FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Drugs used in diabetes, Other blood glucose lowering drugs, excluding insulins, ATC code: A10BX09
Maltese: Mediċini li jintużaw fid-dijabete, Mediċini oħra li jbaxxu l-glukows fid-demm, eskl. insulini, Kodiċi ATC:
English: Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1Metformin ≥ 1500 mg/day; 2sitagliptin 100 mg/day aLOCF: Last observation (prior to rescue for rescued subjects) carried forward bAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value *p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + oral glucose-lowering medicinal product
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + prodott mediċinali li jbaxxi l-glukows
English: 2Fifty percent of subjects were on insulin monotherapy at baseline; 50% were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80% were on metformin alone, 12% were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Maltese: Minn dan il-grupp tal-aħħar, 80% kienu fuq metformin waħdu, 12% kienu fuq metformin flimkien ma' terapija b'sulphonylurea, u l-oħrajn kienu fuq prodotti mediċinali orali li jbaxxu l-glukows.
English: The mean change from baseline in HbA1c at 24 weeks was -0.44% and -0.33%, for dapagliflozin 10 mg and placebo, respectively.
Maltese: 06% mil-linja bażi għal dapagliflozin 10 mg u plaċebo, rispettivament.
English: The safety and efficacy of dapagliflozin in children aged 0 to < 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' dapagliflozin fit-tfal minn età ta' 0 sa' < 18-il sena ma ġewx determinati s'issa.
English: Primary episodes occurred at a rate of 1.62% per patient-year in subjects treated with dapagliflozin and 2.06% in comparator-treatment subjects, per patient-year.
Maltese: L-episodji primarji seħħew bir-rata ta' 1.62% kull sena ta' pazjent f'pazjenti ttrattati b'dapagliflozin u b'rata ta' 2.06% f'pazjenti ttrattati bi prodott ta' paragun.
English: Studies with add-on sulphonylurea and add-on insulin therapies had higher rates of hypoglycaemia (see section 4.5).
Maltese: Studji fejn ġew miżjuda terapiji b'sulphonylurea u terapiji b'insulina kellhom rati ogħla ta' ipogliċemija (ara sezzjoni 4.5).
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: At 48 weeks, the difference for dapagliflozin as add-on to sitagliptin (with or without metformin) compared with placebo was -2.22 kg. At 102 weeks, the difference for dapagliflozin as add-on to metformin compared with placebo, or as add-on to insulin compared with placebo was -2.14 and -2.88 kg, respectively.
Maltese: Wara 48 ġimgħa, id-differenza għal dapagliflozin bħala sustanza miżjuda ma' sitagliptin (bi jew mingħajr metformin) meta mqabbel ma' plaċebo kienet -2.22 kg.
English: − tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 ‘Forxiga contains lactose'), crospovidone (E1201), silicon dioxide (E551), magnesium stearate (E470b).
Maltese: Kull pillola Forxiga 5 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin 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), anhydrous lactose (ara sezzjoni 2 ‘Forxiga fih lactose'), crospovidone (E1201), silicon dioxide (E551), magnesium stearate (E470b). - kisja tar-rita: polyvinyl alcohol (E1203), titanium dioxide (E171),macrogol 3350, talc (E553b), yellow iron oxide (E172).
English: The effects of smoking, diet, herbal products and alcohol use on the pharmacokinetics of dapagliflozin have not been studied.
Maltese: L-effett tat-tipjip, dieta, prodotti mill-ħxejjex u l-użu tal-alkoħol fuq il-farmakokinetika ta' dapagliflozin ma kienux studjati.
English: adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Maltese: F'individwi ≥ 65 sena, reazzjonijiet avversi ta' tnaqqis fil-volum, irrappurtati bl-aktar mod komuni bħala pressjoni baxxa, kienu rrappurtati f'1.7% u 0.8% tal-individwi ikkurati b'dapagliflozin u tal-pazjenti ikkurati bi plaċebo rispettivament (ara sezzjoni 4.4).
English: Further evaluation of patients who had renal-related adverse events showed that most had serum creatinine changes of ≤ 0.5 mg/dL from baseline.
Maltese: Evalwazzjoni ulterjuri tal-pazjenti li kellhom avvenimenti avversi relatati mal-kliewi uriet li ħafna kellhom tibdil fil-kreatinina fis-serum ta' ≤ 0.5 mg/dL mil-linja bażi.
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products), the HbA1c reductions were -0.71% and -0.06% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Maltese: F'Ġimgħa 104 għall-insulina (bi jew mingħajr prodotti mediċinali li jbaxxu l-livell ta' glukożju orali addizzjonali), it-tnaqqis fl-HbA1c kien bidla medja aġġustata ta' -0.71% u -0.
English: Bristol-Myers Squibb S.r.l.
Maltese: Glukows fl-awrina
English: These subjects had detectable glucose in the urine for a dose-related period of time (at least 5 days for the 500 mg dose), with no reports of dehydration, hypotension or electrolyte imbalance, and with no clinically meaningful effect on QTc interval.
Maltese: Dawn l-individwi kellhom glukows li seta' jitkejjel fl-awrina għal perijodu ta' ħin relatat mad-doża (mill-anqas 5 ijiem għal doża ta' 500 mg), blebda rapport ta' deidratazzjoni, pressjoni baxxa jew żbilanċ fl-elettroliti, u bl-ebda effett ta' sinifikat kliniku fuq l-intervall QTc.
English: Due to the limited therapeutic experience in patients 75 years and older, initiation of dapagliflozin therapy is not recommended.
Maltese: Minħabba l-esperjenza terapewtika limitata f'pazjenti li għandhom 75 sena jew aktar, mhux rakkomandat li tinbeda terapija b'dapagliflozin .
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju ogħla ta' DKA jinkludu pazjenti b'riżerva ta' funzjoni baxxa ta' betaċelluli (eż. pazjenti bid-dijabete tat-tip 2 b' C-peptide baxx jew dijabete awtoimmuni moħbija fl-adulti (LADA) jew pazjenti bi storja ta' pankreatite), pazjenti b'kundizzjonijiet li jwasslu għal teħid restritt tal-ikel jew deidrazzjoni severa, pazjenti li għalihom jitnaqqsu d-dożi tal-insulina u pazjenti b'rekwiżiti miżjuda tal-insulina minħabba mard mediku akut, kirurġija jew abbuż tal-alkoħol.
English: EXP
Maltese: LOCF:
English: Body weight (kg) Baseline (mean) Change from baseline c
Maltese: Piż tal-ġisem (kg) Linja bażi (medja) Bidla mil-linja bażi c
English: The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared to glipizide, thus demonstrating non-inferiority (Table 3).
Maltese: Ir-riżultati wrew medja ta' tnaqqis fl-Hb1Ac simili mil-linja bażi sa' Ġimgħa 52, imqabbel ma' glipizide, b'hekk juri li mhux inferjuri (Tabella 3).
English: Volume depletion
Maltese: U KWANTITATTIVA
English: Creatinine renal clearance decreasedb
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: (95% CI) Subjects with mean daily insulin dose reduction of at least 10% (%) LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: Waqt provi kliniċi, il-proporzjon globali tal-individwi b'tumuri malinni jew mhux speċifikati kien simili bejn dawk ikkurati b'dapagliflozin (1.50%) u plaċebo/kumparatur (1.50%), u ma kienx hemm sinjal ta' kanċeroġinità jew mutaġeniċità mid-dejta fl-annimali (ara sezzjoni 5.3). Meta jitqiesu ilkażijiet ta' tumuri li jseħħu fis-sistemi differenti tal-organi, il-punt tal-istima għar-riskju relattiv assoċjat ma' dapagliflozin kien akbar minn 1 għal xi tumuri (bużżieqa tal-awrina, prostata, sider) u taħt 1 għal oħrajn (eż demm u limfatika, ovarji, passaġġ renali), ma wassalx għal żieda fir-riskju globali ta' tumur assoċjat ma' dapagliflozin.
English: • Keep this medicine out of the sight and reach of children.
Maltese: • jekk ta' spiss jaqbduk infezzjonijiet fil-passaġġ tal-awrina.
English: Patients with baseline HbA1c ≥ 9%
Maltese: Individwi (%) li kisbu: HbA1c < 7% (LOCF)
English: Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Maltese: Interruzzjoni temporanja tal-kura b'dapagliflozin hija rakkomandata f'pazjenti li jiżviluppaw nuqqas ta' volum sakemm in-nuqqas jiġi ikkoreġut (ara sezzjoni 4.8).
English: (95% CI) Subjects (%) achieving: HbA1c < 7% (LOCF)d Adjusted for baseline Body weight (kg) (LOCF)d Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1glimepiride 4 mg/day; 2Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose, which must be at least half maximum dose, of a sulphonylurea for at least 8 weeks prior to enrollment.
Maltese: 2Metformin (formulazzjonijiet li jerħu l-mediċina mill-ewwel jew bil-mod) ≥1500 mg/jum flimkien mad-doża massima ttollerata, li trid tkun mill-anqas nofs id-doża massima, ta' sulphonylurea għal mill-anqas 8 ġimgħat qabel ir-reġistrazzjoni.
English: Results at Week 24 (LOCFa) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products)
Maltese: a) b'dapagliflozin f'taħlita miżjud mal-insulina (waħidha jew ma' prodotti mediċinali orali li jbaxxu l-glukows)
English: Inhibition of glucose and sodium co-transport by dapagliflozin is also associated with mild diuresis and transient natriuresis.
Maltese: Inibizzjoni tal-ko-trasport ta' glukows u sodium permezz ta' dapagliflozin hija assoċjata wkoll ma' dijuresi ħafifa u natrijuresi transitorja.
English: • diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - 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.
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 - telf fil-piż f'qasir żmien - 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: In an add-on to metformin and a sulphonylurea study, up to 24 weeks, no episodes of major hypoglycaemia were reported.
Maltese: Fi studju fejn ġie miżjud ma' metformin u sulphonylurea, sa 24 ġimgħa, ma ġie rrappurtat l-ebda episodju ta' ipogliċemija maġġuri.
English: Possible signs of dehydration are listed at the top of section 4, ‘Possible side effects'.
Maltese: Is-sinjali li jista' jkun hemm ta' deidratazzjoni qed jiġu elenkati fil-parti ta' fuq ta' sezzjoni 4, “Effetti sekondarji li jista' jkollu”.
English: In a juvenile toxicity study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Maltese: Fi studju dwar it-tossiċita fiż-żgħar, meta dapagliflozin ingħata direttament lill-firien żgħar minn jum 21 wara t-twelid sa' jum 90 wara t-twelid, dilatazzjonijiet renali pelviċi u tubulari kienu rrappurtati fil-livelli tad-dożi kollha; l-esponiment ta' wild bl-aktar dożi baxxi eżaminati kienu ≥ 15-il darba l-ogħla mid-doża rakkomandata fil-bniedem.
English: Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia.
Maltese: Insulina u sustanzi li jikkawżaw il-ħelsien tal-insulina, bħal sulphonylureas, jikkawżaw ipogliċemija.
English: Nb
Maltese: b
English: A 24-week study in 182 diabetic subjects using dual energy X-ray absorptiometry (DXA) to evaluate body composition demonstrated reductions with dapagliflozin 10 mg plus metformin compared with placebo plus metformin, respectively, in body weight and body fat mass as measured by DXA rather than lean tissue or fluid loss.
Maltese: Studju ta' 24 ġimgħa f'182 individwi dijabetiċi permezz ta' assorbimetrija b'raġġi-X b'enerġija duplika (DXA) sabiex tiġi evalwata l-kompożizzjoni tal-ġisem wera tnaqqis b'dapagliflozin 10 mg flimkien ma' metformin meta mqabbel mal-plaċebo ma' metformin, rispettivament, fil-piż tal-ġisem u fil-massa tax-xaħam fil-ġisem imkejjel bid-DXA minflok tessut mingħajr xaħam jew telf ta' fluwidi.
English: CBC III, Karadžičova 12
Maltese: III, Karadžičova 12
English: Lactose anhydrous Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate
Maltese: Lactose anhydrous Microcrystalline cellulose Hydroxypropyl cellulose Croscarmellose sodium Magnesium stearate
English: Invokana contains lactose
Maltese: Invokana fih lactose
English: ATC code: A10BX11.
Maltese: A10BX11.
English: Balanitis or balanoposthitis**, h
Maltese: Balanite jew balanopostite**,h
English: Iron oxide yellow (E172)
Maltese: Iron oxide isfar (E172)
English: How to take Invokana
Maltese: Tiħux Invokana
English: INFORMATION IN BRAILLE invokana 100 mg invokana 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE invokana 100 mg invokana 300 mg
English: Each tablet contains 39.2 mg lactose.
Maltese: Kull pillola fiha 39.2 mg lactose.
English: Malta AM MANGION LTD.
Maltese: MANGION LTD.
English: Each tablet contains 117.78 mg lactose.
Maltese: Kull pillola fiha 117.78 mg lactose.
English: rare
Maltese: rari
English: Canagliflozin + insulin
Maltese: Canagliflozin + insulina
English: Vulvovaginal candidiasis**, g common
Maltese: Kandidjasi vulvovaġinali**,g komuni
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2013
English: Elderly (≥ 65 years old)
Maltese: Anzjani (età ≥ 65 sena)
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Maltese: • carbamazepine, phenytoin, jew phenobarbital (mediċini li jintużaw biex jikkontrollaw l aċċessjonijiet)
English: Drug/Laboratory test interference
Maltese: Interferenza bejn il-mediċina/test tal-laboratorju
English: • The other ingredients are: tablet core: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, and microcrystalline cellulose film-coating: macrogol (3350), polyvinyl alcohol, talc, and titanium dioxide (E171).
Maltese: • Is-sustanzi l-oħra huma: qalba tal-pillola: croscarmellose sodium, hydroxypropyl cellulose, lactose anhydrous, magnesium stearate, u microcrystalline cellulose kisja tar-rita: macrogol (3350), polyvinyl alcohol, talc u titanium dioxide (E171).
English: SI-1000 Ljubljana Tel: +386 1 401 18 30
Maltese: Ljubljana Tel: +386 1 401 18 30
English: The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
Maltese: (UGT1A9*3/*3, frekwenza< 0.1%) probabbilment ikun aktar aċċentwat, iżda ma ġiex investigat.
English: Dehydration*
Maltese: Deidratazzjoni*
English: CZ-150 00 Praha 5 - Smíchov Tel: +420 227 012 227
Maltese: Praha 5 - Smíchov Tel: +420 227 012 227
English: • The active substance is canagliflozin.
Maltese: • Is-sustanza attiva hija canagliflozin.
English: Angioedemad
Maltese: Anġjoedemad
English: Via C. Janssen Borgo San Michele 04100 Latina Italy
Maltese: Janssen Borgo San Michele 04100 Latina L-Italja
English: Gastrointestinal disorders common
Maltese: Disturbi gastro-intestinali komuni
English: The racial distribution was 72% White, 16% Asian, 4% Black, and 8% other groups.
Maltese: Iddistribuzzjoni tar-razez kienet 72% Bojod, 16% Asjatiċi, 4% Suwed, u 8% gruppi oħra.
English: Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin.
Maltese: Canagliflozin jintrabat b'mod estensiv mal-proteini fil-plażma (99%), l-aktar mal-albumina.
English: Both UGT1A9 and UGT2B4 are subject to genetic polymorphism.
Maltese: Kemm UGT1A9 kif ukoll UGT2B4 huma suġġetti għal polimorfiżmu ġenetiku.
English: Enzyme inducers (such as St. John's wort [Hypericum perforatum], rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may give rise to decreased exposure of canagliflozin.
Maltese: John's wort [Hypericum perforatum], rifampicin, barbiturati, phenytoin, carbamazepine, ritonavir, efavirenz) jistgħu jikkawżaw tnaqqis fl-esponiment għal canagliflozin.
English: The pack sizes are cartons of 10 x 1, 30 x 1, 90 x 1, or 100 x 1 tablets.
Maltese: Iddaqsijiet tal-pakkett huma kartun ta' 10 x 1, 30 x 1, 90 x 1, or 100 x 1 pillola/i.
English: Hrvatska Johnson & Johnson S.E.
Maltese: Hrvatska Johnson & Johnson S.E. d.o.o.
English: The study included 8 subjects with normal renal function (CrCl ≥ 80 mL/min), 8 subjects with mild renal impairment (CrCl 50 mL/min to < 80 mL/min), 8 subjects with moderate renal impairment (CrCl 30 mL/min to < 50 mL/min), and 8 subjects with severe renal impairment (CrCl < 30 mL/min) as well as 8 subjects with ESRD on haemodialysis.
Maltese: L-istudju inkluda 8 individwi b'funzjoni normali tal-kliewi (CrCl ≥ 80 mL/min), 8 individwi b'indeboliment ħafif tal-kliewi (CrCl 50 mL/min sa < 80 mL/min), 8 individwi b'indeboliment moderat tal-kliewi (CrCl 30 mL/min sa < 50 mL/min), u
English: Investigations common
Maltese: Investigazzjonijiet komuni
English: Monotherapy (26 weeks) Canagliflozin
Maltese: Monoterapija (26 ġimgħa) Canagliflozin
English: • rifampicin (an antibiotic used to treat tuberculosis)
Maltese: • rifampicin (antibijotiku li jintuża biex jikkura t-tuberkulożi)
English: Placebo + insulin (N = 565)
Maltese: Plaċebo + insulina (N = 565)
English: The apparent terminal half-life (t1/2) (expressed as mean ± standard deviation) was 10.6 ± 2.13 hours and 13.1 ± 3.28 hours for the 100 mg and 300 mg doses, respectively.
Maltese: Il-half-life terminali apparenti (t1/2) (espressa bħala medja ± standard deviation) kienet 10.6 ± 2.13 sigħat u 13.1 ± 3.28 sigħat għad-dożi ta' 100 mg u 300 mg, rispettivament.
English: No clinically relevant effect on CYP3A4 was observed in vivo (see section 4.5).
Maltese: Ma kien osservat l-ebda effett kliniku rilevanti fuq CYP3A4 in vivo (ara sezzjoni 4.5). Eliminazzjoni
English: Frequency categories are defined according to the following convention: 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), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti skont il-konvenzjoni li ġejja: 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), rari ħafna (< 1/10,000),
English: ** See section 4.4.
Maltese: * Marbuta ma' tnaqqis fil-volum; ara sezzjoni 4.4. ** Ara sezzjoni 4.4.
English: Pack sizes of 10 x 1, 30 x 1, 90 x 1, and 100 x 1 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 10 x 1, 30 x 1, 90 x 1, u 100 x 1 pilloli/a miksija b'rita.
English: No data are available.
Maltese: L-ebda dejta m'hi disponibbli.
English: Patients with baseline HbA1c > 10% to ≤ 12%
Maltese: Pazjenti b'HbA1c > 10% sa ≤ 12% fil-linja bażi
English: The 100 mg tablet also contains iron oxide yellow (E172).
Maltese: Ilpillola ta' 100 mg fiha wkoll iron oxide isfar (E172).
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2,CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6, CYP3A4 at higher than therapeutic concentrations.
Maltese: CYP2B6, CYP2C8, CYP2C9, u lanqas induċa CYP1A2, CYP2C19, CYP2B6, CYP3A4 taċ-ċitokroma P450 f'konċentrazzjonijiet ogħla minn dawk terapewtiċi.
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (AUC) and peak concentration (Cmax) were observed.
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-mediċini), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (AUC)
English: 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Maltese: 3% versus 4.0%; kolesterol LDL 5.7% u 9.3% versus 1.3%; kolesterol mhux HDL 2.2% u 4.4% versus 0.7%; trigliċeridi 2.4% u 0.0% versus 7.6%.
English: Dizziness postural*, Syncope*
Maltese: Sturdament mal-waqqaf*, Sinkope*
English: • Invokana 300 mg film-coated tablets (tablets) are white, capsule-shaped, 17 mm long, with
Maltese: • Invokana 300 mg pilloli miksijin b'rita (pilloli) huma bojod, għamla ta' kapsula, twal 17-il mm,
English: Placebo + metformin (N=183)
Maltese: Plaċebo + metformin (N = 183)
English: Add-on therapy with insulind (18 weeks)
Maltese: Terapija miżjuda mal-insulinad (18-il ġimgħa)
English: Dyslipidemiai, Haematocrit increased**, j uncommon
Maltese: Dislipidemijai, Żieda fl-ematokrit**,j mhux komuni
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience System organ class Frequency
Maltese: Tabella 1: Lista f'tabella ta' reazzjonijiet avversi (MedDRA) fi studji kkontrollati bi plaċeboa u mill-esperjenza ta' wara t-tqegħid fis-suq Klassi tas-sistemi u tal-organi Frekwenza
English: • efavirenz or ritonavir (a medicine used to treat HIV infection)
Maltese: • efavirenz jew ritonavir (mediċina li tintuża biex tikkura infezzjoni bl-HIV)
English: compared to 0.0% for placebo.
Maltese: 0.3% għall-plaċebo.
English: Diabetic ketoacidosis**
Maltese: Ketoaċidożi tad-dijabete**
English: PL-02-135 Warszawa Tel.: +48 22 237 60 00
Maltese: Warszawa Tel.: +48 22 237 60 00
English: Cholestyramine may potentially reduce canagliflozin exposure.
Maltese: Hemm possibbiltà li cholestyramine inaqqas l-esponiment għal canagliflozin.
English: If interrupted, consideration should be given to more frequent glucose monitoring.
Maltese: Jekk jitwaqqaf, għandu jitqies monitoraġġ aktar frekwenti tal glukows.
English: CrCl < 60 mL/min.
Maltese: 30, u 100 mg/kg.
English: “CFZ” on one side and “300” on the other side.
Maltese: b“CFZ” fuq naħa waħda u “300” fuq in-naħa l-oħra.
English: Lactose intolerance
Maltese: Intolleranza għall-lactose