FrancophonIA/ELRC3.0 huggingface dataset:
English: United Kingdom Orion Pharma (UK) Ltd. Tel: +44 1635 520 300
Maltese: Orion Pharma Poland Sp. z o.o. Tel.: +48 22 8333177
English: In clinical studies, undesirable dopaminergic effects, e.g. dyskinesia, were more common in patients who received entacapone and dopamine agonists (such as bromocriptine), selegiline or amantadine compared to those who received placebo with this combination.
Maltese: Fi studji kliniċi, irriżulta li effetti dopaminerġiċi mhux mixtieqa (eż. diskineżja) kienu aktar komuni f'pazjenti li ħadu entacapone u agonisti ta' dopamine (bħal bromocriptine), selegiline jew amantadine, milli f'dawk il-pazjenti li rċevew plaċebo ma' din it-taħlita.
English: Pharmacokinetic interaction with benserazide has not been studied.
Maltese: L-interazzjoni farmakokinetika ma' benserazide ma ġietx studjata.
English: It is available as tablets (5 mg).
Maltese: Jiġi f'pilloli (5 mg).
English: The full EPAR for Desloratadine Actavis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Desloratadine Actavis jinstab ukoll fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Desloratadine Actavis is a ‘generic medicine'.
Maltese: Desloratadine Actavis huwa ‘mediċina ġenerika'.
English: Desloratadine Actavis is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Maltese: Desloratadine Actavis jintuża biex itaffi s-sintomi tar-rinite allerġika (infjammazzjoni fil-passaġġi nażali kkawżata minn allerġija, pereżempju minn riħ tal-ħuxlief (hay fever) jew allerġija għal akari tat-trab (dust mites) jew urtikarja (kundizzjoni fil-ġilda kkawżata minn allerġija, b'sintomi li jinkludu ħakk u ħorriqija).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Desloratadine Actavis on 13 January 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Desloratadine Actavis fl-13 ta' Jannar 2012.
English: This is a summary of the European public assessment report (EPAR) for Desloratadine Actavis.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Desloratadine Actavis.
English: Desloratadine Actavis is a medicine containing the active substance desloratadine.
Maltese: Desloratadine Actavis huwa mediċina li fiha s-sustanza attiva desloratadina.
English: The CHMP concluded that, in accordance with EU requirements, Desloratadine Actavis has been shown to have comparable quality and to be bioequivalent to Aerius.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, intwera li l-kwalità ta' Dasselta Actavis hija kumparabbli mal-prodott mediċinali bijoekwivalenti Aerius.
English: The active substance in Desloratadine Actavis, desloratadine, is an antihistamine.
Maltese: Is-sustanza attiva f'Desloratadine Actavis, id-desloratadina, hija sustanza antistaminika.
English: Because Desloratadine Actavis is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aerius.
Maltese: Billi Desloratadine Actavis huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet li jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza Aerius.
English: Why has Desloratadine Actavis been approved?
Maltese: Għaliex ġie approvat Desloratadine Actavis?
English: Because Desloratadine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Ġaladarba Desloratadine Actavis huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Desloratadine Actavis?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Desloratadine Actavis?
English: What is Desloratadine Actavis?
Maltese: Kif tintuża Desloratadine Actavis?
English: This means that Desloratadine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aerius.
Maltese: Dan ifisser li Desloratadine Actavis jixbah lill-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Aerius.
English: How has Desloratadine Actavis been studied?
Maltese: Kif ġie studjat Desloratadine Actavis?
English: The full EPAR for Poulvac E. coli can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Poulvac E. coli jinsab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Other information about Poulvac E. coli:
Maltese: Aktar informazzjoni dwar Poulvac E. coli:
English: It contains the live bacteria Escherichia coli, type O78, strain EC34195 with a gene (aroA) deleted.
Maltese: Fih il-batterji ħajjin Escherichia coli, tip O78, razza EC34195 b'ġene (aroA) imneħħi.
English: Poulvac E. coli contains small amounts of the bacterium E. coli serotype O78.
Maltese: Poulvac E. coli fih ammonti żgħar tal-batterju E. colserotip O78.
English: Poulvac E. coli is a vaccine that is used in chickens and turkeys for active immunisation against an infection caused by Escherichia coli serotype O78 called colibacillosis.
Maltese: Poulvac E. coli huwa vaċċin li jintuża fit-tiġieġ u d dundjani għal immunizzazzjoni attiva kontra infezzjoni kkawżata mill-Escherichia coli serotip O78 imsejjaħ kolibaċillożi.
English: This is a summary of the European Public Assessment Report (EPAR) for Poulvac E. coli.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Poulvac E. coli.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Poulvac E. coli on 15 June 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea għal Poulvac E. coli fil-15 ta' Ġunju 2012.
English: Poulvac E. coli avian colibacillosis vaccine (live)
Maltese: Poulvac E. coli vaċċin tal-kolibaċillożi avjarja (ħaj)
English: Colibacillosis can cause injuries to the sac that surrounds the heart (pericarditis), the sac surrounding the liver (perihepatitis) and the ‘air sacs', the specialised bags within the bird's body where air is stored during breathing (airsacculitis), and can lead to death of the bird.
Maltese: Il-kolibaċillożi tista' tikkawża ġrieħi fil-borża ta' madwar il-qalb (perikardite), il-borża ta' madwar il-fwied (periepatite) u l-‘boroż talarja', il-boroż speċifiċi fil-ġisem tat-tajra fejn tinħażen l-arja waqt it-teħid tan-nifs (erakkulità), u tista' twassal għall-mewt tat-tajra.
English: What are the risks associated with Poulvac E. coli?
Maltese: X'inhuma r-riskji assoċjati ma' Poulvac E. coli?
English: The field study with over 200,000 commercial broilers showed a significant reduction in colibacillosis lesions and deaths in vaccinated animals.
Maltese: L-istudju fuq il-post b'aktar minn 200,000 tiġieġa tassimna wera tnaqqis konsiderevoli ta' ġrieħi u mwiet ikkawżati mill-kolibaċillożi fl-annimali mlaqqma.
English: Why is Poulvac E. coli approved?
Maltese: Għaliex ġie approvat Poulvac E. coli?
English: The studies also demonstrated that the vaccine provides chickens with eight weeks protection against colibacillosis lesions and 12 weeks protection against mortality from colibacillosis with spray vaccination and 12 weeks protection against lesions and mortality with drinking water vaccination.
Maltese: L-istudji wrew ukoll li lvaċċin jipprovdi lit-tiġieġ bi 8 ġimgħat protezzjoni kontra l-ġrieħi tal-kolibaċillożi u 12-il ġimgħa protezzjoni kontra l-mortalità mill-kolibaċillożi b'tilqima bl-isprej u 12-il ġimgħa protezzjoni kontra ġrieħi u mortalità b'tilqima mal-ilma tax-xorb.
English: It can only be obtained with a prescription.
Maltese: It-tajr jikkonsma t-tilqima meta jnaddaf rixu.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Poulvac E. coli's benefits are greated that its risks and recommended that it be approved in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Poulvac E. coli huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat fl-UE.
English: Animals undergoing antibacterial or immunosuppressive treatment (treatment that reduces the activity of the immune system) should not be vaccinated.
Maltese: L-annimali li jkunu qegħdin jieħdu kura antibatterika jew immunosoppressiva (kura li tnaqqas l-attività tas-sistema immunitarja) m'għandhomx jitlaqqmu.
English: When Poulvac E. coli is given to a chicken or turkey, the animal's immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against it.
Maltese: Fil-futur, jekk l-annimali jkunu esposti għall-batterji, issistema immunitarja tkun tista' tipproduċi l-antikorpi aktar malajr.
English: How is Poulvac E. coli used?
Maltese: Kif jaħdem Poulvac E. coli?
English: Poulvac E. coli is available as a freeze dried powder (lyophilisate) which can be made into a suspension.
Maltese: Poulvac E. coli jiġi bħala trab lijofilizzat li jista' jsir f'suspensjoni.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1139/001 OCALIVA
Maltese: Mnejn jingħata Il-pakkett
English: Vabomere (meropenem / vaborbactam)
Maltese: Vabomere (meropenem / vaborbaktam)
English: Further information on Vabomere can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vabomere.
Maltese: ema.europa.eu/medicines/human/EPAR/Vabomere.
English: Other information about Vabomere
Maltese: Informazzjoni oħra dwar Vabomere
English: • complicated abdominal infections of the tissues and organs in the belly (intra-abdominal infections);
Maltese: • infezzjonijiet ikkumplikati addominali tat-tessuti u tal-organi fiż-żaqq (infezzjonijiet intra addominali);
English: Tests for bacteria in the urine found that 67% (128 out of 192) of patients treated with Vabomere were cured, compared with 58% (105 out of 182) of patients treated with piperacillin and tazobactam.
Maltese: It-testijiet għall-batterji fl-urina sabu li 67 % (128 minn 192) tal-pazjenti kkurati b'Vabomere fiequ, meta mqabbla ma' 58 % (105 minn 182) tal-pazjenti kkurati b'piperaċillin u tażobaktam.
English: The first study, involving patients with complicated urinary tract infection (including kidney infection), compared Vabomere with a combination of piperacillin (another beta-lactam antibiotic) and tazobactam (a beta-lactamase inhibitor).
Maltese: L-ewwel studju, li involva pazjenti b'infezzjoni kkumplikata tal-apparat urinarju (inkluża infezzjoni tal-kliewi), qabbel Vabomere ma' kombinazzjoni ta' piperaċillin (antibijotiku beta-lattamiku ieħor) u tażobaktam (inibitur betalattamażi).
English: Vabomere contains the active substances meropenem and vaborbactam.
Maltese: Vabomere fih is-sustanzi attivi meropenem u vaborbaktam.
English: How is Vabomere used?
Maltese: Vabomere?
English: Of those treated with Vabomere, overall 60% (21 out of 35) of patients were cured, compared with 32% (6 out of 19) of patients receiving best available antibiotic treatment.
Maltese: Minn dawk ikkurati b'Vabomere, b'mod ġenerali 60 % (21 minn 35) tal-pazjenti fiequ, meta mqabbla ma' 32 % (6 minn 19) tal-pazjenti li ħadu l-aħjar kura antibijotika disponibbli.
English: • complicated (difficult-to-treat) infections of the urinary tract, including kidneys;
Maltese: • infezzjonijiet ikkumplikati (li diffiċli tikkurahom) tal-apparat tal-awrina, inklużi l-kliewi;
English: What are the risks associated with Vabomere?
Maltese: X'inhuma r-riskji assoċjati ma' Vabomere?
English: The active substances in Vabomere, meropenem and vaborbactam, work in different ways.
Maltese: Iż-żewġ sustanzi attivi f'Vabomere, il-meropenem u l-vaborbaktam, jaħdmu b'modi differenti.
English: The second study involved patients with complicated urinary tract infection (including kidney infection), complicated intra-abdominal infections, lung infections caught in hospital and bacteraemia.
Maltese: It-tieni studju involva pazjenti b'infezzjoni kkumplikata fl-apparat tal-awrina (inkluża infezzjoni talkliewi), infezzjonijiet ikkumplikati intra-addominali, infezzjonijiet tal-pulmun li jittieħdu mill-isptar u batteremija.
English: Vabomere was found effective at treating infections in two studies.
Maltese: Vabomere nstab li kien effettiv fil-kura ta' infezzjonijiet f'żewġ studji.
English: Fewer patients treated with Vabomere (14%) died within 4 weeks compared with those receiving best available antibiotic treatment (26%).
Maltese: Inqas pazjenti kkurati b'Vabomere (14 %) mietu fi żmien 4 ġimgħat meta mqabbla ma' dawk li ħadu l-aqwa kura antibijotika disponibbli (26 %).
English: Meropenem belongs to the carbapenem class of antibiotics, which belongs to the wider group of antibiotics known as beta-lactams.
Maltese: Ilmeropenem tappartjeni għall-klassi ta' antibijotiċi tal-karbapenem, li tappartjeni għall-grupp usa' ta' antibijotiċi magħrufa bħala beta-lattamiċi.
English: As for all medicines, data on the use of Vabomere are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Vabomere hija ssorveljata kontinwament.
English: For the full list of side effects of Vabomere, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Vabomere, ara l-fuljett ta' tagħrif.
English: Side effects reported with Vabomere are carefully evaluated and any necessary action taken to protect patients.
Maltese: Leffetti sekondarji rrappurtati b'Vabomere huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: It can also be used for infections caused by Gram-negative bacteria when other treatments might not work.
Maltese: Jista' jintuża wkoll għal infezzjonijiet ikkawżati minn batterji Gram-negattivi meta kuri oħra jistgħu ma jaħdmux.
English: No special concerns about side effects have been raised by the addition of vaborbactam to meropenem.
Maltese: Ma kien hemm ebda tħassib speċjali dwar l-effetti sekondarji maż-żieda ta' vaborbaktam ma' meropenem.
English: How does Vabomere work?
Maltese: Kif jaħdem Vabomere?
English: The most common side effects with Vabomere (which may affect up to 1 in 10 people) are headache, diarrhoea, inflammation of the vein around the infusion site and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Vabomere (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma wġigħ ta' ras, dijarea, infjammazzjoni tal-vina madwar is-sit tal-infużjoni u nawżja (tħossok ma tiflaħx).
English: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe).
Maltese: • infezzjonijiet tal-pulmun li jittieħdu mill-isptar (pulmonite li ttieħdet mill-isptar), li jinkludu pulmonite assoċjata ma' ventilazzjoni mekkanika (pulmonite li tittieħed minn ventilazzjoni mekkanika, li hija magna li tgħin lil pazjent biex jieħu n-nifs).
English: Why is Vabomere authorised in the EU?
Maltese: Għaliex Vabomere huwa awtorizzat fl-UE?
English: Vaborbactam is a beta-lactamase inhibitor, which means that it blocks the action of bacterial enzymes called beta-lactamases.
Maltese: Il-vaborbaktam hija inibitur beta-lattamażi, li jfisser li timblokka l-azzjoni ta' enzimi batteriċi li jissejħu beta-lattamażi.
English: Vabomere must not be used in patients who are hypersensitive (allergic) to any carbapenem antibiotic or in patients who have had a severe allergic reaction to the broader class of beta-lactam antibiotics (such as penicillins and cephalosporins).
Maltese: Vabomere m'għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għal kwalunkwe antibijotiku karbapenem jew f'pazjenti li kellhom reazzjoni allerġika severa għall-klassi usa' ta' antibijotiċi betalattamiċi (bħall-peniċillini u ċ-ċefalosporini) Għal-lista sħiħa tar-restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: These enzymes break down beta-lactam antibiotics such as meropenem and stop them from working.
Maltese: Dawn l-enzimi jkissru l-antibijotiċi beta-lattamiċi bħal meropenem u jwaqqfuhom milli jaħdmu.
English: Rashc, Urticaria rare
Maltese: Raxxc, Urtikarja rari
English: ATC code: A10BD16.
Maltese: A10BD16.
English: Erythema, Pruritis, Urticaria
Maltese: Eritema, Ħakk, Urtikarja
English: Balanitis or balanoposthitis**, h
Maltese: Balanite jew balanopostite**, h
English: The mean Vd ranged between 63- 276 litres.
Maltese: Il-medja ta' Vd kienet fuq firxa bejn 63-276 litru.
English: • Severe renal failure (GFR < 30 mL/min) (see sections 4.2 and 4.4);
Maltese: • Insuffiċjenza renali severa (GFR <30 mL/min) (ara sezzjonijiet 4.2 u 4.4);
English: Vulvovaginal candidiasis**, g common
Maltese: Kandidjasi vulvovaġinali**, g komuni
English: For the list of excipients, see section 6.1.
Maltese: Għal-lista ta' eċċipjenti, ara sezzjoni 6.1.
English: Metformin increases the transport capacity of the membrane glucose transporters GLUT-1 and GLUT-4.
Maltese: Metformin iżid il-kapaċità ta' trasport tat-trasportaturi tal-glukożju GLUT-1 u GLUT-4 tal-membrana.
English: Drug/laboratory test interference
Maltese: Interferenza bejn il-mediċina/test tal-laboratorju
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp B3-B4, Etaj 3
Maltese: Tipografilor nr. 11-15 Clădirea S-Park, Corp B3-B4, Etaj 3
English: The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
Maltese: L-effett li wieħed ikun homozygote (UGT1A9*3/*3, frekwenza< 0.1%) probabbilment ikun aktar aċċentwat, iżda ma ġiex investigat.
English: Immune system disorders rare
Maltese: Disturbi fis-sistema immuni rari
English: See section “Vokanamet with alcohol”.
Maltese: Ara s-sezzjoni, “Vokanamet ma' alkoħol”.
English: Patients with GFR 45 mL/min to < 60 mL/min
Maltese: Pazjenti b'GFR minn 45 mL/min sa < 60 mL/min
English: Tablet core: microcrystalline cellulose, hypromellose, croscarmellose sodium, and magnesium stearate.
Maltese: Qalba tal-pillola: microcrystalline cellulose, hypromellose, croscarmellose sodium, u magnesium stearate.
English: Maximum total daily dose is 300 mg.
Maltese: Doża totali massima ta' kuljum hi 300 mg.
English: (18 weeks) Canagliflozin + insulin
Maltese: Canagliflozin + insulina
English: Sitagliptin 100 mg + metformin and sulfonylurea (N = 378)
Maltese: Sitagliptin 100 mg + metformin u sulphonylurea (N = 378)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 April 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 23 t'April 2014
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 malalbumina.
English: • Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis);
Maltese: • Kull tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi dijabetika);
English: Vokanamet contains two different active substances, canagliflozin and metformin.
Maltese: Vokanamet fih żewġ sustanzi attivi differenti, canagliflozin u metformin.
English: Gastrointestinal disorders common
Maltese: Disturbi gastrointestinali komuni
English: EU/1/14/918/001 (50 mg/850 mg - 20 tablets) EU/1/14/918/002 (50 mg/850 mg - 60 tablets) EU/1/14/918/003 (50 mg/850 mg - 180 tablets) EU/1/14/918/004 (50 mg/1000 mg - 20 tablets) EU/1/14/918/005 (50 mg/1000 mg - 60 tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 tablets) EU/1/14/918/007 (150 mg/850 mg - 20 tablets) EU/1/14/918/008 (150 mg/850 mg - 60 tablets) EU/1/14/918/009 (150 mg/850 mg - 180 tablets) EU/1/14/918/010 (150 mg/1000 mg - 20 tablets) EU/1/14/918/011 (150 mg/1000 mg - 60 tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 tablets)
Maltese: EU/1/14/918/001 (50 mg/850 mg - 20 pillola) EU/1/14/918/002 (50 mg/850 mg - 60 pillola) EU/1/14/918/003 (50 mg/850 mg - 180 pillola) EU/1/14/918/004 (50 mg/1000 mg - 20 pillola) EU/1/14/918/005 (50 mg/1000 mg - 60 pillola) EU/1/14/918/006 (50 mg/1000 mg - 180 pillola) EU/1/14/918/007 (150 mg/850 mg - 20 pillola) EU/1/14/918/008 (150 mg/850 mg - 60 pillola) EU/1/14/918/009 (150 mg/850 mg - 180 pillola) EU/1/14/918/010 (150 mg/1000 mg - 20 pillola) EU/1/14/918/011 (150 mg/1000 mg - 60 pillola) EU/1/14/918/012 (150 mg/1000 mg - 180 pillola)
English: (hypoglycaemia)
Maltese: (ipogliċemija).
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 end-stage renal disease (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 8 individwi b'indeboliment qawwi tal-kliewi (CrCl < 30 mL/min) kif ukoll 8 individwi fl-aħħar stadju ta'mard tal-kliewi (ESRD - end-stage renal disease) fuq id-dijaliżi tad-demm.
English: • a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p = 0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p = 0.021)
Maltese: • tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5 każ/1,000 sena ta' pazjent versus dieta waħedha 20.6 każ/1,000 sena ta' pazjent, (p = 0.011), u versus il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina 18.9 każ/1,000 sena ta' pazjent (p = 0.021)
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: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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: Cholestyramine may potentially reduce canagliflozin exposure.
Maltese: Hemm possibbiltà li cholestyramine jnaqqas l-esponiment għal canagliflozin.
English: Gastro-intestinal symptomsb
Maltese: Sintomi gastrointestinali b
English: The racial distribution of patients who received canagliflozin was 72% White, 16% Asian, 4% Black, and 8% other groups.
Maltese: Id-distribuzzjoni tar-razez tal pazjenti li rċevew canagliflozin kienet 72% Bojod, 16% Asjatiċi, 4% Suwed, u 8% gruppi oħra.
English: Glimepiride (titrated) + metformin (N = 482)
Maltese: Canagliflozin + metformin Glimepiride (titrat) + metformin (N = 482)