repatha 420 mg darba fix-xahar.
English: For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Maltese: Għar-riżultati tal-istudju rigward l-effetti fuq LDL-C, avvenimenti kardjovaskulari u l-popolazzjonijiet studjati ara sezzjoni 5
English: • The medicine in the pre-filled syringe is clear and colourless to slightly yellow.
Maltese: • Il-mediċina fis-siringa mimlija għal-lest hija trasparenti u mingħajr kulur sa ftit safranija.
English: Cardiovascular risk reduction in adults with established atherosclerotic cardiovascular disease
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/006
Maltese: TAL-AWTORIZZAZZJONI TAT-TQEGĦID FIS-SUQ EU/1/15/1016/006
English: For instructions on administration, see section 6.6 and the ‘Instructions for Use' provided in the carton.
Maltese: Għal istruzzjonijiet dwar l-għoti, ara sezzjoni 6.6 u l-‘Istruzzjonijiet għall-Użu' ipprovduti fil-kaxxa.
English: Repatha 140 mg solution for injection in pre-filled syringe The needle cover of the glass pre-filled syringe is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Maltese: Repatha 140 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest L-għatu tal-labra tas-siringa mimlija għal-lest tal-ħġieġ huwa magħmul minn lastku naturali niexef (derivattiv tal-latex), li jista' jikkawża reazzjonijiet allerġiċi.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared to ezetimibe (p < 0.001) (see table 3).
Maltese: Repatha naqqas TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 u Lp(a), b'mod sinifikanti mil-linja bażi sa medja ta' ġimgħat 10 u 12 meta mqabbel ma' ezetimibe (p < 0.001) (ara tabella 3).
English: Repatha 420 mg once monthly significantly reduced LDL-C from baseline at 52 weeks compared with placebo (p < 0.001).
Maltese: Repatha 420 mg darba fix-xahar naqqas l-LDL-C b'mod sinifikanti mil-linja bażi f'ġimgħa 52 meta mqabbel mal-plaċebo (p < 0.001).
English: To avoid discomfort at the site of injection, allow the medicine to reach room temperature (up to 25ºC) before injecting.
Maltese: Biex jiġi evitat skonfort fis-sit talinjezzjoni, ħalli l-mediċina tilħaq it-temperatura tal-kamra (sa 25°C) qabel ma tinjettaha.
English: • The Repatha pre-filled pen is to be stored in the refrigerator (2ºC to 8ºC).
Maltese: • Repatha pinna mimlija għal-lest għandu jinżamm fil-friġġ (2°C sa 8°C).
English: Treatment effects were maintained over 272 weeks as demonstrated by reduction in LDL-C from week 12 in the parent study to week 260 in the open-label extension.
Maltese: Leffetti tat-trattament inżammu tul 272 ġimgħa kif muri permezz ta' tnaqqis fl-LDL-C minn ġimgħa 12 fl-istudju “oriġinali” sa ġimgħa 260 fl-estensjoni open-label.
English: • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or,
Maltese: • waħdu jew flimkien ma' terapiji oħra li jbaxxu l-lipidi f'pazjenti li huma intolleranti għal statins,
English: Pharmacotherapeutic group: Other lipid modifying agents.
Maltese: Agħżel post differenti kull darba li tinjetta lilek innifsek.
English: Shake the Repatha pre-filled syringe.
Maltese: Mhux magħruf jekk Repatha jinstabx fil-ħalib tas-sider.
English: No studies on pharmacokinetic and pharmacodynamics interaction between Repatha and lipidlowering drugs other than statins and ezetimibe have been conducted.
Maltese: Ma sarux studji dwar l-interazzjoni farmakokinetika u farmakodinamika bejn Repatha u mediċini li jbaxxu l-lipidi minbarra statins u ezetimibe.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/005
Maltese: TAL-AWTORIZZAZZJONI TAT-TQEGĦID FIS-SUQ EU/1/15/1016/005
English: An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins.
Maltese: Żieda ta' madwar 20 % fit-tneħħija ta' evolocumab ġiet osservata f'pazjenti li ngħataw ukoll statins.
English: Expiry date
Maltese: DATA TA' SKADENZA
English: • Plaster
Maltese: • Stikka
English: Use a new automated mini-doser and cartridge.
Maltese: Uża mini-doser awtomatizzat u skartoċċ ġodda.
English: Population (N)
Maltese: n (%)
English: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL-C reduction.
Maltese: F'pazjenti b'indeboliment moderat tal-fwied, ġie osservat tnaqqis fl-esponiment totali għal evolocumab li jista' jwassal għal effett imnaqqas fuq it-tnaqqis tal-LDL-C.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Repatha 140 mg injection evolocumab
Maltese: U MNEJN GĦANDU JINGĦATA Repatha 140 mg injezzjoni evolocumab
English: • an adult with a high cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial] or mixed dyslipidaemia).
Maltese: • persuna adulta li għandek livell ta' kolesterol għoli fid-demm (iperkolesterolemija primarja [eterozigota familjali u mhux familjali] jew dislipidemija mħallta).
English: Repatha 420 mg solution for injection in cartridge
Maltese: Repatha 420 mg soluzzjoni għall-injezzjoni fi skartoċċ
English: Less impact from body weight was seen with repeated subcutaneous evolocumab 420 mg monthly doses.
Maltese: Impatt inqas minħabba l-piż tal-ġisem ġie osservat b'dożi ripetuti ta' evolocumab 420 mg taħt il-ġilda kull xahar.
English: Instructions for use: Repatha single use SureClick pre-filled pen
Maltese: Il-professjonisti tal-kura tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Repatha 140 mg solution for injection in pre-filled syringe 3 years.
Maltese: Repatha 140 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest 3 snin.
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Maltese: Il-metaboliżmu u leliminazzjoni tiegħu huma mistennija li jsegwu r-rotot ta' tneħħija tal-immunoglobulini, li jwassal għal degradazzjoni f'peptidi żgħar u aċidi amminiċi individwali.
English: The use of Repatha has not been studied in children under 12 years of age being treated for homozygous familial hypercholesterolaemia.
Maltese: L-użu ta' Repatha ma ġiex studjat fi tfal taħt it-12-il sena li qed jiġu trattati għal iperkolesterolemija familjali omozigota.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for evolocumab, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal evolocumab, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Correct
Maltese: RESPONSABBLI
English: Treatment effects of Repatha compared with placebo in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to week 12 (%, 95% CI)
Maltese: Effetti tat-trattament b'Repatha meta mqabbel mal-plaċebo f'pazjenti b'iperkolesterolemija familjali omozigota - bidla perċentwali medja mil-linja bażi sa ġimgħa 12 (%, CI ta' 95 %)
English: • Hives, red itchy bumps on your skin (urticaria)
Maltese: • Ħorriqija, ħotob ħomor u li jikluk fuq il-ġilda tiegħek (urtikarja)
English: Effect of Repatha on LDL-C in patients with homozygous familial hypercholesterolaemia - 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 omozigotabidla perċentwali medja mil-linja bażi sa ġimgħa 216 ta' OLE (u Cl ta' 95 % assoċjat)
English: • It is normal to see a few drops of fluid on your skin after you remove the used automated mini doser.
Maltese: • Huwa normali li tara ftit qtar ta' fluwidu fuq il-ġilda tiegħek wara li tneħħi l-mini-doser awtomatizzat użat.
English: 4.5 Interaction with other medicinal products and other forms of interaction No formal drug-drug interaction studies have been conducted for Repatha.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma twettaq l-ebda studju formali ta' interazzjoni bejn mediċina u oħra għal Repatha.
English: Step 1: Prepare A Remove the Repatha pre-filled syringe carton from the refrigerator and wait 30 minutes.
Maltese: A Oħroġ il-pakkett ta' Repatha siringa mimlija għal-lest mill-friġġ u stenna 30 minuta.
English: White plunger
Maltese: Bastun li jimbotta l-mediċina (plunger rod)
English: Cartridge bottom Medicine
Maltese: Bastun li jimbotta l-mediċina
English: An approximately 20% increase in the clearance is in part mediated by statins increasing the concentration of PCSK9 which did not adversely impact the pharmacodynamic effect of evolocumab on lipids.
Maltese: Żieda ta' madwar 20 % fit-tneħħija hija parzjalment medjata minn statins li jżidu l-konċentrazzjoni ta' PCSK9 li ma kellhiex impatt ħażin fuq l-effett farmakodinamiku ta' evolocumab fuq il-lipidi.
English: Changes in other lipid parameters (TC, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a treatment effect of Repatha administration in patients with homozygous familial hypercholesterolaemia.
Maltese: Tibdil f'parametri oħra tal-lipidi (TC, non-HDL-C, TC/HDL-C, u ApoB/ApoA1) ukoll wera effett tat-trattament tal-għoti ta' Repatha f'pazjenti b'iperkolesterolemija familjali omozigota.
English: Changes in other lipid parameters (TC, ApoB, non-HDL-C, TC/HDL-C, and ApoB/ApoA1) also demonstrated a sustained effect of long-term Repatha administration in patients with homozygous familial hypercholesterolaemia.
Maltese: Tibdil f'parametri oħra tal-lipidi (TC, ApoB, non-HDL-C, TC/HDL-C, u ApoB/ApoA1) ukoll wera effett sostnut ta' għoti fit-tul ta' Repatha f'pazjenti b'iperkolesterolemija familjali omozigota.
English: • Do not reuse the automated mini-doser.
Maltese: • Taqlax l-iskartoċċ użat minn mal-mini-doser awtomatizzat.
English: Evolocumab was not carcinogenic in hamsters at exposures much higher than patients receiving evolocumab at 420 mg once monthly.
Maltese: Evolocumab ma kienx karċinoġeniku fil-ħamsters b'esponimenti ħafna ogħla minn dawk f'pazjenti li jkunu qegħdin jieħdu evolocumab 420 mg darba fix-xahar.
English: Following a single subcutaneous dose of 140 mg or 420 mg Repatha administered to healthy adults, median peak serum concentrations were attained in 3 to 4 days.
Maltese: Wara doża waħda taħt il-ġilda ta' 140 mg jew 420 mg Repatha mogħtija lill-adulti f'saħħithom, konċentrazzjonijiet medjana massimi fis-serum intlaħqu fi żmien 3 sa 4 ijiem.
English: • 12 years and older with a high cholesterol level in your blood because of a condition that runs in your family (homozygous familial hypercholesterolaemia or HoFH).
Maltese: • għandek 12-il sena jew iktar u għandek livell għoli ta' kolesterol fid-demm tiegħek minħabba kondizzjoni ġenetika fil-familja tiegħek (iperkolesterolemija familjali omozigota jew HoFH [homozygous familial hypercholesterolaemia]).
English: • an adult with a high cholesterol level in your blood and established atherosclerotic cardiovascular disease (a history of heart attack, stroke or blood vessel problems).
Maltese: • adult b'livell għoli ta' kolesterol fid-demm tiegħek u mard kardjovaskulari aterosklerotiku stabbilit (storja ta' attakk tal-qalb, puplesija jew problemi fil-vini u/jew fl-arterji).
English: • Do not insert the cartridge more than 5 minutes before injection.
Maltese: • Iddaħħalx il-iskartoċċ aktar minn 5 minuti qabel l-injezzoni.
English: Before you use the automated mini-doser and cartridge for use with Repatha, read this important information:
Maltese: Qabel ma tuża il-mini-doser awtomatizzat u skartoċċ għall-użu ma' Repatha, aqra' din linformazzjoni importanti:
English: • The used automated mini-doser will beep when removed from your skin.
Maltese: • Il-mini-doser awtomatizzat użat se jibbipja meta jitneħħa minn mal-ġilda tiegħek.
English: DO NOT: twist or bend the grey needle cap.
Maltese: Mhix disponibbli dejta dwar l-effett ta' evolocumab fuq il-fertilità tal-bniedem.
English: This leaflet was last revised in.
Maltese: Iċċekkja d-data ta' skadenza.
English: LDL-C and other lipid parameters returned to baseline within 12 weeks after discontinuation of Repatha at the beginning of OSLER or OSLER-2 without evidence of rebound.
Maltese: L-LDL-C u parametri oħra tal-lipidi reġgħu lura għal-linja bażi fi żmien 12-il ġimgħa wara l-waqfien ta' Repatha fil-bidu ta' OSLER jew OSLER-2 mingħajr evidenza ta' konsegwenzi ta' livelli għola milli bdew.
English: Patients were randomised 1:1 to either Repatha (140 mg every two weeks or 420 mg once every month) or matching placebo; the mean duration of patient follow-up was 26 months.
Maltese: Il-pazjenti kienu randomised 1:1 għal Repatha (140 mg kull ġimagħtejn jew 420 mg darba fix-xahar) jew plaċebo li jaqbel; it-tul medjan tal-visti ta' segwitu tal-pazjent kien ta' 26 xahar.
English: The intended pharmacological effect of decreased serum LDL-C and total cholesterol were observed in these studies and was reversible upon cessation of treatment.
Maltese: L-effett farmakoloġiku maħsub ta' tnaqqis tal-LDL-C fis-serum u fil-kolesterol totali ġie osservat f'dawn listudji u kien riversibbli wara l-waqfien tat-trattament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1016/002
English: Nasopharyngitis
Maltese: Konklużjonijiet xjentifiċi
English: Further information on Zynquista can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynquista.
Maltese: ema.europa.eu/medicines/human/EPAR/zynquista.
English: Zynquista is available as 200 mg tablets.
Maltese: Zynquista jiġi bħala pilloli ta' 200 mg.
English: Zynquista contains the active substance sotagliflozin.
Maltese: Zynquista fih is-sustanza attiva sotagliflożina.
English: Other information about Zynquista
Maltese: Informazzjoni oħra dwar Zynquista
English: The active substance in Zynquista, sotagliflozin, blocks the action of two proteins known as glucose transporters (SGLT1 and SGLT2) which are found in the intestine and the kidneys.
Maltese: Is-sustanza attiva f'Zynquista, is-sotagliflożina, timblokka l-azzjoni ta' żewġ proteini magħrufa bħala trasportaturi tal-glukożju (SGLT1 u SGLT2) li jinsabu fl-intestin u fil-kliewi.
English: Adding Zynquista 200 or 400 mg to insulin led to a reduction in HbA1c levels of about 0.4 percentage points after 24 weeks of treatment, compared with almost no reduction in HbA1c levels after adding placebo to insulin.
Maltese: Iż-żieda ta' Zynquista 200 jew 400 mg mal-insulina wasslet għal tnaqqis fillivelli tal-HbA1c ta' madwar 0.4 punti perċentwali wara 24 ġimgħa ta' kura, meta mqabbel ma' kważi lebda tnaqqis fil-livelli tal-HbA1c wara ż-żieda ta' plaċebo mal-insulina.
English: In two of these studies, involving a total of 1,575 patients, two doses of Zynquista (200 and 400 mg) were compared with placebo when given in addition to insulin.
Maltese: Fi tnejn minn dawn l-istudji, li involvew total ta' 1,575 pazjent, żewġ dożi ta' Zynquista (200 u 400 mg) tqabblu ma' plaċebo meta ngħataw flimkien mal-insulina.
English: What are the risks associated with Zynquista?
Maltese: X'inhuma r-riskji assoċjati ma' Zynquista?
English: In the third study involving 1,405 patients, only the higher dose of Zynquista (400 mg) was studied.
Maltese: Fit-tielet studju li kien jinvolvi 1,405 pazjent, ġiet studjata biss id-doża akbar ta' Zynquista (400 mg).
English: Zynquista's common side effects, which are related to the way the medicine works, such as increased genital infections, are considered manageable and similar to those of other medicines of a similar class.
Maltese: L-effetti sekondarji komuni ta' Zynquista, li huma relatati mal-mod kif taħdem il-mediċina, bħal aktar infezzjonijiet ġenitali, huma kkunsidrati maniġġabbli u simili għal dawk ta' mediċini oħra ta' klassi simili.
English: On this basis, Zynquista 400 mg added to insulin was effective in around 29% of patients, compared with 15% of patients receiving placebo plus insulin.
Maltese: Fuq din il-bażi, Zynquista 400 mg miżjud mal-insulina kien effettiv f'madwar 29 % tal-pazjenti, meta mqabbel ma' 15 % tal-pazjenti li kienu qed jirċievu plaċebo flimkien mal-insulina.
English: As for all medicines, data on the use of Zynquista are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zynquista hija ssorveljata kontinwament.
English: Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes.
Maltese: Zynquista huwa mediċina tad-dijabete użata flimkien mal-insulina għall-kura ta' adulti bid-dijabite tattip 1.