FrancophonIA/ELRC3.0 huggingface dataset:
English: However, data from previous reviews carried out in 2005, 2006 and 2012 suggested an increased relative risk of arterial thromboembolic events which was sometimes greater than for other commonly prescribed NSAIDs and in some cases as great or greater than that seen with certain COX-2 inhibitors.
Maltese: Madankollu, dejta minn reviżjonijiet preċedenti li saru fl-2005, 2006 u fl-2012, issuġġeriet żieda fir-riskju relattiv ta' avvenimenti tromboemboliċi arterjali li kultant kien akbar milli għal NSAIDs oħra komunement preskritti u f'xi każijiet kbir daqs jew akbar minn dak li jidher b'ċerti inibituri ta' COX-2 . Limitazzjonijiet fid-dejta kienu għamluha diffiċli biex inizjalment ir-riskju jiġi kkwantifikat, iżda mir-reviżjoni tal-2012 bdiet ħierġa stampa konsistenti.
English: If 1,000 patients at moderate risk took diclofenac for a year, there would be about 3 extra cases of heart attack among them, compared with patients not taking diclofenac.
Maltese: Jekk 1,000 pazjent f'riskju moderat jieħdu diclofenac għal sena, fosthom ikun hemm madwar 3 każijiet addizzjonali ta' attakk tal-qalb, meta mqabbla ma' pazjenti li ma jkunux qed jieħdu diclofenac.
English: This followed a review by the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) which found that the effects of systemic diclofenac on the heart and circulation are similar to those of selective COX-2 inhibitors, another group of painkillers.
Maltese: Dan segwa wara reviżjoni mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) talAġenzija Ewropea għall-Mediċini li sab li l-effetti ta' diclofenac sistemiku fuq il-qalb u ċ-ċirkolazzjoni huma simili għal dawk ta' inibituri selettivi ta' COX-2, grupp ieħor ta' analġesiċi.
English: • Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Maltese: • Pazjenti b'fatturi sinifikanti ta' riskju għal avvenimenti kardjovaskulari (eż. pressjoni għolja, iperlipidemija, dijabete mellitus, tipjip) għandhom jirċievu kura b'diclofenac biss wara konsiderazzjoni bir-reqqa.
English: The CMDh agreed with the PRAC conclusion that although the benefits of systemic diclofenac still outweigh the risks, those risks were similar to the risks with COX-2 inhibitors, and it endorsed the recommendation that similar precautions should be applied.
Maltese: Is-CMDh qabel mal-konklużjoni tal-PRAC li għalkemm il-benefiċċji ta' diclofenac sistemiku għadhom jegħlbu r-riskji, dawk ir-riskji kienu simili għar-riskji b'inibituri ta' COX-2, u approva rrakkomandazzjoni li għandhom jiġu applikati prekawzjonijiet simili.
English: The PRAC therefore recommended that the same precautions already in place to minimise the risks of blood clots in the arteries with selective COX-2 inhibitors should be applied to diclofenac.
Maltese: Il-PRAC għalhekk irrakkomanda li listess prekawzjonijiet diġà fis-seħħ biex jiġu minimizzati r-riskji ta' emboli tad-demm fl-arterji b'inibituri selettivi ta' COX-2 għandhom jiġu applikati għal diclofenac.
English: The safety of NSAIDs has been closely monitored by regulatory authorities in the EU.
Maltese: Is-sigurtà tal-NSAIDs ġiet immonitorjata mill-qrib minn awtoritajiet regolatorji fl-UE.
English: As diclofenac-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Maltese: Peress li mediċini li fihom diclofenac huma kollha awtorizzati fuq livell nazzjonali, ir-rakkomandazzjonijiet tal-PRAC intbagħtu lill-Grupp ta' Koordinazzjoni għarRikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Uman (CMDh), li adotta pożizzjoni finali.
English: On 28 June 2013, the Co-ordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh) endorsed by majority new safety advice for diclofenac-containing medicines that are given by means such as capsules, tablets, suppositories or injections, intended to have an effect on the whole body (known as a systemic effect).
Maltese: Fit-28 ta' Ġunju 2013, il-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Uman (CMDh) approva b'maġġoranza pariri ġodda dwar is-sigurtà għal mediċini li fihom diclofenac li jingħataw b'mezzi bħal kapsuli, pilloli, suppożitorji jew injezzjonijiet, maħsuba biex ikollhom effett fuq il-ġisem kollu (magħruf bħala effett sistemiku).
English: The latter identified a small increased risk of these cardiovascular side effects with diclofenac compared with other NSAIDsan increase similar to that seen with the COX-2 inhibitors.
Maltese: Din tal-aħħar identifikat żieda żgħira fir-riskju ta' dawn l-effetti kardjovaskulari sekondarji b'diclofenac meta mqabbla ma' NSAIDs oħra - żieda simili għal dik osservata b'inibituri ta' COX-2.
English: Diclofenac-containing medicines have been authorised by national approval procedures in the EU Member States and have been available for many years under a wide range of trade names.
Maltese: Mediċini li fihom diclofenac ġew awtorizzati permezz ta' proċeduri ta' approvazzjoni nazzjonali fl-Istati Membri tal-UE u ilhom disponibbli għal ħafna snin taħt firxa wiesgħa ta' ismijiet kummerċjali.
English: Reviews of these medicines carried out in 2005, 2006 and 2012 have confirmed that NSAIDs as a class are associated with a small increased risk of arterial thromboembolic events (blood clots in the arteries) especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, which in some cases has led to heart attack or stroke, particularly if used at high dose and for long periods.
Maltese: Reviżjonijiet ta' dawn il-mediċini li twettqu fl-2005, 2006 u fl-2012 ikkonfermaw li l-NSAIDs bħala klassi huma assoċjati ma' żieda żgħira fir-riskju ta' avvenimenti tromboembolitiċi arterjali (emboli tad-demm fl-arterji) speċjalment f'pazjenti b'kundizzjonijiet sottostanti tal-qalb jew taċ-ċirkolazzjoni jew b'ċerti fatturi ta' riskju kardjovaskulari, li f'xi każijiet wasslu għal attakk tal-qalb jew puplesija, b'mod partikolari jekk jintużaw f'doża għolja u għal perjodi twal.
English: The latest review by the PRAC was therefore initiated specifically to assess the benefit-risk of systemic diclofenac.
Maltese: Għalhekk l-aħħar reviżjoni mill-PRAC inbdiet speċifikament biex tevalwa l-benefiċċjuriskju ta' diclofenac sistemiku.
English: • The effectiveness of diclofenac is well established.
Maltese: • L-effikaċja ta' diclofenac hija stabbilita sew.
English: The overall number of heart attacks in people at moderate risk would be expected to increase by around 3 cases per year for every 1,000 people treated with diclofenac (to 11 per 1,000 people per year).
Maltese: L-għadd globali ta' attakki tal-qalb f'persuni f'riskju moderat huwa mistenni li jiżdied b'madwar 3 każijiet fis-sena għal kull 1,000 persuna li tirċievi kura b'diclofenac (sa 11-il persuna minn kull 1,000 fis-sena).
English: As the risk is known to be somewhat higher with the subgroup of NSAIDs known as selective COX-2 inhibitors, increased measures to minimise risk are recommended in their product information.
Maltese: Peress li r-riskju huwa magħruf li huwa kemxejn ogħla bis-sottogrupp ta' NSAIDs magħrufa bħala inibituri selettivi ta' COX-2, fl-informazzjoni dwar il-prodott tagħhom hemm rakkomandazzjonijiet għal miżuri ulterjuri biex ir-riskju jitnaqqas.
English: About 8 people in 1,000 at moderate risk of heart disease are likely to have a heart attack over one year.
Maltese: Madwar 8 persuni minn kull 1,000 f'riskju moderat ta' mard tal-qalb huma mistennija li jkollhom attakk tal-qalb fuq perjodu ta' sena.
English: • Overall, the benefits of this medicine are greater than its risks, but there is a small risk of heart attack or stroke in patients taking systemic diclofenac regularly, especially at high doses (150 mg daily) and for long periods.
Maltese: • B'mod ġenerali, il-benefiċċji ta' din il-mediċina huma akbar minn riskji tagħha, iżda hemm riskju żgħir ta' attakk tal-qalb jew puplesija f'pazjenti li qed jieħdu diclofenac sistemiku regolarment, speċjalment f'dożi għoljin (150 mg kuljum) u għal perjodi twal.
English: Although the risk is likely to be dose-dependent, the PRAC considered that cardiovascular thrombotic risk cannot be excluded across all doses of diclofenac, especially in patients with pre-existing co-morbidities.
Maltese: Għalkemm x'aktarx irriskju jkun jiddependi mid-doża, il-PRAC ikkunsidra li r-riskju trombotiku kardjovaskulari ma jistax jiġi eskluż fid-dożi kollha ta' diclofenac, speċjalment f'pazjenti b'komorbożitajiet pre-eżistenti.
English: The cardiovascular risk with any NSAID depends on a person's underlying risk factors, such as high blood pressure and cholesterol levels and also any underlying heart or circulatory conditions.
Maltese: Ir-riskju kardjovaskulari bi kwalunkwe NSAID jiddependi fuq il-fatturi ta' riskju sottostanti tal-persuna, bħal pressjoni tad-demm għolja u l-livelli tal-kolesterol u wkoll xi kondizzjonijiet sottostanti tal-qalb jew taċ-ċirkolazzjoni.
English: Immediate Packaging Pack size
Maltese: Il-pakkett li jmiss mal prodott
English: Invented name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Possible signs of severe allergic reaction may include:
Maltese: Sinjali possibbli ta' reazzjoni allerġika severa jistgħu jinkludu:
English: Jardiance contains sodium
Maltese: Jardiance fih sodium
English: Each tablet contains lactose monohydrate equivalent to 154.3 mg lactose anhydrous.
Maltese: Kull pillola fiha lactose monohydrate ekwivalenti għal 154.3 mg lactose anidru.
English: Possible signs are listed in section 4 under ‘dehydration'.
Maltese: • Sinjali possibbli huma elenkati f'sezzjoni 4, taħt "deidratazzjoni".
English: - The other ingredients are: tablet core: lactose monohydrate (see end of section 2 under ‘Jardiance contains lactose'), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (see end of section 2 under ‘Jardiance contains sodium'), colloidal anhydrous silica, magnesium stearate film-coating: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
Maltese: - Is-sustanzi l-oħra huma - il-qalba tal-pillola: lactose monohydrate (ara fl-aħħar ta' sezzjoni 2 taħt "Jardiance fih illactose"), microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium (ara l-parti t'isfel ta' sezzjoni 2 taħt ‘Jardiance fih sodium'), colloidal anhydrous silica, magnesium stearate - kisi tal-pillola: hypromellose, titanium dioxide (E171), talc, macrogol (400), iron oxide yellow (E172)
English: Pruritus (generalised) Rash
Maltese: Ħakk (ġeneralizzat) Raxx
English: Jardiance is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.
Maltese: Jardiance huwa membru ta' grupp ta' mediċini msejħa inibituri tal-kotrasportatur 2 tas-sodju-glukożju (SGLT2).
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)*
Maltese: Fasciitis nekrotika talperineum (Kankrena ta' Fournier)
English: Date of latest renewal: 14 February 2019
Maltese: Data tal-aħħar tiġdid: 14 ta' Frar 2019
English: Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased a see subsections below for additional information Mean percent increases from baseline for empagliflozin 10 mg and 25 mg versus placebo, respectively, were total cholesterol 4.9% and 5.7% versus 3.5%; HDL-cholesterol 3.3% and 3.6% versus 0.4 %; LDL-cholesterol 9.5% and 10.0% versus 7.5%; triglycerides 9.2% and 9.9% versus 10.5%.
Maltese: Żidiet perċentwali medji mil-linja bażi għal empagliflozin 10 mg u 25 mg meta mqabbla ma' plaċebo, rispettivament, kienu l-kolesterol totali 4.9% u 5.7% meta mqabbla ma' 3.5%; HDLkolesterol 3.3% u 3.6% meta mqabbla ma' 0.4%; LDL-kolesterol 9.5% u 10.0% meta mqabbla ma' 7.5%; trigliċeridi 9.2% u 9.9% meta mqabbla ma' 10.
English: The steady state mean plasma AUC and Cmax were 1870 nmol.h/l and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h/l and 687 nmol/l with empagliflozin 25 mg once daily.
Maltese: Il-plażma fl-istat fiss medju AUC u Cmax kienu ta' 1870 nmol/l u 259 nmol/l b'empagliflozin 10 mg u 4740 nmol.h/l u 687 nmol/l b'empagliflozin 25 mg li jingħata darba kuljum.
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including empagliflozin.
Maltese: Każijiet rari ta' ketoaċidosi dijabetika (DKA, diabetic ketoacidosis) inklużi każijiet ta' periklu għall-ħajja u fatali, ġew irrapportati f'pazjenti ttrattati b'inibituri ta' SGLT2, inkluż empagliflozin.
English: EU/1/14/930/008 EU/1/14/930/009
Maltese: EU/1/14/930/006 EU/1/14/930/007 EU/1/14/930/008 EU/1/14/930/009
English: Co administration of digoxin, a P-gp substrate, with empagliflozin resulted in a 6% increase in AUC and14% increase in Cmax of digoxin.
Maltese: L-għoti fl-istess waqt ta' digoxin, sottostrat ta' P-gp, ma' empagliflozin irriżulta f'żieda ta' 6% fl-AUC u ta' 14% żieda f'Cmax ta' digoxin.
English: What Jardiance is Jardiance contains the active substance empagliflozin.
Maltese: X'inhu Jardiance Jardiance fih is-sustanza attiva empagliflozin.
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonijie
English: A paediatric Phase 1 study examined the pharmacokinetics and pharmacodynamics of empagliflozin (5 mg, 10 mg and 25 mg) in children and adolescents ≥10 to <18 years of age with type 2 diabetes mellitus.
Maltese: Studju pedjatriku ta' Fażi 1 eżamina l-farmakokinetika u l-farmakodinamika ta' empagliflozin (5 mg, 10 mg u 25 mg) fi tfal u adolexxenti b'età ta' ≥10 snin sa <18-il sena b'dijabete mellitus tat-tip 2.
English: Table 1: Tabulated list of adverse reactions (MedDRA) from reported placebo-controlled studies and from post-marketing experience System organ class
Maltese: Tabella 1: Lista f'tabella tar-reazzjonijiet avversi (MedDRA) minn rapporti ta' studji kkontrollati bi plaċebo u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection (including pyelonephritis and urosepsis)
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra Infezzjonijiet tal-passaġġ urinarju (inklużi pajelonefrite u urosepsis)
English: Possible signs of losing too much fluid from your body are listed in section 4.
Maltese: Sinjali possibbli li tkun qed titlef ħafna fluwidu mill-ġisem tiegħek huma elenkati f'sezzjoni 4.
English: Severe allergic reaction, seen with unknown frequency (frequency cannot be estimated from the available data )
Maltese: Reazzjoni allerġika severa, osservata bi frekwenza mhux magħrufa (ma tistax tittieħed stima talfrekwenza mid-data disponibbli)
English: In patients with mild, moderate or severe renal impairment (eGFR <30 - <90 ml/min/1.73 m2) and patients with kidney failure/end stage renal disease (ESRD), AUC of empagliflozin increased by approximately 18%, 20%, 66%, and 48%, respectively compared to subjects with normal renal function.
Maltese: F'pazjenti b'indeboliment tal-kliewi ħafif, moderat jew sever (eGFR <30 - <90 ml/min/1.73 m2) u pazjenti b'falliment tal-kliewi/mard tal-kliewi tal-aħħar stadju (ESRD - End Stage Renal Disease), lAUC ta' empagliflozin żdied b'madwar 18%, 20%, 66% u 48%, rispettivament meta mqabbel ma' individwi b'funzjoni tal-kliewi normali.
English: Hypoglycaemia (when used with sulphonylurea or insulin)
Maltese: Ipogliċemija (meta ntuża ma' sulphonylurea jew malinsulina)
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din ilmediċina.
English: If Fournier´s gangrene is suspected, Jardiance should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Jardiance għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Diabetic ketoacidosis
Maltese: Ketoaċidosi Dijabetika
English: Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium free'.
Maltese: Kull pillola fiha anqas minn 1 mmol sodium (23 mg), jiġifieri essenzjalment ‘ħieles mis-sodium'
English: In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin resulted in a reduction in systolic blood pressure (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) compared with placebo (-0.5 mmHg) and in diastolic blood pressure (empagliflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) compared with placebo (-0.5 mmHg) at week 24 that were maintained up to week 52.
Maltese: F'analiżi speċifikata minn qabel fejn inġabru r-riżultati ta' 4 studji bi plaċebo bħala kontroll, ittrattament b'empagliflozin irriżulta fi tnaqqis fil-pressjoni sistolika tad-demm (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) meta mqabbel ma' plaċebo (-0.5 mmHg) u fil pressjoni dijastolika tad-demm (empagloflozin 10 mg: -1.8 mmHg; empagliflozin25 mmHg: -2.0 mmHg) meta mqabbel ma' plaċebo (-0.5 mmHg) f'ġimgħa 24 li kienu matenuti sa ġimgħa 52.
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg tablets empagliflozin
Maltese: Jardiance 25 mg pilloli empagliflozin
English: Co-treatment with known inducers of UGT enzymes should be avoided due to a potential risk of decreased efficacy.
Maltese: Trattament flimkien ma' indutturi tal-enzimi UGT għandu jiġi evitat minħabba r-riskju potenzjali ta' tnaqqis fl-effikaċja.
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg tablets empagliflozin
Maltese: Jardiance 10 mg pilloli empagliflozin
English: 16.1%, empagliflozin 25 mg: 11.5%, placebo: 8.4%), add-on to basal insulin with or without metformin and with or without a sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, placebo: 20.6% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1%, placebo 35.3% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8%, empagliflozin 25 mg: 41.3%, placebo: 37.2% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1%, empagliflozin 25 mg: 57.7%, placebo: 58% over the 52-week trial).
Maltese: Żieda fil-frekwenza kienet innutata meta mogħti bħala terapija addizzjonali ma' metformin u sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, plaċebo: 8.4%), terapija addizzjonali għal insulina basali bi jew mingħajr metformin u bi jew mingħajr sulphonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, plaċebo: 20.6 waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg u 25 mg: .36.1%, plaċebo 35.3% fuq prova ta' 78 ġimgħa), u terapija aġġuntiva għal insulina
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excl. insulins, ATC code: A10BK03
Maltese: Mediċini użati fid-dijabete, Mediċini oħra li jbaxxu l-glukosju fiddemm, li jeskludu insulini, Kodiċi ATC:
English: Jardiance 25 mg film-coated tablets Each tablet contains 25 mg empagliflozin.
Maltese: Jardiance 25 mg pilloli miksija b'rita Kull pillola fiha 25 mg empagliflozin.
English: Jardiance works by blocking the SGLT2 protein in your kidneys.
Maltese: Jardiance jaħdem billi jimblokka l-proteina SGLT2 fil-kliewi.
English: In the EMPA-REG OUTCOME study, empagliflozin reduced the risk of heart failure requiring hospitalization compared with placebo (empagliflozin 2.7 %; placebo 4.1 %; HR 0.65, 95 % CI 0.50,
Maltese: Fl-istudju EMPA-REG OUTCOME, empagliflozin naqqas ir-riskju ta' insuffiċjenza tal-qalb li teħtieġ dħul l-isptar meta mqabbel ma' plaċebo (empagliflozin 2.7%; plaċebo 4.1 %;
English: Serum lipids increased
Maltese: Żieda fil-lipidi tas-Serum
English: An increased frequency was noted when given as add-on to basal insulin with or without metformin and with or without a sulfonylurea (empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo: 0% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0%, empagliflozin 25 mg: 1.3%, placebo 0% over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.5%, placebo: 0.5% during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, placebo: 1.6% over the 52-week trial).
Maltese: MDI bi jew mingħajr metformin (empagliflozin 10 mg: 0.5%, empagliflozin 25 mg: 0.5%, plaċebo: 0.5% waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg: 1.6%, empagliflozin 25 mg: 0.5%, plaċebo: 1.6% fuq il-prova ta' 52 ġimgħa).
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (97.5% CI) Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Mean adjusted for baseline value Not evaluated for statistical significance as a result of the sequential confirmatory testing procedure 95% CI LOCF, values after antihypertensive rescue censored *p-value <0.0001
Maltese: (97.5% CI) Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet imexxija 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: Temporary interruption of empagliflozin should be considered in patients with complicated urinary tract infections.
Maltese: Interruzzjoni temporanja ta' empagliflozin għandha tiġi kkonsidrata f'pazjenti b'infezzjonijiet kkomplikati tal-passaġġ urinarju.
English: Tablet core
Maltese: Żvojtjar talvolum
English: Study BIG 1-98
Maltese: Studju BIG 1-98
English: Study D2407
Maltese: Studju D2407
English: (5.4, 6.3 months)
Maltese: (5.4, 6.3 xhur)
English: Thrombophlebitis (including superficial and deep vein thrombophlebitis)
Maltese: Tromboflebite (inkluż tromboflebite tal-vini superfiċjali u profondi)
English: Pruritus, urticaria
Maltese: Ħakk, urtikarja
English: Endometrial proliferative disorders
Maltese: Disturbi proliferattivi endometrijali
English: Objective response rate (ORR)
Maltese: Rata ta' rispons objettiv (ORR)
English: Anxiety (including nervousness), irritability Nervous system disorders Common:
Maltese: Anzjetà (inkluż nervożità), irritabbiltà Disturbi fis-sistema nervuża Komuni:
English: 5-year DFS rate Distant metastases Events
Maltese: Rata ta' DFS f'5 snin Metastasi distanti Episodji
English: Endometrial hyperplasia / endometrial cancer
Maltese: Iperplasija endometrijali / kanċer endometrijali
English: Extended adjuvant treatment (MA-17)
Maltese: Trattament adjuvanti estiż (MA-17)
English: Thromboembolic events
Maltese: Episodji tromboemboliċi
English: Overall survival (secondary)
Maltese: Sopravivenza globali (sekondarja)
English: Adjuvant treatment
Maltese: Trattament adjuvanti
English: Deaths4
Maltese: Imwiet4
English: Placebo N=2586
Maltese: Plaċebo N=2586
English: In dogs letrozole caused signs of moderate toxicity at 100 mg/kg.
Maltese: Fil-klieb letrozole ikkawża sinjali ta' tossiċità moderata b'100 mg/kg.
English: Alopecia, rash (including erythematous, maculopapular, psoriaform, and vesicular rash), dry skin
Maltese: Alopeċja, raxx (inkluż eritematosi, makulopapulari, psoriaformi, u raxx vesikulari), ġilda xotta
English: There was no significant difference in overall survival: ({Invented Name} 51 deaths; placebo 62; HR 0.82; 95% CI 0.56, 1.19).
Maltese: ({Isem (Ivvintat)} 51 mewta; plaċebo 62; HR 0.82; 95% CI 0.56, 1.19).