FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP took these comments into account, and considered that with the additional amendments to the product information for the restriction of use to maxim of 3 days, and the additional data provided for special populations including the elderly, that the overall safety of this fixed-dese combination to be acceptable in the indication for the short-term symptomatic treatment of mild to moderate pain.
Maltese: Is-CHMP ikkunsidra dawn il-kummenti, u kkunsidra li bl-emendi addizzjonali fl-informazzjoni dwar il-prodott għar-restrizzjoni tal-użu sa massimu ta' 3 ijiem, u bid-data addizzjonali pprovduta għal popolazzjonijiet speċjali inkluż l-anzjani, is-sigurtà globali ta' din il-kombinazzjoni ta' doża fissa tkun aċċettabbli fl-indikazzjoni għall-kura sintomatika fi żmien qasir ta' uġigħ ħafif sa moderat.
English: Median time to perceptible pain relief was significantly shorter for the combination than ibuprofen and placebo (p<0.05) and non-significant for the comparison with paracetamol.
Maltese: Il-ħin medjan għas-solliev mill-uġigħ perċeput kien ħafna iqsar għall-kombinazzjoni milli għal ibuprofen u placebo (p<0.05) u ma kienx sinifikanti għat-tqabbil ma' paracetamol.
English: Finally in terms of safety there is supportive data to exclude any additive adverse effects on gastric erosions and bleeding when paracetamol is added to ibuprofen in the ratio of 3.3:1, and the efficacy provided by the fixed dose combination over either of the individual components does show any decreased tolerability/safety.
Maltese: Finalment, f'termini ta' sigurtà, hemm data ta' sostenn biex jiġi eskluż kwalunkwe effett avvers addittiv fuq erożjonijiet u fsada gastriċi meta paracetamol jiżdied ma' ibuprofen fil-proporzjon ta' 3.3:1, u l-effikaċja pprovduta mill-kombinazzjoni ta' doża fissa fuq kwalunkwe wieħed millkompononenti individwali ma turix xi tollerabbiltà/sigurtà mnaqqsa.
English: Furthermore, for this substance combination, there is no interference with their individual metabolic pathways, and they also act through different pharmacological pathways.
Maltese: Barra minn hekk, għal din il-kombinazzjoni ta' sustanzi, m'hemm l-ebda interferenza mar-rotot metaboliċi individwali tagħhom, u dawn jaġixxu wkoll permezz ta' rotot farmakoloġiċi differenti.
English: These risks are well known and are controlled by routine pharmacovigilance practices which CHMP has endorsed.
Maltese: Dawn ir-riskji huma magħrufa sewwa u huma kkontrollati minn prattiċi ta' farmakoviġilanza ta' rutina li aċċetta s-CHMP.
English: Linear interpolation was use to estimate intermittent missing values.
Maltese: Intużat interpolazzjoni lineari sabiex jiġu stmati l-valuri nieqsa intermittenti.
English: Study AFT-MX-1 was a phase III, pivotal study with a prospective, parallel group, double-blind comparison of the analgesic effect of a combination of paracetamol and ibuprofen, paracetamol alone, or ibuprofen alone in patients with postoperative pain.
Maltese: III, bi tqabbil prospettiv, ta' grupp parallel doubleblind tal-effett analġeżiku ta' kombinazzjoni ta' paracetamol u ibuprofen, paracetamol waħdu, jew ibuprofen waħdu f'pazjenti b'uġigħ ta' wara l-operazzjoni.
English: Study AFT-MX-6E was a phase III trial in another acute pain model (arthroscopy).
Maltese: Studju AFT-MX-6E kien prova ta' fażi
English: It is noted that there is significant use of opioid combinations in the EU.
Maltese: Huwa nnutat li hemm użu sinifikanti ta' kombinazzjoniijiet ta' opjojdi fl-UE.
English: • The Committee is of the opinion that the available data is supportive of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Maltese: • Il-Kumitat huwa tal-opinjoni li d-data disponibbli tappoġġa l-effikaċja ta' Paracetamol/ibuprofen 500 mg / 150 mg pilloli miksijin b'rita u ismijiet assoċjati kombinazzjoni ta' doża fissa f'kura sintomatika għal żmien qasir ta' uġigħ ħafif sa moderat.
English: Overall benefit-risk balance
Maltese: Ġestjoni tar-riskju
English: In the study the active substances have all been shown to be statistically superior to placebo.
Maltese: Fl-istudju, intwera li s-sustanzi attivi kollha huma statistikament superjuri għall-plaċebo.
English: The CHMP noted the concerns by these members, but agreed that overall the efficacy of the combination for the short duration of use of 3 days has been demonstrated.
Maltese: Is-CHMP innota t-tħassib minn dawn il-membri, iżda qabel li b'mod globali, l-effikaċja talkombinazzjoni għad-durata qasira tal-użu ta' 3 ijiem intweriet.
English: Furthermore in a study population which included 1.2 million patients, whose aim was to evaluate and compare the risk of specific safety outcomes in patients prescribed ibuprofen and paracetamol concomitantly with those in patients prescribed ibuprofen or paracetamol alone, concluded that the known risk of the safety outcomes examined does not appear to be modified by concomitant use of ibuprofen and paracetamol compared with the mono-components alone.
Maltese: Barra minn hekk f'popolazzjoni ta' studju li inkludiet 1.2 miljun pazjent, li l-għan tiegħu kien li jevalwa u jqabbel ir-riskju ta' eżiti tas-sigurtà speċifiċi f'pazjenti li ġew preskritti ibuprofen u paracetamol fl-istess ħin ma' dawk f'pazjenti li ġew preskritti ibuprofen jew paracetamol waħdu, ikkonkluda li r-riskju magħruf tal-eżiti tas-sigurtà eżaminati ma jidhirx li huwa modifikat minn użu fl-istess ħin ta' ibuprofen u paracetamol meta mqabbel mal-monokomponenti waħidhom.
English: Paracetamol and ibuprofen are two analgesic compounds with long histories of clinical use and both have been shown to be safe and well tolerated at maximum recommended daily doses.
Maltese: Paracetamol u ibuprofen huma żewġ komposti analġeżiċi bi stejjer twal ta' użu kliniku u t-tnejn intwerew li huma siguri u ttollerati tajjeb fid-dożi ta' kuljum rakkomandati massimi.
English: The CHMP was of the opinion that the benefit-risk balance of Paracetamol / ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination is considered to be favourable when used in accordance with the terms of the product information.
Maltese: Is-CHMP kien tal-opinjoni li l-bilanċ bejn il-benefiċċju u r-riskju ta' Paracetamol / ibuprofen 500 mg / 150 mg pilloli miksijin b'rita u ismijiet assoċjati, ilkombinazzjoni ta' doża fissa hija kkunsidrata li hija favorevoli meta tintuża skont it-termini talinformazzjoni dwar il-prodott.
English: On 21 October 2016 the RMS United Kingdom therefore triggered a referral under Article 29(4) of Directive 2001/83/EC as these issues were considered to be a potential serious risk to public health.
Maltese: Fil-21 ta' Ottubru 2016, l-RMS ir-Renju Unit għalhekk ta bidu għal riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE peress li dawn il-kwistjonijiet ġew ikkunsidrati bħala riskju serju potenzjali għas-saħħa pubblika.
English: • The Committee reviewed all the data submitted by the applicant in support of the efficacy of Paracetamol/ibuprofen 500 mg / 150 mg film coated tablets and associated names fixed dose combination in short-term symptomatic treatment of mild to moderate pain.
Maltese: • Il-Kumitat irreveda d-data kollha ppreżentata mill-applikant li tappoġġa l-effikaċja ta' Paracetamol/ibuprofen 500 mg / 150 mg pilloli miksijin b'rita u ismijiet assoċjati kombinazzjoni ta' doża fissa f'kura sintomatika għal żmien qasir ta' uġigħ ħafif sa moderat.
English: A variety of reports show that the addition of codeine to common non-opioid analgesics provides additional pain relief at the cost of tolerability, compromising the benefit-risk ratio.
Maltese: Varjetà ta' rapporti turi li ż-żieda ta' kodeina ma' analġeżiċi mhux opjojdi komuni tipprovdi solliev mill-uġigħ addizzjonali skapitu tat-tollerabbiltà, waqt li jiġi kompromess il-proporzjon benefiċċji-riskji.
English: The important safety risk associated with prolonged use of paracetamol and ibuprofen are well known and are hepatotoxicity, peptic ulceration and gastrointestinal bleeding, nephrotoxicity, cardiac, cardiovascular and cerebrovascular effects .The applicant has provided a comprehensive review of the safety data both from the submitted studies and from overall pooled study data including the exposure of the combination in elderly patients.
Maltese: Ir-riskji tas-sigurtà importanti assoċjati mal-użu fit-tul ta' paracetamol u ibuprofen huma magħrufin sewwa u huma epatotossiċità, ulċerazzjoni peptika u fsada gastrointestinali, nefrotossiċità, effetti kardijaċi, kardjovaskulari u ċerebrovaskulari.
English: Rationale for use of the fixed dose combination ratio
Maltese: Raġunament għall-użu tal-proporzjon tal-kombinazzjoni ta' doża fissa
English: The results showed that the combination provided significantly greater pain relief than either mono-component (p<0.001).
Maltese: Ir-riżultati wrew li l-kombinazzjoni pprovdiet solliev mill-uġigħ ħafna akbar minn kwalunkwe monokomponent (p<0.
English: Study AFT-MX-4 was a phase II exploratory study with a double-blind, randomized, parallel group comparison of the effects of Paracetamol and Ibuprofen Combined with Paracetamol, Low and High Dose Ibuprofen on Patients with Pain from Osteoarthritis of the Knee, and a 12 month open label extension.
Maltese: II, esploratorju bi tqabbil ta' grupp parallel double-blind u randomizzat tal-effetti ta' Paracetamol u Ibuprofen Flimkien ma' Paracetamol, Ibuprofen ta' Doża Baxxa u Għolja f'Pazjenti b'Uġigħ minn Osteoartrite tal-Irkoppa, u estensjoni open label ta' 12il xahar.
English: Study AFT-MX-3 was a dose response study and a double-blind, placebo-controlled, randomised, parallel group comparison of the effects of different paracetamol and ibuprofen combination doses and placebo in participants with pain from removal of 2-4 third molars.
Maltese: Studju AFT-MX-3 kien studju dwar ir-rispons għad-doża u kien tqabbil double-blind, ikkontrollat mill-plaċebo, randomizzat, ta' tqabbil ta' grupp parallel tal-effetti ta' dożi kkombinati differenti ta' paracetamol u ibuprofen u l-plaċebo f'parteċipanti b'uġigħ mit-tneħħija ta' 2-4 molari terzi. Lobjettiv tiegħu kien li jikkumpara Differenzi tal-Intensità tal-Uġigħ Magħduda (SPIDs, Summed Pain Intensity Differences) aġġustati skont il-ħin mil-linja bażi tal-punteġġi tal-intensità tal-uġigħ talIskala Analoga Viżwali (VAS, Visual Analogue Scale) sa 24 siegħa wara l-ewwel doża talmedikazzjoni ta' studju fost l-erba' gruppi ta' kura sabiex tiġi ddeterminata l-forma tar-relazzjoni bejn id-doża u r-rispons.
English: This phase II exploratory study has shown that in osteoarthritis pain, the combination is effective.
Maltese: II esploratorju wera li fl-uġigħ talosteoartrite, il-kombinazzjoni hija effettiva.
English: The primary objective showed that the combination was statistically superior to the active substances individually.
Maltese: Lobjettiv primarju wera li l-kombinazzjoni kienet statistikament superjuri għas-sustanzi attivi b'mod individwali.
English: When comparing with past users, for most safety outcomes, current users of concomitant paracetamol and ibuprofen had relative rates between those for current users of ibuprofen alone and paracetamol alone.
Maltese: Meta mqabbla ma' utenti tal-passat, għal ħafna mill-eżiti tas-sigurtà, l-utenti attwali ta' paracetamol u ibuprofen fl-istess ħin kellhom rati relattivi bejn dawk għall-utenti attwali ta' ibuprofen waħdu u paracetamol waħdu.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla Farmaċewtika
English: 3421 GW Oudewater The Netherlands
Maltese: 3421 GW Oudewater L-Olanda
English: CVMP started the procedure on 6 November 2007.
Maltese: Is-CVMP beda l-proċedura fis-6 ta' Novembru 2007.
English: horse oral
Maltese: żiemel orali
English: paste
Maltese: pejst
English: 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.
Maltese: 5 mg trimethoprim u 25 mg sulfadiazine għal kull kg ta' piż talġisem kuljum għal massimu ta' 5t'ijiem.
English: Equibactin vet Oral Paste proved to be essentially similar to the reference product, Tribrissen Oral Paste.
Maltese: Pejst Orali Equibactin vet. wera li huwa essenzjalment simili għal prodott ta' referenza, Pejst Orali Tribrissen.
English: Oral Paste and Tribrissen oral paste for trimethoprim as well as for sulfadiazine, the products are regarded to be essentially similar.
Maltese: u Pejst Orali Tribrissen għal trimethoprim kif ukoll għal sulfadiazine, il-prodotti jitqiesu li huma essenzjalment simili.
English: Oral Paste in accordance with the outcome of referral procedure EMEA/V/023 under Article 35 of Directive 2001/82/EC as amended, for the reference medicinal product Tribrissen Oral Paste authorised in The Netherlands.
Maltese: Huwa rakkomandat li Pejst Orali Equibactin vet. ivarja f'konformità ma' l-eżiti ta' proċedura ta' referenza EMEA/V/023 skond l-Artikolu 35 ta' Direttiva 2001/82/KE kif emendat, għall-prodott mediċinali ta' referenza Pejst Orali Tribrissen awtorizzat fl-Olanda.
English: Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses.
Maltese: (333 mg/g + 67 mg/g) Pejst Orali għaż-Żwiemel.
English: Oral Paste for Horses proved to be bioequivalent to the reference products Tribrissen (REG NL 5055 in the Netherlands) and Tribissen (Vm 0201/4064 in the UK).
Maltese: Fl-istudju GLP ta' bijoekwivalenza ta' doża waħda fiż-żwiemel, magħmul skond linji gwidi xierqa, Pejst Orali għaż-Żwiemel Equibactin vet. intwera li huwa bijoekwivalenti għall-prodotti ta' referenza Tribrissen (REG NL 5055 fl-Olanda) u Tribissen (Vm 0201/4064 fir-Renju Unit).
English: The original reference product "Tribrissen Oral Paste" was authorised in the Netherlands in 1992.
Maltese: "Pejst Orali Tribrissen" kien awtorizzat fl-Olanda fl-1992.
English: The Netherlands, reference member state in the decentralised procedure, notified the EMEA on 24 September 2007 that the Co-ordination Group for Mutual Recognition and Decentralised ProceduresVeterinary (CMD(v)) failed to reach an agreement for Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses.
Maltese: Fl-24 ta' Settembru 2007, l-Olanda, Stat Membru ta' referenza fil-proċedura deċentralizzata, innotifikat lill-EMEA li l-Grupp ta' Koordinament għal Rikonoxximent Reċiproku u Proċeduri Deċentralizzati - Veterinarji (CMD(v)) ma rnexxielhomx jilħqu ftehim fuq Pejst Orali għaż-Żwiemel Equibactin vet.
English: Product invented name
Maltese: Isem invetat talprodott
English: On 16 November 2007 responses to the questions were received from MAH and the clock restarted.
Maltese: Fis-16 ta' Novembru 2007 kienu rċevuti reazzjonijiet għallmistoqsijiet mingħand l-MAH u l-proċedura ssoktat.
English: Based on the identical composition with respect to active ingredients, Trimethoprim and Sulfadiazine, the same pharmaceutical form, and proven bioequivalence between Equibactin vet.
Maltese: Fuq il-bażi tal-kompożizzjoni fir-rigward tas-sustanzi attivi, Trimethoprim u Sulfadiazine, l-istess għamla farmaċewtika, u bijoekwivalenza bejn Pejst Orali Equibactin vet.
English: In response to question 1, the applicant provided a copy of the original dossier as submitted in support of the application of a decentralised procedure, and any supplementary data submitted during the decentralised procedure in response to the phase I and phase II assessment and the referral procedure in CMD(v) thereafter.
Maltese: F'reazzjoni għal mistoqsija nru 1, l-applikant ipprovda kopja tal-fajl oriġinali kif sottomess bħala sostenn ta' l-applikazzjoni ta' proċedura deċentralizzata, u kwalunkwe dejta supplimentari sottomessa waqt il-proċedura ddeċentralizzata f'reazzjoni għall-istima ta' fażi I u fażi
English: A copy of the dossier of Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and any supplementary data added to it, up to day 60 of the referral procedure in CM(v).
Maltese: (333 mg/g + 67 mg/g) u kwalunkwe dejta supplimentari miżjuda miegħu, sa jum 60 tal-proċedura ta' referenza f'CMD(v).
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter was referred to the CVMP.
Maltese: B'mod konformi ma' l-Artikolu 33(4) tad-Direttiva tal-Kunsill 2001/82/KE, kif emendat, il-kwistjoni kienet riferuta lis-CVMP.
English: It is recommended to vary Equibactin vet.
Maltese: Equibactin vet.
English: CVMP noted that Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses is a generic of Tribrissen oral paste (authorised in the Netherlands) and that the concerns raised by France can only be addressed in the framework of this procedure, in case any differences between both products would justify different conclusions on the safety or efficacy.
Maltese: (333 mg/g + 67 mg/g) huwa ġeneriku ta' pejst orali Tribrissen (awtorizzat fl-Olanda) u li tħassib imqajjem minn Franza jista' jkun biss indirizzat fil-qafas ta' din il-proċedura, f'każ li xi differenzi bejn il-prodotti jistgħu jiġġustifikaw konklużjonijiet differenti fuq is-sigurtà jew l-effikaċja.
English: Consequently, the conclusions on efficacy and safety for the reference product, Tribrissen oral paste, can be extended to the generic product, Equibactin vet.
Maltese: Konsegwentement, il-konklużjonijiet għall-effikaċja u s-sigurtà għal prodott ta' referenza, pejst orali Tribrissen, jistgħu jiġu estiżi għal prodott ġeneriku, Pejst Orali Equibactin vet.
English: A list of questions was adopted on 8 November 2007 and sent to the marketing authorisations holders (MAH), by which the procedure clock was stopped.
Maltese: Lista ta' mistoqsijiet kienet adottata fit-8 ta' Novembru 2007 u din intbagħtet lid-detenturi ta' l-awtorizzazzjoni għat-tqegħid fis-suq (MAH), sa liema żmien l-proċedura twaqqfet.
English: In view of the concerns raised by France, to indicate and to substantiate where necessary any differences between Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for Horses and the reference product Tribrissen Oral Paste (authorised in the Netherlands) that could justify different conclusions on the safety or efficacy for the two products.
Maltese: (333 mg/g + 67 mg/g) u lprodott ta' referenza Pejst Orali Tribrissen (awtorizzat fl-Olanda) li tista' tiġġustifika konklużjonijiet differenti fuq is-sigurtà jew l-effikaċja għaż-żewġ prodotti.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER
Maltese: ANNESS I ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA
English: Oral Paste for Horses with the reference product Tribrissen Oral Paste (authorised in the Netherlands under REG NL 5055).
Maltese: Barra dan, hemm biss l analoġiji ta' Pejst Orali għaż-Żwiemel Equibactin vet. mal-prodott ta' referenza Pejst Orali Tribrissen(awtorizzat fl-Olanda taħt REG NL 5055) li jaffermaw l-istess sigurtà u effikaċja.
English: The applicant agreed to submit a request for variation of Equibactin vet.
Maltese: Is-CVMP innota li Pejst Orali għaż-Żwiemel Equibactin vet.
English: Further information on Esmya can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: Aktar informazzjoni fuq Esmya tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Esmya can be given:
Maltese: Esmya jista' jingħata:
English: The medicine contains the active substance ulipristal acetate.
Maltese: Il-mediċina fiha s-sustanza attiva ulipristal acetate.
English: 49% of women receiving 5 mg Esmya (95 out of the 195 women who were assessed) had no more than one day of spotting (minimal uterine bleeding) within a 35-day interval after each treatment course, and 70% had no more than one day of spotting within a 35-day interval at the end of the fourth treatment course.
Maltese: 49 % tan-nisa li rċevew 5 mg Esmya (95 mill-195 mara li ġew ivvalutati) ma kellhomx aktar minn jum wieħed ta' demm (fsada minima mill-utru) f'intervall ta' 35 jum wara kull kors ta' kura, u 70 % ma kellhomx aktar minn jum wieħed ta' demm f'intervall ta' 35 jum fit-tmiem tar-raba' kors ta' kura.
English: Long-term treatment with Esmya has been investigated in a main study involving 451 women who were given 4 three-month courses of 5 or 10 mg of Esmya.
Maltese: Il-kura fit-tul b'Esmya ġiet investigata fi studju ewlieni li involva 451 mara li ngħataw 4 korsijiet ta' tliet xhur ta' 5 jew 10 mg ta' Esmya.
English: Other information about Esmya
Maltese: Informazzjoni oħra dwar Esmya
English: The active substance in Esmya, ulipristal acetate, blocks the activity of progesterone, a hormone in the body involved in controlling the growth of the lining of the womb.
Maltese: Is-sustanza attiva f'Esmya, l-ulipristal acetate, timblokka l-attività tal-proġesteron, ormon fil-ġisem involut fil-kontroll tat-tkabbir tal-kisja tal-ġuf.
English: A reduction in fibroid size was also observed.
Maltese: Ġie osservat ukoll tnaqqis fid-daqs tal-fibrojdi.
English: Uterine fibroids are non-cancerous (benign) tumours of the womb (uterus).
Maltese: Fibrojdi fl-utru huma tumuri mhux kanċerużi (beninni) tal-ġuf (utru).
English: Esmya received a marketing authorisation valid throughout the European Union on 23 February 2012.
Maltese: Esmya rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea fit-23 ta' Frar 2012.
English: It is available as tablets (5 mg) to be taken by mouth.
Maltese: Dan jiġi bħala pilloli (5 mg) li għandhom jittieħdu mill-ħalq.
English: In some women, progesterone may promote the growth of fibroids, which can cause symptoms such as heavy uterine bleeding (bleeding from the womb during or outside the menstrual period), anaemia (low red blood cell counts, due to bleeding) and abdominal pain (such as period pain).
Maltese: F'xi nisa, il-proġesteron jista' jippromwovi t-tkabbir ta' fibrojdi, li jistgħu jikkawżaw sintomi bħal fsada qawwija mill-utru (fsada mill-ġuf matul jew barra lperjodu ta' mestrwazzjoni), anemija (għadd baxx ta' ċelluli tad-demm ħomor, minħabba fsada) u uġigħ addominali (bħal uġigħ mestrwali).
English: In the second study, Esmya taken for three months was as effective as leuprorelin (another medicine for fibroids) in reducing heavy uterine bleeding, with bleeding reduced in 90% of women treated with Esmya compared with 89% of women treated with leuprorelin.
Maltese: Fit-tieni studju, Esmya meħud għal tliet xhur kien effettiv daqs leuprorelin (mediċina oħra għallfibrojdi) fit-tnaqqis ta' fsada qawwija mill-utru, bil-fsada li naqset f'90 % tan-nisa kkurati b'Esmya meta mqabbel ma' 89 % tan-nisa kkurati b'leuprorelin.
English: • as a single treatment course in women before they have surgery for their fibroids;
Maltese: • bħala kors ta' kura wieħed f'nisa qabel issirilhom kirurġija għall-fibrojdi tagħhom;
English: The most common side effects with Esmya (which may affect more than 1 in 10 patients) are amenorrhea (absence of menstrual period) and endometrial thickening (thickening of the lining of the womb).
Maltese: L-effetti sekondarji l-aktar komuni b'Esmya (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma amenorrea (nuqqas ta' perjodu ta' mestrwazzjoni) u tħaxxin fl-endometriju (tħaxxin fil-kisja talġuf).
English: Esmya improved the symptoms of uterine fibroids in two main studies involving 549 women who were to have surgery to remove the fibroids.
Maltese: Esmya tejjeb is-sintomi ta' fibrojdi fl-utru f'żewġ studji elwenin li involvew 549 mara li kellha ssirilhom kirurġija biex jitneħħew il-fibrojdi.
English: Esmya is a medicine used to treat moderate to severe symptoms of uterine fibroids in adult women who have not yet reached the menopause.
Maltese: Esmya huwa mediċina li tintuża biex tikkura sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti li għadhom ma waslux sal-menopawża.
English: When progesterone activity is blocked, fibroid cells stop dividing and eventually die, which reduces the size of the fibroids and the symptoms caused by them.
Maltese: Meta l-attività tal-proġesteron tiġi mblukkata, iċ-ċelluli tal-fibrojdi jieqfu jinqasmu u eventwalment imutu, u dan inaqqas id-daqs tal-fibrojdi u s-sintomi kkawżati minnhom.
English: As for all medicines, data on the use of Esmya are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Esmya hija ssorveljata kontinwament.