FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000 including isolated reports).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (≥1/100, <1/10), mhux komuni (≥1/1000, <1/100), rari (≥1/10,000, <1/1000) u rari ħafna (<1/10,000 inclużi rapporti iżolati).
English: Glimepiride increases the activity of glycosyl-phosphatidylinositol-specific phospholipase C, which may be associated with drug-induced lipogenesis and glycogenesis in isolated fat and muscle cells.
Maltese: Glimepiride iżid l-attivita` tal- glycosyl-phosphatidylinositol-specific phospholipase C, li jista' jiġi assoċjat ma' lipoġenesi u glikoġenesi kaġunati minn mediċini f'ċelluli iżolati tax-xaħam u l-muskoli.
English: Since glimepiride belongs to the chemical class of sulphonylurea drugs, caution should be used in patients with G6PD-deficiency and a non-sulphonylurea alternative should be considered.
Maltese: Peress li glimepiride tagħmel parti mil-klassi kimika ta' mediċini sulphonylurea, għandha tintuża kawtela f'pazjenti b'nuqqas ta' G6PD u alternattiva li mhijiex sulphonylurea għandha tiġi kkunsidrata.
English: The protein binding of the major metabolite (a para-hydroxy-sulphate) is very high (> 99.99%).
Maltese: L-irbit tal-proteini tal-metabolit prinċipali (sulfat para-hydroxy) hu għoli ħafna (99.99%).
English: Frequencies are defined as: rare ≥1/10,000, <1/1000 and very rare <1/10,000 including isolated reports.
Maltese: Il-frekwenzi huma definiti bħala: rari ≥1/10,000, <1/1000 u rari ħafna <1/10,000 inclużi rapporti iżolati.
English: This was based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and fertility.
Maltese: Dan kien bażat fuq studji konvenzjonali ta' sigurta` farmakoloġika, tossiċita` minn dożi ripetuti, ġenotossiċita`, karċinoġeneċita`, u fertilita`.
English: Rosiglitazone should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Maltese: Rosiglitazone għandu jintuża b'attenzjoni waqt li jkun jittieħed flimkien ma' impedituri CYP2C8 (e.g. gemfibrozil) jew inducers (e.g. rifampicin).
English: The AUC and Cmax of glimepiride increased in a dose-proportional manner following administration of rosiglitazone-glimepiride 4 mg/1 mg, 4 mg/2 mg, and 4 mg/4 mg.
Maltese: L-AUC u Cmax ta' glimepiride żdiedu b'mod proporzjonat skond id-dożi wara t-teħid ta' rosiglitazoneglimepiride 4 mg/1 mg, 4 mg/2 mg, u 4 mg/4 mg.
English: Hepatic impairment: Following rosiglitazone treatment in cirrhotic patients with moderate (ChildPugh B) hepatic impairment, unbound Cmax and AUC were 2- and 3-fold higher than in normal subjects.
Maltese: Wara trattament b'rosiglitazone fuq pazjenti ċirrotiċi bi ħsara moderata (Child-Pugh B) fil-fwied, unbound Cmax u AUC kienu 2 u 3 darbiet aktar minn dawk f'suġġetti normali.
English: Patients should be aware of the risk of pregnancy (see section 4.6).
Maltese: Il-pazjenti għandhom ikunu jafu bir-riskju li joħorġu tqal (ara sezzjoni 4.6).
English: 1 Hypercholesterolaemia was reported in up to 5.3% of patients treated with rosiglitazone
Maltese: 1 Iperkolesterolemija ġiet irrappurtata sa f'5.3% ta'pazjenti fuq terapija ta' rosiglitazone (monoterapija jew terapija orali doppja).
English: Very rare impairment of liver function (e.g. with cholestasis and jaundice)
Maltese: Rari ħafna indeboliment tal-funzjoni tal-fwied (e.g. b'kolestasi u suffejra)
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily produced a sustained improvement in glycaemic control (FPG and HbA1c).
Maltese: Fi studji li jieħdu massimu ta' tliet snin, rosiglitazone mogħti darba jew darbtejn kuljum ipproduċa titjib kontinwu fil-kontroll gliċemiku (FPG u HbA1c).
English: Frequencies are defined as: very common ≥ 1/10; common ≥ 1/100, < 1/10; and uncommon ≥ 1/1000, < 1/100.
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna ≥1/10; komuni ≥1/100, <1/10; u mhux komuni ≥1/1000, <1/100.
English: After intravenous dosing in normal subjects, the volume of distribution was 8.8 l (113 ml/kg), and the total body clearance was 47.8 ml/min.
Maltese: Wara dożi fil-vini fuq suġġetti normali, il-volum ta' distribuzzjoni kien 8.81 (113 ml/mg), u t-tneħħija totali mill-ġisem kienet 47.
English: Approximately 40% of the total radioactivity was recovered in faeces and M1 and M2 (predominant) accounted for about 70% of that recovered in faeces.
Maltese: Kważi 40% tar-radjoattivita` totali ġie rkuprat mill-purgar u M1 u M2 (predominanti) kienu jiffurmaw kważi 70% ta' dak irkuprat mill-purgar.
English: The potential
Maltese: EFFETTI
English: Elimination The elimination half-life of glimepiride is approximately 5 to 8 h. When 14C-glimepiride was given orally, approximately 60% of the total radioactivity was recovered in the urine in seven days and M1 (predominant) and M2 accounted for 80 to 90% of that recovered in the urine.
Maltese: Meta 14Cglimepiride ingħata mill-ħalq, kważi 60% tar-radjoattivita` totali ġiet irkuprata mill-awrina f'sebat ijiem u M1(predominanti) u M2 kienu jiffurmaw minn 80 sa 90% ta' dak irkuprat mill-awrina.
English: M1, but not M2, possesses about 1/3 of the pharmacological activity as compared to its parent in an animal model.
Maltese: M1, iżda mhux M2, tippossiedi kważi 1/3 ta' l-attivita` farmakoloġika meta mqabbla mal-ġenitur tagħha f'annimal mudell.
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3-4 h. There is no evidence for unexpected accumulation of rosiglitazone after once or twice daily dosing.
Maltese: Tneħħija ta' plażma totali ta' rosiglitazone hi madwar 3 l/s u l-half-life ta' eliminazzjoni terminali ta' rosiglitazone hi bejn wieħed u ieħor 3-4 s. Ma hemm ebda evidenza ta' xi akkumulazzjoni mhux mistennija ta' rosiglitazone wara dożi ta' darba jew darbtejn kuljum.
English: Concomitant administration of rosiglitazone with the oral anti-diabetic agents metformin, glimepiride, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
Maltese: It-teħid flimkien ta' rosiglitazone ma' l-aġenti anti-dijabetiċi mill-ħalq metformin, glimepiride, glibenclamide u acarbose ma rriżulta f'ebda interazzjoni farmakokinetika rilevanti klinika.
English: Co-administration of rosiglitazone with rifampicin (an inducer of CYP2C8) resulted in a 66% decrease in rosiglitazone plasma concentrations.
Maltese: L-għoti flimkien ta' rosiglitazone ma' rifampiċin (inducer ta' CYP2C8) irriżulta fi tnaqqis ta' 66% fil-konċentrazzjonijiet tal-plażma b'rosiglitazone.
English: Clinically significant interactions with CYP2C9 substrates or inhibitors are not anticipated.
Maltese: Interazzjonijiet sinifikanti kliniċi ma' substrati jew impedituri ta' CYP2C9 mhumiex mistennija.
English: Glimepiride should be used with caution during concomitant administration of CYP2C9 inhibitors (e.g. fluconazole) or inducers (see section 4.5).
Maltese: Glimepiride għandu jintuża b'attenzjoni waqt li jkun jittieħed flimkien ma' impedituri CYP2C9(e.g. fluconazole) jew inducers (ara sezzjoni 4.5).
English: The incidence of heart failure in combination with insulin (rosiglitazone added to established insulin therapy) was 2.4%, compared to insulin alone, 1.1%.
Maltese: L-inċidenza ta' waqfien tal-qalb f'kombinazzjoni ma' l-insulina (rosiglitazone miżjud ma' terapija b'insulina stabbilita) kienet ta' 2.4%, meta mqabbla ma' insulina waħedha, 1.1%.
English: MAO-inhibitors,
Maltese: impedituri MAO,
English: A switch to insulin should be considered in stress situations (e.g. trauma, surgery, infections).
Maltese: Wieħed jista' jdur għall-insulina f'sitwazzjonijiet ta' tensjoni (e.g trawma, operazzjoni, infezzjonijiet).
English: Two other long-term prospective randomised controlled clinical trials (9,620 patients, study duration >3 years in each study), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded the potential risk of cardiac ischaemia.
Maltese: Żewġ studji kliniċi oħra kbar fuq tul ta' żmien twil, prospettivi, randomised u kontrollati (9,620 pazjent, tul tal-istudju >3 snin f'kull studju), li qabblu rosiglitazone ma' xi aġenti orali anti-dijabetiċi jew plaċebo, ma kkonfermawx jew eskludew ir-riskju potenzjali ta' iskemija kardijaka.
English: • rifampicin (used to treat tuberculosis and other infections)
Maltese: • rifampicin (li jintuża biex jikkura t-tuberkulożi u nfezzjonijiet oħra)
English: Patients unable to achieve glycaemic control on at least half-maximum dose of other sulphonylurea monotherapy (except chlorpropamide, see section 4.4).
Maltese: Pazjenti li ma jistgħux jiksbu kontroll gliċemiku b'doża mill-anqas ta' nofs il-massimu ta' monoterapija oħra b'sulphonylurea (ħlief chlorpropamide, ara sezzjoni 4.4).
English: After oral administration, glimepiride is completely (100%) absorbed from the gastrointestinal tract.
Maltese: Wara li jittieħed mill-ħalq, glimepiride jiġi assorbit kompletament mill-apparat gastrointestinali.
English: Results from an vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.
Maltese: Riżultati minn studju dwar interazzjoni in vivo li dehru fl-istampa juru li glimepiride AUC jiżdied kważi għal darbtejn bil-fluconazole, wieħed mill-aktar impedituri potenti ta' CYP2C9.
English: The maximum recommended daily dose is 8 mg rosiglitazone/4 mg glimepiride (given as one AVAGLIM tablet 8 mg/4 mg, once daily).
Maltese: Id-doża massima rakkomandata għal kuljum hi 8 mg rosiglitazone/4 mg glimepiride (mogħtija bħala pillola waħda AVAGLIM 8 mg/4mg, darba kuljum.).
English: 4.4 Special warnings and precautions for use
Maltese: 4.3 Kontra-indikazzjonijiet
English: In a monotherapy study, the incidence in females for rosiglitazone was 9.3% (2.7 patients per 100 patient years) vs 5.1% (1.5 patients per 100 patient years) for metformin or 3.5% (1.3 patients per 100 patient years) for glibenclamide.
Maltese: Fi studju b'monoterapija, l-inċidenza fin-nisa għal rosiglitazone kienet 9.3% (2.7 pazjenti kull 100 sena ta' ħajja bħala pazjenti) vs 5.1% (1.5 pazjenti kull 100 sena ta' ħajja bħala pazjenti) għal metformin jew 3.5% (1.3 pazjenti kull 100 sena ta' ħajja bħala pazjenti) għal glibenclamide.
English: In an animal model for familial adenomatous polyposis (FAP), treatment with rosiglitazone at 200 times the pharmacologically active dose increased tumour multiplicity in the colon.
Maltese: F'mudell ta' annimal ittestjat għal polipożi familjali adenomatuża (FAP), il-kura b'rosiglitazone b'doża ta' 200 darba iktar mid-doża farmakoloġikament attiva żiedet il-multipliċità ta' tumuri filkolon.
English: The volume of distribution of rosiglitazone is approximately 14 l in healthy volunteers.
Maltese: Il-volum ta' distribuzzjoni ta' rosiglitazone hu bejn wieħed u ieħor 14 1 f'voluntieri f'saħħithom.
English: certain long acting sulphonamides, tetracyclines,
Maltese: tetracyclines,
English: Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients.
Maltese: Tabella 1 telenka reazzjonijiet mhux mixtieqa identifikati minn analiżi ta' provi kliniċi li nvolvew aktar minn 5,000 pazjent li kienu fuq trattament b'rosiglitazone.
English: Moreover in patients with congestive heart failure NYHA class I-II, a placebocontrolled one-year trial demonstrated worsening or possible worsening of heart failure in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Maltese: NYHA klassi I-II, prova ta' sena kontrollata bi plaċebo wriet deterjorament jew deterjorament possibbli ta' waqfien tal-qalb f'6.4% ta' pazjenti trattati b'rosiglitazone, meta mqabbla ma' 3.5% bi plaċebo.
English: 9 Elevation of liver enzymes may occur.
Maltese: 9 Jista' jkun hemm żieda fl-enzimi tal-fwied.
English: The major metabolite (a para-hydroxy-sulphate) with high affinity to the soluble human PPARγ, exhibited relatively high potency in a glucose tolerance assay in obese mice.
Maltese: Il-metabolit prinċipali (sulfat para-hydroxy) b'xebħ kbir mal-PPARγ uman li jinħall, wera potenza relattivament għolja f'analiżi ta' tolleranza ta' glukosju fi ġrieden ħoxnin.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates
Maltese: Studju in vivo dwar interazzjoni ma' warfarin indika li rosiglitazone ma joħloqx interazzjoni ma' substrati CYP2C9 in vivo.
English: Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e.g. rifampicin) or inhibitors (e.g.
Maltese: Hu magħruf li l-metaboliżmu tiegħu hu influwenzat mit-teħid konkomitanti ta' inducers (e.g. rifampicin) jew impedituri (e.g. fluconazole) ta' CYP2C9.
English: Adverse reaction
Maltese: Antagonisti
English: Κύπρος GlaxoSmithKline Cyprus Ltd
Maltese: SmithKline Beecham Ltd
English: AVAGLIM 4 mg/4 mg film-coated tablets AVAGLIM 8 mg/4 mg film-coated tablets rosiglitazone/glimepiride
Maltese: AVAGLIM pilloli ta' 4 mg/4 mg miksijin b'rita Rosiglitazone/glimepiride
English: For patients inadequately controlled on glimepiride monotherapy (typically 4 mg).
Maltese: Dwar pazjenti mhux kontrollati adegwatament b'monoterapija ta' glimepride (tipikament 4 mg).
English: Overdose of sulphonylureas, including glimepiride, can result in severe life-threatening hypoglycaemia lasting 12 to 72 hours, which may recur after apparent recovery.
Maltese: Doża eċċessiva ta' sulphonylureas, inkluż glimepiride, jistgħu iwasslu għal ipogliċemija li tista' tkun fatali u li ddum minn 12 sa 72 siegħa, li tista tirrepeti ruħha wara li tkun għaddiet.
English: What Avaglim looks like and contents of the pack Avaglim 4 mg/4 mg tablets are pink, rounded triangular-shaped, and marked "gsk" on one side and
Maltese: Id-dehra ta' Avaglim u l-kontenuti tal-pakkett Il-pilloli Avaglim 4mg/4mg huma roża, ittundjati, forma ta' trijanglu, u mmarkati "gsk" fuq naħa waħda u "4/4" fuq l-oħra.
English: Limited data with AVAGLIM is also consistent with this combined adverse reaction profile.
Maltese: Tagħrif limitat dwar AVAGLIM hu wkoll konsistenti ma' dan il-profil ta' reazzjoni avversa kombinata.
English: Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use or were caused by the pharmacodynamic effect (hypoglycaemia) of the substance.
Maltese: Effetti pre-kliniċi ġew osservati biss f'esponimenti meqjusa li jeċċedu suffiċjentement l-ogħla esponiment uman u indikaw rilevanza minima għal użu kliniku jew kienu kawżati mill-effett farmakokinetiku (ipogliċemija) tas-sustanza.
English: The contribution of the major metabolite (a para-hydroxy-sulphate) to the overall antihyperglycaemic activity of rosiglitazone has not been fully elucidated in man and it cannot be ruled out that the metabolite may contribute to the activity.
Maltese: Il-kontribuzzjoni tal-metabolit ewlieni (sulfat paraidrosija ) għall-attivita` ġenerali anti-ipergliċemika ta' rosiglitazone me ġietx iċċarata għal kollox filbniedem u ma jistax jiġi eskluż li l-metabolit jista' jikkontribwixxi għall-attivita`.
English: Red, biconvex, rounded triangular tablet with “gsk” debossed on one side and “8/4” on the other side
Maltese: Pillola ħamra, bi-konvessa, triangolari u magħmula fit-tond li għandha minqux “gsk” fuq naħa waħda u “8/4” fuq in-naħa l-oħra.
English: Treatment of patients with G6PD-deficiency with sulphonylurea agents can lead to haemolytic anaemia.
Maltese: Trattament b'sustanzi sulphonylurea, f'pazjenti li għandhom nuqqas ta' G6PD jista' jwassal għal anemija emolitika.
English: A multiple-dose titration study with glimepiride conducted in 16 patients with type 2 diabetes mellitus with renal impairment using doses ranging from 1 to 8 mg daily for three months showed that all patients with a creatinine clearance less than 22 ml/min had adequate control of their glucose levels with a dosage regimen of only 1 mg daily (see section 4.2 and 4.4).
Maltese: Studju ta' titrazzjoni b'ħafna dożi ta' glimepiride li twettqu fuq 16-il pazjent bid-dijabete mellitus ta' tip 2 b'indeboliment tal-kliewi bl-użu ta' dożi li jvarjaw minn 1 sa 8 mg kuljum għal tliet xhur urew li l-pazjenti kollha bi tneħħija ta' kreatinina li tkun inqas minn 22 ml/min kellhom kontroll adegwat tallivelli tal-glukosju tagħhom b'sistema ta' dożi ta' 1 mg biss kuljum (ara sezzjoni 4.2 u 4.4).
English: Patients with mild or moderate renal impairment (creatinine clearance 30 to 80 ml/min) may be at an increased risk of hypoglycaemia (see sections 4.2, 4.3 and 4.4).
Maltese: Pazjenti b'indeboliment ħafif jew moderat tal-kliewi (tneħħija ta' kreatinina 30 sa 80 ml/min) jistgħu ikunu f'riskju ogħla ta' ipogliċemija (ara sezzjonijiet 4.2, 4.3, u 4.4).
English: 3.6 (1.8) mg 1995.5 (682.6) mg *Similar relative effective doses (i.e approximately half maximal dose) for other sulphonylureas
Maltese: (682.6) mg *Dożi effettivi relattivi simili (i.e madwar nofs id-doża massima) għal sulphonylureas oħra (glibenclamide u glicazide).
English: Your doctor should regularly test your
Maltese: Inti jkollok testijiet tad-demm regolari
English: In clinical trials, the glucose lowering effects observed with rosiglitazone are gradual in onset with near maximal reductions in fasting plasma glucose (FPG) evident following approximately 8 weeks of therapy.
Maltese: Fi provi kliniċi, l-effetti li jnaqqsu l-glukosju osservati b'rosiglitazone jibdew bil-mod waqt li kważi ttnaqqis massimu fil-glukosju bi plażma fis-sawm (FPG) evidenti wara bejn wieħed u ieħor 8 ġimgħat ta' terapija.
English: Rosiglitazone can cause dose-dependent fluid retention.
Maltese: Rosiglitazone jista' jikkawża retenzjoni ta' fluwidu marbuta mad-doża.
English: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Maltese: Reazzjonijiet mhux mixtieqa għal kull terapija huma elenkati hawn taħt skond is-sistema tal-ġisem, klassi ta' organi u frekwenza assoluta.
English: Do not use Avaglim after the expiry date shown on the pack.
Maltese: Tużax Avaglim wara d-data ta' skadenza li tidher fuq il-pakkett.
English: In another long-term study, there was an increased incidence of bone fracture for subjects in the combined rosiglitazone group compared to active control [8.3% vs 5.3%, Risk ratio 1.57 (95% CI 1.26 - 1.97)].
Maltese: Fi studju ieħor fuq tul ta' żmien twil, kien hemm żjieda flinċidenza ta' ksur fl-għadam għall-individwi fil-grupp ta' rosiglitazone kombinat meta mqabbel malkontroll attiv [8.3% kontra 5.3%, Proporzjon ta' riskju 1.57 (95% CI 1.26 - 1.97)].
English: Glimepiride is an orally active hypoglycaemic substance belonging to the sulphonylurea group.
Maltese: Rosiglitazone maleate, membru tal-kategorija thiazolidinedione u glimepiride, membru tal-kategorija sulphonylurea.
English: Under the influence of sympatholytic drugs such as betablockers, clonidine, guanethidine and reserpine, the signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent.
Maltese: Taħt l-influwenza ta' mediċini simpatolitiċi bħal betablockers, clonidine, guanethidine u reserpine, issinjali ta' kontra-regolament adrenerġiku għal ipogliċemija jistgħu jonqsu jew ma jkunux hemm.
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone or glimepiride between males and females.
Maltese: Ġeneru: Minn ġabra ta' analiżi farmakokinetika tal-popolazzjoni, ma kien hemm ebda differenzi notevoli fil-farmakokinetiċi ta' rosiglitazone jew glimepiride bejn nisa u rġiel.
English: Each tablet contains either: 4 mg or 8 mg rosiglitazone and 4 mg glimepiride.
Maltese: Kull pillola fiha jew : 4 mg jew 8 mg rosiglitazone u 4 mg glimepiride.
English: Marketing Authorisation Holder: SmithKline Beecham Ltd, 980 Great West Road, Brentford,
Maltese: FIS-SUQ SmithKline Beecham Ltd, 980
English: • lower blood sugar than normal (hypoglycaemia)
Maltese: • zokkor fid-demm aktar baxx minn normal (ipogliċemija)
English: Glimepiride acts mainly by stimulating the release of insulin from the beta cells of the pancreas.
Maltese: Glimepiride taġixxi prinċipalment billi tistimula r-rilaxx ta' insulina miċ-ċelluli beta tal-pankreas.
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Maltese: It-twaħħil tal-proteini tal-plażma ta' rosiglitazone hu għoli (bejn wieħed u ieħor 99.8%) u mhuwiex influwenzat minn konċentrazzjoni jew minn eta`.
English: Avaglim 8 mg/4 mg tablets are red, rounded triangular-shaped, and marked "gsk" on one side and
Maltese: Il-pilloli Avaglim 8mg/4mg huma ħomor, ittundjati, forma ta' trijanglu u immarkati "gsk" fuq naħa waħda u "8/4" fuq l-oħra.
English: In the fed state, the rate and extent of absorption of the rosiglitazone-glimepiride 4 mg/4 mg combination were equivalent to concomitant administration of 4 mg rosiglitazone and 4 mg glimepiride.
Maltese: Fuq stonku mimli, ir-rata u l-firxa ta' assorbiment tal-kombinazzjoni rosiglitazone-glimepiride 4 mg/4 mg kienu ekwivalenti għat-teħid konkomitanti ta' 4 mg rosiglitazone u 4 mg glimepiride.
English: Very rare nausea
Maltese: Rari lewkopenja
English: 4.2 Posology and method of administration
Maltese: 4.6 Tqala u Treddigħ
English: Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone and 4 mg glimepiride.
Maltese: Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg rosiglitazone u 4 mg glimepiride.
English: The major routes of metabolism are N-demethylation and hydroxylation, followed by conjugation with sulphate and glucuronic acid.
Maltese: Ir-rotot ewlenin ta' metaboliżmu huma N-demetilazzjoni u idrosilazzjoni, segwiti konjugazzjoni ma' sulfat u aċidu glukuroniku.
English: An increase in the rosiglitazone component to 8 mg/day should be undertaken cautiously following appropriate clinical evaluation to assess the patient's risk of developing adverse reactions relating to fluid retention (see 4.4 and 4.8).
Maltese: Żjieda fil-komponent ta' rosiglitazone għal 8 mg/4 mg trid tiġi kkunsidrata b'attenzjoni wara evalwazzjoni klinika xierqa li tistabbilixxi r-riskju li pazjent jista' jiżviluppa effetti mhux mixtieqa relatati ma' retenzjoni ta' fluwidi (ara sezzjoni 4.4 u 4.8).
English: Very rare diarrhoea
Maltese: Rari tromboċitopenja
English: Premenopausal anovulatory women
Maltese: Rari anemija emolitika
English: - contains lactose (approximately 104 mg) For a full list of excipients, see section 6.1.
Maltese: Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Each tablet contains rosiglitazone maleate corresponding to 4 mg rosiglitazone and 4 mg glimepiride.
Maltese: Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 4 mg rosiglitazone u 4 mg glimepiride
English: Thiazolidinediones can cause fluid retention which may exacerbate or precipitate signs or symptoms of congestive heart failure.
Maltese: Thiazolidinediones jistgħu jikkawżaw retenzjoni ta' fluwidu li tista' tħarrax jew tipprovoka sinjali jew sintomi ta' insuffiċjenza tal-qalb konġestiva.
English: Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and glimepiride is similar to that of the combined adverse reaction profile for the two active substances.
Maltese: Tagħrif minn studji double-blind jikkonferma li l-profil ta' sigurta` ta' rosiglitazone u glimepiride flimkien hu l-istess bħall-profil tar-reazzjoni avversa kombinata għaż-żewġ sustanzi attivi.
English: In vitro studies demonstrate that rosiglitazone is predominantly metabolised by CYP2C8, with CYP2C9 as only a minor pathway.
Maltese: Studji in vitro juru li rosiglitazone jimmetabolizza prinċipalment b'CYP2C8, waqt li CYP2C9 ikun sempliċement passaġġ żgħir.