FrancophonIA/ELRC3.0 huggingface dataset:
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some older people with no symptoms of dementia.
Maltese: Plakek β-amilojde huma depożiti xi drabi preżenti fil-moħħ ta' nies bi problemi tal-memorja kkawżati minn dimenzja (bħal marda ta' Alzheimer, dimenzja korpi-Lewy u dimenzja tal-marda ta' Parkinson) u wkoll fil-moħħ ta' xi nies anzjani b'ebda sintomu ta' dimenzja.
English: How is Vizamyl used?
Maltese: Kif jaħdem Vizamyl?
English: A later re-analysis looked again at data from the original 68 patients together with results from others who had died after the end of the original study, making a total of 106 patients.
Maltese: Analiżi mill-ġdid li saret wara reġgħet ħarset lejn id-dejta mit-68 pazjenti oriġinali flimkien ma' riżultati minn oħrajn li kienu mietu wara t-tmiem tal-istudju oriġinali, li jagħmlu total ta' 106 pazjenti.
English: At the end of the study, 68 had autopsies carried out on them to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Maltese: Fl-aħħar tal-istudju, 68 sarulhom awtopsji biex tingħata prova b'mod konklussiv jekk kellhomx ammonti sinifikanti ta' plakek β-amilojde f'moħħhom.
English: Vizamyl was investigated in one main study in 176 patients nearing the end of their lives who had consented to autopsies when they died, in order to prove conclusively whether or not they had significant amounts of β-amyloid plaques in their brains.
Maltese: Vizamyl ġie investigat fi studju wieħed ewlieni f'176 pazjenti li kienu waslu fit-tmiem ta' ħajjithom li taw il-kunsens tagħhom biex isiru awtopsji fuqhom meta jmutu, sabiex tingħata prova b'mod konklussiv jekk kellhomx ammonti sinifikanti ta' plakek β-amilojde f'moħħhom.
English: The CHMP did however note that, due to the limited effects of currently available treatments for Alzheimer's disease, there is no strong evidence of an immediate improvement in the management of patients or in patient outcomes following PET scans with Vizamyl.
Maltese: Madankollu, is-CHMP innota li, minħabba l-effetti limitati tal-kuri disponibbli bħalissa għall-marda ta' Alzheimer, m'hemmx evidenza b'saħħita ta' titjib immedjat fil-ġestjoni ta' pazjenti jew fir-riżultati talpazjenti wara skans PET b'Vizamyl.
English: A risk management plan has been developed to ensure that Vizamyl is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vizamyl jintuża bl-aktar mod sigur possibbli.
English: This is considered a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Maltese: Dan huwa kkunsidrat titjib sinifikanti fid-dijanjożi ta' pazjenti bi problemi tal-memorja li qegħdin jiġu evalwati għall-marda ta' Alzheimer u tipi oħra ta' dimenzja.
English: There is, however, a risk of false positive results (when patients without plaques are rated as positive), therefore Vizamyl scans should not be used on their own to diagnose dementia, but together with a clinical evaluation of the patient.
Maltese: Hemm, madankollu, riskju ta' riżultati pożittivi foloz (meta l-pazjenti mingħajr plakek jiġu kklassifikati bħala pożittivi), għalhekk skans ta' Vizamyl m'għandhomx jintużaw waħidhom biex tiġi dijanjostikata dimenzja, iżda flimkien ma' evalwazzjoni klinika tal-pazjent.
English: After the image is obtained, it is read by nuclear medicine physicians specifically trained in interpreting PET scans with Vizamyl.
Maltese: Vizamyl huwa disponibbli bħala soluzzjoni li tingħata b'injezzjoni fil-vina, madwar 90 minuta qabel tinkiseb immaġini minn skan PET. Wara li tinkiseb l-immaġini, din tinqara minn tabib tal-mediċina nukleari mħarreġ speċifikament fl-interpretazzjoni ta' skans PET b'Vizamyl.
English: If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Maltese: Jekk fl-iskan PET jidhru ftit jew ebda plakek β-amilojde (skan negattiv), il-pazjent x'aktarx m'għandux il-marda tal-Alzheimer.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vizamyl'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' Vizamyl huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The Committee noted that PET scans with Vizamyl have a high sensitivity and specificity for detecting a significant amount of beta-amyloid plaques in the brain, and that scans closely reflect what was seen at autopsy.
Maltese: Il-Kumitat innota li l-iskans PET b' Vizamyl għandhom sensittività u speċifiċità għoljin għall-identifikar ta' ammonti sinifikanti ta' plakek beta-amilojde fil-moħħ, u li l-iskans jirreflettu mill-qrib dak li deher mill-awtopsji.
English: This means that the PET scans correctly identified as positive between 81-93% of the patients who had significant amounts of plaques in their brain.
Maltese: Dan ifisser li l-iskans PET identifikaw b'mod korrett bħala pożittivi bejn 81-93% tal-pazjenti li kellhom ammonti sinifikanti ta' plakek f'moħħhom.
English: In terms of safety, Vizamyl involves exposure of the patient to small amounts of radiation, which is in the range of other approved radiopharmaceuticals, and the safety profile is therefore acceptable.
Maltese: F'termini ta' sikurezza, Vizamyl jinvolvi espożizzjoni tal-pazjent għal ammonti żgħar ta' radjazzjoni, li hija fil-firxa ta' radjofarmaċewtiċi oħrajn approvati, u l-profil ta' sigurtà għalhekk huwa aċċettabbli.
English: Vizamyl can only be obtained with a prescription, and PET scans with Vizamyl should only be requested by doctors experienced in the clinical management of patients with diseases such as Alzheimer's disease and other dementias.
Maltese: Vizamyl jista' jinkiseb biss b'riċetta ta' tabib, u skans PET b'Vizamyl għandhom jintalbu biss minn tobba esperjenzati fil-ġestjoni klinika ta' pazjenti b'mard bħall-marda ta' Alzheimer u dimenzji oħrajn.
English: Ref. EMEA/611497/2008
Maltese: EMEA/611497/2008
English: International non-proprietary name (INN): ciclosporin
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): ċiklosporina
English: What is Vekacia?
Maltese: X'inhu Vekacia?
English: Vekacia was designated as an orphan medicinal product on 6 April 2006.
Maltese: Vekacia ġie kklassifikat bħala prodott mediċinali orfni fis-6 ta' April 2006.
English: The patients were treated with Vekacia at a concentration of 0.05% (0.5 mg ciclosporin per millilitre) or of 0.1% (1 mg/ml), or with placebo (dummy eye drops).
Maltese: Il-pazjenti kienu kkurati b'Vekacia b'konċentrazzjoni ta' 0.05% (0.5 mg ta' ċiklosporina għal kull millimentru jew b'0.1% (1 mg/ml), jew bi plaċebo (qtar tal-għajnejn finta).
English: The active substance in Vekacia, ciclosporin, is an immunosuppressant.
Maltese: Is-sustanza attiva f'Vecacia, ċiklosporina, hija mediċina immunosoppressiva.
English: On 14 November 2008, Novagali Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vekacia, for the treatment of vernal keratoconjunctivitis.
Maltese: Fl-14 ta' Novembru 2008, Novagali Pharma S.A. uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Vekacia, għat-trattament tal-keratokonġuntivite tar-rebbiegħa (vernal keratoconjunctivitis).
English: This is inflammation of the conjunctiva (the membrane that lines the eyelid) and the cornea (the transparent layer in front of the pupil), which is caused by allergy.
Maltese: Din hija infjammazzjoni tal-konġuntiva (il-membrana li tirrita l-kappell tal-għajn) u l-kornea (is-saff trasparenti quddiem il-ħabba), li tiġi kkawżata mill-allerġija.
English: In patients with vernal keratoconjunctivitis, ciclosporin given as eye drops was expected to suppress the local immune reactions that trigger inflammation in the conjunctiva and cornea.
Maltese: Fil-pazjenti li jbatu mill-keratokonġuntivite tar-rebbiegħa, iċ-ċiklosporina li kienet tingħata bħala qtar tal-għajnejn kien mistennija li trażżan r-reazzjonijiet immunitarji lokali li jikkawżaw l-infjammazzjoni fil-konġuntiva u l-kornea.
English: The application was at day 175 when the company withdrew.
Maltese: L-applikazzjoni kienet waslet f'jum 175 meta l-kumpanija rtiratha.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Abbażi tar-reviżjoni taddokumentazzjoni inizjali, is-CHMP iħejji lista ta' mistoqsijiet fil-120 jum, li mbagħad tintbagħat lill kumpanija.
English: Vekacia was expected to be used to treat vernal keratoconjunctivitis.
Maltese: Vekacia kien mistenni li jintuża għat-trattament tal-keratokonġuntivite tar-rebbiegħa.
English: Because ciclosporin has been used for many years, the applicant presented data on experimental models from the scientific literature.
Maltese: Minħabba li ċ-ċiklosporina ilha tintuża għal ħafna snin, l-applikant ippreżenta d-dejta fuq mudelli sperimentali mid-dokumentazzjoni xjentifika.
English: To support the use of Vekacia in vernal keratoconjunctivitis, the company presented the results of one study in 118 children (over the age of four years) and adolescents.
Maltese: Sabiex issostni l-użu ta' Vakacia fil-keratokonġuntivite tar-rebbiegħa, il-kumpanija ppreżentat irriżultati ta' studju f'118-il tifel u tifla (minn erba' snin 'il fuq) u adoloxxenti.
English: What were the main concerns of the CHMP?
Maltese: Għal xiex kien mistenni li jintuża Vekacia?
English: The CHMP had concerns that the effectiveness of Vekacia had not been shown when compared to the vehicle.
Maltese: Is-CHMP kien imħasseb li l-effikaċja ta' Vekacia ma ntweritx meta tqabblet mal-veikolu.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vekacia could not have been approved for the treatment of vernal keratoconjunctivitis.
Maltese: Skont l-analiżi tad-dejta u t-tweġiba tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fi żmien lirtirar, is-CHMP kellu xi tħassib u kellu opinjoni proviżorja li Vekacia ma setax jiġi approvat għattrattament tal-keratokonġuntivite tar-rebbiegħa.
English: It was to be available as eye drops.
Maltese: Din kellha tkun disponibbli bħala qtar tal-għajnejn.
English: Ciclosporin has been used since the mid1980s to help prevent rejection in transplant patients (when the immune system attacks the transplanted organ).
Maltese: Iċ-ċiklosporina ilha tintuża sa min-nofs it-tmeninijiet sabiex tgħin fil-prevenzjoni tar-rifjut f'pazjenti li jkunu rċivew trapjant (meta s-sistema immunitarja tattakka l-organu trapjantat).
English: Questions and answers on the withdrawal of the marketing application for Vekacia
Maltese: Mistoqsija u Tweġiba dwar l-irtirar tal-applikazzjoni għat-tqegħid fis-suq għal Vekacia
English: What was the recommendation of the CHMP at that time?
Maltese: Kif kien mistenni li jaħdem Vekacia?
English: Symptoms that were looked at included: burning, itching, pain, sticky eyelids, the sensation of a foreign body in the eyes or photophobia (oversensitivity of the eyes to light).
Maltese: Fost is-sintomi li ġew ssemmew kien hemm: ħruq, ħakk, uġigħ, twaħħil fil-kappel tal-għajnejn, is-sensazzjoni ta' xi ħaġa barranija fl-għajn jew fotofobija (sensittività żejda tal-għajnejn għad-dawl).
English: Further information on Econor can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/Econor.
Maltese: ema.europa.eu/medicines/veterinary/EPARs/Econor.
English: Econor is an antibiotic.
Maltese: Econor huwa antibijotiku.
English: The active substance of Econor is valnemulin, an antibiotic of the pleuromutilin group.
Maltese: Is-sustanza attiva f'Econor hija l-valnemulin, antibijotiku tal-grupp tal-plewromutilini.
English: This overview was last updated in September 2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'Settembru 2018.
English: Econor received a marketing authorisation valid throughout the European Union on 12 March 1999.
Maltese: Econor irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha fit12 ta' Marzu 1999.
English: In a study involving 1,152 weaned rabbits, after an outbreak of ERE, treatment with Econor for 21 days reduced mortality during a 4 week period from 23% in untreated rabbits to 11% in those given 20 mg valnemulin per kg of feed, and about 8% in those given 35 mg valnemulin per kg feed.
Maltese: Fi studju li involva 1,152 fenek miftum, wara tifqigħa ta' ERE, il-kura b'Econor għal 21 jum naqqset ilmortalità matul perjodu ta' erba' ġimgħat minn 23 % fi fniek mhux ikkurati għal 11 % f'dawk li ngħataw 20 mg valnemulin għal kull kg ta' għalf, u għal madwar 8 % f'dawk li ngħataw 35 mg valnemulin għal kull kg ta' għalf.
English: Other information about Econor
Maltese: Informazzjoni oħra dwar Econor
English: Econor contains the active substance valnemulin.
Maltese: Econor fih is-sustanza attiva valnemulin.
English: However, infection with Mycoplasma hyopneumoniae was not eliminated.
Maltese: Madankollu, infezzjoni b'Mycoplasma hyopneumoniae ma ġietx eliminata.
English: Extreme care should, therefore, be taken when using Econor in pigs of Scandinavian origin.
Maltese: Għaldaqstant, jenħtieġ li tingħata attenzjoni estrema meta Econor jintuża fi ħnieżer ta' oriġini Skandinava.
English: In prevention of porcine colonic spirochaetosis (colitis), Econor in feed at a dose of 1 to 1.5 mg valnemulin per kg bodyweight daily (i.e. 25 mg per kg feed) was effective in controlling the clinical signs and prevented weight loss caused by the disease in untreated pigs.
Maltese: Fil-prevenzjoni tal-ispiroketożi konolika tal-ħnieżer (kolite), Econor fl-għalf b'doza ta' 1 sa 1.5 mg valnemulin għal kull kg ta' piż tal-ġisem kuljum (jiġifieri 25 mg għal kull kg ta' għalf) kien effettiv filkontroll tas-sinjali kliniċi u pprevjena telf fil-piż ikkawżat mill-marda fi ħnieżer mhux ikkurati.
English: What are the risks associated with Econor?
Maltese: X'inhuma r-riskji assoċjati ma' Econor?
English: The most common side effects in pigs are pyrexia (high temperature) and a lack of appetite; in severe cases, they might become uncoordinated and remain lying down.
Maltese: L-effetti sekondarji l-aktar komuni fil-ħnieżer huma l-piressija (temperatura għolja) u nuqqas ta' aptit; f'każijiet severi, jistgħu jitilfu l-koordinazzjoni u jibqgħu f'pożizzjoni mimduda.
English: Econor is available as a premix for medicated feeding stuff for pigs (10% and 50%) and rabbits (10%), and as an oral powder for pigs (10%).
Maltese: Econor jiġi bħala taħlita lesta minn qabel għal għalf medikat għall-ħnieżer (10 % u 50 %) u l-fniek (10 %), u bħala trab orali għal ħnieżer (10 %).
English: It works by blocking the production of proteins inside the bacteria and thereby stopping their growth.
Maltese: Din taħdem billi timblokka l-produzzjoni tal-proteini ġewwa l-batterji u għaldaqstant twaqqaf it-tkabbir tagħhom.
English: Rabbits must not be given overdoses of Econor as this may disturb gastrointestinal flora (gut bacteria) leading to the development of enterotoxaemia (infection of the gut).
Maltese: Il-fniek ma għandhomx jingħataw dożi eċċessivi ta' Econor peress li dan jista' jfixkel il-flora gastrointestinali (batterji tal-imsaren) u jwassal għall-iżvilupp ta' enterotossemja (infezzjoni talimsaren).
English: In rabbits, Econor is used to reduce mortality during an outbreak of epizootic rabbit enteropathy (ERE).
Maltese: Fil-fniek, Econor jintuża biex inaqqas il-mortalità matul tifqigħa ta' enteropatija epiżootika tal-fniek (ERE).
English: For treatment of porcine proliferative enteropathy (ileitis), Econor in feed at a dose of 3 to 4 mg valnemulin per kg bodyweight daily (i.e. 75 mg per kg feed) for 10 days improved the clinical condition of the pigs, reduced diarrhoea and reduced weight loss.
Maltese: Għall-kura tal-enteropatija proliferattiva tal-ħnieżer (ileite), Econor fl-għalf b'doża ta' 3 sa 4 mg valnemulin għal kull kg tal-piż tal-ġisem kuljum (jiġifieri 75 mg għal kull kg ta' għalf) għal 10 ijiem tejjeb il-kundizzjoni klinika tal-ħnieżer, naqqas id-dijarea u naqqas it-telf fil-piż.
English: In studies in the treatment and prevention of swine enzootic pneumonia, Econor in feed at a dose of 10 to 12 mg valnemulin per kg bodyweight daily (i.e. 200 mg per kg feed) for up to 4 weeks reduced lung lesions, improved clinical signs and pig growth rates compared to untreated pigs.
Maltese: Fi studji dwar il-kura u l-prevenzjoni ta' pulmonite enżootika tal-ħnieżer, Econor fl-għalf b'doża ta' 10 sa 12 mg valnemulin għal kull kg tal-piż tal-ġisem kuljum (jiġifieri 200 mg għal kull kg ta' għalf) sa mhux aktar minn erba' ġimgħat naqqas il-leżjonijiet fil-pulmun, tejjeb is-sinjali kliniċi u r-rati tattkabbir tal-ħnieżer meta mqabbla ma' ħnieżer mhux ikkurati.
English: It is used in pigs to treat or prevent a number of infectious diseases that are caused by bacteria and affect the lungs (i.e. swine enzootic pneumonia) or the gut (i.e. swine dysentery, porcine proliferative enteropathy or porcine colonic spirochaetosis).
Maltese: Jintuża fil-ħnieżer biex jikkura jew jipprevjeni numru ta' mard infettiv li huwa kkawżat minn batterji u jaffettwa l-pulmun (jiġifieri pulmonite enżootika tal-ħnieżer) jew l-imsaren (jiġifieri diżenterija talħnieżer, enteropatija proliferattiva tal-ħnieżer jew spiroketożi konolika tal-ħnieżer).
English: This is a disease associated with changes in the normal balance of bacteria in the gut which allow growth of clostridia, bacteria that produce a toxin which paralyses the intestine.
Maltese: Din hi marda assoċjata mal-bidliet fil-bilanċ normali tal-batterji fl-imsaren li jippermettu ttkabbir tal-klostridja, batterji li jipproduċu tossina li tipparalizza l-musrana.
English: Further information on Torisel 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: It is given as an infusion lasting 30 to 60 minutes.
Maltese: Jingħata bħala infużjoni li ddum bejn 30 sa 60 minuta.
English: Further information on the orphan designations can be found on the European Medicines Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (renal cell carcinoma: 6 April 2006, expired November 2017; mantle cell lymphoma: 6 November 2006).
Maltese: Aktar informazzjoni dwar id-denominazzjonijiet orfni tista' tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (karċinoma taċ-ċellola renali: 6 ta' April 2006, skada f'Novembru 2017; linfoma taċ-ċellola mantellari.: 6 ta' Novembru 2006).
English: Torisel received a marketing authorisation valid throughout the EU on 19 November 2007.
Maltese: Torisel irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-19 ta' Novembru 2007.
English: The active substance in Torisel, temsirolimus blocks a protein called ‘mammalian target of rapamycin' (mTOR).
Maltese: Is-sustanza attiva f'Torisel, it-temsirolimus, timblokka proteina msejħa ‘mammalian target of rapamycin' (mTOR - mira tar-rapamiċina fil-mammiferi).
English: Other information about Torisel
Maltese: Aktar informazzjoni dwar Torisel
English: Patients were treated with 25 mg Torisel, with interferon alfa or with 15 mg Torisel in combination with interferon alfa.
Maltese: Il-pazjenti kienu kkurati b'25 mg Torisel, b'interferon alfa jew b'15 mg Torisel flimkien ma' interferon alfa.
English: The most common side effects with Torisel (which may affect more than 1 in 5 patients) include infections, pneumonia (infection of the lungs), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), decreased appetite, hyperglycaemia (high blood sugar levels), hypercholesterolaemia (high blood cholesterol levels), dysgeusia (taste disturbances), difficulty breathing, nose bleeds, cough, vomiting, stomatitis (inflammation of the lining of the mouth), diarrhoea, nausea (feeling sick), rash, pruritus (itching), oedema (swelling), tiredness, weakness, fever and mucosal inflammation (inflammation of moist body surfaces).
Maltese: L-effetti sekondarji l-aktar komuni b'Torisel (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 5) jinkludu infezzjonijiet, pulmonite (infezzjoni fil-pulmun), tromboċitopenija (għadd baxx ta' pjastrini fiddemm), anemija (għadd baxx ta' ċelloli ħomor fid-demm), nuqqas fl-aptit, ipergliċemija (livelli għoljin ta' glukożju fid-demm), iperkolesterolemija (livelli għoljin ta' kolesterol fid-demm), disgweżja (disturbi fit-togħma), diffikultà fit-teħid tan-nifs, tnixxija ta' demm mill-imnieħer, sogħla, remettar, stomatite, (infjammazzjoni tal-kisi tal-ħalq), dijarea, nawżja (tħossok ma tiflaħx), raxx, prurite (ħakk), edema (nefħa), għeja, dgħufija, deni u infjammazzjoni mukożali (infjammazzjoni tal-uċuħ niedja tal-ġisem).
English: Mantle cell lymphoma
Maltese: Linfoma taċ-ċellola mantellari
English: Patients are given an antihistamine injection to prevent an allergic reaction around 30 minutes before each dose of Torisel.
Maltese: Il-pazjenti għandhom jingħataw injezzjoni antistamina sabiex tiġi evitata reazzjoni allerġika madwar 30 minuta qabel kull doża ta' Torisel.
English: The most serious side effects of Torisel are allergic (hypersensitivity) reactions, serious reactions that occur during the infusion or soon afterwards, infections, lung disorders including pneumonitis (inflammation of the lungs) and pulmonary embolism (blood clot in the lung), bleeding in the brain, kidney failure, tearing (perforation) of the intestine, complications affecting the healing of wounds, hyperglycaemia (high blood sugar), thrombocytopenia (low levels of platelets), neutropenia (low levels of neutrophils, a type of white blood cell that fights infection) and hyperlipaemia (high blood levels of a type of fat).
Maltese: L-effetti sekondarji l-aktar serji b'Torisel huma reazzjonijiet allerġiċi (ipersensittività), reazzjonijiet serji li jseħħu waqt l-infużjoni jew immedjatament wara, infezzjonijiet, disturbi fil-pulmun inkluż pnewmonite (infjammazzjoni fil-pulmun) u emboliżmu pulmonari (koagulazzjoni fil-pulmun), emorraġija fil-moħħ, insuffiċjenza tal-kliewi, tiċrit (perforazzjoni) tal-intestini, komplikazzjonijiet li jaffettwaw il-ġrieħi li jkunu qed jitfejqu, ipergliċemija (livelli għoljin ta' glukożju fid-demm), tromboċitopenija (livelli baxxi ta' pjastrini fid-demm), newtropenija (livelli baxxi ta' newtrofili, tip ta'
English: Patients receiving Torisel lived for 4.8 months on average without their disease getting worse compared with 1.9 months in those receiving the alternative treatment.
Maltese: Il-pazjenti li ngħataw Torisel għexu medja ta' 4.8 xhur mingħajr ma lmarda tagħhom aggravat meta mqabbla ma' 1.9 xhur f'dawk li ngħataw il-kura alternattiva.
English: Patients receiving Torisel alone survived 10.9 months on average compared with 7.3 months in those receiving interferon alfa alone.
Maltese: 9 xhur meta mqabbla ma' 7.3 xhur f'dawk li ngħataw interferon alfa waħdu.
English: As for all medicines, data on the use of Torisel are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Torisel hija ssorveljata kontinwament.
English: These diseases are rare, and Torisel was designated an ‘orphan medicine' (a medicine used in rare diseases) on various dates.
Maltese: Dan il-mard huwa rari, u Torisel ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) f'diversi dati.
English: Torisel is available as a concentrate and solvent that are made up into a solution for infusion (drip) into a vein.
Maltese: Torisel jiġi bħala konċentrat u solvent li jitħalltu biex isiru soluzzjoni għal infużjoni (dripp) fil-vina.