FrancophonIA/ELRC3.0 huggingface dataset:
English: They have “S12” and the Boehringer Ingelheim logo on one side and “850” on the other.
Maltese: Għandhom “S12” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “850” fuq in-naħa l-oħra.
English: Microscopic evidence of the effects of exaggerated pharmacology on the kidney observed in some species included tubular dilatation, and tubular and pelvic mineralisation at approximately 4-times the clinical AUC exposure of empagliflozin associated with the 25 mg dose.
Maltese: Evidenza mikroskopika fuq l-effetti ta' farmakoloġija esaġerata fuq il-kliewi li ġiet osservata f'xi speċi kienet tinkludi twessigħ tubulari, u mineralizzazzjoni tubulari u pelvika f'madwar 4 darbiet l-esponiment ta' AUC kliniku ta' empagliflozin marbuta mad-doża ta' 25 mg.
English: If Fournier´s gangrene is suspected, Synjardy should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Synjardy għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), or very rare (<1/10,000), and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: The clinical relevance of these decreases is unknown.
Maltese: Ir-rilevanza klinika ta' dan it-tnaqqis mhix magħrufa.
English: No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Maltese: Ma ġewx osservati metaboliti prinċipali ta' empagliflozin fil-plażma tal-bniedem, kif iddefinit tal-anqas minn 10% tal-materjal kollu relatat mal-mediċina, u l-aktar metaboliti abundanti kienu tliet konjugati ta' glucuronide (2-, 3-, u 6-O-glucorinide).
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: Huwa responsabbli, bħala t-trasportatur predominanti, għar-riassorbiment ta' glukosju mill-filtrat glomerulari lura għal ġoċ-ċirkolazzjoni.
English: Lactic acidosis Vitamin B12 deficiency
Maltese: Aċidożi lattika Defiċjenza ta' vitamina
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7% at week 52
Maltese: Pazjenti (%) li jiksbu HbA1c < 7% b'HbA1cfil-linja bażi ≥ 7% f'Ġimgħa 52
English: Empagliflozin daily resulted in a statistically significant reduction in body weight, systolic and diastolic blood pressure and a statistically significantly lower proportion of patients with hypoglycaemic events compared to glimepiride (2.5% for empagliflozin, 24.2% for glimepiride, p<0.0001).
Maltese: Empagliflozin kuljum irriżulta fi tnaqqis statistikament sinifikanti fil-piż tal-ġisem, fil-pressjoni sistolika u dijastolika tad-demm u proporzjon statistikament sinifikanti aktar baxx f'pazjenti b'każijiet ipogliċemiċi meta mqabbla ma' glimepiride (2.5% għal empagliflozin, 24.2% għal glimepiride, p< 0.0001).
English: They have “S5” and the Boehringer Ingelheim logo on one side and “850” on the other.
Maltese: Għandhom “S5” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “850” fuq in-naħa l-oħra.
English: Most toxicity was consistent with secondary pharmacology related to urinary glucose loss and electrolyte imbalances including decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism and gluconeogenesis, urinary changes such as polyuria and glucosuria, and microscopic changes including mineralisation in kidney and some soft and vascular tissues.
Maltese: Il-maġġoranza tat-tossiċità kienet konsistenti ma' farmakoloġija sekondarja relatata ma' telf ta' glukosju urinarju u żbilanċi fl-elettroliti inkluż tnaqqis fil-piż tal-ġisem u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidratazzjoni, tnaqqis ta' glukosju fis-serum u żidiet f'parametri oħra fis-serum li jirriflettu żieda fil-metaboliżmu ta' proteini u glukoneoġenesi, bidliet urinarji bħal polijurja u glukosurja, u bidliet mikroskopiċi li jinkludu mineralizzazzjoni fil-kliewi u xi tessuti rotob u vaskulari.
English: In patients with mild, moderate or severe renal impairment (creatinine clearance <30 - <90 ml/min) 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 (tneħħija tal-krejatinina < 30 - < 90 ml/min) u pazjenti b'falliment tal-kliewi/mard tal-kliewi tal-aħħar stadju (ESRD - End Stage Renal Disease), l-AUC ta' empagliflozin żdiedet b'madwar 18%, 20%, 66% u 48%, rispettivament meta mqabbla ma' individwi b'funzjoni tal-kliewi normali.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently in metformin-treated patients who received empagliflozin 10 mg (4.0%) and empagliflozin 25 mg (3.9%) compared to placebo (1.3%), and were reported more frequently for empagliflozin compared to placebo in female patients.
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra Monolijasi vaġinali, vulvovaġinite, balanite u infezzjonijiet ġenitali oħra kienu rapportati bi frekwenza akbar f'pazjenti kkurati b'empagliflozin 10 mg (4.0%) u empagliflozin 25 mg (3.9%) imqabbla ma' plaċebo (1.3%), u kienu rapportati bi frekwenza akbar għal empagliflozin mqabbel ma' plaċebo f'pazjenti nisa.
English: In the pooled placebo-controlled double-blind trials of 18 to 24 weeks duration, the overall frequency of urinary tract infection reported as adverse event was higher in patients treated with empagliflozin 10 mg on a background of metformin compared to patients treated with placebo or empagliflozin 25 mg on a background of metformin (see section 4.8).
Maltese: F'ġabra ta' provi double-blind ikkontrollati bi plaċebo ta' 18 sa 24 ġimgħa, il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala avveniment avvers kienet simili f'pazjenti kkurati b'empagliflozin 10 mg fuq terapija fl-isfond ta' metformin mqabbla ma' pazjenti kkurati bi plaċebo jew b'empagliflozin 25 mg fuq terapija fl-sfond ta' metformin (ara sezzjoni 4.8).
English: Boehringer Ingelheim RCV GmbH & Co KG Magyarországi Fióktelepe Tel.: +36 1 299 89 00
Maltese: KG Magyarországi Fióktelepe Tel: +36 1 299 89 00
English: Single dose study: after single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Maltese: Studju dwar dożi waħdanin: wara dożi waħdanin ta' metformin hydrochloride 500 mg, il-pazjenti pedjatriċi wrew profil farmakokinetiku simili għal dak osservat f'adulti b'saħħithom.
English: • stomach ache (abdominal pain)
Maltese: • uġigħ fl-istonku (uġigħ addominali)
English: Urinary tract infection, seen commonly (may affect up to 1 in 10 people) The signs of urinary tract infection are:
Maltese: Infezzjoni tal-passaġġ urinarju, li ġie osservat komunement (li tista' taffettwa sa persuna 1 f'10) Is-sinjali ta' infezzjonijiet tal-passaġġ urinarju huma:
English: Synjardy is contraindicated in patients with GFR<30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function, see section 4.3.
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament fil-preżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
English: Your doctor may ask you to stop taking Synjardy.
Maltese: Ma twettaq l-ebda studju ta' interazzjoni għal Synjardy.
English: They have “S5” and the Boehringer Ingelheim logo on one side and “1000” on the other.
Maltese: Għandhom “S5” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “1000” fuq in-naħa l-oħra.
English: Treatment with empagliflozin in combination with metformin with or without other antidiabetic medicinal products (pioglitazone, sulfonylurea, DPP-4 inhibitors, and insulin) led to clinically relevant improvements in HbA1c, fasting plasma glucose (FPG), body weight, systolic and diastolic blood pressure.
Maltese: It-trattament ta' empagliflozin flimkien ma' metformin bi jew mingħajr prodotti mediċinali kontra d-dijabete oħrajn (pioglitazone, sulphonylurea, impedituri ta' DPP-4, u insulina) wasslu għal titjib klinikament rilevanti fl-HbA1c, il-glukosju fil-plażma waqt sawm (FPG), il-piż tal-ġisem u l-pressjoni tad-demm sistolika u dijastolika.
English: Baseline (mean) Change from baseline Difference from glimepiride
Maltese: Linja bażi (medja) Bidla mil-linja bażi Differenza minn glimepiride
English: Empagliflozin 24 months data, as add-on to metformin in comparison to glimepiride In a study comparing the efficacy and safety of empagliflozin 25 mg versus glimepiride (up to 4 mg per day) in patients with inadequate glycaemic control on metformin alone, treatment with empagliflozin daily resulted in superior reduction in HbA1c (Table 6), and a clinically meaningful reduction in FPG, compared to glimepiride.
Maltese: Fi studju li jqabbel l-effikaċja u s-sigurtà ta' empagliflozin 25 mg ma' glimepiride (sa 4 mg kuljum) f'pazjenti b'kontroll gliċemiku inadegwat li qegħdin fuq metformin biss, it-trattament b'empagliflozin kuljum irriżulta fi tnaqqis superjuri f'HbA1c (Tabella 6), u tnaqqis klinikament validu fil-FPG, meta mqabbel ma' glimepiride.
English: Placebo controlled double-blinded trials of 18 to 24 weeks of exposure included 3456 patients, of which 1271 were treated with empagliflozin 10 mg as add-on to metformin and 1259 with empagliflozin 25 mg as add-on to metformin.
Maltese: Provi double blinded ikkontrollati bi plaċebo ta' 18 sa 24 ġimgħa ta' espożizzjoni inkludew 3,456 pazjent, li minnhom 1,271 kienu kkurat b'empagliflozin 10 mg bħala terapija aġġuntiva ma' metformin u 1,259 b'empagliflozin 25 mg bħala terapija aġġuntiva ma' metformin.
English: Empagliflozin induced renal tumours in male mice at 1,000 mg/kg/day, but not at 300 mg/kg/day, which corresponds to approximately 11-times the maximal clinical exposure to empagliflozin.
Maltese: Empagliflozin induċa tumuri tal-kliewi fi ġrieden irġiel f'doża ta' 1,000 mg/kg/jum, iżda mhux f'doża ta' 300 mg/kg/jum, li tikkorrispondi għal madwar 11 il darba l-espożizzjoni klinika massima ta' empagliflozin.
English: Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets Empagliflozin/metformin hydrochloride
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita Synjardy 5 mg/1,000 mg pilloli miksijin b'rita Synjardy 12.5 mg/850 mg pilloli miksijin b'rita Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita Empagliflozin/metformin hydrochloride
English: Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
Maltese: • Inibituri ta' OCT2 (bħal cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib,
English: Table 2: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studies and from post-marketing experience
Maltese: Tabella 2: Lista f'tabella tar-reazzjonijiet avversi (MedDRA) minn studji kkontrollati bi plaċebo u mill-esperjenza ta' wara t-tqegħid fis-suq.
English: Following administration of a dose of 850 mg metformin hydrochloride, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 minute prolongation of the time to peak plasma concentration were observed.
Maltese: Wara l-għoti ta' doża ta' metformin hydrochloride 850 mg, kienu osservati konċentrazzjoni massima fil-plażma aktar baxxa b'40%, tnaqqis ta' 25% fl-AUC u dewmien ta' 35 minuta tal-ħin biex tintlaħaq l-ogħla konċentrazzjoni fil-plażma.
English: Of these, 266 or 264 patients were treated with empagliflozin 10 mg or 25 mg as add-on to metformin plus insulin, respectively.
Maltese: Minn dawn, 266 jew 264 pazjent kienu kkurati b'empagliflozin 10 mg jew 25 mg bħala terapija aġġuntiva ma' metoformin flimkien mal-insulina, rispettivament.
English: In a pre-specified pooled analysis of 4 placebo controlled studies, treatment with empagliflozin (68% of all patients were on metformin background) resulted in body weight reduction compared to placebo at week 24 (-2.04 kg for empagliflozin 10 mg, -2.26 kg for empagliflozin 25 mg and -0.24 kg for placebo) that was maintained up to week 52 (-1.96 kg for empagliflozin 10 mg, -2.25 kg for empagliflozin 25 mg and -0.16 kg for placebo).
Maltese: F'analiżi ppuljata speċifikata minn qabel ta' 4 studji kkontrollati bi plaċebo, il-kura b'empagliflozin (68% tal-pazjenti kollha kienu fuq terapija fl-isfond ta' metformin) irriżultat fi tnaqqis fil-piż tal-ġisem mqabbel ma' plaċebo f'Ġimgħa 24 (-2.04 kg għal empagliflozin 10 mg, -2.26 kg għal empagliflozin 25 mg u -0.24 kg għal plaċebo) li kien stabbli sa Ġimgħa 52 (-1.96 kg għal empagliflozin 10 mg, -2.25 kg għal empagliflozin 25 mg u -0.
English: Mean changes from baseline in haematocrit were 3.6% and 4.0% for empagliflozin 10 mg and 25 mg, respectively, compared to 0% for placebo.
Maltese: Bidliet medji mil-linja bażi fl-ematokrit kienu 3.6% u 4.0% għal empagliflozin 10 mg u 25 mg, rispettivament, meta mqabbla ma' 0% għal plaċebo.
English: A greater proportion of patients treated with empagliflozin and with a baseline HbA1c ≥7.0% achieved a target HbA1c of <7% compared to placebo (Table 8).
Maltese: Proporzjon akbar ta' pazjenti kkurati b'empagliflozin u b'HbA1c fil-linja bażi ≥ 7.0% kisbu HbA1c fil-mira ta' < 7% mqabbel ma' plaċebo (Tabella 8).
English: Subgroup analysis for patients on additional background of metformin (PPS-Completers, LOCF) Mean adjusted for baseline value not evaluated for statistical significance as a part of the sequential confirmatory testing procedure Week 19-40: treat-to-target regimen for insulin dose adjustment to achieve pre-defined glucose target levels (pre-prandial <100 mg/dl (5.5 mmol/l), post-prandial <140 mg/dl (7.8 mmol/l) * p-value ≤0.0005 ** p-value <0.005
Maltese: Analiżi ta' sottogrupp għal pazjenti li qed jingħataw terapija fl-isfond addizzjonali ta' metformin (FAS, LOCF) Analiżi ta' sottogrupp għal pazjenti li qed jingħataw terapija fl-isfond addizzjonali ta' metformin (PPS-Completers, LOCF) Medja aġġustata għall-valur ta' linja bażi mhux evalwat għal sinifikat ta' statistika bħala riżultat ta' proċedura ta' ttestjar konfermatorju sekwenzjali Ġimgħa 19-40: programm ta' kura biex jiġu stabbiliti miri għall-aġġustament tad-doża ta' insulina sabiex jintlaħqu livelli definiti minn qabel ta' livelli ta' glukosju fil-mira (qabel ikla < 100 mg/dl (5.5 mmol/l), wara l-ikla < 140 mg/dl (7.8 mmol/l) * valur p ≤ 0.0005 ** valur p < 0.005
English: The active substances are empagliflozin and metformin.
Maltese: Is-sustanzi attivi huma empagliflozin u metformin.
English: Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%
Maltese: Pazjenti (%) li jilħqu HbA1c <7% b'HbA1c ≥7% tal-linja bażi
English: Synjardy 5 mg/850 mg film-coated tablets EU/1/15/1003/001
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita EU/1/15/1003/001
English: • if you are 85 years old or older as you should not start taking Synjardy;
Maltese: • jekk għandek 85 sena jew aktar m'għandekx tibda tieħu Synjardy.
English: Synjardy 12.5 mg/850 mg film-coated tablets EU/1/15/1003/019
Maltese: Synjardy 12.5 mg/850 mg pilloli miksijin b'rita EU/1/15/1003/019
English: Major hypoglycaemia (events requiring assistance) The overall frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin, and for the combination of empagliflozin with metformin in drug-naïve patients compared to those treated with empagliflozin and metformin as individual components, and as adjunct to standard care therapy.
Maltese: Il-frekwenza globali ta' pazjenti b'avvenimenti ipogliċemiċi maġġuri kienet baxxa (< 1%) u simili għal empagliflozin u plaċebo bħala terapija aġġuntiva ma' metformin, u għall-kombinazzjoni ta'
English: The most commonly reported adverse events in clinical trials were hypoglycaemia in combination with insulin and/or sulphonylurea, urinary tract infections, genital tract infections and increased urination (see description of selected side effects).
Maltese: L-avvenimenti avversi rapportati l-aktar frekwentament fi provi kliniċi kienu l-ipogliċemija flimkien mal-insulina u/jew sulphonylurea, infezzjonijiet tal-passaġġ urinarju, infezzjonijiet tal-passaġġ ġenitali u żieda fil-mogħdija tal-awrina.(ara d-deskrizzjoni ta' effetti sekondarji magħżula).
English: Empagliflozin did not increase the incidence of tumours in female mice at doses up to 1,000 mg/kg/day, which corresponds to approximately 62-times the maximal clinical exposure to empagliflozin.
Maltese: Empagliflozin ma żiedx l-inċidenza ta' tumuri fi ġrieden nisa sa dożi ta' 1,000 mg/kg/jum, li tikkorrispondi għal madwar 62 darba l-espożizzjoni klinika massima ta' empagliflozin.
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Maltese: Il-bijodisponibilità assoluta ta' pillola ta' metformin hydrochloride 500 mg jew 850 mg hija ta' madwar 50-60% f'suġġetti b'saħħithom.
English: Systemic exposure of empagliflozin increased in a dose-proportional manner.
Maltese: L-esponiment sistemiku ta' empagliflozin żdied f'manjiera proporzjonali mad-doża.
English: SBP (mmHg) Baseline (mean) Change from baseline Difference from placebo (95% CI) Mean adjusted for baseline value Not evaluated for statistical significance; not part of sequential testing procedure for the secondary endpoints MMRM model on FAS (OC) included baseline HbA1c, baseline eGFR (MDRD), geographical region, visit, treatment, and treatment by visit interaction.
Maltese: Mhux evalwati għas-sinifikat statistiku; mhux parti mill-proċedura ta' ttestjar sekwenzjali għall-punti ta' tmiem sekondarji Mudell MMRM fuq FAS (OC) inkluda HbA1c tal-linja bażi, eGFR (MDRD) tal-linja bażi, reġjun ġeografiku, żjara, kura, u kura b'interazzjoni permezz ta' żjara.
English: Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Patients randomized to the empagliflozin 10 mg or 25 mg groups were receiving empagliflozin 10 mg or 25 mg and linagliptin 5 mg with background metformin * p-value <0.0001
Maltese: Il-pazjenti randomizzati għall-grupp tal-plaċebo kienu qed jirċievu l-plaċebo kif ukoll linagliptin 5 mg b'metformin ta' sfond Pazjenti randomizzati għall-gruppi ta' empagliflozin 10 mg jew 25 mg kienu qed jirċievu empagliflozin 10 mg jew 25 mg u linagliptin 5 mg b'metformin ta' sfond * valur-p <0.
English: In this analysis, AUC was estimated to be 5.82%, 10.4%, and 17.3% lower in subjects with BMI of 30, 35, and 45 kg/m2, respectively, compared to subjects with a body mass index of 25 kg/m
Maltese: 4% u 17.3% inqas f'individwi b'BMI ta' 30, 35 u 45 kg/m2, rispettivament, meta mqabbla ma' individwi b'indiċi tal-piz tal-ġisem ta' 25 kg/m Generu Sesswali
English: Synjardy 12.5 mg/1,000 mg film-coated tablets EU/1/15/1003/028
Maltese: Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita EU/1/15/1003/028
English: • iodinated contrast agents (medicines used during an X-ray, see section ‘Warnings and precautions'.
Maltese: • aġenti tal-kuntrast jodinati (mediċini li jintużaw matul X-ray, ara sezzjoni “Twissijiet u prekawzjonijiet”.
English: In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin 10 mg or 25 mg as add-on to metformin resulted in statistically significant reductions in HbA1c at Week 24 (adjusted mean change from baseline of -1.49% for empagliflozin 25 mg, -1.40% for empagliflozin 10 mg, and -0.44% for placebo).
Maltese: F'analiżi speċifikata minn qabel ta' individwi bl-HbA1c fil-linja bażi ≥ 9.0%, il-kura b' empagliflozin 10 mg jew 25 mg bħala terapija aġġuntiva ma' metformin irriżultat fi tnaqqis statistikament sinifikanti fl-HbA1c f'Ġimgħa 24 (bidla medja aġġustata mil-linja bażi ta' -1.49% għal empagliflozin 25 mg, -1.40% għal empagliflozin 10 mg, u -0.
English: The reduction of cardiovascular death was comparable for empagliflozin 10 mg and 25 mg (see Figure 1) and confirmed by an improved overall survival (Table
Maltese: It-tnaqqis ta' mwiet kardjovaskulari kien komparabbli għal empagliflozin 10 mg u 25 mg (Figura 1) u kkonfermat b'sopravivenza ġenerali mtejba (Tabella 9).
English: Dark brownish purple, oval, biconvex film coated tablets debossed with “S12” and the Boehringer Ingelheim logo on one side and “1000” on the other side (tablet length: 21.1 mm, tablet width: 9.7 mm).
Maltese: Pilloli ovali, ta' lewn vjola fil-kannella skur, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'“S12” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “1000” fuq in-naħa l-oħra (tul tal-pillola: 21.1 mm, wisa' tal-pillola: 9.7 mm).
English: In a pre-specified pooled analysis of 4 placebo-controlled studies, treatment with empagliflozin (68% of all patients were on metformin background) 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 ppuljata speċifikata minn qabel ta' 4 studji kkontrollati bi plaċebo, il-kura b'empagliflozin (68% tal-pazjenti kollha kienu fuq terapija fl-isfond ta' metformin) irriżultat fi tnaqqis fil-pressjoni sistolika tad-demm (empagliflozin 10 mg: -3.9 mmHg; empagliflozin 25 mg: -4.3 mmHg) mqabbel ma' plaċebo -(-0.5 mmHg) u fil-pressjoni dijastolika tad-demm (empagloflozin 10 mg: -1.8 mmHg; empagliflozin 25 mg: -2.0 mmHg) mqabbel ma' plaċebo (-0.5 mmHG), f'Ġimgħa 24 li baqa' stabbli sa Ġimgħa 52.
English: Synjardy 5 mg/850 mg film-coated tablets Synjardy 5 mg/1,000 mg film-coated tablets Synjardy 12.5 mg/850 mg film-coated tablets Synjardy 12.5 mg/1,000 mg film-coated tablets
Maltese: Synjardy 5 mg/850 mg pilloli miksijin b'rita Synjardy 5 mg/1,000 mg pilloli miksijin b'rita Synjardy 12.5 mg/850 mg pilloli miksijin b'rita Synjardy 12.5 mg/1,000 mg pilloli miksijin b'rita
English: An embryofetal development study in pregnant rats did not indicate a teratogenic effect attributed to the co-administration of empagliflozin and metformin at exposures of approximately 14-times the clinical AUC exposure of empagliflozin associated with the highest dose, and 4-times the clinical AUC exposure of metformin associated with the 2000 mg dose.
Maltese: Studju dwar l-iżvilupp embrijofetali f'firien nisa tqal ma indikax effett teratoġeniku attribwibbli għall-għoti flimkien ta' empagliflozin u metformin f'espożizzjonijiet ta' madwar 14-il darba l-espożizzjoni AUC klinika ta' empagliflozin assoċjata mal-ogħla doża, u 4 darbiet l-espożizzjoni AUC klinika ta' metformin assoċjata mad-doża ta' 2,000 mg.
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg tablets empagliflozin/metformin HCL
Maltese: Synjardy 12.5 mg/850 mg pilloli empagliflozin/metformin HCL