FrancophonIA/ELRC3.0 huggingface dataset:
English: The absolute bioavailability (AUC) for a single oral 150 mg migalastat hydrochloride dose or a single 2-hour 150 mg intravenous infusion was approximately 75%.
Maltese: Il-bijodisponibbiltà assoluta (AUC) għal doża waħda orali ta' 150 mg migalastat hydrochloride jew infużjoni fil-vina waħda ta' sagħtejn ta' 150 mg kienet bejn wieħed u ieħor ta' 75%.
English: Limited data suggest that co-administration of a single dose of Galafold and a standard enzyme replacement therapy infusion results in an increased exposure to agalsidase of up to 5-fold.
Maltese: Data limitata tindika li l-għoti flimkien ta' doża waħda ta' Galafold u infużjoni tat-terapija standard ta' sostizzjoni tal-enzima tirriżulta f'żieda fl-esponiment għal agalsidase ta' 5 darbiet.
English: The first OLE trial (AT1001-041) included patients from Phase 2 and Phase 3 studies and has completed.
Maltese: L-ewwel prova OLE (AT1001-041) kienet tinkludi pazjenti minn studji ta' Fażi 2 u 3, u din tlestiet.
English: c.G786C or c.G786T
Maltese: c.G786C jew c.G786T
English: c.978G>C or c.978G>T
Maltese: c.978G>C jew c.978G>T
English: c.648T>A or c.648T>G
Maltese: 648T>A jew c.648T>G
English: c.G72C or c.G72T
Maltese: c.G72C jew c.G72T
English: The second Phase 3 trial (FACETS) was a 6-month randomised double-blind placebo-controlled trial (through month 6) with an 18-month open-label period to evaluate the efficacy and safety of Galafold in 50 male and female patients with Fabry disease who were naïve to ERT, or had previously been on ERT and had stopped for at least 6 months and who have amenable mutations (ERT-naïve trial).
Maltese: It-tieni prova tal-Fażi 3 (FACETS) kienet prova ta' 6 xhur randomizzata double-blind ikkontrollata bi plaċebo (matul xahar 6) b'perjodu ta' 18-il xahar open-label sabiex jiġu evalwati l-effikaċja u s-sigurtà ta' Galafold f'50 pazjent irġiel u nisa bil-marda ta' Fabry mingħajr esperjenza tal-ERT, jew li qabel kienu fuq l-ERT u kienu waqfu għal mill-anqas 6 xhur u li għandhom mutazzjonijiet li jirrispondu għal Galafold (prova mingħajr esperjenza tal-ERT).
English: There are limited data from the use of Galafold in pregnant women.
Maltese: Hemm data limitata dwar l-użu ta' Galafold f'nisa tqal.
English: c.T102G or c.T102A
Maltese: T102G jew c.T102A
English: The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Maltese: L-infertilità assoċjata mal-kura b'migalastat kienet irrapportata f'esponimenti klinikament rilevanti .
English: Capsule shell Gelatin
Maltese: Il-qoxra tal-kapsula Ġelatina
English: c.936G>T or c.936G>C
Maltese: c.936G>T jew c.936G>C
English: c.G288A or c.G288T or c.G288C M96I
Maltese: G288A jew c.G288T jew c.G288C
English: c.T789A or c.T789G
Maltese: c.T789A jew c.T789G
English: c.G228C or c.G228A or c.G228T M76I
Maltese: G228C jew c.G228A jew c.G228T
English: c.886A>T or c.886A>C
Maltese: c.886A>T jew c.886A>C
English: c.667T>A or c.668G>C
Maltese: c.667T>A jew c.668G>C
English: c.402T>G or c.402T>A
Maltese: 402T>G jew c.402T>A
English: c.G126A or c.G126C or c.G126T M42I
Maltese: c.G126A jew c.G126C jew c.G126T
English: c.786G>C or c.786G>T
Maltese: c.786G>C jew c.786G>T
English: c.T798A or c.T798G
Maltese: T798A jew c.T798G
English: c.G678T or c.G678C
Maltese: G678T jew c.G678C
English: c.678G>T or c.678G>C
Maltese: c.678G>T jew c.678G>C
English: UNKNOWN (del Exon3 and 4?)
Maltese: MHUX MAGĦRUF (del Exon3 u 4?)
English: c.687T>A or c.687T>G
Maltese: c.687T>A jew c.687T>G
English: UNKNOWN (del Exon3_7?)
Maltese: MHUX MAGĦRUF (del Exon3_7?)
English: c.798T>A or c.798T>G
Maltese: c.798T>A jew c.798T>G
English: Once in lysosomes dissociation of migalastat restores -Gal A activity, leading to the catabolism of GL-3 and related substrates.
Maltese: Ġaladarba fil-liżożomi, id-diżassoċjazzjoni ta' migalastat ġġib lura l-attività -Gal A, u dan iwassal għal kataboliżmu ta' GL-3 u sottostrati relatati.
English: Luxembourg/Luxemburg Amicus Therapeutics Europe Limited Tél/Tel: 800 27003 e-mail: MedInfo@amicusrx.com
Maltese: Luxembourg/Luxemburg Amicus Therapeutics Europe Limited Tél/Tel: 800 27003 e-mail:
English: c.789T>A or c.789T>G
Maltese: c.789T>A jew c.789T>G
English: In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Maltese: GL-3 kellhom it-tendenza li jonqsu fl-awrina u fil-kapillari interstizjali tal-kliewi (kidney interstitial capillaries).
English: Patients randomised to Galafold in Stage 1 demonstrated statistically significant greater reduction (±SEM) in mean interstitial capillary GL-3 deposition (-0.25±0.10; -39%) at month 6 compared to placebo (+0.07 ± 0.13; +14%) (p=0.008).
Maltese: 10; -39%) f'xahar 6 meta mqabbel mal-plaċebo (+0.07 ± 0.13; +14%) (p=0.008).
English: Rash Pruritus
Maltese: Struzzjonijiet sabiex tiftaħ
English: Pregnancy
Maltese: Paresteżija
English: • Reduced sense of touch or sensation
Maltese: • Nuqqas ta' sens tal-mess jew sensazzjoni
English: Protein Sequence change p.T412Sfs*37
Maltese: p.T412Sfs*37
English: The mean annualised rate of change from baseline in eGFRCKD-EPI in patients treated for 30 months with Galafold was -1.72 mL/min/1.73 m
Maltese: Il-medja tar-rata annwalizzata (mean annualised rate) ta' bidla mil-linja bażi f'eGFRCKD-EPI f'pazjenti kkurati għal 30 xahar b'Galafold kienet ta' -1.72 mL/min/1.73 m
English: c.[644A>G; 811G>A; 937G>T] c.A644G/G811A/G937T
Maltese: c.[644A>G; 811G>A; 937G>T] c.
English: c.963G>C or c.963G>T
Maltese: 963G>C jew c.963G>T
English: c.G888A or c.G888T or c.G888C M296I
Maltese: G888A jew c.G888T jew c.G888C
English: In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Maltese: Fil-prova mingħajr esperjenza tal-ERT u l-estensjoni open-label, il-funzjoni tal-kliewi baqgħet stabbli għal sa 5 snin ta' kura b'Galafold.
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
Maltese: c.126G>A jew c.126G>C jew c.126G>T
English: c.G870A or c.G870C or c.G870T M290I
Maltese: c.G870A jew c.G870C jew c.G870T
English: Galafold is not intended for concomitant use with enzyme replacement therapy.
Maltese: Galafold mhuwiex intiż għall-użu fl-istess ħin ma'terapija ta' sostituzzjoni tal-enzima.
English: Galafold has not been studied in patients with Fabry disease who have a GFR less than 30 mL/min/1.73 m2.
Maltese: Galafold ma ġiex studjat f'pazjenti li jbatu mill-marda ta' Fabry li għandhom GFR anqas minn 30 mL/min/1.73 m2.
English: c.G677A or c.G678A
Maltese: G677A jew c.G678A
English: c.G1074T or c.G1074C
Maltese: c.1074G>T jew c.1074G>C c.G1074T jew c.G1074C
English: c.646delT
Maltese: 646delT
English: Fabry disease-causing mutations in the GLA gene result in a deficiency of the lysosomal enzyme -galactosidase A (-Gal A) that is required for glycosphingolipid substrate (e.g., GL-3, lyso-Gb3) metabolism.
Maltese: Mutazzjonijiet li jikkawżaw il-marda ta' Fabry fil-ġene GLA jirriżultaw f'nuqqas tal-enzima tal-lisożomi -galactosidase A (-Gal A) meħtieġa għall-metaboliżmu tas-sottostrat glycosphingolipid (eż., GL-3, lyso-Gb3) Għaldaqstant l-attività -Gal A mnaqqsa hija assoċjata mal-akkumulazzjoni progressiva ta' sottostrat f'organi u tessuti vulnerabbli, li twassal għal morbidità u mortalità assoċjati mal-marda ta' Fabry.
English: Galafold 123 mg hard capsules Migalastat
Maltese: Galafold 123 mg kapsuli ibsin migalastat
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Maltese: Popolazzjoni tal-anzjani L-ebda aġġustament tad-doża mhuwa meħtieġ abbażi tal-età (ara sezzjoni 5.2).
English: Protein Sequence change c.290delC
Maltese: Bidla fis-Sekwenza tal-Proteina c.123delC
English: The safety and efficacy of Galafold in children aged 0 to 15 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Galafold fit-tfal minn eta' 0 sa 15-il sena ma ġewx determinati s'issa.
English: The first Phase 3 trial (ATTRACT) was a randomised open-label active comparator trial that evaluated the efficacy and safety of Galafold compared to enzyme replacement therapy (ERT) (agalsidase beta, agalsidase alfa) in 52 male and female patients with Fabry disease who were receiving ERT prior to trial entry and who have amenable mutations (ERT-experienced trial).
Maltese: L-ewwel prova tal-Fażi 3 (ATTRACT) kienet prova, randomizzata open-label b' komparatur attiv li evalwat l-effikaċja u s-sigurtà ta' Galafold meta mqabbel mat-terapija ta' sostituzzjoni tal-enzima (ERT) (agalsidase beta, agalsidase alfa) fi 52 pazjent irġiel u nisa bil-marda ta' Fabry li kienu qed jirċievu l-ERT qabel daħlu fil-prova u li għandhom mutazzjonijiet li jirrispondu ghal Galafold (prova b' esperjenza tal-ERT).
English: The mean change from baseline in LVMi at Month 18 to 24 in patients with left ventricular hypertrophy at baseline (females with baseline LVMi > 95 g/m or males with baseline LVMi > 115 g/m 2) was -18.6 (95% CI: -38.2, 1.0; n=8).
Maltese: (nisa b'LVMi tal-linja bażi > 95 g/m u rġiel b'LVMi tal-linja bażi > 115 g/m2) kienet -8.4 (95% CI: -15.
English: • Stomach ache
Maltese: • Stitikezza
English: In case of overdose, general medical care is recommended.
Maltese: F'każ ta' doża eċċessiva, hija rrakkomandata kura medika ġenerali.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class.
Maltese: Ma' kull grupp ta' frekwenza, ir-reazzjonijiet avversi huma ppreżentati f'ordni ta' frekwenza dejjem tonqos fi ħdan kull Klassi tas-Sistema tal-Organi.
English: DD month YYYY
Maltese: TA' KIF JINGĦATA
English: No clinically significant differences in LVMi were observed during the initial 6-month placebo-controlled period.
Maltese: Ma kinux osservati differenzi klinikament sinifikanti waqt il-perjodu inizjali ta' 6 xhur ikkontrollat mill-plaċebo.
English: Following administration of the same doses, the mean elimination half-life (t1/2) ranged from approximately 3 to 5 hours.
Maltese: Wara l-għoti tal-istess dożi, il-half-life medja tal-eliminazzjoni (t1/2) varjat minn bejn wieħed u ieħor 3 sa 5 sigħat.
English: If a double mutation is present on the same chromosome (males and females), that patient is amenable if the double mutation is present in one entry in Table 2 (e.g., D55V/Q57L).
Maltese: Jekk ikun hemm mutazzjoni doppja preżenti fl-istess kromożoma (irġiel u nisa), dak il-pazjent jirrispondi għal Galafold jekk il-mutazzjoni doppja tkun preżenti f'entrata waħda f'Tabella 2 (eż., D55V/Q57L).
English: Talk to your doctor before taking Galafold if you are currently taking enzyme replacement therapy.
Maltese: Ma għandekx tieħu Galafold jekk qiegħed tirċievi wkoll terapija ta' sostituzzjoni tal-enzima.
English: During the open-label extension, statistically significant (p<0.05) improvements from baseline were observed in the diarrhoea and indigestion domains, with a trend of improvement in the constipation domain.
Maltese: Waqt l-estensjoni open-label, ġie osservat titjib statistikament sinfikanti (p<0.05) mil-linja bażi fl-oqsma tad-dijarea u l-indiġestjoni, b'xejra ta' titjib fil-qasam tal-istitikezza.
English: c.G1081A or c.G1081C
Maltese: c.1081G>A jew c.1081G>C c.G1081A jew c.G1081C
English: While taking Galafold you should use effective birth control.
Maltese: Waqt li qed tieħu Galafold għandek tuża kontraċettiv effettiv.
English: Certain GLA mutations can result in the production of abnormally folded and unstable mutant forms of α-Gal A. Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of -Gal A, the genotypes of which are referred to as amenable mutations.
Maltese: MAGĦRUFA fil-kolonna ta' 'bidla fis-sekwenza tal-proteina' tindika li l-bidliet fis-sekwenza tal-proteina kkawżati mill-mutazzjonijiet ma jistgħux jiġu dedotti faċilment mill-bidliet fin-nukleotidi u jridu jkunu determinati permezz ta' esperimenti.
English: • Feeling sick (nausea)
Maltese: • Qtugħ ta' nifs (dispnea)
English: was -33.1 (CI:-60.9, -5.4; n=4).
Maltese: (95%) CI: -57.9, -2.2; n=4) u f'Xahar 48 kienet ta' -33.1 (CI:-60.9, -5.4; n=4).
English: galafold 123 mg hard capsules
Maltese: Galafold 123 mg kapsuli ibsin
English: Plasma lyso- Gb3 levels also remained low in patients on ERT for up to 18 months.
Maltese: Il-livelli ta' lyso-Gb3 fil-plażma wkoll baqgħet baxxa f'pazjenti li baqgħu fuq l-ERT għal sa 18-il xahar.
English: 92.9 g/m for the ERT arm and the mean change from baseline in LVMi at Month 18 was -6.6 (95% CI: -11.0, -2.1; n=31) for Galafold and -2.0 (95% CI: -11.0, 7.0; n=13) for ERT.
Maltese: Il-valuri fil-linja bażi kienu 95.3 g/m2 għall-parti tal-istudju dwar Galafold, u 92.9 g/m għall-parti tal-istudju dwar ERT, u l-bidla medja mil-linja bażi f'LVMi f'Xahar 18 kienet -6.6 (95% CI: -11.0, -2.1; n=31) għal Galafold, u -2.0 (95% CI: -11.0, 7.0; n=13) għal ERT. Il-bidla mil-linja bażi għal Xahar 18 fil-LVMi (g/m 2) f'pazjenti b'ipertrofija ventrikulari tax-xellug
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
Maltese: Galafold mhuwiex rakkomandat għall-użu f'pazjenti li jbatu minn insuffiċjenza tal-kliewi severa, definita bħala GFR stmat ta' anqas minn 30 mL/min/1.73m
English: Treatment with Galafold in Phase 2 pharmacodynamic trials generally resulted in increases in endogenous α-Gal A activity in WBCs, as well as in skin and kidney for the majority of patients.
Maltese: Il-kura b'Galafold fi provi farmakodinamiċi tal-Fażi 2 irriżultaw b'mod ġenerali f'żidiet fl-attività endoġena α-Gal A f'WBCs, kif ukoll fil-ġilda u fil-kliewi għall-maġġoranza tal-pazjenti.
English: In the ERT-experienced trial, renal function remained stable for up to 18 months of treatment with Galafold.
Maltese: Fil-prova b' esperjenza tal-ERT, il-funzjoni tal-kliewi baqgħet stabbli sa 18-il xahar ta' kura b'Galafold.
English: What you need to know before you take Galafold 3.
Maltese: X'għandek tkun taf qabel ma tieħu Galafold 3.
English: Galafold has no or negligible influence on the ability to drive and use machines.
Maltese: Galafold m'għandu l-ebda influwenza jew influwenza negliġibbli fuq il-kapaċità ta' sewqan u tħaddim ta' magni.
English: C63Y c.194G>C (putative splicing site) c.G194C (putative splicing site) UNKNOWN (S65T) c.194G>T (putative splicing site) c.G194T (putative splicing site) UNKNOWN (S65I) c.196G>C
Maltese: Fil-fniek, effett tossiku fuq l-iżvilupp kien osservat biss f'dożi tossiċi għall-omm (ara sezzjoni 5.3). Galafold mhuwiex rakkomandat waqt it-tqala.
English: Tel: 800 795 572 e-mail: MedInfo@amicusrx.com
Maltese: Amicus Therapeutics S.r.l. Tel: 800 795 572 e-mail: MedInfo@amicusrx.com
English: Protein Sequence change
Maltese: Bidla fis-Sekwenza tal-Proteina
English: Amicus Therapeutics Europe Limited Tfn: 020 795 493 e-post: MedInfo@amicusrx.com
Maltese: Amicus Therapeutics Europe Limited Τηλ.: 800 97595 e-mail: MedInfo@amicusrx.com
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Maltese: L-ebda aġġustament tad-doża ta' Galafold ma huwa meħtieġ f'pazjenti b'indeboliment tal-fwied (ara sezzjoni 5.2).
English: Similar findings have been noted pre-clinically following treatment with other iminosugars (see section 5.3).
Maltese: Sejbiet simili kienu osservati preklinikament wara l-kura b'zokkor imminiku (iminosugars) ieħor (ara sezzjoni 5.3). Migalastat ma affetwax il-fertilità fil-firien nisa.
English: These measures will help protect the environment.
Maltese: Mhux il-mutazzjonijiet kollha ġew ittestjati.
English: What Galafold looks like and contents of the pack Opaque, blue, and white hard capsules, marked with “A1001” in black ink, containing white to pale brown powder.
Maltese: Kif jidher Galafold u l-kontenuti tal-pakkett Kapsuli ibsin opaki, blu u bojod, immarkati b'“A1001” b'linka sewda, li fihom trab abjad għal kannella ċar.
English: The effect of age was evaluated in a population pharmacokinetic analysis on plasma migalastat clearance in the ERT-naïve study population.
Maltese: Fertilità fin-nisa Għadu mhuwiex magħruf jekk din il-mediċina taffetwax il-fertilità fin-nisa.
English: Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females.
Maltese: Il-marda ta' Fabry hija disturb progressiv tal-ħażna ta' lisożomi tat-tip X-linked li taffetwa lill-irġiel u lin-nisa.
English: Amicus Therapeutics Europe Limited Tel: 800 0111 911 e-post: MedInfo@amicusrx.com
Maltese: Amicus Therapeutics Europe Limited Teл.: 00800 111 3214 имейл: MedInfo@amicusrx.com
English: BLISTER SLEEVE
Maltese: Għeja Uġigħ
English: In a rat 104-week carcinogenicity study, there was an increased incidence of pancreatic islet cell adenomas in males at a dose level 19-fold higher than the exposure (AUC) at the clinically efficacious dose.
Maltese: Fi studju fil-firien dwar ir-riskju ta' kanċer ta' 104 ġimgħat, kien hemm żieda fl-inċidenza ta' adenomi taċ-ċelloli islet pankreatiċi fl-irġiel f'livell tad-doża 19-il darba aktar mill-esponiment (AUC) fid-doża klinikament effikaċi.
English: M267R c.801G>A (putative splicing site) c.G801A (putative splicing site) UNKNOWN (M267I) c.803T>C
Maltese: c.801G>A (sit probabbli ta' tagħqid)
English: Amicus Therapeutics, UK Limited Tel: +44 175 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
Maltese: 3888 567 / 08 0823 46864 e-mail: MedInfo@amicusrx.com
English: • Pain
Maltese: • Għeja
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Halimatoz tista' tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The proportion of patients who had at least a 75% reduction in symptoms after 16 weeks of treatment was 68% with Halimatoz and 63% with Humira.
Maltese: Il-proporzjon ta' pazjenti li kellhom tnaqqis ta' mill-inqas 75 % tas-sintomi wara 16-il ġimgħa ta' kura kien ta' 68 % b'Halimatoz u 63 % b'Humira.
English: Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Maltese: Halimatoz fih is-sustanza attiva adalimumab u huwa “mediċina bijosimili”.
English: The reference medicine for Halimatoz is Humira.
Maltese: Ilmediċina ta' referenza għal Halimatoz hija Humira.
English: Other information about Halimatoz
Maltese: Informazzjoni oħra dwar Halimatoz
English: What are the risks associated with Halimatoz?
Maltese: X'inhuma r-riskji assoċjati ma' Halimatoz?
English: The active substance in Halimatoz, adalimumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a substance in the body called tumour necrosis factor (TNF).
Maltese: Is-sustanza attiva f'Halimatoz, l-adalimumab, hija antikorp monoklonali (tip ta' proteina) li tfassal biex jagħraf u jeħel ma' sustanza fil-ġisem imsejħa fattur ta' nekrożi tumorali (TNF).
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Maltese: Barra minn hekk, Halimatoz kien effettiv daqs Humira fi studju li jinvolvi 465 pazjent bi psorjażi bi plakka moderata jew gravi.
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Maltese: • spondiloartrite assjali (infjammazzjoni tas-sinsla tad-dahar li tikkawża wġigħ fid-dahar), inkluża spondilite ankilożanti u fejn ir-raġġi X ma jurux mard iżda jkun hemm sinjali ċari ta' infjammazzjoni;
English: Laboratory studies comparing Halimatoz with Humira have shown that the active substance in Halimatoz is highly similar to that in Humira in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Halimatoz ma' Humira wrew li s-sustanza attiva f'Halimatoz hija simili ħafna għal dik f'Humira f'termini ta' struttura, purità u attività bijoloġika.
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Halimatoz huwa simili ħafna għal mediċina bijoloġika oħra (il-”mediċina ta' referenza”) li diġà hija awtorizzata fl-UE.
English: How is Halimatoz used?
Maltese: Halimatoz?
English: For the full list of side effects and restrictions with Halimatoz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Halimatoz, ara l-fuljett ta' tagħrif.
English: All these data were considered sufficient to conclude that Halimatoz will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Halimatoz jaġixxi bl-istess mod bħal Humira f'termini ta' effettività u sigurtà fl-użu approvat tiegħu.
English: Halimatoz must not be used in patients with active tuberculosis or other severe infections, or in patients with moderate to severe heart failure (an inability of the heart to pump enough blood around the body).
Maltese: Halimatoz ma għandux jintuża f'pazjenti b'tuberkolożi attiva jew infezzjonijiet gravi oħra, jew f'pazjenti b'insuffiċjenza kardijaka moderata sa gravi (il-qalb ma tkunx kapaċi tippompja biżżejjed demm madwar il-ġisem).
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses
Maltese: • idradenite suppurativa (akne inversa), marda tal-ġilda fit-tul li tikkawża boċċi, axxessi (ġbir ta' materja) u ċikatriċi fuq il-ġilda;
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Halimatoz hija ssorveljata kontinwament.
English: For more information on biosimilar medicines, see here.
Maltese: Għal iktar informazzjoni dwar il-mediċini bijosimili, ara hawn.
English: By attaching to TNF, adalimumab blocks its activity, thereby reducing inflammation and other symptoms of the diseases.
Maltese: Meta teħel mat-TNF, l-adalimumab timblokka l-attività tiegħu, għaldaqstant tnaqqas linfjammazzjoni u sintomi oħra tal-mard.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Halimatoz has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċiediet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Halimatoz wera li għandu struttura, purità u attività bijoloġika simili ħafna għal Humira u jiġi distribwit bl-istess mod fil-ġisem.
English: The dose and frequency of injection depends on the condition to be treated and the dose for a child is usually calculated according to the child's weight; because Halimatoz is only available in doses of 40 mg, it is not suitable for children who need less than a 40-mg dose.
Maltese: Id-doża u l-frekwenza tal-injezzjoni jiddependu fuq il-kundizzjoni li trid tiġi kkurata u d-doża għat-tfal normalment tiġi kkalkolata skont il-piż tat-tfal; peress li Halimatoz huwa disponibbli biss f'dożi ta' 40 mg, mhuwiex xieraq għal tfal li jeħtieġu doża iżgħar minn 40 mg.
English: Studies have also shown that giving Halimatoz produces similar levels of the active substance in the body to giving Humira.
Maltese: L-istudji wrew ukoll li l-għoti ta' Halimatoz jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' Humira.
English: Like other medicines of its class, Halimatoz may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Maltese: Bħal mediċini oħra tal-klassi tiegħu, Halimatoz jista' jaffettwa l-abbiltà tas-sistema immuni li tiġġieled l-infezzjonijiet u l-kanċer, u kien hemm xi każijiet ta' infezzjonijiet serji u kanċers tad-demm f'pazjenti li kienu qed jużaw adalimumab.
English: How does Halimatoz work?
Maltese: Kif jintuża Halimatoz?
English: Why is Halimatoz authorised in the EU?
Maltese: Għaliex Halimatoz ġie awtorizzat fl-UE?