FrancophonIA/ELRC3.0 huggingface dataset:
English: Ocrevus is given as an infusion (drip) into a vein.
Maltese: Ocrevus jingħata bħala infużjoni (dripp) ġol-vina.
English: The most important and most frequently reported side effects with Ocrevus are infusion reactions (such as itching, rash, and difficulty breathing) and infections.
Maltese: L-effetti sekondarji l-aktar importanti u rrappurtati b'mod l-aktar frekwenti b'Ocrevus huma reazzjonijiet għall-infużjoni (bħal ħakk, raxx, u diffikultà biex tieħu nifs) u infezzjonijiet.
English: Ocrevus is used in two types of patients:
Maltese: Ocrevus jintuża f'żewġ gruppi ta' pazjenti:
English: For the full list of side effects reported with Ocrevus, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Ocrevus, ara lfuljett ta' tagħrif.
English: Before each infusion, the patient is given other medicines (a corticosteroid and an antihistamine) to help to prevent potentially dangerous reactions.
Maltese: Qabel kull infużjoni, il-pazjent jingħata mediċini oħra (kortikosterojde u antistamina) biex jgħinu jipprevjenu reazzjonijiet potenzjalment perikolużi.
English: • adults with relapsing forms of multiple sclerosis (RMS), where the patient has flare-ups (relapses)
Maltese: • adulti b'forom rikaduti tal-isklerożi multipla (RMS), fejn il-pazjent ikollu ggravar (rikaduti) segwit minn perjodi b'sintomi aktar ħfief jew bl-ebda sintomu;
English: Studies have shown that Ocrevus is effective at reducing the number of relapses and it can also reduce the worsening of symptoms in some patients.
Maltese: L-istudji wrew li Ocrevus huwa effettiv biex inaqqas in-numru ta' rikaduti u jista' wkoll inaqqas liggravar tas-sintomi f'xi pazjenti.
English: France Tel: + 33 1 40 33 93 14
Maltese: Franza Tel: + 33 1 40 33 93 14
English: - The active substance is mitotane.
Maltese: - Is-sustanza attiva hi mitotane.
English: 63800 COURNON D'AUVERGNE FRANCE
Maltese: 63800 COURNON D'AUVERGNE FRANZA
English: Opportunistic mycosis
Maltese: Mikożi opportunistika
English: Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
Maltese: HRA Pharma Rare Diseases Tel: + 33 1 40 33 93 14 medinfo-rd@hra-pharma.com
English: 76-78, avenue du Midi
Maltese: CENTRE SPECIALITES PHARMACEUTIQUES 76-78, avenue du Midi
English: Date of first authorisation: 28 April 2004 Date of last renewal: 28 April 2009
Maltese: Data tal-aħħar tiġdid: 28 ta' April 2009
English: The activity of liver enzymes (gamma-GT, aminotransferase, alkaline phosphatase) is commonly increased.
Maltese: L-attività ta' l-enżimi tal-fwied (gamma-GT, aminotransferase, alkaline phosphatase) normalment tiżdied.
English: Older patients (≥ 65 years old)
Maltese: Pazjenti akbar fl-età (≥ 65 sena)
English: Table 1: Frequency of adverse reactions identified from literature data
Maltese: Tabella 1: Frekwenza ta' reazzjonijiet mhux mixtieqa identifikati mid-dejta tal-letteratura
English: HRA Pharma Rare Diseases 200 avenue de Paris
Maltese: HRA Pharma Rare Diseases 200 avenue de Paris 92320 CHATILLON
English: Mitotane apparently causes increased formation of 6-betahydroxy cholesterol.
Maltese: Mitotane apparentement jikkawża żieda fil-formazzjoni ta' 6-beta-hydroxy cholesterol.
English: SN: NN:
Maltese: NN:
English: For induction with cytochrome P450, see section 4.5.
Maltese: Għal induzzjoni b'cytochrome P450, ara s-sezzjoni 4.5.
English: EU/1/04/273/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/273/001
English: Bottle of 100 tablets.
Maltese: Flixkun ta' 100 pillola.
English: Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100 sa <1/10), Mhux komuni (≥1/1,000 sa <1/100), Rari (≥1/10,000 sa <1/1,000), Rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Anaemia Thrombocytopenia
Maltese: Anemija Tromboċitopenja
English: Lysodren 500 mg tablets
Maltese: Lysodren 500 mg pillola
English: Store in the original packaging.
Maltese: Aħżen fil-pakkett oriġinali.
English: The name of my Doctor is: Phone: ……………………………….
Maltese: Tel: …….....………………………….
English: - The other ingredients are maize starch, microcrystalline cellulose (E 460), macrogol 3350 and silica colloidal anhydrous.
Maltese: - Is-sustanzi l-oħra huma lamtu tal-qamħirrun, microcrystalline cellulose (E 460), macrogol 3350 u silica colloidal anhydrous.
English: Lysodren may interfere with several medicines.
Maltese: Lysodren jista' jinterferixxi ma' diversi mediċini oħra.
English: They are bisected on one side and impressed "BL" over "L1" on the other side.
Maltese: Huma maqsumin fuq naħa waħda u mnaqqxin b'“BL” fuq “L1” fuq in-naħa l-oħra.
English: Lysodren is available in plastic bottles of 100 tablets.
Maltese: Lysodren jiġi fi fliexken tal-plastik ta' 100 pillola.
English: Lysodren 500 mg tablets mitotane
Maltese: Lysodren 500 mg pilloli mitotane
English: The target plasma mitotane concentration (14 mg/l) was reached in all patients within 3 to 5 months and the total mitotane dose ranged between 283 and 387 g (median value: 363 g).
Maltese: Il-konċentrazzjoni ta' mitotane mixtieqa fil-plażma (14 mg/l) intlaħqet fil-pazjenti kollha fi 3 sa 5 xhur u d-doża totali varjat bejn 283 u 387 g (valur medjan:
English: Leucopenia (including neutropenia), anemia and thrombocytopenia have been reported frequently during mitotane treatment (see section 4.8).
Maltese: Lewkopenja (inkluż newtropenja), anemija u tromboċitopenja ġew irrapportati b'mod frekwenti matul kura b'mitotane (ara sezzjoni 4.8).
English: Dyspepsia
Maltese: Dispepsija
English: Mitotane plasma levels and the possible relationship with its efficacy were studied in the FIRM ACT trial, a randomized, prospective, controlled, open-label, multicenter, parallel-group study to compare the efficacy of etoposide, doxorubicin and cisplatin plus mitotane (EDP/M) to that of streptozotocin plus mitotane (Sz/M) as first-line treatment in 304 patients.
Maltese: Il-livelli ta' mitotane fil-plażma u r-relazzjoni possibbli mal-effikaċja tiegħu ġew studjati fil-prova FIRM ACT, studju multiċentri, open-label, randomizzat, prospettiv u kkontrollat bi grupp parallel sabiex titqabbel l-effikaċja ta' etoposide, doxorubicin u cisplatin flimkien ma' mitotane (EDP/M) ma' dik ta' streptozotocin flimkien ma' mitotane (Sz/M) bħala l-kura preferita fi 304 pazjenti.
English: Metabolism studies in man have identified the corresponding acid, 1,1-(o,p'-dichlorodiphenyl) acetic acid (o,p'-DDA), as the major circulating metabolite, together with smaller quantities of the 1,1-(o,p'
Maltese: Studji tal-metaboliżmu fil-bniedem identifikaw l-aċidu korrespondenti, 1,1-(o,p'-dichlorodiphenyl) acetic acid (o,p'-DDA), bħala l-metabolit maġġuri li jiċċirkola, flimkien ma' kwantitajiet iżgħar talanalogu 1,1-(o,p'-dichlorodiphenyl)-2,2 dichloroethene (o,p'-DDE) ta' mitotane.
English: Risk of adrenal insufficiency: All patients with non functional tumour and 75% of patients with functional tumour show signs of adrenal insufficiency.
Maltese: Il-pazjenti kollha b'tumuri mhux funzjonali u 75% tal-pazjenti b'tumur funzjonali juru sinjali ta' indeboliment adrenali.
English: Other undesirable central nervous effects have been reported in literature such as memory defects, aggressiveness, central vestibular syndrome, dysarthria, or Parkinson syndrome.
Maltese: Effetti oħra mhux mixtieqa tas-sistema nervuża ġew rrrappurtati fil-litteratura bħal difetti fil-memorja, aggressività, sindromu vestibulari ċentrali, diżartrija, jew sindromu tal-Parkinsons.
English: Leucopoenia has been reported in 8 to 12 % of patients.
Maltese: Lewkopenja ġiet rappurtata fi 8 sa 12 % tal-pazjenti.
English: The experience in patients in this age group is very limited.
Maltese: L-esperjenza filpazjenti f'dan il-grupp ta' età hija limitata ferm.
English: Gastrointestinal disorders are the most frequently reported (10 to 100 % of patients) and are reversible when the dose is reduced.
Maltese: Disturbi gastrointestinali huma l-effetti li jiġu rrappurtat bl-akbar frekwenza (10 sa 100 % tal-pazjenti) u huwa riversibbli meta d-doża tiġi mnaqqsa.
English: The usual starting dose for adults is 2 to 3 g (4 to 6 tablets) per day.
Maltese: Id-doża normali tal-bidu għall-adulti hija ta' 2 sa 3 g (4 sa 6 pilloli) kuljum.
English: Other medicines and Lysodren
Maltese: Mediċini oħra u Lysodren
English: 20 mg/l (see section 4.8).
Maltese: - 20 mg/l.
English: What is in this leaflet:
Maltese: Ħin ta' fsada:
English: • Risk management plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: After intravenous administration, 25% of the dose was excreted as metabolites within 24 hours.
Maltese: Wara li ngħata minn ġol-vina, 25% tad-doża tneħħiet mill-ġisem bħala metaboliti fi żmien 24 siegħa.
English: Hormone binding protein: Mitotane has been shown to increase plasma levels of hormone binding proteins (e.g. sex hormone-binding globulin (SHBG) and corticosteroid-binding globulin (CBG).
Maltese: Intwera li mitotane iżid il-livelli ta' proteini li jingħaqdu ma' lormoni tal-plażma (eż. globulina li tingħaqad mal-ormoni tas-sess (SHBG) u globulina li tingħaqad mal-kortikosteroji (CBG).
English: Clinical information comes mainly from a prospective trial (n= 24 patients) in children and adolescents aged at diagnosis from 5 months to 16 years (median age: 4 years) who had an unresectable primary tumour or who presented a tumour recurrence or a metastasic disease; most of the children (75%) presented with endocrine symptoms.
Maltese: L-informazzjoni klinika tiġi prinċipalment minn prova prospettiva (n=24 pazjenti) fit-tfal u adoloxxenti ta' età fid-dijanjożi minn 5 xhur sa 16-il sena (età medjana, 4 snin) li kellhom tumur primarju li ma setax jitneħħa jew li kellhom tumur li reġa' tfaċċa jew marda metastatika; il-biċċa lkbira tat-tfal (75 %) kellhom sintomi endokrinali.
English: Muscoloskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: Haemorrhagic cystitis Haematuria Proteinuria
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq
English: Store in the original container.
Maltese: Aħżen fil-kontenitur oriġinali.
English: OUTER CARTON BOTTLE LABEL
Maltese: KARTUNA TA' BARRA
English: In the absence of information on the specific P450 isoenzymes involved, caution should be taken when co-prescribing active substances metabolised by this route such as, among others, anticonvulsants, rifabutin, rifampicin, griseofulvin and St. John's wort (Hypericum perforatum).
Maltese: Fl-assenza ta' informazzjoni dwar l-isoenżimi P450 speċifiċi involuti, wieħed għandu joqgħod attent meta jiġu preskritti flimkien sustanzi attivi li jiġu metabolizzati b'dan il-mod bħal, fost oħrajn, antikonvulsanti, rifabutin, rifampicin, griseofulvin u St.
English: Skin rashes which have been reported in 5 to 25 % of patients do not seem to be dose related.
Maltese: Raxx fil-ġilda li ġie rrapportat f'5 sa 25 % tal-pazjenti ma jidhirx li huwa relatat mad-doża.
English: PC:
Maltese: SN:
English: Mitotane has not been studied in a comprehensive clinical development program.
Maltese: Mitotane ma ġiex studjat fi programm ta' żvilupp kliniku komprensiv.
English: Autoimmune hepatitis
Maltese: Epatite awto-immuni
English: Myasthenia
Maltese: Mijastenja
English: Treatment can be resumed when mitotane plasma levels will be ranged between 14 - 20 mg/l.
Maltese: It-trattament jista' jerġa' jinbeda meta l-livelli tal-plażma ta' mitotane jkunu bejn 14 - 20 mg/l.
English: Substances metabolised through cytochrome P450: Mitotane has been shown to have an inductive effect on cytochrome P450 enzymes.
Maltese: Sustanzi metabolizzati permezz ta' cytochrome P450 u partikolarment permezz ta' cytochrome 3A4:
English: - antiepileptics - rifabutin or rifampicin, used to treat tuberculosis - griseofulvin, used in the treatment of fungal infections - herbal preparations containing St. John's wort (Hypericum perforatum) - Sunitinib: to treat cancer
Maltese: - antiepilettiċi - rifabutin jew rifampicin, użati biex jikkuraw it-tuberkolożi - griseofulvin, użat fil-kura ta' infezzjonijiet fungali - preparazzjonijiet erbali li fihom St.
English: The threshold of 20 mg/l was reached for cumulative amounts of mitotane of approximately 500 g. In another study, 3 patients with adrenal carcinoma received Lysodren according to a precise protocol allowing fast introduction of a high dose if the product was well tolerated: 3 g (as 3 intakes) on day 1, 4.5 g on day 2, 6 g on day 3, 7.5 g on day 4 and 9 g on day 5.
Maltese: Fi studju ieħor, 3 pazjenti b'karċinoma adrenali ngħataw Lysodren skond protokoll preċiż li jippermetti l-introduzzjoni mgħaġġla ta' doża għolja jekk il-prodott ikun ittollerat tajjeb: 3 g (bħala 3 dożi) fl-ewwel ġurnata, 4.5 g fit-tieni ġurnata, 6 g fit-tielet ġurnata, 7.5 g fir-raba' ġurnata u 9 g fil-ħames ġurnata.
English: Ataxia Paresthesia Vertigo Sleepiness
Maltese: Kif għandek tieħu Lysodren
English: Particularly, mitotane has been shown to have an inductive effect on cytochrome 3A4.
Maltese: B'mod partikolari, mitotane intwera li għandu effett induttiv fuq cytochrome 3A4.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.emea.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu/.
English: Mitotane is an adrenal cytotoxic active substance, although it can apparently also cause adrenal inhibition without cellular destruction.
Maltese: Mitotane huwa sustanza attiva ċitotossika adrenali, għalkemm tista' apparentament tikkawża wkoll inibizzjoni adrenali, mingħajr distruzzjoni ċellulari.
English: Available clinical information comes mainly from published data in patients with inoperable or metastatic adrenal carcinoma.
Maltese: L-informazzjoni klinika disponibbli ġejja prinċipalment mill-informazzjoni ppublikata dwar pazjenti b'karċinoma adrenali inoperabbli jew metastatika.
English: Endocrine disorders Adrenal insufficiency
Maltese: Indeboliment adrenali
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Lactation (see section 4.6)
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Since mitotane increases plasma levels of steroid binding proteins, free cortisol and corticotropin (ACTH) determinations are necessary for optimal dosing of steroid substitution (see section 4.8).
Maltese: Minħabba li Mitotane jżid il-livelli tal-plażma ta' proteini li jeħlu ma' sterojdi, hemm bżonn ta' determinazzjonijiet ta' cortisol u corticotropin liberi (ACTH) għal aħjar dożaġġ ta' sostituzzjoni ta' sterjodi (ara sezzjoni 4.8).
English: However, dichlorodiphenyltrichlorethane (DDT) and other polychlorinated biphenyl analogues are known to have deleterious effects on fertility, pregnancy and development, and mitotane could be expected to share these properties.
Maltese: Madankollu, dichlorodiphenyltrichlorethane (DDT) u analogi bifenali poliklorinati oħrajn huma magħrufin li għandhom effetti negattivi fuq il-fertilità, tqala u żvilupp, u wieħed jistenna li mitotane jkollu dawn ilkaratteristiċi.
English: Package leaflet: Information for the user Lysodren 500 mg tablets mitotane
Maltese: Informazzjoni għall-utent Lysodren ta' 500 mg pilloli mitotane
English: Data on a limited number of exposed pregnancies indicate abnormalities on the adrenals of the foetus after exposure to mitotane.
Maltese: Informazzjoni dwar numru limitat ta' każijiet ta' tqala esposti tindika anormalitajiet fuq l-adrenali talfetu wara espożizzjoni għal mitotane.
English: Following discontinuation of mitotane treatment, it is slowly released from storage sites in fat, leading to reported terminal plasma half-lives ranging from 18 to 159 days.
Maltese: Meta titwaqqaf il-kura b'mitotane, jiġi merħi bil-mod mis-siti ta' ħażna fix-xaħam, li jwassal għal halflives terminali li jvarjaw minn 18 sa 159 ġurnata.
English: There was a positive linear correlation between the cumulative dose of Lysodren and the plasma levels of mitotane.
Maltese: Kien hemm korrelazzjoni lineari pożittiva bejn id-doża kumulattiva ta' Lysodren u l-livelli ta' mitotane filplażma.
English: Gynaecomastia
Maltese: Ġinekomastija
English: 2.800 04010 Sermoneta (Latina) Italy or
Maltese: Sermoneta (Latina)
English: 92320 CHATILLON
Maltese: L01XX23
English: Medicinal products active on central nervous system: Mitotane can cause central nervous system undesirable effects at high concentrations (see section 4.8).
Maltese: Mitotane jista' jikkawża effetti mhux mixtieqa fuq is-sistema nervuża ċentrali meta jingħataw konċentrazzjonijiet għoljin (ara sezzjoni 4.8).
English: Lysodren (Braille applies only to outer carton)
Maltese: INFORMAZZJONI BIL-BRAILLE Lysodren (Il-Braille japplika għall-kartuna ta' barra biss)
English: Plasma triglycerides increased
Maltese: Żieda fit-trigliċeridi talplażma
English: Maculopathy Retinal toxicity Diplopia
Maltese: Makulopatija Tossiċità retinali Viżta doppja Opaċità tal-lenti
English: 6.3 Shelf life
Maltese: 6 TAGĦRIF
English: - if you are being treated with medicines containing spironolactone (see "Other medicines and
Maltese: - jekk qed tirċievi kura b'mediċini li fihom spironolactone (ara “Mediċini oħra u Lysodren”).
English: Nervous system undesirable effects occur in approximately 40 % of patients.
Maltese: Effetti mhux mixtieqa fuq is-sistema nervuża jseħħu bejn wieħed u ieħor f'40 % tal-pazjenti.
English: Mitotane overdose may lead to central nervous system impairment especially if mitotane plasma levels are above 20 mg/l.
Maltese: Doża eċċessiva ta' mitotane tista' twassal għal disturbi fis-sistema nervuża ċentrali speċjalment jekk il-livelli tal-plażma ta' mitotane huma ogħla minn 20 mg/l.
English: Hypouricaemia
Maltese: Ipertrigliċeridimja
English: mg/l could suggest that patients with mitotane plasma levels ≥ 14 mg/l could have an improvement in disease control rate (62.9% versus 33.5%; p< 0.
Maltese: L-analiżi talpazjenti li kisbu livelli ta' mitotane ta' ≥ 14 mg/l mill-anqas darba waħda f'6 xhur meta mqabbla malpazjenti li l-livelli ta' mitotane tagħhom kienu < 14 mg/l tista' tissuġġerixxi li l-pazjenti b'livelli ta' mitotane fil-plażma ta' ≥ 14 mg/l jista' jkollhom titjib fil-kontroll tal-marda (62.9% kontra 33.5%; p<
English: - dizziness, headache
Maltese: Uġigħ ta' ras
English: Dose adjustment is aimed to reach a therapeutic window (mitotane plasma levels 14 - 20 mg/l) which ensures optimal use of Lysodren with acceptable safety.
Maltese: L-aġġustament tad-doża huwa immirat sabiex jilħaq marġini terapewtika (livelli ta' plażma mitotane 14 - 20 mg/L) li jassigura l-użu ta' Lysodren b'sigurtà aċċettabbli.
English: Overall, the disease-free interval was 7 months (2 to 16 months).
Maltese: Globalment, l-intervall mingħajr mard kien ta' 7 xhur (2 sa 16-il xahar).
English: Symptomatic treatment of advanced (unresectable, metastatic or relapsed) adrenal cortical carcinoma (ACC).
Maltese: Kura sintomatika ta' karċinoma avvanzata fil-kortiċi adrenali (ACC) (li ma titneħħiex b'intervent kirurġiku, metastatika jew meta reġgħet ħarġet il-marda).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Therefore, the plasma concentrations of the substances metabolised via cytochrome P450 may be modified.
Maltese: Sustanzi metabolizzati permezz ta' cytochrome P450:
English: Blood and lymphatic system disorders
Maltese: Disturbi fis-sistema endokrinarja
English: Concomitant use with spironolactone (see section 4.5)
Maltese: Użu fl-istess ħin ma' spironalactone (ara sezzjoni 4.5).
English: Dose adjustments may be necessary to achieve the desired therapeutic levels in the window between 14 - 20 mg/l and avoid specific adverse reactions (see section 4.2).
Maltese: Jista' jkun hemm bżonn ta' aġġustamenti fid-doża sabiex jintlaħqu l-livelli terapewtiċi korretti fil-firxa ta' bejn 14 - 20 mg/l u jiġu evitati reazzjonijiet avversi speċifiċi (ara sezzjoni 4.2).
English: Adverse reactions listed below are classified according to frequency and system organ class.
Maltese: Irreazzjonijiet avversi elenkati hawn taħt huma kklassifikati skont is-sistema ta' klassifika tal-organi u lfrekwenza.
English: Tell your doctor immediately if you experience any of the following side effects: - Adrenal insufficiency: fatigue, abdominal pain, nausea, vomiting, diarrhoea, confusion - Anaemia: cutaneous pallor, muscular fatigability, feeling breathless, vertigo especially when standing up - Liver damage: yellowing of the skin and eyes, itching, nausea, diarrhoea, fatigue, dark coloured urine - Neurological disorders: movement and coordination disorders, abnormal sensations like pins and needles, memory loss, concentration difficulty, difficulty to talk, vertigo
Maltese: - Insuffiċienza adrenali: għeja kbira, uġigħ addominali, nawsja, remettar, dijarea, konfużjoni - Anemija: sfurija kutanja, għeja muskolari, disturbi fi-nifs, vertigo speċjalment meta tqum bil wieqfa - Indeboliment fil-fwied: sfurija tal-ġilda u l-għajnejn, ħakk, nawsja, dijarea, għeja kbira, awrina skura
English: Cytotoxic.
Maltese: Kodiċi ATC:
English: Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: Metabolism and nutrition disorders
Maltese: Distrubi filmetaboliżmu u nnutrizzjoni
English: Each tablet contains 500 mg of mitotane.
Maltese: Kull pillola fiha 500 mg ta' mitotane.
English: In addition, mitotane induces a state of adrenal insufficiency which leads to the disappearance of Cushing syndrome in patients with secreting adrenal carcinoma and necessitates substitution hormonotherapy.
Maltese: Mitotane jikkawża wkoll stat ta' insuffiċjenza adrenali li twassal biex ma jidhirx aktar is-sindromu Cushing f'pazjenti b'karċinoma adrenali li tnixxi u li tirrikjedi terapija ta' sostituzzjoni bl-ormoni.
English: Psychiatric disorders Confusion
Maltese: Disturbi psikjatriċi
English: - fever - general aching - flushing, high or low blood pressure, feeling of dizziness/vertigo when you suddenly stand up - increased production of saliva - eye disorders: visual impairment, vision blurred, double vision, distortion of images, complain of glare - fungal infection - liver damage (may cause yellowing of the skin and eyes, dark coloured urine) - decreased uric acid in blood tests - bladder inflammation with bleeding - presence of blood in urine, presence of proteins in urine - balance disorder - distortion of the sense of taste - impaired digestion - ovarian macrocysts (with symptoms such as pelvic pain, bleeding) - decreased androstenedione (precursor of sex hormones) in blood tests in females - decreased testosterone (sex hormone) in blood tests in females - sex hormone binding globulin (a protein which binds sex hormones) increased in blood tests - decreased free testosterone (sex hormone) in blood tests in males
Maltese: - distorsjoni tas-sens tat-togħma - indiġestjoni indebolita - Makroċesti ovarji (b'sintomi bħal uġigħ pelviku, tnixxija ta'demm) - Androstenedjon imnaqqas (prekursur tal-ormoni sesswali) f'testijiet tad-demm fin-nisa - Testosteron imnaqqas (ormon sesswali) f'testijiet tad-demm fin-nisa - Globulina li tgħaqqad l-ormon sesswali (proteina li tgħaqqad l-ormoni tas-sess) żdiedet fit-testijiet tad-demm
English: No unchanged mitotane has been found in bile or in urine, where o,p'-DDA predominates, together with several of its hydroxylated metabolites.
Maltese: Ma nstabx mitotane mhux mibdul fil-bile jew fl-awrina, fejn l-o,p'-DDA tippredomina, flimkien ma' diversi metaboliti idrossilati tiegħu.