FrancophonIA/ELRC3.0 huggingface dataset:
English: o Description of MRI protocols for baseline, routine screening and in case of PML suspicion o Anti-JCV antibody testing, frequency of testing, interpretation of qualitative and quantitative results, seroprevalence of JCV-antibodies and seroconversion rate over time o Monitoring strategy after discontinuation of TYSABRI treatment o The need to inform patients about the benefits and risk of TYSABRI and provide them with:
Maltese: suspett ta' PML o Ittestjar ta' antikorpi kontra JCV, il-frekwenza tal-ittestjar, l-interpretazzjoni tar-riżultati kwalitattivi u kwantitattivi, is-seroprevalenza ta' antikorpi kontra JCV u r-rata ta'
English: Infections including other opportunistic infections
Maltese: Infezzjonijiet li jinkludu infezzjonijiet opportunistiċi oħra
English: Pack size of one vial per carton.
Maltese: Daqs tal-pakkett huwa kunjett wieħed f'kull kartuna.
English: Of these, 581 patients received a fixed 300 mg dose as monotherapy.
Maltese: Minn dawn, 581 pazjent rċevew doża fissa ta' 300 mg bħala monoterapija.
English: Anti-JCV antibody negative patients may still be at risk of PML for reasons such as a new JCV infection, fluctuating antibody status or a false negative test result.
Maltese: Pazjenti negattivi għal antikorpi kontra JCV jistgħu xorta jkollhom riskju ta' PML għal raġunijiet bħal infezzjoni ġdida JCV, stat varjabbli ta' antikorpi jew riżultat ta' test negattiv falz.
English: TYSABRI contains 2.3 mmol (or 52 mg) sodium per vial of medicinal product.
Maltese: TYSABRI fih 2.3 mmol (jew 52 mg) ta' sodium f'kull kunjett tal-prodott mediċinali.
English: 15 ml concentrate in a vial (type I glass) with a stopper (bromobutyl rubber) and a seal (aluminium) with a flip-off cap.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 15 ml ta' konċentrat f'kunjett (ħġieġ tat-tip I) b'tapp (lasktu bromobutyl) u siġill (aluminju) b'għatu flip-off.
English: Some patients may have been exposed to immunosuppressive medicinal products (e.g. mitoxantrone, cyclophosphamide, azathioprine).
Maltese: cyclophosphamide, azathioprine).
English: • If you have previously taken a medicine called an immunosuppressant.
Maltese: • Jekk qabel ħadt mediċina msejjħa immunosoppressanti.
English: TYSABRI is contraindicated in children and adolescents below the age of 18 years (see section 4.3).
Maltese: Popolazzjoni pedjatrika TYSABRI huwa kontra-indikat fi tfal b'età inqas minn 18-il sena (ara sezzjoni 4.3).
English: Progressive multifocal leukoencephalopathy (PML).
Maltese: Lewkoenċefalopatija multifokali progressiva (PML).
English: Each vial contains 2.3 mmol (or 52 mg) sodium.
Maltese: Kull kunjett fih 2.3 mmol (jew 52 mg) ta' sodium.
English: Remove flip-off cap from the vial.
Maltese: Neħħi lgħatu flip-off mill-kunjett.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) the medicinal product contains 17.7 mmol (or 406 mg) sodium.
Maltese: Meta jiġi dilwit f'100 ml ta' sodium chloride 9 mg/ml (0.9%) il-prodott mediċinali ikun fih 17.7 mmol (jew 406 mg) ta' sodium.
English: Natalizumab is a recombinant humanised anti-α4-integrin antibody produced in a murine cell line by recombinant DNA technology.
Maltese: Natalizumab huwa antikorp rikombinat umanizzat anti-α4-integrin prodott minn razza ta' ċelluli tal-ġrieden permezz ta' teknoloġija tat-tfassil tad-DNA.
English: Sixteen of the 29 were classified as major defects.
Maltese: Sittax mid-29 ġew ikklassifikati bħala difetti maġġuri.
English: Concurrent use of these agents with TYSABRI may increase the risk of infections, including opportunistic infections, and is contraindicated (see section 4.3).
Maltese: L-użu ta' dawn l-aġenti fl-istess waqt ma' TYSABRI jista' jżid ir-riskju ta' infezzjonijiet, inkluż infezzjonijiet opportunistiċi, u huwa kontra-indikat (ara sezzjoni 4.3).
English: PML usually leads to severe disability or death (see section 4.4).
Maltese: PML ġeneralment twassal għal diżabilità severa jew mewt (ara sezzjoni 4.4).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27th June 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 27 ta' Ġunju 2006
English: During treatment with TYSABRI, small reductions in haemoglobin (mean decrease 0.6 g/dl), haematocrit (mean decrease 2%) and red blood cell counts (mean decrease 0.1 x 106/l) were seen.
Maltese: 0.6 g/dl), ematokrita (tnaqqis medju ta' 2%) u fl-għadd taċ-ċelluli ħomor fid-demm (tnaqqis medju ta' 0.1 x 106/l).
English: Unopened vial:
Maltese: Studju AFFIRM:
English: TYSABRI 300 mg concentrate for solution for infusion natalizumab
Maltese: TYSABRI 300 mg konċentrat għal soluzzjoni għall-infużjoni natalizumab
English: A condition called JCV GCN (JC virus granule cell neuronopathy) is also caused by JC virus and has occurred in some patients who have been given TYSABRI.
Maltese: Kundizzjoni msejħa JCV GCN (JC virus granule cell neuronopathy) li hija wkoll ikkawżata mill-virus JC ġiet irrappurtata f'xi pazjenti kkurati b'TYSABRI.
English: See section 4.3.
Maltese: Ara sezzjoni 4.8
English: • Feeling sick (nausea)
Maltese: • Allerġija severa (sensittività eċċessiva)
English: The completed prospective TYSABRI pregnancy registry contained 355 pregnancies with available outcomes.
Maltese: Ir-reġistru prospettiv komplet tat-tqala ta' TYSABRI kien fih 355 tqala b'riżultati disponibbli.
English: In clinical trials, herpes infections (Varicella-Zoster virus, Herpes-simplex virus) occurred slightly more frequently in natalizumab-treated patients than in placebo-treated patients.
Maltese: Fi provi kliniċi, infezzjonijiet ta' herpes (Varicella-Zoster virus, Herpes-simplex virus) seħħew ftit aktar frekwenti f'pazjenti bil-kura natalizumab minn f'pazjenti bil-kura placebo.
English: Patients should be re-informed about the risk factors for PML, like duration of treatment, immunosuppressant use prior to receiving TYSABRI and the presence of antiJohn Cunningham virus (JCV) antibodies (see section 4.4.
Maltese: Il-pazjenti għandhom jerġgħu jiġu infurmati dwar il-fatturi ta' riskju għal PML, bħal tul tal-kura, użu ta' immunosoppressanti qabel ma tirċievi TYSABRI u l-preżenza ta' antikorpi kontra l-virus ta' John Cunningham (JCV) (ara sezzjoni 4.4.).
English: Stopping TYSABRI therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Symptoms can include; walking problems, numbness in the face, arms or legs, problems seeing things, tiredness, feeling off-balance or light headed, bladder and bowel problems, difficulty in thinking and concentrating, depression, acute or chronic pain, sexual problems, and stiffness and muscle spasms.
Maltese: Is-Sintomi jistgħu jinkludu; problemi biex timxi, tnemnim fil-wiċċ, idejn jew saqajn, problemi biex tara, għejja, tħossok titlef il-bilanċ jew sturdut, problemi tal-bużżieqa tal-awrina u tal-musrana, diffikultà biex taħseb u tikkonċentra, depressjoni, uġigħ akut jew kroniku, problemi sesswali, u egħbusija u spażmi fil-muskoli.
English: Progressive Multifocal Leukoencephalopathy (PML)
Maltese: Multifokali Progressiva (PML)
English: This active ingredient is called a monoclonal antibody.
Maltese: Din is-sustanza attiva tissejjaħ antikorp monoklonali.
English: There were 316 live births, 29 of which were reported to have birth defects.
Maltese: Kien hemm 316-il twelid ta' trabi ħajjin, li 29 minnhom ġie rrappurtat li kellhom difetti tat-twelid.
English: When diluted the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Maltese: Meta jiġi dilwit is soluzzjoni għall-infużjoni fiha madwar 2.6 mg/ml ta' natalizumab.
English: When diluted in 100 ml sodium chloride 9 mg/ml (0.9%) this medicinal product contains 17.7 mmol (or 406 mg) sodium per dose.
Maltese: Meta jiġi dilwit f'100 ml ta' sodium chloride 9 mg/ml (0.9%) il-prodott mediċinali ikun fih 17.7 mmol (jew 406 mg) ta' sodium f'kull doża.
English: • Patient details, signature and date
Maltese: • Dettalji tal-pazjent, firma u data
English: • If your doctor has told you that you have PML (progressive multifocal leukoencephalopathy).
Maltese: • Jekk it-tabib tiegħek qallek li għandek PML (lewkoenċefalopatija multifokali progressiva).
English: • Patients who have all three risk factors for PML (i.e., are anti-JCV antibody positive and have received more than 2 years of TYSABRI therapy, and have received prior immunosuppressant therapy),
Maltese: • Pazjenti li jkollhom it-tliet fatturi kollha ta' riskju għal PML (i.e., ikunu pożittivi għal antikorpi kontra JCV u jkunu rċivew aktar minn sentejn ta' terapija b'TYSABRI, u jkunu rċivew terapija b'immunosoppressanti fil-passat),
English: Malignancies
Maltese: MEDIĊINALI
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 20 mg of natalizumab.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 20 mg ta' natalizumab.
English: MRI (0-2 years) Median % change in T2hyperintense lesion volume
Maltese: MRI (0-sentejn) Medjan tat-tibdil % fil-volum ta'
English: Uncommon side effects that may affect up to 1 in 100 people:
Maltese: Effetti sekondarji mhux komuni li jistgħu jaffettwaw sa persuna waħda minn kull 100:
English: Persistent antibodies were associated with a substantial decrease in the effectiveness of TYSABRI and an increased incidence of hypersensitivity reactions.
Maltese: Antikorpi persistenti kienu assoċjati ma tnaqqis sostanzjali fl-effikaċja ta' TYSABRI u ma' incidenza akbar ta' reazzjonijiet ta' sensittività eċċessiva.
English: When diluted (see section 6.6), the solution for infusion contains approximately 2.6 mg/ml of natalizumab.
Maltese: Meta jiġi dilwit (ara sezzjoni 6.6), is-soluzzjoni għall-infużjoni fiha madwar 2.6 mg/ml ta'
English: Additional infusion-related reactions associated with persistent antibodies included rigors, nausea, vomiting and flushing (see section 4.4).
Maltese: Effetti mhux mixtieqa oħra relatati mal-infużjoni assoċjati ma' antikorpi persistenti inkludew rogħda ta' bard, tqalliġh, rimettar u fwawar (ara sezzjoni 4.4).
English: This reduces nerve damage caused by MS.
Maltese: Dan inaqqas il-ħsara lin-nervaturi kkawżata minn MS.
English: JC virus also causes JCV granule cell neuronopathy (GCN) which has been reported in patients treated with TYSABRI.
Maltese: Il-virus JC jikkawża wkoll newropatija taċ-ċelluli granuli (granule cell neuronopathy, GCN)) ta' JCV li ġiet irrappurtata f'pazjenti kkurati b'TYSABRI.
English: Proportion progressed1(24-week confirmation)
Maltese: Proporzjon li avvanzaw1(24 ġimgħa ta' konferma)
English: How to store TYSABRI
Maltese: Tużax TYSABRI
English: 4.5 Interaction with other medicinal products and other forms of interaction TYSABRI is contraindicated in combination with beta-interferons or glatiramer acetate (see section
Maltese: TYSABRI huwa kontra-indikat flimkien ma' beta-interferons jew glatiramer acetate (ara sezzjoni 4.3).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: • Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: • Żid il-15 ml ta' konċentrat għal soluzzjoni għall-infużjoni ma' 100 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: If not used immediately, the diluted solution must be stored at 2˚C - 8˚C and infused within 8 hours of dilution.
Maltese: Jekk ma jintużax immedjatament, is-soluzzjoni dilwita għandha tinħażen f'temperatura ta' 2˚C - 8˚C u infuża sa 8 sigħat wara d-dilwazzjoni.
English: In a randomised, open label study of 60 patients with relapsing MS there was no significant difference in the humoral immune response to a recall antigen (tetanus toxoid) and only slightly slower and reduced humoral immune response to a neoantigen (keyhole limpet haemocyanin) was observed in patients who were treated with TYSABRI for 6 months compared to an untreated control group.
Maltese: Fi studju randomised, open label ta' 60 pazjent b'MS li tirkadi ma kien hemm l-ebda differenza sinifikanti fir-rispons umorali immuni għal recall antiġen (tetanus toxoid) u kien osservat biss rispons umorali immuni kemmxejn aktar bil-mod u mnaqqas għal neoantigen (keyhole limpet haemocyanin)
English: These antibodies are a sign that you have been infected by JC virus.
Maltese: Dawn l-antikorpi huma sinjal li ġejt infettat mill-virus JC.
English: • Patient alert card
Maltese: • Kartuna ta' Allarm tal-pazjent
English: For storage conditions after dilution of the medicinal product see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara d-dilwizzjoni tal-prodott mediċinali, ara sezzjoni 6.3. 6.5
English: TYSABRI therapy and without prior history of immunosuppressant therapy.
Maltese: terapija b'TYSABRI, u ma jkollhom l-ebda storja medika ta' terapija b'immunosoppressanti.
English: Anti-JCV antibody testing provides supportive information for risk stratification of TYSABRI treatment.
Maltese: Ittestjar għall-antikorpi kontra JCV jipprovdi informazzjoni ta' appoġġ għal stratifikazzjoni tar-riskju ta' kura b'TYSABRI.
English: • The recommended dose for adults is 300 mg given once every 4 weeks.
Maltese: • Id-doża rakkomandata għall-adulti hija 300 mg mogħtija darba kull 4 ġimgħat.
English: Relapse rate
Maltese: Tqala u treddigħ
English: • Prescriber name, signature and date
Maltese: • Isem tat-tabib, firma u data
English: • Severe allergy (hypersensitivity) • Progressive multifocal leukoencephalopathy (PML)
Maltese: • Lewkoenċefalopatija multifokali progressiva (PML)
English: Hypersensitivity to natalizumab or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal natalizumab jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Each vial of TYSABRI contains 2.3 mmol (or 52 mg) of sodium.
Maltese: Kull kunjett ta' TYSABRI fih 2.3 mmol (jew 52 mg) ta' sodium.
English: In the sub-group of patients indicated for treatment of rapidly evolving relapsing remitting MS (patients with 2 or more relapses and 1 or more Gd+ lesion), the annualised relapse rate was 0.282 in the TYSABRI treated group (n = 148) and 1.455 in the placebo group (n = 61) (p <0.001).
Maltese: fil-grupp ikkurat b'TYSABRI (n = 148) u 1.455 fil-grupp ikkurat bil-plaċebo (n = 61) (p <0.001).
English: Mean number of T1-hypointense lesions
Maltese: Numru medju ta' leżjonijiet ipointensi f'T1
English: 1 Progression of disability was defined as at least a 1.0 point increase on the EDSS from a baseline EDSS >=1.0 sustained for 12 or 24 weeks or at least a 1.5 point increase on the EDSS from a baseline EDSS =0 sustained for 12 or 24 weeks.
Maltese: 1 Progressjoni tad-diżabilità kienet definita bħala żjieda ta' l-inqas punt fuq l-EDSS mill-linja bażika ta' EDSS >=1.0 miżmum għal 12 jew 24 ġimgħa jew ta' l-inqas żjieda ta' punt u nofs fuq l-EDSS milllinja bażika ta' EDSS =0 miżmum għal 12 jew 24 ġimgħa.
English: Re-testing of anti-JCV antibody negative patients every 6 months is recommended.
Maltese: F'pazjenti negattivi għall-antikorpi kontra JCV huwa rrakkomandat ittestjar mill-ġdid kull 6 xhur.
English: • TYSABRI must not be mixed with other medicinal products or diluents.
Maltese: • TYSABRI m'għandux jitħallat ma' prodotti mediċinali jew dilwenti oħra.
English: For medicinal products such as interferon and glatiramer acetate, concomitant exposure of this duration was not associated with safety risks in clinical trials.
Maltese: Għall-prodotti mediċinali bħal interferon u glatiramer acetate, espożizzjoni fl-istess waqt ta' dan it-tul ma kienetx assoċjata ma' riskji ta' sikurtà fi provi kliniċi.
English: Increases from baseline for lymphocytes, monocytes, eosinophils and basophils ranged from 35% to 140% for individual cell types but mean cell counts remained within normal ranges.
Maltese: Żjieda mill-linja bażi ta' limfoċiti, monoċiti, eżinofili u bażofili varjat minn 35% sa 140% għal kull tip ta' ċellula individwali iżda l-għadd medju taċ-ċelluli baqa' fil-firxa normali.
English: After 2 years all patients should be re-informed about the risk of PML with TYSABRI.
Maltese: Wara sentejn, il-pazjenti għandhom jiġu infurmati mill-ġdid dwar ir-riskju ta' PML b'TYSABRI.
English: Data on the safety and efficacy of natalizumab at 2 years were generated from controlled, doubleblind studies.
Maltese: Dejta dwar is-sigurtà u l-effikaċja ta' natalizumab wara sentejn kienet iġġenerata minn studji kkontrollati u double-blind.
English: It is considered unlikely that natalizumab will affect fertility performance in humans following the maximum recommended dose.
Maltese: Huwa kkunsidrat improbabbli li natalizumab jaffetwaw ir-rendiment tal-fertilità fil-bnedmin wara d-doża massima rrakkomandata.
English: Patients can switch directly from beta interferon or glatiramer acetate to natalizumab providing there are no signs of relevant treatment-related abnormalities e.g. neutropenia.
Maltese: Il-pazjenti jistgħu jaqilbu direttament minn beta interferon jew glatiramer acetate għal natalizumab dejjem jekk m'hemm l-ebda sinjali ta' anormalitajiet rilevanti relatati mal-kura e.ż. newtropenija.
English: A population pharmacokinetics analysis was conducted on samples from over 1,100 MS patients receiving doses ranging from 3 to 6 mg/kg natalizumab.
Maltese: Twettqet analiżi tal-farmakokinetika tal-popolazzjoni fuq kampjuni ta''l fuq minn 1,100 pazjenti b'MS li kienu qed jirċievu dożi ta' natalizumab li varjaw minn 3 sa 6 mg/kg.
English: Progressive Multifocal Leukoencephalopathy (PML) Use of TYSABRI has been associated with an increased risk of PML, an opportunistic infection caused by JC virus, which may be fatal or result in severe disability.
Maltese: L-użu ta' TYSABRI kien assoċjat ma' żjieda fir-riskju ta' PML, infezzjoni opportunistika kkawżata mill-virus JC, li tista' tkun fatali jew twassal għal diżabilità severa.
English: Add the 15 ml concentrate for solution for infusion to 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Żid il-15 ml ta' konċentrat għal soluzzjoni għall-infużjoni ma' 100 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: EDSS-baseline, median (range)
Maltese: Tul ta' żmien mid-dijanjożi, snin medjan (firxa)
English: Leukocyte migration across the BBB involves interaction between adhesion molecules on inflammatory cells and endothelial cells of the vessel wall.
Maltese: Il-migrazzjoni tal-lewkoċiti mill-BBB tinvolvi interazzjoni bejn il-molekoli ta' adeżjoni fuq iċ-ċelluli infjammati u ċ-ċelluli endotiljali tal-ħajt tal-kanal.
English: Dizziness
Maltese: Soġġetti
English: A few patients have had an allergic reaction to TYSABRI.
Maltese: Numru żgħir ta' pazjenti kellhom reazzjoni allerġika għal TYSABRI.
English: The nature of the infections was generally similar in natalizumab- and placebo-treated patients.
Maltese: In-natura tal-infezzjonijiet kienu ġeneralment simili fil-pażjenti kkurati b'natalizumab u f'dawk ikkurati bil-plaċebo.
English: The reactions are reported as MedDRA preferred terms under the MedDRA primary system organ class.
Maltese: Ir-reazzjonijiet huma rrappurtati bħala termini ppreferuti MedDRA taħt is-sitema primarja tal-klassifika tal-organi MedDRA.
English: The anti-JCV antibody assay (ELISA) should not be used to diagnose PML.
Maltese: L-analiżi ta' antikorpi kontra JCV (ELISA) m'għandhux jintuża għad-dijanjosi ta' PML.
English: Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in multiple sclerosis patients receiving TYSABRI (see section 4.8).
Maltese: Każijiet serji, ta' theddida għall-ħajja, u xi kultant fatali ġew irrappurtati fl isfond ta' wara t-tqegħid fis-suq f'pazjenti bi sklerożi multipla li kienu qed jirċievu TYSABRI (ara sezzjoni 4.8).
English: For further information on anti-JCV antibody testing please see Physician Information and Management Guidelines.
Maltese: Għal aktar informazzjoni dwar l-ittestjar għal antikorpi kontra JCV, jekk jogħġbok ara l-Linji Gwida ta' Informazzjoni lit-Tabib u Mmaniġġjar.
English: Will TYSABRI always work?
Maltese: TYSABRI dejjem se jaħdem?
English: Opportunistic infections were also detected in MS patients treated with TYSABRI as a monotherapy (see section 4.8).
Maltese: Instabu wkoll infezzjonijiet opportunistiċi f'pazjenti b'MS kkurati b'TYSABRI bħala monoterapija (ara sezzjoni 4.8).
English: o PML management algorithm o The recommendation that patients should have MRI scans at the following times:
Maltese: o Algoritmu ta' immanniġjar ta' PML o Ir-rakkomandazzjoni li l-pazjenti għandu jkollhom MRI scans fiż-żminijiet segwenti:
English: Adverse reactions reported with natalizumab with an incidence of 0.5% greater than reported with placebo are shown below.
Maltese: Reazzjonijiet avversi rrappurtati b'natalizumab b'inċidenza ta' 0.5% akbar minn dik irrappurtat bil-plaċebo huma mniżżla taħt.
English: Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7799
Maltese: Tel: +353 (0)1 463 7799
English: PHARMACOLOGICAL PROPERTIES
Maltese: Effetti farmakodinamiċi
English: Reductions in female guinea pig fertility were observed in one study at doses in excess of the human dose; natalizumab did not affect male fertility.
Maltese: Kien osservat tnaqqis fil-fertilità ta' fniek tal-indi femminili fi studju wieħed b'dożi akbar mid-doża tal-bniedem; natalizumab m'affettwax il-fertilità maskili.
English: • Confirmation that the doctor has discussed the risks of PML and the risk of IRIS if treatment is discontinued following suspicion of PML
Maltese: • Konferma li t-tabib iddiskuta r-riskji ta' PML u r-riskju ta' IRIS jekk il-kura titwaqqaf wara suspett ta' PML
English: • Immunosuppressant use prior to receiving TYSABRI.
Maltese: • Użu ta' immunosoppressanti qabel ma tirċievi
English: Use aseptic technique when preparing TYSABRI solution for intravenous infusion.
Maltese: Uża teknika asettika meta tipprepara soluzzjoni ta' TYSABRI għall-infużjoni ġol-vini.
English: Once the clinician has excluded PML and/or JCV GCN (if necessary, by repeating clinical, imaging and/or laboratory investigations if clinical suspicion remains), dosing of TYSABRI may resume.
Maltese: Ladarba it-tabib jeskludi PML u/jew JCV GCN, (jekk hemm bżonn billi jiġu ripetuti immaġini kliniċi u/jew investigazzjonijiet tal-laboratorju jekk jibqa' suspett kliniku), l-għotja ta' TYSABRI tista' titkompla.
English: • Adult patients aged 18 years and over with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Maltese: jew • Pazjenti adulti b'età minn 18-il-sena 'l fuq bi sklerozi multipla severa li tirkada u tbatti u li qed tiżviluppa malajr definiti b'żewġ episodji jew aktar ta' rkadar li jikkawżaw diżabilità f'sena, u b'leżjoni waħda jew aktar li tidher aħjar b'Gadolinium f'MRI tal-moħħ jew bi żjieda sinnifikanti fil-kwantità ta' leżjonijiet T2 meta mqabbel ma' MRI reċenti ta' qabel.
English: Age yrs, median (range) MS-history yrs, median (range) Time since diagnosis, yrs median (range)
Maltese: Eta' snin, medjan (firxa) Passat-MS snin, medjan (firxa)
English: Maidenhead
Maltese: Sturdament
English: • Sore throat and runny or blocked up nose
Maltese: • Diffikultà biex tieħu n-nifs
English: Body weight was found to influence clearance in a less-thanproportional manner, such that a 43% change in body weight resulted in a 31% to 34% change in clearance.
Maltese: Instab li l-piż tal-ġisem influwenza t-tneħħijja f'mod inqas minn proporzjonali, b'tali mod li tibdil ta' 43% fil-piż tal-ġisem wassal għall-tibdil ta' 31% sa 34% fit-tneħħijja.
English: Rare, serious cases of anaemia and haemolytic anaemia have been reported in patients treated with TYSABRI in post-marketing observational studies.
Maltese: Każijiet rari u serji ta' anemija u anemija emolitika ġew irrappurtati f'pażjenti fuq TYSABRI fi studji ta' osservazzjoni wara t-tqegħid fis-suq.
English: • It is important to continue with your medicine for as long as you and your doctor decide that it is helping you.
Maltese: • Huwa mportanti li tkompli bil-mediċina tiegħek sakemm int u t-tabib tiegħek tiddeċiedu li qed tgħinek.