FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Invokana can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invokana on 15.11.2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Invokana fi 15.11.2013.
English: What are the risks associated with Invokana?
Maltese: X'inhuma r-riskji assoċjati ma' Invokana?
English: Why is Invokana approved?
Maltese: Għal xiex ġie approvat Invokana?
English: Important side effects identified included dehydration and urinary tract infection, but these were considered to be manageable.
Maltese: Effetti sekondarji importanti identifikati inkludew deidrazzjoni u infezzjoni fl-apparat urinarju, iżda dawn kienu kkunsidrati bħala maniġġabbli.
English: The most common side effects with Invokana are hypoglycaemia (low blood glucose levels) when used together with insulin or a sulphonylurea, vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida) urinary tract infection (infection of the structure that carries the urine) and polyuria (abnormally large production of urine) or pollakiuria (abnormally frequent urination).
Maltese: L-effetti sekondarji l-aktar komuni b'Invokana huma ipogliċemija (livelli baxxi ta' glukożju fid-demm) meta jintuża flimkien mal-insulina jew is-sulfonilurea, kandidjasi vulvovaġinali (traxx, infezzjoni fungali fil-parti ġenitali tal-mara kkawżata minn Candida) infezzjoni fl-apparat urinarju (infezzjoni tal-istruttura li tgħaddi l-urina) u polijurja (produzzjoni tal-awrina kbira b'mod anormali) jew pollakjurja (awrina frekwenti b'mod anormali).
English: The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called sodium‑glucose co‑transporter 2 (SGLT2).
Maltese: Is-sustanza attiva f'Invokana, il-kanagliflozin, taħdem billi timblokka proteina fil-kliewi msejħa kotrasportatur 2 tal-glukożju tas-sodju (SGLT2).
English: This is a summary of the European public assessment report (EPAR) for Invokana.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Invokana.
English: A study was also performed in patients with moderately reduced kidney function, and one in older patients aged between 55 and 80 years.
Maltese: Twettaq ukoll studju f'pazjenti b'funzjoni tal-fwied moderatament indebolita, u wieħed f'pazjenti anzjani li għandhom bejn 55 u 80 sena.
English: In patients with moderately reduced kidney function the dose should be limited to 100 mg once a day.
Maltese: F'pazjenti b'funzjoni tal-kliewi moderatament imnaqqsa, id-doża għandha tkun limitata għal 100 mg darba kuljum.
English: Invokana is a diabetes medicine that contains the active substance canagliflozin.
Maltese: Invokana huwa mediċina kontra d-dijabete li fiha s-sustanza attiva kanagliflozin.
English: • When Invokana was used on its own at a dose of 100 mg, it decreased HbA1c levels by 0.91% more than placebo after 26 weeks, while the 300 mg dose led to a reduction of 1.16% more than placebo.
Maltese: • Meta Invokana ntuża waħdu b'doża ta' 100 mg, naqqas il-livelli ta' HbA1c b'0.91 % aktar minn plaċebo wara 26 ġimgħa, filwaqt li d-doża ta' 300 mg wasslet għal tnaqqis ta' 1.16 % aktar minn plaċebo.
English: • The study in older patients showed that Invokana had clinically relevant effects also in patients above 75 years of age with HbA1c reductions compared with placebo of 0.70% and 0.57% with the 300 mg and 100 mg doses, respectively.
Maltese: • L-istudju f'pazjenti anzjani wera li Invokana kellu effetti klinikament rilevanti wkoll f'pazjenti li għandhom aktar minn 75 sena bi tnaqqis f'HbA1c ta' 0.70 % u 0.57 % meta mqabbel mal-plaċebo bid-dożi ta' 300 mg u 100 mg, rispettivament.
English: • The study in patients with moderately reduced kidney function showed that the effects of Invokana were reduced in these patients, but still clinically relevant: the reduction of HbA1c levels compared with placebo was 0.30% with the 100 mg dose.
Maltese: • L-istudju f'pazjenti b'funzjoni tal-kliewi moderatament mnaqqsa wera li l-effetti ta' Invokana tnaqqsu f'dawn il-pazjenti, iżda xorta kienu klinikament rilevanti: it-tnaqqis tal-livelli ta' HbA1c meta mqabbel mal-plaċebo kien ta' 0.30 % bid-doża ta' 100 mg.
English: • When Invokana was used as add-on to insulin at a dose of 300 mg, it decreased HbA1c levels by 0.73% more than placebo after 18 weeks, while the 100 mg dose led to a reduction of 0.65% more than placebo.
Maltese: • Meta Invokana ntuża bħala żieda mal-insulina b'doża ta' 300 mg, naqqas il-livelli ta' HbA1c b'0.73 % aktar minn plaċebo wara 18-il ġimgħa, filwaqt li d-doża ta' 100 mg wasslet għal tnaqqis ta' 0.65 % aktar minn plaċebo.
English: As the effects of Invokana are dependent on kidney function, the effectiveness and tolerability of the medicine are reduced in patients with reduced kidney function.
Maltese: Peress li l-effetti ta' Invokana jiddependu mill-funzjoni tal-kliewi, l-effikaċja u t-tollerabbiltà talmediċina jitnaqqsu f'pazjenti b'funzjoni tal-kliewi indebolita.
English: Invokana is available as tablets (100 and 300 mg) and can only be obtained with a prescription.
Maltese: Invokana jiġi bħala pilloli (100 u 300 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku kanagliflozin
English: The use of Invokana is therefore not recommended in patients with severely reduced kidney function.
Maltese: Għaldaqstant, l-użu ta' Invokana mhuwiex rakkomandat f'pazjenti b'funzjoni tal-kliewi indebolita severament.
English: Regarding its safety, this was considered similar to other medicines of the same class (SGLT2 inhibitors).
Maltese: Fir-rigward tas-sigurtà tiegħu, dan kien ikkunsidrat simili għal mediċini oħrajn tal-istess klassi (inibituri SGLT2).
English: How is Invokana used?
Maltese: Kif jaħdem Invokana?
English: The CHMP concluded that Invokana was shown to be effective at controlling blood glucose levels.
Maltese: Is-CHMP ikkonkluda li Invokana ntwera li huwa effikaċi fil-kontroll tal-livelli ta' glukożju fid-demm.
English: Invokana was shown to be more effective than placebo, and at least as effective as comparator medicines, at reducing the levels of HbA1c when used alone and in combination with other diabetes medicines:
Maltese: Invokana ntwera li huwa aktar effikaċji minn plaċebo, u tal-anqas effikaċi daqs il-mediċini tat-tqabbil, fit-tnaqqis tal-livelli ta' HbA1c meta jintuża waħdu u flimkien ma' mediċini oħra kontra d-dijabete:
English: A risk management plan has been developed to ensure that Invokana is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Invokana jintuża bl-aktar mod sigur possibbli.
English: • Across the studies that looked at Invokana when used as add-on to one or two other diabetes medicines, the reductions in HbA1c levels after 26 weeks compared with placebo ranged from 0.76% to 0.92% with the 300 mg dose, and from 0.62% to 0.74% with the 100 mg dose.
Maltese: 92 % bid-doża ta' 300 mg, u minn 0.62 % sa 0.74 % bid-doża ta' 100 mg.
English: SGLT2 is a protein that absorbs glucose from the urine back into the bloodstream as the blood is filtered in the kidneys.
Maltese: SGLT2 huwa proteina li tassorbi l-glukożju mill-awrina lura fil-fluss tad-demm hekk kif id-demm jiġi ffiltrat fil-kliewi.
English: The recommended starting dose is 100 mg once a day.
Maltese: Id-doża tal-bidu rakkomandata hija ta' 100 mg darba kuljum.
English: Three studies looked at Invokana when used as add-on to one other diabetes medicine (metformin or insulin), and three further studies looked at Invokana when used as add-on to two other diabetes medicines (including metformin), when these medicines together with exercise and diet were not providing adequate control of the diabetes.
Maltese: Tliet studji eżaminaw Invokana meta ntuża bħala żieda ma' mediċina oħra kontra d-dijabete (metformina jew insulina), u tliet studji oħra eżaminaw Invokana meta ntuża bħala żieda ma' żewġ mediċini oħra kontra d-dijabete (inkluż metformina), meta dawn il-mediċini flimkien mal-eżerċizzju u ddieta ma kinux qed jipprovdu kontroll adegwat tad-dijabete.
English: Invokana has been evaluated in 9 main studies involving a total of around 10,000 patients with type 2 diabetes.
Maltese: Invokana ġie evalwat f'9 studji ewlenin li kienu jinvolvu total ta' madwar 10 000 pazjent b'dijabete tattip 2.
English: • Invokana was also shown to be at least as effective as the diabetes medicines glimepiride and sitagliptin after 52 weeks of treatment.
Maltese: • Invokana ntwera wkoll li huwa tal-anqas effettiv daqs il-mediċini kontra d-dijabete glimepiride u sitagliptin wara 52 ġimgħa ta' kura.
English: Intravenous use vial (glass) closed by a Teflon faced grey chlorobutyl rubber stopper
Maltese: Kontenut Daqs talpakkett fjala (ħġieġ) magħluq b'tapp tal-gomma chlorobutyl griż miksi fil-wiċċ bit-Teflon fjala (ħġieġ) magħluqa b'tapp talgomma bromobutyl griż li mhux miksi
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem ivvintat Qawwa Għamla farmaċewtika
English: EU (MA) Number Invented name
Maltese: Il-pakkett li jmiss mal-prodott
English: July 2014; 109(7):950-66.
Maltese: Lulju 2014; 109(7): 950-66.
English: 2 Chalasani NP, Hayashi PH, Bonkovsky HL et al. ACG Clinical Guideline: The diagnosis and management of idiosyncratic drug-induced liver injury.
Maltese: 2 Chalasani NP, Hayashi PH, Bonkovsky HL et al. Linja Gwida Klinika ACG:
English: Hysterectomy is a very common curative surgical procedure within gynaecology associated with a low mortality (mortality figures quoted range from 0.02% to 0.17%) and a low risk of intra- or postoperative complications (quoted from 5% to 8%).
Maltese: L-isterektomija hija proċedura kirurġika kurattiva komuni ħafna fil-ġinekoloġija assoċjata ma' mortalità baxxa (iċ-ċifri talmortalità kkwotati jvarjaw minn 0.02% sa 0.17%) u riskju baxx ta' kumplikazzjonijiet waqt jew wara loperazzjoni (ikkwotati minn 5% sa 8%).
English: 1 Stewards EA; Uterine Fibroids.
Maltese: 1 Stewards EA; Uterine Fibroids (Il-Fibrojdi tal-Utru). Lancet,27 ta' Jannar 2001;
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Esmya (ulipristal acetate).
Maltese: • Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004 bħala riżultat tad-data ta' farmakoviġilanza għal Esmya (ulipristal acetate).
English: Usually, DILI events occur within the first 6 months after starting a new medication2.
Maltese: Normalment, l-avvenimenti DILI jseħħu fl-ewwel 6 xhur wara li tinbeda medikazzjoni ġdida2.
English: Esmya (ulipristal acetate, 5 mg) is a centrally authorised medicinal product indicated for pre-operative treatment, as well as intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Maltese: Esmya (ulipristal acetate, 5 mg) huwa prodott mediċinali awtorizzat skont il-proċedura ċentralizzata indikat għall-kura ta' qabel l-operazzjoni, kif ukoll għall-kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva.
English: The PRAC also considered the views expressed by experts at an ad hoc expert group meeting.
Maltese: Il-PRAC ikkunsidra wkoll il-fehmiet espressi mill-esperti f'laqgħa ad hoc tal-grupp ta' esperti.
English: Data from clinical trials, non-clinical studies including in vitro testing were also reviewed.
Maltese: Id-data minn provi kliniċi, studji mhux kliniċi inklużi testijiet in vitro ġiet irrieżaminata wkoll.
English: • The PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Maltese: • Il-PRAC ikkonkluda li Esmya (ulipristal acetate) jista' jkollu riskju għal ħsara serja fil-fwied.
English: Uterine fibroids are the single most common indication for hysterectomy1.
Maltese: Il-fibrojdi tal-utru huma l-indikazzjoni l-aktar komuni għall-isterektomija1.
English: As assessed in the initial marketing authorisation of Esmya, the clinical efficacy of ulipristal acetate in the pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age was based on short-term studies demonstrating the ability of the active substance to reduce fibroid-related bleeding, anaemia and fibroid size if administered in a daily dose of 5 mg for up to three months.
Maltese: Kif ivvalutat fl-awtorizzazzjoni inizjali għat-tqegħid fis-suq ta' Esmya, l-effikaċja klinika ta' ulipristal acetate fil-kura ta' qabel l-operazzjoni ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva kienet ibbażata fuq studji ta' perjodu qasir li juru l-ħila tas-sustanza attiva li tnaqqas il-fsada relatata mal-fibrojdu, l-anemija u d-daqs tal-fibrojdu jekk tingħata f'doża ta' kuljum ta' 5 mg sa tliet xhur.
English: • The PRAC recommended that intermittent treatment of moderate to severe symptoms of uterine fibroids with Esmya should be restricted to adult women of reproductive age who are not eligible for surgery.
Maltese: • Il-PRAC irrakkomanda li kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi tal-utru b'Esmya għandha tkun ristretta għal nisa adulti ta' età riproduttiva li mhumiex eliġibbli għal kirurġija.
English: On 30 November 2017, the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data, and requested the PRAC to assess the impact of the above concerns on the benefit-risk balance of Esmya and to issue a recommendation on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fit-30 ta' Novembru 2017, il-Kummissjoni Ewropea tat bidu għal proċedura skont l-Artikolu 20 tarRegolament(KE) Nru 726/2004 bħala riżultat tad-data dwar il-farmakoviġilanza, u talbet lill-PRAC jivvaluta l-impatt tat-tħassib ta' hawn fuq dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' Esmya u biex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjonijiet rilevanti għat-tqegħid fis-suq għandhomx jinżammu, jiġu varjati, sospiżi jew revokati.
English: Three cases of serious liver injury leading to a hepatic transplantation were reported between the marketing authorisation of Esmya (ulipristal acetate) and November 2017.
Maltese: Tliet każijiet ta' ħsara serja fil-fwied li twassal għal trapjant tal-fwied kienu rrappurtati bejn lawtorizzazzjoni għat-tqegħid fis-suq ta' Esmya (ulipristal acetate) u Novembru 2017.
English: Although uterine fibroids are benign, moderate to severe forms are often associated with significant morbidity, such as heavy bleeding, anaemia, pain, discomfort and reduced quality of life.
Maltese: Għalkemm il-fibrojdi tal-utru huma beninni, forom moderati sa severi huma spiss assoċjati ma' morbożità sinifikanti, bħal emorraġija qawwija, anemija, uġigħ, skonfort u tnaqqis fil-kwalità tal-ħajja.
English: This last indication was authorised based on results from another study providing data for up to 4 intermittent treatment courses of 3 months each with ulipristal acetate along with data for repeated treatment courses from the previous studies.
Maltese: Din l-aħħar indikazzjoni kienet awtorizzata abbażi tar-riżultati minn studju ieħor li pprovda data għal sa 4 korsijiet ta' kura intermittenti ta' 3 xhur kull wieħed b'ulipristal acetate flimkien ma' data għal korsijiet ta' kura ripetuti mill-istudji preċedenti.
English: In line with the exclusion criteria in the clinical studies of Esmya, patients with ALT or AST> 2 x ULN (isolated or in combination with bilirubin >2 x ULN) should not initiate treatment.
Maltese: F'konformità mal-kriterji ta' esklużjoni fl-istudji kliniċi ta' Esmya, pazjenti b'ALT jew AST> 2 x ULN (iżolati jew flimkien ma' bilirubin> 2 x ULN) m'għandhomx jibdew il-kura.
English: Taking into account the clinical utility of Esmya in the intermittent treatment indication, where no other long-term pharmacological alternative is authorised, this indication should be limited to adult women of reproductive age who are not eligible for surgery.
Maltese: Filwaqt li titqies l-utilità klinika ta' Esmya flindikazzjoni ta' kura intermittenti, fejn l-ebda alternattiva farmakoloġika fit-tul oħra mhija awtorizzata, din l-indikazzjoni għandha tkun limitata għal nisa adulti f'età riproduttiva li mhumiex eliġibbli għal kirurġija.
English: Given the estimated exposure to Esmya of approximately 200,000 to 275,000 patient-years, the number of cases of serious liver injury leading to liver transplantation appears higher than expected, although background incidence on drug induced liver injury is uncertain.
Maltese: Minħabba lesponiment stmat għal Esmya ta' madwar 200,000 sa 275,000 sena tal-pazjent, in-numru ta' każijiet ta' ħsara serja fil-fwied li wasslet għal trapjant tal-fwied jidher li huwa ogħla minn dak mistenni, għalkemm hemm inċertezza dwar l-inċidenza ta' sfond dwar ħsara fil-fwied ikkaġunata mill-mediċina.
English: PRAC considered all the data submitted by the MAH, as well as data provided by the National Competent Authorities including follow-up information on cases of liver transplantation.
Maltese: Il-PRAC ikkunsidra d-data kollha sottomessa mill-MAH, kif ukoll data pprovduta mill-Awtoritajiet Nazzjonali Kompetenti inkluża informazzjoni ta' segwitu dwar każijiet ta' trapjant tal-fwied.
English: Uterine fibroids are the most common female pelvic tumour.
Maltese: Il-fibrojdi tal-utru huma t-tumur pelviku l-aktar komuni fin-nisa.
English: The available data raise serious concerns, and warrant risk minimisation measures to be taken.
Maltese: Id-data disponibbli tqajjem tħassib serju, u titlob li jittieħdu miżuri ta' minimizzazzjoni tar-riskju.
English: Balancing this to the benefits of Esmya treatment of moderate to severe symptoms of uterine fibroids, the PRAC concluded that the indicated population should be restricted for safety reasons.
Maltese: L-ibbilanċjar ta' dan mal-benefiċċji tal-kura ta' Esmya minn sintomi moderati sa severi ta' fibrojdi tal-utru, il-PRAC ikkonkluda li l-popolazzjoni indikata għandha tkun ristretta għal raġunijiet ta' sigurtà.
English: Although the general characteristics of Esmya do not support it to be a typical DILI causing agent, based on the current review, and taking experts views into consideration, the PRAC concluded that Esmya (ulipristal acetate) may carry a risk for serious liver injury.
Maltese: Għalkemm il-karatteristiċi ġenerali ta' Esmya ma jippermettux li jkun aġent tipiku li jikkawża DILI, abbażi tar-rieżami attwali, u filwaqt li jqis il-fehmiet tal-esperti, il-PRAC ikkonkluda li Esmya (ulipristal acetate) jista' jkun ta' riskju għal ħsara serja fil-fwied.
English: and assuming that all such cases are due to Esmya, regardless of causality, the peak time to onset of liver injury is around 140 days and the vast majority of the reported potential drug induced liver injuries occurring between 1 and 8 months (2 treatment cycles including 2 months pause).
Maltese: Abbażi tal-każijiet ta' wara t-tqegħid fis-suq ta' ħsara potenzjali fil-fwied irrappurtati b'Esmya, u jekk wieħed jassumi li dawn il-każijiet kollha huma dovuti għal Esmya, irrispettivament mill-kawżalità, iż-żmien massimu għall-bidu tal-ħsara fil-fwied huwa madwar 140 jum u l-maġġoranza l-kbira tal-ħsara fil-fwied potenzjali rrappurtata kkawżata mill-mediċina li sseħħ bejn xahar u 8 xhur (żewġ ċikli ta' kura inkluża pawża ta' xahrejn).
English: • The PRAC was also of the opinion that mechanistic studies should be conducted, to further investigate a possible mechanism for hepatic toxicity.
Maltese: • Il-PRAC kien ukoll tal-fehma li għandhom jitwettqu studji mekkanistiċi, biex jiġi investigat aktar mekkaniżmu possibbli għal tossiċità tal-fwied.
English: The views expressed by ad-hoc experts consulted during the course of the procedure were also considered.
Maltese: Il-fehmiet espressi minn esperti ad-hoc ikkonsultati matul il-kors tal-proċedura ġew ikkunsidrati wkoll.
English: This is the rationale that justifies the mandatory liver monitoring within the first 2 treatment courses, while during later courses, monitoring is recommended as clinically indicated.
Maltese: Dan huwa r-raġunament li jiġġustifika lmonitoraġġ obbligatorju tal-fwied fl-ewwel żewġ korsijiet ta' kura, filwaqt li matul korsijiet suċċessivi, huwa rakkomandat monitoraġġ kif indikat klinikament.
English: • The PRAC reviewed the totality of the data regarding the risk for liver injury with Esmya provided by the marketing authorisation holder and National Competent Authorities on cases of liver injury and liver transplantation reported since the initial marketing authorisation of the product.
Maltese: • Il-PRAC irrieżamina d-data kollha dwar ir-riskju għal ħsara fil-fwied b'Esmya pprovduta middetentur tal-awtorizzazzjoni għat-tqegħid fis-suq u l-Awtoritajiet Nazzjonali Kompetenti dwar każijiet ta' ħsara fil-fwied u trapjanti tal-fwied irrappurtati mill-awtorizzazzjoni inizjali għattqegħid fis-suq tal-prodott.
English: However, due to exclusion criteria covering patients with elevated transaminases, or other signs of liver disease, as well as the limited size of the safety database in these studies, the absence of findings in clinical trials has to be interpreted with caution.
Maltese: Madankollu, minħabba kriterji ta' esklużjoni li jkopru pazjenti bi transaminases elevati, jew sinjali oħra ta' mard tal-fwied, kif ukoll id-daqs limitat tal-bażi tad-data tas-sigurtà f'dawn l-istudji, in-nuqqas ta' sejbiet fi provi kliniċi għandha tiġi interpretata b'kawtela.
English: It is also clarified that Esmya can be used as one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Maltese: Huwa ċċara wkoll li Esmya jista' jintuża bħala kors wieħed ta' kura qabel operazzjoni ta' sintomi moderati sa severi ta' fibrojdi tal-utru f'nisa adulti ta' età riproduttiva.
English: • The PRAC further concluded that Esmya should be contraindicated in patients with underlying hepatic disorder.
Maltese: • Il-PRAC ikkonkluda wkoll li Esmya għandu jkun kontraindikat f'pazjenti b'disturb fil-fwied sottostanti.
English: Other surgical treatments such as myomectomy and uterine artery embolisation are also valid alternatives to hysterectomy, but they are not suitable for all cases and are also associated with a higher rate for complications than hysterectomy.
Maltese: Kuri kirurġiċi oħra bħal mijomektomija u embolizzazzjoni talarterja tal-utru huma wkoll alternattivi validi għall-isterektomija, iżda mhumiex xierqa għall-każijiet kollha u huma wkoll assoċjati ma' rata ogħla ta' kumplikazzjonijiet minn isterektomija.
English: • The PRAC also found it necessary to introduce a patient card to be provided in each package of Esmya, to ensure that patients are adequately informed on the possible risks of liver injury and the implemented risk minimisation measures.
Maltese: • Il-PRAC sab ukoll neċessarju li jintroduċi kard tal-pazjent li għandha tiġi pprovduta f'kull pakkett ta' Esmya, biex jiġi żgurat li l-pazjenti jkunu infurmati kif xieraq dwar ir-riskji possibbli ta' ħsara fil-fwied u l-miżuri implimentati ta' minimizzazzjoni tar-riskju.
English: The marketing authorisation of Esmya was extended to include the therapeutic indication for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
Maltese: L-awtorizzazzjoni għattqegħid fis-suq ta' Esmya ġiet estiża biex tinkludi l-indikazzjoni terapewtika għall-kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi tal-utru f'nisa adulti ta' età riproduttiva.
English: Based on the safety findings and possible mechanism of action, the experts of the ad hoc experts group were of the view that a causal association between Esmya and severe liver injury is plausible.
Maltese: Abbażi tas-sejbiet ta' sigurtà u l-mekkaniżmu possibbli ta' azzjoni, l-esperti tal-grupp ta' esperti ad hoc kienu tal-fehma li assoċjazzjoni kawżali bejn Esmya u ħsara serja fil-fwied hija plawżibbli.