FrancophonIA/ELRC3.0 huggingface dataset:
English: Of over 1500 patients enrolled in study BM 16549 comparing monthly with daily dosing regimens of ibandronic acid, 14% and 18% of patients used histamine (H2) blockers or proton pump inhibitors after one and two years, respectively.
Maltese: Imblokkaturi ta' H2 jew inibituri tal-pompi tal-protoni Fi prova li saret fuq aktar minn 1500 pazjent arwolat fi studju BM16549 li jqabbel ir-reġimens ta' dożaġġ kuljum ta' ibandronic acid, 14 % u 18 % tal-pazjenti ħadu imblokkaturi tal-histamine (H2) jew impedituri tal-proton pump wara sena jew sentejn rispettivament.
English: Among these patients, the incidence of upper gastrointestinal events in the patients treated with ibandronic acid 150 mg once monthly was similar to that in patients treated with ibandronic acid 2.5 mg daily.
Maltese: każijiet gastrointestinali ta' fuq fil-pazjenti trattati b'ibandronic acid 150 mg darba fix-xahar kienet simili għal dawk il-pazjenti trattati b'ibandronic acid 2.5 mg kuljum.
English: After taking your tablet, wait at least 30 minutes.
Maltese: Wara li tieħu l-pillola tiegħek, stenna mill-inqas 30 minuta.
English: Month 2
Maltese: Xahar 2
English: Chest pain, influenza-like illness, malaise, pain
Maltese: Uġigħ fissider, marda li tixbaħ lill-influwenza, telqa, uġigħ
English: When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year.
Maltese: Meta jintuża kriterju aktar strett, li jgħaqqad kemm il-BMD tal-ispina lumbari u t-total tal-ġenbejn 83.9% (p<0.001) u 65.7% ta' pazjenti li ħadu ibandronic acid 150 mg darba fix-xahar jew ibandronic acid 2.5 mg kuljum, rispettivament, irrispondew fl-ewwel sena.
English: Bioavailability is reduced by about 90% when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects.
Maltese: Ilbijodisponibilità hija mnaqqsa b'90 % meta ibandronic acid jingħata ma' kolazzjon normali meta mqabbla mal-bijodisponibilità f'pazjenti sajmin.
English: Ibandronic Acid Teva 150 mg film-coated tablets Ibandronic acid
Maltese: Ibrandronic Acid Teva 150 mg pilloli miksija b'rita ibandronic acid
English: Hypocalcaemi a*
Maltese: Ipokalċimija*
English: However, based on a knowledge of this class of compounds, oral overdose may result in upper gastrointestinal adverse reactions (such as upset stomach, dyspepsia, oesophagitis, gastritis, or ulcer) or hypocalcaemia.
Maltese: Madankollu, skont tagħrif dwar din il-klassi ta' komposti doża eċċessiva orali tista' twassal għal każijiet avversi fil-parti gastrointestinali ta' fuq (bħal taqlib fl-istonku, ħruq fl-istonku, esofagite, gastrite, jew ulċera) jew ipokalċemija.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Ibandronic Acid Teva in patients with concomitant risk factors.
Maltese: Eżami dentali b'dentistrija preventiva u stima tal-benefiċċju u r-riskju individwali huma rakkomandati qabel trattament b'Ibrandronic Acid Teva f'pazjenti b'fatturi ta' riskju konkomitanti.
English: Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 150 mg ta' ibandronic acid (bħala sodium monohydrate).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu
English: As renal function decreases with age, this is the only factor to take into consideration (see renal impairment section).
Maltese: Hekk kif il-funzjoni tal-kliewi tonqos bl-età, dan huwa l-uniku fattur li għandu jiġi kkunsidrat (ara s-sezzjoni ta' indeboliment tal-kliewi).
English: Continuing to take Ibandronic Acid Teva
Maltese: Tieħux Ibrandronic Acid Teva
English: Ibandronic acid is a highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates, which act selectively on bone tissue and specifically inhibit osteoclast activity without directly affecting bone formation.
Maltese: Ibandronic acid jinibixxi selettivament l-attività tal-osteoclasts, li jnaqqas l-assorbiment mill-ġdid tal-għadam u b'hekk inaqqas il-komplikazzjonijiet skeletriċi tal-marda malinna.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Maltese: għaqda mal-proteini fil-plażma tal-bniedem hi ta' madwar 87 % f'konċentrazzjonijiet terapewtiċi ugħalhekk interazzjoni ma' prodotti mediċinali oħra minħabba spostament mhuwiex probabbli.
English: In addition, ibandronic acid does not inhibit the major human hepatic P450 isoenzymes and does not induce the hepatic cytochrome P450 system in rats.
Maltese: Barra dan, ibandronic acid ma jinibixxix lisoenzimi P450 maġġuri umani tal-fwied u ma jinduċix is-sistema taċ-ċitokromju P450 tal-fwied filfirien.
English: The range of observed apparent half-lives is broad and dependent on dose and assay sensitivity, but the apparent terminal half-life is generally in the range of 10-60 hours.
Maltese: Il-firxa osservata ta' half-lives apparenti hija wiesgħa u tiddependi fuq id-doża u s-sensittività talanaliżi, imma l-half-life apparenti terminali ġeneralment taqa' fil-firxa ta' bejn 10-60 siegħa.
English: Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Maltese: Ibrandronic Acid Teva 50 mg pilloli miksija b'rita ibandronic acid
English: In humans, the efficacy of both daily and intermittent administration with a dose-free interval of 9-10 weeks of ibandronic acid was confirmed in a clinical trial (MF 4411), in which ibandronic acid demonstrated anti-fracture efficacy.
Maltese: Fil-bniedem, leffikaċja kemm tal-għoti kuljum u intermittenti b'intervall mingħajr doża mifruxa fuq 9-10 ġimgħat ta' ibandronic acid kienet ikkonfermata fi prova klinika (MF 4411), li fiha ibandronic acid wera effikaċja ta' kontra l-ksur.
English: PVC/Aclar/PVC - Aluminium blisters in cardboard boxes of 1 or 3 tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih PVC/Aclar/PVC - Folji tal-aluminju f'kaxxi tal-kardbord ta' pillola 1 jew 3 pilloli.
English: It does not interfere with osteoclast recruitment.
Maltese: Huwa ma jinterferixxix fit-teħid ta' osteoclasts.
English: Stevens-Johnson syndrome†, Erythema multiforme†, Dermatitis bullous†
Maltese: Sindrome ta' Stevens-Johnson†, Eritema
English: • Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes).
Maltese: • Ibqa' wieqaf/wieqfa (bilqiegħda jew bilwieqfa) waqt li qed tieħu l-pilloli tiegħek u għas-siegħa ta' wara (60 minuta).
English: Film-coated tablet.
Maltese: Mhux applikabbli.
English: Ibandronic Acid Teva with food and drink
Maltese: Ibrandronic Acid Teva jista' jagħmel dan ukoll.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-folja u l-kartuna wara EXP.
English: • Swallow the tablet whole.
Maltese: • Ibla' l-pillola sħieħa.
English: At one year (primary analysis), 91.3 % (p=0.005) of patients receiving ibandronic acid 150 mg once monthly had a lumbar spine BMD increase above or equal to baseline (BMD responders), compared with 84.0 % of patients receiving ibandronic acid 2.5 mg daily.
Maltese: Wara sena (analiżi primarja), 91.3 % (p=0.005) tal-pazjenti li ħadu ibandronic acid 150 mg darba fixxahar kellhom żieda fil-BMD tal-ispina lumbari li kinet aktar jew ugwali għal punt ta' riferiment bażi ta' BMD (risponsi ta' BMD), meta mqabbla ma' 84.0 % ta' pazjenti li ħadu 2.5 mg darba kuljum.
English: Talk to your doctor before taking Ibandronic Acid Teva: - If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
Maltese: - Jekk għandek xi disturbi oħra fil-metaboliżmu ta' minerali (bħal defiċjenza ta' Vitamina D). - Jekk il-kliewi tiegħek mhux jiffunzjonaw b'mod normali.
English: It is important that you take Ibandronic Acid Teva at the right time and in the right way.
Maltese: Huwa importanti li tieħu Ibandronic Acid Teva fil-ħin u b'mod korrett.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/642/001 28 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/642/001 28 pillola miksija b'rita
English: If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).
Maltese: Jekk tiżviluppa dawn is-sintomi, waqqaf it-teħid ta' Ibandronic Acid Teva u għid lit-tabib tiegħek minnufih (ara sezzjonijiet 3 u 4).
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Ibandronic Acid Teva.
Maltese: Il-pazjenti kollha għandhom ikunu mħeġġa biex iżommu iġene orali tajba, jagħmlu eżaminazzjonijiet dentali b'mod regolari, u jirrappurtaw immedjatament kwalunkwe sintomi orali bħal snien jiċċaqalqu, uġigħ jew nefħa jew feriti li ma jfiequx jew li jnixxu matul it-trattament b'Ibrandronic Acid Teva.
English: • severe stomach pain.
Maltese: • Din il-mediċina ġiet mogħtija lilek biss.
English: Total clearance of ibandronic acid was reduced to 44 ml/min in the subjects with severe renal impairment compared with 129 mL/min in subjects with normal renal function.No dosage adjustment is necessary for patients with mild renal impairment (CLcr ≥50 and <80 mL/min).
Maltese: It-tneħħija totali ta' ibandronic acid kien imnaqqas għal 44 mL/min fl-individwi b'indeboliment sever tal-kliewi meta mqabbel ma' 129 mL/min f'pazjenti b'funzjoni normali tal-kliewi.
English: System Organ Class Common Uncommon
Maltese: Sistema tal-Klassifika tal-Organi
English: Wed. Thu.
Maltese: Kemm għandek tieħu
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).
Maltese: Kull pillola miksija b'rita fiha 50 mg ta' ibandronic acid (bħala sodium monohydrate).
English: - Concomitant therapies: corticosteroids, chemotherapy, angiogenesis inhibitors, radiotherapy to head and neck.
Maltese: - Terapiji mogħtija fl-istess waqt: kortikosterojdi, kimoterapija, inibituri tal-anġjoġenesi, radjuterapija għar-ras u l-għonq.
English: Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma.
Maltese: Fatturi possibbli ta' riskju għal osteonekrosi tal-kanal estern tassmigħ jinkludu l-użu ta' sterojdi u kimoterapija u/jew fatturi lokali ta' riskju bħal infezzjoni jew trawma.
English: OTHER
Maltese: L
English: The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation.
Maltese: Ir-riskju ta' esperjenzi esofaġeali severi jidhru li huma akbar f'pazjenti li ma jikkonformawx ma struzzjonijiet dwar id-dożaġġ u/jew li jibqgħu jieħdu bisfosfonati orali wara li jiżviluppaw sintomi indikattivi ta' irritazzjoni esofaġeali.
English: Ocular inflammation†
Maltese: Multiforme†, Dermatite blInfafet†
English: Furthermore, ibandronic acid 150 mg once monthly was proven superior to ibandronic acid 2.5 mg daily for increases in lumbar spine BMD in a prospectively planned analysis at one year, p=0.002, and at two years, p<0.001.
Maltese: Barra minn hekk, ibandronic acid 150 mg li jittieħed darba fix-xahar intwera li hu superjuri għal ibandronic acid 2.5 mg li jittieħed kuljum minħabba ż-żidiet fil-BMD tal-ispina lumbari f'analiżi prospettiva ppjanata fi żmien sena, p=0.002, u f'sentejn, p<0.
English: Daily treatment with 2.5 mg resulted in progressive increases in BMD at vertebral and nonvertebral sites of the skeleton.
Maltese: Kura ta' kuljum b'2.5 mg irriżultat f'żidiet progressivi fil-BMD f'siti vertebrali u mhux vertebrali taliskeletru.
English: Milk or antacids should be given to bind Ibandronic Acid Teva, and any adverse reactions treated symptomatically.
Maltese: Mudelli tal-annimali jikkonfermaw li ibandronic acid huwa impeditur qawwi tal-attività osteoklastika.
English: Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).
Maltese: Tiħux Ibandronic Acid Teva ma' ikel jew xorb ieħor ħlief ilma għax Ibandronic Acid Teva huwa inqas effettiv jekk jittieħed ma' ikel jew xorb (ara sezzjoni 3).
English: • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints.
Maltese: • sintomi jixbħu lill-influwenza, inkluż deni, tregħid u tertir, sensazzjoni ta' skomdu, uġigħ fl għadam u uġigħ fil-muskoli u l-ġogi.
English: For these patients, there was no difference in the incidence of upper gastrointestinal adverse events with the 150 mg once monthly regimen compared to the 2.5 mg daily regimen.
Maltese: Għal dawn il-pazjenti ma kienx hemm differenza fl-inċidenza ta' reazzjonijiet avversi gastrointestinali ta' fuq bir-reġiment ta' 150 mg darba fix-xahar meta mqabbla mar-reġimen ta' 2.5 mg li jittieħed kuljum.
English: Three-year lumbar spine BMD increase compared to placebo was 5.3 % and 6.5 % compared to baseline.
Maltese: Iż-żieda fuq tliet snin fil-BMD tal-ispina lumbari meta mqabbla mal-plaċebo kienet ta' 5.3 % u 6.5 % meta mqabbla mal-linja bażi ta' riferiment.
English: Gender Bioavailability and pharmacokinetics of ibandronic acid are similar in men and women.
Maltese: Il-bijodisponibilità u l-farmakokinetiċi ta' ibandronic acid huma simili kemm fl-irġiel u fin-nisa.
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Maltese: Ikkuntattja lit-tabib u lid-dentist tiegħek minnufih jekk ikollok xi problemi fil-ħalq jew snien tiegħek bħal snien laxki, uġigħ jew nefħa, feriti li ma jfiequx jew tnixxija, peress li dawn jistgħu jkunu sinjali ta' osteonekrosi tax-xedaq.
English: Water may be taken at any time during the course of Ibandronic Acid Teva treatment (see section 4.5).
Maltese: Ilma jista' jittieħed f'kull ħin matul il-kors ta' kura b'Ibandronic Acid Teva (ara sezzjoni 4.5).
English: In particular, products containing calcium, including milk and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Ibandronic Acid Teva, which is consistent with findings in animal studies.
Maltese: B'mod partikolari, Prodotti li fihom il-kalċju, inkluż il-ħalib, u ketajins multivalenti oħra (bħal aluminju, manjesju u l-ħadid), u l-ikel, x'aktarx jinterferixxu fl-assorbiment Ibrandronic Acid Teva, li hu konsistenti ma' riżultati fi studji fuq l-annimali.
English: There are no data on the effects of ibandronic acid from humans.
Maltese: M'hemmx informazzjoni dwar l-effetti ta' ibandronic acid mill-bnedmin.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis.
Maltese: Effett sekondarju imsejjaħ osteonekrosi tax-xedaq (ONJ - osteonecrosis of the jaw) (ħsara fl-għadam fix-xedaq) kien irrappurtat b'mod rari ħafna fl-ambjent ta' wara t-tqegħid fis-suq f'pazjenti li kienu qed jirċievu Ibrandronic Acid Teva għall-osteoporożi.
English: Nevertheless, according to clinical assessment of the individual patient, it is recommended that renal function, serum calcium, phosphate and magnesium should be monitored in patients treated with Ibandronic Acid Teva.
Maltese: Madankollu, skont l-eżami kliniku tal-pazjent individwali, huwa rakkomandat li jsir monitoraġġ tal-funzjoni renali, tal-kalċju fis-serum, tal-fosfat u tal-manjesju f'pazjenti li jiġu ttrattati b'Ibandronic Acid Teva.
English: Osteonecrosis of jaw*†,
Maltese: Is-sustanzi l-oħra huma:
English: Prevention of skeletal events in patients with breast cancer and bone metastases with ibandronic acid 50 mg tablets was assessed in two randomized placebo controlled phase III trials with a duration of 96 weeks.
Maltese: Pożoloġija Id-doza rakkomandata hija pillola waħda miksija b'rita ta' 50 mg kuljum.
English: Whereas
Maltese: Billi
English: Annex IV Scientific conclusions
Maltese: Anness IV
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 għallprodotti elenkati fl-Anness A;
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Maltese: Għalhekk is-CHMP jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għal Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance u Synjardy.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy remain favourable subject to the amendments to the product information described above.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance u Synjardy jibqa' favorevoli soġġett għall-emendi flinformazzjoni dwar il-prodott deskritti hawn fuq.
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Maltese: L-istudji CANVAS u CANVAS-R u l-Istudji CREDENCE u DECLARE huma ppjanati li jitlestew fl-2017 u fl-2020, rispettivament.
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 tattip 2;
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, l-użu 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: Having considered all available data, the PRAC was of the view that the growing data on amputation in the CANVAS and CANVAS-R trial confirm an increased amputation risk for canagliflozin; it is unlikely that the difference in amputation risk seen with canagliflozin compared to placebo is a finding by chance.
Maltese: Wara li kkunsidra d-data disponibbli kollha, il-PRAC kien tal-fehma li d-data li dejjem qed tiżdied dwar l-amputazzjonijiet fil-prova ta' CANVAS u CANVAS-R tikkonferma riskju miżjud ta' amputazzjoni għal cangliflozin; mhuwiex probabbli li d-differenza fir-riskju ta' amputazzjoni li dehret b'canagliflozin meta mqabbel mal-plaċebo hija sejba b'kumbinazzjoni.
English: A Direct Healthcare Professional Communication (DHPC) was circulated on 2 May 2016 to inform healthcare professionals that a two-fold higher incidence of lower limb amputation (primarily of the toe) had been seen in a clinical trial with canagliflozin; in addition, the need to counsel patients about the importance of routine preventative foot care was highlighted.
Maltese: Fit-2 ta' Mejju 2016, ġiet iċċirkolata Komunikazzjoni Diretta tal-Professjonisti fil-Qasam tal-Kura tasSaħħa (DHPC, Direct Healthcare Professional Communication) sabiex tinforma lill-professjonisti filqasam tal-kura tas-saħħa li fi prova klinika b'canagliflozin, ġiet innutata inċidenza ta' darbtejn aktar fin-numru ta' amputazzjonijiet tan-naħa ta' isfel tar-riġlejn (primarjament tas-saba' tas-sieq); barra minn hekk, ġie enfasizzat il-bżonn li l-pazjenti jingħataw parir dwar l-importanza ta' kura tas-saqajn preventiva ta' rutina.
English: Overall summary of the scientific evaluation by the PRAC
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika mill-PRAC
English: PRAC noted that an increased amputation risk has only become apparent with canagliflozin so far, but one large cardiovascular outcome study (DECLARE) is still on-going for dapagliflozin and amputation events were not been systematically captured within the completed large cardiovascular outcome study conducted with empagliflozin (EMPA-REG).
Maltese: Il-PRAC innota li s'issa, riskju miżjud ta' amputazzjoni sar apparenti biss b'canagliflozin, iżda studju wieħed kbir ta' eżitu kardjovaskulari (DECLARE) għadu għaddej għal dapagliflozin u l-avvenimenti ta' amputazzjoni ma nqabdux b'mod sistematiku fl-istudju ta' eżitu kardjovaskulari kbir mitmum imwettaq b'empagliflozin (EMPA-REG).
English: The European Commission (EC) triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 15 April 2016; the PRAC was requested to assess the impact on the benefit-risk balance of canagliflozin containing medicinal products, to assess whether this is a class issue and to issue a recommendation by 31 March 2017 on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked and whether provisional measures are necessary to ensure the safe and effective use of these medicinal products.
Maltese: Il-Kummissjoni Ewropea (KE) tat bidu għal proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 fil-15 ta' April 2016; il-PRAC intalab jivvaluta l-impatt fuq il-bilanċ bejn il-benefiċċju u rriskju ta' prodotti mediċinali li fihom canagliflozin, biex jivvaluta jekk din hijiex kwistjoni ta' klassi u biex sal-31 ta' Marzu 2017, joħroġ rakkomandazzjoni dwar jekk għandhomx jinżammu, jiġu varjati, sospiżi jew revokati l-awtorizzazzjonijiet għat-tqegħid fis-suq rilevanti u jekk humiex neċessarji miżuri provviżorji sabiex jiġi żgurat l-użu sigur u effettiv ta' dawn il-prodotti mediċinali.
English: In March 2016 the EMA was informed by the Marketing authorization holder (MAH) of canagliflozin about an approximately 2-fold increase of lower limb amputations in canagliflozin-treated subjects compared to placebo in the MAH sponsored ongoing cardiovascular (CV) event study CANVAS.
Maltese: F'Marzu 2016, l-EMA ġiet infurmata mid-Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) ta' canagliflozin dwar żieda ta' madwar darbtejn aktar fin-numru ta' amputazzjonijiet tan-naħa ta' isfel tar-riġlejn f'individwi kkurati b'canagliflozin meta mqabbel mal-plaċebo fl-istudju ta' avveniment kardjovaskulari (CV) CANVAS li għadu għaddej sponsorjat mill-MAH.
English: The warning for canagliflozin also includes information that, in patients developing amputation preceding events, consideration may be given to discontinue treatment.
Maltese: It-twissija għal canagliflozin tinkludi wkoll informazzjoni li, f'pazjenti li jkunu qed jiżviluppaw avvenimenti ta' qabel amputazzjoni, għandu jiġi kkunsidrat it-twaqqif tal-kura.