FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability of daclizumab 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Maltese: Il-bijodisponibilità assoluta ta' daclizumab 150 mg mogħti taħt il-ġilda kienet ta' madwar 90%, ibbażat fuq analiżi farmakokinetika tal-popolazzjoni fi studju inkroċjat dwar dożaġġ mogħti taħt il-ġilda u ġol-vini.
English: The DECIDE study was double-blind, randomised, parallel-group, active-controlled with Zinbryta 150 mg every 4 weeks (n=919) versus interferon beta-1a (intramuscular) 30 micrograms weekly (n=922), for a minimum of 2 to a maximum of 3 years (96 to 144 weeks).
Maltese: L-istudju DECIDE kienet double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, grupp parallel, ikkontrollat b'mod attiv, b'Zinbryta 150 mg kull 4 ġimgħat (n=919), kontra interferon beta-1a (ġol-muskoli) 30 mikrogramma kull ġimgħa (n=922), għal minimu ta' sentejn sa massimu ta' 3 snin (96 sa 144 ġimgħa).
English: In the active-controlled study (the DECIDE study), 919 patients received Zinbryta (150 mg, every 4 weeks) and 922 patients received interferon beta-1a intramuscular, (30 microgram weekly) for a minimum of 2 years and up to 3 years.
Maltese: 919-il pazjent irċivew Zinbryta (150 mg, kull 4 ġimgħat) u 922 pazjent irċivew interferon beta-1a ġolmuskoli, (30 mikrogramma kull ġimgħa) għal minimu ta' sentejn u sa 3 snin.
English: In clinical studies Zinbryta increased the incidence of skin reactions [18% vs 13% (placebo); 37% vs 19% (interferon beta-1a (intramuscular))] and serious skin reactions [<1% vs 0% (placebo); 2% vs <1% (interferon beta-1a (intramuscular))] compared to placebo and interferon beta-1a (intramuscular).
Maltese: 19% (interferon beta-1a (ġol-muskoli))] u reazzjonijiet serji tal-ġilda [<1% vs 0% (plaċebo); 2% vs <1% (interferon beta-1a (ġol-muskoli))] meta mqabbel ma' plaċebo u interferon beta-1a (ġol-muskoli).
English: Treatment-emergent anti-drug antibodies and neutralising antibodies were observed in 19% (175/913) and 8% (71/913) of study patients, respectively.
Maltese: Antikorpi kontra l-mediċina li żviluppaw mill-kura u antikorpi newtralizzanti ġew osservati f'19% (175/913) u 8%
English: The Finger Flange will allow you to better grip the syringe and should remain attached.
Maltese: Il-Finger Flange se jippermettilek li taqbad is-siringa aħjar u għandu jibqa' mwaħħal.
English: Tuberculosis infections have been reported in patients treated with Zinbryta.
Maltese: Infezzjonijiet tat-tuberkulożi ġew irraportati f'pażjenti kkurati b'Zinbryta.
English: Figure 1: Percentage of patients relapse-free (DECIDE study)
Maltese: Figura 1: Perċentwali ta' pazjenti mingħajr rikaduta (studju DECIDE)
English: Events - CTCAE] Grade 2; at least one measurement) occurred in 4% of placebo-treated and 5% of Zinbryta-treated patients in the SELECT study, and 9% of the interferon beta-1a (intramuscular)-treated and 8% of Zinbryta-treated patients in the DECIDE study.
Maltese: Adverse Events)] Grad 2; mill-inqas kejl wieħed) seħħ f'4% tal-pazjenti kkurati bi plaċebo, u f'5% tal pazjenti kkurati b'Zinbryta fl-istudju SELECT, u f'9% tal-pazjenti kkurati b'interferon beta-1a (ġolmuskoli), u fi 8% tal-pazjenti kkurati b'Zinbryta fl-istudju DECIDE.
English: In addition, there was a statistically significant effect on 24 week confirmed disability progression in Zinbryta treated patients with a hazard ratio 0.73 [95% CI: 0.55, 0.98].
Maltese: Barra minn hekk, kien hemm effett statistikament sinifikanti fuq il-progressjoni tal-marda kkonfermata sostnuta għal mill-inqas 24 ġimgħa f'pazjenti kkurati b'Zinbryta bi proporzjon ta' periklu ta' 0.73 [95% CI: 0.55, 0.98].
English: Prior to treatment initiation with Zinbryta, serum transaminases (ALT and AST) and total bilirubin levels should be obtained, and patients should be screened for Hepatitis B (HBV) and C (HCV).
Maltese: Qabel il-bidu tal-kura b'Zinbryta, għandhom jinkisbu l-livelli tat-transaminases fis-serum (ALT u AST) u bilirubina totali, u l-pazjenti għandhom jiġu ttestjati għall-Epatite B (HBV) u C (HCV).
English: Daclizumab clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Maltese: It-tneħħija ta' daclizumab f'pazjenti li żviluppaw antikorpi newtralizzanti kienet, bħala medja, 19% ogħla (ara sezzjoni 4.8 Immunoġeniċità).
English: These symptoms vary from patient to patient but usually involve problems such as difficulty with walking, vision and balance.
Maltese: Dawn is-sintomi jvarjaw minn pazjent għal ieħor, iżda normalment jinvolvu problemi bħal diffikultà biex timxi, problemi fil-vista u fil-bilanċ.
English: Cumulative incidences of peak ALT or AST increase (based on laboratory data) observed in clinical trials
Maltese: Inċidenzi kumulattivi ta' żieda fl-ALT jew AST massimu (ibbażat fuq dejta tal-laboratorju) osservati fil-provi kliniċi
English: The most common skin reactions were rash, dermatitis, and eczema.
Maltese: L-iktar reazzjonijiet komuni tal-ġilda kienu raxx, dermatite, u ekżema.
English: Hazard ratio [95% CI]
Maltese: Proporzjon tar-rata [95% CI]
English: Daclizumab is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Maltese: Daclizumab mhux mistenni li jgħaddi minn eliminazzjoni mill-kliewi, jew metaboliżmu minn enzimi tal-fwied (ara sezzjoni 4.2).
English: Based on the cross-study population pharmacokinetic analysis, daclizumab pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Maltese: daclizumab ma ġietx influwenzata mill-età (medda: 18 sa 66 sena; n=1,670) jew mis-sess tal-persuna
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK OUTER CARTON (with blue box)
Maltese: KARTUNA TAL-PAKKETT MULTIPLU (bil-kaxxa blu)
English: Subgroup analyses of the SELECT and DECIDE studies demonstrated a consistent effect of Zinbryta compared to placebo and interferon beta-1a (intramuscular) across subgroups defined by demographic and MS disease characteristics.
Maltese: Analiżijiet tas-sottogrupp tal-istudji SELECT u DECIDE urew effett konsistenti ta' Zinbryta meta mqabbel mal-plaċebo u interferon beta-1a (ġol-muskoli) fis-sottogruppi kollha definiti skont ilkaratteristiċi demografiċi u tal-marda tal-MS. Fl-analiżi tas-sottogrupp DECIDE, kien hemm tnaqqis statistikament sinifikanti osservat meta mqabbel ma' interferon beta-1a (ġol-muskoli) fuq ARR u nnumru ta' leżjonijiet iperintensi
English: • The importance of monitoring the liver function (AST, ALT and total bilirubin levels) at least monthly (or more frequently as clinically indicated) as close as possible before each treatment administration, and for up to six months after the last dose;
Maltese: • L-importanza tal-monitoraġġ tal-funzjoni tal-fwied (AST, ALT u livelli tal-bilirubina totali) mill-inqas kull xahar (jew aktar spiss kif klinikament indikat) kemm jista' jkun qrib qabel kull għoti tat-trattament, u għal sa 6 xhur wara l-aħħar doża;
English: Infections, some serious (e.g. pneumonia and bronchitis), have been reported with Zinbryta.
Maltese: Infezzjonijiet, xi wħud minnhom serji (eż. pnewmonja u bronkite), ġew irrappurtati b'Zinbryta.
English: Zinbryta is contraindicated in patients with a history of severe hypersensitivity (e.g. anaphylaxis or anaphylactoid reactions) to daclizumab or to any of the excipients (see section 6.1).
Maltese: 4.3 Kontraindikazzjonijiet Zinbryta hu kontraindikat f'pazjenti bi storja medika ta' sensittività eċċessiva severa (eż. reazzjonijiet anafilassi jew anafilattojdi) għal daclizumab jew għal kwalunkwe wieћed mill-eċċipjenti elenkati (ara sezzjoni 6.1).
English: Eczema†
Maltese: Mediċina c.
English: p<0.0001 * Rates and risk reductions/endpoints are calculated over the treatment period up to 144 weeks.
Maltese: *Rati u tnaqqis fir-riskju/punti aħħarin huma kkalkulati fuq il-perjodu ta' kura sa 144 ġimgħa.
English: • Uncommon (≥1/1,000 to <1/100)
Maltese: • Rari ħafna (<1/10,000)
English: A 29 gauge, 0.5 inch staked needle is pre-affixed to the syringe.
Maltese: Labra b'daqs ta' 29 gauge, ta' 0.5 pulzier, staked, tkun imwaħħla minn qabel mas-siringa.
English: - 3 month multipack containing three 150 mg pre-filled pens (3 boxes containing 1 pen each).
Maltese: - Pakkett multiplu li jservi 3 xhur li jkun fih tliet pinen mimlija għal-lest ta' 150 mg (3 kaxxi li jkun fihom 1 pinna kull waħda).
English: In the DECIDE study (see section 5.1), patients were tested for anti-drug (daclizumab) antibodies at week 4 and approximately every 3 months thereafter.
Maltese: Fl-istudju DECIDE (ara sezzjoni 5.1), il-pazjenti ġew ittestjati għal antikorpi kontra l-mediċina (daclizumab) wara 4 ġimgħat u bejn wieħed u ieħor kull 3 xhur wara dak il-perjodu.
English: • gauze pad
Maltese: • pad tal-garża
English: Pruritus
Maltese: Garża
English: Name and address of the manufacturer of the biological active substance:
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva:
English: A pre-filled syringe of Zinbryta is contained within a spring-powered pen injector called Zinbryta Pen.
Maltese: o Tista' tara bżieżaq tal-arja fil mediċina Zinbryta.
English: Store in a refrigerator (2oC-8oC).
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen fi friġġ (2oC-8oC).
English: Treatment with Zinbryta 150 mg every 4 weeks versus placebo significantly reduced the annualised relapse rate (ARR) and risk of relapse compared to placebo.
Maltese: Il-kura b'Zinbryta 150 mg kull 4 ġimgħat kontra l-plaċebo naqqset b'mod sinifikanti r-rata ta' rikaduti annwalizzata (ARR) u r-riskju ta' rikaduta meta mqabbla mal-plaċebo.
English: At week 96, Zinbryta demonstrated a statistically significant reduction in the number of new or newly enlarging T2 hyperintense lesions, the number of new T1 Gd-enhancing lesions and the mean number of new T1 hypointense lesions.
Maltese: F'ġimgħa 96, Zinbryta wera tnaqqis statistikament sinifikanti fin-numru l-għadd tan-numru ta' leżjonijiet ġodda T2 iperintensi jew leżjonijiet ġodda
English: The most common types of infections were upper respiratory tract infections and viral infections.
Maltese: Liktar tipi komuni ta' infezzjonijiet kienu infezzjonijiet fil-parti ta' fuq tal-apparat respiratorju u infezzjonijiet virali.
English: - 3 month multipack containing three 150 mg pre-filled syringes (3 boxes containing 1 syringe each).
Maltese: - Pakkett multiplu li jservi 3 xhur li jkun fih tliet siringi mimlija għal-lest ta' 150 mg (3 kaxxi li jkun fihom 1 siringa kull waħda).
English: Prior to launch of Zinbryta in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel it-tnedija ta' Zinbryta f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi l-media tal komunikazzjoni, metodi ta' distribuzzjoni, u kwalunkwe aspetti oħrajn tal-programm, mal-Awtorità
English: In clinical studies, the pharmacodynamic effects of Zinbryta 150 mg administered subcutaneously every 4 weeks were consistent with modulation of IL-2 signalling as evidenced by the rapid and sustained saturation of the target CD25 receptors on circulating T-cells and a sustained approximately 2-fold increase in serum IL-2 concentration.
Maltese: kienu konsistenti mal-modulazzjoni tas-senjalar ta' IL-2, kif muri mis-saturazzjoni mgħaġġla u sostnuta tar-riċetturi ta' CD25 fil-mira fuq ċelluli T li jkunu jiċċirkolaw, u żieda sostnuta ta' madwar id-doppju tal-konċentrazzjoni ta' IL-2 fis-serum.
English: Autoimmune haemolytic anaemia has been reported in patients treated with Zinbryta which resolved with standard treatment and discontinuation of Zinbryta.
Maltese: Anemija emolitika awtoimmuni ġiet irrappurtata f'pazjenti kkurati b'Zinbryta, li fieqet b'kura standard u waqfien ta' Zinbryta.
English: physical score) compared to interferon beta-1a (intramuscular).
Maltese: (interferon beta-1a (ġol-muskoli))] meta mqabbel ma' plaċebo u interferon beta-1a (ġol-muskoli).
English: • dark (tea-coloured) urine
Maltese: • awrina skura (minn lewn it-te)
English: Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Zinbryta should be allowed to warm to room temperature (20°C-30°C) (about 30 minutes) prior to injection.
Maltese: Ġaladarba jitneħħa mill-friġġ, Zinbryta għandu jitħalla jisħon sat-temperatura tal-kamra (20°C-30°C) (madwar 30 minuta) qabel l-injezzjoni.
English: When observed during Zinbryta clinical studies, lymphopenia was mostly mild to moderate (≥ 500/mm3).
Maltese: Meta osservata matul l-istudji kliniċi b'Zinbryta, il-limfopenija kien fil-biċċa l-kbira tagħha minn ħafifa sa moderata (≥ 500/mm3).
English: Fulminant hepatitis
Maltese: Epatite fulminanti
English: A small subset of microglial aggregates were associated with microhaemorrhage but with no evident functional sequelae in monkeys.
Maltese: Sottosett żgħir ta' aggregati mikroglijali ġew assoċjati ma' mikroemorraġija, iżda mingħajr ebda sintomi wara fix-xadini.
English: CLINICAL PARTICULARS
Maltese: Punti aħħarin kliniċi
English: • dark urine
Maltese: • awrina skura
English: The colitis improved with discontinuation of Zinbryta and standard treatment.
Maltese: Il-kolite tjiebet mat-twaqqif ta' Zinbryta u kura standard.
English: Among the evaluable patients, the majority of treatment-emergent neutralising antibody responses were transient (6% [56 of 913]) and 2% of patients (15 of 913) had persistent responses.
Maltese: Fost il-pazjenti li setgħu jiġu evalwati, il-maġġoranza tar-reazzjonijiet ta' antikorpi newtralizzanti li żviluppaw mill-kura kienu temporanji (6% [56 minn 913]), u 2% talpazjenti (15 minn 913) kellhom risponsi persistenti.
English: Parts of the Zinbryta pre-filled syringe (See Figure C)
Maltese: Partijiet tas-Siringa Mimlija għal-Lest Zinbryta (ara Figura Ċ)
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab
Maltese: Zinbryta 150 mg injezzjoni daclizumab
English: Animal studies do not indicate direct or indirect harmful effects with respect to reprotoxicity (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva (ara 5.3).
English: Denmark
Maltese: • deni
English: Daclizumab is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Maltese: bħal iżoenzimi ta' CYP (ara sezzjoni 4.5).
English: After your injection After Use - Parts of your Zinbryta Pen (see Figure K):
Maltese: Wara l-injezzjoni tiegħek Wara l-Użu - Partijiet tal-Pinna Zinbryta (ara Figura K):
English: Other medicines and Zinbryta
Maltese: Mediċini oħra u Zinbryta
English: Following a recovery period of up to 12 weeks, there was evidence of reversibility.
Maltese: Wara perjodu ta' rkupru ta' sa 12-il ġimgħa, kien hemm evidenza ta' riversibilità.
English: In addition, Zinbryta reduced clinically meaningful worsening in the patient reported physical impact of MS (≥7.5 point worsening from baseline to week 96 in the MSIS-29
Maltese: Perċentwali ta' pazjenti b'aggravament klinikament sinifikanti fil-punteġġ fiżiku MSIS-29 (≤7.5 punti)
English: Preparing for your injection Note:
Maltese: Data ta ' Meta Tiskadi:
English: Clinical trial data from the DECIDE study demonstrated consistent treatment effects in the highly active disease subgroup.
Maltese: Dejta mill-provi kliniċi mill-istudju DECIDE uriet effetti konsistenti tal-kura fis-sottogrupp b'marda attiva ħafna.
English: Step 2: Check The Zinbryta Pre-filled Syringe
Maltese: Pass 2: Iċċekkja ż-Zinbryta Siringa Mimlija għal-Lest
English: Together, these immunomodulatory effects of daclizumab are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.
Maltese: Flimkien, dawn l-effetti immunomodulatorji ta' daclizumab huma maħsuba li jnaqqsu l-patoloġija tas
English: In patients with severe active infection, a delay in initiation of Zinbryta therapy should be considered (see section 4.8).
Maltese: F'pazjenti bl-infezzjoni attiva severa, għandu jiġi kkunsidrat l-ittardjar tal-bidu tat-terapija b'Zinbryta (ara sezzjoni 4.8).
English: Time on study (weeks) Number of patients at risk
Maltese: Medja tan-numru ta' pazjenti f'riskju
English: In patients with neutralising antibodies, daclizumab clearance was increased on average by 19% (see section 5.2).
Maltese: F'pazjenti b'antikorpi newtralizzanti, it-tneħħija ta' daclizumab żdiedet b'medja ta' 19% (ara sezzjoni 5.2).
English: The magnitude of the immune response to the seasonal influenza vaccine, and proportion of patients with seroconversion and seroprotection were consistent with those observed in healthy volunteer populations.
Maltese: Il-kobor tar-rispons immuni għat-tilqima kontra l-influwenza staġjonali, u l-proporzjon ta' pazjenti b'serokonverżjoni u seroprotezzjoni, kienu konsistenti ma' dawk osservati f'popolazzjonijiet ta' voluntiera b'saħħithom.
English: Skin reactions generally resolved with standard care, including treatment with topical or systemic steroids.
Maltese: Ir-reazzjonijiet ġeneralment fiequ b'kura standard, li tinkludi kura bi sterojdi topiċi jew sistematiċi.
English: • If a refrigerator is not available, Zinbryta syringes/pens can be stored at room temperature (up to 30oC) in the original pack for up to 30 days.
Maltese: • Jekk friġġ ma tkunx disponibbli, is-siringi/pinen Zinbryta jistgħu jinħażnu fit-temperatura talkamra (sa 30°C) fil-pakkett oriġinali għal sa 30 jum.
English: Treatment initiation is not recommended in patients with ALT or AST ≥ 2 times the upper limit of normal (ULN) and is contraindicated in patients with pre-existing hepatic impairment (see section 4.3).
Maltese: (ULN, upper limit of normal) u hu kontraindikat f'pazjenti b'indeboliment tal-fwied li kien jeżisti minn qabel (ara sezzjoni 4.3).
English: Daclizumab pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Maltese: Il-farmakokinetika ta' daclizumab hi deskritta tajjeb minn mudell b'żewġ kompartimenti b'assorbiment u eliminazzjoni tal-ewwel ordni.
English: Zinbryta significantly reduced the ARR and the risk of relapse, compared to interferon beta-1a (intramuscular)-treated patients.
Maltese: Zinbryta naqqas b'mod sinifikanti l-ARR u r-riskju ta' rikaduta, meta mqabbel ma' pazjenti kkurati b'interferon beta-1a (ġol-muskoli).
English: Hazard ratio* [95% CI]
Maltese: Proporzjon ta' riskju # * [95% CI]
English: • paleness
Maltese: • sfurija
English: Colitis has been reported with Zinbryta.
Maltese: Il-kolite ġiet irrappurtat b'Zinbryta.
English: • infections of the airways, such as coughs and colds (nasopharyngitis, upper respiratory tract infection)
Maltese: • infezzjonijiet tal-passaġġi tal-arja, bħal sogħla u rjiħat (nażofarinġite, infezzjoni fin-naħa ta' fuq tal-apparat respiratorju)
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or AST > 3 times the ULN; o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form; o Receipt of the Patient Card;
Maltese: 3 darbiet tal-ULN; o Il-pazjent jifhem l-informazzjoni pprovduta dwar ir-riskju; o Li l-pazjent ikun irċieva kopja tal-formola ta' rikonoxximent; o Li l-pazjent ikun irċieva l-Kard tal-Pazjent;
English: o If Zinbryta has been outside of the refrigerator for more than a total of 30 days or if you are not sure how long Zinbryta has been at room temperature, throw the syringe/pen away (see section 7, Instructions for injecting Zinbryta).
Maltese: o Jekk Zinbryta ikun tħalla barra mill-friġġ għal aktar minn total ta' 30 jum, jew jekk ma tkunx ċert kemm Zinbryta jkun ilu fit-temperatura tal-kamra, armi s-siringa/pinna (ara sezzjoni 7, Istruzzjonijiet biex tinjetta Zinbryta).
English: • fever
Maltese: • stikk
English: Daclizumab was detected in the milk of 11/14 lactating monkeys at levels that were <0.122% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Maltese: Daclizumab instab fil-ħalib ta' 11/14-il xadina li kienu qed ireddgħu, f'livelli li kienu <0.122% tal-livelli fis-serum tal-omm, bla ebda reazzjonijiet avversi osservati fil-frieħ.
English: • the syringe/pen is cracked or broken.
Maltese: • is-siringa/pinna tkun imxaqqa jew miksura.
English: An increased incidence of serious colitis (<1%) was reported in patients treated with Zinbryta in clinical studies.
Maltese: Żieda fl-inċidenza ta' kolite serja (<1%) ġiet irrappurtata f'pazjenti kkurati b'Zinbryta fl-istudji kliniċi.
English: Lymphocyte count decreased
Maltese: Jibda likklikkjar
English: Step 8: Check to make sure you have received your full dose of Zinbryta (see Figure J).
Maltese: Pass 8: Iċċekkja biex tiżgura li tkun irċivejt id-doża sħiħa tiegħek ta' Zinbryta (ara Figura J).
English: The safety and effectiveness of Zinbryta in this age group are not known.
Maltese: Is-sigurtà u l-effettività ta' Zinbryta f'dan il-grupp ta' età mhumiex magħrufa.
English: The clinical relevance of microglial aggregates is unknown, however no deleterious neurologic effects attributed to the microscopic change have been observed in monkeys.
Maltese: Ir-rilevanza klinika ta' aggregati mikroglijali mhijiex magħrufa, madankollu l-ebda effetti ta' ħsara newroloġika attribwiti għall-bidla mikroskopika ma ġew osservati fix-xadini.
English: Giving your injection Step 5: Remove the Zinbryta Pen cap a.
Maltese: Neħħi l-għatu tal-Pinna Zinbryta a.
English: • Keep the Zinbryta pre-filled syringe/pen in its original package to protect from light.
Maltese: • Żomm is-siringa/pinna mimlija għal-lest ta' Zinbrytafil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: Oropharyngeal pain†
Maltese: Popolazzjoni pedjatrika
English: Caution is recommended when administering medicinal products of known hepatotoxic potential including non-prescription products and herbal supplements concomitantly with Zinbryta (see section 4.4).
Maltese: Kawtela hi rakkomandata meta wieħed jagħti prodotti mediċinali b'potenzjal epatotossiku magħruf, li jinkludu prodotti mingħajr riċetta u supplimenti li ġejjin mill-ħxejjex, fl-istess ħin ma' Zinbryta (ara sezzjoni 4.4).
English: No meaningful differences in clinical efficacy or safety were observed among the subgroups of MS patients by weight quartile in the DECIDE study.
Maltese: Ma ġew osservati l-ebda differenzi sinifikanti fl-effikaċja klinika jew is-sigurtà fost is-sottogruppi ta' pazjenti b'MS skont il-quartile tal-piż fl-istudju DECIDE.
English: Table 3: Study design and baseline characteristics for SELECT study and DECIDE study Study name
Maltese: Tabella 3: Disinn tal-istudju u karatteristiċi fil-linja bażi għall-istudju SELECT u l-istudju DECIDE Isem tal-istudju
English: Medicine Visible
Maltese: TAL-PRODOTT MEDIĊINALI
English: There is limited data on concomitant use of Zinbryta with MS symptomatic therapies.
Maltese: Hemm dejta limitata dwar l-użu fl-istess ħin ta' Zinbryta ma' terapiji sintomatiċi oħrajn għal MS.
English: • Common (≥1/100 to <1/10)
Maltese: Komuni ħafna (≤ 1/10)
English: Following subcutaneous administration of daclizumab, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Maltese: Wara l-għoti taħt il-ġilda ta' daclizumab, iż-żmien medjan biex jintlaħqu l-konċentrazzjonijiet massimi fis-serum (Tmax) varja minn 5 sa 7 ijiem.
English: Total lymphocyte counts returned to baseline levels approximately 8-12 weeks after the last dose of Zinbryta (150mg).
Maltese: L-għadd totali ta' limfoċiti reġa' lura għal-livelli tal-linja bażi wara madwar 8-12-il ġimgħa wara laħħar doża ta' Zinbryta (150 mg).
English: Table 5: DECIDE study clinical and MRI results (96 to 144 weeks) (Values refer to results at 96 weeks, unless otherwise indicated.)
Maltese: Riżultati tal-istudju DECIDE u tal-MRI (96 sa 144 ġimgħa)