FrancophonIA/ELRC3.0 huggingface dataset:
English: Medicines which may increase the risk of side effects with Novantrone:
Maltese: Mediċini li jistgħu jżidu r-riskju ta' effetti sekondarji b'Novantrone:
English: Fatal cases of Acute Myeloid Leukaemia (AML) have been reported (see section 4.4).
Maltese: Ġew irrappurtati każijiet fatali ta' Lewkimja tal-Majelojde Akuta (AML) (ara sezzjoni 4.4).
English: Elevated aspartate aminotransferase levels
Maltese: Livelli għoljin ta' aspartate aminotransferase
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the vial contains 2 mg mitoxantrone (as hydrochloride).
Maltese: U KWANTITATTIVA Kull 1 ml tal-kunjett fih 2 mg mitoxantrone (bħala hydrochloride).
English: The remaining 35 % was composed of monocarboxylic and dicarboxylic acid derivatives and their glucuronide conjugates.
Maltese: Il-bqija tal-35% kien kompost minn derivattivi ta' monocarboxylic u dicarboxylic acid u l-konjugati glucuronide tagħhom.
English: A reduction of neurologic disability worsening and frequency of clinical relapses was observed.
Maltese: Ġie osservat tnaqqis fl-aggravar ta' disabilità newroloġika u tal-frekwenza ta' rikaduti kliniċi.
English: Congestive heart failure Cardiomyopathy Sinus bradycardia Myocardial infarction (including fatal events)
Maltese: Indeboliment konġestiv tal-qalb Infart mijokardijaku (inkluż episodji fatali)
English: (anaemia).
Maltese: Aġenzija }
English: Inducers of the BCRP transporter could potentially decrease mitoxantrone exposure.
Maltese: Indutturi tat-trasportatur tal-BCRP jistgħu potenzjalment inaqqsu l espożizzjoni ta' mitoxantrone.
English: Of the material recovered in urine, 65 % was unchanged active substance.
Maltese: Mill-materjal irkuprat fl-awrina, 65 % kien sustanza attiva mhux mibdula.
English: - Abnomal absence of menstruation (amenorrhea).
Maltese: - Bidla tal-kulur tal-awrina - Assenza mhux normali tal-mestrwazzjoni (amenorrea)
English: Other medicines and Novantrone
Maltese: Mediċini oħra u Novantrone
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, including sulphites that may be produced during the manufacturing of mitoxantrone.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe eċċipjent elenkat fis-sezzjoni 6.1, inkluż sulfiti li jistgħu jiġu prodotti matul il-manifattura ta' mitoxantrone.
English: Mitoxantrone is indicated for the treatment of acute myeloid leukaemia (AML) in adults.
Maltese: Mitoxantrone huwa indikat fil-kura ta' lewkimja tal-majelojde akuta (AML) fl-adulti.
English: In comparative oncology trials, the overall cumulative probability rate of moderate or severe decreases in LVEF at this dose was 13%.
Maltese: Fi provi tal-onkoloġija komparattiva, ir-rata tal-probabilità kumulattiva ġenerali ta' tnaqqis moderat jew sever f'LVEF f'din id-doża kienet 13 %.
English: In patients administered 15-90 mg/m2, there is a linear relationship between dose and the area under the concentration curve (AUC).
Maltese: F'pazjenti mogħtija 15-90 mg/m2, hemm relazzjoni lineari bejn id-doża u l-erja taħt il-kurva tal-konċentrazzjoni (AUC, area under curve).
English: Inhibitors of the BCRP transporter (e.g. eltrombopag, gefitinib) could result in an increased bioavailability.
Maltese: L-inibituri tat-trasportatur BCRP (eż. eltrombopag, gefitinib) jistgħu jwasslu għal bijodisponibilità miżjuda.
English: Acute myeloid leukaemia, myelodysplastic syndrome, acute leukaemia
Maltese: Lewkimja tal-majelojde akuta, sindrome majelodisplastiku, lewkimja akuta
English: Recovery ≤ 21 days
Maltese: Irkupru ≤ 21 jum
English: If WBC nadir > 1,500 µl and platelet nadir > 50,000 µl
Maltese: Jekk nadir ta' WBC > 1,500 µl u nadir tal-plejtlits > 50,000 µl
English: Distribution to tissues is extensive: steady-state volume of distribution exceeds 1,000 L/m2.
Maltese: Distribuzzjoni Id-distribuzzjoni għat-tessut hija estensiva: volum fl-istat fiss tad-distribuzzjoni jaqbeż 1,000 L/m2.
English: In human studies, only 10 % and 18 % of the dose were recovered in urine and faeces respectively as either active substance or metabolite during the 5-day period following administration of the medicinal product.
Maltese: Fi studji umani, 10 % u 18 % biss tad-doża ġew irkuprati fl-awrina u fl-ippurgar rispettivament jew bħala sustanza attiva jew bħala metabolit matul il-perjodu ta' 5t'ijiem wara l-għoti tal-prodott mediċinali.
English: There have been reports of local/regional neuropathy, some irreversible, following intra-arterial injection.
Maltese: Kien hemm rapporti ta' newropatija lokali/reġjonali, uħud minnhom irriversibbli, wara injezzjoni intra-arterjali.
English: Topoisomerase II inhibitors (a groups of anticancer medicines including mitoxantrone) in combination with other chemotherapy and/or radiotherapy.
Maltese: - Inibituri Topoisomerase II (gruppi ta' mediċini kontra l-kanċer inkluż mitoxantrone) f'kombinazzjoni ma' kemoterapija u/jew radjoterapija oħra.
English: Distribution into testes is relatively low.
Maltese: Iddistribuzzjoni għat-testikoli hija relattivament baxxa.
English: Mitoxantrone is genotoxic and is considered a potential human teratogen.
Maltese: Mitoxantrone huwa ġenotossiku u huwa meqjus teratoġen uman potenzjali.
English: Cases of congestive heart failure with left-ventricular ejection fraction (LVEF) < 50 % have also been reported (see section 4.4).
Maltese: Każijiet ta' kollass konġestiv tal-qalb bi frazzjoni ta' rilaxx mill-ventriklu tax-xellug (LVEF, left-ventricular ejection fraction) < 50 % ġew irrapportati wkoll (ara sezzjoni 4.4).
English: The table below is based on safety data derived from clinical trials and spontaneous reporting in oncological indications and from clinical trials, post authorisation safety studies and spontaneous reporting for patients treated for multiple sclerosis.
Maltese: It-tabella ta' hawn taħt hija bbażata fuq id-dejta tas-sigurtà miksuba minn provi kliniċi u minn rapportar spontanju f'indikazzjonijiet onkoloġiċi u minn provi kliniċi, studji tas-sigurtà wara l-awtorizzazzjoni u rapportar spontanju għal pazjenti kkurati għal sklerożi multipla.
English: Signs and symptoms of infection and differential blood count with WHO grade 1: following dose 9 mg/m² Signs and symptoms of infection and differential blood count with WHO grade 2: following dose 6 mg/m²
Maltese: Sinjali u sintomi ta' infezzjoni u ta' għadd tad-demm differenzjali bi grad 1 tal-WHO: wara doża 9 mg/m² Sinjali u sintomi ta' infezzjoni u ta' għadd tad-demm differenzjali bi grad 2 tal-WHO: wara doża 6 mg/m²
English: Congestive heart failure Myocardial infarction (including fatal events)
Maltese: Infart mijokardijaku (inkluż episodji fatali)
English: Severe injury with permanent sequelae can result from intrathecal administration.
Maltese: Jista' jirriżulta korriment sever b'sequelae permanenti minn amministrazzjoni intratekali.
English: If WBC nadir < 1,000 µl or platelet nadir < 25,000 µl
Maltese: Jekk nadir ta' WBC < 1,000 µl jew nadir tal-plejtlits < 25,000 µl
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2 (see section 5.1).
Maltese: Id-doża kumulattiva tul il-ħajja kollha massima ma għandhiex taqbeż 72 mg/m2 (ara sezzjoni 5.1).
English: Mitoxantrone was mutagenic and clastogenic in all in vitro test systems and in rats in vivo.
Maltese: Mitoxantrone kien mutaġeniku u klastoġeniku fis-sistemi tat-testijiet in vitro kollha u fil-firien in vivo.
English: - Swelling (oedema).
Maltese: - Nefħa (edema)
English: Mitoxantrone has been shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, tumour necrosis factor alpha, and interleukin-2.
Maltese: Mitoxantrone intwera in vitro li jinibixxi l-profilerazzjoni taċ-ċellola B, iċ-ċellola T u tal-makrofaġi u jfixkel il-preżentazzjoni tal-antiġen, kif ukoll is-sekrezzjoni ta' interferon gamma, nekrożi ta' tumur fattur alpha, u interleukin-2.
English: Abdominal pain Gastrointestinal haemorrhage Mucosal inflammation Pancreatitis
Maltese: Uġigħ addominali Emorraġija gastrointestinali
English: If WBC nadir < 1,500 µl or platelet nadir < 50,000 µl
Maltese: Jekk nadir ta' WBC < 1,500 µl jew nadir tal-plejtlits < 50,000 µl
English: WBC and platelet nadir
Maltese: Nadir tal-WBC u tal-plejtlits
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1. [Li għandu jimtela fuq livell nazzjonali]
English: In men, no data are available, but tubular atrophy of the testes and reduced sperm counts were observed in animals (see section 5.3).
Maltese: Fl-irġiel, m'hemm lebda dejta disponibbli, iżda ġiet osservata atrofija tubulari tat-testikoli kif ukoll għadd imnaqqas ta' spermi fl annimali (ara sezzjoni 5.3).
English: Signs and symptoms of infection and differential blood count with WHO grade 3 to 4: discontinuation of therapy
Maltese: Sinjali u sintomi ta' infezzjoni u ta' għadd tad-demm differenzjali bi grad 3 sa 4 tal-WHO: waqfien tatterapija
English: STATEMENT OF ACTIVE SUBSTANCE(S) Mitoxantrone [To be completed nationally]
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Mitoxantrone
English: Mitoxantrone is contraindicated in women who are breast-feeding (see sections 4.4 and 4.6).
Maltese: Mitoxantrone huwa kontraindikat f'nisa li jkunu qegħdin ireddgħu (ara sezzjonijiet 4.4 u 4.6).
English: Mitoxantrone is excreted slowly in urine and faeces as either unchanged active substance or as inactive metabolites.
Maltese: Mitoxantrone jiġi eliminat bilmod fl-awrina u fl-ippurgar bħala sustanza attiva mhux mibdula jew bħala metaboliti inattivi.
English: Most complete remissions will occur following the initial course of induction therapy.
Maltese: Ħafna mir-remissjonijiet kompleti jseħħu wara l-kors inizjali tat-terapija ta' induzzjoni.
English: Its therapeutic efficacy has been reported in numerous malignancies.
Maltese: Leffikaċja terapewtika tiegħu ġiet irrapportata f'diversi malinni.
English: Consolidation therapy, which was used in two large randomised multicentre trials, consists of mitoxantrone 12 mg/m2 given by intravenous infusion daily on Days 1 and 2, and cytarabine, 100 mg/m2
Maltese: Terapija ta' konsolidazzjoni, li ntużat f'żewġ provi multiċentriċi randomizzati kbar, tikkonsisti minn mitoxantrone 12 mg/m2 mogħti permezz ta' infużjoni fil-vina kuljum f'Jiem 1 sa 2 u cytarbine, 100 mg/m2
English: The most serious side effects with mitoxantrone are myocardial toxicity and myelosuppression.
Maltese: L-aktar effetti sekondarji serji b'mitoxantrone huma tossiċità mijokardijaka u majelosoppressjoni.
English: Amongst the 80 enrolled patients the median values for the lowest white blood cell count and platelet count were 400/μl (WHO grade 4), and 9.500/μl (WHO grade 4),
Maltese: Fost it-80 pazjent arwolati, il-valuri medjani għall-inqas għadd ta' ċelloli tad-demm bojod u għadd ta' plejtlits kienu 400/μl (grad 4 ta' WHO), u 9.500/μl (grad 4 ta' WHO), rispettivament.
English: A single course of mitoxantrone 6 mg/m2 intravenous (IV) bolus, etoposide 80 mg/m2 intravenous for a period of 1 hour, and cytarabine (Ara-C) 1 g/m2 intravenous for a period of 6 hours daily for 6 days
Maltese: Kors waħdieni ta' mitoxantrone 6 mg/m2 bolus ġol-vina (IV), etoposide 80 mg/m2 ġol-vina għal perjodu ta' 1 siegħa, u cytarabine (Ara-C) 1 g/m2 ġol-vina għal perjodu ta' 6 sigħat kuljum għal 6 ijiem (MEC) wera attività antilewkimika bħala terapija ta' salvataġġ għal AML refrattarja.
English: Weight fluctuations Tumour lysis syndrome*
Maltese: Flutwazzjonijiet fil-piż Sindrome tal-liżi tat-tumur*
English: Recovery > 21 days
Maltese: Irkupru > 21 jum
English: Mitoxantrone is indicated for treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability where no alternative therapeutic options exist (see sections 4.2, 4.4 and 5.1).
Maltese: Mitoxantrone huwa indikat għall-kura ta' pazjenti bi sklerożi multipla ta' rikaduta attiva ħafna assoċjata ma' disabilità li tevolvi rapidament, fejn ma teżisti ebda għażla terapewtika alternattiva (ara sezzjonijiet 4.2, 4.4
English: (myelodysplastic syndrome).
Maltese: (sindrome majelodisplastika)
English: Mitoxantrone should not ordinarily be not receive a lifetime cumulative dose greater than 72 mg/m administered to multiple sclerosis patients, with either LVEF of < 50% or a clinically-significant reduction in LVEF.
Maltese: Normalment, mitoxantrone ma għandux jingħata lil pazjenti bi sklerożi multipla, jew b'LVEF ta' < 50% jew bi tnaqqis klinikament sinifikanti f'LVEF.
English: There is no relevant use of mitoxantrone in the paediatric population.
Maltese: Ma hemm ebda użu relevanti ta' mitoxantrone fil-popolazzjoni pedjatrika.
English: Differential blood count 7 days before mitoxantrone infusion
Maltese: Għadd tad-demm differenzjali 7 ijiem qabel infużjoni ta' mitoxantrone
English: - Mucosal inflammation.
Maltese: Sklerożi Multipla infużjoni.
English: Pharmacotherapeutic group: Antineoplastic agents, Anthracyclines and related substances ATC-Code: L01DB07
Maltese: Sustanzi antineoplastiċi, Antraċiklini u sustanzi relatati Kodiċi ATC:
English: Based on data from two comparative trials of mitoxantrone plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days, in combination with low oral doses of corticosteroids.
Maltese: Abbażi tad-dejta minn żewġ provi komparattivi ta' mitoxantrone flimkien ma' kortikosterojdi meta mqabbla ma' kortikosterojdi waħdihom, id-dożaġġ rakkomandat ta' mitoxantrone huwa 12 sa 14 mg/m2 mogħti bħala infużjoni qasira ġol-vini kull 21 jum f'kombinazzjoni ma' dożi orali baxxi ta' kortikosterojdi.
English: Novantrone might increase the risk for transient or persistent absence of menstruation (amenorrhoea) in women of childbearing age.
Maltese: Novantrone jista' jżid ir-riskju għal nuqqas temporanju jew persistenti ta' menstruwazzjoni (amenorrea) f'nisa fl-età li jista' jkollhom it-tfal.
English: In a pharmacokinetic study in children with de novo acute myeloid leukaemia, ciclosporin co-medication resulted in a 42% decreased clearance of mitoxantrone.
Maltese: Fi studju farmakokinetiku fi tfal b'lewkimja majelojde akuta de novo, il-ko-medikazzjoni b'ciclosporin irriżultat f'eliminazzjoni mnaqqsa bi 42 % ta' mitoxantrone.
English: For induction, the recommended dosage is 12 mg/m2 of mitoxantrone daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7.
Maltese: Għall-induzzjoni, id-dożaġġ rakkomandat huwa 12 mg/m2 ta' mitoxantrone kuljum f'Jiem 1 sa 3 mogħti bħala infużjoni ġol-vina, u 100 mg/m2 ta' cytarabine għal 7 ijiem mogħti bħala infużjoni għal 24 siegħa kontinwi fuq Jiem 1 sa 7.
English: Heart, kidney, gastrointestinal tract, and testes were additional targets.
Maltese: passaġġ gastro-intestinali, u t-testikoli kienu miri addizzjonali.
English: - Abnormal electrocardiogram.
Maltese: Elettrokardjogramma mhux normali
English: Weight fluctuations * Acute T and B lymphoblastic leukaemia and non-Hodgkin lymphomas (NHL) are most commonly associated with TLS
Maltese: Sklerożi Multipla * Lewkimja limfoblastika T u B akuta u limfomi mhux Hodgkin (NHL) huma assoċjati b'mod komuni ħafna ma' TLS
English: - Headache.
Maltese: FEJN MA
English: Cases of ECG anomalies have been reported.
Maltese: Tossiċità kardijaka Ġew irrapportati każijiet ta' anomaliji fl-ECG.
English: Combining mitoxantrone with potentially cardiotoxic active substances (e.g. anthracyclines) increases the risk of cardiac toxicity.
Maltese: Il-kombinazzjoni ta' mitoxantrone ma' sustanzi attivi potenzjalment kardjotossiċi (eż. antraċiklini) żżid irriskju ta' tossiċità kardijaka.
English: When pregnant rabbits were treated during organogenesis, an increased incidence of premature delivery was observed at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Maltese: Meta fniek nisa tqal ġew ikkurati matul organoġeneżi, ġiet osservata inċidenza miżjuda ta' twelid prematur f'dożi > 0.01 drabi d-doża umana rakkomandata fuq bażi ta' mg/m2.
English: Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic medicinal products may increase the risk of cardiac toxicity.
Maltese: Marda kardjovaskulari attiva jew rieqda, radjuterapija preċedenti jew konkomittanti għall-erja medjastinali/perikardijaka, terapija preċedenti b'antraċiklini jew b'antraċenedjoni oħrajn, jew użu konkomitanti ta' prodotti mediċinali kardjotossiċi oħrajn jistgħu jżidu r-riskju ta' tossiċità kardijaka.
English: Mitoxantrone in combination regimens is indicated in the remission-induction treatment of blast crisis in chronic myeloid leukaemia.
Maltese: Mitoxantrone f'korsijiet ta' kombinazzjoni huwa indikat fil-kura tal-induzzjoni ta' remissjoni ta' kriżi blast fillewkimja tal-majelojde kronika.
English: - Low blood pressure.
Maltese: huwa immunosuppressjoni.
English: Novantrone belongs to the group of medicines known as antineoplastic or anti-cancer medicines.
Maltese: Novantrone jappartjeni għall-grupp ta' mediċini magħruf bħala mediċini antineoplastiċi jew kontra l-kanċer.
English: Treatment of pregnant rats during the organogenesis period of gestation was associated with foetal growth retardation at doses > 0.01 times the recommended human dose on an mg/m2 basis.
Maltese: organoġeneżi ta' ġestazzjoni kien assoċjat ma' dewmien fit-tkabbir tal-fetu f'dożi > 0.01 drabi d-doża umana rakkomandata fuq bażi ta' mg/m2.
English: This is caused by possible side effects, such as confusion or feeling tired (see section 4).
Maltese: Dan huwa kkawżat minn effetti sekondarji possibbli, bħal konfużjoni jew sensazzjoni ta' għeja (ara sezzjoni 4).
English: The active substance was carcinogenic in experimental animals at doses below the proposed clinical dose.
Maltese: Is-sustanza attiva kienet karċinoġenika f'annimali esperimentali f'dożi taħt id-doża klinika proposta.
English: Thrombocytopenia Granulocytopenia
Maltese: Popolazzjoni tal-isklerożi multipla
English: Novantrone must not be administered under the skin (subcutaneous), in a muscle (intramuscular), or into the artery (intra-arterial).
Maltese: Novantrone ma għandux jingħata taħt il-ġilda (subkutaneju), f'muskolu (ġol-muskoli), jew fl-arterja (intra arterjali).
English: Treatment with mitoxantrone 12 to 14 mg/m² was effective in the treatment of various cancers.
Maltese: Il-kura b'mitoxantrone 12 sa 14 mg/m² kienet effettiva fil-kura ta' kanċers varji.
English: In metastatic breast cancer, combinations of Novantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Maltese: F'kanċer tas-sider metastatiku, ilkombinazzjonijiet ta' Novantrone ma' sustanzi ċitotossiċi oħrajn, inkluż cyclophosphamide u 5-fluorouracil jew methotrexate u mitomycin C intwerew li huma effettivi.
English: Mitoxantrone is indicated in combination with corticosteroids for palliation (e.g. pain relief) related to advanced castrate resistant prostate cancer.
Maltese: Mitoxantrone huwa indikat f'kombinazzjoni ma' kortikosterojdi għal paljazzjoni (eż. serħan mill-uġigħ) relatat ma' kanċer tal-prostata reżistenti għal kastrat avvanzat.
English: Patients who receive immunosuppressive agents like mitoxantrone have a reduced immunological response to infection.
Maltese: Pazjenti li jirċievu sustanzi immunosuppressivi bħal mitoxantrone għandhom rispons immunoloġiku indebolit għal infezzjoni.
English: Bone marrow failure Myelosuppression
Maltese: Disturbi vaskulari Mhux komuni
English: The combination of mitoxantrone with other immunosuppressive agents may increase the risk of excessive immunodepression and lymphoproliferative syndrome.
Maltese: Il-kombinazzjoni ta' mitoxantrone ma' sustanzi immunosuppressivi oħrajn tista' żżid ir-riskju ta' immunodepressjoni eċċessiva u tas-sindrome limfoproliferattiv.
English: Mitoxantrone may cause a blue-green colouration to the urine for 24 hours after administration.
Maltese: Mitoxantrone jista' jikkawża kolorazzjoni blu-ħadra għall-awrina għal 24 siegħa wara l-amministrazzjoni.
English: In metastatic breast cancer, combinations of mitoxantrone with other cytotoxic agents including cyclophosphamide and 5-fluorouracil or methotrexate and mitomycin C have been shown to be effective.
Maltese: F'kanċer tas-sider metastatiku, ilkombinazzjonijiet ta' mitoxantrone ma' sustanzi ċitotossiċi oħrajn, inkluż cyclophosphamide u 5-fluorouracil jew methotrexate u mitomycin C intwerew li huma effettivi.
English: - Inflammation of the pancreas.
Maltese: Infjammazzjoni mukosali Pankreatite
English: Functional cardiac changes may occur in patients with multiple sclerosis treated with mitoxantrone.
Maltese: Tibdil fil-funzjoni kardijaka jista' jseħħ f'pazjenti bi sklerożi multipla kkurati b'mitoxantrone.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentament mill-awtoritajiet kompetenti talIstat Membru, bi ftehim mal-Istat Membru ta' Referenza, kif xieraq, skont il-proċeduri stabbiliti filKapitolu 4 tat-Titlu III tad-Direttiva 2001/83/KE.
English: No teratogenic effects were observed in these studies, but the maximum doses tested were well below the recommended human dose (0.02 and 0.05 times in rats and rabbits, respectively, on an mg/m2
Maltese: Ma ġie osservat ebda effett teratoġeniku f'dawn l-istudji, iżda d-dożi massimi ttestjati kienu ferm taħt id-doża rrakkomandata fl-umani (0.02 u 0.05 drabi fil-firien u fil-fniek, rispettivament, fuq bażi ta' mg/m2).
English: The maximum lifetime cumulative dose should not exceed 72 mg/m2.
Maltese: Id-doża kumulattiva tul il-ħajja kollha massima ma għandhiex taqbeż 72 mg/m2.
English: Contusion Haemorrhage Hypotension
Maltese: Majelosoppressjoni Indeboliment tal-mudullun
English: - Severe allergic reaction (anaphylactic reaction including anyphylactic 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: - Reazzjoni allerġika severa (reazzjoni anafilattika inkluż xokk anafilattiku) - tista' tesperjenza raxx bilħakk għall-għarrieda (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, u jista' jkun li tħossok li se jagħtik ħass ħażin)
English: Tell your doctor or pharmacist or nurse immediately if you get any of the following signs or symptoms during treatment with Novantrone: - fever, infections, unexplained bleeding or bruising, weakness and easy fatigability; - breathlessness (including breathlessness at night), cough, fluid retention (swelling) in the ankles or legs , heart fluttering (irregular heart beat).
Maltese: - Deni, infezzjonijiet, fsada jew tbenġil mhux spjegat, dgħjufija u għeja malajr - Qtugħ ta' nifs (inkluż qtugħ ta' nifs bil-lejl), sogħla, ritenzjoni ta' fluwidu (nefħa) fl-għekiesi jew fir riġlejn, taħbit irregolari tal-qalb.
English: Keep this leaflet.
Maltese: Reazzjonijiet ta'
English: Novantrone concentrate should be slowly injected into a free flowing intravenous infusion of isotonic saline or 5% glucose solution over a period of not less than 3 to 5 minutes.
Maltese: Il-konċentrat ta' Novantrone għandu jiġi injettat bil-mod b'infużjoni ġol-vini li tgħaddi bla intoppi ta' salina isotonika jew soluzzjoni ta' 5 % glucose fuq perjodu ta' mhux inqas minn 3 sa 5 minuti.
English: Single doses ranged from 5 to 12 mg/m2, dose intervals from once per month to once per 3 months.
Maltese: Dożi singoli varjaw minn 5 sa 12 mg/m2, intervalli fid-doża minn darba fix-xahar għal darba kull 3 xhur.
English: If Novantrone is used alone:
Maltese: Jekk Novantrone jintuża waħdu: