FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Maltese: • Il-Kumitat qies ir-riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE,
English: The difference in median VAS score was 8 mm at day 3-4 and 4.6mm at day 7-8.
Maltese: Id-differenza fil-punteġġ ta' VAS medjan kienet 8 mm f'jum 3-4 u 4.6 mm f'jum 7-8.
English: The applicant has also reviewed the available published clinical trial literature on topical diclofenac which includes a study on effects of Emulgel on Joint Pain (Predel 2012), study on DHEP (Diclofenac hydroxyethylpyrrolidine plaster), Heparin plaster or placebo plaster (Constantino C et al. 2011) and an uncontrolled study on DHEP gel.
Maltese: L-applikant irreveda wkoll il-letteratura tal-provi kliniċi ppubblikata disponibbli dwar diclofenac topiku li tinkludi studju dwar l-effetti ta' Emulgel fuq l-Uġigħ fil-Ġogi (Predel 2012), l-istudju dwar DHEP (Diclofenac hydroxyethylpyrrolidine plaster), Heparin plaster jew placebo plaster (Constantino C et al. 2011) u studju mhux ikkontrollat dwar DHEP ġel.
English: The original application in 2000 under Article 4.8 (a) (II) of Directive 65/65/EEC - bibliographic for new pharmaceutical form and strength, was supported with published literature on efficacy of topical diclofenac as well as data from pharmacokinetics and a clinical study (9702 SUV) of the proposed 4% cutaneous spray formulation.
Maltese: L-applikazzjoni oriġinali fl-2000 skont l-Artikolu 4.8 (a) (II) tad-Direttiva 65/65/KEE - biblijografika għal għamla farmaċewtika u qawwa ġodda, ġiet appoġġjata mil-letteratura ppubblikata dwar l-effikaċja ta' diclofenac topiku kif ukoll mid-data mill-farmakokinetika u studju kliniku (9702 SUV) talformulazzjoni ta' sprej ta' fuq il-ġilda ta' 4% proposta.
English: The applicant included a review of the Predel 2013 study [previously pre-publication known as Study 9702SUV] on the efficacy of Spraygel in acute ankle injury.
Maltese: L-applikant inkluda reviżjoni tal-istudju Predel 2013 [preċedentement pre-pubblikazzjoni magħrufa bħala Studju 9702SUV] dwar l-effikaċja ta' Spraygel f'korriment akut tal-għaksa.
English: MIKA Pharma GmbH requested that the marketing authorisation for Diclofenac Sodium Spray Gel 4% granted by the UK in 2001, and subsequently granted by Austria, Estonia, Hungary, Ireland, Latvia, Lithuania and Slovenia, be also recognised in Germany, Italy and Spain as part of a “second wave” Mutual recognition procedure (MRP).
Maltese: MIKA Pharma GmbH talbet li l-awtorizzazzjoni għat-tqegħid fis-suq ta' Diclofenac Sodium Spray Gel 4% mogħtija mir-Renju Unit fl-2001, u sussegwentament mill-Awstrija, l-Estonja, l-Ungerija, l-Irlanda, il-Latvja, il-Litwanja u s-Slovenja, tiġi rikonoxxuta wkoll fil-Ġermanja, l-Italja u Spanja bħala parti minn Proċedura ta' rikonoxximent reċiproku (MRP - Mutual recognition procedure) “tat-tieni fażi”.
English: The plasma and tissue pharmacokinetic (PK) data of SprayGel in healthy volunteers, and patients with acute inflammation, are compared to those of Voltaren Sodium Gel and Voltaren Emulgel.
Maltese: Id-data farmakokinetika (PK) tal-plażma u t-tessuti ta' SprayGel f'voluntiera b'saħħithom, u f'pazjenti b'infjammazzjoni akuta, huma kkumparati ma' dawk ta' Voltaren Sodium Gel u Voltaren Emulgel.
English: Day 60 of the CMDh procedure was on 29 March 2018, and since two Member States raised concerns regarding potential serious risk to public health (PSRPH) related to lack of efficacy for the specific 4% spraygel product and inadequate bridging to literature, in particular with other topical diclofenac formulations (including Voltarol Emulgel) for which it was acknowledged that there was adequate evidence of efficacy and safety, the Reference Member State (UK) triggered on 5 April 2018 a referral under Article 29(4) of Directive 2001/83/EC, requesting the CHMP to assess the impact of the objections raised that constitute a potential serious risk to public health.
Maltese: Jum 60 tal-proċedura tas-CMDh kien fid-29 ta' Marzu 2018, u peress li żewġ Stati Membri esprimew tħassib rigward ir-riskju serju potenzjali għas-saħħa pubblika (PSRPH, potential serious risk to public health) relatat man-nuqqas ta' effikaċja għall-prodott 4% spray gel speċifiku u l-indirizzar inadegwat tal-letteratura, b'mod partikolari formulazzjonijiet oħrajn ta' diclofenac topiku (li jinkludu Voltarol Emulgel) li għalihom ġie rikonoxxut li kien hemm evidenza adegwata tal-effikaċja u s-sigurtà, l-Istat Membru ta' Referenza (ir-Renju Unit) attiva fil-5 ta' April 2018 riferiment taħt l-Artikolu 29(4) tadDirettiva 2001/83/KE, fejn talab lis-CHMP jivvaluta l-impatt tal-oġġezzjonijiet miġjuba li jikkostitwixxu riskju serju potenzjali għas-saħħa pubblika.
English: An effect was seen on the critical secondary endpoint of spontaneous pain visual analogue scale (VAS).
Maltese: Deher effett fuq il-punt ta' tmiem sekondarju kritiku ta' skala analoga viżiva (VAS, visual analogue scale) ta' uġigħ spontanju.
English: The application subject to this referral therefore concerns a repeat-use mutual recognition procedure (UK-H-0563-001-E-002) for Diclofenac sodium 4% cutaneous spray, solution (PL 18017/0006) with UK as RMS and which involves Italy, Spain, Germany as Concerned Member States.
Maltese: L-applikazzjoni soġġetta għal dan ir-riferiment għalhekk tikkonċerna proċedura ta' rikonoxximent reċiproku ta' użu ripetut (UK-H-0563-001-E-002) għal Diclofenac sodium 4% sprej ta' fuq il-ġilda, soluzzjoni (PL 18017/0006) bir-Renju Unit bħala RMS u li tinvolvi lill-Italja, lil Spanja, lill-Ġermanja bħala Stati Membri Kkonċernati.
English: The applicant's submissions as part of the referral procedure incorporates literature data and discussions on Quality, Clinical Pharmacology, Clinical Efficacy and Clinical Safety aspects.
Maltese: Is-sottomissjonijiet tal-applikant bħala parti mill-proċedura ta' riferiment jinkorporaw data milletteratura u diskussjonijiet dwar aspetti tal-Kwalità, il-Farmakoloġija Klinika, l-Effikaċja Klinika u sSigurtà Klinika.
English: The only intra-study comparative data that is available is from study Martin et al. 1997 which indicated that the systemic absorption is comparable for Spraygel and Emulgel, but a conclusion on equivalence - and clinical relevance of systemic absorption - cannot be drawn.
Maltese: L-unika data kumparattiva intrastudju li hija disponibbli hija mill-istudju Martin et al. 1997 li indika li l-assorbiment sistemiku huwa komparabbli għal Spragyel u Emulgel, iżda ma tistax tinstilet konklużjoni dwar l-ekwivalenza - u r-rilevanza klinika tal-assorbiment sistemiku.
English: • The Committee was of the view that the totality of data submitted justified the efficacy of the applied medicinal product as well as the bridging to the literature, in particular to existing data on topical diclofenac formulations including Voltarol Emulgel formulations.
Maltese: • Il-Kumitat kien tal-fehma li t-totalità tad-data sottomessa tiġġustifika l-effikaċja tal-prodott mediċinali applikat kif ukoll it-tnaqqis tad-diskrepenaza mal-letteratura, b'mod partikolari maddata eżistenti dwar formulazzjonijiet ta' diclofenac topiku inklużi formulazzjonijiet ta' Voltarol Emulgel.
English: 74/94 treated with placebo (78.7%); p = 0.0292 (one-tail) and p = 0.0467 (two-tail).
Maltese: Ir-rispons iddefinit tal-punt tat-tmiem primarju, li huwa espress bħala tnaqqis fin-nefħa ta' mill-inqas 50% matul l-ewwel 10 ijiem tat-trattament għas-"Sett Sħiħ ta' Analiżi" (FAS, Full Analysis Set), intlaħaq f'87/97 pazjenti ttrattati b'diclofenac spray gel (89.7%) meta mqabbla ma' 74/94 ikkurati bi plaċebo (78.7%); p = 0.0292 (unilaterali) u p = 0.0467 (bilaterali).
English: All these studies provide evidence on modest efficacy for authorised topical diclofenac formulations of which the most robust is study Predel 2012 with Emulgel,.
Maltese: Dawn l-istudji kollha jipprovdu evidenza dwar leffikaċja modesta għal formulazzjonijiet ta' diclofenac topiku awtorizzati u minnhom l-iżjed robust huwa l-istudju Predel 2012 b'Emulgel.
English: The CHMP agreed that topical NSAIDs, including Diclofenac Sodium Spray Gel 4 %, have a proven safety record over many more than 10 years, which is supported by their low systemic bioavailability compared to e.g. oral pharmaceutical forms.
Maltese: Is-CHMP qabel li NSAIDs topiċi, inkluż Diclofenac Sodium Spray Gel 4%, għandhom rekord ta' sigurtà mixhuda bi prova fuq ħafna aktar minn 10 snin, u dan hu appoġġjat mill-bijodisponibbiltà sistemika baxxa tagħhom meta mqabbla ma' pereżempju għamliet farmaċewtiċi orali.
English: Therefore the CHMP agreed by majority, that the benefit-risk balance of Diclofenac Sodium Spray Gel 4 % is favourable.
Maltese: Għalhekk is-CHMP qabel b'maġġoranza, li l-bilanċ tal-benefiċċji u r-riskji ta' Diclofenac Sodium Spray Gel 4% huwa favorevoli.
English: The qualitative comparison is based on composition, degree of ionization and complete solubility of active substance.
Maltese: It-tqabbil kwalitattiv huwa bbażat fuq il-kompożizzjoni, il-grad ta' jonizzazzjoni u s-solubbiltà kompleta tas-sustanza attiva.
English: The Committee considered the available data submitted in support of the use of Diclofenac Sodium Spray Gel 4 % Cutaneous Spray, Solution and associated names , which included a comparison of quality aspects in relation to authorised topical diclofenac products, and literature covering pharmacokinetic (local and systemic) as well as efficacy and safety data.
Maltese: Il-Kumitat qies id-data disponibbli sottomessa biex tappoġġja l-użu ta' Diclofenac Sodium Spray Gel 4% Sprej ta' Fuq il-Ġilda, Soluzzjoni u ismijiet assoċjati, li inkludiet tqabbil ta' aspetti tal-kwalità fir-rigward ta' prodotti ta' diclofenac topiku awtorizzati, u l-letteratura li tkopri d-data farmakokinetika (lokali u sistemika) kif ukoll iddata dwar l-effikaċja u s-sigurtà.
English: Nevertheless, while it is acknowledged that the efficacy of Emulgel cannot be directly attributed to Diclofenac Sodium Spray Gel 4 %, it is also reasonable to infer that Diclofenac Sodium Spray Gel 4 % has a beneficial effect based on the supportive Predel 2013 study, PK comparisons and cross-study comparisons in a similar range as seen for other topical diclofenac products.
Maltese: Madanakollu, filwaqt li huwa rikonoxxut li l-effikaċja ta' Emulgel ma tistax tiġi attribwita b'mod dirett lil Diclofenac Sodium Spray Gel 4%, huwa wkoll raġonevoli li jiġi inferit li Diclofenac Sodium Spray Gel 4% għandu effett ta' benefiċċju bbażat fuq l-istudju ta' appoġġ Predel 2013, il-paraguni PK u t-tqabbil bejn studju u ieħor f'medda simili kif osservat għal prodotti ta' diclofenac topiku oħrajn.
English: Although the strength of the proposed cutaneous spray is 4% as compared to the Emulgel which is 1% or 2%, this difference in the cutaneous spray was designed to deliver a similar amount of diclofenac to local tissues as the Emulgel.
Maltese: Għalkemm il-qawwa tal-isprej ta' fuq il-ġilda propost hija 4% meta mqabbla malEmulgel li hija ta' 1% jew 2%, din id-differenza fl-isprej ta' fuq il-ġilda kienet maħsuba biex tipprovdi ammont simili ta' diclofenac lit-tessuti lokali għal dak ta' Emulgel.
English: Nevertheless, it is consistently seen across studies that measurable levels of diclofenac have been reported after application of the spraygel both in systemic exposure and topical exposure (subcutaneous tissue and muscle tissue) at the site of action.
Maltese: Madanakollu, huwa konsistentement osservat fl-istudji li livelli li jistgħu jitkejlu ta' diclofenac ġew irrappurtati wara l-applikazzjoni ta' spraygel kemm fl-esponiment sistemiku kif ukoll fl-esponiment topiku (tessut ta' taħt il-ġilda u tessut tal-muskoli) fis-sit tal-azzjoni.
English: In particular their use and substitution for oral and other systemically administered NSAIDS makes a major contribution to patient well-being in view of the available safety data, which supports a markedly lower risk of potentially serious adverse events compared to systemically administered diclofenac containing products.
Maltese: B'mod partikolari l-użu u s-sostituzzjoni tagħhom għal NSAIDs orali u mogħtija b'mod sistemiku ieħor jagħtu kontribut kbir għall-benesseri tal-pazjent fid-dawl tad-data dwar is-sigurtà disponibbli, li tappoġġja riskju ferm aktar baxx ta' avvenimenti avversi potenzjalment serji meta mqabbel ma' prodotti mogħtija b'mod sistemiku li fihom diclofenac.
English: Overall summary of the scientific evaluation by the CHMP In summary, when taken together the totality of scientific evidence supports that Diclofenac Sodium Spray Gel 4 % has an acceptable safety and efficacy profile.
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mis-CHMP Fil-qosor, meta tittieħed flimkien it-totalità tal-evidenza xjentifika tappoġġja l-fatt li Diclofenac Sodium Spray Gel 4% għandu profil tas-sigurtà u tal-effikaċja aċċettabbli.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Maltese: • Il-Kumitat qies it-totalità tad-data mibgħuta mill-applikant fir-rigward tal-oġġezzjonijiet imqajma bħala riskju serju potenzjali għas-saħħa pubblika.
English: The study was designed and powered to demonstrate superiority with a significant level of 5% one-sided, but the current requirement is now that a significance level of 2.5% one-sided, which the study could not reach.
Maltese: L-istudju kien maħsub u mogħti s-setgħa biex juri ssuperjorità b'livell sinifikanti ta' 5% unilaterali, iżda r-rekwiżit attwali issa huwa livell ta' sinifikanza ta' 2.5% unilaterali, li l-istudju ma setax jilħaq.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif validi huma l-verżjonijiet finali miksubin matul il-proċedura tal-grupp tal-Koordinazzjoni.
English: 12 November, 2012
Maltese: 12 ta' Novembru 2012
English: At 52, 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5 %, 4.3 % and 5.0 %, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8 %, 47.0 % and 50.0 %, respectively).
Maltese: Fil-ġimgħat 52, 104 u 208, proporzjon inqas b'mod sinifikanti fil-grupp ikkurat b'dapagliflozin (3.5 %, 4.3 % and 5.0 %, rispettivament) kellu mill-anqas episodju wieħed ta' ipogliċemija meta mqabbel mal-grupp fuq kura bi glipizide (40.8 %, 47 % u 50.0 % rispettivament).
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Forxiga is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: Il-proporzjon ta' riskju li jqabbel lil dapagliflozin ma' prodott ta' paragun kien ta' 0.79 (95 % Intervall ta' fiduċja [CI]: 0.58, 1.07), li jindika li f'din l-analiżi dapagliflozin mhuwiex assoċjat ma' żieda fir-riskju kardjovaskulari f'pazjenti b'dijabete (diabetes mellitus) tat-tip 2.
English: Forxiga 10 mg tablets dapagliflozin
Maltese: Forxiga 10 mg pilloli dapagliflozin
English: Forxiga 5 mg tablets dapagliflozin
Maltese: Forxiga 5 mg pilloli dapagliflozin
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides -2.7 % versus -0.7 %.
Maltese: Valuri tal-ematokrit >55 % ġew irrapportati f'1.3 % tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4 % tal-individwi fuq plaċebo Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5 % kontra 0.0 %; kolesterol HDL 6.0 % kontra 2.7 %; kolesterol LDL 2.9 % kontra1.0 %; trigliċeridi -2.7 % kontra -0.7 %. ara sezzjoni 4.4
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide.
Maltese: Fil-Ġimgħa 208, ittibdil medju aġġustat mil-linja bażi f'HbA1c kien ta' -0.10 % għal dapagliflozin u ta' 0.20 % għal glipizide.
English: a) of a placebo-controlled study of dapagliflozin as monotherapy
Maltese: a) ta' studju kontrollat bi plaċebo b'dapagliflozin bħala monoterapija
English: Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.
Maltese: Pilloli sofor, konvessi miż-żewġ naħat, forma ta' djamant dijagonali b'dijagonali ta' madwar 1.1 x 0.8 cm, miksijin b'rita b'10” imnaqqax fuq naħa u “1428” imnaqqax fuq in-naħa l-oħra.
English: Forxiga 5 mg film-coated tablets EU/1/12/795/001 14 film-coated tablets EU/1/12/795/002 28 film-coated tablets EU/1/12/795/003 98 film-coated tablets EU/1/12/795/004 30 x 1 (unit dose) film-coated tablets EU/1/12/795/005 90 x 1 (unit dose) film-coated tablets
Maltese: Forxiga 5 mg pilloli miksijin b'rita EU/1/12/795/001 14-il pillola miksija b'rita EU/1/12/795/002 28 pillola miksija b'rita EU/1/12/795/003 98 pillola miksija b'rita EU/1/12/795/004 30 x 1 (doża waħda) pillola miksija b'rita EU/1/12/795/005 90 x 1 (doża waħda) pillola miksija b'rita
English: LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali li jbaxxi l-glukows valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows Żieda gradwali fir-reġimens tal-insulina (inklużi insulina li taħdem malajr, intermedja, u basali) kien permess biss jekk l-individwi laħqu kriterji FPG stabiliti minn qabel.
English: • The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for post-marketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Maltese: • Il-PRAC ikkunsidra wkoll li għandha tinġabar informazzjoni addizzjonali dwar avvenimenti ta' amputazzjoni permezz ta' formoli ta' rapporti ta' każijiet (CRFs, case report forms) xierqa għal provi kliniċi, kwestjonarji ta' segwitu għal każijiet ta' wara t-tqegħid fis-suq, lużu ta' listi komuni ta' termini ppreferuti (PT, preferred term) ta' MedDRA għal avvenimenti ta' qabel amputazzjoni, u metaanaliżi ta' studji kbar inkluż studji ta' eżitu kardjovaskulari.
English: Forxiga 10 mg film-coated tablets EU/1/12/795/006 14 film-coated tablets EU/1/12/795/007 28 film-coated tablets EU/1/12/795/008 98 film-coated tablets EU/1/12/795/009 30 x 1 (unit dose) film-coated tablets EU/1/12/795/010 90 x 1 (unit dose) film-coated tablets
Maltese: Forxiga 5 mg pilloli miksijin b'rita EU/1/12/795/006 14-il pillola miksija b'rita EU/1/12/795/007 28 pillola miksija b'rita EU/1/12/795/008 98 pillola miksija b'rita EU/1/12/795/009 30 x 1 (doża waħda) pillola miksija b'rita EU/1/12/795/010 90 x 1 (doża waħda) pillola miksija b'rita
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to10 mg dapagliflozin
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.
English: These infections were more frequent in females (8.4 % and 1.2 % for dapagliflozin and placebo, respectively), and subjects with a prior history were more likely to have a recurrent infection.
Maltese: Dawn l-infezzjonijiet kienu aktar frekwenti fin-nisa (8.4 % u 1.2 % għal dapagliflozin u plaċebo, rispettivament), u individwi li kellhom fil-passat kellhom aktar probabilità li tirkadilhom l-infezzjoni.
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5 % and ≤ 10 %).
Maltese: Fi studju mhux inferjuri ta' 52-ġimgħa, kontrollat b'mod attiv (b'perjodi ta' estensjoni ta' 52 ġimgħa u ta' 104 ġimgħat), Forxiga kien evalwat bħala terapija add-on imqabbel ma' sulphonylurea (glipizide) miżjud ma' terapija b'metformin f'individwi b'kontroll gliċemiku mhux xieraq (HbA1c > 6.5 % u ≤ 10 %).
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza bijoloġika attiva
English: Forxiga has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m 2) or end-stage renal disease (ESRD).
Maltese: Forxiga mhux rakkomandat għall-użu f'pazjenti b'indeboliment renali moderat għal sever (pazjenti b'CrCl < 60 ml/min jew [eGFR] < 60 ml/min/1.73 m2).Forxiga ma ġiex studjat f'każijiet ta' indeboliment renali sever (CrCl < 30 ml/min jew eGFR < 30 ml/min/1.73 m2) jew mard renali fl-aħħar-stadju (ESRD).
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of lower limb amputation in patients treated with Sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus;
Maltese: • Il-PRAC irrieżamina t-totalità tad-data ppreżentata mid-detenturi tal-awtorizzazzjoni għattqegħid fis-suq fir-rigward tar-riskju ta' amputazzjoni tan-naħa ta' isfel tar-riġlejn f'pazjenti kkurati b'inibituri tal-kotrasportatur 2 ta' sodju-glukożju (SGLT2) għad-dijabete mellitus tat-tip 2;
English: Forxiga 5 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Forxiga 5 mg pilloli miksijin b'rita Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: Forxiga 10 mg film-coated tablets Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Maltese: Forxiga 10 mg pilloli miksijin b'rita Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.
English: tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 ‘Forxiga contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Maltese: Kull pillola Forxiga 5 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin Kull pillola Forxiga 10 mg miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin Is-sustanzi l-oħra huma: - qalba tal-pillola: microcrystalline cellulose (E460i), anhydrous lactose (ara sezzjoni 2 ‘Forxiga fih lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b). - kisja tar-rita: polyvinyl alcohol (E1203), titanium dioxide (E171),macrogol 3350, talc (E553b), yellow iron oxide (E172).
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss tal-valuri tal-glucose fid-demm, taħt 14 mmol/1 (250 mg/dl).
English: Forxiga 5 mg film-coated tablets Forxiga 10 mg film-coated tablets
Maltese: Forxiga 5 mg pilloli miksijin b'rita Forxiga 10 mg pilloli miksijin b'rita
English: MA (EU) number (Invented) name Strength
Maltese: Numru tal-MA (EU)
English: inhaler (ABS/PE/PP) 3 inhalers (3 x 60 doses)
Maltese: 3 inalaturi (3 x 60 doża)
English: Pack size inhaler (ABS/PE/PP) 1 inhaler (60 doses)
Maltese: Inalatur wieħed (60 doża)