FrancophonIA/ELRC3.0 huggingface dataset:
English: 88397 Biberach an der Riss GERMANY
Maltese: 88397 Biberach an der Riss
English: • tuberculosis
Maltese: • tuberkulożi
English: The active substance is alemtuzumab.
Maltese: Is-sustanza attiva hi alemtuzumab.
English: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem Belgium
Maltese: Sanofi Belgium Leonardo Da Vincilaan 19 B-1831 Diegem
English: HR: 0.58 p-value: 0.0084
Maltese: HR: 0.58 valur p: 0.0084
English: Fertility and reproduction
Maltese: Fertilità u riproduzzjoni
English: 3 years‡
Maltese: 3 snin‡
English: Genzyme Ltd.
Maltese: Manifattur Genzyme Ltd.
English: SC IFNB-1a
Maltese: IFNB-1a
English: The difference was statistically significant (p=0.0002).
Maltese: Id-differenza kienet statistikament sinifikanti (p=0.0002).
English: 37 Hollands Road Haverhill Suffolk CB9 8PU United Kingdom
Maltese: 37 Hollands Road Haverhill Suffolk CB9 8PU Ir-Renju Unit
English: When?
Maltese: Meta?
English: E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
Maltese: TA' EĊĊIPJENTI E339, disodium edetate, E508, E340, E433, sodium chloride, ilma għall-injezzjonijiet
English: Human Immunodeficiency Virus (HIV) infection.
Maltese: Infezzjoni bil-Virus tal-Immunodefiċjenza Umana (HIV).
English: 4.5/3.8 years
Maltese: 4.5/3.8 snin
English: Proteinuria, haematuria
Maltese: Proteinurija, ematurija
English: SC IFNB-1a (N=202)
Maltese: IFNB-1a (N=202)
English: SC IFNB-1a (N=187)
Maltese: IFNB-1a (N=187)
English: The antibody has an approximate molecular weight of 150 kD.
Maltese: L-antikorp għandu piż molekulari approssimattiv ta' 150 kD.
English: = 205) and 0.51 (95% CI: 0.40, 0.64) in the IFNB-1a group (n = 102) (p<0.0001).
Maltese: (n = 205) u 0.51 (95% CI: 0.40, 0.64) fil-grupp ittrattat b'IFNB-1a (n
English: System Organ Class
Maltese: Klassi tasSistemi u talOrgani
English: 2.0/1.6 years
Maltese: 2.0/1.6 snin
English: 1.5/1.3 years
Maltese: 1.5/1.3 snin
English: Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Maltese: Ir-reazzjonijiet avversi huma elenkati skont id-Dizzjunarju Mediku għal Attivitajiet Regolatorji (MedDRA), Klassi tas-Sistemi u tal-Organi (SOC) u Terminu Ppreferut (PT).
English: Summary of the safety profile in clinical studies
Maltese: Sommarju tal-profil tas-sigurtà fi studji kliniċi
English: • listeriosis/listeria meningitis
Maltese: • listerjosi/meninġite b'listeria
English: Aspartate aminotransferase increased, alanine aminotransferase increase
Maltese: Żieda fl aspartate aminotransfera se, żieda fl alanine aminotransfera se
English: Additional follow-up provided data through a median of 4.8 years (maximum 6.7).
Maltese: Segwitu addizzjonali pprovda dejta sa medjan ta' 4.8 sena (massimu 6.7).
English: Pulmonary alveolar haemorrhage**
Maltese: Emorraġija pulmonarja alveolari**
English: Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Maltese: Injetta ġo 100 ml ta' soluzzjoni għall-infużjoni ta' sodium chloride 9 mg/ml (0.9%) jew f'soluzzjoni għallinfużjoni ta' glucose (5%).
English: SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
Maltese: Magyarország SANOFI-AVENTIS Zrt Tel: +36 1 505 0050
English: CB9 8PU United Kingdom
Maltese: CB9 8PU Ir-Renju Unit
English: Atrial fibrillation*
Maltese: Fibrillazzjoni atrijali*
English: Myocardial ischaemia**, myocardial infarction**
Maltese: Iskemija mijokardjali**, infart mijokardjali**,
English: LEMTRADA contains potassium and sodium
Maltese: LEMTRADA fih potassium u sodium
English: MRI Endpoints (0-2 years)
Maltese: Punti aħħarin tal-MRI (0-sentejn)
English: United Kingdom sanofi-aventis Cyprus Ltd.
Maltese: Κύπρος sanofi-aventis Cyprus Ltd.
English: Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years).
Maltese: Avvenimenti serji ta' ITP ġew osservati fi 12-il pazjent (1%) ikkurati fi provi kliniċi kkontrollati f'MS (ekwivalenti għal rata annwalizzata ta' 4.7 każijiet/1,000 sena ta' esponiment ta' pazjent).
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Maltese: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 to < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Flushing*
Maltese: Fwawar*
English: Pack size: carton with 1 vial.
Maltese: Daqs tal-pakkett: kartuna b'kunjett 1.
English: 1 Herpes virus infections include PTs: Oral herpes, Herpes simplex, Genital herpes, Herpes virus infection, Genital herpes simplex, Herpes dermatitis, Ophthalmic herpes simplex, Herpes simplex serology positive.
Maltese: 1 Infezzjonijiet bil-virus tal-herpes jinkludu PTs: herpes orali, Herpes simplex, herpes ġenitali, infezzjoni bil-virus tal-herpes, herpes simplex ġenitali, Herpes fil-ġilda, herpes simplex oftalmoloġika, seroloġija pożittiva għal Herpes simplex.
English: • Use aseptic techniques to withdraw 1.2 ml of LEMTRADA from the vial and inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Maltese: • Uża teknika asettika biex tiġbed 1.2 ml ta' LEMTRADA mill-kunjett u tinjetta ġo soluzzjoni għall-infużjoni ta' 100 ml ta' sodium chloride 9 mg/ml (0.9%) jew soluzzjoni għall-infużjoni ta' glucose (5%).
English: Insomnia*, anxiety, depression
Maltese: Nuqqas ta' rqad*, ansjetà, depressjoni
English: A clear, colourless to slightly yellow concentrate with pH 7.0 - 7.4.
Maltese: Konċentrat ċar, bla kulur sa ftit isfar, b'pH ta' 7.0 - 7.4.
English: Concentrate
Maltese: Konġuntivite,
English: Tuberculosis has been reported for patients treated with LEMTRADA and IFNB-1a in controlled clinical trials.
Maltese: It-tuberkulożi ġiet irrappurtata għal pazjenti kkurati b'LEMTRADA u IFNB-1a fil-provi kliniċi kkontrollati.
English: Very Common Common
Maltese: Mhux Komuni Rari
English: o Immune Thrombocytopenic Purpura (ITP)
Maltese: o Purpura Tromboċitopenika Immuni (ITP)
English: • Complete baseline tests and screening as decribed in SmPC section 4.
Maltese: • Testijiet kompleti bħala linja bażi u eżaminazzjoni kif deskritti fl-SmPC sezzjoni 4.
English: Sanofi Tel +44 (0)845 372 7101
Maltese: Tel +44 (0)845 372 7101
English: • decreased/weak immune system
Maltese: • rispons b'mod esaġerat tas-sistema immuni
English: Pancytopenia, haemolytic anaemia, acquired haemophilia A
Maltese: Panċitopenja, anemija emolitika, emofilja A
English: Study design/demographics for Studies 1, 2, 3 and 4 are shown in Table 2 Table 2: Study Design and Baseline Characteristics for Studies 1, 2, 3 and 4 Study 1
Maltese: Id-disinn/demografika tal-Istudju għall-Istudji 1, 2, 3 u 4, qed jintwerew f'Tabella 2 Tabella 2: Disinn tal-Istudju u Karatteristiċi fil-Linja Bażi għall-Istudji 1, 2, 3 u 4 Studju 1
English: Initial treatment of 2 courses:
Maltese: Trattament inizjali ta' 2 korsijiet:
English: Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the 21-28 kD cell surface glycoprotein CD52.
Maltese: Alemtuzumab hu antikorp monoklonali umanizzat derivat minn DNA rikombinanti dirett kontra lglikoproteina CD52 ta' wiċċ iċ-ċellula 21-28 kD. Alemtuzumab hu antikorp kappa
English: Patients who participated in CAMMS223, CAMMS323, or CAMMS32400507 (see baseline characteristics above)
Maltese: Pazjenti li pparteċipaw f'CAMMS223, CAMMS323, jew CAMMS32400507 (ara l-karattersitiċi fil-linja bażi fuq)
English: Change from Baseline in EDSS at Year 23 (95% CI)
Maltese: Bidla mil-Linja Bażi f'EDSS f'Sena 23 (95% CI)
English: How to store LEMTRADA
Maltese: Tużax LEMTRADA
English: • asthma
Maltese: • ażma
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 2°C - 8°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 8 sigħat f'temperatura ta' 2°C - 8°C.
English: Nephrolithiasis, ketonuria, nephropathies including antiGBM disease
Maltese: Nefrolitjasi, ketonurja, nefropatiji inkluż il-marda anti-GBM
English: Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 3 years.
Maltese: 2 CAMMS223) evalwa s-sigurtà u l-effikaċja ta' LEMTRADA f'pazjenti b'RRMS fuq perjodu ta' 3 snin.
English: Supportive analyses from Study 2 (CAMMS32400507) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (48% reduction, p=0.0121), and significantly fewer relapses that led to steroid treatment (56% reduction, p<0.0001) or to hospitalization (55% reduction, p=0.0045) compared to IFNB-1a.
Maltese: Analiżijiet ta' appoġġ minn Studju 2 (CAMMS32400507) urew li LEMTRADA 12-il mg/jum wassal għal numru sinifikanti inqas ta' pazjenti kkurati b'LEMTRADA li kellhom rikaduti severi (tnaqqis ta' 48%, p=0.0121), u numru sinifikanti inqas ta' rikaduti li wasslu għal kura bi sterojdi (tnaqqis ta' 56%, p<0.0001) jew għal rikoveri l-isptar (tnaqqis ta' 55%, p=0.0045) meta mqabbel ma' IFNB-1a
English: Investigations
Maltese: Test
English: Blood test
Maltese: Test ta'
English: o Perform laboratory tests (complete blood count with differential, serum transaminases, serum creatinine, test of thyroid function and urinanalysis with microscopy).
Maltese: o Agħmel testijiet ta' laboratorju (għadd komplut tad-demm b'differenzjal, transaminażi fis-serum , kreatinina fis-serum, test tal-funzjoni tat-tirojde u analiżi tal-awrina flimkien mal-mikroskopija).
English: 2 Herpes zoster infections include PTs: Herpes zoster, Herpes zoster cutaneous disseminated, Ophthalmic herpes zoster, Herpes ophthalmic, Herpes zoster infection neurological, Herpes zoster meningitis.
Maltese: 2 Infezzjonijiet b'Herpes zoster jinkludu PTs: Herpes zoster, Herpes zoster kutanja mifruxa, herpes zoster oftalmoloġika, Herpes oftalmoloġika, infezzjoni newroloġika b'Herpes zoster, meninġite b'Herpes zoster.
English: Infusion-associated Reactions (IARs)
Maltese: Reazzjonijiet assoċjati mal-infużjoni (IARs)
English: Patients were treated with LEMTRADA 12 mg/day (N=108) or 24 mg/day (N=108) administered once per day for 5 days at month 0 and for 3 days at month 12 or subcutaneous IFNB-1a 44 µg (N=107) administered 3 times per week for 3 years.
Maltese: Il-pazjenti ġew ikkurati b'LEMTRADA 12-il mg/jum (N=108) jew 24 mg/jum (N=108) mogħti darba kuljum għal 5 ijiem f'xahar 0 u għal 3 ijiem f'xahar 12 jew IFNB-1a 44 µg mogħti minn taħt il-ġilda (N=107) mogħti 3 darbiet kull ġimgħa għal 3 snin.
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 wieћed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Immune Thrombocytopenic Purpura (ITP)
Maltese: Purpura Tromboċitopenika Immuni (ITP)
English: A post authorisation safety study is needed to address these concerns.
Maltese: Authorisation Safety Study - PASS):
English: Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Maltese: Alemtuzumab jeħel ma' CD52, antiġen ta' wiċċ iċ-ċellula preżenti f'livelli għoljin fuq limfoċiti T (CD3+) u B (CD19+), u f'livelli iktar baxxi fuq ċelluli li huma qattiela naturali, monoċiti, u makrofaġi.
English: Rate ratio (95% CI) Risk reduction
Maltese: Rata ta' Rikaduta1 Rata ta' Rikaduta Annwalizzata (ARR) (95% CI) Proporzjon ta' rata (95% CI) Tnaqqis tar-riskju
English: Autoimmune hepatitis
Maltese: Epatite awtoimmuni
English: In clinical trials, there were 2 cases of anti-GBM disease.
Maltese: Fil-provi kliniċi, kien hemm 2 każijiet ta' marda anti-GBM.
English: Haemophagocytic lymphohistiocytosis (HLH)
Maltese: Limfoistjoċitożi emofagoċitika (Haemophagocytic lymphohistiocytosis-HLH)
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Straße 65
Maltese: KG Birkendorfer Straße 65
English: Thyroid disease poses special risks in women who are pregnant (see section 4.6).
Maltese: Mard tat-tirojde jġib riskji speċjali f'nisa li jkunu tqal (ara sezzjoni 4.6).
English: In controlled clinical studies, 0.2% of LEMTRADA-treated MS patients developed acute acalculous cholecystitis, compared to 0% of patients treated with INFB-1a.
Maltese: Fi studji kliniċi kkontrollati, 0.2% ta' pazjenti b'MS ittrattati b'LEMTRADA żviluppaw koleċistite akalkuluża akuta , meta mqabbla ma' 0% ta' pazjenti ttrattati b'INFB-1a.
English: Cardiac disorders Tachycardia* Bradycardia*, palpitations*
Maltese: Bradikardija*, palpitazzjonijie t*
English: Clinical endpoints
Maltese: Punti aħħarin kliniċi
English: The incidence of thyroid events was higher in patients with a medical history of thyroid disorders both in the LEMTRADA and interferon beta 1a (IFNB1a) treatment groups.
Maltese: L-inċidenza ta' avvenimenti tat-tirojde kienet ogħla f'pazjenti bi storja medika ta' disturbi tat-tirojde kemm fil-grupp ta' kura ta' LEMTRADA kif ukoll filgrupp ta' interferon beta 1a (IFNB-1a).
English: LEMTRADA may increase the risk of acute acalculous cholecystitis.
Maltese: Lemtrada jista' jżid ir-riskju ta' koleċistite akalkuluża akuta .
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC code: L04AA34
Maltese: Immunosoppressanti selettivi, Kodiċi ATC:
English: Serious varicella zoster virus infections, including primary varicella and varicella zoster re-activation, have occurred more often in patients treated with LEMTRADA 12 mg (0.4%) in clinical trials as compared to IFNB-1a (0%).
Maltese: Infezzjonijiet serji bil-virus ta' variċella żoster, li jinkludu variċella primarja u attivazzjoni mill-ġdid ta' variċella żoster, seħħew aktar ta' spiss f'pazjenti kkurati bi 12-il mg LEMTRADA (0.4%) fil-provi kliniċi meta mqabbla ma' IFNB-1a (0%).
English: Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA.
Maltese: Newtrofili, monoċiti, eosinofili, basofili u ċelluli li huma qattiela naturali jiġu affettwati biss temporanjament minn LEMTRADA.
English: Cervical human papilloma virus (HPV) infection, including cervical dysplasia and anogenital warts, has also been reported in patients treated with LEMTRADA 12 mg (2%).
Maltese: Infezzjoni taċ-ċerviċi bil-virus tal-papilloma uman (HPV), li tinkludi displasija taċ-ċerviċi u felul anoġenitali, ġiet irrappurtata wkoll f'pazjenti kkurati bi 12-il mg LEMTRADA (2%).
English: Cytokine release syndrome*, hypersensitivity including anaphylaxis*
Maltese: cytokine*, sensittività eċċessiva inkluża l anafilassi
English: - Alterations in the number, proportions, and properties of some lymphocyte subsets post-treatment - Increased representation of regulatory T cell subsets - Increased representation of memory T- and B-lymphocytes - Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)
Maltese: - Żieda fir-rappreżentanza ta' limfoċiti T u B tal-memorja - Effetti temporanji fuq komponenti ta' immunità konġenita (i.e. newtrofili, makrofaġi, ċelluli NK)
English: The percentage of patients with new or enlarging T2 lesions declined from 50.8% the year prior to Course 3 to 35.9% one year after, and new gadolinium-enhancing lesions from 32.2% to 11.9%.
Maltese: Il-perċentwal ta' pazjenti b'leżjonijiet T2 ġodda jew li qed jikbru naqas minn 50.8% fis-sena ta' qabel Kors 3 sa 35.9% sena wara, u leżjonijiet li jidhru aħjar b'gadolinium minn 32.2% sa 11.9%.
English: PC: {number} SN: {number} NN: {number}
Maltese: Il-frekwenza ta' PML f'pazjenti
English: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Maltese: België/Belgique/Belgien/ Luxemburg/Luxembourg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: Administration of 12 mg/day resulted in a mean Cmax of 3014 ng/ml on day 5 of the initial treatment course, and 2276 ng/ml on day 3 of the second treatment course.
Maltese: L-għoti ta' 12-il mg/jum wassal għal Cmax ta' 3014 ng/ml f'jum 5 tal-kors ta' kura inizjali, u 2276 ng/ml f'jum 3 tat-tieni kors ta' kura.
English: Skin papilloma
Maltese: Tumuri malinni
English: Haemophagocytic lymphohistiocytos is (HLH)
Maltese: Limfoistj oċitożi emofagoċ itika (HLH)
English: LEMTRADA 12 mg sterile concentrate alemtuzumab
Maltese: LEMTRADA 12 mg konċentrat għal soluzzjoni għall-infużjoni alemtuzumab
English: 0.545], p<0.0006) and reduced the ARR by 67% (rate ratio 0.33 [95% CI: 0.196, 0.552], p<0.0001) as compared to subcutaneous IFNB-1a.
Maltese: Wara 3 snin, LEMTRADA naqqas ir-riskju ta' CDW wara 6 xhur b'76% (proporzjon ta' periklu ta' 0.24 [95% CI: 0.110, 0.545], p<0.0006) u naqqas l-ARR b'67% (proporzjon ta' rata ta' 0.33 [95% CI: 0.196, 0.552], p<0.0001) meta mqabbel ma' IFNB-1a mogħti minn taħt il-ġilda.
English: In clinical trials, 74% of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies at baseline developed a thyroid event compared with 38% of patients with a baseline negative status.
Maltese: Fil-provi kliniċi, 74% tal-pazjenti b'antikorpi pożittivi għal peroxidase kontra t-tirojde (anti-TPO, antithyroid peroxidase) fil-linja bażi żviluppaw avveniment tat-tirojde meta mqabbla ma' 38% tal-pazjenti bi stat negattiv fil-linja bażi.
English: For further information on autoimmune reactions, infections and other information.
Maltese: Għal informazzjoni addizzjonali dwar reazzjonijiet awtoimmuni, infezzjonijiet u informazzjoni oħra.
English: Missed LEMTRADA doses
Maltese: Mediċini oħra u LEMTRADA
English: • infection due to a virus known as Epstein-Barr virus
Maltese: Disturbi limfoproliferattivi assoċjati mal-Virus ta' Epstein-Barr
English: HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation.
Maltese: HLH hija sindrome ta' attivazzjoni immuni patoloġika u hija ta' theddida għall-ħajja u kkaratterizzata minn sintomi u sinjali kliniċi ta' infjammazzjoni sistemika estrema.
English: Listeriosis/listeri a meningitis, Epstein-Barr infection, herpes virus infection,1
Maltese: Listerjożi/meninġi te b'listeria, Reattivazzjoni talvirus Epstein-Barr (EBV)
English: A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median follow-up of 6.1 years (maximum 12 years), resulting in 8,635 patient-years of safety follow-up.
Maltese: Total ta' 1,486 pazjent ikkurati b'LEMTRADA (12-il mg jew 24 mg) kienu jiffurmaw il-popolazzjoni tassigurtà f'analiżi miġbura ta' studji kliniċi ta' MS b'segwitu medjan ta' 6.1 snin (massimu ta' 12-il sena) li rriżultaw fi 8,635 sena ta' pazjent ta' segwitu ta' sigurtà.
English: Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Maltese: Kull kunjett fih 12 mg ta' alemtuzumab f'1.2 ml (10 mg/ml).
English: Most events were mild to moderate in severity.
Maltese: Il-biċċa l-kbira tal-avvenimenti kienu minn ħfief sa moderati fis severità.
English: Cytopenias
Maltese: Newtropenja
English: Pre-treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: The number of normal sperm was significantly reduced (<10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Maltese: In-numru ta' sperma normali tnaqqas b'mod sinifikanti (<10%) meta mqabbel mal-kontrolli, u l-perċentwal tal-isperma anormali (irjus maqtugħa jew l-ebda rjus) żdied b'mod sinifikanti (sa 3%).
English: In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
Maltese: Fil-provi kliniċi, il-pazjenti ngħataw aciclovir 200 mg darbtejn kuljum jew ekwivalenti.
English: Myocardial ischaemia and myocardial infarction
Maltese: Iskemija mijokardjali u infart mijokardjali
English: Terms marked with asterisk (*) in Table 1 include adverse reactions reported as Infusion Associated Reactions.
Maltese: It-termini mmarkati b'asterisk (*) f'Tabella 1 jinkludu reazzjonijiet avversi rrappurtati bħala Reazzjonijiet Assoċjati mal-Infużjoni.
English: Confirmed disability improvement (CDI)
Maltese: Konferma li d-diżabilità qegħda titjieb (CDI, Confirmed disability improvement)
English: • Haemophagocytic lymphohistiocytosis
Maltese: • Limfoistjoċitożi emofagoċitika
English: Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases, has been reported in LEMTRADA-treated patients.
Maltese: F'pazjenti ttrattati b'LEMTRADA, ġiet rrappurtata reattivazzjoni tal-virus Epstein-Barr (EBV), inkluż każijiet severi ta' epatite kawża ta' EBV.
English: The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections.
Maltese: L-iktar reazzjonijiet avversi komuni b'LEMTRADA (f'≥20% tal-pazjenti) kienu raxx, uġigħ ta' ras, deni u infezzjonijiet tal-apparat respiratorju.
English: Urticaria*, rash*, pruritus*,
Maltese: Urtikarja*, raxx*, ħakk*, raxx ġeneralizzat*
English: Classical biotransformation studies have not been conducted.
Maltese: Ma sarux studji dwar bijotrasformazzjoni klassika.
English: • stroke
Maltese: • Tilqim
English: Infections were generally of typical duration and resolved following conventional medical treatment.
Maltese: L-infezzjonijiet ġeneralment kienu ta' tul tipiku u fiequ wara kura medika konvenzjonali.
English: Median % Change in Brain Parenchymal Fraction
Maltese: Medjan ta' % tal-bidla fil-Porzjon Parenkimali tal-Moħħ
English: The study was declared successful if at least one of the two coprimary endpoint was met. 2 CDW was defined as an increase of at least 1 point on the expanded disability status scale (EDSS) from a baseline EDSS score ≥1.0 (1.5 point increase for patients with baseline EDSS of 0) that was sustained for 6 months.
Maltese: 2 CDW ġie definit bħala żieda ta' mill-inqas punt wieħed fuq l-iskala tal-istat ta' diżabilità mkabbra (EDSS) minn punteġġ EDSS fil-linja bażi ta' ≥ 1.0 (żieda ta' 1.5 punti għal pazjenti b'EDSS fil-linja bażi ta' 0) li kienet sostnuta għal 6 xhur.
English: Epstein-Barr Virus-associated lymphoproliferative disorders Epstein-Barr Virus-associated lymphoproliferative disorders have been observed outside company-sponsored studies.
Maltese: Disturbi limfoproliferattivi assoċjati mal-Virus ta' Epstein-Barr ġew osservati fi studji li ma kinux sponsorjati mill-kumpanija.
English: Superficial fungal infections, especially oral and vaginal candidiasis, occurred more commonly in LEMTRADA -treated patients (12%) than in patients treated with IFNB-1a (3%) in controlled clinical trials in MS.
Maltese: Infezzjonijiet fungali superfiċjali, speċjalment kandidjasi orali u vaġinali, seħħew b'mod l-iktar komuni f'pazjenti kkurati b'LEMTRADA (12%) milli f'pazjenti kkurati b'IFNB-1a (3%) fi provi kliniċi kkontrollati f'MS.
English: This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free'.
Maltese: Din il-mediċina fiha anqas minn mmol 1 ta' sodium (23 mg) f'kull infużjoni, i.e. hi essenzjalment ‘ħielsa mis-sodium'.
English: Through all available follow-up, including patients who received additional treatment courses, the most common IARs included headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnoea, dysgeusia, chest discomfort, generalised rash, tachycardia, bradycardia, dyspepsia, dizziness, and pain.
Maltese: Mis-segwitu kollu disponibbli, inkluż ta' pazjenti li rċivew korsijiet addizzjonali ta' trattament, l-aktar IARs komuni jinkludu wġigħ ta' ras, raxx, deni, dardir, urtikarja, ħakk, nuqqas ta' rqad, tkexkix ta' bard, fwawar, għeja kbira, qtugħ ta' nifs, indeboliment fis-sens tat-togħma, skumdità fis-sider, raxx mifrux, takikardija, bradikardija, dispepsja, sturdament, u wġigħ.
English: Menorrhagia, menstruation irregular
Maltese: mestrwazzjoni irregolari
English: While not observed in clinical trials, alveolar haemorrhage manifested as haemoptysis may occur with anti-GBM disease.
Maltese: Filwaqt li ma ġietx osservata fil-provi kliniċi, emorraġija alveolari li tidher bħala emoptisi tista' sseħħ mal-marda anti-GBM.