FrancophonIA/ELRC3.0 huggingface dataset:
English: c.612G>T or c.612G>C
Romanian: c.612G>T sau c.612G>C
English: c.G261C or c.G261T
Romanian: c.G261C sau c.G261T
English: c.471G>C or c.471G>T
Romanian: c.471G>C sau c.471G>T
English: c.207C>A or c.207C>G
Romanian: c.207C>A sau c.207C>G
English: c.153G>A or c.153G>T or c.153G>C
Romanian: c.153G>A sau c.153G>T sau c.153G>C
English: c.285G>T or c.285G>C
Romanian: c.285G>T sau c.285G>C
English: c.241T>C or c.241T>A
Romanian: c.241T>C sau c.241T>A
English: c.G612T or c.G612C
Romanian: c.G612T sau c.G612C
English: c.519C>A or c.519C>G
Romanian: c.519C>A sau c.519C>G
English: c.C305G or c.C305A
Romanian: c.C305G sau c.C305A
English: c.124A>C or c.124A>T
Romanian: c.124A>C sau c.124A>T
English: Following ascending single oral doses (25-675 mg migalastat hydrochloride), no trends were found for clearance, CL/F).
Romanian: Nu au fost evidențiate tendințe pentru clearance, CL/F, în urma creșterii dozelor unice orale (25-675 mg clorhidrat de migalastat).
English: c.552T>A or c.552T>G
Romanian: c.552T>A sau c.552T>G
English: Galafold is to be taken every other day.
Romanian: Galafold trebuie luat o dată la două zile.
English: c.G609C or c.G609T
Romanian: c.G609C sau c.G609T
English: c.131G>A or c.132G>A
Romanian: c.131G>A sau c.132G>A
English: c.C453G or c.C453A
Romanian: c.C453G sau c.C453A
English: c.G243T or c.G243C
Romanian: c.G243T sau c.G243C
English: c.G132T or c.G132C
Romanian: c.G132T sau c.G132C
English: c.T258G or c.T258A
Romanian: c.T258G sau c.T258A
English: c.T280A or c.G281C
Romanian: c.T280A sau c.G281C
English: c.982G>A or c.982G>C
Romanian: c.982G>A sau c.982G>C
English: c.C525G or c.C525A
Romanian: c.C525G sau c.C525A
English: c.C747G or c.C747A
Romanian: c.C747G sau c.C747A
English: UNKNOWN (del Exon3?)
Romanian: NECUNOSCUTĂ (del Exon3?)
English: c.T960G or c.T960A
Romanian: c.T960G sau c.T960A
English: L177X c.547G>A (putative splicing site) c.G547A (putative splicing site) UNKNOWN (G183S) c.548G>T
Romanian: c.547G>A (sit putativ de splice) c.G547A (sit putativ de splice)
English: c.G144T or c.G144C
Romanian: c.G144T sau c.G144C
English: c.279C>G or c.279C>A
Romanian: c.279C>G sau c.279C>A
English: c.T514A or c.G515C
Romanian: c.T514A sau c.G515C
English: c.A840T or c.A840C
Romanian: c.A840T sau c.A840C
English: M267R c.801G>A (putative splicing site) c.G801A (putative splicing site) UNKNOWN (M267I) c.803T>C
Romanian: c.801G>A (sit putativ de splice) c.G801A (sit putativ de splice)
English: c.T154A or c.G155C
Romanian: c.T154A sau c.G155C
English: c.C897G or c.C897A
Romanian: c.C897G sau c.C897A
English: c.G567C or c.G567T
Romanian: c.G567C sau c.G567T
English: c.233C>G or c.233C>A
Romanian: c.233C>G sau c.233C>A
English: c.132G>T or c.132G>C
Romanian: c.132G>T sau c.132G>C
English: c.243G>T or c.243G>C
Romanian: c.243G>T sau c.243G>C
English: c.816C>A or c.816C>G
Romanian: c.816C>A sau c.816C>G
English: Fatigue Pain
Romanian: Oboseală Durere
English: c.525C>G or c.525C>A
Romanian: c.525C>G sau c.525C>A
English: UNKNOWN (del Exon5_7?)
Romanian: NECUNOSCUTĂ (del Exon5_7?)
English: c.G830A or c.G831A
Romanian: c.G830A sau c.G831A
English: c.103G>C or c.103G>A
Romanian: c.103G>C sau c.103G>A
English: c.A588T or c.A588C
Romanian: c.A588T sau c.A588C
English: c.144G>T or c.144G>C
Romanian: c.144G>T sau c.144G>C
English: c.T610C or c.T610A
Romanian: c.T610C sau c.T610A
English: UNKNOWN (del Exon1_2?)
Romanian: NECUNOSCUTĂ (del Exon1_2?)
English: c.881T>G or c.881T>A
Romanian: c.881T>G sau c.881T>A
English: c.540G>C or c.540G>T
Romanian: c.540G>C sau c.540G>T
English: c.G831T or c.G831C
Romanian: c.G831T sau c.G831C
English: c.T859C or c.T859A
Romanian: c.T859C sau c.T859A
English: c.258T>G or c.258T>A
Romanian: c.258T>G sau c.258T>A
English: c.707G>A or c.708G>A
Romanian: c.707G>A sau c.708G>A
English: c.166T>A or c.167G>C
Romanian: c.166T>A sau c.167G>C
English: c.108G>C or c.108G>T
Romanian: c.108G>C sau c.108G>T
English: c.830G>A or c.831G>A
Romanian: c.830G>A sau c.831G>A
English: c.T369G or c.T369A
Romanian: c.T369G sau c.T369A
English: c.G141C or c.G141T
Romanian: c.G141C sau c.G141T
English: c.G485A or c.G486A
Romanian: c.G485A sau c.G486A
English: c.610T>C or c.610T>A
Romanian: c.610T>C sau c.610T>A
English: c.453C>G or c.453C>A
Romanian: c.453C>G sau c.453C>A
English: c.609G>C or c.609G>T
Romanian: c.609G>C sau c.609G>T
English: c.567G>C or c.567G>T
Romanian: c.567G>C sau c.567G>T
English: c.T408A or c.T408G
Romanian: c.T408A sau c.T408G
English: c.G216A or c.G216T or c.G216C M72I
Romanian: c.G216A sau c.G216T sau c.G216C
English: c.G860A or c.G861A
Romanian: c.G860A sau c.G861A
English: c.305C>G or c.305C>A
Romanian: c.305C>G sau c.305C>A
English: c.734G>A or c.735G>A
Romanian: c.734G>A sau c.735G>A
English: c.G71A or c.G72A
Romanian: c.G71A sau c.G72A
English: c.C456A or c.C456G
Romanian: c.C456A sau c.C456G
English: c.960T>G or c.960T>A
Romanian: c.960T>G sau c.960T>A
English: c.T465A or c.T465G
Romanian: c.T465A sau c.T465G
English: c.141G>C or c.141G>T
Romanian: c.141G>C sau c.141G>T
English: c.G108C or c.G108T
Romanian: c.G108C sau c.G108T
English: c.831G>T or c.831G>C
Romanian: c.831G>T sau c.831G>C
English: If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose.
Romanian: Dacă au trecut mai mult de 12 ore, trebuie să reluați administrarea Galafold în următoarea zi și la următoarea oră de administrare planificată, conform schemei de administrare o dată la două zile.
English: c.C966A or c.C966G
Romanian: c.C966A sau c.C966G
English: c.G394A or c.G394C
Romanian: c.G394A sau c.G394C
English: • Sudden need to defecate
Romanian: • Necesitate bruscă de a elimina materii fecale
English: c.439G>A or c.439G>C
Romanian: c.439G>A sau c.439G>C
English: c.G861C or c.G861T
Romanian: c.G861C sau c.G861T
English: c.G439A or c.G439C
Romanian: c.G439A sau c.G439C
English: c.870G>A or c.870G>C or c.870G>T
Romanian: c.870G>A sau c.870G>C sau c.870G>T
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.
Romanian: Valorile de la momentul inițial au fost de 95,3 g/m pentru grupul de tratament cu Galafold și de 92,9 g/m pentru grupul de tratament cu TSE, iar modificarea medie în Luna 18 față de momentul inițial a IMVS a fost de -6,6 (IÎ 95%: -11,0, -2,1; n=31) pentru grupul de tratament cu Galafold și de -2,0 (IÎ 95%: 11,0, 7,0; n=13) pentru grupul de tratament cu TSE.
English: (dyspnoea)
Romanian: (dispnee)
English: c.859T>C or c.859T>A
Romanian: c.859T>C sau c.859T>A
English: c.860G>A or c.861G>A
Romanian: c.860G>A sau c.861G>A
English: Q212X c.639G>A (putative splicing site) c.G639A (putative splicing site) UNKNOWN c.[644A>G; 811G>A]
Romanian: c.639G>A (sit putativ de splice) c.G639A (sit putativ de splice)
English: c.T337C or c.T339A or c.T339G F113L
Romanian: c.T337C sau c.T339A sau c.T339G
English: Protein Sequence change c.290delC
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.946delG
English: c.897C>G or c.897C>A
Romanian: c.897C>G sau c.897C>A
English: c.514T>A or c.515G>C
Romanian: c.514T>A sau c.515G>C
English: c.G837C or c.G837T
Romanian: c.G837C sau c.G837T
English: c.T676C or c.T676A
Romanian: c.T676C sau c.T676A
English: c.394G>A or c.394G>C
Romanian: c.394G>A sau c.394G>C
English: c.G486C or c.G486T
Romanian: c.G486C sau c.G486T
English: c.154T>A or c.155G>C
Romanian: c.154T>A sau c.155G>C
English: c.71G>A or c.72G>A
Romanian: c.71G>A sau c.72G>A
English: c.966C>A or c.966C>G
Romanian: c.966C>A sau c.966C>G
English: c.888G>A or c.888G>T or c.888G>C
Romanian: c.888G>A sau c.888G>T sau c.888G>C
English: c.T667A or c.G668C
Romanian: c.T667A sau c.G668C
English: c.485G>A or c.486G>A
Romanian: c.485G>A sau c.486G>A
English: c.T648A or c.T648G
Romanian: c.T648A sau c.T648G
English: c.102T>G or c.102T>A
Romanian: c.102T>G sau c.102T>A
English: c.588A>T or c.588A>C
Romanian: c.588A>T sau c.588A>C
English: The change from baseline to Month 18 in LVMi (g/m 2) in patients with left ventricular hypertrophy (females with baseline LVMi > 95 g/m and males with baseline LVMi > 115 g/m2) was -8.4 (95% CI: -15.7, 2.6; n=13) for migalastat and 4.5 (95% CI: -10.7, 18.4; n=5) for ERT. After 30 months treatment with Galafold, the mean change from baseline in LVMi was -3.8 (95% CI: -8.9, 1.3; n=28) and the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline was -10.0 (95% CI: -16.6, -3.3; n=10).
Romanian: Modificarea IMVS (g/m2) de la momentul inițial până în luna 18 la pacienții cu hipertrofie ventriculară stângă (femei cu IMVS inițial > 95 g/m și bărbați cu IMVS inițial > 115 g/m a fost de -8,4 (IÎ 95%: -15,7, 2,6; n=13) pentru migalastat și de 4,5 (IÎ 95%: -10,7, 18,4; n=5) pentru TSE.
English: c.708G>C or c.708G>T
Romanian: c.708G>C sau c.708G>T
English: c.T102G or c.T102A
Romanian: c.T102G sau c.T102A
English: c.T817C or c.T819A or c.T819G F273L
Romanian: c.T817C sau c.T819A sau c.T819G
English: c.465T>A or c.465T>G
Romanian: c.465T>A sau c.465T>G
English: c.456C>A or c.456C>G
Romanian: c.456C>A sau c.456C>G
English: c.T70C or c.T70A
Romanian: c.T70C sau c.T70A
English: c.840A>T or c.840A>C
Romanian: c.840A>T sau c.840A>C
English: c.G936T or c.G936C
Romanian: c.G936T sau c.G936C
English: c.288G>A or c.288G>T or c.288G>C
Romanian: c.288G>A sau c.288G>T sau c.288G>C
English: c.408T>A or c.408T>G
Romanian: c.408T>A sau c.408T>G
English: c.A712C or c.T714A or c.T714G S238R
Romanian: c.A712C sau c.T714A sau c.T714G
English: c.T834G or c.T834A
Romanian: c.T834G sau c.T834A
English: c.G126A or c.G126C or c.G126T M42I
Romanian: c.G126A sau c.G126C sau c.G126T
English: c.486G>C or c.486G>T
Romanian: c.486G>C sau c.486G>T
English: c.861G>C or c.861G>T
Romanian: c.861G>C sau c.861G>T
English: UNKNOWN (del Exon3_7?)
Romanian: NECUNOSCUTĂ (del Exon3_7?)
English: c.G707A or c.G708A
Romanian: c.G707A sau c.G708A
English: c.A868C or c.A868T
Romanian: c.A868C sau c.A868T
English: c.T484C or c.T484A
Romanian: c.T484C sau c.T484A
English: c.T687A or c.T687G
Romanian: c.T687A sau c.T687G
English: c.C666A or c.C666G
Romanian: c.C666A sau c.C666G
English: C]-migalastat hydrochloride in the concentration range between 1 and
Romanian: C] la concentrații cuprinse între 1 și 100 M.
English: c.369T>G or c.369T>A
Romanian: c.369T>G sau c.369T>A
English: c.676T>C or c.676T>A
Romanian: c.676T>C sau c.676T>A
English: c.T402G or c.T402A
Romanian: c.T402G sau c.T402A
English: c.T894G or c.T894A
Romanian: c.T894G sau c.T894A
English: c.G153A or c.G153T or c.G153C M51I
Romanian: c.G153A sau c.G153T sau c.G153C
English: c.747C>G or c.747C>A
Romanian: c.747C>G sau c.747C>A
English: c.720G>C or c.720G>T
Romanian: c.720G>C sau c.720G>T
English: c.G963C or c.G963T
Romanian: c.G963C sau c.G963T
English: c.G228C or c.G228A or c.G228T M76I
Romanian: c.G228C sau c.G228A sau c.G228T
English: c.70T>C or c.70T>A
Romanian: c.70T>C sau c.70T>A
English: c.784T>A or c.784T>C
Romanian: c.784T>A sau c.784T>C
English: c.G720C or c.G720T
Romanian: c.G720C sau c.G720T
English: c.978G>C or c.978G>T
Romanian: c.978G>C sau c.978G>T
English: c.G978C or c.G978T
Romanian: c.G978C sau c.G978T
English: c.G772C or c.G772A
Romanian: c.G772C sau c.G772A
English: c.729G>C or c.729G>T
Romanian: c.729G>C sau c.729G>T
English: Galafold is not recommended for use in patients with Fabry disease who have estimated GFR less than 30 mL/min/1.73 m
Romanian: Galafold este contraindicat la pacienții cu boală Fabry care prezintă o rată de filtrare glomerulară estimată mai mică de 30 ml/min/1,73 m
English: c.G561T or c.G561A or c.G561C M187I
Romanian: c.G561T sau c.G561A sau c.G561C
English: c.G729C or c.G729T
Romanian: c.G729C sau c.G729T
English: c.G778C or c.G778A
Romanian: c.G778C sau c.G778A
English: c.T784A or c.T784C
Romanian: c.T784A sau c.T784C
English: c.G708C or c.G708T
Romanian: c.G708C sau c.G708T
English: c.T706C or c.T706A
Romanian: c.T706C sau c.T706A
English: c.402T>G or c.402T>A
Romanian: c.402T>G sau c.402T>A
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
Romanian: c.194G>C (sit putativ de splice) c.G194C (sit putativ de splice)
English: c.G678T or c.G678C
Romanian: c.G678T sau c.G678C
English: c.677G>A or c.678G>A
Romanian: c.677G>A sau c.678G>A
English: c.868A>C or c.868A>T
Romanian: c.868A>C sau c.868A>T
English: c.678G>T or c.678G>C
Romanian: c.678G>T sau c.678G>C
English: c.834T>G or c.834T>A
Romanian: c.834T>G sau c.834T>A
English: c.648T>A or c.648T>G
Romanian: c.648T>A sau c.648T>G
English: c.G785A or c.G786A
Romanian: c.G785A sau c.G786A
English: c.A886T or c.A886C
Romanian: c.A886T sau c.A886C
English: c.936G>T or c.936G>C
Romanian: c.936G>T sau c.936G>C
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Romanian: M1R c.3G>A sau c.3G>T sau c.3G>C c.G3A sau c.G3T sau c.G3C M1I c.19G>T
English: c.72G>C or c.72G>T
Romanian: c.72G>C sau c.72G>T
English: c.484T>C or c.484T>A
Romanian: c.484T>C sau c.484T>A
English: c.G870A or c.G870C or c.G870T M290I
Romanian: c.G870A sau c.G870C sau c.G870T
English: c.894T>G or c.894T>A
Romanian: c.894T>G sau c.894T>A
English: UNKNOWN (del Exon2_3?)
Romanian: NECUNOSCUTĂ (del Exon2_3?)
English: c.772G>C or c.772G>A
Romanian: c.772G>C sau c.772G>A
English: c.785G>A or c.786G>A
Romanian: c.785G>A sau c.786G>A
English: c.666C>A or c.666C>G
Romanian: c.666C>A sau c.666C>G
English: c.G677A or c.G678A
Romanian: c.G677A sau c.G678A
English: (torticollis)
Romanian: (prurit)
English: c.702T>G or c.702T>A
Romanian: c.702T>G sau c.702T>A
English: c.T702G or c.T702A
Romanian: c.T702G sau c.T702A
English: BLISTER FOIL
Romanian: BLISTER
English: c.706T>C or c.706T>A
Romanian: c.706T>C sau c.706T>A
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
Romanian: c.126G>A sau c.126G>C sau c.126G>T
English: c.A442C or c.T444A or c.T444G S148R
Romanian: c.A442C sau c.T444A sau c.T444G
English: c.778G>C or c.778G>A
Romanian: c.778G>C sau c.778G>A
English: c.687T>A or c.687T>G
Romanian: c.687T>A sau c.687T>G
English: c.G888A or c.G888T or c.G888C M296I
Romanian: c.G888A sau c.G888T sau c.G888C
English: c.G786C or c.G786T
Romanian: c.G786C sau c.G786T
English: c.A1023C or c.A1023T
Romanian: c.1023A >C sau c.1023A>T c.A1023C sau c.A1023T
English: c.963G>C or c.963G>T
Romanian: c.963G>C sau c.963G>T
English: c.667T>A or c.668G>C
Romanian: c.667T>A sau c.668G>C
English: (paraesthesia)
Romanian: (epistaxis)
English: c.886A>T or c.886A>C
Romanian: c.886A>T sau c.886A>C
English: c.786G>C or c.786G>T
Romanian: c.786G>C sau c.786G>T
English: c.G72C or c.G72T
Romanian: c.G72C sau c.G72T
English: c.G288A or c.G288T or c.G288C M96I
Romanian: c.G288A sau c.G288T sau c.G288C
English: (95% CI: -2.653, -0.782; n=31).
Romanian: -0,782; n=31).
English: Table 2: Galafold (migalastat) amenability table
Romanian: Tabelul 2: Tabelul mutațiilsau sensibile la Galafold (migalastat) Modificarea unei nucleotide
English: c.798T>A or c.798T>G
Romanian: c.798T>A sau c.798T>G
English: c.T798A or c.T798G
Romanian: c.T798A sau c.T798G
English: Protein Sequence change p.T412Sfs*37
Romanian: p.T412Sfs*37
English: c.789T>A or c.789T>G
Romanian: c.789T>A sau c.789T>G
English: c.T789A or c.T789G
Romanian: c.T789A sau c.T789G
English: Galafold 123 mg hard capsules migalastat
Romanian: Galafold 123 mg capsule migalastat
English: Tel: 900 941 616 e-mail: MedInfo@amicusrx.com
Romanian: Amicus Therapeutics S.L.U. Tel: 900 941 616 e-mail: MedInfo@amicusrx.com
English: If you get any side effects, talk to your doctor, pharmacist, or nurse.
Romanian: Dacă aveți orice reacții adverse, adresați-vă medicului dumneavoastră, farmacistului sau asistentei medicale.
English: galafold 123 mg hard capsules
Romanian: Galafold 123 mg capsule
English: Galafold 123 mg hard capsules
Romanian: galafold 123 mg capsule
English: Protein Sequence change c.744delT
Romanian: Modificarea unei nucleotide Modificarea secvenței proteice c.646dupT
English: c.1081G>A or c.1081G>C
Romanian: c.1081G>A sau c.1081G>C c.G1081A sau c.G1081C
English: c.G1074T or c.G1074C
Romanian: c.1074G>T sau c.1074G>C c.G1074T sau c.G1074C
English: • Painful stiff neck
Romanian: • Dureri de stomac
English: Tel: 800 795 572 e-mail: MedInfo@amicusrx.com
Romanian: Amicus Therapeutics S.r.l. Tel: 800 795 572 e-mail: MedInfo@amicusrx.com
English: See package leaflet for further instructions.
Romanian: Pentru instrucțiuni suplimentare, vezi prospectul.
English: After follow up in the OLE, the mean change from baseline in LVMi in patients with left ventricular hypertrophy at baseline at Month 36 was -30.0 (95%) CI: -57.9, -2.2; n=4) and at Month 48
Romanian: După studiul de urmărire din faza de extensie deschisă, modificarea medie a IMVS de la momentul inițial până în luna 36 a fost de -30,0 (IÎ 95%: -57,9, -2,2; n=4), iar la luna 48 a fost de -33,1 (IÎ:-60,9, -5,4; n=4).
English: • Tiredness
Romanian: Torticolis
English: (vertigo)
Romanian: (vertij)
English: • Tingling in extremities
Romanian: • Furnicături în extremități (parestezie)
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).
Romanian: Modificarea medie a IMVS de la momentul inițial până în lunile 18-24 la pacienții cu hipertrofie ventriculară stângă la momentul inițial (femei cu IMVS inițial > 95 g/m sau bărbați cu
English: 1.478; n=34) in the Galafold group compared to -1.03 mL/min/1.73 m
Romanian: Modificarea anuală medie a RFGeCKD-EPI a fost de -0,40 ml/min/1,73 m (IÎ 95%: -2,272, 1,478; n=34) în grupul tratat cu Galafold, comparativ cu -1,03 ml/min/1,73 m (IÎ 95%: -3,636, 1,575; n=18) în grupul TSE.
English: Reporting of side effects
Romanian: Raportarea reacții adverse
English: An alert card will also be given to patients.
Romanian: De asemenea, pacienților li se va da un card de avertizare.
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.
Romanian: Proporția pacienților care au avut o reducere a simptomelor de cel puțin 75 % după 16 săptămâni de tratament a fost de 68 % cu Halimatoz și de 63 % cu Humira.
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Romanian: Informații suplimentare cu privire la Halimatoz sunt disponibile pe site-ul agenției: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Romanian: Ce măsuri se iau pentru utilizarea sigură și eficace a Halimatoz?
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Romanian: Aceasta înseamnă că Halimatoz este similar în proporție foarte mare cu un alt medicament biologic („medicamentul de referință”), care este deja autorizat în UE.
English: The reference medicine for Halimatoz is Humira.
Romanian: Medicamentul de referință pentru Halimatoz este Humira.
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Romanian: În plus, Halimatoz a fost la fel de eficace ca Humira într-un studiu care a cuprins 465 de pacienți cu psoriazis în plăci moderat sau sever.
English: After training, patients or their carers may inject Halimatoz if their doctor considers it appropriate.
Romanian: După instruire, pacienții sau îngrijitorii acestora pot face singuri injecția cu Halimatoz, dacă medicul lor consideră potrivit acest lucru.
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Romanian: Reacțiile adverse raportate la Halimatoz sunt evaluate cu atenție și sunt luate orice măsuri necesare pentru protecția pacienților.
English: Other information about Halimatoz
Romanian: Alte informații despre Halimatoz
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.
Romanian: Doza și frecvența injecției depind de afecțiunea tratată, iar doza pentru copii și adolescenți se calculează de obicei în funcție de greutatea acestora; având în vedere că Halimatoz este disponibil doar în doze de 40 mg, medicamentul nu este indicat la copii și adolescenți care necesită o doză mai mică de 40 mg.
English: Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
Romanian: Halimatoz este un medicament care acționează asupra sistemului imunitar și se utilizează pentru tratarea următoarelor afecțiuni:
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Romanian: Similar tuturor medicamentelor, datele cu privire la utilizarea Halimatoz sunt monitorizate continuu.
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Romanian: Compania care comercializează Halimatoz trebuie să furnizeze pachete educaționale pentru medicii care urmează să prescrie medicamentul.
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.
Romanian: Similar cu alte medicamente din această clasă, Halimatoz poate să afecteze capacitatea sistemului imunitar de a lupta împotriva infecțiilor și împotriva cancerului și au existat câteva cazuri de infecții grave și de cancere ale sângelui la pacienți care utilizau adalimumab.
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.
Romanian: Agenția Europeană pentru Medicamente a hotărât că, în conformitate cu cerințele UE pentru medicamente biosimilare, Halimatoz are structura, puritatea și activitatea biologică foarte similare cu Humira și se distribuie în organism în același mod.
English: Why is Halimatoz authorised in the EU?
Romanian: De ce a fost autorizat Halimatoz în UE?
English: An overview of Halimatoz and why it is authorised in the EU
Romanian: O prezentare generală a Halimatoz și de ce este autorizat acest medicament în UE
English: Because Halimatoz is a biosimilar medicine, the studies on effectiveness and safety of adalimumab carried out with Humira do not all need to be repeated for Halimatoz.
Romanian: Deoarece Halimatoz este un medicament biosimilar, nu este necesar ca toate studiile efectuate pentru Humira cu privire la eficacitatea și siguranța adalimumabului să fie repetate pentru Halimatoz.
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Romanian: Halimatoz se utilizează în mare parte la adulți cu afecțiuni severe, moderat severe sau în curs de agravare, sau atunci când pacienții nu pot urma alte tratamente.
English: Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Romanian: Halimatoz conține substanța activă adalimumab și este un „medicament biosimilar”.
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).
Romanian: Substanța activă din Halimatoz, adalimumabul, este un anticorp monoclonal (un tip de proteină) care a fost conceput să recunoască și să se lege de o substanță din organism numită factor de necroză tumorală (FNT).
English: For the full list of side effects and restrictions with Halimatoz, see the package leaflet.
Romanian: Pentru lista completă a reacțiilor adverse și a restricțiilor asociate cu Halimatoz, citiți prospectul.