FrancophonIA/ELRC3.0 huggingface dataset:
English: Mitoxantrone was found to be mutagenic in bacterial and mammalian test systems, as well as in vivo in rats.
Maltese: Mitoxantrone nstab li huwa mutaġeniku f'sistemi ta' testijiet batterjali u mammaljani, kif ukoll in vivo filfirien.
English: Combination Therapy
Maltese: Terapija ta' Kombinazzjoni
English: Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation (see section 5.2).
Maltese: Mitoxantrone u l-metaboliti tiegħu jiġu eliminati permezz tas-sistema biljari u permezz tal-awrina, iżda mhuwiex magħruf jekk il-mogħdijiet metaboliċi jew ta' eliminazzjoni humiex saturabbli, jistgħux jiġu inibiti jew indotti, jew jekk mitoxantrone u l-metaboliti tiegħu jgħaddux minn ċirkolazzjoni enteroepatika (ara sezzjoni 5.2).
English: The haematopoietic system was the primary target organ of toxicity showing myelosuppression.
Maltese: Is-sistema ematopojetika kienet l-organu primarju fil-mira tat-tossiċità li uriet majelosoppressjoni.
English: - Infections caused by microorganisms which do not normally cause diseases with a healthy immune system (opportunistic infections).
Maltese: - Infezzjonijiet ikkawżati minn mikro-organiżmi li normalment ma jikkawżawx mard b'sistema immuni b'saħħitha (infezzjonijiet opportunistiċi)
English: Treatment with mitoxantrone 12 mg/m² administered every three months was superior to 5 mg/m² and placebo in one clinical study with highly active inflammatory active MS disease.
Maltese: Kura b'mitoxantrone 12 mg/m² mogħtija kull tliet xhur kienet superjuri għal 5 mg/m² u plaċebo fi studju kliniku wieħed b'marda MS attiva infjammatorja attiva ħafna.
English: Acute myeloid leukemia (AML) and Myelodysplastic syndrome A group of anticancer medicines (topoisomerase II inhibitors), including Novantrone, may cause the following diseases when used alone but especially in combination with other chemotherapy and/or radiotherapy:
Maltese: Grupp ta' mediċini kontra l-kanċer (inibituri topoisomerase II), inkluż Novantrone, jistgħu jikkawżaw ilmard li ġej meta jintużaw waħidhom iżda speċjalment f'kombinazzjoni ma' kemoterapija u/jew radjuterapija oħra:
English: • cancer of white blood cells (acute myeloid leukaemia, AML)
Maltese: • kanċer ta' ċelloli tad-demm bojod (lewkimja tal-majelojde akuta, AML)
English: Laboratory measurement cannot predict clearance of the active substance and dose adjustments (see section 5.2).
Maltese: Il-kejl tal-laboratorju ma jistax ibassar l-eliminazzjoni tassustanza attiva u tal-aġġustamenti tad-doża (ara sezzjoni 5.2).
English: Levels of uric acid, electrolytes and urea should be monitored.
Maltese: Il-livelli tal-uric acid, lelettroliti u l-urea għandhom jiġu mmonitorjati.
English: Fatigue Pyrexia
Maltese: Dardir Rimettar
English: Novantrone concentrate also can be administered as a short infusion (15 to 30 minutes) diluted in 50 to 100 ml isotonic saline or 5% glucose solution.
Maltese: 100 ml salina isotonika jew soluzzjoni ta' 5 % glucose.
English: Novantrone is used in the treatment of: advanced stage (metastatic form) of breast cancer; a form of lymph node cancer (non-Hodgkin's lymphoma); a cancer of the blood in which the bone marrow (the spongy tissue inside the large bones) makes too many white blood cells (acute myeloid leukaemia); a cancer of the white blood cells (chronic myeloid leukaemia) at a stage where it is difficult to control the number of white blood cells (blast crisis).
Maltese: Tużax Novantrone: - jekk inti allerġiku/a għal mitoxantrone jew għal xi ingredjenti oħra ta' din il-mediċina (ara sezzjoni 6). - jekk inti allerġiku/a għal sulfit; - jekk għandek xi forma ta' ażżma (ażżma bronkjali) b'allerġija għas-sulfit; - jekk qed tredda' (ara s-sezzjoni “Tqala u Treddigħ”)
English: The most serious side effects are damage to the heart (myocardial toxicity) and myelosuppression (reduced activity of the bone marrow).
Maltese: L-aktar effetti sekondarji serji huma ħsara għall-qalb (tossiċità mijokardijaka) u majelosoppressjoni (attività mnaqqsa tal-mudullun).
English: Immunisation with live virus vaccines (e.g. yellow fever vaccination) increases the risk of infection and other adverse reactions such as vaccinia gangrenosa and generalized vaccinia, in patients with reduced immunocompetence, such as during treatment with mitoxantrone.
Maltese: It-tilqim bil-vaċċin tal-virus ħaj (eż. vaċċin għad-deni isfar) iżid ir-riskju ta' infezzjoni u ta' reazzjonijiet avversi oħrajn bħal vaccinia gangrenosa u vaccinia ġeneralizzata, f'pazjenti b'immunokompetenza mnaqqsa, bħal matul il-kura b'mitoxantrone.
English: There is no known specific antidote for mitoxantrone.
Maltese: Ma hemm ebda antidotu speċifiku magħruf għal mitoxantrone.
English: Amenorrhoea * Amenorrhea may be prolonged and may be consistent with premature menopause General disorders and administration site conditions Common
Maltese: * Amenorrea tista' tkun imtawwla u tista' tkun konsistenti ma' menopawża prematura Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Topoisomerase II inhibitors, including mitoxantrone, when used concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS) (see section 4.8).
Maltese: Inibituri Topoisomerase II, inkluż mitoxantrone, meta użati flimkien ma' sustanzi antineoplastiċi oħrajn u/jew radjoterapija, ġew assoċjati mal-iżvilupp ta' Lewkimja tal-Majelojde Akuta (AML) jew mas-Sindrome
English: Nail disorders Rash
Maltese: Disturbi fid-dwiefer Raxx
English: Myocardial toxicity, manifested in its most severe form by potentially irreversible and fatal congestive heart failure (CHF), may occur either during therapy with mitoxantrone or months to years after termination of therapy.
Maltese: Tossiċità mijokardijaka, manifestata fl-aktar forma severa tagħha minn kollass tal-qalb konġestiv fatali (CHF, congestive heart failure) u potenzjalment irriversibbli, tista' sseħħ jew matul terapija b'mitoxantrone jew xhur sa snin wara l-waqfien tat-terapija.
English: How to store Novantrone
Maltese: X'fih Novantrone
English: Secondary acute myeloid leukaemia and myelodysplastic syndrome Topoisomerase II inhibitors, including mitoxantrone, when used as monotherapy or especially concomitantly with other antineoplastic agents and/or radiotherapy, have been associated with the development of Acute Myeloid Leukaemia or Myelodysplastic Syndrome.
Maltese: Inibituri Topoisomerase II, inkluż mitoxantrone, meta użati bħala monoterapija jew b'mod speċjali flimkien ma' sustanzi antineoplastiċi oħrajn u/jew radjoterapija, ġew assoċjati mal-iżvilupp ta' Lewkimja talMajelojde Akuta jew mas-Sindrome Majelodisplastiku.
English: Leukopenia Granulocytopenia White blood cell count abnormal
Maltese: Flebite ġiet irrapportata wkoll fis-sit tal
English: Mitoxantrone has been given as part of combination therapy.
Maltese: Mitoxantrone ngħata bħala parti minn terapija ta' kombinazzjoni.
English: Decrease by 2 mg/m2 from prior dose, after recovery.
Maltese: Tnaqqis b'2 mg/m minn doża preċedenti,
English: Anaemia Neutropenia Leukopenia
Maltese: Anemija Lewkopenja
English: This is in general a transient neutropenia with the lowest count of leucocytes at day 10 after the infusion and recovered around day 20.
Maltese: Normalment, din hija newtopenja temporanja bl-inqas għadd ta' lewkoċiti fil-jum 10 wara l-infużjoni u rkuprati madwar jum 20.
English: When mitoxantrone is used in high doses (> 14 mg/m2/d x 3 days) such as indicated for the treatment of leukaemia, severe myelosuppression will occur.
Maltese: Meta mitoxantrone jintuża f'dożi għoljin (> 14 mg/m2/d x 3 ijiem) bħal kif indikat għall-kura ta' lewkimja,
English: Except for the treatment of acute myeloid leukaemia, mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3.
Maltese: Għajr għall-kura ta' lewkimja tal-majelojde akuta, terapija b'mitoxantrone ġeneralment ma għandhiex tingħata lil pazjenti b'għadd ta' newtrofili tal-linja bażi ta' inqas minn 1,500 cells/mm3.
English: o cancer of white blood cells (acute myeloid leukaemia, AML);
Maltese: o kanċer ta' ċelloli tad-demm bojod (lewkimja tal-majelojde akuta, AML)
English: Novantrone and associated names (see Annex I) 2 mg/ml concentrate for solution for infusion [See Annex I - To be completed nationally] Mitoxantrone
Maltese: Novantrone u ismijiet assoċjati (ara Anness I) 2 mg/ml konċentrat għal soluzzjoni għall-infużjoni [Ara Anness I - Li għandha timtela fuq livell nazzjonali]
English: Differential blood count within 21 days after mitoxantrone infusion Signs and symptoms of infection and differential blood count with WHO grade 3: following dose 10 mg/m²
Maltese: Sinjali u sintomi ta' infezzjoni u ta' għadd tad-demm differenzjali bi grad 3 tal-WHO: wara doża 10 mg/m² Sinjali u sintomi ta' infezzjoni u ta' għadd tad-demm differenzjali bi grad 4 tal-WHO: wara doża 8 mg/m²
English: The safety and efficacy of mitoxantrone have not been studied after treatment with natalizumab, fingolimod, alemtuzumab, dimethyl fumarate, or teriflunomide.
Maltese: alemtuzumab, dimethyl fumarate, jew teriflunomide.
English: These reports have included seizures leading to coma and severe neurologic sequelae, and paralysis with bowel and bladder dysfunction.
Maltese: Dawn ir-rapporti inkludew aċċessjonijiet li wasslu għal koma u sequelae newroloġiċi severi, u paraliżi b'disfunzjoni tal-imsaren u tal-bużżieqa tal-awrina.
English: Thrombocytopenia Neutropenia
Maltese: Anemija Newtropenja Lewkopenja
English: Novantrone is used in combination with other medicinal products in this indication; pain caused by prostate cancer at an advanced stage of prostate cancer in combination with corticosteroids; highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 2 and 3).
Maltese: - Sklerożi multipla ta' rikaduta attiva ħafna assoċjata ma' disabilità li tevolvi rapidament, fejn ma teżisti ebda għażla terapewtika alternattiva (ara sezzjonijiet 2 u 3).
English: Rare (may affect up to 1 in 1,000 people) None.
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: In clinical trials cancer patients who received cumulative doses of 140 mg/m either alone or in combination with other chemotherapeutic agents had a cumulative 2.6% probability of clinical congestive heart failure.
Maltese: Fi provi kliniċi, pazjenti b'kanċer li rċevew dożi kumulattivi ta' 140 mg/m2 jew waħdihom jew f'kombinazzjoni ma' sustanzi kimoterapewtiċi oħrajn kellhom probabilità ta' 2.6 % kumulattiva ta' kollass konġestiv tal-qalb kliniku.
English: This medicine might increase the risk for transitory or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Maltese: Din il-mediċina tista' żżid ir-riskju għal nuqqas temporanju jew persistenti ta' menstruwazzjoni (amenorrea)
English: Cancer patients who received cumulative doses of 140 mg/m2 either alone or in combination with other chemotherapeutic agents had a cumulative 2.6% probability of clinical congestive heart failure.
Maltese: Pazjenti b'kanċer li rċevew dożi kumulattivi ta' 140 mg/m2 jew waħidhom jew f'kombinazzjoni ma' sustanzi kimoterapewtiċi oħrajn kellhom probabilità ta' 2.6 % kumulattiva ta' kollass konġestiv kliniku tal-qalb.
English: Confusion and fatigue may occur following administration of mitoxantrone (see section 4.8).
Maltese: Wara l-għoti ta' mitoxantrone jistgħu jseħħu konfużjoni u għeja (ara sezzjoni 4.8).
English: Anaemia
Maltese: Letarġija
English: There does not seem to be relevant differences in pharmacokinetics of mitoxantrone between elderly and young adult patients.
Maltese: Jidher li mhemmx differenzi relevanti fil-farmakokinetika ta' mitoxantrone bejn pazjenti anzjani u adulti żgħażagħ.
English: Pyrexia
Maltese: Newtropenja
English: Metastatic breast cancer, non-Hodgkin's lymphoma
Maltese: Kanċer tas-sider metastatiku, limfoma mhux ta' Hodgkin
English: This dosage is given in 21 day-cycles, for induction therapy in AML during three consecutive days, for consolidation therapy during two days.
Maltese: Dan id-dożaġġ jingħata f'ċikli ta' 21 jum, għal terapija ta' induzzjoni f'AML matul tliet ijiem konsekuttivi, għal terapija ta' konsolidazzjoni matul jumejn.
English: Because of the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding is contraindicated (see section 4.3) and must be discontinued before starting treatment.
Maltese: Minħabba l-potenzjal ta' reazzjonijiet avversi serji fit-trabi minn mitoxantrone, it-treddigħ huwa kontraindikat (ara sezzjoni 4.3) u għandu jitwaqqaf qabel tinbeda l-kura.
English: Anaphylaxis/anaphylactoid reactions (including shock)
Maltese: anafilassi/anafilattodje (inkluż xokk)
English: - Abdominal pain.
Maltese: - Uġigħ addominali
English: Constipation Diarrhoea Stomatitis
Maltese: Soppressjoni tal-mudullun
English: There have been reports of neuropathy and neurotoxicity, both central and peripheral, following intrathecal injection.
Maltese: Kien hemm rapporti ta' newropatija u newrotossiċita, kemm ċentrali kif ukoll periferali, wara injezzjoni intratekali.
English: ** The casual relationship to mitoxantrone administration is uncertain.
Maltese: ** Ir-relazzjoni kawżali għall-għoti ta' mitoxantrone mhijiex ċerta.
English: Mitoxantrone in combination with cytarabine as initial induction treatment is at least as effective for inducing remission as daunorubicin combinations in adult patients with previously untreated AML.
Maltese: Mitoxantrone f'kombinazzjoni ma' cytarabine bħala kura ta' induzzjoni inizjali huwa għallinqas effettiv għal induzzjoni ta' rimessjoni daqs kombinazzjonijiet ta' daunorubicin f'pazjenti adulti b'AML mhux ikkurati preċedentament.
English: - Abnormal results of blood tests to check liver and kidney functions (raised aspartate aminotransferase levels, elevated creatinine and urea nitrogen concentration in the blood).
Maltese: - Riżultati anormali ta' testijiet tad-demm biex jiċċekkjaw il-funzjoni tal-fwied u tal-kliewi (livelli miżjudin ta' aspartate aminotransferase, konċentrazzjoni għolja ta' kreatinina u ta' nitroġenu fl-urea fid demm)
English: Myelosuppression is a dose-limiting undesirable effect of mitoxantrone.
Maltese: Il-majelosoppressjoni hija effett mhux mixtieq li jillimita d-doża ta' mitoxantrone.
English: Skin discolouration Tissue necrosis (after extravasation)
Maltese: Telf tal-kulur tal-ġilda Nekrożi tat-tessut (wara ekstravażazzjoni)
English: As a guide, when Novantrone is used in combination chemotherapy, the initial dose of Novantrone should be reduced by 2-4 mg/m2 below the doses recommended when Novantrone is used alone.
Maltese: Bħala gwida, meta Novantrone jintuża f'kemoterapija ta' kombinazzjoni, id-doża inizjali ta' Novantrone għandha titnaqqas b'2 sa 4 mg/m2 taħt id-dożi rrakkomandati meta Novantrone jintuża waħdu.
English: - Abnormal results of blood tests to check liver function (raised aspartate aminotransferase levels).
Maltese: - Riżultati anormali ta' testijiet tad-demm biex jiċċekkjaw il-funzjoni tal-fwied (livelli għoljin ta' aspartate aminotransferase)
English: Dosage modification and the timing of subsequent dosing should be determined by clinical judgment depending on the degree and duration of myelosuppression.
Maltese: Modifikazzjoni tad-dożaġġ u t-twaqqit tad-dożaġġ sussegwenti għandhom jiġu ddeterminati b'ġudizzju kliniku li jiddependi mill-grad u mid-durata tal-majelosoppressjoni.
English: Cases of tumour lysis syndrome were reported with the use of mitoxantrone.
Maltese: Każijiet ta' sindrome ta' liżi ta' tumur ġew irrapportati bl-użu ta' mitoxantrone.
English: Mitoxantrone is indicated in the treatment of non-Hodgkin's lymphoma.
Maltese: Mitoxantrone huwa indikat fil-kura ta' limfoma mhux ta' Hodgkin.
English: Decrease by 4 mg/m from prior dose, after recovery.
Maltese: Tnaqqis b'4 mg/m2 minn doża preċedenti, wara l-irkupru.
English: If any signs or symptoms of extravasation have occurred, including burning, pain, pruritus, erythema, swelling, blue discolouration, or ulceration, the administration should be stopped immediately (see section 4.4).
Maltese: Jekk ikunu seħħew xi sinjali jew sintomi ta' ekstravasazzjoni, inkluż ħruq, uġigħ, ħakk, eritema, nefħa, telf fil-kulur jagħti lejn il-blu, jew ulċerazzjoni, l-amministrazzjoni għandha titwaqqaf minnufih (ara sezzjoni 4.4). 4.3 Kontraindikazzjonijiet
English: Mitoxantrone must not be used in treatment of multiple sclerosis in pregnant women (see sections 4.4 and
Maltese: Mitoxantrone ma għandux jintuża fil-kura ta' sklerożi multipla f'nisa tqal (ara sezzjonijiet 4.4 u 4.6).
English: Acute myeloid leukaemia
Maltese: Lewkimja tal-majelojde akuta
English: Lethargy
Maltese: Anzjani
English: As a guide, when mitoxantrone is used in combination chemotherapy with another myelosuppressive agent, the initial dose of mitoxantrone should be reduced by 2 to 4 mg/m2 below the doses recommended for single agent usage; subsequent dosing, as outlined in the table above, depends on the degree and duration of myelosuppression.
Maltese: Bħala gwida, meta mitoxantrone jintuża f'kemoterapija ta' kombinazzjoni ma' sustanza majelosuppressiva oħra, id-doża inizjali ta' mitoxantrone għandha titnaqqas b'2 sa 4 mg/m2 taħt id-dożi rrakkomandati għal użu ta' sustanza waħda; dożaġġ sussegwenti, kif deskritt fit-tabella fuq, jiddependi fuq il-grad u t-tul tal majelosuppressjoni.
English: Mitoxantrone blocks the cell cycle in G2-phase leading to an increase of cellular RNA and polyploidy.
Maltese: G2 u dan iwassal għal żieda fl-RNA ċellulari u f'poliplojdija.
English: Treatment of blast crisis in (chronic) myeloid leukaemia Single dose therapy in relapse
Maltese: o disturb tal-mudullun li jikkawża ċelloli tad-demm b'forma mhux normali u li jwassal għal lewkimja (sindrome majelodisplastika)
English: o Swelling.
Maltese: - Tbenġil
English: - Tingling sensation.
Maltese: - Telf ta' xagħar
English: However, in male animals, damage to the testes and decreased sperm counts were observed.
Maltese: Madankollu, f'annimali rġiel, ġiet osservata ħsara fit-testikoli kif ukoll għadd imnaqqas ta' spermi.
English: - Bone marrow abnormality which causes the formation of abnormal blood cells which leads to leukaemia (myelodisplastic syndrome (MDS)).
Maltese: - Abnormalità tal-mudullun li tikkawża l-formazzjoni ta' ċelloli tad-demm mhux normali li twassal għal lewkimja (sindrome majelodisplastiku, (MDS))
English: - Tiredness, feeling weak and having no energy.
Maltese: Is-sigurtà ta' mitoxantrone f'pazjenti b'indeboliment renali ma ġietx determinata.
English: Anxiety Confusion Paraesthesia Lethargy
Maltese: Indeboliment konġestiv tal-qalb
English: The following table is suggested as a guide to dosage adjustment, in the treatment of metastatic breast cancer and non-Hodgkin's lymphoma according to haematological nadir (which usually occurs about 10 days after dosing).
Maltese: It-tabella li ġejja hija ssuġġerità bħala gwida għall-aġġustament tad-dożaġġ, fil-kura ta' kanċer tas-sider metastatiku u ta' limfoma mhux ta' Hodgkin skont nadir ematolġiku (li normalment iseħħ madwar 10 ijiem wara d-dożaġġ).
English: - Severe itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), or if you feel you like you are going to faint, these may be signs of severe allergic reaction.
Maltese: - Raxx b'ħakk sever (ħorriqija), nefħa tal-idejn, tas-saqajn, tal-għekiesi, tal-wiċċ, tax-xofftejn, tal-ħalq jew tal-gerżuma (li tista' tikkawża diffikulta biex tibla jew biex tieħu n-nifs),jew jekk tħossok qisu se jagħtik ħass ħażin, dawn jistgħu jkunu sinjali ta' reazzjoni allerġika severa
English: Women treated with Mitoxantrone have an increased risk of transitory or persistent amenorrhoea and therefore preservation of gametes should be considered prior to therapy.
Maltese: Nisa kkurati b'Mitoxantrone għandhom riskju miżjud ta' amenorrea temporanja jew persistenti u għaldaqstant, il-preservazzjoni tal-gametes għandha tiġi kkunsidrata qabel it-terapija.
English: Therapy with mitoxantrone should be accompanied by close and frequent monitoring of haematological and chemical laboratory parameters, as well as frequent patient observation.
Maltese: It-terapija b'mitoxantrone għandha tkun akkumpanjata b'monitoraġġ mill-qrib u frekwenti tal-parametri ematoloġiċi u tal-laboratorju kimiku, kif ukoll b'osservazzjoni frekwenti tal-pazjent.
English: - Severe allergic reaction (anaphylactic reaction including anaphylactic shock) - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing, and you may feel you are going to faint).
Maltese: - Livell baxx ta' plejtlits - li jista' jikkawża fsada jew tbenġil - Għadd baxx ta' ċelloli tad-demm bojod speċjali (newtrofili) - Reazzjoni allerġika severa (reazzjoni anafilattika inkluż xokk anafilattiku) - tista' tesperjenza raxx b'ħakk għall-għarrieda (ħorriqija), nefħa tal-idejn, tas-saqajn, tal-għekiesi, tal-wiċċ, tax-xofftejn, tal-ħalq jew tal-gerżuma, li tista' tikkawża diffikultà biex tibla jew biex tieħu n-nifs, u jista' jkun li tħossok li se jagħtik ħass ħażin)
English: Four patients receiving 140 to 180 mg/m2 as a single bolus injection died as a result of severe leukopenia with infection.
Maltese: Erba' pazjenti li kienu qed jirċievu 140 sa 180 mg/m2 bħala injezzjoni bolus waħdanija mietu bħala riżultat ta'
English: - Cancer of the white blood cells (acute myeloid leukemia (AML)).
Maltese: Lewkimja tal-majelojde akuta (AML, Acute myeloid leukemia) u Sindrome majelodisplastiku
English: Mitoxantrone alone or in combination with other cytostatic medicinal products shows objective response in patients with several types of NHL.
Maltese: Mitoxantrone waħdu jew f'kombinazzjoni ma' prodotti mediċinali ċitostatiċi oħrajn juri rispons oġġettiv f'pazjenti b'diversi tipi ta' NHL.
English: Mitoxantrone pharmacokinetics in the paediatric population is unknown.
Maltese: Il-farmakokinetika b'Mitoxantrone fil-popolazzjoni pedjatrika mhijiex magħrufa.
English: Neoplasms benign and malignant (including cysts and polyps) Uncommon
Maltese: Neoplażmi beninni u malinni (inkluż ċesti u polipi)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and Address} {tel} {fax} {e-mail}
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ [Ara Anness I - Li għandha timtela fuq livell nazzjonali]
English: Women of childbearing potential should be informed about increased risk of transitory or persistent amenorrhoea (see section 4.6).
Maltese: Nisa fl-età li jista' jkollhom it-tfal għandhom jiġu infurmati dwar ir-riskju miżjud ta' amenorreja temporanja jew persistenti (ara sezzjoni 4.6).
English: The recommended dosage in relapse is 10 to 12 mg/m2 body surface area given as a single intravenous dose daily over 5 consecutive days (total of 50 to 60 mg/m2).
Maltese: Id-dożaġġ rakkomandat ta' mitoxantrone huwa normalment 12 mg/m2 erja tas-superfiċje tal-ġisem mogħti bħala infużjoni ġol-vini qasira (madwar 5 sa 15-il minuta) li tista' tiġi ripetuta kull 1 sa3 xhur.
English: Mitoxantrone also interferes with ribonucleic acid (RNA) and is a potent inhibitor of topoisomerase II, an enzyme responsible for uncoiling and repairing damaged DNA.
Maltese: Mitoxantrone jinterferixxi wkoll ma' ribonucleic acid (RNA) u huwa inibitur b'saħħtu ta' topoisomerase II, enzim responsabbli għall-ħall u għat-tiswija ta' DNA bil-ħsara.
English: Acute myeloid leukaemia:
Maltese: Lewkimja tal-majelojde akuta;
English: oral suspension
Maltese: Suspensjoni orali
English: Palpitations, bradycardia
Maltese: Palpitazzjonijiet, bradikardija
English: • tricyclic antidepressants e.g. amitriptyline;
Maltese: • antidipressanti triċikliki, eż. amitriptyline.
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' ta' eċċipjenti, ara sezzjoni 6.1.
English: Multipack: 180 (2 packs of 90) tablets
Maltese: U KONTENUT Pakkett b'ħafna: 180 (2 pakketti ta' 90) pilloli.