FrancophonIA/ELRC3.0 huggingface dataset:
English: No animal studies have been conducted with the combined products in AVANDAMET.
Maltese: Ma saru ebda studji fuq annimali bil-prodotti kombinati ta' AVANDAMET.
English: Data from double-blind studies confirm that the safety profile of concomitant rosiglitazone and metformin is similar to that of the combined adverse reaction profile for the two medicinal products.
Maltese: Tagħrif minn studji double-blind jikkonferma li l-profil ta' sigurta` ta' rosiglitazone u metformin flimkien jixbaħ il-profil kkombinat tar-reazzjonijiet mhux mixtieqa għaż-żewġ prodotti mediċinali.
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% filkonċentrazzjonijiet ta' rosiglitazone fil-plażma.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq annimali wrew tossiċità fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: AVANDAMET should be used with caution during concomitant administration of CYP2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin), due to the effect on rosiglitazone pharmacokinetics (see section 4.5).
Maltese: AVANDAMET għandu jintuża b'attenzjoni waqt li jkun jittieħed flimkien ma' impedituri CYP2C8 (e.ż. gemfibrozil) jew inducers (e.ż. rifampicin) minħabba l-effett fuq il-farmakokinetika tarrosiglitazone (ara sezzjoni 4.5).
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 200 iktar mid-doża farmakoloġikament attiva żiedet il-multipliċità ta' tumur fil-kolon.
English: Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Maltese: Biodisponibilità assoluta ta' rosiglitazone wara doża orali kemm ta' 4 mg kif ukoll ta' 8 mg hija ta' madwar 99%.
English: Belgique/Belgien Tél/Tel: + 32 (0)2 656 21 11
Maltese: Luxembourg/Luxemburg GlaxoSmithKline s.a./n.v. Belgique/Belgien Tél/Tel: + 32 (0)2 656 21 11
English: Pruritis
Maltese: Lott
English: Improved glycaemic control was also associated with significant decreases in free fatty acids.
Maltese: It-titjib fil-kontroll gliċemiku kien ukoll assoċjat ma' tnaqqis sinifikanti ta' free fatty acids.
English: Improvement in HbA1c from baseline achieved statistical significance only in the metformin group.
Maltese: Titjib fl-HbA1c mill-linja bażi kiseb statistika sinifikanti biss fil-grupp tal-metformin.
English: The inter-subject variability was large, with a 7-fold difference in unbound AUC between patients.
Maltese: Il-varjabilità bejn issuġġetti kienet kbira b'differenza ta' 7 darbiet f'unbound AUC bejn pazjenti.
English: Pharmacotherapeutic group: Combinations of oral blood glucose lowering medicinal products, ATC code: A10BD03
Maltese: Prodotti mediċinali orali kkombinati li jnaqqsu l-livell ta' zokkor fid-demm, kodiċi ATC:
English: Plasma protein binding is negligible.
Maltese: L-irbit mal-proteini tal-plażma (plażma Protein binding) huwa negliġibbli.
English: An in vivo interaction study with warfarin indicated that rosiglitazone does not interact with CYP2C9 substrates in vivo.
Maltese: Meta ntuża warfarin fi studju ta' interazzjoni in vitro, ġie ndikat li rosiglitazone ma jgħamilx interazzjoni ma' sustrati in vivo ta' CYP2C9.
English: • raised and itchy rash (hives)
Maltese: • raxx imtella u bil-ħakk (hives)
English: Concomitant administration of rosiglitazone with the oral antihyperglycaemic agents glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions.
Maltese: Meta rozoglitazone ġie mogħti flimkien ma' l-aġenti anti-ipergliċemiċi orali glibenclamide u acarbose ma' rriżultax li kien hemm xi interazzjonijiet farmakokinetiċi klinikament relevanti.
English: In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
Maltese: Fi studji kliniċi fuq voluntiera, rosiglitazone ġie amministrat f'dożi orali individwali sa' 20mg u kien ittollerat tajjeb.
English: An adjusted mean reduction in HbA1c of 0.24% was seen for patients taking rosiglitazone added to sulphonylurea, versus a reduction in HbA1c of 0.10% for patients taking metformin added to sulphonylurea, (p=0.0083 for treatment difference).
Maltese: Deher tnaqqis medju aġġustat f'HbA1c ta' 0.24% għall-pazjenti li kienu qed jieħdu rosiglitazone miżjud ma' sulphonylurea, kontra tnaqqis f'HbA1c ta' 0.10% għallpazjenti li kienu qed jieħdu metformin miżjud ma' sulphonylurea, (p=0.0083 għad-differenza fil-kura).
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 fl-inċidenza ta' ksur fl-għadam għall-individwi fil-grupp ta' rosiglitazone kombinat meta mqabbel mal-kontroll attiv [8.3% kontra 5.3%, Proporzjon ta' riskju 1.57 (95% CI 1.26 - 1.97)].
English: • dizziness
Maltese: • ġuħ
English: In this leaflet:
Maltese: Kategorija:
English: As a consequence of different but complementary mechanisms of action, combination therapy of rosiglitazone with metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Maltese: B'konsegwenza tal-mekkaniżmi ta' azzjoni differenti iżda kumplimentari, terapija b'rosiglitazone u metformin irriżultat f'effetti additivi fuq ilkontroll gliċemiku f'pazjenti dijabetiċi ta' tip 2.
English: Gender: In the pooled population pharmacokinetic analysis, there were no marked differences in the pharmacokinetics of rosiglitazone between males and females.
Maltese: Minn ġabra ta' analiżi tal-farmakokinetika tal-popolazzjoni, ma kienx hemm differenza partikolari fil-proċessi farmakokinetiċi ta' rosiglitazone bejn l-irġiel u n-nisa.
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces total cholesterol, LDLc and triglyceride levels.
Maltese: Dan intwera f'dożi terapewtiċi fi studji kliniċi kontrollati fuq żmien medju jew twil: metformin inaqqas il-kolesterol totali, LDLc u livelli ta' trigliċeridi.
English: Hepatobiliary disorders liver function disorders
Maltese: − falliment tas-sistema tal-qalb jew respiratorja
English: INFORMATION IN BRAILLE avandamet 2 mg/500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE avandamet 2mg/500mg
English: Each tablet contains 1 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Maltese: Kull pillola fiha 1 mg rosiglitazone (bħala rosiglitazone maleate) u 500 mg metformin hydrochloride (jikkorrespondu għal bażi ta' 390 mg metformin liberu ).
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and an increased anion gap and lactate/pyruvate ratio.
Maltese: Karatteristiċi dijanjostiċi tal-laboratorju huma pH tad-demm baxx, livelli tal-lactate fil-plażma ‘l fuq minn 5 mmol/l u żjieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: INFORMATION IN BRAILLE avandamet 1 mg/500 mg
Maltese: INFORMAZZJONI BIL-BRAILLE avandamet 1mg/500mg
English: INFORMATION IN BRAILLE avandamet 4 mg/1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE avandamet 4mg/1000mg
English: Pale pink film-coated tablets marked "gsk" on one side and "2/500" on the other.
Maltese: Pilloli roża ċari miksija b'rita, bil-marka “gsk” fuq naħa waħda u “2/500” fuq in-naħa l-oħra.
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20-28%) and a delay in tmax (approximately 1.75 h) were observed compared to dosing in the fasting state.
Maltese: L-ogħti ta' rosiglitazone ma' l-ikel ma rriżulta fl-ebda bidla fl-esponiment globali (AUC), għalkemm tnaqqis żgħir fis-Cmax (madwar 20-28%) u ttardjar fit-tmax (madwar 1.75 h) ġew osservati meta imqabbla ma' l-ogħti ta' doża fi stat ta' sawm.
English: − Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • F'60 ġurnata sa meta jrid tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis ta' riskju)
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilMediċini (EMEA) http:www.emea.europa.eu
English: Table 1 lists adverse reactions identified from an overview of clinical trials involving over 5,000 rosiglitazone-treated patients.
Maltese: It-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: See ‘Conditions you need to look out for' in Section 4.
Maltese: ‘Kundizzjonijiet li hemm bżonn toqgħod attent għalihom' f'Sezzjoni 4.
English: Avandamet 4 mg/1000 mg tablets are pink, marked "gsk" on one side and "4/1000" on the other.
Maltese: Il-pilloli ta' Avandamet 4mg/1000mg huma roża, immarkati "gsk" fuq naħa waħda u "4/1000" fuq loħra.
English: A total of 564 patients withdrew from cardiovascular follow-up, which accounted for 12.3% of rosiglitazone patients and 13% of control patients; representing 7.2% of patient-years lost for cardiovascular events follow-up and 2.0% of patient-years lost for all cause mortality follow-up.
Maltese: Total ta' 564 pazjent irtiraw mill-visti kardjovaskulari ta' wara, li ammontaw għal 12.3% tal-pazjenti b'rosiglitazone u 13% tal-pazjenti bilkontroll; li jirrappreżentaw 7.2% sena ta' pazjenti mitlufa għall-avvenimenti kardjovaskulari fil-visti ta' wara u 2.0% sena ta' pazjenti mitlufa għall-mewt minn kull kawża fil-visti ta' wara.
English: MULTIPACKS ONLY (2x56 TABLETS, WRAPPED IN CLEAR PLASTIC) MULTIPACKS ONLY (3x56 TABLETS, PACKED IN BOX)
Maltese: - PAKKETTI MULTIPLI BISS (3x56 PILLOLI IPPAKKJATI
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' insuffiċjenza 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: AVANDAMET should not be used in patients with renal failure or renal dysfunction e.g. serum creatinine levels > 135 μmol/l in males and > 110 μmol/l in females and/or creatinine clearance < 70 ml/min (see sections 4.3 and 4.4).
Maltese: AVANDAMET m'għandux jintuża f'pazjenti b'insuffiċjenza tal-kliewi jew fejn il-kliewi ma jaħdmux sew, eż. livelli seroloġiċi ta' krejatinina >135µmol/l fl-irġiel u >110µmol/l fin-nisa u/jew clearance tal-krejatinina < 70 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: : + 33 (0)1 39 17 84 44 diam@gsk.com
Maltese: Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 diam@gsk.com
English: • swelling of the retina at the back of the eye (macular oedema)
Maltese: • nefħa fir-retina fuq wara ta' l-għajn (edema makulari)
English: The usual starting dose of AVANDAMET is 4 mg/day rosiglitazone plus 2000 mg/day metformin hydrochloride.
Maltese: Id-doża ta' AVANDAMET li tinbeda ġeneralment tkun 4 mg kuljum rosiglitazone u 2000 mg kuljum metformin hydrochloride.
English: Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Maltese: Kull pillola fiha 2 mg rosiglitazone (bħala rosiglitazone maleate) u 1000 mg metformin hydrochloride (jikkorrespondu għal bażi ta' 780 mg metformin liberu ).
English: Each tablet contains lactose (approximately 11 mg) For a full list of excipients, see section 6.1.
Maltese: Kull pillola fiha lattosju (bejn wieħed u ieħor 11 mg) Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
Maltese: KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
English: INFORMATION IN BRAILLE avandamet 2 mg/1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE avandamet 2mg/1000mg
English: EU/1/03/258/010 14 tablets EU/1/03/258/011 28 tablets EU/1/03/258/012 56 tablets EU/1/03/258/022 180 tablets
Maltese: EU/1/03/258/010 14 pillola EU/1/03/258/011 28 pillola EU/1/03/258/012 56 pillola EU/1/03/258/022 180 pillola
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (3x112 TABLETS)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA TIKKETTA TA' BARRA (B'KAXXA BLU) PAKKETTI MULTIPLI BISS (3x112 PILLOLI)
English: In the final analysis at 5 years, an adjusted mean reduction from baseline in HbA1c of 0.14% for patients on rosiglitazone added to metformin versus an increase of 0.17% for patients taking sulphonylurea added to metformin was seen during treatment with randomised dual-combination therapy (p<0.0001 for treatment difference).
Maltese: Fl-analiżi finali wara 5 snin, tnaqqis medju aġġustat mil-linja bażi f'HbA1c ta' 0.14% għall-pazjenti fuq rosiglitazone miżjud ma' metformin kontra żjieda ta' 0.17% għall-pazjenti li qed jieħdu sulphonylurea miżjud ma' metformin deher waqt kura b'terapija doppja kombinata randomised (p<0.
English: This leaflet was last approved in
Maltese: DATA TA' META ĠIET RIVEDUTA
English: Avandamet 2 mg/1000 mg tablets are yellow, marked "gsk" on one side and "2/1000" on the other.
Maltese: Il-pilloli ta' Avandamet 2mg/1000mg huma sofor, immarkati "gsk" fuq naħa waħda u "2/1000" fuq loħra.
English: Skin and subcutaneous tissue disorders (see Immune system disorders) Angioedema
Maltese: Mard tal-ġilda u tat-tessuti ta' taħt il-ġilda (ara Mard tas-sistema immuni) anġjodema
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 2 mg ta' rosiglitazone (bħala maleate) u 500 mg metformin hydrochloride
English: EU/1/03/258/004 28 tablets EU/1/03/258/005 56 tablets EU/1/03/258/006 112 tablets EU/1/03/258/020 360 tablets
Maltese: EU/1/03/258/004 28 pillola EU/1/03/258/005 56 pillola EU/1/03/258/006 112 pillola EU/1/03/258/020 360 pillola
English: As AVANDAMET contains metformin hydrochloride, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Maltese: Billi AVANDAMET fih metformin hydrochloride, il-kura għandha titwaqqaf 48 siegħa qabel operazzjoni bil-loppju ġenerali, u ġeneralment m'għandux jerġa' jinbeda qabel igħaddu 48 siegħa.
English: AVANDAMET must be discontinued if any deterioration in cardiac status occurs.
Maltese: AVANDAMET għandu jitwaqqaf fil-każ ta' xi deterjorament fl-istat kardijaku.
English: Triple oral therapy (rosiglitazone, metformin and sulphonylurea) (see section 4.4) - Patients on metformin and sulphonylurea: when appropriate AVANDAMET may be initiated at 4 mg/day rosiglitazone with the dose of metformin substituting that already being taken.
Maltese: Terapija orali trippla (rosiglitazone, metformin u sulphonylurea) (ara sezzjoni 4.4) - Pazjenti li qed jieħdu metformin u sulphonylurea: fejn xieraq AVANDAMET jista' jinbeda d'doża ta 4mg kuljum rosiglitazone bid-doża ta' metformin minflok dik li tkun qed tittieħed
English: In their entirety, the available data on the risk of cardiac ischaemia are inconclusive.
Maltese: Ma' tulhom kollha, linformazzjoni disponibbli fuq ir-riskju ta' iskemja kardijaka m'hijiex konklussiva.
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 sections 4.4 and 4.8).
Maltese: Żjieda fil-komponent ta' rosiglitazone għal 8 mg kuljum trid tiġi magħmula b'attenzjoni wara evalwazzjoni klinika xierqa li tistabbilixxi r-riskju li pazjent jista' jiżviluppa effetti sekondarji relatati ma' retenzjoni ta' fluwidu (ara sezzjonijiet 4.4 u 4.8).
English: EU/1/03/258/017, 56 tablets, component of a 168 tablet multipack.
Maltese: EU/1/03/258/017, 56 pilloli, parti minn pakkett multiplu b'168 pillola
English: Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Maltese: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: Cardiac disorders congestive heart failure/pulmonary oedema
Maltese: Mard tal-qalb insuffiċjenza tal-qalb konġestiva /edema pulmonari
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of rosiglitazone (as rosiglitazone maleate) and 500 mg of metformin hydrochloride (corresponding to metformin free base 390 mg).
Maltese: Kull pillola fiha 2 mg rosiglitazone (bħala rosiglitazone maleate) u 500 mg metformin hydrochloride (jikkorrespondu għal bażi ta' 390 mg metformin liberu ).
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 talistudju >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: In this study, the adverse events observed were consistent with the known adverse event profile for each of the treatments, including continuing weight gain with rosiglitazone.
Maltese: F'dan l-istudju, l-eventi avversi li ġew osservati kienu konsistenti mal-profil ta' eventi avversi għal kull trattament, li jinkludu żieda kontinwa fil-piż b'rosiglitazone.
English: Non-clinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Tagħrif mhux kliniku għal metformin ma jiżvela l-ebda periklu speċjali għall-bniedem ibbażat fuq studji konvenzjonali dwar farmakoloġija ta' sigurta', tossiċità f'dożi ripetuti, ġenotossiċità, potenzjal kanċeroġenu u tossiċità ta' riproduzzjoni.
English: EU/1/03/258/001 28 tablets EU/1/03/258/002 56 tablets EU/1/03/258/003 112 tablets EU/1/03/258/019 360 tablets
Maltese: EU/1/03/258/001 28 pillola EU/1/03/258/002 56 pillola EU/1/03/258/003 112 pillola EU/1/03/258/019 360 pillola
English: 4.9 Overdose
Maltese: 4.6 Tqala u Treddigħ
English: 2 An increased incidence of heart failure has been observed when rosiglitazone was added to treatment regimens with a sulphonylurea (either as dual or triple therapy), and appeared higher with 8 mg rosiglitazone compared to 4 mg rosiglitazone (total daily dose).
Maltese: 2Inċidenza ikbar ta' insuffiċjenza tal-qalb ġiet osservata meta rosiglitazone ġie miżjud ma' terapiji b'sulphonylurea (b'terapija doppja jew trippla), u deher li kienet ogħla b'8 mg rosiglitazone meta mqabbla ma 4 mg rosiglitazone (doża sħiħa ta' kuljum).
English: EU/1/03/258/010-012 EU/1/03/258/014 EU/1/03/258/018 EU/1/03/258/022
Maltese: EU/1/03/258/010-012 EU/1/03/258/014
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of rosiglitazone (as rosiglitazone maleate) and 1000 mg of metformin hydrochloride (corresponding to metformin free base 780 mg).
Maltese: Kull pillola fiha 4 mg rosiglitazone (bħala rosiglitazone maleate) u 1000 mg metformin hydrochloride (jikkorrespondu għal bażi ta' 780 mg metformin liberu ).
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline S.p.A.
English: Each tablet contains lactose (approximately 23 mg) For a full list of excipients, see section 6.1.
Maltese: Kull pillola fiha lattosju (bejn wieħed u ieħor 23 mg) Għal-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: EU/1/03/258/018, 56 tablets, component of a 168 tablet multipack.
Maltese: EU/1/03/258/018, 56 pillola, parti minn pakkett multiplu b'168 pillola
English: You must look out for certain symptoms while you are taking Avandamet, to reduce the risk of any problems.
Maltese: Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avandamet, biex tnaqqas ir-riskju ta' xi problemi.
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
Maltese: + 358 (0)10 30 30 30 Finland.tuoteinfo@gsk.com
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: L-eliminazzjoni totali tal-plażma minn rosiglitazone hija madwar 3 1/h u l-half-life għalleliminazzjoni terminali ta' rosiglitazone hi madwar 3-4 h.
English: In studies with a maximal duration of three years, rosiglitazone given once or twice daily in dual oral therapy with metformin produced a sustained improvement in glycaemic control (FPG and HbA1c).
Maltese: Fi studji b'tul massimu ta' tlett snin, rosiglitazone mogħti darba jew darbtejn kuljum f'terapija orali doppja ma' metformin wassal għal titjib sostnut fil-kontroll gliċemiku (FPG u HbA1c).
English: What Avandamet looks like and contents of the pack Avandamet 1 mg/500 mg tablets are yellow and marked "gsk" on one side and "1/500" on the other.
Maltese: Id-dehra ta' AVANDAMET u l-kontenuti tal-pakkett Il-pilloli ta' Avandamet 1mg/500mg huma sofor u mmarkati b'"gsk" fuq naħa waħda u "1/500” fuq l-oħra.
English: In a placebo-controlled one-year trial in patients with congestive heart failure NYHA class I-II, worsening or possible worsening of heart failure occurred in 6.4% of patients treated with rosiglitazone, compared with 3.5% on placebo.
Maltese: I-II , kien hemm deterjorament jew deterjorament possibbli ta' insuffiċjenza tal-qalb f'6.4% tal-pazjenti trattati b'rosiglitazone, meta mqabbla ma' 3.5% bi plaċebo.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of rosiglitazone (as maleate) and 500 mg of metformin hydrochloride.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 1 mg ta' rosiglitazone (bħala maleate) u 500 mg metformin hydrochloride
English: Avandamet 2 mg/500 mg tablets are pale pink, marked "gsk" on one side and "2/500" on the other.
Maltese: Il-pilloli ta' Avandamet 2mg/500mg huma roża, mmarkati b'"gsk" fuq naħa u "2/500" fuq l-oħra.
English: EU/1/03/258/007 14 tablets EU/1/03/258/008 28 tablets EU/1/03/258/009 56 tablets EU/1/03/258/021 180 tablets
Maltese: EU/1/03/258/007 14 pillola EU/1/03/258/008 28 pillola EU/1/03/258/009 156 pillola EU/1/03/258/021 180 pillola
English: EU/1/03/258/013, 56 tablets, component of a 112 tablet multipack.
Maltese: FIS-SUQ EU/1/03/258/013, 56 pilloli, parti minn pakkett multiplu b'112 pillola
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 2 mg ta' rosiglitazone (bħala maleate) u 1000 mg metformin hydrochloride
English: NAME OF THE MEDICINAL PRODUCT AVANDAMET 2 mg/500 mg tablets rosiglitazone/metformin HCl
Maltese: TAL-PRODOTT MEDIĊINALI AVANDAMET 2 mg/500 mg pilloli rosiglitazone/metformin HC1
English: Do not use Avandamet after the expiry date shown on the pack.
Maltese: Tużax Avandamet wara d-data ta' skadenza li tidher fuq il-pakkett.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 4 mg of rosiglitazone (as maleate) and 1000 mg of metformin hydrochloride.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 4 mg ta' rosiglitazone (bħala maleate) u 1000 mg metformin hydrochloride
English: (You can also take this dose as two 1 mg/500 mg tablets, twice a day.)
Maltese: (Tista' wkoll tieħu din id-doża bħala żewġ pilloli ta' 1mg/500mg, darbtejn kuljum.)