FrancophonIA/ELRC3.0 huggingface dataset:
English: Reaction with barium hydroxide results in a greater production of Compound A than does the reaction with soda lime.
Maltese: Ir-reazzjoni mal-barium hydroxide tipproduċi aktar Kompost A milli dik mal-soda lime.
English: Surgical levels of anaesthesia in the healthy dog may be maintained with inhaled concentrations of 3.3 to 3.6% in the presence of premedication.
Maltese: Livelli kirurġiċi ta' anesteżija f'kelb f'saħħtu jistgħu jinżammu b'konċentrazzjonijiet miġbuda minn nifs ta' bejn 3.3 sa 3.6% meta tkun ġiet amministrata pre-medikazzjoni.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 100% sevoflurane
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U INGREDJENT IEĦOR 100% sevoflurane
English: Sevoflurane degradation in soda lime has been shown to increase with temperature.
Maltese: Id-degradazzjoni tas-sevoflurane fis-soda lime ġiet murija li tiżdied bit-temperatura.
English: Alpha-2-agonists cause bradycardia which may occur when they are used with sevoflurane.
Maltese: Alpha-2-agonisti jikkawżaw bradikardja li tista' sseħħ meta jintużaw ma' sevoflurane.
English: PHARMACEUTICAL FORM Inhalation vapour, liquid
Maltese: GĦAMLA FARMAĊEWTIKA Fwar jittieħed man-nifs, likwidu
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: DATA TA' META ĠIET RIVEDUTA DIN IL-KITBA Informazzjoni dettaljata dwar dan il-prodott mediku veterinarju tinstab fuq il-websajt ta' l-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT SevoFlo 100% Inhalation vapour, liquid for dogs and cats.
Maltese: VETERINARJU SevoFlo 100% Fwar jittieħed man-nifs, likwidu għal klieb u l-qtates.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 3 years 6.4 Special precautions for storage
Maltese: Żmien li l-prodott mediċinali veterinarju jista' jinżamm fuq l-ixkaffa ippakkjat għall-bejgħ: 3 snin 6.4
English: Halogenated volatile anaesthetics can react with dry carbon dioxide (CO2) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs.
Maltese: Loppji volatili ħaloġenati jistgħu jirreaġixxu ma' assorbenti ta' diossidu tal-karbonju (CO2) niexef sabiex jipproduċu monossidu tal-karbonju (CO) li jista' jirriżulta f'livelli ogħla ta' carboxyhaemoglobin f'ċerti klieb.
English: Sevoflurane administration is compatible with the benzodiazepines and opioids commonly used in veterinary practice.
Maltese: Sevoflurane huwa kompatibbli ma' benzodijażepini u opijojdi użati ta' spiss fix-xogħol veterinarju.
English: Paddling, retching, salivation, cyanosis, premature ventricular contractions and excessive cardiopulmonary depression have been reported very rarely based on post-authorisation spontaneous reporting experience.
Maltese: Ċaflis, taqlieħ, tbeżliq, tibdil fil-kulur (lejn l-ikħal), kontrazzjonijiet ventrikulari prematuri, u dipressjoni qawwija kardjopulmonari ġew rappurtati rari ħafna bbażati fuq l-esperjenza ta' rapport spontanji wara l-awtorizzazzjoni.
English: These concentrations can be expected to produce surgical anaesthesia within 3 to 14 minutes in dogs and within 2 to 3 minutes in cats.
Maltese: Dawn il-konċentrazzjonijiet għandhom iwasslu għal anesteżija kirurġika fi żmien bejn 3 sa 14-il minuta, fil-klieb u fi żmien 2 sa 3 minuti fil-qtates.
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: inhalation anaesthetic, ATCvet code: QN 01AB08
Maltese: Is-sigurtà tal-prodott mediċinali veterinarju għadha ma ġietx stabbilita waqt it-tqala jew it-treddigħ.
English: Sevoflurane produces unconsciousness by its action on the central nervous system.
Maltese: Sevoflurane iraqqad permezz ta' l-effett tiegħu fuq is-sistema nervuża ċentrali.
English: Halogenated volatile anaesthetics can react with desiccated carbon dioxide (CO2) absorbents to produce carbon monoxide (CO) that may result in elevated levels of carboxyhaemoglobin in some dogs.
Maltese: Loppji volatili ħaloġenati jistgħu jirreaġixxu ma assorbenti ta' diossidu tal-karbonju (CO2) niexef sabiex jipproduċu monossidu tal-karbonju (CO) li jista' jirriżulta f'livelli ogħla ta' carboxyhaemoglobin f'ċerti klieb.
English: Doses required for maintenance of anaesthesia may need to be reduced by approximately 0.5% in geriatric dogs (i.e. 2.8% to 3.1% in premedicated geriatric dogs and 3.2 to 3.3% in unpremedicated geriatric dogs).
Maltese: Id-dożi meħtieġa għaż-żamma ta' anesteżija jistgħu jkollhom jitnaqqsu b'xi 0.5% fil-klieb xjuħ (i.e. 2.8% sa 3.1% fil-klieb xjuħ li ngħatalhom trattament qabel u 3.2 sa 3.3% fi klieb xjuħ biss, li ma ngħatalhomx trattament qabel).
English: Once formed, HFIP is rapidly conjugated with glucuronic acid and eliminated as a urinary metabolite.
Maltese: La darba jifforma, HFIP jingħaqad malajr ma' l-aċidu glukuroniku u jiġi eliminat bħala metabolit fl-urina.
English: Symptoms of human overexposure (inhalation) to sevoflurane vapours include respiratory depression, hypotension, bradycardia, shivering, nausea and headache.
Maltese: Sintomi ta' espożizzjoni żejda min-nies (bix-xamm) għal fwar ta'sevoflurane jinkludu qtugħ ta' nifs, pressjoni baxxa, bradikardja, rogħda, dardir u wġigħ ta' ras.
English: Respiratory depression may lead to respiratory acidosis and respiratory arrest (at sevoflurane concentrations of 2.0 MAC and above) in spontaneously breathing dogs and cats.
Maltese: In-nuqqas respiratorju jista' jwassal għal aċidosi respiratorja u waqfien respiratorju (b'doża ta' 2.0
English: Sevoflurane has a variable effect on heart rate, which tends to increase from baseline at low MAC and fall back with increasing MAC. Sevoflurane causes systemic vasodilation and produces dosedependent decreases in mean arterial pressure, total peripheral resistance, cardiac output and possibly the strength of myocardial contraction and speed of myocardial relaxation.
Maltese: Sevoflurane jikkawża twessiegħ sistemiku tal-vini u arterji u jipproduċi tnaqqis: fil-medja tal-pressjoni arterjali, dipendentement fuq id-doża, fir-reżistenza periferali sħiħa, volum tad-demm li joħroġ mill-qalb u possibilment fis-saħħa tal-kontrazzjoni muskolari tal-qalb u l-veloċità ta' rilassament tal-muskoli tal-qalb.
English: In dogs, transient elevations in aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), bilirubin and white blood cell counts may occur with sevoflurane, as with the use of other halogenated anaesthetic agents.
Maltese: (ALT), lactate dehydrogenase (LDH), bilirubin, u l-għadd ta' ċelloli bojod fid-demm jistgħu jiġru b'sevoflurane, kif ukoll bl-użu ta' aġenti anestetiċi ħaloġenati oħra.
English: PACKAGE LEAFLET: SevoFlo 100% Inhalation vapour, liquid for dogs and cats
Maltese: FIL-PAKKETT GĦAL SevoFlo 100% Fwar jittieħed man-nifs, likwidu għal klieb u qtates,
English: In the dog sevoflurane may increase intracranial pressure at concentrations of 2.0 MAC and above under normal partial pressures of carbon dioxide (normocapnia), but intracranial pressure has been shown to remain within normal range at sevoflurane concentrations of up to 1.5 MAC if hypocapnia is induced by hyperventilation.
Maltese: MAC jew aktar, f'każi normali ta' pressjoni parzjali ta' dijossidu tal-karbonju (normocapnia), iżda lpressjoni intrakranjali ntweriet li baqgħet fil-firxa normali, f'konċentrazzjonijiet ta' sevoflurane sa' 1.5
English: PHARMACEUTICAL FORM Inhalation vapour, liquid.
Maltese: GĦAMLA FARMAĊEWTIKA Fwar jittieħed man-nifs, likwidu.
English: Sevoflurane administration is compatible with the intravenous barbiturates and propofol and in cats alfaxalone and ketamine.
Maltese: Il-għoti tas-sevoflurane huwa kompattibli mal-barbiturati u propofol li jingħataw fil-vina u fil-qtates alfaxolone u ketamina.
English: Maintenance of anaesthesia:
Maltese: Iż-Żamma ta' l-anesteżija:
English: In a laboratory study, the use of an acepromazine/oxymorphone/thiopental/sevoflurane anaesthetic regimen resulted in prolonged recoveries in all the dogs treated, compared to recoveries in dogs anaesthetised with sevoflurane alone.
Maltese: Fi studju fil-laboratorju, l-użu ta' reġimen anestetiku ta' acepromazine/ oxymorphone/ thiopental/ sevoflurane rriżulta f'dewmien fil-fejqan tal-klieb kollha li kienu ttrattati bihom, meta mqabbla ma' fejqan fi klieb li kienu lluppjati b'sevoflurane biss.
English: Since the reaction of carbon dioxide with absorbents is exothermic, this temperature increase will be determined by the quantities of CO2 absorbed, which in turn will depend on fresh gas flow in the anaesthetic circle system, metabolic status of the dog and ventilation.
Maltese: Filwaqt li rreazzjoni tal-karbonju diossidu mal-assorbenti hija eżotermika, din iż-żieda fit-temperatura għandha tiġi stabbilita mill-kwantitajiet ta' CO2 assorbit, li minn hekk tiddependi mill-influss ta' gass frisk fissistema tonda anestetika, l-istat metaboliku tal-kelb u l-ventilazzjoni.
English: The pharmacokinetics of sevoflurane have not been investigated in the cat.
Maltese: Il-profil farmakokinetiku ta' sevoflurane ma ġiex investigat fil-qtates.
English: Limited clinical experience in administering sevoflurane to animals with renal, hepatic and cardiovascular insufficiency suggests that sevoflurane may be safely used in these conditions.
Maltese: Esperjenza klinika ristretta, fl-għoti tas-sevoflurane lill-animali b'insuffiċenza fil-kliewi, fwied u s-sistema karjovaskolari turi li sevoflurane jista' jiġi amministrat f'dawn il-kondizzjonijiet.
English: SevoFlo is presented in a cardboard box containing a 250 ml polyethylene naphthalate (PEN) bottle with a Quik-Fil closure.
Maltese: SevoFlo huwa ppreżentat f'kaxxa tal-kartun li jkun fiha flixkun ta' 250 ml ta' polyethylene naphthalate (PEN) li jingħalaq b'għatu Quik-Fil.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt ta' l-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: The presence of surgical stimulation may require an increase in the concentration of sevoflurane.
Maltese: Minħabba l-preżenza ta' stimulazzjoni kirurġika, jista' jkun hemm bżonn żieda fil-konċentrazzjoni ta'sevoflurane.
English: Premedication:
Maltese: U KWANTITATTIVA
English: 6.5 Nature and composition of immediate packaging SevoFlo is presented in a cardboard box containing a 250 ml polyethylene naphthalate (PEN) bottle with a Quik-Fil closure.
Maltese: In-natura u l-għamla ta' l-ewwel ippakkjar SevoFlo huwa ppreżentat f'kaxxa tal-kartun li jkun fiha flixkun ta' 250 ml ta' polyethylene naphthalate (PEN) li jingħalaq b'għatu Quik-Fil.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C
English: Specific pharmacovigilance requirements:
Maltese: Grupp Farmako-terapewtiku:
English: Name and address of the manufacturer(s) responsible for batch release
Maltese: Isem u indirizz tal-manufattur responsabbli mill-ħruġ tal-lott(i)
English: In the absence of premedication, inhaled concentrations of sevoflurane in the range of 3.7 to 3.8% will provide surgical levels of anaesthesia in the healthy dog.
Maltese: Fejn ma kienx hemm premedikazzjoni, konċentrazzjonijiet ta' sevoflurane fin-nifs ta' bejn 3.7 u 3.8% għandhom jipprovdu livell kirurġiku ta' loppju f'kelb f'saħħtu.
English: In the absence of premedication, inhaled concentrations of sevoflurane in the range 3.7 to 3.8% will provide surgical levels of anaesthesia in the healthy dog.
Maltese: Fejn ma kienx hemm premedikazzjoni, konċentrazzjonijiet ta' sevoflurane fin-nifs ta' bejn 3.7 u 3.8% għandhom jipprovdu livell kirurġiku ta' loppju f'kelb f 'saħħtu.
English: None known.
Maltese: M'hemm xejn magħruf.
English: Longduration, low-flow sevoflurane anaesthesia should be avoided due to the risks of Compound A accumulation.
Maltese: Dewmien żejjed, u influss tal-loppju sevoflurane bil-mod għandu jiġi evitat minħabba r-riskju ta' żieda fil-Kompost A.
English: Intravenous anaesthetics:
Maltese: KWALITAJIET FARMAKOLOĠIĊI
English: In order to preserve renal blood flow, prolonged episodes of hypotension (mean arterial pressure below 60 mmHg) should be avoided in dogs and cats during sevoflurane anaesthesia.
Maltese: Sabiex jinżamm l-influss ta' demm fil-kliewi, perijodi fit-tul ta' pressjoni baxxa fl-arterji (inqas minn 60 mmHg) għandhom jiġu evitati fil-klieb u l-qtates matul loppju bis-sevoflurane.
English: A generic manufacturer may choose to use a different form of the active substance, for example the manufacturer can decide to use a ‘hydrochloride' salt of the active substance because this form is more stable.
Maltese: Il-manifattur ġeneriku jista' jagħżel li juża forma differenti tas-sustanza attiva, pereżempju l-manifattur jista' jiddeċiedi li juża melħ ‘idrokloridu' tas-sustanza attiva għaliex din il-forma hija aktar stabbli.
English: Specifically, a company producing a generic medicine needs to provide information on the quality of the medicine.
Maltese: Speċifikament, kumpanija li tipproduċi mediċina ġenerika għandha bżonn tipprovdi informazzjoni dwar il-kwalità tal-mediċina.
English: The inactive ingredients, or ‘excipients', may differ between the generic medicine and its reference.
Maltese: Issustanzi inattivi, jew ‘eċċipjenti', jistgħu jvarjaw bejn il-mediċina ġenerika u r-referenza tagħha.
English: If a generic medicine contains a different salt of the active substance to the salt used in the reference medicine, regulatory authorities will consider whether additional tests are needed for the medicine to be granted a marketing authorisation.
Maltese: Jekk mediċina ġenerika jkun fiha melħ differenti tas-sustanza attiva mill-melħ użat fil-mediċina ta' referenza, l-awtoritajiet regolatorji jikkunsidraw jekk ikunx meħtieġ isiru testijiet addizzjonali sabiex ilmediċina tingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The innovator company benefits from data and market exclusivity under pharmaceutical legislation (typically 10 years from the date of first authorisation).
Maltese: Il-kumpanija innovatriċi tibbenefika mid-dejta u l-esklussività tas-suq taħt il-leġiżlazzjoni farmaċewtika (normalment 10 snin mid-data tal-ewwel awtorizzazzjoni).
English: A generic medicine contains the same quantity of active substance(s) as the reference medicine.
Maltese: Mediċina ġenerika fiha l-istess kwantità tas-sustanza(i) attiva(i) bħall-mediċina ta' referenza.
English: What is a generic medicine?
Maltese: X'fiha mediċina ġenerika?
English: Regulatory authorities may also perform an inspection of these monitoring systems.
Maltese: L-awtoritajiet regolatorji jistgħu jwettqu wkoll spezzjoni ta' dawn is-sistemi ta' sorveljanza.
English: A generic medicine contains the same active substance(s) as the reference medicine, and it is used at the same dose(s) to treat the same disease(s) as the reference medicine.
Maltese: Mediċina ġenerika fiha l-istess sustanza(i) attiva(i) bħall-mediċina ta' referenza, u tintuża fl-istess doża(i) fil-kura tal-istess mard(a) bħall-mediċina ta' referenza.
English: Marketing authorisations are granted after a regulatory authority, such as the European Medicines Agency, has conducted a scientific evaluation of the medicine's efficacy (how well it works as measured in clinical studies), safety and quality.
Maltese: L-awtorizzazzjonijiet għat-tqegħid fis-suq jingħataw wara li awtorità regolatorja, bħalma hija l-Aġenzija Ewropea tal-Mediċini, tkun wettqet evalwazzjoni xjentifika tal-effikaċja (kemm taħdem tajjeb kif imkejla fl-istudji kliniċi), is-sigurtà u l-kwalità.
English: Generic medicines that are administered directly into the bloodstream, such as those given directly into a vein by injection or infusion (drip), do not need to be tested for bioequivalence against the reference medicine.
Maltese: Mediċini ġeneriċi li jingħataw direttament ġoddemm, bħal dawk li jingħataw direttament ġo vina permezz ta' injezzjoni jew infużjoni (dripp), ma għandhomx bżonn jiġu ttestjati għal bijoekwivalenza kontra l-mediċina ta' referenza.
English: While this ‘use patent' protection is in place, a generic medicine cannot be marketed for the protected indication, even if the period of exclusivity on the reference medicine has expired.
Maltese: Waqt li din il-protezzjoni tal-‘brevetti tal-użu' tkun fis-seħħ, mediċina ġenerika ma tistax titqiegħed fis-suq għall-indikazzjoni protetta, anki jekk il-perjodu ta' esklussività għall-mediċina ta' referenza jkun skada.
English: Once the generic medicine is authorised, the same information will appear in the ‘product information' of the generic medicine (the summary of product characteristics, the labelling and the package leaflet) as in the product information of the reference medicine.
Maltese: Ladarba l-mediċina ġenerika tingħata l-awtorizzazzjoni, l-istess informazzjoni bħall-informazzjoni dwar il-prodott tal-mediċina ta' referenza tkun tidher fl-‘informazzjoni dwar il-prodott' tal-mediċina ġenerika (is-sommarju tal-karatteristiċi tal-prodott, it-tikketti u l-fuljett ta' tagħrif ).
English: How is the safety of generic medicines monitored?
Maltese: Kif inhi ssorveljata s-sigurtà ta' mediċini ġeneriċi?
English: How are generic medicines evaluated?
Maltese: Meta tista' tiġi żviluppata mediċina ġenerika?
English: If the medicine is a hybrid, additional tests may be required, such as the results of clinical trials that test the efficacy of the medicine.
Maltese: Jekk il-mediċina tkun waħda ibrida, jista' jenħtieġ isiru testijiet addizzjonali, bħal riżultati minn provi kliniċi li jittestjaw l-effikaċja tal-mediċina.
English: This type of generic medicine is called a ‘hybrid' medicine, because its authorisation relies in part on the results of tests trials on the reference medicine and in part on new data.
Maltese: Din it-tip ta' mediċina ġenerika tissejjaħ mediċina ‘ibrida', għaliex l-awtorizzazzjoni tagħha tiddependi parzjalment fuq irriżultati tal-provi tat-testijiet fuq il-mediċina ta' referenza u parzjalment fuq dejta ġdida.
English: What does a generic medicine contain?
Maltese: X'inhi mediċina ġenerika?
English: How are generic medicines manufactured?
Maltese: Kif inhuma mmanifatturati l-mediċini ġeneriċi?
English: 2 pre-filled syringes
Maltese: 2 siringi mimlija għal-lest
English: The PRAC issued its final recommendations on 17 May 2018, replacing the temporary measures.
Maltese: Il-PRAC ħareġ ir-rakkomandazzjonijiet finali tiegħu fis-17 ta' Mejju 2018, li jissostitwixxu l-miżuri temporanji.
English: It is estimated that around 765,000 patients have been treated with Esmya to date.
Maltese: Huwa stmat li s'issa madwar 765,000 pazjenta ġew ikkurati b'Esmya.
English: EMA concludes review of medicine for uterine fibroids
Maltese: L-EMA tikkonkludi rieżami ta' mediċina għal fibrojdi fl-utru
English: − Esmya should not be started if levels of alanine transaminase (ALT) or aspartate aminotransferase (AST) are more than 2 times the upper limit of normal (ULN).
Maltese: − Esmya m'għandux jinbeda jekk il-livelli ta' alanina aminotransferażi (ALT) jew aspartataminotransferażi (AST) ikunu aktar minn darbtejn il-limitu massimu tan-normal (ULN).
English: Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb).
Maltese: Esmya jintuża biex jikkura sintomi moderati sa severi ta' fibrojdi fl-utru (tumuri beninni tal-ġuf).
English: Ulipristal acetate is also the active substance of a single-dose medicine authorised for emergency contraception, ellaOne.
Maltese: L-aċetat tal-Ulipristal huwa wkoll is-sustanza attiva ta' mediċina ta' doża waħda awtorizzata għallkontraċettiv ta' emerġenza, ellaOne.
English: (Esmya continues to be indicated for one course (lasting up to 3 months) of pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age.)
Maltese: (Esmya jibqa' jiġi indikat għal kors wieħed (li jdum 3 xhur) ta' kura ta' qabel ilkirurġija għal sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva.)
English: The PRAC's final recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted an opinion.
Maltese: Ir-rakkomandazzjonijiet finali tal-PRAC intbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għal mistoqsijiet dwar il-mediċini għall-użu mill-bniedem, li adotta opinjoni.
English: • You should stop treatment and contact your doctor immediately if you develop symptoms of liver injury (such as tiredness, yellowing of the skin, darkening of the urine, nausea and vomiting).
Maltese: • Għandek twaqqaf il-kura u tikkuntattja lit-tabib tiegħek immedjatament jekk tiżviluppa sintomi ta' ħsara fil-fwied (bħal għeja, sfurija tal-ġilda, awrina skura, dardir u rimettar).
English: The review of Esmya was initiated at the request of European Commission on 30 November 2017, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-rieżami ta' Esmya nbeda fuq talba tal-Kummissjoni Ewropea fit-30 ta' Novembru 2017, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: The review of Esmya was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation.
Maltese: Ir-rieżami ta' Esmya sar mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA wara rapporti ta' ħsara serja fil-fwied, inkluż insuffiċjenza tal-fwied li wasslet għal trapjant.
English: − Liver function tests to be performed before starting each treatment course, monthly during the first 2 treatment courses, and thereafter as clinically indicated.
Maltese: − Testijiet tal-funzjoni tal-fwied li għandhom isiru qabel kull kors ta' kura, kull xahar matul lewwel 2 korsijiet ta' kura, u wara dan kif indikat klinikament.
English: • A liver test will be performed before you start treatment and if the test is abnormal, treatment with Esmya will not be started.
Maltese: • Qabel tibda l-kura, ser isir test tal-fwied u jekk it-test ikun anormali, il-kura b'Esmya mhijiex ser tinbeda.
English: Esmya was authorised in the EU in 2012 for the treatment of moderate to severe symptoms of uterine fibroids, which are benign (non-cancerous) tumours of the womb, in women who have not reached the menopause.
Maltese: Esmya ġie awtorizzat fl-UE fl-2012 għall-kura ta' sintomi moderati sa severi ta' fibrojdi fl-utru, li huma tumuri beninni (mhux kanċerużi) tal-ġuf, f'nisa li għadhom ma waslux għall-menopawża.
English: − Restricted indication in the intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age: Esmya should only be used in women who are not eligible for surgical treatment.
Maltese: − Indikazzjoni ristretta fil-kura intermittenti ta' sintomi moderati sa severi ta' fibrojdi fl-utru f'nisa adulti ta' età riproduttiva:
English: The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
Maltese: Ilmediċina ntweriet li hija effettiva biex tnaqqas fsada u anemija assoċjati mal-kondizzjoni, kif ukoll iddaqs tal-fibrojdi.
English: • Four cases of serious liver injury leading to hepatic transplantation and additional cases of hepatic injury have been reported in patients treated with Esmya (ulipristal acetate).
Maltese: • Ġew irrappurtati erba' każijiet ta' ħsara serja fil-fwied li wasslu għal trapjant epatiku u każijiet addizzjonali ta' ħsara epatika f'pazjenti kkurati b'Esmya (aċetat tal-ulipristal).
English: • The medicine Esmya, used to treat uterine fibroids, has been reviewed because cases of serious liver problems have occurred in women taking the medicine, including four cases that resulted in liver transplantation.
Maltese: • Il-mediċina Esmya, li tintuża biex tikkura fibrojdi fl-utru, ġiet rieżaminata minħabba li seħħew każijiet ta' problemi serji tal-fwied f'nisa li kienu qed jieħdu l-mediċina, inkluż erba' każijiet li rriżultaw fi trapjant tal-fwied.