FrancophonIA/ELRC3.0 huggingface dataset:
English: Total exposure (subject-years) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
Maltese: Esponiment totali (snin ta' individwi) ≥ 3 x ULN > 5 x ULN > 10 x ULN > 20 x ULN
English: • nervousness, anxiety
Maltese: • nervożità, ansjetà
English: The active substance is daclizumab.
Maltese: Is-sustanza attiva hi daclizumab.
English: Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY United Kingdom
Maltese: Innovation House 70 Norden Road Maidenhead Berkshire SL6 4AY Ir-Renju Unit
English: Tonsillitis†
Maltese: Tonsillite†
English: Gauze Pad
Maltese: Pad tal
English: AST or ALT ≥ 3 x ULN AND total bilirubin ≥ x 2 ULN
Maltese: AST jew ALT ≥ 3 x ULN U bilirubina totali ≥ x 2 ULN
English: Placebo (N=204)
Maltese: (N=204)
English: Zinbryta 150 mg p-value
Maltese: Zinbryta 150 mg valur p
English: Pharmacotherapeutic group: immunosuppressants, interleukin inhibitors, ATC code: L04AC01
Maltese: Kategorija farmakoterapewtika: immunosoppressanti, inibituri ta' interleukin, Kodiċi ATC:
English: • Store in a refrigerator (2oC to 8oC).
Maltese: • Aħżen fi friġġ (2oC to 8oC).
English: Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati għal Zinbryta 150mg Sistema tal-Klassifika tal-Organi
English: Rash*†
Maltese: Raxx*†
English: Depression*
Maltese: Depressjoni*
English: België/Belgique/Belgien Biogen Belgium N.V./S.A.
Maltese: België/Belgique/Belgien Biogen Belgium N.V./S.
English: • irritability, getting upset easily
Maltese: • irritabilità, issir irritabbli faċilment
English: Eesti UAB "JOHNSON & JOHNSON" Eesti filiaal
Maltese: JOHNSON" Eesti filiaal
English: Caution!
Maltese: Attenzjoni!
English: Serious reactions, including autoimmune hepatitis, hepatitis and jaundice, were observed in 1.7% of patients in clinical trials.
Maltese: Reazzjonijiet, li jinkludu epatite awtoimmuni, epatite u suffejra, ġew osservati f'1.7% tal-pazjenti fil-provi kliniċi.
English: • 1 Zinbryta 150 mg Pen (see Figure A) Before Use - Parts of Zinbryta Pen (See Figure A):
Maltese: • 1 Zinbryta 150 mg Pinna (ara Figura A) Qabel l-Użu - Partijiet tal-Pinna Zinbryta (ara Figura A): Figura A
English: MRI endpoints#
Maltese: Punti aħħarin tal-MRI#
English: Step 3: Check the Zinbryta Pen (Figure C) a.
Maltese: Pass 3: Iċċekkja l-Pinna Zinbryta (Figura C) a.
English: Interferon beta-1a (intramuscular) 30 micrograms
Maltese: Interferon beta-1a (ġol-muskoli) 30 mikrogramma
English: Sustained severe lymphopenia (< 500/mm3), was not observed in clinical studies with Zinbryta.
Maltese: Limfopenija severa sostnuta (< 500/mm3), ma ġietx osservata flistudji kliniċi b'Zinbryta.
English: INFORMATION IN BRAILLE Zinbryta
Maltese: INFORMAZZJONI BIL-BRAILLE Zinbryta
English: LIST OF EXCIPIENTS Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Maltese: TA ' EĊĊIPJENTI Sodium succinate, succinic acid, sodium chloride, polysorbate 80, ilma għall-injezzjonijiet
English: • sore throat, tonsillitis (pharyngitis, laryngitis)
Maltese: • uġigh fil-griżmejn, tonsillite (farinġite, larinġite)
English: Step 6: Give the injection a.
Maltese: Pass 6: Agħti l-injezzjoni a.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet (PL);
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SmPC, Summary of Product Characteristics) u Fuljett ta' Tagħrif (PL, Package Leaflet)
English: This loss of myelin is called demyelination.
Maltese: Dan it-telf ta' myelin jissejjaħ demyelination.
English: Table 5 and Figures 1-2 show the results for the DECIDE study.
Maltese: Tabella 5 u Figuri 1-2 juru r-riżultati għall-istudju DECIDE.
English: (See Figure K.)
Maltese: (Ara Figura K.)
English: Influenza†
Maltese: Influwenza†
English: Malta Pharma MT limited
Maltese: MT limited
English: The active substance in Zinbryta is daclizumab.
Maltese: Is-sustanza attiva f'Zinbryta hi daclizumab.
English: 96 to 144 weeks
Maltese: 96 sa 144 ġimgħa
English: • increased tiredness
Maltese: • dijarea persistenti
English: • loss of appetite (anorexia)
Maltese: • telf ta' aptit (anoreksja)
English: This is a type of medicine called a monoclonal antibody.
Maltese: Din hi tip ta' mediċina msejħa antikorp monoklonali.
English: (See Figure J.)
Maltese: (Ara Figura J.)
English: • Patient details, signature and date;
Maltese: • Dettalji tal-pazjent, firma u data;
English: Viral infection
Maltese: Infezzjoni virali
English: This takes around 30 minutes.
Maltese: Dan jieħu madwar 30 minuta.
English: For additional information on storage at room temperature, see section 6.3.
Maltese: Għal informazzjoni addizzjonali dwar il-ħażna fit-temperatura tal-kamra, ara sezzjoni 6.3.
English: United Kingdom Biogen Idec Limited
Maltese: Ir-Renju Unit Biogen Idec Limited
English: 1.0 point improvement p=0.0008
Maltese: Titjib ta' 1.0 punt p=0.0008
English: This medicinal product contains 0.14 mmol sodium per dose.
Maltese: Dan il-prodott mediċinali fih 0.14 mg ta' sodium f'kull doża.
English: EU/1/16/1107/003
Maltese: EU/1/16/1107/001 EU/1/16/1107/003
English: Disposal
Maltese: Eliminazzjoni
English: Zinbryta has not been studied in patients with immunodeficiency syndromes.
Maltese: Zinbryta ma ġiex studjat f'pazjenti b'sindromi ta' immunodefiċjenza.
English: As an IgG1 monoclonal antibody, daclizumab is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Maltese: IgG1, daclizumab hu mistenni li jgħaddi minn kataboliżmu għal peptides u amino acids bl-istess mod bħal IgG endoġenu.
English: Table 4: SELECT study clinical and MRI results (at 52 weeks) Placebo
Maltese: Tabella 4: Studju kliniku SELECT u r-riżultati tal-MRI (wara 52 ġimgħa)
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab.
Maltese: Kien hemm esponiment limitat f'pazjenti ta' aktar minn 55 sena fl-istudji kliniċi b'daclizumab.
English: This small volume of distribution indicates that daclizumab is primarily confined to the vascular and interstitial spaces.
Maltese: Dan il-volum żgħir ta' distribuzzjoni jindika li daclizumab jiġi primarjament limitat għall-ispazji vaskulari u interstizjali.
English: Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose.
Maltese: L-esponimenti (AUC) f'dawn l-istudji varjaw minn 55 sa 140 darba ta' dawk osservati bid-doża klinika.
English: Acne†
Maltese: Akne†
English: EU/1/16/1107/004
Maltese: EU/1/16/1107/002 EU/1/16/1107/004
English: The risk of Progressive Multifocal Leukoencephalopathy (PML) associated to the treatment with Zinbryta has not been established.
Maltese: Ir-riskju ta' Lewkoenċefalopatija Multifokali Progressiva (PML) assoċjata mal-kura b'Zinbryta ma ġiex stabbilit.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 01 July 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 01 ta' Lulju 2016
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK INNER CARTON (without blue box)
Maltese: KARTUNA INTERNA TAL-PAKKETT MULTIPLU (bla kaxxa blu)
English: The most common adverse reactions reported for Zinbryta were rash, increased alanine aminotransferase (ALT), depression, nasopharyngitis, upper respiratory tract infection, influenza, oropharyngeal pain, and lymphadenopathy.
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati b'mod komuni għal Zinbryta kienu raxx, żieda f'alanine aminotransferase (ALT), depressjoni, nażofarinġite, infezzjoni fin-naħa ta' fuq tal-apparat respiratorju, influwenza, uġigħ orofarinġeali, u limfadenopatija.
English: Daclizumab did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively).
Maltese: Daclizumab ma affettwax il-kapaċità riproduttiva f'xadini cynomolgus nisa u rġiel (l-AUC fin-nisa u fl-irġiel kien sa 85 u 100 darba ogħla mill-esponiment fid-doża klinika rispettivament).
English: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab is 0.212 L/day with a terminal half-life value of approximately 21 days.
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni minn studju inkroċjat, it-tneħħija ta' daclizumab hi ta' 0.212 L/jum b'valur ta' half-life terminali ta' madwar 21 jum.
English: Multipack: 3 (3 packs of 1) pre-filled syringes.
Maltese: Pakkett multiplu: 3 (3 pakketti ta' 1) siringi mimlija għal-lest Pakkett multiplu: 3 (3 pakketti ta' 1) pinen mimlija għal-lest
English: Hold
Maltese: Għatu
English: At steady state, daclizumab mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentrationtime curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Maltese: (Cmax), il-konċentrazzjoni minima fis-serum (Cmin) u l-valuri taż-żona taħt il-kurva tal-konċentrazzjoni fis-serum fuq l-intervall tad-dożaġġ (AUCtau) kienu madwar 30 mikrogramma/mL, 15 mikrogramma/mL u 640 jum * mikrogramma /mL, rispettivament, b'varjabilità bejn il-pazjenti (% CV) ta' madwar 40%.
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab on microglial cells but are likely to be attributable to an increase in local IL-2 bioavailability.
Maltese: Studji investigattivi in vitro jissuġġerixxu li l-aggregati mikroglijali mhumiex dovuti minħabba effett dirett ta' daclizumab fuq iċ-ċelluli mikroglijali, iżda x'aktarx li huma attribwibbli għal żieda fil bijodisponibilità lokali ta' IL-2.
English: (See Figure I.)
Maltese: (Ara Figura I.)
English: (See Figure H.)
Maltese: (Ara Figura H.)
English: In clinical studies, Zinbryta increased the incidence of depression [5% vs 1% (placebo); 8% vs 6% (interferon beta-1a (intramuscular))]; the incidence of serious reactions of depression was <1% with Zinbryta.
Maltese: Fl-istudji kliniċi, Zinbryta żied il-inċidenza ta' depressjoni [5% vs 1% (plaċebo); 8% vs 6% (interferon beta-1a (ġol-muskoli))]; l-inċidenza ta' reazzjonijiet serji ta' depressjoni kienet ta' <1% b'Zinbryta.
English: The majority of the treatment-emergent anti-drug antibodies responses were transient (12% [110/913]) and the remaining minority (7% [65/913]) were persistent.
Maltese: Il-maġġoranza tar-risponsi tal-antikorpi kontra lmediċina li żviluppaw mill-kura kienu temporanji (12% [110/913]) u l-minoranza li kien fadal (7% [65/913]) kienu persistenti.
English: Although the effect on disability progression was mainly seen in patients with baseline EDSS < 3.5, evidence of efficacy was shown in patients with relapsing secondary progressive MS (SPMS) as defined by baseline EDSS ≥ 3.5 and at least one of the three: confirmed 24 week worsening of EDSS, or ≥ 20% decline on Timed 25-foot Walk (T25FW), or, ≥ 20% decline on 9-Hole Peg Test (9HPT).
Maltese: kif definit minn EDSS fil-linja bażi ta' ≥ 3.5 u mill-inqas wieħed minn dawn it-tlieta: aggravament ikkonfermat ta' EDSS wara 24 ġimgħa, jew tnaqqis ta' ≥ 20% tal-Mixja ta' 25 Pied bil-Ħin (T25FW), jew, tnaqqis ta' ≥ 20% fin-9-Hole Peg Test (9-HPT).
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab exposure is more than dose-proportional in the 50 mg to 100 mg subcutaneous dose range and is dose proportional in the 100 mg to 300 mg subcutaneous dose range.
Maltese: B'mod konsistenti mar-riżultati minn studji individwali, analiżi farmakokinetika tal-popolazzjoni minn studju inkroċjat indikat li l-esponiment ta' daclizumab hu aktar minn proporzjonali għad-doża filmedda ta' doża taħt il-ġilda ta' 50 mg sa 100 mg, u li hu proporzjonali għad-doża fil-medda ta' doża taħt il-ġilda ta' 100 mg sa 300 mg.
English: In the placebo-controlled study (the SELECT study), 417 patients received Zinbryta (150 mg, n=208; 300 mg, n=209; every 4 weeks) for up to 1 year.
Maltese: Fi studju kkontrollat bi plaċebo (l-istudju SELECT), 417-il pazjent irċivew Zinbryta (150 mg, n=208; 300 mg, n=209; kull 4 ġimgħat) għal sa sena.
English: Mean change in MSIS-29 physical score
Maltese: Bidla medja fil-punteġġ fiżiku MSIS-29
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab.
Maltese: Ma kien hemm l-ebda korrelazzjoni apparenti ta' żvilupp ta' antikorpi kontra l-mediċina jew antikorpi newtralizzanti kontra l-mediċina mar-rispons kliniku, reazzjonijiet avversi, jew mal-profil farmakodinamiku ta' daclizumab.
English: Alcohol Wipe
Maltese: Alkoħol
English: Daclizumab modulates IL-2 signalling by blocking CD25-dependent, highaffinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Maltese: riċettur ta' IL-2 b'affinità għolja, dipendenti fuq CD25, li jirriżulta f'livelli ogħla ta' IL-2 disponibbli għas-senjalar permezz ta' riċettur ta' IL-2 b'affinità intermedja.
English: Lymphadenopathy†
Maltese: Limfadenopatija†
English: † MRI analyses used evaluable dataset for each MRI endpoint.
Maltese: L'analiżi bl-MRI użat dejtaset evalwati għal kull endpoint;
English: The other ingredients are sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections (see section 2 ‘Zinbryta contains a small amount of sodium').
Maltese: Is-sustanzi l-oħra huma sodium succinate, succinic acid, sodium chloride, polysorbate 80, ilma għall injezzjonijiet (ara sezzjoni 2 ‘Zinbryta fih ammont żgħir ta' sodium').
English: Compared with interferon beta-1a intramuscular (n=440), Zinbryta (n=404) led to reductions on ARR (rate ratio 0.52 [95% CI: 0.42, 0.64], p<0.0001), number of new or newly enlarging T2 hyperintense lesions (lesion mean ratio 0.46 [95% CI: 0.37, 0.57], p<0.0001), and 24 weeks confirmed disability progression (hazard ratio 0.60 [95% CI: 0.40, 0.89], p=0.012).
Maltese: Meta mqabbel ma' interferon beta-1a ġol-muskoli (n=440), Zinbryta (n=404) wassal għal tnaqqis fuq ARR (Proporzjon tar-rata 0.52 [95% CI: 0.42, 0.64], p<0.0001), numru ta' leżjonijiet iperintensi
English: Daclizumab is a humanised IgG1 monoclonal antibody that binds to CD25 (IL-2Rα), and prevents IL-2 binding to CD25.
Maltese: IgG1 umanizzat li jeħel ma' CD25 (IL-2Rα), u jipprevjeni t twaħħil ta' IL2 ma' CD25.
English: *Observed with a ≥2% higher incidence than placebo †Observed with a ≥2% higher incidence than interferon beta-1a (intramuscular)
Maltese: *Osservat b'inċidenza ta' ≤2% mill-plaċebo †Osservat b'inċidenza ta' ≤2% minn interferon beta-1a (ġol-muskoli)
English: • runny nose (rhinitis)
Maltese: • imnieħer inixxi (rinite)
English: In addition, an increase in CD56bright NK cells and a decrease in regulatory T-cells (defined as CD4+CD127lowFoxP3+ T-cells) was observed within 2 weeks after the first dose, with a sustained 5-fold increase in CD56bright NK cells above baseline and an approximately 60% decrease in regulatory T-cells in the treatment phase, with a return to baseline levels approximately 20-24 weeks after the last dose.
Maltese: Ukoll, żieda fiċ-ċelluli CD56bright NK u tnaqqis fiċċelluli T regolatorji (definiti bħala ċelluli T CD4+CD127lowFoxP3+) ġew osservati fi żmien ġimagħtejn wara l-ewwel doża, b'żieda sostnuta ta' 5 darbiet fiċ-ċelluli CD56bright NK aktar mil-linja bażi, u tnaqqis ta' madwar 60% fiċ-ċelluli T regolatorji fil-fażi tal-kura, b'ritorn għal-livelli fil-linja bażi bejn wieħed u ieħor 20-24 ġimgħa wara l-aħħar doża.
English: Total lymphocyte counts <0.8x109 cells/L ([Common Terminology Criteria for Adverse
Maltese: L-għadd totali ta' limfoċiti ta' <0.8x109 ċelluli/L ([Kriterji ta '
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to protect from light.
Maltese: • Il-ħażna rakkomandata hi refriġerazzjoni kkontrollata f'temperatura ta' 2°C sa 8°C fil-kartuna oriġinali magħluqa sabiex tipproteġi mid-dawl.
English: Zinbryta is contraindicated in patients with pre-existing hepatic impairment (see sections 4.3 and 4.4).
Maltese: Zinbryta hu kontraindikat f'pazjenti b'indeboliment tal-fwied li kien jeżisti minn qabel (ara sezzjonijiet 4.3 u 4.4).
English: The SELECT study was double-blind, randomised, placebo-controlled, with either Zinbryta 150 mg (n=208), or 300 mg (n=209) versus placebo (n=204) every 4 weeks for 52 weeks.
Maltese: SELECT kien double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo, jew b'Zinbryta 150 mg (n=208), jew 300 mg (n=209) kontra plaċebo (n=204) kull 4 ġimgħat għal 52 ġimgħa.
English: Skin reactions, some serious (e.g. exfoliative rash or dermatitis, toxic skin eruption), have been reported with Zinbryta.
Maltese: Reazzjonijiet tal-ġilda, xi wħud serji (eż. raxx bil-qxur jew dermatite, eruzzjoni tossika tal-ġilda), ġew irrappurtati b'Zinbryta.
English: In a clinical study, patients (n=90) on long-term treatment with Zinbryta mounted appropriate immune responses to an inactivated trivalent seasonal influenza vaccine.
Maltese: Fi studju kliniku, pazjenti (n=90) li kienu fuq kura fit-tul b'Zinbryta, żviluppaw risponsi adattati għal tilqima trivalenti mhux attivata kontra influwenza staġjonali.
English: The exact metabolic pathway for daclizumab has not been characterised.
Maltese: Il-passaġġ metaboliku preċiż għal daclizumab ma ġiex ikkaratterizzat.
English: • Rare (≥1/10, 000 to <1/1,000)
Maltese: Komuni (≤1/100 sa <1/10) Mhux komuni (≤1/1,000 sa <1/100) Rari (≥1/10,000 sa <1/1,000)
English: Respiratory tract infection
Maltese: Infezzjoni fl-apparat respiratorju
English: • increases in body temperature (fever)
Maltese: • żidiet fit-temperatura tal-ġisem (deni)
English: In clinical studies, Zinbryta increased the incidence of infections [50% vs 44% (placebo) and 65% vs 57% (interferon beta-1a (intramuscular))] and serious infections [3% vs 0% (placebo); 4% vs 2% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
Maltese: Fl-istudji kliniċi, Zinbryta żied l-inċidenza ta' infezzjonijiet tal-ġilda [50% vs 44% (plaċebo); 65% vs 57% (interferon beta-1a (ġol-muskoli))] u reazzjonijiet serji [3% vs 0% (plaċebo); 4% vs 2%
English: If a patient develops signs or symptoms of autoimmune haemolytic anaemia (e.g. pallor, fatigue, dark urine, jaundice, shortness of breath), consider referring to a specialist and discontinuing Zinbryta (see section 4.8).
Maltese: Jekk il-pazjent jiżviluppa sinjali jew sintomi ta' anemija emolitika awtoimmuni (eż. sfurija, għeja, awrina skura, suffejra, qtugħ ta' nifs), ikkunsidra li tirreferih għand speċjalista u twaqqaf Zinbryta (ara sezzjoni 4.8).
English: The safety of doses above 300 mg administered subcutaneously and 400 mg intravenously have not been evaluated.
Maltese: Is-sigurtà ta' dożi ta' aktar minn 300 mg mogħtija taħt il-ġilda u 400 mg ġol-vini, ma ġietx evalwata.
English: BIOGEN IDEC Limited Innovation House 70 Norden Road Maidenhead Berkshire
Maltese: BIOGEN IDEC Limited Innovation House 70
English: Autoimmune haemolytic anaemia
Maltese: Anemija emolitika awtoimmuni
English: The expiry date refers to the last day of that month.
Maltese: Iċċekkja d-data ta' meta jiskadi.
English: Low red blood cell counts (autoimmune haemolytic anaemia): (Uncommon - may affect up to 1 in 100 people)
Maltese: Għadd baxx ta' ċelluli ħomor tad-demm (anemija emolitika awtoimuni): (Mhux komuni - jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: Educational guidance
Maltese: Gwida edukattiva
English: The safety and efficacy of Zinbryta in children and adolescents below 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zinbryta fi tfal u adolexxenti li għandhom inqas minn 18-il sena ma ġewx determinati s'issa.
English: Possible side effects
Maltese: Effetti sekondarji komuni
English: Rhinitis*
Maltese: Rinite*
English: The most commonly reported adverse reactions leading to discontinuation in patients treated with Zinbryta were hepatic reactions, including elevations of serum transaminases (5%), and cutaneous reactions (4%) (see section 4.4).
Maltese: L-iktar reazzjonijiet avversi li ġew irrappurtati b'mod komuni li wasslu għat-twaqqif f'pazjenti kkurati b'Zinbryta kienu reazzjonijiet epatiċi, li jinkludu żidiet tat-transaminases fis-serum (5%), u reazzjonijiet tal-ġilda (4%) (ara sezzjoni 4.4).
English: A dose dependent increase in incidence of microglial aggregates above background was observed in the brain and spinal cord of monkeys treated with ≥35 mg/kg, (AUC 27 times higher than the clinical dose).
Maltese: Żieda dipendenti fuq id-doża fl-inċidenza ta' aggregati mikroglijali 'l fuq mill-isfond, ġiet osservata fil-moħħ u fis-sinsla ta' xadini kkurati b'≤35 mg/kg, (AUC 27 darba ogħla mid-doża klinika).
English: Reporting of suspected adverse reactions
Maltese: Rappurtar ta 'reazzjonijiet avversi suspettati
English: Eczema nummular
Maltese: Ekżema nummulari
English: Glass Barrel
Maltese: KARTUNA TA' BARRA
English: Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Maltese: Anemija emolitika awtoimmuni ġiet irrappurtata f'< 1% tal-pazjenti kkurati b'Zinbryta fl-istudji kliniċi.
English: • Acknowledgment Form.
Maltese: • Formola ta' Rikonoxximent.
English: Within the studied regimens of daclizumab 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Maltese: Relazzjoni(jiet) farmakokinetika(ċi)/farmakodinamika(ċi) Fil-korsijiet studjati ta' daclizumab 150 mg u 300 mg mogħtija taħt il-ġilda kull 4 ġimgħat f'pazjenti b'MS, ma kien hemm ebda relazzjoni ċara bejn l-esponiment ta' daclizumab u l-punti aħħarin taleffikaċja klinika (ARR, leżjonijiet T2 u leżjonijiet li jidhru aħjar permezz ta' Gd) jew il-punti aħħarin ta' interess tas-sigurtà (stat ta' infezzjoni serja, reazzjoni avversa moderat jew severa tal-ġilda, u AST/ALT ta' > 5 darbiet il-ULN).
English: (Common - may affect up to 1 in 10 people) • lung infection (e.g. pneumonia, bronchitis)
Maltese: • infezzjoni tal-pulmun (e.g. pnewmonja, bronkite)
English: The incidence of discontinuation due to medicine related hepatic disorders was 5% in Zinbryta-treated patients and 4% in interferon beta-1a (intramuscular).
Maltese: L-inċidenza ta' twaqqif minħabba disturbi epatiċi relatati mal-mediċina kienet ta' 5% f'pazjenti kkurati b'Zinbryta, u 4% f'pazjenti kkurati b'interferon beta-1a (ġol-muskoli).
English: Zinbryta can be stored at room temperature (up to 30oC) in the original pack for 30 days.
Maltese: Zinbryta jista' jinħażen fit-temperatura tal-kamra (sa 30oC) fil-pakkett oriġinali għal 30 jum.
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab is 6.34 L in a patient with a body weight of 68 kg (approximate median of evaluated patients).
Maltese: Ibbażat fuq l-analiżi farmakokinetika tal-popolazzjoni minn studju inkroċjat, il-volum tad distribuzzjoni ta' daclizumab fl-istat fiss hu ta' 6.34 L f'pazjent b'piż tal-ġisem ta' 68 kg (il-medjan approssimattiv tal-pazjenti evalwati).
English: Pack sizes: Each pack contains one pre-filled glass syringe/pre-filled pen with an attached needle, ready to inject.
Maltese: Pakkett multiplu ta' tliet pakketti ta' siringa/pinna waħda hu disponibbli wkoll.
English: Mean number of new T1 hypointense lesions
Maltese: Medja tan-numru ta' leżjonijiet ġodda T1 ipointensi.
English: • The management of patients receiving Zinbryta and presenting with signs and symptoms of potential hepatic injury, including treatment discontinuation, potential consideration of additional therapy, and prompt referral to a hepatologist;
Maltese: • L-immaniġġar ta' pazjenti li jkunu qed jirċievu Zinbryta u li jkollhom sinjali u sintomi ta' ħsara potenzjali tal-fwied, li jinkludi t-twaqqif tat-trattament, konsiderazzjoni potenzjali ta' terapija addizzjonali, u riferiment fil-pront għand epatoloġista;