FrancophonIA/ELRC3.0 huggingface dataset:
English: Cuprior trientine
Maltese: Cuprior trientina
English: Cuprior is available as 150 mg tablets.
Maltese: Cuprior jiġi bħala pilloli ta' 150 mg.
English: The full EPAR for Cuprior 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: In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets.
Maltese: Fl-adulti, id-doża totali rakkomandata ta' kuljum hija minn 3 sa 6.5 pilloli, u fit-tfal minn 1.5 sa 4 pilloli.
English: Cuprior contains the active substance trientine.
Maltese: Cuprior fih is-sustanza attiva trientina.
English: Other information about Cuprior
Maltese: Informazzjoni oħra dwar Cuprior
English: It is a hybrid medicine.
Maltese: Dan huwa mediċina ibrida.
English: This is a summary of the European public assessment report (EPAR) for Cuprior.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cuprior.
English: The difference between Cuprior and the reference medicine is that Cuprior contains another form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator.
Maltese: Id-differenza bejn Cuprior u l-mediċina ta' referenza hija li Cuprior fih forma oħra ta' trientina (trientina tetrakloridrata) u ma jeħtieġx li jinħażen fi friġġ.
English: Why is Cuprior approved?
Maltese: Għaliex ġie approvat Cuprior?
English: The active substance in Cuprior, trientine, is a chelating agent.
Maltese: Is-sustanza attiva f'Cuprior, it-trientina, hija aġent ta' kelazzjoni.
English: This means that it is similar to a ‘reference medicine' (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine.
Maltese: Dan ifisser li huwa simili għal ‘mediċina ta' referenza' (f'dan il-każ kapsuli Trientine Dihydrochloride ta' 300 mg) li wkoll fiha ittrientina.
English: The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson's disease.
Maltese: Is-CHMP innota li t-trientina ilha tintuża għal aktar minn 30 sena biex tikkura pazjenti bil-marda ta' Wilson.
English: Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Cuprior huwa mediċina ibrida, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk talmediċina ta' referenza.
English: Cuprior is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Maltese: Cuprior huwa mediċina użata biex tikkura pazjenti ta' 5 snin jew iżjed li għandhom il-marda ta' Wilson, kundizzjoni ġenetika fejn ir-ram assorbit mill-ikel jakkumula fil-ġisem, b'mod partikolari fil-fwied u filmoħħ, u tiġi kkawżata ħsara.
English: How has Cuprior been studied?
Maltese: Kif ġie studjat Cuprior?
English: The tablets are taken in 2 to 4 divided doses.
Maltese: Il-pilloli jittieħdu fi 2 sa 4 dożi maqsuma.
English: Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body.
Maltese: Għalkemm Cuprior jirrilaxxa aktar trientina fil-ġisem mill-mediċina ta' referenza, din iddifferenza tista' tiġi indirizzata mit-tnaqqis fid-doża, li fi kwalunkwe każ tiġi aġġustata skont ir-rispons tal-pazjent u l-livelli ta' ram fil-ġisem.
English: Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition.
Maltese: Cuprior jintuża f'pazjenti li ma jistgħux jieħdu D-penicillamine, mediċina oħra għal din il-kundizzjoni.
English: Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine.
Maltese: Ir-riżultati wrew li Cuprior jipproduċi livelli għola tassustanza attiva fid-demm mill-mediċina ta' referenza.
English: What are the benefits and risks of Cuprior?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Cuprior?
English: Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Maltese: Cuprior jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn speċjalista b'esperjenza filġestjoni tal-marda ta' Wilson.
English: The company also carried out a study to compare the levels of trientine in the blood after having taken Cuprior with those for the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studju biex tqabbel il-livelli ta' trientina fid-demm wara li jkun ittieħed Cuprior ma' dawk għall-mediċina ta' referenza.
English: The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine.
Maltese: Il-kumpanija pprovdiet data mil-letteratura ppubblikata, li turi li t-trientina żżid b'mod sinifikanti leliminazzjoni tar-ram fl-awrina.
English: What measures are being taken to ensure the safe and effective use of Cuprior?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Cuprior?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Cuprior huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The Marketing Authorisation Holder (MAH) shall agree the details of a controlled distribution system for the 20 ml vial of Revatio 0.8 mg/ml solution for injection with the National Competent Authorities and must implement such programme nationally to ensure that prior to prescribing all health care professionals who intend to prescribe and/or dispense Revatio 0.8 mg/ml solution for injection are provided the following: - Information for Healthcare professionals - Copy of the Summary of Product Characteristics (SPC) - Data Capture Form (DCF) designed to facilitate reporting of events of hypotension and associated problems
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ser jaqbel dwar id-dettalji ta' sistema ta' distribuzzjoni kontrollata għall-kunjett ta' 20 ml ta' Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni ma' l-Awtoritajiet Nazzjonali Kompetenti, u għandu jimplimenta dan il-programm nazzjonali sabiex jassigura li qabel ma jinkiteb mit-tobba, dawn il-professjonisti ta-saħħa li qed jaħsbu biex jiktbu jew jgħatu Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni, huma pprovduti b'dawn is-segwenti:
English: The Marketing Authorisation Holder shall agree the information for healthcare professionals, and the healthcare professionals to be targeted, with the national competent authority of each Member State prior to the launch of the 20 ml vial of Revatio 0.8 mg/ml solution for injection in that country.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq ser jaqbel dwar l-Informazzjoni għallProfessjonisti tas-Saħħa, u il-professjonisti tas-saħħa li ser jkunu infurmati, ma' l-awtorità nazzjonali kompetenti ta' kull Stat Membru kollha qabel it-tnedija tal-kunjett ta' 20 ml ta' Revatio 0.8 mg/ml soluzzjoni għall-injezzjoni f'dak il-pajjiż.
English: - Information on the switch from the 50 ml vial to the 20 ml vial for Revatio 0.8 mg/ml solution
Maltese: - Informazzjoni dwar il-Programm ta' Monitoraġġ ta' Farmakoviġilanza relatat mar-riskju potenzjali ta' pressjoni baxxa klinikament relevanti, u problemi relatati magħha, li ser jkun mniedi bl-użu tad-DCF - Informazzjoni dwar il-bidla mill-kunjett ta' 50 ml għal-kunjett ta' 20 ml ta' soluzzjoni ta' Revatio 0.8 mg/ml
English: The Information for Healthcare professionals should contain the following key elements: - Information about the Pharmacovigilance Monitoring Programme regarding the potential risk of clinically relevant hypotension and related problems to be put into place with the use of the DCF.
Maltese: - Informazzjoni għall-Professjonisti tas-saħħa - Kopja tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC) - Il-Formula tal-ġbir tad-dejta (DCF) iddisinjata sabiex tiffaċilita' r-rappurtar ta' episodji ta' pressjoni baxxa tad-demm u problemi assoċċjati magħha
English: Adopted at the 12-15 March 2019 PRAC
Maltese: Adottati fil-PRAC ta' bejn it-12-15 ta' Marzu 2019
English: Nivolumab - Hypoparathyroidism (EPITT no 19310)
Maltese: Nivolumab - Ipoparatirojdiżmu (EPITT nru 19310)
English: Other immune-related adverse reactions: […] Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported post-marketing (see section 4.8).
Maltese: […] Ġew irrappurtati każijiet ta' sindrome ta' VogtKoyanagi-Harada u ta' ipoparatirojdiżmu wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: Preclinical safety data
Maltese: Ipoparatirojdiżmuh
English: • Decreased function of the parathyroid gland
Maltese: • Tnaqqis fil-funzjoni tal-glandola tal-paratirojde
English: Hypoparathyroidismh
Maltese: .8. Effetti mhux mixtieqa
English: Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.
Maltese: Studji epidemjoloġiċi fuq l-iżvilupp newrali fi tfal esposti għal paracetamol fl-utru juru riżultati inkonklużivi.
English: Paracetamol - Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus (EPITT no 17796)
Maltese: Paracetamol - Użu ta' paracetamol fit-tqala u l-iżvilupp newrali tal-wild u effetti fuq l-apparat uroġenitali (EPITT nru
English: Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
Maltese: Studji konvenzjonali li jużaw l-istandards aċċettati attwalment għall-evalwazzjoni tal-effett tossiku fuq is-sistema riproduttiva u l-iżvilupp mhumiex disponibbli.
English: If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Maltese: Jekk ikun meħtieġ klinikament, paracetamol jista' jintuża waqt it-tqala madankollu dan għandu jintuża fl-aktar doża baxxa effettiva għall-iqsar żmien possibbli u bl-iktar frekwenza baxxa possibbli.
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Maltese: Problemi bil-glandoli tiegħek li jipproduċu ormoni (li jinkludu l-glandola pitwitarja, il-glandoli tattirojde, il-paratirojde u l-glandola adrenali) li jistgħu jaffettwaw kif jaħdmu dawn il-glandoli.
English: Frequency: Not known for nivolumab monotherapy / nivolumab in combination with ipilimumab [Table key: h Post-marketing event (also see section 4.4)]
Maltese: h Avveniment ta' wara t-tqegħid fis-suq (ara wkoll sezzjoni 4.4)] Fuljett ta' Tagħrif
English: It contains the active substance tasonermin.
Maltese: Fih is-sustanza attiva tasonermin.
English: The marketing authorisation was renewed on 13 April 2004 and on 13 April 2009.
Maltese: Lawtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit-13 ta' April 2004 u t-13 ta' April 2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) BEROMUN EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) BEROMUN Sommarju tal-EPAR għall-pubbliku
English: The active substance in Beromun, tasonermin, is a copy of the human protein tumour necrosis factor alfa-1a (TNFα).
Maltese: Is-sustanza attiva f'Beromun, tasonermin, hija kopja tal-proteina umana magħrufa bħala l-fattur tannekrożi tat-tumur alfa-1a (TNFα).
English: Melphalan is given during the same operation over 60 minutes, beginning 30 minutes after the start of the Beromun perfusion, when the temperature should be increased to 39 to 40°C.
Maltese: Melphalan jingħata waqt listess operazzjoni fuq perjodu ta' 60 minuta, li jibdew 30 minuta wara il-bidu tal-perfużjoni ta' Beromun meta t-temperatura għandha tiżdied għal bejn 39 u 40°C.
English: Beromun is then injected into the perfusion solution at a dose of 3 mg for an arm and 4 mg for a leg, given over 90 minutes.
Maltese: Beromun imbagħad jiġi injettat fis-soluzzjoni tal-perfużjoni b'doża ta' 3 mg għal driegħ u 4 mg għal riġel, fuq perjodu ta' 90 minuta.
English: Other side effects seen very commonly (in more than 1 patient in 10) are infection, cardiac arrhythmia (unstable heartbeat), nausea (feeling sick), vomiting, liver damage, fatigue (tiredness), chills, pain in the limb, nerve injury, skin reactions, oedema (swelling) and wound infection.
Maltese: Effetti sekondarji oħra komuni ħafna (li dehru f'iktar minn pazjent wieħed minn kull 10) huma infezzjonijiet, aritmija kardijaka (taħbit instabbli tal-qalb), nawżea (dardir), rimettar, ħsara fil-fwied, għeja, tkexkix ta' bard, uġigħ fid-driegħ jew fir-riġel, leżjonijiet fin-nervituri, reazzjonijiet fil-ġilda, edema (nefħa) u infezzjoni f'feriti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Beromun to Boehringer Ingelheim International GmbH on 13 April 1999.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Beromun lil Boehringer Ingelheim International GmbH fit-13 ta' April 1999.
English: Why has Beromun been approved?
Maltese: Għaliex ġie approvat Beromun?
English: Sixty-two of the patients also received interferon-gamma (another anticancer medicine).
Maltese: Tnejn u sittin mill-pazjenti ngħataw ukoll interferongamma (mediċina oħra ta' kontra l-kankru).
English: The active substance in Beromun, tasonermin, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA), which makes them able to produce TNFα.
Maltese: Is-sustanza attiva f'Beromun, tasonermin, tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanati tad-DNA': jiġi magħmul minn batterji li jkunu diġà rċevew ġene (DNA).
English: The independent reviewers agreed that 62% of the patients receiving Beromun and melphalan (90 out of 145) had a better outcome than predicted, since their limb was saved without surgery to remove the tumour or their tumour was removed without causing significant loss of function.
Maltese: Dawn l-esperti indipendenti qablu li 62% tal-pazjent li kienu qed jingħataw Beromun u melphalan (90 minn 145) kellhom riżultati aħjar milli kien imbassar, billi r-riġel jew id-driegħ tagħhom ġie salvat mingħajr intervent kirurġiku għat-tneħħija tat-tumur jew billi t-tumur tneħħa mingħajr telf sinifikanti fil-funzjoni.
English: For a more complete list of the side effects reported with Beromun, see the Package Leaflet.
Maltese: Għal lista iktar kompleta tal-effetti sekondarji rrappurtati ma' Beromun, ara l-Fuljett ta' Tagħrif.
English: What is Beromun?
Maltese: X'inhu Beromun?
English: The replacement TNFα acts in same way as the naturally produced protein.
Maltese: It-TNFα tar-rimpjazzament jaħdem bl-istess mod bħallproteina prodotta b'mod naturali.
English: The blood circulation in the limb is then replaced by the ‘perfusion' of a special liquid and the limb is warmed to a temperature of between 38 and 39°C.
Maltese: Iċ-ċirkulazzjoni fir-riġel jew fid-driegħ tiġi rimpjazzata minn ‘perfużjoni' ta' likwidu speċjali u r-riġel jew driegħ jissaħħan għal temperatura ta' bejn 38 u 39°C.
English: What is the risk associated with Beromun?
Maltese: Għal xiex jintuża Beromun?
English: It must not be used in patients with significant cardiovascular (heart and blood vessel) disease, severe lung disease, a recent or active stomach ulcer, severe ascites (fluid accumulation in the abdomen), blood disorders, kidney or liver disease, or hypercalcaemia (high blood calcium levels), or in women who are pregnant or breast-feeding.
Maltese: Lanqas ma għandu jintuża minn pazjenti b'mard kardjovaskulari sinifikanti (tal-qalb u tal-vini u l-arterji), mard tal-pulmuni gravi, ulċera tal-istonku attiva jew reċenti, axxite (akkumulu gravi ta' fluwidu fl-addomi), problemi fid-demm, mard tal-kliewi jew tal-fwied, jew iperkalċemija (livelli għoljin tal-kalċju fid-demm), jew f'nisa tqal jew li jkunu qed ireddgħu.
English: Beromun has been studied in four main studies involving a total of 188 patients, in which it was given in combination with melphalan.
Maltese: Beromun ġie studjat f'erba' studji ewlenin li fihom b'kollox ħadu sehem 188 pazjent, li fihom Beromun ingħata flimkien ma' melphalan.
English: Beromun is used in patients with soft tissue sarcoma (a type of cancer) of the limb (arm or leg), together with melphalan (an anticancer medicine), using a technique called ‘isolated limb perfusion' (ILP): both medicines are injected into the limb while the blood circulation in the limb is kept isolated (cut off) from the rest of the body.
Maltese: Beromun jintuża f'pazjenti b'sarkoma (tip ta' kanċer) fit-tessut artab fir-riġel jew fid-driegħ, flimkien ma' melphalan (mediċina ta' kontra l-kankru), bl-użu ta' teknika magħrufa bħala ‘perfużjoni iżolata fid-driegħ jew fir-riġel' (ILP): iż-żewġ mediċini jiġu injettati fid-driegħ jew fir-riġel waqt li ċċirkulazzjoni tad-demm tinżamm iżolata (maqtugħa) mill-bqija tal-ġisem.
English: A review of the studies by three independent experts found that only 145 of these patients were candidates for amputation or surgical removal of the tumour that would have resulted in significant loss of function (disability).
Maltese: Meta dawn l-istudji ġew riveduti minn tliet esperti indipendenti ħareġ li 145 biss minn dawn il-pazjenti kienu kandidati għal amputazzjoni jew għattneħħija kirurġika tat-tumur li tirriżulta f'telf sinjifikanti fil-funzjoni (diżabilità).
English: How does Beromun work?
Maltese: Kif jintuża Beromun?
English: Other information about Beromun:
Maltese: Tagħrif ieħor dwar Beromun:
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Beromun's benefits are greater than its risks as an adjunct to surgery for subsequent removal of the tumour so as to prevent or delay amputation, or in the palliative situation, for irresectable soft tissue sarcoma of the limbs, used in combination with melphalan via mild hyperthermic ILP.
Maltese: Iċ-ċentri jrid ikollhom ukoll taqsimiet tal-kura intensiva lesti u faċilitajiet biex issir sorveljanza kontinwa għall-ħruġ ta' mediċini għall-bqija talġisem bl-użu ta' tracers radjuattivi.
English: Some side effects of Beromun are serious and could require a patient to spend time in an intensive care unit after treatment.
Maltese: Xi effetti sekondarji ta' Beromun huma serji u jistgħu jwasslu biex pazjent iqatta' xi ħin f'taqsima tal-kura intensiva wara t-trattament.
English: Beromun treatment should only be carried out in special centres by surgical teams who have experience in the treatment of this type of cancer and ILP.
Maltese: It-trattament b'Beromun għandu jsir f'ċentri speċjali minn timijiet tal-kirurġija li jkollhom esperjenza fit-trattament ta' dan it-tip ta' kankru u tal-ILP.
English: See the Summary of Product Characteristics (also part of the EPAR) for the full list of restrictions.
Maltese: Ara s-Sommarju tal-Karatteristiċi tal-Prodott (ukoll parti mill-EPAR) għal-lista sħiħa ta' restrizzjonijiet.
English: 2 vials + 2 syringes
Maltese: 2 kunjetti + 2 siringi
English: 1 vial + 1 syringe
Maltese: 1 kunjett + 1 siringa
English: Packaging Content (concentration)
Maltese: Mnejn jingħata Il-pakkett Kontenut (konċentrazzjo ni)
English: The full EPAR for Besponsa 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: The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle.
Maltese: 1, 8 u 15 ta
English: Besponsa contains the active substance inotuzumab ozogamicin.
Maltese: Besponsa fih is-sustanza attiva inotuzumab ozogamicin.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Besponsa jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information aboutBesponsa
Maltese: Informazzjoni oħra dwar Besponsa
English: What are the risks associated with Besponsa?
Maltese: -riskji asso ċjati ma' Besponsa?
English: Why is Besponsa approved?
Maltese: Għaliex ġie approvat Besponsa?
English: The most serious side effects are infection, febrile neutropenia, haemorrhage, abdominal pain, fever, tiredness and veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS, a serious liver disease).
Maltese: ' ostruzzjoni sinusojdali occlusive liver disease/SOS, sinusoidal obstruction syndrome, marda serja tal-fwied).
English: Besponsa inotuzumab ozogamicin
Maltese: -kan ċer li tissejjaħ in
English: The monoclonal antibody has been designed to recognise and attach to CD22 on the cancerous B cells.
Maltese: -ċelluli B pożittiva għas-CD22'.
English: An analysis of the first 218 patients treated showed that after at least 2 cycles of treatment, 81% (88 out of 109) of patients receiving Besponsa responded to treatment compared with 29% (32 out of 109) of patients receiving other chemotherapy.
Maltese: Analiżi tal-ewwel 218-il pazjent ikkurati wriet li wara tal-inqas 2 ċikli ta' kura, 81 % (88 minn 109) tal-pazjenti li rċevew Besponsa rrispondew għall-kura meta mqabbel ma ' 29
English: This is a summary of the European public assessment report (EPAR) for Besponsa.
Maltese: ' valutazzjoni (EPAR)
English: The most common side effects with Besponsa (which may affect more than 1 in 5 people) are thrombocytopenia (low blood platelet counts), neutropenia and leucopenia (low white blood cell counts), infection, anaemia (low red blood cell counts), tiredness, haemorrhage (bleeding), fever, nausea (feeling sick), headache, febrile neutropenia (low white cell count with fever), abdominal pain (stomach ache), increased levels of liver enzymes called transaminases and gammaglutamyltransferase, and hyperbilirubinaemia (high blood levels of bilirubin, a breakdown product of red blood cells).
Maltese: Besponsa huwa mediċina tal-kan ċer li tintuża biex tikkura tip ta' kanċer ċelluli B (tip ta ' ċe lluli bojod tad-demm) li jissejjaħ lewkimja limfoblastika akuta (ALL, acute lymphoblastic leukaemia) prekursura taċ-ċelluli B. Besponsa jintuża waħdu fl-adulti li l-kanċer tagħhom ikun re ġa
English: The active substance in Besponsa, inotuzumab ozogamicin, is a monoclonal antibody (a type of protein) that has been linked to a small molecule, N-acetyl-gamma-calicheamicin dimethylhydrazide.
Maltese: -acetyl-gamma-calicheamicin dimethylhydrazide.
English: Because the number of patients with B-cell precursor ALL is low, the disease is considered ‘rare', and Besponsa was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 June 2013.
Maltese: -ċelluli B huwa baxx, il-marda hija kkunsidrata ‘rari', u Besponsa ġie kklassifikat b fis-7 ta ' Ġunju 2013.
English: How does Besponsa work?
Maltese: -istudji?
English: Besponsa is a cancer medicine used to treat a type of blood cancer which affects B cells (a type of white blood cells) called B-cell precursor acute lymphoblastic leukaemia (ALL).
Maltese: -ċelluli B pożittiva għas-CD22 li reġgħet tfaċċat jew li ma rrispondietx għal kura preċedenti, intwera li Besponsa huwa aktar effettiv minn kimoterapija oħra (mediċini li jikkuraw il-kanċer).
English: The CHMP considered that although there have been recent advances in the treatment of B-cell precursor ALL, treatment options for patients remain limited.
Maltese: -ċelluli B, l ħażliet ta -pazjenti għadhom limitati.
English: 3 bottles
Maltese: 3 Fliexken
English: Invented name Strength Pharmaceutical form Route of administration Packaging
Maltese: Kontenut (konċentrazzjoni) Daqs tal-pakkett
English: Content
Maltese: Isem inventat
English: EU Number
Maltese: Numru tal-proċedura ta' lEMEA
English: Name
Maltese: Numru ta'l-EU Isem