FrancophonIA/ELRC3.0 huggingface dataset:
English: • schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Maltese: • skiżofrenija, marda mentali b'għadd ta' sintomi, inkluż diżorganizzazzjoni fil-ħsiebijiet u l-kliem, alluċinazzjonijiet (smigħ jew viżjoni ta' oġġetti li mhumiex hemm), suspetti u delużjonijiet (twemmin falz).
English: Aripiprazole Sandoz is used in adults to treat moderate to severe manic episodes and to prevent new manic episodes in adults whose illness has improved with the medicine in the past.
Maltese: Sabiex jiġu evitati episodji manijaċi f'adulti, l-istess doża għandha titkompla.
English: In patients aged between 15 and 17 years, the starting dose is 2 mg a day (using an aripiprazole product available in liquid form), which is gradually increased to the recommended dose of 10 mg once a day.
Maltese: F'pazjenti li għandhom bejn 15 u 17-il sena, id-doża inizjali hija ta' 2 mg kuljum (permezz ta' prodott li fih aripiprazole f'għamla likwida), li gradwalment tiżdied għad-doża rakkomandata ta' 10 mg darba kuljum.
English: Why is Aripiprazole Sandoz approved?
Maltese: Għaliex ġie approvat Aripiprazole Sandoz?
English: Aripiprazole is thought to act mainly by being a ‘partial agonist' at the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Maltese: Aripiprazole huwa maħsub li jaġixxi primarjament bħala ‘agonist parzjali' għar-riċetturi għan-newrotrażmettituri dopamina u 5-hydroxytryptamine (magħruf ukoll bħala serotonina).
English: In addition, when used for patients aged 13 years or older with moderate to severe manic episodes in bipolar I disorder, the company that markets Aripiprazole Sandoz will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in these patients.
Maltese: Barra minn hekk, meta jintuża f'pazjenti ta' 13-il sena jew aktar b'episodji manijaċi minn moderati sa severi f'disturb bipolari I, il-kumpanija li tqiegħed Aripiprazole Sandoz fis-suq sejra tipprovdi materjal edukattiv li jingħata lill-pazjenti jew min jieħu ħsiebom u lit-tobba biex jispjegaw l-użu sigur talmediċina f'dawn il-pazjenti.
English: The Committee recommended that Aripiprazole Sandoz be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Aripiprazole Sandoz ikun approvat għall-użu fl-UE.
English: A risk management plan has been developed to ensure that Aripiprazole Sandoz is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aripiprazole Sandoz jintuża bl-aktar mod sigur possibbli.
English: For schizophrenia, the recommended starting dose is 10 or 15 mg by mouth per day in adults, followed by a ‘maintenance' dose of 15 mg once a day.
Maltese: Għall-iskiżofrenija, id-doża inizjali rakkomandata li tittieħed mill-ħalq hija ta' 10 jew 15 mg kuljum għall-adulti, segwita minn doża ta' ‘manutenzjoni' ta' 15 mg darba kuljum.
English: Aripiprazole Sandoz is used in patients aged 15 years or over;
Maltese: Aripiprazole Sandoz jintuża f'pazjenti ta' 15-il sena jew aktar;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Aripiprazole Sandoz has been shown to have comparable quality and to be bioequivalent to Abilify.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Aripiprazole Sandoz wera li għandu kwalità komparabbli u huwa bijoekwivlenti għal Abilify.
English: Aripiprazole Sandoz is also used for up to 12 weeks to treat moderate to severe manic episodes in patients aged 13 years or over.
Maltese: Aripiprazole Sandoz jintuża wkoll sa 12-il ġimgħa għall-kura ta' episodji manijaċi minn moderati sa severi f'pazjenti ta' 13-il sena jew aktar.
English: How does Aripiprazole Sandoz work?
Maltese: Kif jintuża Aripiprazole Sandoz?
English: Aripiprazole Sandoz aripiprazole
Maltese: Kif ġie studjat Aripiprazole Sandoz?
English: What are the benefits and risks of Aripiprazole Sandoz?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Aripiprazole Sandoz?
English: For treating manic episodes in bipolar disorder, the recommended starting dose in adults is 15 mg by mouth once a day, either on its own or in combination with other medicines.
Maltese: Għall-kura ta' episodji manijaċi f'disturb bipolari, id-doża inizjali rakkomandata hija ta' 15 mg mill-ħalq darba kuljum, jew waħedha jew f'kombinazzjoni ma' mediċini oħrajn.
English: This disrupts signals transmitted between brain nerve cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Maltese: Dan ifixkel is-sinjali trażmessi bejn iċ-ċelloli tal-moħħ permezz ta' ‘newrotrażmettituri', sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: How is Aripiprazole Sandoz used?
Maltese: Kif jaħdem Aripiprazole Sandoz?
English: This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Maltese: Dan ifisser li aripiprzole jaġixxi bħad-dopamina u 5-hydroxytryptamine billi jattiva dawn ir-riċetturi, iżda b'anqas saħħa minnewrotrażmettituri.
English: The company carried out ‘bioequivalence' studies to show that Aripiprazole Sandoz is bioequivalent to the reference medicine, Abilify.
Maltese: Il-kumpanija wettqet studji ta' ‘bijoekwivalenza' sabiex turi li Aripiprazole Sandoz huwa bijoekwivalenti għall-mediċina ta' referenza, Abilify.
English: Aripiprazole Sandoz is used in patients with the following mental illnesses:
Maltese: Aripiprazole Sandoz jintuża f'pazjenti li jbatu mill-mard mentali li ġej:
English: Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Maltese: Sodium succinate, succinic acid, sodium chloride, polysorbate 80, ilma għall-injezzjonijiet
English: You b. c.
Maltese: b. c.
English: The active substance is daclizumab beta.
Maltese: Is-sustanza attiva hi daclizumab beta.
English: Table 1: Adverse reactions reported for Zinbryta 150mg System Organ Class
Maltese: Tabella 1: Reazzjonijiet avversi rrappurtati għal Zinbryta 150mg
English: • skin infection (folliculitis, acne)
Maltese: • infezzjoni tal-ġilda (follikulite, akne)
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
Maltese: Kien hemm esponiment limitat f'pazjenti ta' aktar minn 55 sena fl-istudji kliniċi b'daclizumab beta.
English: As an IgG1 monoclonal antibody, daclizumab beta is expected to undergo catabolism to peptides and amino acids in the same manner as endogenous IgG.
Maltese: IgG1, daclizumab beta hu mistenni li jgħaddi minn kataboliżmu għal peptides u amino acids bl-istess mod bħal IgG endoġenu.
English: At steady state, daclizumab beta mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentration-time 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: Fl-istat fiss, medja tal-konċentrazzjoni massima ta' daclizumab beta fis-serum (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: Based on the cross-study population pharmacokinetic analysis, the clearance of daclizumab beta 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 beta hi ta' 0.212 L/jum b'valur ta' half-life terminali ta' madwar 21 jum.
English: Daclizumab beta 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 beta ma affettwax il-kapaċità riproduttiva f'xadini cynomolgus nisa u rġiel (l-AUC finnisa u fl-irġiel kien sa 85 u 100 darba ogħla mill-esponiment fid-doża klinika rispettivament).
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: Għalkemm l-effett fuq il-progressjoni tad-diżabilità kien l-aktar osservat f'pazjenti b'EDSS fil-linja bażi ta' < 3.5, evidenza ta' effikaċja ntweriet f'pazjenti b'MS progressiva sekondarja li tirkadi (SPMS) 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: Section 4.8 of the SmPC has been reviewed to add the adverse reaction sarcoidosis with a frequency uncommon and the adverse reaction colitis with a frequency common.
Maltese: Sezzjoni 4.8 tal-SmPC ġiet riveduta biex iżżid ir-reazzjoni avversa sarkojdożi bi frekwenza mhux komuni, u r-reazzjoni avversa kolite bi frekwenza komuni.
English: Key effects of this IL-2 pathway modulation potentially related to the therapeutic effects of daclizumab beta in MS include selective antagonism of activated T-cell responses, and expansion of immunoregulatory CD56bright natural killer (NK) cells, which have been shown to selectively decrease activated T-cells.
Maltese: L-effetti ewlenin ta' din ilmodulazzjoni tal-passaġġ ta' IL-2 potenzjalment relatata mal-effetti terapewtiċi ta' daclizumab beta f'MS, jinkludu antagoniżmu selettiv tar-risposti ta' ċelluli T attivati, u l-espansjoni ta' ċelluli qattiela naturali (NK - natural killer) CD56bright immunoregulatorji, li ntwera li jnaqqsu b'mod selettiv ċelluli T attivati.
English: In vitro investigative studies suggest that microglial aggregates are not due to a direct effect of daclizumab beta 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 beta fuq iċ-ċelluli mikroglijali, iżda x'aktarx li huma attribwibbli għal żieda fil bijodisponibilità lokali ta' IL-2.
English: There was no apparent correlation of anti-drug antibodies or neutralising antibodies development to clinical response, adverse reactions, or pharmacodynamic profile of daclizumab beta.
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 malprofil farmakodinamiku ta' daclizumab beta.
English: Consistent with results from individual studies, a cross-study population pharmacokinetic analysis indicated that daclizumab beta 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 beta 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: The active substance in Zinbryta is daclizumab beta.
Maltese: Is-sustanza attiva f'Zinbryta hi daclizumab beta.
English: The exact metabolic pathway for daclizumab beta has not been characterised.
Maltese: Il-passaġġ metaboliku preċiż għal daclizumab beta ma ġiex ikkaratterizzat.
English: • Summary of Product Characteristics (SmPC) and Package Leaflet (PL);
Maltese: • Sommarju tal-Karatteristiċi tal-Prodott (SmPC, Summary of Product Characteristics) u Fuljett
English: Based on the cross-study population pharmacokinetic analysis, daclizumab beta pharmacokinetics were not influenced by age (range: 18 to 66 years; n=1670) or gender (n = 567 males and 1103 females).
Maltese: daclizumab beta ma ġietx influwenzata mill-età (medda: 18 sa 66 sena; n=1,670) jew mis-sess tal persuna (n=567 irġiel u 1103 nisa).
English: In patients with neutralising antibodies, daclizumab beta clearance was increased on average by 19% (see section 5.2).
Maltese: F'pazjenti b'antikorpi newtralizzanti, it-tneħħija ta' daclizumab beta żdiedet b'medja ta' 19% (ara sezzjoni 5.2).
English: This small volume of distribution indicates that daclizumab beta is primarily confined to the vascular and interstitial spaces.
Maltese: Dan il-volum żgħir ta' distribuzzjoni jindika li daclizumab beta jiġi primarjament limitat għall-ispazji vaskulari u interstizjali.
English: Cumulatively, 24 cases of colitis have been retrieved from clinical trials.
Maltese: Kumulattivament, 24 każ ta' kolite nkisbu mill-provi kliniċi.
English: Within the studied regimens of daclizumab beta 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab beta 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 beta 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 beta u l-punti aħħarin tal-effikaċja 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 talġilda, u AST/ALT ta' > 5 darbiet il-ULN).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab beta
Maltese: Zinbryta 150 mg injezzjoni daclizumab beta SC
English: Based on the cross-study population pharmacokinetic analysis, the steady-state volume of distribution of daclizumab beta 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 beta fl-istat fiss hu ta' 6.34 L f'pazjent b'piż tal-ġisem ta' 68 kg (ilmedjan approssimattiv tal-pazjenti evalwati).
English: Daclizumab beta 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: After your injection After Use - Parts of your Zinbryta Pen (see Figure K):
Maltese: Wara l-Użu - Partijiet tal-Pinna Zinbryta (ara Figura K):
English: Taking into account the PRAC Assessment Report on the PSUR(s) for daclizumab beta, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal daclizumab beta, il konklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Daclizumab beta clearance in patients who developed neutralising antibodies was, on average, 19% higher (see section 4.8 Immunogenicity).
Maltese: It-tneħħija ta' daclizumab beta f'pazjenti li żviluppaw antikorpi newtralizzanti kienet, bħala medja, 19% ogħla (ara sezzjoni 4.8 Immunoġeniċità).
English: Together, these immunomodulatory effects of daclizumab beta 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 beta huma maħsuba li jnaqqsu lpatoloġija tas-CNS f'MS u b'hekk inaqqsu l-okkorrenza ta' rikaduti u l-progressjoni tad-diżabilità.
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;
English: Daclizumab beta modulates IL-2 signalling by blocking CD25dependent, high-affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Maltese: Daclizumab beta jimmodula s-senjalar ta' IL-2 billi jimblokka s-senjalar ta' riċettur ta' IL-2 b'affinità għolja, dipendenti fuq CD25, li jirriżulta f'livelli ogħla ta' IL-2
English: • Recommended storage is controlled refrigeration 2°C to 8°C in the closed original carton to
Maltese: • Il-ħażna rakkomandata hi refriġerazzjoni kkontrollata f'temperatura ta' 2°C sa 8°C fil-kartuna oriġinali magħluqa sabiex tipproteġi mid-dawl.
English: Total NK cell counts increased approximately 1.5-fold as a result of the change in CD56bright NK cells.
Maltese: żdied b'madwar 1.5 darbiet b'riżultat tal-bidla fiċ-ċelluli CD56bright NK.
English: Pad
Maltese: Żomm
English: • Immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis)
Maltese: • Disturb immuni li jista' jaffettwa l-pulmuni, il-ġilda u l-għoqod tal-limfa (sarkojdożi)
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL Each pre-filled pen contains 150 mg of daclizumab beta in 1 mL
Maltese: Kull siringa mimlija għal-lest fiha 150 mg ta' daclizumab beta f'1 mL Kull pinna mimlija għal-lest fiha 150 mg ta' daclizumab beta f'1 mL
English: Daclizumab beta is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Maltese: Daclizumab beta mhux mistenni li jgħaddi minn eliminazzjoni mill-kliewi, jew metaboliżmu minn enzimi tal-fwied (ara sezzjoni 4.2).
English: Daclizumab beta pharmacokinetics are well described by a two-compartment model with first-order absorption and elimination.
Maltese: Il-farmakokinetika ta' daclizumab beta hi deskritta tajjeb minn mudell b'żewġ kompartimenti b'assorbiment u eliminazzjoni tal-ewwel ordni.
English: Lung infections:
Maltese: Infezzjonijiet fil-pulmun:
English: Tear here
Maltese: FEJN MA
English: Daclizumab beta is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Maltese: Daclizumab beta mhux mistenni li jgħaddi minn metaboliżmu mill-enzimi tal-fwied, bħal iżoenzimi ta' CYP (ara sezzjoni 4.5). Eliminazzjoni
English: Inflammation of the bowel (colitis): (Common - may affect up to 1 in 10 people)
Maltese: • awrina skura (minn lewn it-te) (Mhux komuni - jistgħu jaffettwaw sa 1 minn kull 100 persuna)
English: Daclizumab beta 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 beta 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: There is also a plausible mechanism of action for the development of sarcoidosis due to the immunomodulatory effects of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Maltese: Hemm ukoll mekkaniżmu plawsibbli ta' azzjoni għall iżvilupp ta' sarkojdożi minħabba l-effetti immunomodulatorji ta' daclizumab beta u l-involviment ta'
English: Following subcutaneous administration of daclizumab beta 150 mg every 4 weeks, steady-state serum daclizumab beta concentrations were achieved by the 4th dose and daclizumab beta accumulated to a level approximately 2.5-fold compared to a single dose.
Maltese: daclizumab beta serum fl-istat fiss inkisbu sar-4 doża, u daclizumab beta akkumula għal livell ta' madwar 2.5 darbiet meta mqabbel ma' doża waħda.
English: Following subcutaneous administration of daclizumab beta, the median time to reach maximum serum concentrations (Tmax) ranged from 5 to 7 days.
Maltese: Wara l-għoti taħt il-ġilda ta' daclizumab beta, iż-żmien medjan biex jintlaħqu l-konċentrazzjonijiet massimi fis-serum (Tmax) varja minn 5 sa 7 ijiem.
English: Solution for injection 1 pre-filled syringe 1 pre-filled pen
Maltese: Pass 1: Iġbor il-provvisti tiegħek u aħsel idejk
English: Subcutaneous use
Maltese: Doża rakkomandata
English: Available toxicology data in lactating cynomolgus monkeys have shown excretion of daclizumab beta in milk (for details see section 5.3).
Maltese: Billi t-tneħħija mhijiex rotta maġġuri tal-eliminazzjoni, l-ebda aġġustamenti fid-doża mhuma kkunsidrati li huma meħtieġa (ara sezzjoni 5.2).
English: Skin and subcutaneous tissue disorders
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
English: The absolute bioavailability of daclizumab beta 150 mg subcutaneously administered was approximately 90% based on a cross-study population pharmacokinetic analysis of subcutaneous and intravenous dosing.
Maltese: 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: 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
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen
Maltese: Informazzjoni għall-utent Zinbryta 150 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Maltese: Zinbryta 150 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest daclizumab beta
English: SC
Maltese: Ħakk
English: (See Figure J.)
Maltese: (Ara Figura I.)
English: • Patients who had failed to respond to a full and adequate course (at least 1 year) of prior DMT treatment, having had at least 1 relapse in the previous year while on therapy, and at least 9 T2 hyperintense lesions in cranial MRI or at least 1 Gd-enhancing lesion, or having an unchanged or increased relapse rate in the prior year as compared to the previous 2 years.
Maltese: • Pazjenti li ma rrispondewx għal kors sħiħ u adegwat (mill-inqas sena ta' kura) ta' kura fil-passat b'DMT, u li kellhom mill-inqas 1 rikaduta fis-sena ta' qabel waqt li kienu qegħdin fuq it terapija, u mill-inqas 9 leżjonijiet iperintensi
English: Clinical endpoints Number of patients Annualised relapse rate Rate ratio [95% CI]
Maltese: MRI scans ta' kull xahar) Proporzjon tal-medja leżjoni[95% CI]
English: In two 9 month studies conducted in cynomolgus monkeys daclizumab beta was subcutaneously administered at bi-weekly doses of 10-200 mg/kg.
Maltese: F'żewġ studji li damu 9 xhur, li saru fuq xadini cynomolgus, daclizumab beta ingħata taħt il-ġilda f'dożi kull ġimagħtejn ta' 10-200 mg/kg.
English: It is essentially ‘sodium-free' and can be used by people on a sodium-restricted diet.
Maltese: Hu essenzjalment "ħieles mis-sodium" u għandu jintuża minn nies li jkun fuq dieta ristretta tas-sodium.
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Maltese: Fl-istudji kliniċi, l-effetti farmakodinamiċi ta' Zinbryta 150 mg mogħti taħt il-ġilda kull 4 ġimgħat,
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C Do not place Zinbryta pre-filled syringe back into the refrigerator after warming to room Do not freeze or expose to high temperatures.
Maltese: • Jekk ikun meħtieġ, Zinbryta jista' jinħażen fil-kartuna oriġinali magħluqa mingħajr refriġerazzjoni, f'temperatura sa 30°C għal sa 30 jum.
English: • alcohol wipe
Maltese: • tajjara bl-alkoħol