FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the EU to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of the development of resistance.
Maltese: Wara l-eżitu tal-proċedura ta' riferiment skont l-Artikolu 34 imsemmija hawn fuq għal Linco-Spectin 100, il-Belġju qies li huwa fl-interess tal-UE li jiġi promoss l-użu effettiv u razzjonali tal-kombinazzjoni ta' linkomiċina-spektinomiċina fi prodotti mediċinali veterinarji li jingħataw b'mod orali, u b'hekk jiġi limitat ir-riskju tal-iżvilupp ta' reżistenza.
English: Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry
Maltese: Mistoqsijiet u tweġibiet dwar prodotti mediċinali veterinarji li fihom kombinazzjoni ta' linkomiċina u spektinomiċina għall-għoti b'mod orali lill-ħnieżer u/jew lit-tjur
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the overall benefit-risk balance for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-bilanċ ġenerali talbenefiċċju-riskju għal taħlitiet lesti minn qabel għal għalf medikat u għal trab għall-għoti mal-għalf li jkun fihom kombinazzjoni ta' linkomiċina u spektinomiċina huwa negattiv, peress li l-użu ta' dawn ilprodotti fl-iskedi tad-dożaġġ rakkomandati jinvolvi riskju għoli tal-għażla u tal-iżvilupp ta' reżistenza minħabba l-esponiment għal livelli antimikrobiċi baxxi għal perjodi twal.
English: The CVMP further concluded that the overall benefit-risk balance for powders for use in the drinking water containing a combination of lincomycin and spectinomycin is positive and agreed harmonised indications, dosing regimens and warning sentences on prudent use.
Maltese: Is-CVMP ikkonkluda wkoll li l-bilanċ ġenerali tal-benefiċċju-riskju għal trab għall-użu fl-ilma tax-xorb li jkun fih kombinazzjoni ta' linkomiċina u spektinomiċina huwa pożittiv u qabel dwar indikazzjonijiet, skemi tad-dożaġġ u sentenzi ta' twissija armonizzati dwar l-użu prudenti.
English: Based on the evaluation of the currently available data, the CVMP concluded that the overall benefitrisk balance for premixes for medicated feeding stuff and powders containing a combination of lincomycin and spectinomycin, to be administered with the feed, is negative, as the use of these products at the recommended dosing regimens entails a high risk of resistance selection and development due to exposure to low antimicrobial levels for prolonged periods.
Maltese: Abbażi tal-valutazzjoni tad-data attwalment disponibbli, is-CVMP ikkonkluda li l-bilanċ ġenerali talbenefiċċju-riskju għal taħlitiet lesti minn qabel għal għalf medikat u għal trab li jkun fihom kombinazzjoni ta' linkomiċina u spektinomiċina, għall-għoti mal-għalf, huwa negattiv, peress li l-użu ta' dawn il-prodotti fl-iskeda tad-dożaġġ rakkomandata jinvolvi riskju għoli tal-għażla u tal-iżvilupp ta' reżistenza minħabba l-esponiment għal livelli antimikrobiċi baxxi għal perjodi twal.
English: The CVMP was requested to assess the available data and to review the indications, dosage regimens and withdrawal periods for pigs and poultry in order to ensure consumer safety, efficacious treatment in pigs, chickens and other poultry species, as well as a lower risk of the development of antimicrobial resistance to lincomycin and spectinomycin.
Maltese: Is-CVMP intalab jivvaluta d-data disponibbli u biex jirrevedi l-indikazzjonijiet, l-iskemi tad-dożaġġ u lperjodi tal-irtirar għall-ħnieżer u għat-tjur sabiex tiġi żgurata s-sikurezza tal-konsumatur, it-trattament effikaċi fil-ħnieżer, fit-tiġieġ u fi speċijiet oħra ta' tjur, kif ukoll riskju aktar baxx tal-iżvilupp ta' reżistenza antimikrobika għal linkomiċina u spektinomiċina.
English: RSG + SU RSG +MET +SU
Maltese: RSG + MET RSG + SU RSG +MET +SU
English: Glycerol triacetate
Maltese: Glycerol triacaetate
English: Date of latest renewal: 11 July 2005
Maltese: Data ta' l-aħħar tiġdid: 11 ta' Lulju 2005
English: Manufacturer: Glaxo Wellcome Production, ZI du Terras, 53100 Mayenne, France.
Maltese: Glaxo Wellcome Production, ZI du terras, 53100, Mayenne, Franza.
English: Rosiglitazone is a selective agonist at the PPARγ (peroxisomal proliferator activated receptor gamma) nuclear receptor and is a member of the thiazolidinedione class of anti-diabetic agents.
Maltese: Rosiglitazone huwa agonist selettiv fir-receptor nuklejari PPARγ (peroxisome proliferator activated receptor gamma) u huwa membru tal-klassi ta' aġenti anti-diabetiċi thiazolidinedione.
English: Glaxo Wellcome Production Z.I.
Maltese: Glaxo Wellcome Production Z.I. Du terras
English: The active substance is rosiglitazone.
Maltese: Is-sustanza attiva hija rosiglitazone.
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Maltese: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spanja.
English: Triple oral therapy
Maltese: Terapija orali trippla
English: The other ingredients are: sodium starch glycollate (Type A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, magnesium stearate, titanium dioxide (E171), macrogol 3000, glycerol triacetate and iron oxide red (E172).
Maltese: Is-sustanzi l-oħra huma: sodium starch glycollate (Tip A), hypromellose, hypromellose 6cP, microcrystalline cellulose, lactose monohydrate, titanium dioxide (171), macrogol 3000, glycerol triacetate, u iron oxide red (E172).
English: Film coating (Opadry orange OY-L-23028): Hypromellose 6cP
Maltese: Rita tal-kisja (Opadry oranġjo OY-L-23028): Hypromellose 6cP
English: Du Terras 53100 Mayenne France or
Maltese: 53100 Mayenne Franza jew
English: The 4 mg tablet also contains purified talc and iron oxide yellow (E172).
Maltese: Il-pillola ta' 4mg fiha wkoll purified talc u iron oxide yellow (E172).
English: Film coating (Opadry pink OY-L-24802):
Maltese: Rita tal-kisja (Opadry pink OY-L-24802):
English: EU/1/00/137/005 7 tablets EU/1/00/137/006 28 tablets EU/1/00/137/007 56 tablets EU/1/00/137/014 84 tablets EU/1/00/137/017 90 tablets EU/1/00/137/008 112 tablets EU/1/00/137/009 56 tablet unit dose pack
Maltese: EU/1/00/137/005 7 pilloli miksijin b'rita EU/1/00/137/006 28 pillola miksijin b'rita EU/1/00/137/007 56 pillola miksijin b'rita EU/1/00/137/014 84 pillola miksijin b'rita EU/1/00/137/017 90 pillola miksijin b'rita EU/1/00/137/008 112 pillola miksijin b'rita EU/1/00/137/009 56 pillola miksijin b'rita, pakkett b'dożi individwali
English: − an Acute Coronary Syndrome (unstable angina, NSTEMI and STEMI) (see section 4.4)
Maltese: − Sindromu Koronarju Akut (anġina instabbli, NSTEMI u STEMI) (ara sezzjoni 4.4)
English: INFORMATION IN BRAILLE avandia 2 mg
Maltese: INFORMAZZJON BIL-BRAILLE avandia 2mg
English: Stop taking Avandia.
Maltese: Tieħux Avandia.
English: INFORMATION IN BRAILLE avandia 4 mg
Maltese: INFORMAZZJON BIL-BRAILLE avandia 4mg
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 inkluż rapporti iżolati.
English: No clinically relevant interactions with digoxin, the CYP2C9 substrate warfarin, the CYP3A4 substrates nifedipine, ethinylestradiol or norethindrone were observed after co-administration with rosiglitazone.
Maltese: Meta rosiglitazone ingħata flimkien ma' digoxin, is-sustrat CYP2C9 warfarin, is-sustrati CYP3A4 nifedipine, ethinylestradiol jew noretindrone ma ġew osservati l-ebda interazzjonijiet klinikament relevanti.
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 ≥1/1,000, <1/100.
English: Avandia tablets come in different strengths.
Maltese: Il-pilloli ta' Avandia jiġu f'dożi differenti.
English: An active controlled clinical trial (rosiglitazone up to 8 mg daily or metformin up to 2,000 mg daily) of 24 weeks duration was performed in 197 children (10-17 years of age) with type 2 diabetes.
Maltese: Prova klinika kkontrollata attiva (rosiglitazone sa 8mg kuljum jew metformin sa 2,000mg kuljum) li dam 24 ġimgha sar fuq 197 tifel u tifla (eta' bejn 10 u 17-il sena) b'dijabete tat-tip 2.
English: Pharmacotherapeutic group: oral blood glucose lowering drugs, thiazolidinediones, ATC code: A10
Maltese: Kategorija farmakoterapewtika: mediċini orali li jbaxxu l-glukożju fid-demm, thiazolidinediones, Kodiċi ATC:
English: Plasma protein binding of rosiglitazone is high (approximately 99.8%) and is not influenced by concentration or age.
Maltese: Lirbit ta' rosiglitazone mal-proteini tal-plażma huwa għoli (madwar 99.8%) u mhuwiex influwenzat mill-konċentrazzjoni jew mill-età.
English: Common Common Very common Very common RSG - Rosiglitazone monotherapy; RSG + MET - Rosiglitazone with metformin; RSG + SURosiglitazone with sulphonylurea; RSG + MET + SU - Rosiglitazone with metformin and sulphonylurea
Maltese: RSG + MET - Rosiglitazone flimkien ma' metformin; RSG + SU - Rosiglitazone flimkien ma' sulphonylurea;
English: EU/1/00/137/016 180 tablets
Maltese: EU/1/00/137/016 180 pillola
English: Each tablet contains either: 2 mg, 4 mg or 8 mg rosiglitazone.
Maltese: Kull pillola fiha jew: 2mg, 4mg jew 8mg.
English: EU/1/00/137/002 56 tablets
Maltese: EU/1/00/137/002 56 pillola
English: Gastrointestinal disorders constipation
Maltese: Mard gastro-intestinali stitikezza
English: in their entirety the available data on the risk of cardiac ischaemia are inconclusive (see section 4.8).
Maltese: Madankollu, globalment id-dejta disponibbli dwar ir-riskju ta' iskemija kardijaka mhux konklussiva (ara sezzjoni 4.8).
English: 3 In a retrospective analysis of data from 42 pooled short-term clinical studies, the overall incidence of events typically associated with cardiac ischaemia was higher for rosiglitazone containing regimens, 2.00% versus combined active and placebo comparators, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
Maltese: 3F'analiżi retrospettiva ta' tagħrif minn 42 studji kliniċi fuq tul ta' żmien qasir, miġbura flimkien, linċidenza ġenerali ta' każi assoċjati tipikament ma' iskemija kardijaka kienet ogħla fil-każ ta' terapija li jkun fiha rosiglitazone, 2.00% kontra komparaturi attivi u plaċebo flimkien, 1.53% [hazard ratio (HR) 1.30 (95% confidence interval (CI) 1.004 - 1.69)].
English: − hepatic impairment
Maltese: − indeboliment epatiku
English: The terminal half-life for radioactivity was about 130 hours indicating that elimination of metabolites is very slow.
Maltese: Il-half-life terminali għar-radjuattività kienet madwar 130 h u dan jindika li l-eliminazzjoni tal-metaboli issir bil-mod ħafna.
English: EU/1/00/137/013 168 tablets
Maltese: EU/1/00/137/013 168 pillola
English: EU/1/00/137/003 112 tablets
Maltese: EU/1/00/137/003 112 pillola
English: The protein binding of the major metabolite (para-hydroxy-sulphate) is very high (>99.99%).
Maltese: L-irbit mal-proteini tal-metabolit prinċipali (sulfat para-idrossidu) hu għoli ħafna (>99.99%).
English: or
Maltese: Ara
English: Don't take Avandia.
Maltese: Ieqaf ieħu Avandia.
English: 56 film-coated tablets, unit dose pack
Maltese: 56 pillola miksijin b'rita, pakkett b'dożi individwali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/137/005-009, EU/1/00/137/014, EU/1/00/137/017
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 July 2000
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 11 ta' Lulju 2000
English: Avandia 4 mg tablets are orange, marked "GSK" on one side and "4" on the other.
Maltese: Il-pilloli ta' Avandia 4mg huma oranġjo, immarkati "GSK" fuq naħa waħda u "4" fuq l-oħra.
English: Total plasma clearance of rosiglitazone is around 3 l/h and the terminal elimination half-life of rosiglitazone is approximately 3 to 4 hours.
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: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/137/002-004, EU/1/00/137/013, EU/1/00/137/016
English: Rosiglitazone should be used with caution in patients with severe renal insufficiency (creatinine clearance < 30 ml/min).
Maltese: Rosiglitazone għandu jintuża b'attenzjoni fil-pazjenti b'insuffiċjenza renali qawwija (eliminazzjoni ta' kreatinina < 30 ml kull minuta).
English: Frequency of adverse reaction by treatment regimen RSG RSG + MET
Maltese: Frekwenza ta' reazzjonijiet avversi skond it-tip ta' terapija RSG
English: AVANDIA 2 mg film-coated tablets AVANDIA 4 mg film-coated tablets AVANDIA 8 mg film-coated tablets rosiglitazone
Maltese: AVANDIA 2mg pilloli miksijin b'rita AVANDIA 4mg pilloli miksijin b'rita AVANDIA 8mg pilloli miksijin b'rita rosiglitazone
English: Metabolism and nutrition disorders hypercholesterolaemia1 Common Common Common
Maltese: Mard marbut mal-metaboliżmu u n-nutrizzjoni iperkolesterolemija1
English: EU/1/00/137/004 56 tablet unit dose pack
Maltese: EU/1/00/137/004 56 pillola f'pakkett b'dożi individwali
English: Absolute bioavailability of rosiglitazone following both a 4 and an 8 mg oral dose is approximately 99%.
Maltese: Il-bijodisponibilità assoluta ta' rosiglitazone wara doża orali ta' 4 kif ukoll ta' 8 mg hija madwar 99%.
English: As a consequence of different but complementary mechanisms of action, dual oral therapy of rosiglitazone with a sulphonylurea or metformin resulted in additive effects on glycaemic control in type 2 diabetic patients.
Maltese: B'konsegwenza tal-mekkaniżmi ta' azzjoni differenti iżda kumplimentari, terapija orali doppja b'rosiglitazone flimkien ma'sulphonylurea jew metformin irriżulta f'effetti additivi fuq il-kontroll gliċemiku f'pazjenti dijabetiċi ta' tip 2.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/00/137/010-012, EU/1/00/137/015, EU/1/00/137/018
English: The volume of distribution of rosiglitazone is approximately 14 litres in healthy volunteers.
Maltese: Il-volum tad-distribuzzjoni ta' rosiglitazone huwa madwar 14-il litru fil-voluntiera b'saħħithom.
English: There is limited experience with rosiglitazone in patients with elevated liver enzymes (ALT >2.5X upper limit of normal).
Maltese: Teżisti esperjenza limitata b'rosiglitazone f'pazjenti b'livell għoli ta' enzimi talfwied (ALT >2.5 darba l-limitu ta' fuq tan-normal).
English: Concomitant administration with the oral anti-diabetic agents metformin, glibenclamide and acarbose did not result in any clinically relevant pharmacokinetic interactions with rosiglitazone.
Maltese: Meta rosiglitazone ġie mogħti flimkien ma' l-aġenti anti-diabetiċi orali metformin, 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 volontiera, rosiglitazone ġie amministrat f'dożi orali individwali sa' 20mg u kien ittollerat tajjeb.
English: Contains lactose (approximately 105 mg).
Maltese: Fih lattosju (bejn wieħed u ieħor 105 mg)
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 ta' rosiglitazone fil-plażma.
English: The tablets are provided in blister packs containing 7, 28, 84, 90 or 112 film-coated tablets.
Maltese: In-natura tal-materjal tal-kontenitur u ta' dak li hemm ġo fih Pakketti b'folji blister opaki (PVC/aluminju). 7, 28, 84, 90 jew 112 pilloli miksijin b'rita.
English: Moreover in patients with congestive heart failure NYHA class I-II, a placebo-controlled 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 , 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: 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: Adverse reactions for each treatment regimen are presented below by system organ class and absolute frequency.
Maltese: Reazzjonijiet mhux mixtieqa għal kull tip ta' terapija huma elenkati hawn taħt skond il-klassi tassistemi u l-organi u l-frekwenza assoluta.
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 approvati jew plaċebo, ma kkonfermawx jew eskludew ir-riskju potenzjali ta' iskemija kardijaka.
English: Rosiglitazone is indicated in the treatment of type 2 diabetes mellitus:
Maltese: Rosiglitazone hu indikat fit-trattament tad-dialbete mellitus tat-tip 2:
English: Avandia 8 mg tablets are red-brown, marked "GSK" on one side and "8" on the other.
Maltese: Il-pilloli ta' Avandia 8mg huma kannella fl-aħmar, immarkati "GSK" fuq naħa waħda u "8" fuq loħra.
English: • chest pain (angina)
Maltese: • uġigħ fis-sider (anġina)
English: Allergic reactions: These are very rare in people taking Avandia.
Maltese: Reazzjonijiet allerġiċi : Dawn huma rari ħafna f'nies li jieħdu Avandia.
English: as monotherapy - in patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance as dual oral therapy in combination with - metformin, in patients (particularly overweight patients) with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin - a sulphonylurea, only in patients who show intolerance to metformin or for whom metformin is contraindicated, with insufficient glycaemic control despite monotherapy with a sulphonylurea as triple oral therapy in combination with - metformin and a sulphonylurea, in patients (particularly overweight patients) with insufficient glycaemic control despite dual oral therapy (see section 4.4).
Maltese: bħala monotherapija - fil-pazjenti (b'mod partikolari dawk li għandhom piż żejjed) li mhumiex ikkontrollati biżżejjed bid-dieta u bl-eżerċizzju u li għalihom il-metformin m'huwiex adattat minħabba kontraindikazzjoni jew intolleranza bħala terapija orali doppja ma' - metformin, fil-pazjenti (b'mod partikolari dawk li għandhom piż żejjed) li m'għandhomx kontroll glikimiku suffiċjenti minkejja l-ogħla doża ttollerata ta' monoterapija b'metformin - sulphonylurea, f'dawk il-pazjenti biss li juru intolleranza għall metformin jew għall-dawk li għalihom il-metformin huwa kontra-indikat, u li m'ghandhomx kontroll glikimiku suffiċjenti minkejja monoterapija b'sulphonylurea bħala terapija orali trippla flimkien ma' - metformin u sulphonylurea, fil-pazjenti (b'mod partikolari dawk li għandhom piż żejjed) li m'għandhomx kontroll glikimiku suffiċjenti minkejja terapija orali doppja (aera sezzjoni 4.4).
English: 7 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 112 film-coated tablets 56 film-coated tablets, unit dose pack
Maltese: 7 pilloli miksijin b'rita 28 pillola miksijin b'rita 84 pillola miksijin b'rita 90 pillola miksijin b'rita 112 pillola miksijin b'rita
English: Contains lactose (approximately 209 mg).
Maltese: Fih lattosju (bejn wieħed u ieħor 209 mg)
English: Common cardiac ischaemia3*
Maltese: Iskemja kardijaka3* Komuni
English: Signs include:
Maltese: Manifattur:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 8 mg rosiglitazone
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 8 mg rosiglitazone
English: 168 film-coated tablets
Maltese: 168 pillola miksijin b'rita
English: Administration of rosiglitazone with food resulted in no change in overall exposure (AUC), although a small decrease in Cmax (approximately 20% to 28%) and a delay in tmax (ca.1.75 h) were observed compared to dosing in the fasting state.
Maltese: L-għoti ta' rosiglitazone ma' l-ikel ma rriżulta fl-ebda bidla fl-espożizzjoni totali (AUC), għalkemm tnaqqis żgħir fis-Cmax (madwar 20-28%) u dewmien fit-tmax (ca.1.75 h) ġew innotati meta mqabbla ma' l-għoti tad-doża fi stat ta' sawm.
English: Contains lactose (approximately 108 mg).
Maltese: Fih lattosju (bejn wieħed u ieħor 108 mg)
English: In patients administered rosiglitazone in combination with a sulphonylurea, an increase in rosiglitazone 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: Fil-pazjenti li jingħataw rosiglitazone flimkien ma sulphonylurea, żjieda fid-doża ta' rosiglitazone għal 8mg kuljum għandha ssir b'kawtela wara li ssir evalwazzjoni klinika xierqa li teżamina kemm il-pazjent għandu ir-riskju li jiżviluppa reazzjonijiet mhux mixtieqa li għandhom x'jaqsmu mar-retenzjoni tal-fluwidu (ara sezzjoni 4.4 u 4.8).
English: You must look out for certain symptoms while you are taking Avandia, to reduce the risk of any problems.
Maltese: Għandek toqgħod attent għal ċerti sintomi waqt li tkun qed tieħu Avandia, biex tnaqqas ir-riskju ta' xi problemi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains rosiglitazone maleate corresponding to 2 mg rosiglitazone
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha rosiglitazone maleate li jikkorrispondi għal 2 mg rosiglitazone
English: HOW TO STORE AVANDIA
Maltese: X'fih Avandia
English: • Don't breast-feed while you are taking Avandia.
Maltese: • Treddgħax waqt li tkun qed tieħu Avandia.
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 jiġi metabolizzat l-aktar mis-CYP2C8, is-CYP2C9 hija rotta minuri biss.
English: Use of rosiglitazone is contraindicated in patients with:
Maltese: L-użu ta' rosiglitazone hu kontra-indikat fil-pazjenti li għandhom:
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: Common granulocytopaenia
Maltese: TAL-PRODOTT MEDIĊINALI