FrancophonIA/ELRC3.0 huggingface dataset:
English: • weight loss, dehydration, thirst, swelling of the lower legs, temperature change sensation, low
Maltese: • tnaqqis fil-piż, deidrazzjoni, għatx, nefħa fir-riġlejn, sensazzjoni ta' bidla fit-temperatura, livelli
English: Resume MabCampath at 10 mg when ANC ≥ 500/μl and platelet count ≥ 50,000/μl.
Maltese: Kompli MabCampath b'10 mg meta l-ANC huwa ≥ 500/μl u l-għadd ta' plejtlits huwa ≥ 50,000/μl.
English: It is highly recommended that anti-infective prophylaxis (e.g. trimethoprim/sulfamethoxazole 1 tablet twice daily, 3 times weekly, or other prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and an effective oral anti-herpes agent, such as famciclovir, 250 mg twice daily) should be initiated while on therapy and for a minimum of 2 months following completion of treatment with MabCampath or until the CD4+ count has recovered to 200 cells/l or greater, whichever is the later.
Maltese: Hija rrakkomandata ħafna li tiġi mibdija profilassi anti-infettiva waqt it-terapija (e.ż. pillola waħda darbtejn kuljum, tliet darbiet fil-ġimgħa ta' trimethoprim/sulfamethoxazole, jew profilassi oħra kontra il-pnewmonja Pneumocystis jiroveci (PCP) u mediċina orali effettiva kontra lherpes bħal famciclovir, 250 mg darbtejn kuljum) u għal ta' l-inqas xagħrejn wara li l-kura b'MabCampath tkun tlestiet jew sakemm l-għadd totali ta' CD4+ ikun irkupra għal 200 ċellula/l jew aktar, skond liema jiġi l-aħħar.
English: Each pack of MabCampath contains 3 ampoules.
Maltese: Kull pakkett ta' MabCampath fih 3 ampulli.
English: DATE OF REVISION OF THE TEXT
Maltese: Ελλάδα/Κύπρος
English: After the last 30 mg dose, the median volume of distribution at steady-state was 0.15 l/kg (range: 0.1-0.4 l/kg), indicating that distribution was primarily to the extracellular fluid and plasma compartments.
Maltese: Wara l-aħħar doża ta' 30 mg, il-volum medjan ta' distribuzzjoni fi stat fiss kien ta' 0.15 l/kg (firxa: 0.1 - 0.4 l/kg), li jindika li d-distribuzzjoni kienet primarjament fil-kompartamenti ta'
English: • have other side effects, most often blood disorders from taking MabCampath.
Maltese: • ikollok effetti sekondarji oħra, ħafna drabi disturbi marbuta mad-demm ikkawżati minn MabCampath.
English: The other ingredients are disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate and water for injections.
Maltese: Is-sustanzi l-oħra huma disodium edetate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, dibasic sodium phosphate u ilma għall-injezzjonijiet.
English: • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy
Maltese: • Rakkomandazzjoni li jiġu evitati tilqim b'vaċċini ħajjin għal ta' lanqas 12-il xahar wara ttmiem ta' terapija b'MabCampath
English: Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52).
Maltese: Alemtuzumab huwa antikorp monoklonali umanizzat tat-tip IgG1 kappa magħmul permezz ta' inġinerija ġenetika, speċifiku għal glycoprotein (CD52) tal-wiċċ taċ-ċellula limfoċita tat-tip 21-28 kD.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit, ara sezzjoni 6.3.
English: It is not known if MabCampath can affect human reproductive capacity (see section 5.3).
Maltese: Mhux magħruf jekk MabCampath jaffettwax il-ħila riproduttiva umana (ara sezzjoni 5.3).
English: Cytomegalovirus viraemia Cytomegalovirus infection
Maltese: Infezzjoni kkawżata minn Cytomegalovirus
English: Of the first-line patients (n=282) in whom baseline cytogenetic (FISH) data were available in Study 4, chromosomal aberrations were detected in 82%, while normal karyotype was detected in 18%.
Maltese: Mill-pazjenti kkurati għall-ewwel darba (n=282) li għalihom it-tagħrif ċitoġeniku fil-linja bażi (FISH) kien disponibbli fi Studju 4, aberrazzjonijiet kromosomali ġew osservati fi 82%, filwaqt li karjotip normali kien osservat fi 18%. Laberrazzjonijiet kromosomali kienu mqassma f'kategoriji skond il-mudell ġerarkiku ta' Döhner.
English: ≥ 50% decrease from baseline in patients initiating therapy with a baseline ANC ≤ 250/μl and/or a
Maltese: Tnaqqis ta' ≥ 50% mil-linja bażi f'pazjenti li ħa jibdew it-terapija b'ANC fil-linja bażi ta' ≤ 250/μl u/jew għadd ta' plejtlits fil-linja bażi ta' ≤ 25,000/μl
English: The most frequent adverse reactions with MabCampath are: infusion reactions (pyrexia, chills, hypotension, urticaria, nausea, rash, tachycardia, dyspnoea), cytopenias (neutropenia, lymphopenia, thrombocytopenia, anaemia), infections (CMV viraemia, CMV infection, other infections), gastrointestinal symptoms (nausea, emesis, abdominal pain), and neurological symptoms (insomnia, anxiety).
Maltese: L-iktar reazzjonijiet avversi frekwenti b'MabCampath huma: reazzjonijiet tal-infużjoni (deni, tertir ta' bard, pressjoni baxxa, urtikarja, nawseja, raxx, takikardija, qtugħ ta' nifs), ċitopeniji (newtropenija, limfopenija, tromboċitopenija, anemija), infezzjonijiet (viremija b'CMV, infezzjoni b'CMV, infezzjonijiet oħrajn), sintomi gastrointestinali (nawseja, emesi, uġigħ addominali), u sintomi newroloġiċi (nuqqas ta' rqad, ansjetà).
English: MabCampath was shown to be superior to chlorambucil as measured by the primary endpoint progression free survival (PFS) (see Figure 1).
Maltese: MabCampath intwera li hu superjuri għal chlorambucil kif imkejjel mill-mira primarja ta' sopravivenza mingħajr progressjoni (ara Figura 1).
English: Premedications
Maltese: Premedikazzjonijiet
English: Throat tightness Pulmonary infiltration Pleural effusion Breath sounds decreased
Maltese: Bronkspażmu Infiltrazzjoni pulmonari Effużjoni plewrali
English: Although no formal drug interaction studies have been performed with MabCampath, there are no known clinically significant interactions of MabCampath with other medicinal products.
Maltese: Għalkemm ma sarux studji formali dwar l-interazzjonijiet b'MabCampath, mhux magħrufa interazzjonijiet ta' sinifikanza klinika ta' MabCampath ma' prodotti mediċinali oħra.
English: Common side effects (affects 1 to 10 patients in every 100 patients treated in clinical trials):
Maltese: Effetti sekondarji komuni (jaffettwaw minn pazjent wieħed sa 10 minn kull 100 ikkurati fil-provi kliniċi):
English: Maculo-papular rash Skin disorder
Maltese: Raxx makulo-papulari Raxx eritematuż Disturbi tal-ġilda
English: The safety and efficacy of MabCampath were evaluated in a Phase 3, open-label, randomized comparative trial of first line (previously untreated) Rai stage I-IV B-CLL patients requiring therapy (Study 4).
Maltese: Is-sigurtà u l-effikaċja ta' MabCampath kienu evalwati fi prova ta' Fażi 3, open-label, randomised u komparattiva ta' pazjenti b'B-CLL ta' Rai stage I-IV kkurati għall-ewwel darba (mhux ikkurati qabel) li kienu jeħtieġu terapija (Studju 4).
English: The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Maltese: L-ammont meħtieġ tal-kontenut tal-kunjett għandu jiġi miżjud ma' 100 ml ta' soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) jew ta' glucose (5%).
English: Infusion reactions: Serious and sometimes fatal reactions, including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome (ARDS), respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency and cardiac arrest have been observed.
Maltese: Kienu osservati reazzjonijiet serji u kultant fatal li jinkludu bronkospażmu, ipoksja, sinkope, infiltrati fil-pulmun, sindrome akuta ta' distress respiratorju (ARDS), arrest respiratorju, infart mijokardijaku, arritmiji, insuffiċjenza kardijaka akuta u arrest kardijaku.
English: Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3).
Maltese: Tagħrif dwar is-sigurtà f'pazjenti b'B-CLL kkurati qabel huwa bbażżat fuq 149 pazjent rekrutat fi studji single arm ta' MabCampath (Studji 1, 2 u 3).
English: The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Maltese: L-ammont meħtieġ tal-kontenut ta' l-ampulla għandu jiġi miżjud ma' 100 ml ta' soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) jew ta' glucose (5%), permezz ta' filtru sterili ta' 5 µm, li mhux tal-fibra u li ma tantx jorbot proteini.
English: One ml contains 10 mg of alemtuzumab.
Maltese: 1ml fih 10 mg ta' alemtuzumab.
English: Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T cell lymphocyte depletion.
Maltese: IgG uman huwa magħruf li jgħaddi mill-barriera tas-sekonda; MabCampath jista' jgħaddi mill-barriera tas-sekonda u b'hekk jista' jikkaġuna tnaqqis limfoċetiku taċ-ċelluli B u T tal-fetu.
English: Therapy should be discontinued if there is evidence of disease progression.
Maltese: It-terapija għandha tiġi mwaqqfa jekk ikun hemm evidenza ta' progressjoni tal-marda.
English: Gastrointestinal haemorrhage Ulcerative stomatitis Stomatitis
Maltese: Disturbi gastrointestinali emorraġija gastrointestinali
English: Males and females of childbearing potential should use effective contraceptive measures during treatment and for 6 months following MabCampath therapy (see sections 4.6 and 5.3).
Maltese: Nisa u rġiel li jista' jkollhom it-tfal għandhom jużaw miżuri effettivi ta' kontraċezzjoni waqt il-kura u għal sitt xhur wara li jtemmu t-terapija b'MabCampath (ara sezzjonijiet 4.6 u 5.3).
English: incontinence
Maltese: Insomnija
English: • abdominal bleeding (e.g. in the stomach and intestine)
Maltese: • fsada addominali (e.ż. fl-istonku u fl-imsaren)
English: The antigen has been found on a small percentage (< 5%) of granulocytes, but not on erythrocytes or platelets.
Maltese: L-antiġen instab fuq perċentwali żgħir (<5%) ta' granuloċiti, iżda mhux fuq eritroċiti jew plejtlits.
English: The cytogenetic profile of B-CLL has been increasingly recognized as providing important prognostic information and may predict response to certain therapies.
Maltese: Il-profil ċitoġenetiku ta' B-CLL qed ikun identifikat dejjem aktar li jagħti informazzjoni prognostika importanti u tista' tipprevedi r-rispons ta' ċertu terapiji.
English: Caution should be exercised in the handling and preparation of the MabCampath solution.
Maltese: Għandu jkun hemm kawtela waqt l-immaniġġjar u l-preparazzjoni tas-soluzzjoni ta' MabCampath.
English: A positive Coombs test has also been observed.
Maltese: Kien osservat ukoll riżultat pożittiv għat-test ta' Coombs.
English: • unsteadiness, increased muscle tone
Maltese: • nuqqas ta' stabbiltà, żjieda fit-ton tal-muskoli
English: • tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)
Maltese: • sindrome tad-disintegrazzjoni tat-tumur (disturb metaboliku, li jista' jibda b'uġigħ fil-ġenbejn u demm fl-awrina)
English: Upper respiratory tract infection
Maltese: Infiltrazzjoni pulmonari
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U D-DETENTUR TA' LAWTORIZZAZZJONI RESPONSABBLI
English: Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species.
Maltese: Evalwazzjoni ta' qabel l-użu kliniku ta' alemtużumab f'annimali kienet ristretta għal xadini cynomolgus minħabba n-nuqqas ta' l-espressjoni ta' l-antiġen CD52 fi speċi li mhumiex primati.
English: MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
Maltese: MabCampath kien mogħti bħala infużjoni fil-vini fuq perijodu ta' sagħtejn, fl-iskeda ta' doża rrakkomandata, li bdiet bi 3 mg u żdidet sa 30 mg, 3 darbiet fil-ġimgħa, sa 12-il ġimgħa.
English: Agranulocytosis Lymphopenia Lymphadenopathy Epistaxis
Maltese: Mudullun imrażżan Epistassi
English: MabCampath 30 mg/ml concentrate for solution for infusion Alemtuzumab
Maltese: MabCampath 30 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: Depersonalisation Personality disorder Abnormal thinking Impotence Nervousness
Maltese: Depersonalizzazzjoni Disturb fil-personalità
English: • fluid in the lungs, difficulty breathing, harsh sound when breathing, runny nose, abnormal findings in the lungs, lymph gland disorders
Maltese: • fluwidu fil-pulmuni, diffikultà biex tieħu n-nifs, ħoss mhux normali man-nifs, imnieħer iqattar, affarijiet anormali fil-pulmun, disturbi tal-glandoli limfatiċi
English: Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e. loss of CD52 receptors in the periphery).
Maltese: Ir-rata ta' tneħħija sistematika naqset b'għoti ripetut minħabba tnaqqis fit-tneħħija medjata mir-riċetturi (i.e. telf ta' riċetturi CD52 fil-periferiji).
English: Complete remissions were also superior in patients with sole 13q deletion treated with MabCampath (27% v 0%; p=0.0009).
Maltese: Irkupru komplut kien ukoll superjuri f'pazjenti bi tneħħija ta' 13q waħedha ikkurati b'MabCampath (27% v 0%; p=0.0009).
English: Acute infusion reactions including fever, chills, nausea, vomiting, hypotension, fatigue, rash, urticaria, dyspnoea, headache, pruritus and diarrhoea have been reported.
Maltese: Kienu rrapportati reazzjonijiet akuti għall-infużjoni, inkluż deni, sirdat, tqalligħ, rimettar, pressjoni baxxa, għeja, raxx, uritkarja, qtugħ ta' nifs, uġigħ ta' ras, ħakk u dijarea.
English: Pharyngitis Infection
Maltese: Infezzjoni virali
English: MabCampath 10 mg/ml concentrate for solution for infusion Alemtuzumab
Maltese: MabCampath 10 mg/ml konċentrat għal soluzzjoni għall-infużjoni
English: • injection site reactions including redness, swelling, pain, bruising, inflammation
Maltese: • reazzjonijiet fis-sit ta' l-injezzjoni inkluż ħmura, nefħa, uġigħ, tbenġil, infjammazzjoni
English: However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression.
Maltese: Madankollu, jekk tiġi kkunsidrata kura mill-ġdid, ikun prudenti li tiġi kkonfermata l-preżenza ta' l-espressjoni ta' CD52.
English: In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥200 cells/µl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/l.
Maltese: F'pazjenti li jirċievu MabCampath bħala terapija preferita, l-irkupru ta' l-għadd ta' CD4+ għal ≥200 ċellula/µl seħħ sa 6 xhur wara l-kura, madankollu, fi żmien xahrejn wara l-kura l-medjan kien ta' 183 ċellula/µl.
English: Previously treated B-CLL patients:
Maltese: Pazjenti b'B-CLL ikkurati qabel:
English: The recommended anti-infective prophylaxis treatment appears to be effective in reducing the risk of PCP and herpes infections (see section 4.4).
Maltese: Il-kura rakkomandata għal profilassi kontra l-infezzjonijiet tidher li hija effettiva biex tnaqqas ir-riskju t' infezzjonijiet ikkawżati minn PCP u herpes (ara sezzjoni 4.4).
English: Anaphylactic reaction
Maltese: Reazzjoni allerġika
English: Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21-28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes.
Maltese: Alemtużumab huwa antikorp monoklonali umanizzat tat-tip IgG1 kappa magħmul permezz ta' inġinerija ġenetika, speċifiku għal glycoprotein (CD52) fuq il-wiċċ ta' ċellula limfoċita tat-tip 21-28 kD, li jinsab prinċipalment fuq il-wiċċ ta' ċelluli limfoċiti B u T periferali tad-demm normali u malinni.
English: Mucositis
Maltese: Sinkope
English: Chest pain Influenza-like symptoms
Maltese: Sintomi bħal ta' l-influwenza
English: Each ampoule contains 30 mg of alemtuzumab.
Maltese: Kull ampulla fiha 30 mg ta' alemtuzumab.
English: Bronchospasm Dyspnoea
Maltese: Bronkospażmu
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku ta' l-Aġenzija Ewropeja dwar il-Mediċini: http://www.ema.europa.eu.
English: Sepsis
Maltese: Sepsi
English: Renal function abnormal
Maltese: Funzjoni tal-kliewi mhux normali
English: • heart disorders (heart stopping, heart attack, heart congestion, irregular heart rate) • blood disorders (abnormal clotting, decreased protein, low potassium levels)
Maltese: • disturbi tad-demm (tagħqid tad-demm anormali, tnaqqis fil-proteina, livelli baxxi ta' potassju)
English: Severe anaphylactic and other hypersensitivity reactions
Maltese: Reazzjoni anafilattika Sensittività eċċessiva
English: Urinary tract infection Sinusitis
Maltese: Infezzjoni fl-apparat urinarju Sinusite
English: In CLL, too many lymphocytes are produced.
Maltese: F'CLL, jiġu prodotti limfoċiti żejda.
English: Oedema mouth Oedema
Maltese: Uġigħ fis-sider
English: • have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.
Maltese: • fil-passat inti ġejt ikkurat b'kimoterapiji jew mediċini ġenerali li għandhom riskju għoli li jikkaġunaw ħsara lill-qalb, it-tabib tiegħek għandu mnejn ikun jixtieq jimmonitorja l-funzjoni kardijaka tiegħek (ECG, rata tal-qalb, piż tal-ġisem) waqt li tkun qed tirċievi MabCampath.
English: Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes.
Maltese: Alemtuzumab ġie ddisinjat beix jeħel ma' glycoprotein (proteina li hija miksija b'molekoli taz-zokkor) li tinstab fil-wiċċ tal-limfoċiti.
English: Nasopharyngitis Rhinitis
Maltese: Mudullun imrażżan
English: • are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath (see section 6 “Further Information”).
Maltese: • allerġiku/a (tbati minn sensittività eċċessiva) għal alemtużumab jew għal proteini ta' oriġini simili jew sustanzi oħra ta' MabCampath (ara sezzjoni 6 “Aktar Tagħrif”).
English: One ml contains 30 mg of alemtuzumab.
Maltese: 1ml fih 30 mg ta' Alemtuzumab.
English: Each vial contains 30 mg of alemtuzumab.
Maltese: Kull kunjett fih 30 mg ta' alemtuzumab.
English: Malaise
Maltese: Konfużjoni
English: As such, half-life was 8 hours (range: 2-32 hours) after the first 30 mg dose and was 6 days (range: 1-14 days) after the last 30 mg dose.
Maltese: B'hekk, il-half-life kienet ta' 8 sigħat (firxa: 2-32 siegħa) wara l-ewwel doża ta' 30 mg u kienet ta' 6 ijiem (firxa: 1-14-il ġurnata) wara l-aħħar doża ta' 30 mg.
English: Reconstituted solution: MabCampath contains no antimicrobial preservative.
Maltese: MabCampath ma fih l-ebda preservattiv kontra l-mikrobi.
English: Solutions may be stored at 15C-30C or refrigerated.
Maltese: Is-soluzzjonijiet jistgħu jinħażnu f'temperatura ta' 15C - 30C jew fil-friġġ.
English: This may predispose patients to opportunistic infections.
Maltese: Dan jista' jippredisponi lill-pazjenti għall-infezzjonijiet opportunistiċi.
English: Each pack of MabCampath contains 3 vials.
Maltese: Kull pakkett ta' MabCampath fih 3 kunjetti.
English: *If the delay between dosing is  7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg
Maltese: *Jekk id-dewmien bejn id-dożaġġ huwa  7 ġranet, ibda' t-terapija b'MabCampath 3 mg u żid għal 10 mg u wara għal 30 mg skond kif ikun ittollerat
English: Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Genzyme Europe B.V. Képviselet Tel: +36 1 310 7440
Maltese: Képviselet Tel: +36 1 310 7440
English: • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Maltese: • Ir-riskju ta' reazzjonijiet għall-infużjoni o Il-bżonn li tingħata mediċina minn qabel o Li kura għal reazzjonijiet ta' sensittività eċċessiva, li tinkludi miżuri għarrisuxxitazzjoni għandha tkun disponibbli waqt l-għoti o Li r-riskju ta' reazzjonijiet għall-infużjoni huwa l-ogħla fl-ewwel ġimgħa ta' terapija o Li jekk ir-reazzjoni hija moderata jew severa, id-doża għandha titkompla fl-istess livell (ie. id-doża m'għandiex tiżdied) sakemm kull doża tkun ittollerata tajjeb o Li jekk ma tingħatax terapija għal aktar minn 7 ijiem, aMabCampath għandu jerġa' jinbeda mill-ġdid b'doża li tiżdied b'mod gradwali
English: Withhold MabCampath therapy.
Maltese: Waqqaf it-terapija ta' MabCampath.
English: Figure 1: Progression free survival in first line study (by treatment group)
Maltese: Figura 1: Sopravivenza mingħajr progressjoni fl-istudju b'pazjenti kkurati għall-ewwel darba (skont il-grupp ta' kura)
English: Arthralgia Myalgia Skeletal pain Back pain
Maltese: Uġigħ skeltrali Uġigħ fid-dahar
English: It is recommended that patients be premedicated with oral or intravenous steroids 30 - 60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated.
Maltese: Huwa rrakkomandat li pazjenti jkunu kkurati minn qabel bi sterojdi orali jew fil-vini 30-60 minuta qabel kull infużjoni ta' MabCampath waqt żjieda fid-doża u kif indikat klinikament.
English: Musculoskeletal chest pain
Maltese: Spażmi fil-muskoli
English: Very common side effects (seen in at least 1 in every 10 patients treated in clinical trials):
Maltese: Effetti sekondarji komuni ħafna (osservati f'ta' l-inqas pazjent wieħed minn kull 10 ikkurati fil-provi kliniċi):
English: Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu kkurati minn qabel bi sterojdi orali jew fil-vini, antistamina u analġeżiku xierqa li jingħataw 30-60 minuta qabel l-għoti ta' kull infużjoni ta' MabCampath waqt l-għoti ta' dożi aktar qawwija u wara dan kif indikat b'mod kliniku (ara sezzjoni 4.4).
English: Arthralgia
Maltese: Ematurja
English: Uncommon side effects (affects 1 to 10 patients in every 1,000 patients treated in clinical trials):
Maltese: Effetti sekondarji mhux komuni (jaffettwaw minn pazjent wieħed sa 10 minn kull 1,000 ikkurati filprovi kliniċi):
English: Cyanosis Bradycardia Tachycardia Sinus tachycardia
Maltese: KIF TAĦŻEN MABCAMPATH
English: Because of the potential for Transfusion Associated Graft Versus Host Disease (TAGVHD) it is recommended that patients who have been treated with MabCampath receive irradiated blood
Maltese: Minħabba l-possibiltà ta' Transfusion Associated Graft Versus Host Disease (TAGVHD), huwa rrakkomandat li pazjenti li kienu ikkurati b'MabCampath jirċievu prodotti tad-demm irradjati.
English: Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric
Maltese: Pazjenti jista' jkollhom reazzjonijiet allerġiċi jew ta' sensittività eċċessiva għal MabCampath u għal antikorpi monoklonali murini jew kimeriċi.