FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies reSURFACE 1 and reSURFACE 2 assessed the changes from baseline at Week 12 in the two coprimary endpoints: 1) PASI 75 and 2) PGA of “0” (cleared) or “1” (minimal), with at least a 2-point improvement from baseline.
Maltese: 1) PASI 75 u 2) PGA ta' “0” (tneħħiet) or “1” (minimali), b'tal-inqas titjib ta' 2 punti mil-linja bażi.
English: Wait for 30 minutes (if stored in the refrigerator)
Maltese: Stenna għal 30 minuta (jekk maħżun fi friġġ)
English: In these studies, patients were randomised to either placebo or tildrakizumab (including 200 mg and 100 mg at 0, 4 and every twelve weeks thereafter [Q12W]), up to 52 or 64 weeks.
Maltese: F'dawn l-istudji, il-pazjenti ġew randomizzati għal jew plaċebo jew tildrakizumab (inkluż 200 mg u 100 mg f'0, 4 u kull 12-il ġimgħa wara dan [Q12W]), sa 52 jew 64 ġimgħa.
English: p-values calculated using the Cochran-Mantel-Haenszel (CMH) test stratified by body weight (≤90 kg, >90 kg) and prior exposure to biologic therapy for psoriasis (yes/no).
Maltese: n = numru ta' pazjenti fis-sett ta' analiżi sħiħ li għalih hemm dejta disponibbli, wara l-imputazzjoni meta tkun applikabbli. valuri-p ikkalkulati permezz tat-test Cochran-Mantel-Haenszel (CMH) stratifikat mill-piż tal-ġisem (≤90 kg, >90 kg) u esponiment preċedenti għal terapija bijoloġika għall-psorjasi (iva/le).
English: Small-molecule metabolic pathways (e.g., CYP450 enzymes, glucuronosyltransferases) do not contribute to its clearance.
Maltese: Passaġġi metaboliċi ta' molekuli żgħar (eż., enzimi CYP450,
English: Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly.
Maltese: Ilumetri m'għandux jiġi injettat f'partijiet fejn il-ġilda tkun affettwata mill-psorjasi bil-qoxra jew li tkun sensittiva, imbenġla, ħamra, iebsa, ħoxna jew bil-qoxra.
English: Steady-state is achieved by 16 weeks with the clinical regimen of 0, 4, and every 12 weeks thereafter, with 1.1-fold accumulation in exposure between week-1 and week-12 independent of dose.
Maltese: L-istat fiss inkiseb sa 16-il ġimgħa bir-reġimen kliniku ta' 0, 4, u 12-il ġimgħa wara dan, b'akkumulazzjoni ta' 1.1 darbi fl-esponiment bejn ġimgħa-1 u ġimgħa-12 indipendenti mid-doża.
English: The most common adverse reactions are upper respiratory tract infections, headache, gastroenteritis, nausea, diarrhoea, injection site pain and back pain.
Maltese: Ir-reazzjonijiet avversi l-aktar komuni huma infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju, uġigħ ta' ras, gastoenterite, nawsja, dijarea, uġigħ fis-sit tal-injezzjoni u uġigħ fid-dahar.
English: c No imputation for missing data.
Maltese: b Imputazzjoni ta' min ma rrispondiex għal dejta nieqsa.
English: Summary of Response Rates in Studies reSURFACE 1 and reSURFACE 2
Maltese: Sommarju tar-Rati tar-Rispons fl-Istudji reSURFACE 1 u reSURFACE 2
English: At week 12 and across studies, tildrakizumab was associated with statistically significant improvement in Health-related Quality of Life as assessed by the DLQI (Table 2).
Maltese: F'ġimgħa 12 u fl-istudji, tildrakizumab ġie assoċjat ma' titjib statistikament sinifikanti fil-Kwalità talĦajja relatata mas-saħħa kif ivvalutata mid-DLQI (Tabella 2).
English: Studies in mouse tumor models showed that selective inhibition of IL-23p19 does not increase carcinogenic risk.
Maltese: Studji f'mudelli tat-tumur tal-ġurdien urew li inibizzjoni selettiva ta' IL-23p19 ma żżidx ir-riskju karċinoġeniku.
English: Anti-TB therapy should be considered prior to initiating Ilumetri in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Maltese: Għandha tiġi kkunsidrata terapija kontra t-TB qabel il-bidu ta' Ilumetri f'pazjenti bi storja fil-passat ta' TB latenti jew attiva li fihom ma jistax jiġi kkonfermat kors ta' kura adegwat.
English: Population pharmacokinetic analysis indicated that age did not have a clinically significant influence on the clearance of tildrakizumab in adult subjects with plaque psoriasis.
Maltese: L-analiżi tal-farmakokinetika tal-popoplazzjoni indikat li l-età ma kellhiex influwenza klinikament sinifikanti fuq it-tneħħija ta' tildrakizumab f'individwi adulti bi psorjasi bil-qoxra.
English: No effects on fertility parameters such as reproductive organs, menstrual cycle length, and/or hormones were observed in male and female cynomolgus monkeys that were administered tildrakizumab at doses resulting in >100 times the human exposure at the recommended clinical dose based on AUC.
Maltese: Ma ġie osservat l-ebda effett fuq il-parametri tal-ferilità bħal organi riproduttivi, tul taċ-ċiklu talmenstruwazzjoni, u/jew ormoni f'xadini cynomolgus irġiel u nisa li ngħataw tildrakizumab f'dożi li jirriżultaw f'>100 darba l-esponiment fil-bniedem bid-doża klinika rrakkomandata bbażata fuq AUC.
English: Sucrose
Maltese: Gastroenterite
English: 90-degree angle.
Maltese: 28 ġimgħa.
English: grade improvement from Baseline (%) PASI 90 (%)
Maltese: PGA ta' “tneħħiet” jew “minimali” b'titjib ta' grad ≥2 mil-Linja bażi (%) PASI 90 (%)
English: Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways.
Maltese: Mediċini konkomitanti li jaffettwaw il-farmkokinetika ta' Ilumetri mhumiex mistennija peress li dan jitneħħa mill-ġisem permezz ta' proċessi ta' kataboliżmu tal-proteini ġenerali bl-ebda kontribuzzjoni ta' enzimi taċ-ċitokromu P450 (CYP450), u dan ma jiġix eliminat minn passaġġi fil-kliewi jew fil-fwied.
English: You may see 1 or 2 drops of liquid and that is okay.
Maltese: Tista' tara qatra 1 jew 2 qatriet ta' likwidu u dan normali.
English: Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo.
Maltese: Ġew integrati tliet studji kkontrollati bil-plaċebo (Fażi 2b u tnejn ta' Fażi 3) biex jevalwaw is-sigurtà ta' Ilumetri meta mqabbel mal-plaċebo.
English: Tildrakizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 50 mg to 400 mg following subcutaneous administration, with clearance being independent of dose.
Maltese: Tildrakizumab wera farmakokinetika proporzjonali għad-doża f'individwi bi psorjasi bil-qoxra fuq medda tad-doża minn 50 mg sa 400 mg wara għoti taħt il-ġilda, bi tneħħija indipendenti mid-doża.
English: Water for injections
Maltese: Infezzjonijiet u infestazzjonijiet
English: Tildrakizumab is catabolized into component amino acids by general protein degradation processes.
Maltese: Tildrakizumab jiġi kkatabolizzat f'komponenti ta' ammino-aċidi permezz ta' proċessi ta' degradatazzjoni tal-proteini ġenerali.
English: • On a clean, well-lit work surface, place the: - alcohol wipes - cotton ball or gauze pad
Maltese: • Fuq wiċċ li se tuża nadif u mdawwal tajjeb, poġġi: - wipes tal-alkoħol - tajjara jew garża
English: The pre-filled syringe must not be shaken.
Maltese: Is-sintomi tiegħek jistgħu jerġgħu jidhru wara t-twaqqif.
English: Pre-treatment evaluation for tuberculosis
Maltese: TAL-PRODOTT MEDIĊINALI
English: You must look out for signs of these conditions while you are taking Ilumetri.
Maltese: Għandek toqgħod attent għal sinjali ta' dawn il-kondizzjonijiet waqt li tkun qed tieħu Ilumetri.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1
English: Inspect the medicine
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Inject
Maltese: INJEZZJONI
English: How to store Ilumetri
Maltese: Jekk tieqaf tuża Ilumetri
English: Infections and infestations Upper respiratory tract infectionsa Very common Nervous system disorders Headache
Maltese: Disturbi fis-sistema nervuża
English: The maintenance of response in studies reSURFACE1 and reSURFACE2 are presented in Table 3.
Maltese: Iż-żamma tar-rispons fl-istudji reSURFACE1 u reSURFACE2 hija ppreżentata fit-Tabella 3.
English: Diarrhoea
Maltese: MEDIĊINALI
English: Common aIncluding nasopharyngitis.
Maltese: Ilma għall-injezzjonijiet
English: The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ilumetri fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
Maltese: Barra minn hekk, Ilumetri m'għandux impatt fuq il-farmakokinetika ta' mediċini konkomitanti li jiġu mmetabolizzati minn enzimi ta' CYP450 jew permezz ta' mekkaniżmi diretti jew indiretti (ara sezzjoni 5.2).
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Maltese: Tużax din il-mediċina wara d-data meta tiskadi li tidher fuq il-kartuna u t-tikketta tas-siringa mimlija għallest wara EXP.
English: • Inspect Ilumetri visually for particulate matter and discoloration prior to administration.
Maltese: • Spezzjona Ilumetri viżwalment għal materja partikolata u skulurament qabel l-għoti.
English: Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
Maltese: Fil-provi kliniċi ngħataw b'mod sigur dożi sa 10 mg/kg ġol-vini.
English: Common side effects (may affect up to 1 in 10 people): - Gastroenteritis - Nausea - Diarrhoea - Injection site pain - Back pain - Headache
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn persuna 1 minn kull 10):
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi attiva/i
English: **These patients were switched to placebo at week 28.
Maltese: **Dawn il-pazjenti nqelbu għal plaċebo f'ġimgħa 28.
English: Clean injection site
Maltese: Aħsel idejk
English: - The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80,
Maltese: - Is-sustanzi mhux attivi l-oħra huma L-histidine, L-histidine hydrochloride monohydrate,
English: Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara 5.3). Bћala prekawzjoni hu preferribli li ma jintużax Ilumetri waqt it-tqala.
English: The geometric mean exposure (AUC0-τ at steady state) in adult patients weighing >90 kg following a 100 mg or 200 mg SC dose was predicted to be about 30% lower than in an adult patient weighing ≤90 kg (see section 4.2).
Maltese: L-esponiment medju ġeometriku (AUC0-τ fi stat fiss) f'pazjenti adulti li jiżnu >90 kg wara doża taħt il-ġilda ta' 100 mg jew 200 mg kien previst li jkun madwar 30% iktar baxx milli f'pazjent adult li jiżen
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Ilumetri in one or more subsets of the paediatric population in the treatment of plaque psoriasis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddiferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b' Ilumetri f'wieħed jew iktar kategoriji tal-popolazzjoni pedjatrika fil-kura ta' psorjasi bil-qoxra (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur.
Maltese: Il-pazjenti għandhom jingħataw istruzzjonijiet biex ifittxu parir mediku jekk iseħħu sinjali jew sintomi li jissuġġerixxu li seħħet infezzjoni kronika jew akuta klinikament relevanti.
English: Do not shake or freeze the pre-filled syringe.
Maltese: Neħħi s-siringa użata
English: Baseline PGA score was marked or severe in 33.4% of patients.
Maltese: Il-punteġġ PGA fil-linja bażi kien immarkat jew sever fi 33.4 % tal-pazjenti.
English: Ilumetri is available in unit packs containing 1 pre-filled syringe and packs comprising 2 pre-filled syringes.
Maltese: Ilumetri huwa disponibbli f'pakketti b'siringa waħda li fihom 1 siringa mimlija għal-lest u f'pakketti li jinkludu 2 siringi mimlijin għal-lest .
English: Maintenance and durability of PASI 90 response over time is presented in Figure 1.
Maltese: Iż-żamma u d-durabilità ta' rispons ta' PASI 90 maż-żmien huma ppreżentati fil-Figura 1.
English: Thereafter, resume dosing at the regularly scheduled interval.
Maltese: Wara dan, kompli ddożaġġ fl-intervall skedat regolarment.
English: Patients receiving Ilumetri should be closely monitored for signs and symptoms of active TB during and after treatment.
Maltese: Ilpazjenti li jirċievu Ilumetri għandhom jiġu mmonitorjati mill-qrib għal sinjali u sintomi ta' TB attiva waqt u wara l-kura.
English: The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
Maltese: Id-doża rakkomandata ta' Illumetri hija 100 mg b'injezzjoni taħt il-ġilda f'ġimgħat 0, u 4 u kull 12il ġimgħa wara dan.
English: Other evaluated outcomes included the proportion of patients who achieved PASI 90, PASI 100, the proportion of patients with DLQI 0 or 1, and maintenance of efficacy up to 52/64 weeks.
Maltese: Riżultati oħrajn li ġew evalwati kienu jinkludu l-proporzjon ta' pazjenti li kisbu PASI 90, PASI 100, il-proporzjon ta' pazjenti b' DLQI 0 jew 1, u ż-żamma tal-effikaċja sa 52/64 ġimgħa.
English: Placeb o
Maltese: U L-UŻU
English: These 355 patients on placebo were subsequently crossed over to tildrakizumab.
Maltese: Dawn it-355 pazjent fuq il-plaċebo sussegwentement inqalbu għal tildrakizumab.
English: Population PK analysis indicated a 31% higher bioavailability in healthy subjects compared to patients.
Maltese: L-analiżi PK tal-popolazzjoni indikat bijodisponibilità li hija 31% ogħla f'individwi b'saħħithom meta mqabbla mal-pazjenti.
English: - Choose a different location for the second injection.
Maltese: - Agħżel post differenti għat-tieni injezzjoni.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq il-fertilità (ara 5.3).
English: OTHER
Maltese: LISTA
English: After repeated dosing to pregnant cynomolgus monkeys, serum concentrations were quantifiable in the fetus, but the reproduction toxicity studies did not reveal any untoward effects.
Maltese: Wara dożaġġ ripetut lil xadini cynomolgus tqal, il-konċentrazzjonijiet fis-seru kienu kwantifikabbli fil-fetu, iżda studji dwar l-effett tossiku fuq is-sistema riproduttiva ma wrew l-ebda effett mhux mistenni.
English: Vaccinations
Maltese: Immunoġeniċità
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of tildrakizumab in pregnant women.
Maltese: Għal tildrakizumab m'hemmx dejta jew hemm dejta limitata (inqas min 300 riżultat ta' tqala) dwar l-użu ta' fin-nisa tqal.
English: Description of selected adverse reaction Immunogenicity
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: The full EPAR for Luminity 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 European Commission granted a marketing authorisation valid throughout the European Union for Luminity on 20 September 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Luminity fl-20 ta' Settembru 2006.
English: This is a summary of the European public assessment report (EPAR) for Luminity.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Luminity.
English: In two of these studies, Luminity was compared with placebo (a dummy treatment).
Maltese: F'żewġ studji fost dawn, Luminity tqabbel ma' plaċebo (trattament finta).
English: Luminity is a solution for injection or infusion (drip) into a vein that contains microspheres (tiny bubbles) of perflutren gas as the active substance.
Maltese: Luminity huwa soluzzjoni għal injezzjoni jew infużjoni (dripp fil-vina) li fiha mikrosferi (bżieżaq ċkejkna) ta' perflutren gass bħala sustanza attiva.
English: There have been five main studies of Luminity, involving a total of 401 patients.
Maltese: Saru ħames studji prinċipali ta' Luminity, li b'kollox involvew 401 pazjent.
English: Luminity perflutren-containing lipid microspheres
Maltese: Luminity mikrosferi ta' lipidi li fihom il-perflutrenu
English: It is a contrast agent (a medicine that helps obtain better images of organs and tissues during a scan).
Maltese: Huwa aġent ta' kuntrast (mediċina li tgħin tikseb immaġnijiet aħjar ta' organi u tessuti waqt sken).
English: As all five original studies were carried out with a technique known as ‘fundamental' ultrasound imaging, the company also presented the results of some studies to show that the results seen using fundamental imaging could also be obtained when using the imaging techniques known as ‘harmonic' and ‘non linear'.
Maltese: Billi l-ħames studji kollha twettqu b'teknika magħrufa bħala ultrasound imaging ‘fundamentali', il-kumpanija ppreżentat ukoll ir-riżultati ta' xi studji li wrew li r-riżultati miksuba b'teħid ta' immaġini fundamentali setgħu jinkisbu wkoll tekniki ta' teħid ta' immaġini magħrufa bħala ‘armoniċi' u ‘mhux lineari'.
English: What is the risk associated with Luminity?
Maltese: X'inhu r-riskju assoċjat ma' Luminity?
English: This is then given into a vein either as a ‘bolus' injection (given all at once) or as an infusion after being diluted.
Maltese: Din imbagħad tingħata fil-vina f'forma ta' injezzjoni ‘bolus' (linjezzjoni tingħata kollha f'daqqa), jew f'forma ta' infużjoni wara li tiġi dilwita.
English: During echocardiography, the perflutren microspheres in Luminity reflect ultrasound waves differently from the surrounding tissues.
Maltese: Waqt l-ekokardjografija, il-mikrosferi ta' perflutrenu f'Luminity jirriflettu vibrazzjonijiet tal-ultrasound b'mod differenti mit-tessuti tal-madwar.
English: The most common side effects with Luminity (seen in between 1 and 10 patients in 100) are headache and flushing (reddening of the skin).
Maltese: L-effetti sekondarji l-aktar komuni b'Luminity (li dehru f'madwar 1 sa 10 pazjenti minn 100) huma wġigħ ta' ras u ħmura fil-ġilda.
English: Why has Luminity been approved?
Maltese: Għaliex ġie approvat Luminity?
English: How has Luminity been studied?
Maltese: Kif ġie studjat Luminity?
English: Luminity should only be given by doctors trained in performing and reading images obtained with contrast echocardiography, in hospitals or clinics where appropriate resuscitation equipment is available in case of heart or lung problems or allergic reactions.
Maltese: Luminity għandu jingħata minn tobba mħarrġa fit-twettiq u l-interpretazzjoni ta' immaġini li jinkisbu bl-ekokardjografija b'kuntrast, fi sptarijiet u kliniki fejn huwa disponibbli tagħmir ta' risuxxitazzjoni adegwat f'każ ta' problemi tal-qalb jew tal-pulmun jew reazzjonijiet allerġiċi.
English: What is Luminity?
Maltese: X'inhu Luminity?
English: What benefit has Luminity shown during the studies?
Maltese: Liema benefiċċju wera Luminity waqt l-istudji mwettqa?
English: Luminity is used in adults to obtain a clearer image of the chambers of the heart, especially of the left ventricle, during echocardiography (a diagnostic test where an image of the heart is obtained using ultrasound).
Maltese: Luminity jintuża biex tinkiseb immaġini iktar ċara tal-kmamar tal-qalb, partikolarment tal-ventrikolu tax-xellug, matul ekokardjografija (test dijanjostiku li bih tinkiseb immaġini tal-qalb bl-użu talultrasound).
English: Other information about Luminity
Maltese: Kif jintuża Luminity?
English: Luminity is used in patients with suspected or confirmed coronary artery disease (obstruction of the blood vessels supplying the heart muscle), when the image obtained without a contrast agent is not good enough.
Maltese: Luminity jintuża f'pazjenti li jbatu mill-marda tal-arterja koronarja, suspetta jew konfermata (ostruzzjoni tal-arterji u tal-vini li jfornu l-muskolu kardijaku), meta l-immaġini miksuba permezz ta' aġent ta' kuntrast ma tkunx tajba biżżejjed.
English: The CHMP decided that Luminity's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Luminity huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: This ensures that the medicine is shaken in the correct way and for long enough to make up a ‘dispersion' of microspheres of perflutren gas of the right size to get a good quality image.
Maltese: Dan jiżgura li l-mediċina titħallat korrettament u għal perjodu ta' żmien twil biżżejjed biex issir “dispersjoni” tal-mikrosferi tal-gass perflutren tad-daqs mixtieq biex ikun hemm immaġini ta' kwalità tajba.
English: The way Luminity is given and the dose depend on the technique being used for the echocardiography.
Maltese: Il-mod kif jingħta Luminity u d-dożi jiddependu mit-teknika użata fl-ekokardjografija.
English: For the full list of all side effects and restrictions with Luminity, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Luminity, ara l-fuljett ta' tagħrif.
English: 40 mg/0.8 ml
Maltese: Daqs talpakkett mg/0.8 ml
English: 2 carton pack.
Maltese: Pakkett ta' 2 kartuni.
English: Each carton contains: 1 vial + 1 syringe + 1 needle + 1 sterile adapter + 2 alcohol pads
Maltese: Kull kartuna fiha: kunjett 1 + siringa 1 + labra 1 + adapter sterili 1 + 2 kuxxinetti bl-alkoħol
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 2 pre-filled syringes + 2
Maltese: 2 pinen mimlijin għal-lest + 2 kuxxinetti bl-alkoħol
English: Solution for injection Subcutaneous use vial (glass)
Maltese: Soluzzjoni għallinjezzjoni kunjett (ħġieġ)
English: 1 alcohol pad
Maltese: 2 kuxxinetti bl-alkoħol
English: 1 pre-filled syringe with needle guard
Maltese: Il-pakkett li jmiss malprodott
English: It contains the active substance alemtuzumab (10 mg/ml or 30 mg/ml).
Maltese: Fih is-sustanza attiva alemtuzumab (10 mg/ml jew 30 mg/ml).
English: The full EPAR for MabCampath 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: One study included 297 patients who had not received treatment before.
Maltese: Studju inkluda 297 pazjent li ma kinux irċievew trattament qabel.
English: The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'MabCampath, alemtuzumab, hija antikorp monoklonali.
English: • who have an active infection that has spread throughout the body; • with HIV infection;
Maltese: • b'infezzjoni HIV;
English: The marketing authorisation holder is Genzyme Europa BV.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Genzyme Europe BV.
English: This summary was last updated in 04-2011.
Maltese: Dan is-sommarju ġie aġġornat f'04-2011.