FrancophonIA/ELRC3.0 huggingface dataset:
English: c.G242A or c.G243A
Latvian: c.G242A vai c.G243A
English: c.131G>A or c.132G>A
Latvian: c.131G>A vai c.132G>A
English: c.A840T or c.A840C
Latvian: c.A840T vai c.A840C
English: c.C525G or c.C525A
Latvian: c.C525G vai c.C525A
English: c.816C>A or c.816C>G
Latvian: c.816C>A vai c.816C>G
English: c.279C>G or c.279C>A
Latvian: c.279C>G vai c.279C>A
English: c.285G>T or c.285G>C
Latvian: c.285G>T vai c.285G>C
English: c.982G>A or c.982G>C
Latvian: c.982G>A vai c.982G>C
English: c.T960G or c.T960A
Latvian: c.T960G vai c.T960A
English: c.G144T or c.G144C
Latvian: c.G144T vai c.G144C
English: c.G567C or c.G567T
Latvian: c.G567C vai c.G567T
English: c.C747G or c.C747A
Latvian: c.C747G vai c.C747A
English: c.T280A or c.G281C
Latvian: c.T280A vai c.G281C
English: c.243G>T or c.243G>C
Latvian: c.243G>T vai c.243G>C
English: c.T859C or c.T859A
Latvian: c.T859C vai c.T859A
English: c.C453G or c.C453A
Latvian: c.C453G vai c.C453A
English: UNKNOWN (del Exon3?)
Latvian: NEZINĀMS (del Exon3?)
English: c.540G>C or c.540G>T
Latvian: c.540G>C vai c.540G>T
English: c.132G>T or c.132G>C
Latvian: c.132G>T vai c.132G>C
English: c.233C>G or c.233C>A
Latvian: c.233C>G vai c.233C>A
English: UNKNOWN (del Exon1_2?)
Latvian: NEZINĀMS (del Exon1_2?)
English: c.103G>C or c.103G>A
Latvian: c.103G>C vai c.103G>A
English: c.T610C or c.T610A
Latvian: c.T610C vai c.T610A
English: c.1074G>T or c.1074G>C
Latvian: c.1074G>T vai c.1074G>C
English: c.881T>G or c.881T>A
Latvian: c.881T>G vai c.881T>A
English: c.830G>A or c.831G>A
Latvian: c.830G>A vai c.831G>A
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
Latvian: Vidējais eGFĀCKD-EPI izmaiņu rādītājs no sākumstāvokļa gadā pacientiem, kuri ārstēti 30 mēnešus ar Galafold, bija -1,72 ml/min/1,73 m (95% TI: -2,653, -0,782; n=31).
English: c.T154A or c.G155C
Latvian: c.T154A vai c.G155C
English: c.G831T or c.G831C
Latvian: c.G831T vai c.G831C
English: c.525C>G or c.525C>A
Latvian: c.525C>G vai c.525C>A
English: c.707G>A or c.708G>A
Latvian: c.707G>A vai c.708G>A
English: Hepatic impairment No dosage adjustment of Galafold is required in patients with hepatic impairment (see section 5.2).
Latvian: Pacientiem ar aknu darbības traucējumiem nav nepieciešama Galafold devas pielāgošana (skatīt 5.2. apakšpunktu).
English: c.258T>G or c.258T>A
Latvian: c.258T>G vai c.258T>A
English: c.G141C or c.G141T
Latvian: c.G141C vai c.G141T
English: c.A588T or c.A588C
Latvian: c.A588T vai c.A588C
English: c.T369G or c.T369A
Latvian: c.T369G vai c.T369A
English: c.C897G or c.C897A
Latvian: c.C897G vai c.C897A
English: c.609G>C or c.609G>T
Latvian: c.609G>C vai c.609G>T
English: c.T408A or c.T408G
Latvian: c.T408A vai c.T408G
English: c.T514A or c.G515C
Latvian: c.T514A vai c.G515C
English: c.G830A or c.G831A
Latvian: c.G830A vai c.G831A
English: It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on or switched to Galafold.
Latvian: Pacientiem, kuriem uzsākta ārstēšana ar Galafold, vai kuri pārgājuši uz Galafold lietošanu, ieteicams regulāri (ik pēc 6 mēnešiem) kontrolēt nieru darbību, ehokardiogrāfijas parametrus un bioķīmiskos marķierus.
English: UNKNOWN (del Exon5_7?)
Latvian: NEZINĀMS (del Exon5_7?)
English: c.610T>C or c.610T>A
Latvian: c.610T>C vai c.610T>A
English: c.G860A or c.G861A
Latvian: c.G860A vai c.G861A
English: c.166T>A or c.167G>C
Latvian: c.166T>A vai c.167G>C
English: c.734G>A or c.735G>A
Latvian: c.734G>A vai c.735G>A
English: c.141G>C or c.141G>T
Latvian: c.141G>C vai c.141G>T
English: c.305C>G or c.305C>A
Latvian: c.305C>G vai c.305C>A
English: c.144G>T or c.144G>C
Latvian: c.144G>T vai c.144G>C
English: c.G216A or c.G216T or c.G216C M72I
Latvian: c.G216A vai c.G216T vai c.G216C
English: c.453C>G or c.453C>A
Latvian: c.453C>G vai c.453C>A
English: c.567G>C or c.567G>T
Latvian: c.567G>C vai c.567G>T
English: c.108G>C or c.108G>T
Latvian: c.108G>C vai c.108G>T
English: c.960T>G or c.960T>A
Latvian: c.960T>G vai c.960T>A
English: c.859T>C or c.859T>A
Latvian: c.859T>C vai c.859T>A
English: galafold 123 mg hard capsules
Latvian: Galafold 123 mg cietās kapsulas
English: Punch out the perforated circles on days you are not taking Galafold.
Latvian: Dienās, kurās nelietojat Galafold, izspiediet perforētos aplīšus.
English: c.T465A or c.T465G
Latvian: c.T465A vai c.T465G
English: You should only take Galafold once every other day.
Latvian: Lietojiet Galafold katru otro dienu.
English: c.G108C or c.G108T
Latvian: c.G108C vai c.G108T
English: c.870G>A or c.870G>C or c.870G>T
Latvian: c.870G>A vai c.870G>C vai c.870G>T
English: Galafold 123 mg hard capsules migalastat
Latvian: Galafold 123 mg cietās kapsulas migalastat
English: The baseline values were 95.3 g/m for the Galafold arm and
Latvian: Galafolda grupas sākuma vērtības bija 95,3 g/m2, enzīmu aizstājterapijas grupas sākuma vērtības bija 92,9 g/m2, un vidējās LVMi izmaiņas
English: c.C456A or c.C456G
Latvian: c.C456A vai c.C456G
English: • Sudden need to defecate
Latvian: • Neatliekama vajadzība izkārnīties
English: c.860G>A or c.861G>A
Latvian: c.860G>A vai c.861G>A
English: c.G861C or c.G861T
Latvian: c.G861C vai c.G861T
English: c.G485A or c.G486A
Latvian: c.G485A vai c.G486A
English: c.439G>A or c.439G>C
Latvian: c.439G>A vai c.439G>C
English: c.C966A or c.C966G
Latvian: c.C966A vai c.C966G
English: c.T676C or c.T676A
Latvian: c.T676C vai c.T676A
English: c.831G>T or c.831G>C
Latvian: c.831G>T vai c.831G>C
English: c.G439A or c.G439C
Latvian: c.G439A vai c.G439C
English: c.G71A or c.G72A
Latvian: c.G71A vai c.G72A
English: c.897C>G or c.897C>A
Latvian: c.897C>G vai c.897C>A
English: c.394G>A or c.394G>C
Latvian: c.394G>A vai c.394G>C
English: c.71G>A or c.72G>A
Latvian: c.71G>A vai c.72G>A
English: c.888G>A or c.888G>T or c.888G>C
Latvian: c.888G>A vai c.888G>T vai c.888G>C
English: c.T337C or c.T339A or c.T339G F113L
Latvian: c.T337C vai c.T339A vai c.T339G
English: • Persistent itch (pruritus)
Latvian: • Ilgstoša nieze (prurīts)
English: What you need to know before you take Galafold 3.
Latvian: Kas ir Galafold un kādam nolūkam tās lieto 2. Kas Jums jāzina pirms Galafold lietošanas 3. Kā lietot Galafold?
English: c.966C>A or c.966C>G
Latvian: c.966C>A vai c.966C>G
English: c.154T>A or c.155G>C
Latvian: c.154T>A vai c.155G>C
English: c.102T>G or c.102T>A
Latvian: c.102T>G vai c.102T>A
English: c.T667A or c.G668C
Latvian: c.T667A vai c.G668C
English: Lot
Latvian: Louth
English: Galafold is not recommended for use in patients with severe renal insufficiency, defined as estimated GFR less than 30 mL/min/1.73m
Latvian: Galafold nav ieteicams lietot pacientiem ar smagu nieru mazspēju, kuriem aprēķinātais GFĀ ir mazāks par 30 ml/min./1,73m2 (skatīt 5.2. apakšpunktu).
English: c.514T>A or c.515G>C
Latvian: c.514T>A vai c.515G>C
English: c.G837C or c.G837T
Latvian: c.G837C vai c.G837T
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).
Latvian: Pēc 30 mēnešu ārstēšanas ar Galafold vidējais izmaiņu rādītājs no sākumstāvokļa KKMI bija -3,8 (95% TI: -8,9, 1,3; n=28) vidējais izmaiņu rādītājs no sākumstāvokļa KKMI pacientiem ar kreisā kambara hipertrofiju bija -10,0 (95% TI: -16,6, -3,3; n=10).
English: c.G486C or c.G486T
Latvian: c.G486C vai c.G486T
English: c.G394A or c.G394C
Latvian: c.G394A vai c.G394C
English: c.837G>C or c.837G>T
Latvian: c.837G>C vai c.837G>T
English: Printing ink Shellac
Latvian: Uzdrukas tinte Šellaka
English: c.861G>C or c.861G>T
Latvian: c.861G>C vai c.861G>T
English: c.708G>C or c.708G>T
Latvian: c.708G>C vai c.708G>T
English: c.T817C or c.T819A or c.T819G F273L
Latvian: c.T817C vai c.T819A vai c.T819G
English: c.T648A or c.T648G
Latvian: c.T648A vai c.T648G
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Latvian: Ja Jūs plānojat mazuli, konsultējieties ar savu ārstu, farmaceitu vai medmāsu.
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.
Latvian: 18. mēnesī, salīdzinot ar sākuma vērtībām, galafolda grupai bija -6,6 (95% TI: -11,0, -2,1; n=31) un enzīmu aizstājterapijas grupai bija -2,0 (95% TI: -11,0, 7,0; n=13).
English: c.T894G or c.T894A
Latvian: c.T894G vai c.T894A
English: c.T834G or c.T834A
Latvian: c.T834G vai c.T834A
English: c.485G>A or c.486G>A
Latvian: c.485G>A vai c.486G>A
English: c.465T>A or c.465T>G
Latvian: c.465T>A vai c.465T>G
English: • Tiredness
Latvian: • Nogurums
English: c.A868C or c.A868T
Latvian: c.A868C vai c.A868T
English: c.588A>T or c.588A>C
Latvian: c.588A>T vai c.588A>C
English: c.A712C or c.T714A or c.T714G S238R
Latvian: c.A712C vai c.T714A vai c.T714G
English: c.676T>C or c.676T>A
Latvian: c.676T>C vai c.676T>A
English: c.408T>A or c.408T>G
Latvian: c.408T>A vai c.408T>G
English: Defaecation urgency Dyspepsia
Latvian: Defekācijassteidzamība Dispepsija
English: c.T70C or c.T70A
Latvian: c.T70C vai c.T70A
English: c.288G>A or c.288G>T or c.288G>C
Latvian: c.288G>A vai c.288G>T vai c.288G>C
English: c.456C>A or c.456C>G
Latvian: c.456C>A vai c.456C>G
English: c.T102G or c.T102A
Latvian: c.T102G vai c.T102A
English: c.T687A or c.T687G
Latvian: c.T687A vai c.T687G
English: c.369T>G or c.369T>A
Latvian: c.369T>G vai c.369T>A
English: c.G936T or c.G936C
Latvian: c.G936T vai c.G936C
English: c.G707A or c.G708A
Latvian: c.G707A vai c.G708A
English: In a single dose study with Galafold in non-Fabry subjects with varying degrees of renal insufficiency, exposures were increased by 4.3-fold in subjects with severe renal impairment (GFR < 30 mL/min/1.73 m
Latvian: Galafold nav pētītas pacientiem ar Fabri slimību, kuriem aprēķinātais GFĀ ir mazāks par 30 ml/min./1,73 m2. Vienas devas pētījumā ar Galafold, iesaistot pacientus, kam nebija Fabri slimības, bet ar dažādas pakāpes nieru mazspēju, iedarbība tika palielināta 4,3 reizes pacientiem ar smagiem nieru darbības traucējumiem (GFĀ < 30 ml/min/1.73 m
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).
Latvian: Izmaiņu KKMI (g/m2) rādītājs no sākumstāvokļa līdz 18. mēnesim pacientiem ar kreisā kambara hipertrofiju (sievietēm ar sākumstāvokļa KKMI> 95 g/m un vīriešiem ar sākumstāvokļa KKMI> 115 g/m 2) bija -8,4 (95% TI:
English: c.840A>T or c.840A>C
Latvian: c.840A>T vai c.840A>C
English: c.486G>C or c.486G>T
Latvian: c.486G>C vai c.486G>T
English: c.T402G or c.T402A
Latvian: c.T402G vai c.T402A
English: c.C666A or c.C666G
Latvian: c.C666A vai c.C666G
English: c.T484C or c.T484A
Latvian: c.T484C vai c.T484A
English: UNKNOWN (del Exon3_7?)
Latvian: NEZINĀMS (del Exon3_7?)
English: Protein Sequence change c.744delT
Latvian: Olbaltumvielu sekvences izmaiņas c.256delT
English: c.720G>C or c.720G>T
Latvian: c.720G>C vai c.720G>T
English: c.747C>G or c.747C>A
Latvian: c.747C>G vai c.747C>A
English: c.G978C or c.G978T
Latvian: c.G978C vai c.G978T
English: c.G729C or c.G729T
Latvian: c.G729C vai c.G729T
English: UNKNOWN (del Exon2_3?)
Latvian: NEZINĀMS (del Exon2_3?)
English: c.G772C or c.G772A
Latvian: c.G772C vai c.G772A
English: Muscle spasms Myalgia
Latvian: Muskuļu spazmas Mialģija
English: c.784T>A or c.784T>C
Latvian: c.784T>A vai c.784T>C
English: Weight increased
Latvian: • Ķermeņa masas palielināšanās
English: c.978G>C or c.978G>T
Latvian: c.978G>C vai c.978G>T
English: Headache and dizziness were the most common adverse reactions reported at doses of Galafold of up to 1250 mg and 2000 mg, respectively.
Latvian: Lietojot Galafold līdz pat 1250 mg un 2000 mg devās, visbiežāk novērotās blakusparādības bija galvassāpes un reiboņi.
English: c.G963C or c.G963T
Latvian: c.G963C vai c.G963T
English: c.T784A or c.T784C
Latvian: c.T784A vai c.T784C
English: c.834T>G or c.834T>A
Latvian: c.834T>G vai c.834T>A
English: c.729G>C or c.729G>T
Latvian: c.729G>C vai c.729G>T
English: c.G153A or c.G153T or c.G153C M51I
Latvian: c.G153A vai c.G153T vai c.G153C
English: c.T706C or c.T706A
Latvian: c.T706C vai c.T706A
English: c.G778C or c.G778A
Latvian: c.G778C vai c.G778A
English: c.772G>C or c.772G>A
Latvian: c.772G>C vai c.772G>A
English: c.402T>G or c.402T>A
Latvian: c.402T>G vai c.402T>A
English: c.G126A or c.G126C or c.G126T M42I
Latvian: c.G126A vai c.G126C vai c.G126T
English: c.G561T or c.G561A or c.G561C M187I
Latvian: c.G561T vai c.G561A vai c.G561C
English: c.894T>G or c.894T>A
Latvian: c.894T>G vai c.894T>A
English: (95% CI: -1.89, 0.40; n=41).
Latvian: 2) bija -18,6 (95% TI: -38.2, 1,0; n=8).
English: c.648T>A or c.648T>G
Latvian: c.648T>A vai c.648T>G
English: c.G720C or c.G720T
Latvian: c.G720C vai c.G720T
English: c.G708C or c.G708T
Latvian: c.G708C vai c.G708T
English: c.677G>A or c.678G>A
Latvian: c.677G>A vai c.678G>A
English: c.G678T or c.G678C
Latvian: c.G678T vai c.G678C
English: c.A886T or c.A886C
Latvian: c.A886T vai c.A886C
English: c.484T>C or c.484T>A
Latvian: c.484T>C vai c.484T>A
English: c.G785A or c.G786A
Latvian: c.G785A vai c.G786A
English: c.70T>C or c.70T>A
Latvian: c.70T>C vai c.70T>A
English: c.702T>G or c.702T>A
Latvian: c.702T>G vai c.702T>A
English: c.785G>A or c.786G>A
Latvian: c.785G>A vai c.786G>A
English: c.G228C or c.G228A or c.G228T M76I
Latvian: c.G228C vai c.G228A vai c.G228T
English: c.72G>C or c.72G>T
Latvian: c.72G>C vai c.72G>T
English: c.706T>C or c.706T>A
Latvian: c.706T>C vai c.706T>A
English: c.868A>C or c.868A>T
Latvian: c.868A>C vai c.868A>T
English: LABELLING AND PACKAGE LEAFLET
Latvian: Galafold ārējais izskats un iepakojums
English: c.778G>C or c.778G>A
Latvian: c.778G>C vai c.778G>A
English: c.666C>A or c.666C>G
Latvian: c.666C>A vai c.666C>G
English: c.T702G or c.T702A
Latvian: c.T702G vai c.T702A
English: c.963G>C or c.963G>T
Latvian: c.963G>C vai c.963G>T
English: c.G870A or c.G870C or c.G870T M290I
Latvian: c.G870A vai c.G870C vai c.G870T
English: c.A442C or c.T444A or c.T444G S148R
Latvian: c.A442C vai c.T444A vai c.T444G
English: c.G677A or c.G678A
Latvian: c.G677A vai c.G678A
English: c.687T>A or c.687T>G
Latvian: c.687T>A vai c.687T>G
English: c.786G>C or c.786G>T
Latvian: c.786G>C vai c.786G>T
English: c.A1023C or c.A1023T
Latvian: c.1023A >C vai c.1023A>T c.A1023C vai c.A1023T
English: c.936G>T or c.936G>C
Latvian: c.936G>T vai c.936G>C
English: c.678G>T or c.678G>C
Latvian: c.678G>T vai c.678G>C
English: c.G72C or c.G72T
Latvian: c.G72C vai c.G72T
English: c.667T>A or c.668G>C
Latvian: c.667T>A vai c.668G>C
English: c.G786C or c.G786T
Latvian: c.G786C vai c.G786T
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Latvian: M1R c.3G>A vai c.3G>T vai c.3G>C c.G3A vai c.G3T vai c.G3C M1I c.19G>T
English: Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed.
Latvian: Ārstēšana visu noteikto devu lietošanas gadījumā izraisīja pārejošu un pilnībā atgriezenisku neauglību žurku tēviņiem.
English: c.G288A or c.G288T or c.G288C M96I
Latvian: c.G288A vai c.G288T vai c.G288C
English: Protein Sequence change p.T412Sfs*37
Latvian: p.T412Sfs*37
English: c.G888A or c.G888T or c.G888C M296I
Latvian: c.G888A vai c.G888T vai c.G888C
English: c.T798A or c.T798G
Latvian: c.T798A vai c.T798G
English: c.798T>A or c.798T>G
Latvian: c.798T>A vai c.798T>G
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
Latvian: c.126G>A vai c.126G>C vai c.126G>T
English: c.886A>T or c.886A>C
Latvian: c.886A>T vai c.886A>C
English: c.789T>A or c.789T>G
Latvian: c.789T>A vai c.789T>G
English: c.T789A or c.T789G
Latvian: c.T789A vai c.T789G
English: c.[157A>C; 158A>T]
Latvian: c.[157A>C;
English: • Muscle spasms
Latvian: • Sirdsklauves
English: Do not cut, crush, or chew the capsule.
Latvian: Kapsulu nedrīkst sagriezt uz pusēm, saspiest vai sakost.
English: Protein Sequence change c.290delC
Latvian: Olbaltumvielu sekvences izmaiņas c.1208delT
English: c.1081G>A or c.1081G>C
Latvian: c.1081G>A vai c.1081G>C c.G1081A vai c.G1081C
English: After an average of 3.4 years of treatment, the mean annualised rate of change in eGFRCKD-EPI was -0.74 mL/min/1.73 m
Latvian: Vidējais izmaiņu rādītājs pēc aptuveni 3,4 gadu ilgas ārstēšanas bija -0,74 ml/min/1,73 m gadā (95% TI: -1,89, 0,40; n=41).
English: • Diarrhoea
Latvian: Diareja
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
Latvian: KKMI>115 g/m rādītājs no sākumstāvokļa pacientiem ar kreisā kambara hipertrofiju 36. mēnesī bija -30,0 (95% TI:57,9, -2,2; n=4) un 48. mēnesī bija -33,1 (TI: -60,9, -5,4; n=4).
English: • Constipation
Latvian: • Vēdergraizes
English: LOT:
Latvian: SĒRIJA:
English: 6.5 Nature and contents of container
Latvian: 6. Iepakojuma saturs un cita informācija
English: Diarrhoea Nausea
Latvian: Dispnoja Deguna asiņošana
English: Dyspnoea Epistaxis
Latvian: DERĪGUMA TERMIŅŠ
English: UNKNOWN
Latvian: Izkliede
English: c.[604T>C; 644A>G]
Latvian: c.[644A>G; 811G>A]
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Sīkāka informācija par Halimatoz ir atrodama aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: These packs will include information on the safety of the medicine.
Latvian: Šajos materiālos tiks iekļauta informācija par zāļu drošumu.
English: Halimatoz (adalimumab)
Latvian: Halimatoz (adalimumabs)
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.
Latvian: Procentuālais skaits pacientu, kuriem pēc 16 nedēļu ilgas ārstēšanas simptomi bija samazinājušies par vismaz 75 %, bija 68 %, lietojotHalimatoz, un 63 %, lietojot Humira.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Latvian: Kas tiek darīts, lai garantētu drošu un efektīvu Halimatoz lietošanu?
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Latvian: Tas nozīmē, ka Halimatoz ir ļoti līdzīgas citām bioloģiskajām zālēm (“atsauces zālēm”), kas jau ir reģistrētas ES.
English: Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.
Latvian: Tāpēc aģentūra uzskatīja, ka, tāpat kā Humira gadījumā, Halimatoz ieguvums pārsniedz identificēto risku, un tās var reģistrēt.
English: Other information about Halimatoz
Latvian: Cita informācija par Halimatoz
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Latvian: Tāpat kā par visām zālēm, dati par Halimatoz lietošanu tiek pastāvīgi uzraudzīti.
English: In addition, Halimatoz was as effective as Humira in a study involving 465 patients with moderate or severe plaque psoriasis.
Latvian: Turklāt Halimatoz bija tikpat efektīvas kā Humira pētījumā, kurā piedalījās 465 pacienti ar vidēji smagu vai smagu perēkļveida psoriāzi.
English: An overview of Halimatoz and why it is authorised in the EU
Latvian: Halimatoz pārskats un kāpēc tās ir reģistrētas ES
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Latvian: Ziņotās ar Halimatoz lietošanu saistītās blakusparādības tiek rūpīgi izvērtētas, un tiek veikti visi pacientu aizsardzībai nepieciešamie pasākumi.
English: The reference medicine for Halimatoz is Humira.
Latvian: Halimatoz atsauces zāles ir Humira.
English: Why is Halimatoz authorised in the EU?
Latvian: Kāpēc Halimatoz ir reģistrētas ES?
English: Halimatoz is available as a solution for injection under the skin in a pre-filled syringe or pen and is usually given every 2 weeks.
Latvian: Halimatoz ir pieejamas kā šķīdums injekcijām zem ādas pilnšļircē vai pildspalvveida pilnšļircē, un zāles parasti ievada ik pēc 2 nedēļām.
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.
Latvian: Tāpat kā citas šīs klases zāles, Halimatoz var ietekmēt imūnsistēmas spēju cīnīties pret infekcijām un vēzi, un dažiem pacientiem, kuri lieto adalimumabu, ir novērotas smagas infekcijas un asins vēži.
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Latvian: Halimatoz galvenokārt lieto pieaugušajiem, kuru stāvoklis ir smags, vidēji smags vai pasliktinās, vai pacientiem, kuri nevar lietot citas zāles.
English: The company that markets Halimatoz must provide educational packs for doctors who prescribe the medicine.
Latvian: Uzņēmumam, kas piedāvā tirgū Halimatoz, jānodrošina informatīvo materiālu kopums ārstiem, kuri izraksta šīs zāles.
English: What is Halimatoz and what is it used for?
Latvian: Kas ir Halimatoz un kāpēc tās lieto?
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.
Latvian: Eiropas Zāļu aģentūra nolēma, ka saskaņā ar ES prasībām par bioloģiski līdzīgām zālēm Halimatoz ķīmiskās struktūras, tīrības un bioloģiskās aktivitātes ziņā ir ļoti līdzīgas Humira un abas zāles vienādi izplatās organismā.
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.
Latvian: Visi šie dati tika uzskatīti par pietiekamiem, lai secinātu, ka Halimatoz efektivitāte un drošums apstiprināto lietošanas veidu gadījumā ir tāds pats kā Humira.
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).
Latvian: Halimatoz nedrīkst lietot pacientiem ar aktīvu tuberkulozi, citām smagām infekcijām vai vidēju līdz smagu sirds mazspēju (sirds nespēju sūknēt pietiekamu asins daudzumu organismā).
English: Halimatoz contains the active substance adalimumab and is a ‘biosimilar medicine'.
Latvian: Halimatoz satur aktīvo vielu adalimumabu un ir “bioloģiski līdzīgas zāles”.
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).
Latvian: Halimatoz aktīvā viela adalimumabs ir monoklonāla antiviela (olbaltumvielas veids), kas izstrādāta, lai organismā atpazītu vielu, ko dēvē par audzēju nekrozes faktoru (TNF), un piesaistītos tai.
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using Halimatoz.
Latvian: Acu ārstiem, ārstējot uveītu, arī jākonsultējas ar ārstiem, kuriem ir pieredze Halimatoz lietošanā.
English: Halimatoz can only be obtained by prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Halimatoz is used.
Latvian: Halimatoz var iegādāties tikai pret recepti, un ārstēšana jāsāk un jāuzrauga ārstam, kuram ir pieredze to slimību ārstēšanā, kuru gadījumā lieto Halimatoz.