FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of patients were also receiving one or more of the following concomitant treatments for SLE: corticosteroids, immunomodulatory medicinal products, anti-malarials, non-steroidal anti-inflammatory medicinal products.
Maltese: Il-biċċa l-kbira tal-pazjenti kienu qed jirċievu wkoll wieħed jew aktar minn dawn il-kuri konkomitanti għal SLE li ġejjin: kortikosterojdi, prodotti mediċinali immunomodulatorji, mediċini kontra l-malarja, prodotti mediċinali antiinfjammatorji mhux sterojdi.
English: Patients who develop an infection while undergoing treatment with Benlysta should be monitored closely and careful consideration given to interrupting immunosuppressant therapy including belimumab until the infection is resolved.
Maltese: Pazjenti li jiżviluppaw infezzjoni waqt li jkunu qed jieħdu kura b'Benlysta għandhom jiġu mmonitorjati mill-qrib u għandha tingħata konsiderazzjoni b'reqqa għall-interruzzjoni ta' terapija immunosoppressanti inkluż belimumab sakemm l-infezzjoni tiġi riżolta.
English: Do not shake.
Maltese: Neħħi l-għatu.
English: The safety registry will evaluate the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus.
Maltese: Ir-reġistru ta' sigurtà jkun jevalwa l-inċidenza ta' mwiet minn kull kawża u każijiet avversi ta' interess speċjali f'pazjenti b'lupus erythematosus sistemiku.
English: The relative contribution of BLyS levels to the pathophysiology of SLE is not fully understood.
Maltese: għall-patofiżjoloġija ta' SLE mhix mifhuma kompletament.
English: It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus.
Maltese: Huwa jnaqqas in-numru ta' ċelluli B fid-demm tiegħek billi jimblokka l-azzjoni ta' BLyS, proteina li tgħin iċ-ċelluli B jgħixu aktar fit-tul u tinstab f'livelli għoljin f'persuni li għandhom il-lupus.
English: • migraine
Maltese: • emigranja
English: Benlysta 120 mg powder for concentrate for solution for infusion.
Maltese: Benlysta 120 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: The two studies were similar in design except that BLISS-76 was a 76-week study and BLISS-52 was a 52-week study.
Maltese: Iż-żewġ studji kienu jixxiebhu fit-tfassil tagħhom ħlief li BLISS-76 kien studju ta' 76 ġimgħa u BLISS-52 kien studju ta' 52 ġimgħa.
English: The incidence of infusion reactions and hypersensitivity reactions after intravenous administration occurring within 3 days of an infusion was 12% in the group receiving Benlysta and 10% in the group receiving placebo, with 1.2% and 0.3%, respectively, requiring permanent treatment discontinuation.
Maltese: L-inċidenza ta' reazzjonijiet tal-infużjoni u ta'reazzjonijiet ta' sensittività eċċessiva wara għoti ġol-vini li jseħħu fi żmien 3 ijiem minn infużjoni kienet ta' 14 % fil-grupp li kien qed jingħata Benlysta u ta' 10 % filgrupp li kien qed jingħata l-plaċebo, b'1 % u 0.3 %, rispettivament, li kienu jeħtieġu twaqqif permanenti tal kura.
English: In the subcutaneous study where serum samples from more than 550 patients with SLE were tested, no antibelimumab antibodies were detected during or after treatment with belimumab 200 mg subcutaneously.
Maltese: Fl-istudju taħt il-ġilda fejn ġew ittestjati kampjuni tas-serum minn aktar minn 550 pazjent b'SLE, ma ġie osservat l-ebda antikorp ta' belimumab waqt jew wara l-kura b'belimumab 200 mg taħt il-ġilda.
English: These may affect up to 1 in 100 people: • itchy, bumpy rash (hives), skin rash.
Maltese: • ponot jikluk u mqabbżin (ħorriqija), raxx tal-ġilda.
English: Prepare and inspect the pre-filled syringe Allow to come to room temperature
Maltese: Ipprepara u spezzjona l-pinna mimlija għal-lest Ħalliha tiġi għal temperatura ambjentali
English: Allow 10 to 15 minutes for the vial to warm to room temperature (15°C to 25°C).
Maltese: Ħalli bejn 10 sa 15-il minuta biex il-kunjett jisħon sat-temperatura tal-kamra (15°C sa 25°C).
English: Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology.
Maltese: IgG1λ uman, magħmul f'linja ta' ċelluli mammiferi (NS0) permezz ta' teknoloġija rikombinanti tad-DNA.
English: Assay sensitivity for neutralising antibodies and non-specific anti-drug antibody (ADA) is limited by the presence of active drug in the collected samples.
Maltese: Is-sensittività tal-analiżi għal antikorpi li jinnewtralizzaw u antikorp mhux speċifiku kontra l-mediċina (ADA) hija limitata bil-preżenza tal-mediċina attiva fil-kampjuni miġbura.
English: Delayed-type, non-acute hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Belimumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Maltese: Belimumab huwa proteina li r-rotta metabolika mistennija tiegħu hija d-degradazzjoni f'peptides żgħar u aċidi amminiċi individwali permezz ta' enzimi proteolitiċi li huma mifruxa ħafna.
English: The recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.
Maltese: L-iskeda ta' għoti ta' dożi rrakkomandata hija ta' 10 mg/kg ta' Benlysta fil-Jiem 0, 14 u 28, u kull 4 ġimgħat minn hemm 'il quddiem.
English: You are usually given Benlysta on the first day of treatment then again 14 and 28 days later.
Maltese: Is-soltu inti tingħata Benlysta fl-ewwel ġurnata ta' kura mbagħad terġa' tingħata l-kura 14 u 28 jum wara.
English: The risk of first flare was reduced by 22% during the 52 weeks of observation in the group receiving Benlysta compared with the group receiving placebo (hazard ratio=0.78; p=0.0061).
Maltese: Ir-riskju talewwel żbroff tnaqqas bi 22 % matul t-52 ġimgħa ta' osservazzjoni fil-grupp li ngħata Benlyta meta mqabbel mal-grupp li ngħata l-plaċebo (proporzjon ta' periklu=0.78; p=0061).
English: Following subcutaneous administration the bioavailability of belimumab was approximately 74%.
Maltese: Wara għoti taħt il-ġilda d-disponibbiltà ta' belimumab kienet madwar 74 %.
English: Amount of Benlysta Vial size
Maltese: GĦAMLA KWALITATTIVA
English: However, belimumab was detected in the milk from female monkeys administered 150 mg/kg every 2 weeks.
Maltese: Madankollu, belimumab instab fil-ħalib ta' xadini nisa li ngħataw 150 mg/kg kull ġimagħtejn.
English: GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
Maltese: Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44
English: * All patients received standard therapy
Maltese: Belimumab + Standard Therapy
English: EU/1/11/700/006 1 pre-filled syringe EU/1/11/700/007 4 pre-filled syringes
Maltese: EU/1/11/700/006 siringa 1 mimlija għal-lest.
English: After reconstitution, a volume of 5 ml (corresponding to 400 mg belimumab) can be withdrawn from each 20 ml vial.
Maltese: Wara r-rikostituzzzjoni, volum ta' 5 ml (li jikkorrispondi għal 400 mg ta' belimumab) jista' jinġibed minn kull kunjett ta' 20 ml.
English: In a substudy, a small group of patients who had previously received either tetanus, pneumococcal or influenza vaccinations were found to maintain protective titres after treatment with Benlysta.
Maltese: F'sottostudju, grupp żgħir ta' pazjenti li qabel kienu rċivew tilqim tat-tetnu, tal-pneumococcus jew tal-influenza instabu li żammew titres protettivi wara kura b'Benlysta.
English: Paediatric population: No pharmacokinetic data are available for subcutaneous administration of Benlysta in paediatric patients.
Maltese: Effetti farmakodinamiċi Tibdiliet fil-bijomarkaturi dehru fi provi kliniċi b'Benlysta mogħti ġol-vini.
English: BLISS-52 was conducted in South America, Eastern Europe, Asia, and Australia.
Maltese: L-istudju BLISS-52 sar fl-Amerika t'Isfel, fl-Ewropa tal-Lvant, fl-Asja, u fl-Awstralja.
English: Benlysta 120 mg powder for concentrate for solution for infusion Benlysta 400 mg powder for concentrate for solution for infusion belimumab This medicine is subject to additional monitoring.
Maltese: Benlysta 120 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Benlysta 400 mg trab għal konċentrat għal soluzzjoni għall-infużjoni belimumab
English: The recommended dose is 10 mg for each kilogram (kg) of your body weight.
Maltese: Id-doża rakkomandata hija ta' 10 mg għal kull kilogramma (kg) tal-piż tal-ġisem tiegħek.
English: Available in packs of 1 or 4 pre-filled pens in each pack and multipacks comprising 12 pre-filled pens (3 packs of 4 pre-filled pens).
Maltese: Jiġi f'pakketti ta' pinna mimlija għal-lest 1 jew 4 pinen mimlija għal-lest u f'pakkett multiplu li fih 12il pinna mimlija għal-lest ta' doża waħda (3 pakketti jew 4 pinen mimlija għal-lest).
English: The median time to the first flare was delayed in the pooled group receiving Benlysta compared to the group receiving placebo (110 vs 84 days, hazard ratio=0.84, p=0.012).
Maltese: Iż-żmien medjan għall-ewwel żbroff seħħ aktar tard fil-grupp miġbur flimkien li kien qed jingħata Benlysta meta mqabbel mal-grupp li kien qed jingħata plaċebo (110 vs 84 jum, proporzjon ta' periklu =0.84, p=0.012). Żbroff qawwi kien osservat fi 15.
English: Weight-normalised belimumab dosing leads to decreased exposure for underweight subjects (BMI <18.5) and to increased exposure for obese subjects (BMI ≥30).
Maltese: Għoti ta' dożi ta' belimumab normalizzat għall-piż iwassal għal tnaqqis fl-esponiment għal pazjenti li jiżnu anqas milli suppost (BMI <18.5) u għal żieda fl-esponiment f'individwi b'ħafna piż żejjed (BMI >30).
English: Medicines that weaken your immune system, such as Benlysta, may put you at higher risk of getting a rare but serious and life-threatening brain infection called progressive multifocal leukoencephalopathy (PML).
Maltese: In-nies li jkunu qed jieħdu mediċini li jaffettwaw is-sistema immuni tagħhom jistgħu jkunu f'riskju akbar li jkollhom l-infezzjonijiet, inkluż infezzjoni tal-moħħ rari iżda serja imsejħa Lewkoenċefalopatija multifokali progressiva (PML)..
English: The following information is intended for healthcare professionals only:
Maltese: Popolazzjonijiet Speċjali ta' Pazjenti Popolazzjoni pedjatrika:
English: The package leaflet should be provided to the patient each time Benlysta is administered (see section 4.2).
Maltese: Il-fuljett ta' tagħrif għandu jiġi pprovdut lill-pazjent kull darba li jingħata Benlysta (ara sezzjoni 4.2).
English: Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Maltese: Effetti fuq il-fertilità fl-irġiel u finnisa għadhom ma ġewx evalwati b'mod formali fi studji fl-annimali (ara sezzjoni 5.3).
English: Benlysta can have side effects which may make you less able to drive or use machines.
Maltese: Benlysta jista' jkollu effetti sekondarji li jistgħu jagħmluk inqas kapaċi biex issuq jew tħaddem magni.
English: The proportion of black patients achieving an SRI-S2K response was higher in patients receiving Benlysta but the difference was not statistically significant compared with placebo.
Maltese: Il-proporzjon ta' pazjenti suwed li kisbu rispons ta' SRI-S2K kien ogħla f'pazjenti li rċevew Benlysta iżda d-differenza ma kinitx statistikament sinifikanti meta mqabbel mal-plaċebo.
English: Leucopenia: The incidence of leucopenia reported as an adverse event was 3% in the group receiving Benlysta and 2% in the group receiving placebo.
Maltese: L-inċidenza ta' lewkopenija rrappurtata bħala każ avvers kienet ta' 3% fl-grupp li kien qed jingħata Benlysta u ta' 2% fil-grupp li kien qed jingħata plaċebo.
English: Stopping treatment with Benlysta
Maltese: Spezzzjona s-soluzzjoni Benlysta
English: • Do not recycle or throw the used syringe, or container of used syringes in household waste.
Maltese: • Tirriċiklax jew tarmi s-siringa użata, jew il-kontenitur ta' siringi użati, fi skart domestiku.
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 I-43056 San Polo di Torrile, Parma Italy
Maltese: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90
English: Inject Benlysta Insert the needle
Maltese: Jekk tuża Benlysta aktar milli suppost
English: Benlysta 200 mg solution for injection in pre-filled syringe belimumab This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Patients were excluded from the study if they had severe active central nervous system lupus or severe active lupus nephritis.
Maltese: Jekk il-pazjenti kellhom lupus attiv u qawwi tas-sistema nervuża ċentrali jew nefrite qawwija attiva tal-lupus, dawn ġew esklużi.
English: Infections occurring in at least 3% of patients receiving Benlysta and at least 1% more frequently than patients receiving placebo were viral upper respiratory tract infection, bronchitis, and urinary tract infection bacterial.
Maltese: Infezzjonijiet li seħħew f'mill-anqas 3% tal-pazjenti li kienu qed jingħataw Benlysta u mill-anqas 1% b'mod aktar frekwenti minn pazjenti li kienu qed jingħataw l-plaċebo kienu infezzjonijiet fl-apparat tal-awrina u bronkite.
English: RRMS (McDonald criteria)
Maltese: RRMS (kriterji McDonald)
English: Common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100).
English: MRI screening for PML
Maltese: MRI screening għal PML
English: Polysorbate 80 (E433) Water for injections
Maltese: Polysorbate 80 (E433) Ilma għall-injezzjonijiet
English: Luxembourg/Luxemburg Biogen Belgium N.V./S.A.
Maltese: Luxembourg/Luxemburg Biogen Belgium N.V./S.
English: PML and IRIS (Immune Reconstitution Inflammatory Syndrome)
Maltese: PML u IRIS (Sindrome Infjammatorja tar-Rikostituzzjoni Immuni)
English: Anaemia and haemolytic anaemia
Maltese: Anemija u anemija emolitika
English: Pharma MT limited Tel: +356 213 37008/9
Maltese: MT limited Tel: +356 213 37008/9
English: Pharmacotherapeutic group: Selective immunosuppressive agents, ATC code: L04AA23 Pharmacodynamic effects
Maltese: Aġenti immunosoppressivi selettivi, Kodiċi ATC: L04AA23.
English: TYSABRI contains the active substance (natalizumab).
Maltese: TYSABRI fih is-sustanza attiva (natalizumab).
English: MedDRA System Organ Class Adverse reaction
Maltese: Sistema tal-Klassifika talOrgani MedDRA
English: • Unusual infections (so-called “Opportunistic infections”)
Maltese: • Infezzjonijiet mhux tas-soltu (hekk magħrufa “Infezzjonijiet opportunistiċi”)
English: Natalizumab blocks the interaction of α4β7 integrin with the mucosal addressin cell adhesion molecule-1 (MadCAM-1).
Maltese: Natalizumab jimblokka l-interazzjoni ta' integrin α4β7 mal-molekola-1 ta' adeżjoni ta' addressin ta' ċellula mukosali (MadCAM-1).
English: The active substance is natalizumab.
Maltese: Is-sustanza attiva hi natalizumab.
English: Placebo / Natalizumab 300 mg i.v.
Maltese: Plaċebo / Natalizumab 300 mg i.v. kull 4 ġimgħat
English: UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410
Maltese: JOHNSON" Eesti filiaal Tel: +372 617 7410
English: Store in a refrigerator (2˚C - 8˚C).
Maltese: Aħżen fi friġġ (2˚C - 8˚C).
English: Rare side effects that may affect up to 1 in 1,000 people:
Maltese: Effetti sekondarji rari li jistgħu jaffettwaw sa persuna waħda minn kull 1,000:
English: Hazard ratio for disability progression was 0.36 (95% CI: 0.17, 0.76) p = 0.008.
Maltese: L-indiċi ta' riskju għall-progressjoni tad-diżabilità kien 0.36 (95% CI: 0.17, 0.76) p = 0.008.
English: Marketing Authorisation Holder Biogen Idec Limited Innovation House 70 Norden Road
Maltese: Biogen Idec Limited Innovation House 70
English: Monotherapy; randomised double-blind placebo-controlled parallel-group trial for 120 weeks
Maltese: Monoterpija; prova randomised, double-blind, ikkontrollata bilplaċebo, fi gruppi parallel, li dam 120 ġimgħa
English: Each 15 ml vial of concentrate contains 300 mg natalizumab (20 mg/ml).
Maltese: Kull kunjett ta' 15 ml ta' konċentrat fih 300 mg natalizumab (20 mg/ml).
English: TYSABRI can also have other side effects.
Maltese: TYSABRI jista' jkollu effetti sekondrji oħra.
English: Sodium phosphate, monobasic, monohydrate, Sodium phosphate, dibasic, heptahydrate, Sodium chloride (see section 2 ‘TYSABRI contains sodium'), Polysorbate 80 (E433)
Maltese: Sodium phosphate, monobasic, monohydrate Sodium phosphate, dibasic, heptahydrate Sodium chloride (ara sezzjoni 2 ‘TYSABRI fih sodium'), Polysorbate 80 (E433)
English: The mean ± SD steady-state clearance was 13.1 ± 5.0 ml/h, with a mean ± SD half-life of 16 ± 4 days.
Maltese: Il-medja ± SD tat-tneħħijja fi stat stabbli kienet ta' 13.1 ± 5.0 ml/h, b' medja ± SD tal-half-life ta' 16 ± 4 ġranet.
English: The patients were randomised with a 2:1 ratio to receive TYSABRI 300 mg (n = 627) or placebo (n = 315) every 4 weeks for up to 30 infusions.
Maltese: Il-pazjenti kienu randomised f'proporzjon ta' 2:1 biex jirċievu TYSABRI 300 mg (n = 627) jew plaċebo (n = 315) kull 4 ġimgħat sa 30 infużjoni.
English: Specifically, natalizumab binds to the α4β1 integrin, blocking the interaction with its cognate receptor, vascular cell adhesion molecule-1 (VCAM-1), and ligands osteopontin, and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1).
Maltese: Speċifikatament, natalizumab jeħel mal-integrin α4β1, u b'hekk jimblokka l-interazzjoni mar-riċettur kumplimentari tiegħu, molekola-1 ta' adeżjoni ta' ċellula vaskulari (VCAM-1), u mal-ligandi osteopontin, u segment-1 ta' konnessjoni (CS-1), dominju ta' splicing alternattiv ta' fibronectin.
English: • The presence of anti-JCV antibodies.
Maltese: • Il-preżenza ta' antikorpi kontra JCV.
English: Mean average steady-state trough natalizumab concentrations over the dosing period ranged from 23 μg/ml to 29 μg/ml.
Maltese: Il-medja ta' konċentrazzjonijiet fi stat stabbli ta' natalizumab tul il-perijodu ta' dożaġġ varjat minn 23 μg/ml sa 29 μg/ml.
English: UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88
Maltese: JOHNSON" Tel: +370 5 278 68 88
English: Symptoms of JCV GCN are similar to symptoms of PML (i.e. cerebellar syndrome).
Maltese: Is-sintomi ta' JCV GCN huma simili għas-sintomi ta' PML (i.e. sindrome ċerebellari).
English: Rate ratio 0.32 CI95% 0.26 ; 0.40
Maltese: Proporzjon tar-rata 0.32 CI95% 0.26 ; 0.40
English: o Infusion reactions o Hypersensitivity reactions o Antibody formation
Maltese: o Reazzjonijiet għall-infużjoni o Reazzjonijiet ta' sensittività eċċessiva o Formazzjoni ta' antikorpi
English: In placebo-controlled trials in 1,617 MS patients treated with natalizumab for up to 2 years (placebo: 1,135), adverse events leading to discontinuation of therapy occurred in 5.8% of patients treated with natalizumab (placebo: 4.8%).
Maltese: Fi provi kkontrollati bil-plaċebo f'1,617 pazjent b'MS kkurat b'natalizumab sa sentejn (plaċebo: 1,135), effetti avversi li wasslu għal twaqqif tat-terapija seħħew f'5.8% tal-pazjenti kkurati b'natalizumab (plaċebo: 4.8%).
English: Children and adolescents below the age of 18 years.
Maltese: Tfal u adoloxxenti b'età inqas minn 18-il sena.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/346/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/346/001
English: Following the repeat intravenous administration of a 300 mg dose of natalizumab to MS patients, the mean maximum observed serum concentration was 110 ± 52 μg/ml.
Maltese: Wara għotja ripetuta ġol-vini ta' doża ta' 300 mg ta' natalizumab f'pazjenti b'MS, il-medja ta'konċentrazzjoni massima osservata fis-serum kienet ta' 110 ± 52 μg/ml.
English: TYSABRI contains sodium
Maltese: TYSABRI fih sodium
English: What are the symptoms of multiple sclerosis?
Maltese: X'inhuma s-sintomi ta' l-isklerożi multipla?
English: Biogen Idec Limited, Innovation House, 70 Norden Road, Maidenhead, Berkshire,
Maltese: Norden Road, Maidenhead, Berkshire,
English: Hazard ratio 0.46, CI95% 0.33; 0.64, p<0.001
Maltese: Proporzjon ta' riskju 0.46, CI95% 0.33; 0.64, p<0.001
English: Anti-JCV antibody testing
Maltese: Il-preżenza ta' antikorpi kontra JCV
English: LIST OF EXCIPIENTS sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) and water for injections.
Maltese: sodium phosphate, monobasic, monohydrate; sodium phosphate, dibasic, heptahydrate; sodium chloride; polysorbate 80 (E433) u ilma għall-injezzjoni.
English: Over the 2-year duration of the studies, 43.5% of patients treated with natalizumab reported adverse reactions (placebo: 39.6%).
Maltese: Tul is-sentejn li damu l-istudji, 43.5% tal-pazjenti kkurati b'natalizumab irrappurtawa reazzjonijiet avversi tal-mediċina (plaċebo: 39.6%).
English: Hypersensitivity reactions have been associated with TYSABRI, including serious systemic reactions (see section 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva kienu assoċjati ma' TYSABRI, inkluż reazzjonijiet sistemiċi serji (ara sezzjoni 4.8).
English: Signs of a possible liver problem:
Maltese: Sinjali ta' problema possibbli fil-fwied:
English: − Severe diarrhoea
Maltese: − Dijarea severa
English: Genesis Pharma SA Τηλ: +30 210 8771500
Maltese: Τηλ: +30 210 8771500
English: Hazard ratio 0.58, CI95% 0.43; 0.73, p<0.001
Maltese: Proporzjon ta' riskju 0.58, CI95% 0.43; 0.73, p<0.001
English: • If you are taking either beta-interferon or glatiramer acetate.
Maltese: • Jekk qed tieħu beta-interferon jew glatiramer acetate.
English: • Use aseptic technique when preparing TYSABRI solution for intravenous (IV) infusion.
Maltese: • Uża teknika asettika meta tipprepara soluzzjoni ta' TYSABRI għall-infużjoni ġol-vini (IV).
English: Rate ratio 0.33 CI95% 0.26 ; 0.41
Maltese: Proporzjon tar-rata 0.33 CI95% 0.26 ; 0.41
English: Combination with beta-interferons or glatiramer acetate.
Maltese: Użu flimkien ma' beta-interferons jew glatiramer acetate.
English: • Adult patients aged 18 years and over with high disease activity despite treatment with a betainterferon or glatiramer acetate.
Maltese: • Pazjenti adulti b'età minn 18-il-sena 'l fuq li għandhom attività għolja tal-marda għalkemm ikkurati b'interferon-beta jew glatiramer acetate.
English: In a study in monkeys, the number of abortions was doubled in the natalizumab 30 mg/kg treatment groups versus matching control groups.
Maltese: Fi studji fix-xadini, in-numru ta' aborti rduppjaw fil-gruppi kkurati b'natalizumab 30 mg/kg meta mqabbla mal-gruppi ta' kontroll pariġġ.
English: The risk of PML with TYSABRI is higher:
Maltese: Ir-riskju ta' PML b'TYSABRI huwa ogħla:
English: TYSABRI increases the risk of developing encephalitis and meningitis caused by herpes simplex and varicella zoster viruses.
Maltese: TYSABRI iżid ir-riskju li jiżviluppaw enċefalite u meninġite kkawżati minn viruses ta' herpes simplex u varicella zoster.
English: Proportion progressed1(12-week confirmation; primary outcome)
Maltese: Proporzjon li avvanzaw1(12-il ġimgħa ta' konferma; żvilupp primarju)
English: The presence of persistent antinatalizumab antibodies increased natalizumab clearance approximately 3-fold, consistent with reduced serum natalizumab concentrations observed in persistently antibody-positive patients, (see section 4.8).
Maltese: Il-preżenza ta' antikorpi persistenti għal natalizumab żiedu t-tneħħijja ta' natalizumab b'madwar 3-darbiet, konsistenti ma' tnaqqis fil-konċentrazzjonijiet fis-serum ta' natalizumab osservati f'pazjenti li kellhom antikorpi persistenti, (ara sezzjoni 4.8).
English: Symptoms of JCV GCN are similar to PML.
Maltese: Is-sintomi ta' JCV GCN huma simili għal PML.
English: These occurred in 23.1% of MS patients treated with natalizumab (placebo: 18.7%).
Maltese: Dawn seħħew f'23.1% tal-pazjenti b'MS kkurati b'natalizumab (plaċebo: 18.7%).
English: Sodium content in TYSABRI
Maltese: Mediċini oħra u TYSABRI
English: Biogen Idec Limited Innovation House 70 Norden Road Maidenhead Berkshire
Maltese: Norden Road Maidenhead Berkshire