FrancophonIA/ELRC3.0 huggingface dataset:
English: The low molecular weight cobalamins-(III) formed including hydroxocobalamin are termed free cobalamins-(III); the sum of free and protein-bound cobalamins is termed total cobalamins-(III).
Maltese: Ic-cobalamins-(III) b'piż molekulari baxx li ffurmaw, li jinkludu hydroxocobalamin, huma msejħa cobalamins-(III) ħielsa; it-total ta' cobalamins ħielsa u ta' dawk imwaħħlin mal-proteini jissejjaħ cobalamins-(III) totali.
English: • Animal pharmacology
Maltese: • Farmakoloġija fl-annimali
English: Caution is required in the interpretation of urinary colorimetric tests for as long as chromaturia is present.
Maltese: Attenzjoni hi meħtieġa fl-interpretazzjoni ta' testijiet kolorimetriċi ta' l-awrina sakemm il-kromaturja tkun preżenti.
English: The mean age of the paediatric patients was about six years and the mean dose of hydroxocobalamin was about 120 mg/kg body weight.
Maltese: Il-medja ta' l-età talpazjenti pedjatriċi kienet ta' madwar sitt snin u d-doża medja ta' hydroxocobalamin kienet ta' madwar 120 mg/kg ta' piż tal-ġisem.
English: Developmental toxicity, including teratogenicity, was observed in rats and rabbits at dose levels of 150 mg/kg and higher administered daily throughout organogenesis.
Maltese: It-tossiċità waqt l-iżvilupp, li tinkludi t-teratoġeniċità kienet osservata fil-firien u fil-fniek f'livelli ta' doża ta' 150 mg/kg u ogħla mogħtija kuljum matul l-organoġenesi.
English: The remaining 102 subjects were healthy volunteers who had not been exposed to cyanide at the time of hydroxocobalamin administration.
Maltese: Ilbqija tal-102 suġġetti kienu voluntiera b'saħħithom li ma kinux esposti għal cyanide fil-ħin ta' l-għoti ta' hydroxocobalamin.
English: After reconstitution with 200 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.
Maltese: Wara rrikostituzzjoni b'200 mL ta' diluwent, kull millitru tas-soluzzjoni rikostitwita jkun fih 25 mg ta' hydroxocobalamin.
English: • kidney injuries such as acute kidney impairment and urine crystals.
Maltese: • ħsara fil-kliewi bħal indeboliment akut tal-kliewi u kristalli fl-awrina.
English: Therefore, as a precaution, after Cyanokit administration, regular monitoring of renal function (including blood urea nitrogen and serum creatinine) should be performed until 7 days after drug onset.
Maltese: Għalhekk, bħala prekawzjoni, wara l-għoti ta' Cyanokit, għandu jsir monitoraġġ regolari tal-funzjoni tal-kliewi (inkluż urea nitrogen fid-demm u l-krejatinina fis-serum) sa 7 ijiem wara l-bidu talmediċina.
English: Powder for solution for infusion containing 2.5 g of hydroxocobalamin.
Maltese: Trab għal soluzzjoni għall-infużjoni li fih 2.5 g ta' hydroxocobalamin.
English: VIAL
Maltese: UŻU
English: • altered mental status
Maltese: • stat mentali mibdul
English: However, taken into account: - that no more than two injections of hydroxocobalamin are to be administered, - the potentially life threatening condition, - the lack of alternative treatment, hydroxocobalamin may be given to a pregnant woman.
Maltese: Madankollu, jekk wieħed jikkunsidra li: - mhux iktar minn żewġ injezzjonijiet ta' hydroxocobalamin jistgħu jingħataw, - il-kundizzjoni li potenzjalment tista' tipperikola l-ħajja, - in-nuqqas ta' trattamenti alternattivi adegwati, hydroxocobalamin jista' jingħata lil mara tqila.
English: Cyanokit 2.5 g powder for solution for infusion hydroxocobalamin
Maltese: Cyanokit 2.5 g trab għal soluzzjoni għall-infużjoni Hydroxocobalamin
English: Cyanokit is to be administered together with appropriate decontamination and supportive measures.
Maltese: Cyanokit għandu jingħata flimkien ma' miżuri adegwati ta' dekontaminazzjoni u sapport.
English: After reconstitution with 100 mL of diluent, each mL of the reconstituted solution contains 25 mg of hydroxocobalamin.
Maltese: Wara rrikostituzzjoni b'100 mL ta' diluwent, kull millilitru tas-soluzzjoni rikostitwita jkun fih 25 mg ta' hydroxocobalamin.
English: The Cyanokit vial is to be rocked or inverted for at least 30 seconds to mix the solution.
Maltese: Il-kunjett ta' Cyanokit għandu jixxengel jew jinqaleb għal mill-inqas 30 sekonda biex tħallat issoluzzjoni.
English: • Keep this leaflet.
Maltese: • nuqqas ta' kwiet
English: Cyanokit 5 g powder for solution for infusion hydroxocobalamin
Maltese: Cyanokit 5 g trab għal soluzzjoni għall-infużjoni Hydroxocobalamin
English: Urine colouration may last up to 35 days after administration of Cyanokit (see section 4.4 ).
Maltese: Din il-bidla fil-lewn tal-urina tista' ddum sa 35 ġurnata wara l għoti ta' Cyanokit (ara sezzjoni 4.4).
English: The maximal increase in blood pressure has been observed toward the end of infusion (see section 4.8).
Maltese: Iż-żieda massima fil-pressjoni tad-demm kienet osservata lejn ittmiem ta' l-infużjoni (ara sezzjoni 4.8).
English: Headache; injection site reaction; peripheral oedema.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Uġigħ ta' ras; reazzjoni fil-post ta' l-injezzjoni; edema periferali.
English: Effects on blood cyanide assay
Maltese: Effetti sekondarji possibbli Kif jinħażen Cyanokit
English: Cyanokit 2.5 g powder for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Cyanokit 2.5 g trab għal soluzzjoni għall-infużjoni
English: Dogs were poisoned by intravenous administration of a lethal dose of potassium cyanide.
Maltese: Il-klieb kienu avvelenati permezz ta' l-għoti ġol-vini ta' doża letali ta' potassium cyanide.
English: Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication.
Maltese: Id-deċiżjonijiet dwar it-trattament jridu jsiru abbażi ta' l-istorja klinika u/jew sinjali u sintomi ta' intossikazzjoni ta' cyanide.
English: Phosphate
Maltese: Potassju
English: For the purpose of ambulatory use, Cyanokit may be exposed during short periods to the temperature variations of
Maltese: Għal skopijiet ta' użu ambulatorju, Cyanokit jista' jkun espost waqt perjodi qosra għal varjazzjonijiet tat-temperatura
English: 12-16 hours
Maltese: 12-16-il siegħa
English: Each vial is to be reconstituted with 100 mL of diluent using the supplied sterile transfer device.
Maltese: Kull kunjett għandu jkun rikostitwit b'100 mL ta' diluwent bl- użu ta' strumenti sterili għattrasferiment li hu provdut.
English: • if you are allergic to hydroxocobalamin or vitamin B12.
Maltese: • jekk inti allerġiku/a għal hydroxocobalamin jew vitamina
English: Hydroxocobalamin has not been evaluated for carcinogenic potential.
Maltese: Hydroxocobalamin ma kienx evalwat għall-potenzjal karċinoġeniku.
English: In vitro tests indicate that the extent and duration of the interference is dependant on numerous factors such as the dose of hydroxocobalamin, analyte, analyte concentration, methodology, analyser, concentrations of cobalamins-(III) including cyanocobalamin and partially the time between sampling and measurement.
Maltese: Testijiet in vitro jindikaw li l-grad u t-tul ta' żmien ta' l-interferenza jiddependu fuq fatturi diversi bħad-doża ta' hydroxocobalamin, l-analyte, il-konċentrazzjoni ta' analyte, il-metodoloġija, l-analizzatur, il-konċentrazzjonijiet ta' cobalamins-(III) li jinkludu cyanocobalamin u parzjalment fuq il-ħin bejn meta jittieħed il-kampjun u l-kejl.
English: Cyanokit 5 g powder for solution for infusion
Maltese: IL-PRODOTT MEDIĊINALI Cyanokit 5 g trab għal soluzzjoni għall-infużjoni
English: While determination of blood cyanide concentration is not required and must not delay treatment with hydroxocobalamin, it may be useful for documenting cyanide poisoning.
Maltese: Filwaqt li d-determinazzjoni tal-konċentrazzjoni fid-demm ta' cyanide mhijiex meħtieġa u m'għandhux jittardja t-trattament b'hydroxocobalamin, tista' tkun utili biex tiddokumenta l-avvelenament b'cyanide.
English: • chest pressure.
Maltese: • pressjoni fis-sider.
English: Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogens, including cyanogenic plants, aliphatic nitriles, or prolonged exposure to sodium nitroprusside.
Maltese: Sorsi ta' avvelenament b'cyanide jinkludu hydrogen cyanide u l-imlieħi tiegħu, cyanogens, li jinkludu pjanti ċijanoġeniċi, aliphatic nitriles, jew espożizzjoni fit-tul għal sodium nitroprusside.
English: Lymphocytes
Maltese: Plejtlets
English: In cyanide-poisoned patients, hydroxocobalamin is expected to bind cyanide to form cyanocobalamin, which is excreted in the urine.
Maltese: F'pazjenti li jkunu avvelenati b'cyanide, hydroxocobalamin hu mistenni li jingħaqad ma' cyanide biex jifforma cyanocobalamin, li jitneħħa fl-awrina.
English: Cyanocobalamin is a stable, non-toxic compound that is excreted in the urine.
Maltese: Cyanocobalamin hu kompost stabbli, mhux tossiku, li jitneħħa fl-awrina.
English: In anaesthetised rabbits, hydroxocobalamin exerted haemodynamic effects (increased mean arterial blood pressure and total peripheral resistance, decreased cardiac output) related to its nitric oxidescavenging property.
Maltese: Fi fniek li kienu taħt l-effett tal-loppju, hydroxocobalamin ħoloq effetti emodinamiċi (żieda fil-medja arterjali tal-pressjoni tad-demm u fir-reżistenza periferali totali, tnaqqis fir-risultat kardijaku) relatati man-natura tiegħu ta' nitric oxide-scavenging.
English: Czech Republic
Maltese: Repubblika Ceka
English: Rua Dr. António Loureiro Borges 2 - Arquiparque - Miraflores 1495-131 Algés
Maltese: António Loureiro Borges 2 - Arquiparque - Miraflores 1495-131 Algés
English: Results from the Information Network of Departments of Dermatology (IVDK).
Maltese: Results from the Information Network of Departments of Dermatology (IVDK). Deutsche Medizinische Wochenschrift 2005;
English: Risk
Maltese: Riskju
English: Member State EU/EEA
Maltese: MEMBRI (EEA)
English: Deutsche Medizinische Wochenschrift 2005; Vol 130; 50: 2881-2886) provide evidence for an increased risk of allergic contact dermatitis in the general population of patients using bufexamac.
Maltese: Vol 130; 50: 2881-2886) jipprovdu prova għal riskju akbar ta' dermatite allerġika b'kuntatt fil-popolazzjoni ġenerali ta' pazjenti li użaw bufexamac.
English: Luxembourg PF MEDICAMENT 45, Place Abel Gance 92654 Boulogne Cedex France
Maltese: PF MEDICAMENT 45, Place Abel Gance 92654 Boulogne Cedex France
English: Place Lucien Auvert 77020 Melun cedex France
Maltese: Place Lucien Auvert 77020
English: 50mg Bufexamac (+5mg Lidocaine)/ 1g ointment
Maltese: 50mg Bufexamac (+5mg Lidocaine)/ 1g
English: BUFAL 5 POUR CENT, crème en tube
Maltese: POUR CENT, crème en tube
English: The CHMP considered the matter in accordance with Article 107(2) of Directive 2001/83/EC, as amended during the April 2010 CHMP plenary meeting.
Maltese: Is-CHMP ikkunsidra l-kwistjoni skont l-Artikolu 107(2) tad-Direttiva 2001/83/KE, kif emendat waqt il-laqgħa plenarja tas-CHMP ta' April 2010.
English: Dermapharm GmbH Türkenstraße 25/12 A-1090 Wien Austria
Maltese: L-Awstrija Dermapharm GmbH Türkenstraße 25/12
English: • hyperkeratotic conditions, chronic und subacute, - Proctological
Maltese: • kundizzjonijiet iperkeratotiċi, kroniċi u sotto-akuti, - Proktoloġiku
English: • chronic dermatoses,
Maltese: • dermatożi kronika,
English: 250mg Bufexamac, +10mg Lidocaine suppository
Maltese: 250mg Bufexamac, +10mg Lidocaine
English: Additional data on the incidence of contact allergies to bufexamac showed that in a sample of ca. 40.000 patch-tested patients, 1.4% exhibited sensitisation to bufexamac.
Maltese: Dejta addizzjonali dwar l-inċidenza ta' allerġiji b'kuntatt ma' bufexamac urew li f'kampjun ta' madwar 40,000 pazjent li sarilhom test fuq il-ġilda, 1.4% urew sensitizzazzjoni għal bufexamac.
English: • acute and chronic anal eczema,
Maltese: • ekżema anali akuta u kronika,
English: The following factors were associated with a significantly increased risk for bufexamac sensitisation: anogenital localisation of eczema, other sensitisations, atopic dermatitis, eczema of the legs, female gender, and geographic factors.
Maltese: Il-fatturi li ġejjin kienu assoċjati ma' riskju miżjud b'mod sinnifikanti għal sensitizzazzjoni għal bufexamac: lokalizzazzjoni ta' ekżema anoġenitali, sensitizzazzjonijiet oħrajn, dermatite atopika, ekżema tassaqajn, sess femminili, u fatturi ġejografiċi.
English: BUFEXAMAC NOVALIS 5 pour cent, crème
Maltese: NOVALIS 5 pour cent, crème
English: • dermatitis, chronic and subacute,
Maltese: • dermatożi, kronika u sotto-akuta,
English: Medicinal products containing bufexamac are authorised in twelve EU Member States presented as ointment, cream, and/or suppository formulations (see Annex I for the list of bufexamac containing medicinal products authorised in the EU).
Maltese: Prodotti mediċinali li fihom bufexamac huma awtorizzati fi tnax-il Stat Membru tal-UE ippreżenati bħala ingwent, krema u/jew formolazzjonijiet suppożitorji (ara Anness I għal lista ta' prodotti mediċinali li fihom bufexamac awtorizzati fl-UE).
English: • to reduce symptoms of 1st and 2nd grade haemorrhoids.
Maltese: • għat-tnaqqis ta' sintomi ta' morliti tal-1 u t-2 grad.
English: In addition, recent publications on contact allergy (e.g. Gniazdowska 1999, Waltermamm 2009), confirmed that the efficacy of bufexamac in skin diseases is questionable.
Maltese: Gniazdowska 1999, Waltermamm 2009), ikkonfermaw li l-effikaċja ta' bufexamac f'mard tal-ġilda hija diskutibbli.
English: • anal fissure,
Maltese: • qasma anali,
English: Whereas,
Maltese: Billi ,
English: 250 mg suppository
Maltese: 250 mg
English: Bulgaria Stada Arzneimittel AG Stadastrasse 2-1
Maltese: Il-Bulgarija Stada Arzneimittel AG Stadastrasse 2-1
English: PARFENAC 5 POUR CENT, crème
Maltese: POUR CENT, crème
English: The decision of the German Competent Authority was based on numerous publications and spontaneous reports on contact-allergic reactions following the administration of medicinal products containing bufexamac and recent publications of data on the incidence of and the risk factors for contact sensitisation to bufexamac.
Maltese: Id-deċiżjoni tal-Awtorità Kompetenti tal-Ġermanja kienet ibbażata fuq numru ta' pubblikazzjonijiet u rapporti spontanji dwar reazzjonijiet allergiċi b'kuntatt wara amministrazzjoni ta' prodotti mediċinali li fihom bufexamac u pubblikazzjonijiet riċenti ta' dejta dwar l-inċidenza u l-fatturi ta' riskju għal sensitizzazzjoni b'kuntatt ta' bufexamac.
English: • eczema,
Maltese: • ekżema,
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing bufexamac.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendat, għall-prodotti mediċinali li fihom bufexamac.
English: Bulgaria Stada Arzneimittel AG, Stadastrasse 2-18
Maltese: Il-Bulgarija Stada Arzneimittel AG, Stadastrasse 2-18
English: Slovakia STADA Arzneimittel AG Stadastrasse 2 - 18
Maltese: Is-Slovakkja STADA Arzneimittel AG Stadastrasse 2 - 18
English: The risk of sensitisation has been investigated in various studies published in recent years.
Maltese: Ir-riskju ta' sensitizazzjoni ġie invesitgat f'diversi studji ippubblikati fis-snin riċenti.
English: Cutaneous emulsion
Maltese: Emulsjoni għallġilda
English: In addition, most of the about 450 case reports on bufexamac in National Competent Authority's (BfArM, DE) Adverse Drug Reactions (ADR) database relate to ADRs of the skin or of the immune system, including 189 cases of contact dermatitis.
Maltese: Barra minn hekk, ħafna minn madwar 450 każ irrapportat dwar bufexamac fil-bażi ta' dejta tarReazzjonijiet Avversi tal-Mediċini (ADR) tal-Awtorità Nazzjonali Kompetenti (BfArM, DE) huma fir-rigward ta' ADRs tal-ġilda jew tas-sistema immunitarja, inklużi 189 każ ta' dermatite b'kuntatt.
English: • to reduce inflammatory symptoms of skin in neurodermatitis and chronic eczema,
Maltese: • Għat-tnaqqis ta' sintomi infjammatorji tal-ġilda f'newrodermatite u ekżema kronika,
English: Updated results of the postmarketing experience regarding the serious allergic contact dermatitis with bufexamac and data from a recent publication on this subject (e.g. Schnuch A et al.: A common and insidious side-effect: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
Maltese: Riżultati aġġornati tal-esperjenza ta' wara t-tqegħid fis-suq dwar id-dermatite allerġika serja b'kuntatt b'bufexamac u d-dejta minn pubblikazzjoni riċenti dwar is-suġġett (eż.. Schnuch A et al.: A common and insidious side-effect:
English: Ointment
Maltese: Stat
English: MASTU S FORTE Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg suppository
Maltese: MASTU S FORTE Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg
English: • The Committee considered the benefit-risk ratio of bufexamac under the normal conditions of use and considered that the aforementioned evidenced risk of contact allergic reactions is not acceptable, taking into account that the efficacy of bufexamac is limited in the treatment of dermatological and proctological diseases.
Maltese: • Il-Kumitat ikkunsidra l-bilanċ ta' benefiċċju-riskju ta' bufexamac taħt kundizzjonijiet normali tal-użu u kkunsidra li r-riskju pprovat qabel ta' reazzjonijiet allerġiċi ta' kuntatt mhuwiex aċċettabbli, meta jitqies li l-effikaċja ta' bufexamac hija limitata fit-trattament ta' mard dermatoloġiku u proktoloġiku.
English: Bufexamac is used as a non-steroidal antiphlogistic substance for topical treatment of dermatological and proctological diseases.
Maltese: Allergic contact dermatitis caused by bufexamac used in the treatment of dermatitis.
English: Lithuania Stada Arzneimittel AG Stadastrasse 2-18
Maltese: Il-Litwanja Stada Arzneimittel AG Stadastrasse 2-18
English: Furthermore, significant differences between epidemiological data and the number of spontaneous reports on contact dermatitis in the various pharmacovigilance databases clearly suggest significant underreporting and probably underestimation of the frequency of contact-allergic reactions.
Maltese: Barra minn hekk, differenzi sinifikanti bejn dejta epidemjonloġika u n-numru ta' rapporti spontanji dwar dermatite b'kuntatt fil-bażi ta' dejta farmakoviġilanti varji juru b'mod ċar nuqqas ta' rapporti sinifikanti u nuqqas probabbli fl-istima tal-frekwenza ta' reazzjonijiet allerġiċi b'kuntatt.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING BUFEXAMAC (see Annex I)
Maltese: TAL-EVALWAZZJONI TAL-PRODOTTI MEDIĊINALI LI FIHOM BUFEXAMAC (ara Anness I)
English: On 12 January 2010, the Federal Institute for Drugs and Medical Devices (BfArM) issued a Rapid Alert informing the Members States, the European Medicines Agency and the European Commission in accordance with Article 107 of Directive 2001/83/EC, as amended, of its intention to revoke the marketing authorisations of all bufexamac containing medicinal products for topical use in Germany due to an increased risk of serious allergic contact dermatitis and risk factors for contact sensitisation to bufexamac.
Maltese: Fit-12 ta' Jannar 2010, l-Istitut Federali għall-Mediċini u Apparat Mediku (BfArM) ħareġ Twissija Rapida li tinforma lill-Istati Membri, lill-Aġenzija Ewropea għall-Mediċini u lill-Kummissjoni Ewropea skont l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendat, bl-intenzjoni tiegħu li jirrevoka l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali kollha li fihom bufexamac għall-użu fuq il-ġilda fil-Ġermanja minħabba riskju akbar ta' dermatite allerġika b'kuntatt u fatturi ta' riskju għal sensitizzazzjoni b'kuntatt għal bufexamac.
English: • acute und chronic anal inflammatory symptoms of skin,
Maltese: • sintomi infjammatorji anali tal-ġilda, akuti u kroniċi,
English: Romania STADA ARZNEIMITTEL AG Stadastrasse 2-18
Maltese: Ir-Rumanija STADA ARZNEIMITTEL AG Stadastrasse 2-18
English: However, the CHMP maintains the opinion that the proposed risk minimisation measures are not sufficient to substantially reduce or avoid the risk of contact allergy in patient populations treated with bufexamac containing medicinal products.
Maltese: Madankollu, is-CHMP jibqa' talopinjoni li l-miżuri ta' minimizzazzjoni tar-riskju proposti mhumiex biżżejjed sabiex inaqqsu b'mod sostanzjali jew jevitaw ir-riskju ta' allerġija b'kuntatt fil-popolazzjoni ta' pazjenti ttrattati bi prodotti mediċinali li fihom bufexamac.
English: Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g rectal ointment
Maltese: Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g
English: • The Committee noted that the pre-existence of some of the indicated diseases to be treated with bufexamac may constitute risk factors for bufexamac sensitisation and serious hypersensitivity reactions.
Maltese: • Il-Kumitat innota li l-eżistenza minn qabel tal-mard indikat għat-trattament b'bufexamac jista' jkun fattur ta' riskju għal sensitizzazzjoni b'bufexamac u reazzjonijiet ta' ipersensittività serji.
English: Route of administration
Maltese: Rua Dr.
English: Hungary Stada Arzneimittel AG Stadastrasse 2-18
Maltese: L-Ungerija Stada Arzneimittel AG Stadastrasse 2-18
English: Rectal ointment
Maltese: BUFEXAMAC
English: Further information on Mylotarg can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mylotarg
Maltese: Informazzjoni oħra dwar Mylotarg
English: Mylotarg contains the active substance gemtuzumab ozogamicin.
Maltese: Mylotarg fih is-sustanza attiva gemtuzumab ozogamicin.
English: What are the risks associated with Mylotarg?
Maltese: X'inhuma r-riskji assoċjati ma' Mylotarg?
English: The active substance in Mylotarg, gemtuzumab ozogamicin, consists of two parts: a cytotoxic (cellkilling) substance and a monoclonal antibody (a type of protein).
Maltese: Is-sustanza attiva f'Mylotarg, gemtuzumab ozogamicin, tikkonsisti f'żewġ partijiet: sustanza ċitotossika (li toqtol iċ-ċelloli) u antikorp monoklonali (tip ta' proteina).
English: It is used in combination with daunorubicin and cytarabine (other cancer medicines).
Maltese: Dan jintuża f'kombinazzjoni ma' daunorubicin u cytarabine (mediċini oħra kontra l-kanċer).
English: It is not used for a type of AML called acute promyelocytic leukaemia (APL).
Maltese: Dan ma jintużax għal tip ta' AML imsejħa lewkimja promijeloċitika akuta (acute promyelocytic leukaemia, APL).
English: Other serious side effects with the combination therapy are liver disease, including veno-occlusive disease (a liver injury), and tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Maltese: Effetti sekondarji oħrajn serji bit-terapija kombinata huma mard tal-fwied, inkluża l-marda venookklużiva (ħsara filfwied), u s-sindromu tat-tumur ta' lisi (komplikazzjoni minħabba t-tkissir taċ-ċelloli tal-kanċer).
English: AML is rare, and Mylotarg was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000.
Maltese: AML hija rari, u Mylotarg ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit18 ta' Ottubru 2000.
English: As for all medicines, data on the use of Mylotarg are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Mylotarg hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Mylotarg, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Mylotarg, ara l-fuljett ta' tagħrif.
English: Mylotarg, given in combination with daunorubicin and cytarabine, has been shown to prolong the time patients lived before the cancer came back by up to 8 months.
Maltese: Mylotarg, mogħti f'kombinazzjoni ma' daunorubicin u cytarabine, intwera li jtawwal iż-żmien li għexu lpazjenti qabel ma l-kanċer reġa' feġġ b'massimu ta' 8 xhur.