FrancophonIA/ELRC3.0 huggingface dataset:
English: Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Maltese: Deterjorament talkliewi, progressjoni għal insuffiċjenza tal-kliewi u dijalisi ġew irrappurtati f'pazjenti wara d-doża inizjali jew doża waħda ta' 4 mg zoledronic acid.
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Maltese: Prodotti mediċinali oħrajn li fihom zoledronic acid bħala sustanzi attivi huma disponibbli għal indikazzjonijiet ta' osteoporożi u l-kura tal-marda tal-Paget tal-għadam.
English: Package leaflet: Information for the user Zoledronic acid medac 4 mg/100 ml solution for infusion Zoledronic acid
Maltese: Informazzjoni għall-utent Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni
English: The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with zoledronic acid 4 mg every 3-4 weeks in oncology patients.
Maltese: L-iżbilanċ osservat f'din il-prova ma ġiex osservat fi provi oħrajn b'zoledronic acid, li jinkludu dawk b'zoledronic acid 4 mg kull 3-4 ġimgħat f'pazjenti tal-onkoloġija.
English: Spezialpräparate mbH
Maltese: medac GmbH
English: • Keep Zoledronic acid medac out of the sight and reach of children.
Maltese: • Żomm Zoledronic acid medac fejn ma jidhirx u ma jintlaħaqx mit-tfal.
English: The dose must be given as a single intravenous infusion over no less than 15 minutes.
Maltese: Id-doża għandha tingħata bħala infużjoni waħda ġol-vini f'mhux inqas minn 15-il minuta.
English: Zoledronic acid recommended dose*
Maltese: Zoledronic acid
English: To prepare reduced doses for patients with baseline CLcr ≤ 60 ml/min, refer to Table 1 below.
Maltese: Biex tipprepara dożi mnaqqsa għal pazjenti b'CLcr ≤ 60 ml/min fil-linja bażi, irreferi għal Tabella 1 hawn taħt.
English: CARTON FOR 4 VIALS
Maltese: KARTUNA GĦAL 4
English: Zoledronic acid 4 mg reduced the risk of SREs by 41% in a multiple event analysis (risk ratio=0.59, p=0.019) compared with placebo.
Maltese: Iż-żmien medjan għall-bidu tal-ewwel SRE ma ntlaħaqx fil-parti tal-istudju fejn il-parteċipanti ġew ikkurati b'zoledronic acid fit-tmiem tal-istudju, u kien imtawwal b'mod sinifikanti meta mqabbel mal-plaċebo (p=0.007). Zoledronic acid 4 mg naqqas ir-riskju ta' SREs b'41 % f'analiżi ta' każijiet multipli (proporzjon tar-riskju=0.59, p=0.019) meta mqabbel mal-plaċebo.
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Maltese: Biex jiġu evalwati l-effetti ta' 4 mg zoledronic acid kontra pamidronate 90 mg, ir-riżultati ta' żewġ studji multiċentriċi importanti ħafna f'pazjenti b'TIH, ġew ikkombinati f'analiżi ppjanata minn qabel.
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Maltese: Zoledronic acid mhuwiex irrakkomandat għall-pazjenti li jkollhom indeboliment sever tal-kliewi qabel tinbeda t-terapija, li għal din il-popolazzjoni hi definita bħala CLcr < 30 ml/min.
English: The occurrence of osteonecrosis is multifactorial and is associated with various risk factors.
Maltese: L-okkorrenza ta' osteonekrożi hija multifattorjali u hija assoċjata ma' diversi fatturi ta' riskju.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion
Maltese: Zoledronic acid medac 4 mg/5 ml sterili konċentrat
English: The type of adverse reactions observed in this population were similar to those previously seen in adults with advanced malignancies involving the bone (see section 4.8).
Maltese: It-tip ta' reazzjonijiet avversi osservati f'din il-popolazzjoni kienu simili għal dawk li dehru qabel f'adulti b'tumuri malinni avvanzati li jinvolvu l-għadam (ara sezzjoni 4.8).
English: How to prepare and administer Zoledronic acid medac
Maltese: Kemm ta' spiss jingħata Zoledronic acid medac
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the postmarketing setting in patients receiving zoledronic acid.
Maltese: Osteonekrosi tax-xedaq (ONJ) ġiet irrappurtata b'mod mhux komuni fil-provi kliniċi u f'ambitu ta' wara t-tqegħid fis-suq f'pazjenti,li jkunu qed jirċievu zoledronic acid.
English: Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid 4 mg and other bisphosphonates as well as use of other nephrotoxic medicinal products.
Maltese: Fatturi li jistgħu jżidu l-potenzjal għal deterjorament fil-funzjoni tal-kliewi jinkludu deidratazzjoni, indeboliment tal-kliewi li kien jeżisti minn qabel, ċikli multipli ta' zoledronic acid medac u bisfosfonati oħrajn, kif ukoll l-użu ta' prodotti mediċinali nefrotossiċi oħrajn.
English: - Conjunctivitis.
Maltese: − Konġuntivite.
English: Median time to SRE (days)
Maltese: Medjan ta' żmien għal SRE (jiem)
English: A subset had recurrence of symptoms when rechallenged with zoledronic acid or another bisphosphonate.
Maltese: Sottosett kellu rikorrenza tas-sintomi meta kien iċċalinġjat mill-ġdid zoledronic acid jew bi bisfosfonat ieħor.
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2 - 2.5 mg.
Maltese: Fi studji ta' Fazi I dwar is-sejbien tad-doża f'pazjenti b'iperkalċemija minn ħafifa sa moderata kkaġunata minn tumur (TIH), id-dożi effettivi li ġew ittestjati kienu fil-medda ta' madwar 1.2-2.5 mg.
English: • Do not use Zoledronic acid medac after the expiry date stated on the vial and carton after EXP.
Maltese: • Tużax Zoledronic acid medac wara d-data ta' skadenza li tidher fuq il-flixkun u l-kartuna wara
English: Zoledronic acid medac is supplied as unit packs containing 1 vial or 4 vials and as multipacks of 4 or 10 cartons each containing 1 vial.
Maltese: Zoledronic acid medac hu fornut bħala pakketti li jkun fihom 1 flixkun jew bħala pakketti multipli li jkun fihom 4 jew 10 kaxxi tal-kartun, li kull waħda jkun fiha flixkun 1.
English: Prior to administration, 5 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (sodium chloride 9 mg/ml (0.9%) solution or 5% w/v glucose solution).
Maltese: Qabel l-għoti, 5 ml ta' konċentrat minn kunjett wieħed, jew il-volum tal-konċentrat miġbud kif meħtieġ, irid jiġi dilwit b'mod addizzjonali b'100 ml ta' soluzzjoni għall-infużjoni bla calcium (sodium chloride 9 mg/ml (0.9%) soluzzjoni jew 5 % w/v soluzzjoni ta' glucose).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for zoledronic acid (indicated for cancer and fractures), the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal zoledronic acid (indikat għall-kanċer u ksur), il-konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/779/004
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/779/004
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Maltese: Fl-istudji kliniċi, il-kura b'zoledronic acid tkompliet biss meta l-livell ta' kreatinina rritorna għal livell ta' 10 % tal-valur fil-linja bażi (ara sezzjoni 4.4).
English: Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare.
Maltese: Għalhekk, l-informazzjoni tal-prodott għandha tiġi aġġornata biex tirrifletti fis-sezzjonijiet 4.4 u 4.8 tal-SmPC twissija dwar osteonekrożi ta' siti anatomiċi oħra u żżid din ir-reazzjoni avversa bi frekwenza ta' rari ħafna.
English: Package leaflet: Information for the user Zoledronic acid medac 4 mg/5 ml concentrate for solution for infusion Zoledronic acid
Maltese: Informazzjoni għall-utent Zoledronic acid medac 4 mg/5 ml konċentrat għal soluzzjoni għall-infużjoni
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Maltese: Analiżi ta' każijiet multipli wriet tnaqqis ta' 36% fir-riskju li wieħed jiżviluppa
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid medac.
Maltese: Il-pazjenti kollha għandhom jiġu inkoraġġiti biex iżommu iġjene orali tajba, imorru għal check-ups dentali ta' rutina, u jirrappurtaw immedjatament kwalunkwe sintomi orali bħal mobilità dentali, uġigħ jew nefħa, jew jekk il-feriti fil-ħalq ma jfiqux jew jekk ikun hemm xi tnixxija matul il-kura b'Zoledronic acid medac.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodiumfree'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In the zoledronic acid-treated group, statistically significant improvement in pain scores (using the Brief Pain Inventory, BPI) was seen at 4 weeks and at every subsequent time point during the study, when compared to placebo (Figure 1).
Maltese: Fil-grupp ikkurat b'zoledronic acid, ġie osservat titjib statistikament sinifikanti fil-punteġġi tal-uġigħ (bl-użu tal-Brief Pain Inventory, BPI) wara 4 ġimgħat u f'kull punt sussegwenti taż-żmien waqt l-istudju, meta mqabbel mal-plaċebo (Figura 1).
English: LABEL ON MULTIPACKS WITH 10 VIALS WRAPPED IN TRANSPARENT FOIL (INCLUDING BLUE BOX)
Maltese: F'FOJL TRASPARENTI (LI TINKLUDI L-KAXXA BLU) TIKKETTA FUQ IL-PAKKETTI MULTIPLI
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Maltese: • Biex tipprepara soluzzjoni għall-infużjoni li jkun fiha 4 mg ta' zoledronic acid, iddilwi b'mod addizzjonali l-konċentrat (5.0 ml) b'100 ml ta' soluzzjoni għall-infużjoni bla calcium jew soluzzjoni oħra għall-infużjoni divalenti li jkun fiha l-cations.
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
Maltese: Zoledronic acid għandu jitkompla biss meta l-kreatinina fis-serum terġa' lura għal livell ta' 10% fil-linja bażi (ara sezzjoni 4.2).
English: Zoledronic acid medac 4 mg/100 ml solution for infusion should be given as a single intravenous infusion in no less than 15 minutes.
Maltese: Zoledronic acid medac 4 mg/100 ml soluzzjoni għall-infużjoni għandu jingħata bħala infużjoni waħda ġol-vini f'mhux inqas minn 15-il minuta.
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when zoledronic acid is used in combination with thalidomide.
Maltese: F'pazjenti b'maeloma multipla, ir-riskju ta' disfunzjoni tal-kliewi jista' jiżdied meta zoledronic acid jintuża flimkien ma' thalidomide.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Maltese: − Reazzjonijiet minħabba sensittività eċċessiva.
English: Remove the following amount of Zoledronic acid medac solution for infusion (ml)
Maltese: Neħħi il-ammont li ġej ta' Zoledronic acid medac soluzzjoni għallinfużjoni (ml)
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Maltese: Meta tkun ser tibda l-kura b'zoledronic acid f'pazjenti b'majeloma multipla jew leżjonijiet ta' metastasi fl-għadam minn tumuri solidi, il-kreatinina fis-serum u t-tneħħija tal-kreatinina (CLcr) għandhom jiġu ddeterminati.
English: Vomiting, nausea Abdominal pain
Maltese: Reazzjoni ta' sensittività eċċessiva Edema anġjonewrotika
English: In patients who show evidence of renal deterioration during treatment, zoledronic acid should be withheld.
Maltese: F'pazjenti li juru evidenza ta' deterjorament tal-kliewi waqt il-kura, zoledronic acid għandu jitwaqqaf.
English: Increasing the infusion time from 5 to 15 minutes caused a 30 % decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Maltese: Iż-żieda fil-ħin tal-infużjoni minn 5 għal 15-il minuta, ikkawżat tnaqqis ta' 30 % fil-konċentrazzjoni ta' zoledronic acid fit-tmiem tal-infużjoni, iżda ma kellha l-ebda effett fuq l-erja taħt il-kurva tal-konċentrazzjoni fil-plażma kontra l-ħin.
English: Pregnancy
Maltese: Osteonekrożi
English: The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors.
Maltese: Irrapporti ta' osteonekrożi f'siti oħra b'zoledronic acid jissuġġerixxu xebh fil-frekwenza ta' rappurtar (wirk>irkoppa>omeru) meta mqabbel ma' siti ta' osteonekrożi affettwati b'mod komuni abbażi ta' fatturi anatomiċi.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Maltese: Hu rakkomandat li pazjenti b'indeboliment ħafif sa moderat tal-kliewi jingħataw dożi mnaqqsa ta' zoledronic acid (ara sezzjoni “Pożoloġija” hawn fuq u sezzjoni 4.4).
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: It is available as chewable tablets (2.5 mg/20 mg, 5 mg/40 mg and 10 mg/80 mg).
Maltese: Jiġ bħala pilloli tal-magħad (2.5 mg/20 mg, 5 mg/40 mg u 10 mg/80 mg).
English: Benazepril hydrochloride / spironolactone
Maltese: Benazepril idroklorur / spironolattone
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Maltese: Benazeprilat huwa ‘inibitur tal-enzima li tikkonverti l-anġjotensina (ACE)'.
English: The tablets are given to the dog once a day with food at a dose of 0.25 mg benazepril hydrochloride and 2 mg spironolactone per kilogram bodyweight.
Maltese: Il-pilloli jingħataw lill-kelb darba kuljum mal-ikel f'doża ta' 0.25 mg benazepril idroklorur u 2 mg spironolattone għal kull kilogramma tal-piż tal-ġisem.
English: Cardalis is a veterinary medicine that contains two active substances, benazepril hydrochloride and spironolactone.
Maltese: Cardalis huwa mediċina veterinarja li fiha żewġ sustanzi attivi, benazepril idroklorur / spironolattone.
English: The main measure of effectiveness was good treatment compliance, which was defined as dogs consuming at least 90% of their tablets.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-konformità ma' kura tajba, li ġiet definita peress li l-klieb kienu qed jikkunsmaw mill-inqas 90 % tal-pilloli li kienu qed jieħdu.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Maltese: Benazepril huwa prodroga, sustanza kkonvertita f'benazeprilat fil-ġisem.
English: Why has Cardalis been approved?
Maltese: Għaliex ġie approvat Cardalis?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Cardalis on 23 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Cardalis fit-23 ta' Lulju 2012.
English: Non-castrated male dogs treated with spironolactone may show atrophy (wasting) of the prostrate (a gland of the male reproductive system) that is reversible.
Maltese: Il-klieb irġiel mhux imsewwija kkurati bi spironolattone jista' jkollhom atrofija (tnewwin) tal-prostata (glandola tas-sistema riproduttiva tal-irġiel) li hija riversibbli.
English: What is Cardalis?
Maltese: X'inhu Cardalis?
English: Cardalis must not be used in dogs with Addison's disease or hypoadrenocorticism (a condition where the adrenal gland does not produce sufficient amounts of hormones), hyperkalaemia (increased blood potassium levels) or hyponatraemia (reduced blood sodium levels).
Maltese: Cardalis m'għandux jintuża fi klieb bil-marda ta' Addison jew li jbatu minn iperadrenokortiċiżmu (kundizzjoni fejn il-glandola adrenali ma tipproduċix ammonti suffiċjenti ta' ormoni), iperkalemija (żieda fil-livelli tal-potassju fid-demm) jew iponatremija (livelli mnaqqsa ta' sodju fid-demm).
English: The company presented a laboratory study in Beagle dogs comparing treatment with spironolactone and benazepril as single active substances (in the products Prilactone and Fortekor which are already authorised in the EU) to treatment with Cardalis.
Maltese: Il-kumpanija ppreżentat studju fil-laboratorju fil-klieb tar-razza Beagle li qabbel il-kura bi spironolattone u benazepril bħala sustanzi attivi waħedhom (fil-prodotti Prilactone u Fortekor li huma diġà awtorizzati fl-UE) mal-kura b'Cardalis.
English: In the laboratory study, Cardalis was shown to be bioequivalent to combined treatment with products containing the single active substances (medicines are bioequivalent when they produce the same levels of active substance in the body).
Maltese: Fl-istudju fil-laboratorju, Cardalis intwera li huwa bijoekwivalenti għall-kura kkombinata bi prodotti li fihom is-sustanzi attivi waħedhom (il-mediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli ta' sustanza attiva fil-ġisem).
English: What is the risk associated with Cardalis?
Maltese: X'inhu r-riskju assoċjat ma' Cardalis?
English: How has Cardalis been studied?
Maltese: Kif ġie studjat Cardalis?
English: Spironolactone blocks the actions of aldosterone, a hormone that causes the kidneys to retain salt and water within the body with harmful effects on the cardiovascular system.
Maltese: Spironolattone jimblokka l-azzjonijiet ta' aldosterone, ormon li jġiegħel lill-kliewi jżommu l-melħ u lilma fil-ġisem li jħallu effetti ħżiena wkoll fuq is-sistema kardjovaskulari.
English: Regular monitoring should continue in dogs with reduced kidney function as they may have an increased risk of hyperkalaemia (raised potassium levels in the blood) during treatment.
Maltese: Il-monitoraġġ regolari għandu jkompli fil-klieb b'funzjoni mnaqqsa tal-kliewi minħabba li dawn jista' jkollhom riskju akbar ta' iperkalemija (livelli għoljin ta' potassju fid-demm) waqt il-kura.
English: The field study showed Cardalis to be voluntarily and fully consumed 92% of the time when offered with or without food and around 86% of dogs showed good compliance with treatment.
Maltese: L-istudju fuq il-post wera li Cardalis huwa kkunsmat b'mod volontarju u għal kollox 92% tal-ħin meta jingħata mal-ikel jew fuq stonku vojt u madwar 86 % tal-klieb ikkonformaw sew mal-kura.
English: Cardalis must not be used in cases of aortic or pulmonary stenosis (narrowing of the aorta or pulmonary blood vessels) affecting the heart's blood output.
Maltese: Cardalis m'għandux jintuża f'każi ta' stenożi aortika jew pulmonari (tidjiq tal-aorta jew tal-arterji tad-demm tal-pulmun) li taffettwa l-produzzjoni ta' demm mill-qalb.
English: The benefit/risk balance can be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ bejn ilbenefiċċju u r-riskju jinsab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: People with known hypersensitivity (allergy) to spironolactone or benazepril should avoid contact with Cardalis.
Maltese: Cardalis jintuża biex jikkura klieb li jbatu minn insuffiċjenza konġestiva tal-qalb.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II, vażokostrittur qawwi (sustanza li ddejjaq l-arterji tad-demm).
English: Further information on Lemtrada can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lemtrada
Maltese: Aktar informazzjoni dwar Lemtrada tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/lemtrada
English: Other information about Lemtrada
Maltese: Informazzjoni oħra dwar Lemtrada
English: Lemtrada received a marketing authorisation valid throughout the EU on 12 September 2013.
Maltese: Lemtrada ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-12 ta' Settembru 2013.
English: Lemtrada has been studied in two main studies involving 1,421 patients with relapsing-remitting multiple sclerosis.
Maltese: Lemtrada ġie studjat f'żewġ studji ewlenin li involvew 1,421 pazjent bi sklerożi multipla rikadutaremittenti.
English: In the second study, the average number of relapses per year in patients given Lemtrada was half the number in patients given interferon beta-1a (0.26 versus 0.52), and around 13% of patients given Lemtrada had a sustained progression of disability compared with around 21% of patients given interferon beta-1a.
Maltese: Fit-tieni studju, l-għadd medju ta' rikaduti fis-sena f'pazjenti mogħtija Lemtrada kien nofs in-numru ta' pazjenti mogħtija interferon beta1a (0.26 meta mqabbel ma' 0.52), u madwar 13 % tal-pazjenti mogħtija Lemtrada esperjenzaw progressjoni sostnuta tad-diżabilità meta mqabbla ma' madwar 21 % tal-pazjenti li ngħataw interferon beta-1a.
English: In both studies, Lemtrada was compared with another medicine for multiple sclerosis, interferon beta-1a.
Maltese: Fiż-żewġ studji, Lemtrada tqabbel ma' mediċina oħra għall-isklerożi multipla, interferon beta-1a.
English: What are the risks associated with Lemtrada?
Maltese: X'inhuma r-riskji assoċjati ma' Lemtrada?
English: It is initially given in two courses of treatment: a first course of 12 mg daily for 5 days, followed 12 months later by a second course of 12 mg daily for 3 days.
Maltese: Inizjalment dan jingħata f'żewġ korsijiet ta' kura: l-ewwel kors ta' 12 mg kuljum għal 5 ijiem, segwit bit-tieni kors ta' 12 mg kuljum għal 3 ijiem wara 12-il xahar.
English: Lemtrada contains the active substance alemtuzumab.
Maltese: Lemtrada fih is-sustanza attiva alemtużumab.
English: In the first study, the average number of relapses per year in patients given Lemtrada was less than half the number in patients given interferon beta-1a (0.18 versus 0.39), but there was no meaningful effect in terms of progression of disability.
Maltese: Fl-ewwel studju, l-għadd medju ta' rikaduti fis-sena f'pazjenti li ngħataw Lemtrada kien inqas minn nofs in-numru f'pazjenti li ngħataw interferon beta-1a (0.18 meta mqabbel ma' 0.39), iżda ma kien hemm l-ebda effett sinifikanti f'termini ta' progressjoni tad-diżabilità.
English: The most important side effects with Lemtrada are autoimmune conditions (where the body's defence system attacks normal tissue), including thyroid gland disorders, immune thrombocytopenic purpura (a bleeding disorder caused by low blood platelet counts) and kidney damage, as well as low blood cell counts, reactions to the infusion and infections.
Maltese: L-effetti sekondarji l-aktar importanti b'Lemtrada huma kundizzjonijiet awtoimmuni (fejn is-sistema difensiva tal-ġisem stess tattakka t-tessut normali), inklużi disturbi fil-glandola tat-tirojde, purpura tromboċitopenika immuni (disturb ta' fsada kkawżat minn għadd baxx ta' pjastrini tad-demm) u ħsara fil-kliewi, kif ukoll għadd baxx taċ-ċelloli tad-demm, reazzjonijiet għall-infużjoni u infezzjonijiet.
English: The active substance in Lemtrada, alemtuzumab, is a type of protein called a monoclonal antibody that has been designed to attach to another protein called CD52.
Maltese: Issustanza attiva f'Lemtrada, l-alemtużumab, hija tip ta' proteina msejħa antikorp monoklonali li ġiet imfassla biex teħel ma' proteina oħra msejħa CD52. CD52 tinstab fil-limfoċiti, ċelloli bojod tad-demm li jagħmlu parti mis-sistema immunitarja.