FrancophonIA/ELRC3.0 huggingface dataset:
English: For the different doses of metformin, Synjardy is available in strengths of 5 mg empagliflozin plus 850 mg metformin hydrochloride, 5 mg empagliflozin plus 1,000 mg metformin hydrochloride, 12.5 mg empagliflozin plus 850 mg metformin hydrochloride, and 12.5 mg empagliflozin plus 1,000 mg metformin hydrochloride.
Maltese: 5 mg empagliflozin flimkien ma' 850 mg metformin hydrochloride, 5 mg empagliflozin flimkien ma' 1,000 mg metformin hydrochloride, 12.5 mg empagliflozin flimkien ma' 850 mg metformin hydrochloride, u 12.5 mg empagliflozin flimkien ma' 1,000 mg metformin hydrochloride.
English: Overall hypoglycaemia
Maltese: Ipogliċemija globali
English: Treatment with empagliflozin as add-on to metformin or metformin plus sulfonylurea resulted in clinically meaningful improvement of 2-hour post-prandial glucose (meal tolerance test) at 24 weeks (add-on to metformin, placebo: +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl; add-on to metformin plus sulphonylurea, placebo: -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Maltese: empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg mg/dl, terapija aġġuntiva ma' metformin u sulphonylurea: plaċebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
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 oħraa 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'
English: • in patients inadequately controlled with metformin in combination with other glucose-lowering medicinal products, including insulin (see sections 4.5 and 5.1 for available data on different combinations)
Maltese: • f'pazjenti mhux ikkontrollati b'mod adegwat bil-metformin flimkien ma' prodotti mediċinali oħra li jnaqqsu l-glukosju li jinkludu l-insulina (ara sezzjonijiet 4.5 u 5.1 għal-data disponibbli fuq kombinazzjonijiet differenti).
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Il-glukokortikojdi (mogħtija permezz ta' rotot sistematiċi u lokali), l-agonisti ta' beta-2, u d-dijuretiċi għandhom attività ipergliċemika intrinsika.
English: Peak plasma levels of empagliflozin were similar in subjects with moderate renal impairment and kidney failure/ESRD compared to patients with normal renal function.
Maltese: empagliflozin fil-plażma kienu simili f'individwi b'indeboliment tal-kliewi moderat u falliment tal-kliewi/ESRD meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Dysuria2
Maltese: Disurja2
English: Table 1 Adverse reactions reported in placebo-controlled studies System organ class
Maltese: Tabella 1: Reazzjonijiet avversi rapportati fi studji kkontrollati bi plaċebo.
English: Table 2: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapya
Maltese: Tabella 2: Riżultati ta' effikaċja fi studji ta' 24 ġimgħa kkontrollati bi plaċeboa
English: Body Weight (kg)
Maltese: Piż tal-Ġisem (kg)
English: Combination requiring precautions for use
Maltese: Metformin Kombinazzjonijiet li mhumiex rakkomandati
English: 4 Mean adjusted for baseline SBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products 5 Mean adjusted for baseline DBP, baseline HbA1c, baseline eGFR, geographical region and number of antihypertensive medicinal products * p-value <0.0001
Maltese: Il-medja aġġustata għal DBP tal-linja bażi, HbA1c tal-linja bażi, eGFR tal-linja bażi, ir-reġjun ġeografiku u numru ta' prodotti mediċinali kontra l-pressjoni għolja
English: In a prospective, pre-specified meta-analysis of independently adjudicated cardiovascular events from 12 phase 2 and 3 clinical studies involving 10,036 patients with type 2 diabetes, empagliflozin did not increase cardiovascular risk.
Maltese: F'metanaliżi prospettiva, speċifikata minn qabel ta' każijiet kardjovaskulari aġġudikati indipendentement minn 12-il studju kliniku ta' Fażi 2 u 3 li kienu jinvolvu 10,036 pazjent b'dijabete ta' tip 2, il-kura b'empagliflozin ma kinitx assoċjata ma' żieda fir-riskju kardjovaskulari.
English: It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis.
Maltese: Huwa importanti li tikkonforma mal-istruzzjonijiet tiegħek dwar it-teħid ta' mediċini u djetetiċi u programm ta' eżerċizzju regolari għaliex dan jista' jnaqqas ir-riskju ta' aċidożi lattika.
English: A total of 4704 patients with type 2 diabetes were treated in 7 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 1109 patients received empagliflozin 10 mg and 1863 received empagliflozin 25 mg as add-on to metformin therapy.
Maltese: B'kollox 4,704 pazjenti b'dijabete ta' tip 2 kienu kkurati f'7 studji kliniċi double blind, ikkontrollati bi plaċebo jew b'mod attiv li damu tal-anqas 24 ġimgħa, li minnhom 1,109 pazjenti ngħataw empagliflozin 10 mg u 1,863 pazjent ngħataw empagliflozin 25 mg bħala terapija aġġuntiva ma' metformin.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: HbA1c (%) at week 78 Baseline (mean) Change from baseline1 Difference from placebo1
Maltese: HbA1c (%) f'Ġimgħa 78 Linja bażi (medja) Bidla mil-linja bażi1
English: • iodinated contrast agents (medicines used during an X-ray, see section 2 ‘Warnings and precautions'.
Maltese: • aġenti tal-kuntrast jodinati (mediċini li jintużaw matul X-ray, ara sezzjoni 2 “Twissijiet u prekawzjonijiet”.
English: Taste disturbance3
Maltese: Disturb fit-togħma3
English: • loss of appetite
Maltese: • nuqqas ta' aptit Komuni
English: România Boehringer Ingelheim RCV GmbH & Co KG
Maltese: România Boehringer Ingelheim RCV GmbH & Co
English: Interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Maltese: linagliptin, simvastatin, warfarin, ramipril, digoxin, dijuretiċi u kontraċettivi orali.
English: Other associated risk factors should be considered to avoid lactic acidosis such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic impairment and any condition associated with hypoxia (such as decompensated cardiac failure, acute myocardial infarction) (see section 4.3).
Maltese: Għandhom jitqiesu fatturi ta' riskji assoċjati oħrajn sabiex tiġi evitata l-aċidożi lattika bħal dijabete mhux ikkontrollata tajjeb, ketożi, sawm fit-tul, teħid eċċessiv ta' alkoħol, indeboliment tal-fwied u kwalunkwe kundizzjoni assoċjata ma' nuqqas ta' ossiġnu (bħal insuffiċjenza kardijaka mhux kumpensata, infart mijokardijaku akut) (ara sezzjoni 4.3).
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/m2.
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/m2.
English: During the initial 18 weeks and the last 12 weeks, the insulin dose was kept stable, but was adjusted to achieve pre-prandial glucose levels <100 mg/dl [5.5 mmol/l], and post-prandial glucose levels <140 mg/dl [7.8 mmol/l] between Weeks 19 and 40.
Maltese: < 100 mg/dl [5.5 mmol/l], u livelli ta' glukosju ta' wara l-ikla < 140 mg/dl [7.8 mmol/l] bejn Ġimgħat 19 u 40.
English: Table 5 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformina
Maltese: Riżultati tal-effikaċja f'Ġimgħat 18 u 78 fi studju kkontrollat bi plaċebo ta' empagliflozin bħala terapija addizzjonali mal-insulina bażali u metformina
English: A total of 7052 patients with type 2 diabetes were treated in clinical studies to evaluate the safety of empagliflozin as add-on to metformin, of which 4740 patients were treated with empagliflozin as add-on to metformin.
Maltese: Total ta' 7,052 pazjent b'dijabete ta' tip 2 kienu kkurati fl-istudji kliniċi sabiex tiġi evalwata s-sigurtà ta' empagliflozin bħala terapija aġġuntiva ma' metformin, li minnhom 4,740 pazjent kienu kkurati b'empagliflozin bħala terapija aġġuntiva ma' metformin.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX12.5 mg/850 mg
Maltese: TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU12.5 mg/850 mg
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: (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 combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: empagliflozin, an inhibitor of sodium-glucose co-transporter 2 (SGLT2), and metformin hydrochloride, a member of the biguanide class.
Maltese: impeditur tal-kotrasportatur 2 tas-sodju-glukosju, u metformin hydrochloride, membru tal-klassi biguanide.
English: As expected from the mechanism of action, increased urination (as assessed by PT search including pollakiuria, polyuria, nocturia) was observed at higher frequencies in metformin-treated patients who received empagliflozin 10 mg (3.0%) and empagliflozin 25 mg (2.9%) compared to placebo (1.4%) as add-on to metformin therapy.
Maltese: PT inkluż pollakijurja, polijurja u nokturja) kienet osservata bi frekwenza ogħla f'pazjenti kkurati b'metformin li ngħataw empagliflozin 10 mg (3.0%) u empagliflozin 25 mg (2.9%) meta mqabbla ma'
English: • diarrhoea or stomach ache
Maltese: • diffikultà tieħu nifs
English: Table 3: Efficacy results at 104 week in an active controlled study comparing empagliflozin to glimepiride as add on to metformina
Maltese: Tabella 3: Riżultati ta' effikaċja wara 104 ġimgħat fi studju kontrollat b'mod attiv li qabbel empagliflozin ma' glimepiride bħala terapija addizzjonali għal metformina
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACKS - INTERMEDIATE CARTON WITHOUT BLUE BOX - 5 mg/1,000 mg
Maltese: PAKKETTI MULTIPLI - KARTUNA INTERMEDJA MINGĦAJR KAXXA BLU5 mg/1,000 mg
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'
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Maltese: metformin fil-plażma (Cmax) ma qabżux 5 mikrogrammi/ml, anki fid-dożi massimi.
English: Film-coated tablet (tablet).
Maltese: empagliflozin fil-plażma (Cmin).
English: Difference from glimepiride1 (97.5% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy b Up to 4 mg glimepiride
Maltese: a Sett ta' analiżi sħiħa (FAS - Full analysis set) fejn intużat l-aħħar osservazzjoni li ġiet miġjuba 'l quddiem (LOCF - Last observation carried forward) qabel l-għoti ta' terapija għal salvataġġ gliċemiku.
English: Urinary tract infection1, 2
Maltese: balanite u infezzjoni ġenitali oħra1, 2
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/850 mg
Maltese: TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU5 mg/850 mg
English: 2 Identified adverse reactions of empagliflozin monotherapy 3 Identified adverse reactions of metformin monotherapy 4 Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia)
Maltese: 2 Reazzjonijiet avversi identifikati tal-monoterpaija b'empagliflozin 3 Reazzjonijiet avversi identifikati tal-monoterapija b'metformin 4 Il-kura fit-tul b'metformin kienet assoċjata ma' tnaqqis fl-assorbiment ta' vitamina
English: • if you have problems with your kidneys;
Maltese: • jekk għandek problemi bil-kliewi;
English: Change from baseline1
Maltese: Bidla mil-linja bażi1
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER WRAPPER LABEL ON MULTIPACKS - INCLUDING THE BLUE BOX5 mg/1,000 mg
Maltese: TIKKETTA TA' BARRA FUQ IL-PAKKETTI MULTIPLI - INKLUŻA L-KAXXA BLU5 mg/1,000 mg
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Maltese: metformin hydrochloride 500 mg jew 850 mg hija ta' madwar 50-60% f'suġġetti b'saħħithom.
English: Interstitial cell tumours in the testes were observed with a higher incidence in rats at 300 mg/kg/day and above, but not at 100 mg/kg/day which corresponds to approximately 18-times the maximal clinical exposure to empagliflozin.
Maltese: Inċidenza ogħla ta' tumuri fiċ-ċelluli interstizjali fit-testikoli kienet osservata fil-firien f'doża ta' 300 mg/kg/jum u iżjed, iżda mhux f'doża ta' 100 mg/kg/jum li tikkorrispondi għal madwar 18-il darba l-espożizzjoni klinika massima ta ◌◌' empagliflozin.
English: Brownish yellow, oval, biconvex film coated tablets debossed with “S5” 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 isfar fil-kannella, mżaqqa fuq żewġ naħat, miksija b'rita, imnaqqxa b'“S5” u l-logo ta' Boehringer Ingelheim fuq naħa waħda u “1000” fuq in-naħa l-oħra (tul tal-pillola: 21.1 mm,
English: Major hypoglycaemia (hypoglycaemia requiring assistance) The frequency of patients with major hypoglycaemic events was low (<1%) and similar for empagliflozin and placebo as add-on to metformin.
Maltese: Il-frekwenza ta' pazjenti b'avvenimenti ipogliċemiċi maġġuri kienet baxxa (< 1%) u simili għal empagliflozin u plaċebo bħala terapija aġġuntiva ma' metformin.
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 5).
Maltese: Proporzjon akbar ta' pazjenti kkurati b'empagliflozin u b'HbA1c fil-linja bażi ≥ 7.0% kisbu HbA1c fil-mira ta' < 7%
English: Therapy should usually not be resumed earlier than 48 hours following surgery and only after renal function has been reevaluated and found to be normal.
Maltese: Il-kura normalment ma għandhiex titkompla qabel ma jkunu għaddew 48 siegħa wara l-kirurġija u biss wara li l-funzjoni tal-kliewi tkun ġiet evalwata mill-ġdid u tinstab li hija normali.
English: • at least two to four times a year in patients with serum creatinine levels at the upper limit of normal and in elderly subjects
Maltese: • tal-anqas darbtejn sa erba' darbiet fis-sena f'pazjenti b'livelli tal-krejatinina fis-serum fil-limitu ta' fuq tan-normal u f'pazjenti anzjani.
English: An increased frequency was noted when empagliflozin given as add-on to metformin and a sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5% and placebo: 8.4%) or as add-on to metformin and insulin (empagliflozin 10 mg: 31.3%, empagliflozin 25 mg: 36.2% and placebo: 34.7%).
Maltese: (empagliflozin 10 mg: 31.3%, empagliflozin 25 mg: 36.2%, plaċebo 34.7%).
English: Volume depletion1, 2
Maltese: Żvojtar tal-volum1,
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection1, 2
Maltese: Monilijasi vaġinali, vulvovaġinite,
English: Due to the metformin component, co-administration of anaesthesia can increase the risk of side effects.
Maltese: metformin, l-għoti flimkien tal-anesteżija jista' jżid ir-riskju ta' effetti sekondarji.
English: Each Synjardy 5 mg/850 mg film-coated tablet (tablet) contains 5 mg empagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull Synjardy 5 mg/850 mg pillola miksija b'rita fiha 5 mg empagliflozin u 850 mg metformin hydrochloride.
English: Synjardy should be discontinued, at least temporarily, until the situation is clarified.
Maltese: Synjardy għandu jitwaqqaf, tal-anqas temporanjament, sakemm is-sitwazzjoni tiġi ċċarata.
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 3), and a clinically meaningful reduction in FPG, compared to glimepiride.
Maltese: f'pazjenti b'kontroll gliċemiku inadegwat li qegħdin fuq metformin biss, it-trattament b'empagliflozin kuljum irriżulta fi tnaqqis superjuri f'HbA1c (Tabella 3), u tnaqqis klinikament validu fil-FPG, meta mqabbel ma' glimepiride.
English: N HbA1c (%) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N Patients (%) achieving HbA1c <7% with baseline HbA1c ≥7%2 N Body Weight (kg) Baseline (mean) Change from baseline1 Difference from placebo1 (97.5% CI) N SBP (mmHg)2 Baseline (mean) Change from baseline1 Difference from placebo1 (95% CI)
Maltese: Proporzjon akbar ta' pazjenti bl-HbA1c fil-linja bażi ≥ 7.0% u kkurati b'empagliflozin flimkien ma' linagliptin kisbu HbA1c fil-mira ta' < 7% mqabbel ma' linagliptin 5 mg.
English: The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Maltese: Jekk jogħġbok innota r-riskju partikolari li ġej ta' aċidożi lattika.
English: • itching
Maltese: (NSAID).
English: 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: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: it-trasportatur ewlieni responsabbli għall-assorbiment ta' glukosju fl-imsaren.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Maltese: EU/1/15/1003/025 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/026 180 (2 x 90 x 1) pilloli miksija b'rita EU/1/15/1003/027 200 (2 x 100 x 1) pilloli miksija b'rita
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Maltese: EU/1/15/1003/034 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/035 180 (2 x 90 x 1) pilloli miksija b'rita EU/1/15/1003/036 200
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Maltese: EU/1/15/1003/016 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/017 180 (2 x 90 x 1) pilloli miksija b'rita EU/1/15/1003/018 200 (2 x 100 x 1) pilloli miksija b'rita
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 2 packs, each containing 60 x 1 film-coated tablets.
Maltese: Pakkett multiplu li fih 2 pakketti, kull wieħed fih 60 x 1 pillola miksija b'rita.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Maltese: EU/1/15/1003/007 120 (2 x 60 x 1) pilloli miksija b'rita EU/1/15/1003/008 180 (2 x 90 x 1) pilloli miksija b'rita EU/1/15/1003/009 200 (2 x 100 x 1) pilloli miksija b'rita
English: Patients with baseline HbA1c ≥9% In a pre-specified analysis of subjects with baseline HbA1c ≥9.0%, treatment with empagliflozin
Maltese: Pazjenti bl-HbA1c fil-linja bażi ≥ 9%
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: 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: This may induce metformin accumulation and may increase the risk for lactic acidosis.
Maltese: Dan jista' jwassal għal akkumulazzjoni ta' metformin u jista' jżid ir-riskju ta' aċidożi lattika.
English: - Keep this leaflet.
Maltese: kulħadd.
English: Peak plasma levels of empagliflozin were roughly 20% higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function.
Maltese: empagliflozin fil-plażma kienu madwar 20% ogħla f'individwi b'indeboliment tal-kliewi ħafif għal sever meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: (95% CI) a Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy bSubgroup analysis for patients on additional background of metformin (FAS, LOCF) 1 Mean adjusted for baseline value
Maltese: a 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: Diuretics
Maltese: Ketoaċidosi
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: