FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment with dapagliflozin 10 mg as a monotherapy or as an add-on to either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in FPG (-1.90 to -1.20 mmol/L [-34.2 to -21.7 mg/dL]) compared to placebo (-0.33 to 0.21 mmol/L [-6.0 to 3.8 mg/dL]).
Maltese: Kura b'dapagliflozin 10 mg bħala monoterapija jew miżjud ma' metformin, glimipiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wasslet għal tnaqqis statistikament sinifikanti tal-FPG (-1.90 għal -1.20 mmol/L [-34.2 għal -21.7 mg/dL]) imqabbel mal-plaċebo (-0.33 għal 0.21 mmol/L [-6.0 għal 3.8 mg/dL]).
English: • Contact details of the dapagliflozin prescriber' and ‘Name of patient'.
Maltese: • Dettalji ta' kuntatt tal-preskrivent ta' dapagliflozin u “Isem il-pazjent”.
English: Least squares mean adjusted for baseline value Non-inferior to glipizide + metformin p-value < 0.0001
Maltese: Mhux inferjuri għal glipizide + metformin valur-p < 0.0001
English: Efficacy Parameter
Maltese: Parametru taleffikaċja
English: • Guide for Health Care Professionals including a prescriber's checklist
Maltese: • Gwida għall-Professjonisti tal-Kura tas-Saħħa inkluż lista ta' kontroll tal-preskrivent
English: In an add-on to glimepiride study, at Weeks 24 and 48, minor episodes of hypoglycaemia were reported more frequently in the group treated with dapagliflozin 10 mg plus glimepiride (6.0% and 7.9%, respectively) than in the placebo plus glimepiride group (2.1% and 2.1%, respectively).
Maltese: Fi studju fejn ġie miżjud glimepiride, fil-ġimgħat 24 u 48, episodji minuri ta' ipogliċemija kienu rrappurtati b'mod aktar frekwenti fil-grupp ikkurat b'dapagliflozin 10 mg ma' glimepiride (6.0% u 7.9% rispettivament) milli fil-grupp bi plaċebo ma' glimepiride (2.1% u 2.1% rispettivament).
English: Results at Week 24 (LOCF a) of a placebo-controlled study of dapagliflozin as monotherapy
Maltese: Riżultati f'Ġimgħa 24 (LOCF a) ta' studju kontrollat bi plaċebo b'dapagliflozin bħala monoterapija
English: • Do not start caloric restriction or carbohydrate restriction while treated
Maltese: • Tibdiex restrizzjoni kalorika jew restrizzjoni tal-karboidrati waqt li qed tiġi kkurat
English: Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati mill-investigaturi bħala possibbilment relatati, probabbilment relatati jew relatati mal-kura talistudju u rrapportati f'≥ 0.2% tal-individwi u ≥ 0.1% iktar u mill-inqas 3 individwi iktar ittrattati b'10 mg dapagliflozin meta mqabbla ma' plaċebo.
English: Superiority of dapagliflozin over placebo was not demonstrated for MACE (p=0.172).
Maltese: Is-superjorità ta' dapagliflozin fuq il-plaċebo ma ntwerietx għal MACE (p=0.172).
English: • The risk of DKA is increased with dapagliflozin treatment.
Maltese: • Ir-riskju ta' DKA jiżdied bil-kura b'dapagliflozin.
English: Eighty-one percent (81%) of the subjects had a body mass index (BMI)  27.
Maltese: Wieħed u tmenin fil-mija (81%) tal-individwi kellhom indiċi tal-massa tal-ġisem (BMI) ≥ 27.
English: Statistically significant (p < 0.0001) differences in percent reduction of total insulin dose from baseline for dapagliflozin 5 mg relative to placebo at Week 24 were -8.80% and -10.78% in the two studies, respectively.
Maltese: Differenzi statistikament sinifikanti (p < 0.0001) fit-tnaqqis perċentwali tad-doża totali ta' insulina mil-linja bażi għal dapagliflozin relattiv għal plaċebo f'Ġimgħa 24 kienu -8.80% u -10.
English: The number of patients with severe hypoglycaemia was balanced across treatment groups (6.9% and 7.5% at Week 24 in the dapagliflozin 5 mg and placebo groups, respectively).
Maltese: In-numru ta' pazjenti b'ipogliċemija severa kien ibbilanċjat fil-gruppi talkura (6.9%, 7.4% u 7.5% f'Ġimgħa 24 fil-gruppi ta' dapagliflozin 5 mg, 10 mg u plaċebo, rispettivament).
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Postmarketing cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene) have been reported in female and male patients taking SGLT2 inhibitors (see section 4.8).
Maltese: Ġew irrappurtati każijiet ta' wara t-tqegħid fis-suq ta' faxxite nekrotizzanti tal-perinew (magħrufa wkoll bħala kankrena ta' Fournier) f'pazjenti nisa u rġiel li kienu qed jieħdu inibituri ta' SGLT2 (ara sezzjoni 4.8).
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to -0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
Maltese: Fi studju ddedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2, il-kura b'dapagliflozin uriet tnaqqis fil-FPG f'Ġimgħa 24: -1.19 mmol/L (-21.46 mg/dL) meta mqabbel ma' -0.27 mmol/L (-4.87 mg/dL) għall-plaċebo (p=0.001).
English: In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, respectively, compared to healthy matched control subjects.
Maltese: F'individwi b'indeboliment epatiku ħafif jew moderat (Klassijiet Child-Pugh A u B) is-Cmax u AUC medji ta' dapagliflozin kienu sa' 12 u 36% ogħla, rispettivament, meta mqabbla ma' individwi b'saħħithom imqabbla għall-kontroll.
English: - At blood ketone readings over 3.0 mmol/L (or urine ketones reading +++) you probably have diabetic ketoacidosis, go to the emergency department without delay and stop taking Forxiga.
Maltese: - Għal qari tal-“ketone” fid-demm aktar minn 3.0 mmol/L (jew qari tal-“ketone” fl-awrina +++) probabbli għandek ketoaċidożi dijabetika, mur f'dipartiment tal-emerġenza mingħajr dewmien u ieqaf ħu Forxiga.
English: Urine Ketone Actions
Maltese: Ketone fl-Awrina Azzjonijiet
English: Forxiga is indicated in adults for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.
Maltese: Forxiga huwa indikat f'adulti għall-kura ta' dijabete mellitus tat-tip 1 mhux ikkontrollata biżżejjed bħala żieda mal-insulina f'pazjenti b'BMI ≥ 27 kg/m2, meta l-insulina waħidha ma tipprovdix kontroll gliċemiku xieraq minkejja l-aħjar terapija bl-insulina.
English: Forxiga5mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli Forxiga 5 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: - At blood ketone readings over 1.5 to 3.0 mmol/L (or urine ketones reading ++) you may be developing diabetic ketoacidosis, seek medical advice immediately and stop taking Forxiga.
Maltese: - Għal qari tal-“ketone” fid-demm aktar minn 1.5 sa 3.0 mmol/L (jew qari tal-“ketone” flawrina ++) jaf qed tiżviluppa ketoaċidożi dijabetika, fittex parir mediku immedjatament u ieqaf ħu Forxiga.
English: In the dapagliflozin cardiovascular outcomes study with 17,160 type 2 diabetes mellitus patients and a median exposure time of 48 months, a total of 6 cases of Fournier's gangrene were reported, one in the dapagliflozin-treated group and 5 in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin bi 17,160 pazjent bid-dijabete mellitus tat-tip 2 u żmien ta' esponiment medjan ta' 48 xahar, ġew irrappurtati total ta' 6 każijiet ta' kankrena ta' Fournier, wieħed fil-grupp ikkurat b'dapagliflozin u 5 fil-grupp ikkurat bi plaċebo.
English: LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Maltese: LOCF: l-aħħar osservazzjoni (qabel is-salvataġġ ta' pazjenti salvati) miġjuba 'l quddiem L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju double-blind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi p-value <0.0001.
English: Dapagliflozin 10 mg demonstrated non-inferiority versus placebo for the composite of cardiovascular death, myocardial infarction or ischaemic stroke (one-sided p < 0.001).
Maltese: Dapagliflozin 10 mg wera superjorità kontra plaċebo fil-prevenzjoni tal- kompost ta' dħul fl-isptar għal insuffiċjenza tal-qalb jew mewt kardjovaskulari (Figura 1).
English: • The other ingredients are: tablet core: microcrystalline cellulose (E460i), lactose (see section 2 ‘Forxiga contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Maltese: Kull pillola Forxiga 10 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), lactose (ara sezzjoni 2 ‘Forxiga fih lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b). - kisja tar-rita: polyvinyl alcohol (E1203), titanium dioxide (E171),macrogol 3350, talc (E553b), yellow iron oxide (E172).
English: Forxiga is indicated in adults for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise - as monotherapy when metformin is considered inappropriate due to intolerance.
Maltese: Forxiga huwa indikat f'adulti għall-kura ta' dijabete mellitus tat-tip 2 mhux ikkontrollata biżżejjed bħala żieda mad-dieta u mal-eżerċizzju - bħala monoterapija meta metformin huwa meqjus mhux xieraq minħabba nuqqas ta' tolleranza.
English: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Maltese: Il-valutazzjoni primarja tas-sigurtà u t-tollerabbiltà sar f'analiżi kollettiva speċifikata minn qabel ta' 13-il studju ta' perjodu qasir (sa 24 ġimgħa) ikkontrollat bil-plaċebo bi 2,360 individwu kkurati b'dapagliflozin 10 mg u 2,295 kkurati bi plaċebo.
English: Fourteen double-blind, randomised, controlled clinical studies were conducted with 7,056 subjects with type 2 diabetes to evaluate the glycaemic efficacy and safety of Forxiga; 4,737 subjects in these studies were treated with dapagliflozin.
Maltese: Erbatax-il studju kliniku double-blind, randomised, ikkontrollati twettqu b' 7,056 individwu b'dijabete mellitus tat-tip 2 sabiex ikunu evalwati s-sigurtà u l-effikaċja gliċemika ta' Forxiga; 4,737 individwu f'dawn l-istudji kienu kkurati b'dapagliflozin.
English: Forxiga10mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Maltese: Il-pilloli Forxiga 10 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: • Signs/symptoms of DKA - if not adequately managed DKA can be severe and fatal.
Maltese: • Sinjali/sintomi ta' DKA - jekk ma tiġix immaniġġjata b'mod adegwat, DKA tista' tkun severa u fatali.
English: • Talk with your doctor about the risk of diabetic ketoacidosis before you start to take Forxiga.
Maltese: • Tkellem mat-tabib tiegħek dwar ir-riskju ta' ketoaċidożi dijabetika qabel tibda tieħu Forxiga.
English: If Fournier's gangrene is suspected, Forxiga should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk tiġi suspettata kankrena ta' Fournier, Forxiga għandu jitwaqqaf u għandha tinbeda kura minnufih (li tinkludi antibijotiċi u tneħħija kirurġika).
English: • The Patient Alert Card should be presented to any HCP consulted.
Maltese: • Il-Kard ta' Twissija tal-Pazjent għandha tiġi ppreżentata lil kwalunkwe HCP ikkonsultat.
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%).
Maltese: Fi studju mhux inferjuri ta' 52-ġimgħa, kontrollat b'mod attiv (b'perjodi ta' estensjoni ta' 52 ġimgħa u ta' 104 ġimgħat), Forxiga kien evalwat bħala terapija add-on imqabbel ma' sulphonylurea (glipizide) miżjud ma' terapija b'metformin f'individwi b'kontroll gliċemiku mhux xieraq (HbA1c > 6.5% u ≤ 10%).
English: Improvement in homeostasis model assessment for beta cell function (HOMA beta-cell) has been observed in clinical studies with Forxiga.
Maltese: Titjib fl-istima talmudell tal-omejostasi għall-funzjoni taċ-ċelluli beta (HOMO ċelluli-beta) deher fi studji kliniċi b'Forxiga.
English: • It should be ensured that ketone levels are normal.
Maltese: • Għandu jiġi żgurat li l-livelli tal-“ketone” ikunu normali.
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 8), and led to greater reductions in fasting plasma glucose (FPG) (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metformin (sa 2000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 8), u wasslet għal tnaqqis ikbar fl-FPG (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metformin).
English: Prior to launch of the new adult indication for dapagliflozin, for the treatment of insufficiently controlled type 1 diabetes mellitus as an adjunct to insulin in patients with BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycaemic control despite optimal insulin therapy, in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational materials, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Miżuri addizzjonali għall-minimizzazzjoni tar-riskji Qabel it-tnedija tal-indikazzjoni ġdida fl-adulti għal dapagliflozin, għall-kura ta' dijabete mellitus tattip 1 mhux ikkontrollata biżżejjed bħala żieda mal-insulina f'pazjenti b'BMI ≥ 27 kg/m2, meta linsulina waħidha ma tipprovdix kontroll gliċemiku adegwat minkejja l-aħjar terapija bl-insulina, f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jaqbel dwar ilkontenut u l-format tal-materjal edukattiv, inkluż midja tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in fasting plasma glucose (FPG) (compared to the individual components) and body weight (compared to metformin).
Maltese: Il-kura b'dapagliflozin 10 mg f'kombinazzoni ma' metformin (sa 2000 mg kuljum) ipprovdiet titjib sinifikanti fl-HbA1c meta mqabbel mal-komponenti individwali (Tabella 6), u wasslet għal tnaqqis ikbar fl-FPG (meta mqabbel mal-komponenti individwali) u fil-piż tal-ġisem (meta mqabbel ma' metformin).
English: p-values are two-sided.
Maltese: 24 ġimgħa.
English: dapagliflozin should be discontinued.
Maltese: dapagliflozin.
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Maltese: Pazjenti li jużaw pompa tal-infużjoni tal-insulina għandhom riskju ogħla ta' DKA u għandhom ikollhom esperjenza fl-użu tal-pompa, strateġiji komuni tas-soluzzjoni ta' problemi meta jseħħu interruzzjonijiet tal-għoti tal-insulina permezz tal-pompa (problemi bis-sit tal-inserzjoni, tubu msaddad, riżerva vojta, eċċ.) u l-użu ta' injezzjonijiet tal-insulina supplimentali b'pinna jew siringa kif meħtieġ f'każ li ma taħdimx il-pompa.
English: HbA1c (%) Baseline (mean) Change from baseline
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi
English: If well tolerated, the dose may be increased to 10 mg when indicated (see sections 4.1 of the 10 mg SmPC, 4.4 and 5.2).
Maltese: Jekk tkun tollerata sew, iddoża tista' tiżdied għal 10 mg meta jiġi indikat (ara sezzjonijiet 4.1 tal-SmPC ta' 10 mg, 4.4 u 5.2).
English: • It should be ensured that the patient demonstrates the ability to monitor ketone levels.
Maltese: • Pazjenti li ma jistgħux jew ma jridux jimmonitorjaw il-“ketones”.
English: Ketonaemia
Maltese: Dijuretiċi
English: • Patients should be informed, in a dedicated education session, on the risk of DKA, how to recognize DKA risk factors, signs or symptoms, how and when to monitor ketone levels and what actions to take at elevated ketone readings (see section 4.4).
Maltese: • Il-pazjenti għandhom jiġu infurmati, f'sessjoni ta' edukazzjoni ddedikata, dwar ir-riskju ta' DKA, kif jirrikonoxxu fatturi ta' riskju ta' DKA, sinjali jew sintomi, kif u meta għandhom jimmonitorjaw il-livelli tal-“ketone” u x'azzjonijiet għandhom jieħdu meta l-qari tal-“ketone” ikun għoli (ara sezzjoni 4.4).
English: How to take Forxiga
Maltese: X'inhu Forxiga
English: The safety profile of dapagliflozin in subjects with type 1 diabetes mellitus was similar to the known safety profile of dapagliflozin in subjects with type 2 diabetes mellitus, with the exception of a higher number of DKA events in dapagliflozin-treated subjects in the type 1 diabetes mellitus studies.
Maltese: Il-profil tas-sigurtà ta' dapagliflozin f'individwi b'dijabete mellitus tat-tip 1 kien simili għall-profil tas-sigurtà magħruf ta' dapagliflozin f'individwi b'dijabete mellitus tat-tip 2, bl-eċċezzjoni ta' numru ogħla ta' avvenimenti ta' DKA f'individwi kkurati b'dapagliflozin fl-istudji tad-dijabete mellitus tattip 1.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glucose fid-demm, inqas minn 14 mmol/L (250 mg/dL).
English: • DKA may occur in patients treated with dapagliflozin even if blood glucose levels are below 14 mmol/l (250 mg/dl), i.e. an explanation of the concept of euglycaemic DKA
Maltese: • DKA tista' sseħħ f'pazjenti kkurati b'dapagliflozin anki jekk il-livelli tal-glucose fid-demm ikunu inqas minn 14 mmol/l (250 mg/dl), jiġifieri, spjegazzjoni tal-kunċett ta' DKA ewgliċemika.
English: What Forxiga looks like and contents of the pack Forxiga 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Maltese: • Forxiga 10 mg pilloli miksijin b'rita huma sofor u b'forma ta' djamant madwar 1.1 x 0.8 cm mid-dijagonali.
English: • For pump users: restrict dapagliflozin prescription to patients experienced in pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur in case of pump failure.
Maltese: • Għall-utenti tal-pompa: illimita l-preskrizzjoni ta' dapagliflozin għal pazjenti li għandhom esperjenza fl-użu tal-pompa, strateġiji komuni ta' soluzzjoni ta' problemi meta jseħħu interruzzjonijiet tal-għoti tal-insulina permezz tal-pompa f'każ li ma taħdimx il-pompa.
English: Tablet core
Maltese: Primary Endpoints
English: These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat - rapid weight loss.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi dijabetika (ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet): - livelli ogħla ta' “korpi ketone” fl-awrina jew fid-demm tiegħek - tħossok ma tiflaħx jew tkun ma tiflaħx - uġigħ fl-istonku - għatx eċċessiv - nifs mgħaġġel u fil-fond - konfużjoni - ngħas mhux tas-soltu jew għejja - riħa ħelwa ta' mnifsejk, togħma ħelwa jew metallika f'ħalqek, jew riħa differenti tal-awrina jew l-għaraq tiegħek
English: Results of one 28-week study of dapagliflozin and prolonged-release exenatide versus dapagliflozin alone and prolonged-release exenatide alone, in combination with metformin (intent to treat patients)
Maltese: Riżultati ta' studju wieħed ta' 28 ġimgħa ta' dapagliflozin u exenatide li jerħi lmediċina bil-mod meta mqabbel ma' dapagliflozin waħdu u exenatide li jerħi l-mediċina bil-mod waħdu, f'kombinazzjoni ma' metformin (intenzjoni li jikkura l-pazjenti)
English: What Forxiga looks like and contents of the pack Forxiga 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Maltese: Forxiga 5 mg pilloli miksijin b'rita huma sofor u tondi b'dijametru ta' 0.7 cm.
English: ATCvet code: QP53AX73.
Maltese: QP53AX73.
English: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne FRANCE
Maltese: Ceva Santé Animale 10, av. de La Ballastière 33500 Libourne FRANZA
English: Date of last renewal: 08/02/2019
Maltese: Data tal-aħħar tiġdid: 08/02/2019
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Vectra Felis spot-on
Maltese: VETERINARJU Vectra Felis spot-on
English: 1 spot-on applicator 3 spot-on applicators 4 spot-on applicators 6 spot-on applicators 12 spot-on applicators 24 spot-on applicators
Maltese: 3 applikaturi lokalizzati 4 applikaturi lokalizzati 6 applikaturi lokalizzati 12-il applikatur lokalizzat 24 applikatur lokalizzat
English: Pyriproxyfen is a photostable insect growth regulator (IGR).
Maltese: Pyriproxyfen huwa r-regolatur ta' żvilupp fotostabbli tal-insett (‘Insect Growth Regulator', IGR).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/06/2014
Maltese: Data tal-ewwel awtorizzazzjoni: 06/06/2014
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali trattati li juru effett(i) mhux mistieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal trattat) - mhux komuni (aktar minn wieħed iżda inqas minn 10 annimali f'1,000 annimal trattat) - rari (aktar minn wieħed iżda inqas minn 10 annimali f'10,000 annimal trattat) - rari ħafna (inqas minn animal wieħed f'10,000 animal trattat, inklużi rapporti iżolati).
English: Method and route of administration:
Maltese: Metodu u rotta t'amministrazzjoni: