FrancophonIA/ELRC3.0 huggingface dataset:
English: Protein Sequence change c.1202C>G or c.1202C>A c.C1202G or c.C1202A
Lithuanian: W399S c.1202C>G arba c.1202C>A c.C1202G arba c.C1202A S401X c.1215T>A
English: c.G108C or c.G108T
Lithuanian: c.G108C arba c.G108T
English: c.141G>C or c.141G>T
Lithuanian: c.141G>C arba c.141G>T
English: c.70T>C or c.70T>A
Lithuanian: c.70T>C arba c.70T>A
English: p.S364Lfs*9
Lithuanian: S364Lfs*9
English: p.M353Dfs*20
Lithuanian: M353Dfs*20
English: p.V254Gfs*9
Lithuanian: V254Gfs*9
English: c.G439A or c.G439C
Lithuanian: c.G439A arba c.G439C
English: c.G216A or c.G216T or c.G216C M72I
Lithuanian: c.G216A arba c.G216T arba c.G216C
English: p.E358Dfs*15
Lithuanian: E358Dfs*15
English: Elderly population No dosage adjustment is required based on age (see section 5.2).
Lithuanian: Senyvų pacientų populiacija Koreguoti vaistinio preparato dozavimo pagal amžių nereikia (žr.
English: c.G394A or c.G394C
Lithuanian: c.G394A arba c.G394C
English: c.T667A or c.G668C
Lithuanian: c.T667A arba c.G668C
English: c.G861C or c.G861T
Lithuanian: c.G861C arba c.G861T
English: - If you have any further questions, ask your doctor, pharmacist, or nurse.
Lithuanian: - Jeigu kiltų daugiau klausimų, kreipkitės į gydytoją arba slaugytoją.
English: c.514T>A or c.515G>C
Lithuanian: c.514T>A arba c.515G>C
English: c.T817C or c.T819A or c.T819G F273L
Lithuanian: c.T817C arba c.T819A arba c.T819G
English: Galafold is not indicated for use in patients with non-amenable mutations (see section 5.1).
Lithuanian: Galafold nėra skirtas pacientams, kuriems nustatytos gydymui nepasiduodančios mutacijos (angl.
English: c.1196G>A or c.1197G>A c.G1196A or c.G1197A
Lithuanian: E398A c.1196G>A arba c.1197G>A c.G1196A arba c.G1197A W399X c.1196G>C
English: BLISTER SLEEVE
Lithuanian: • Baltymas šlapime
English: c.870G>A or c.870G>C or c.870G>T
Lithuanian: c.870G>A arba c.870G>C arba c.870G>T
English: c.T676C or c.T676A
Lithuanian: c.T676C arba c.T676A
English: c.439G>A or c.439G>C
Lithuanian: c.439G>A arba c.439G>C
English: Table 3: Mutations not amenable to Galafold (migalastat)
Lithuanian: Gydymui Galafold (migalastatu) nepasiduodančios mutacijos.
English: c.840A>T or c.840A>C
Lithuanian: c.840A>T arba c.840A>C
English: c.1147T>C or c.1149C>G or c.1149C>A
Lithuanian: Baltymų sekos pakitimas c.1147T>C arba c.1149C>G arba c.1149C>A
English: c.784T>A or c.784T>C
Lithuanian: c.784T>A arba c.784T>C
English: c.888G>A or c.888G>T or c.888G>C
Lithuanian: c.888G>A arba c.888G>T arba c.888G>C
English: c.G486C or c.G486T
Lithuanian: c.G486C arba c.G486T
English: c.154T>A or c.155G>C
Lithuanian: c.154T>A arba c.155G>C
English: c.G837C or c.G837T
Lithuanian: c.G837C arba c.G837T
English: c.394G>A or c.394G>C
Lithuanian: c.394G>A arba c.394G>C
English: c.288G>A or c.288G>T or c.288G>C
Lithuanian: c.288G>A arba c.288G>T arba c.288G>C
English: c.T337C or c.T339A or c.T339G F113L
Lithuanian: c.T337C arba c.T339A arba c.T339G
English: c.708G>C or c.708G>T
Lithuanian: c.708G>C arba c.708G>T
English: Women of childbearing potential/Contraception in males and females Galafold is not recommended in women of childbearing potential not using contraception.
Lithuanian: Galafold nerekomenduojama vartoti kontracepcijos priemonių nenaudojančioms vaisingo amžiaus moterims.
English: c.588A>T or c.588A>C
Lithuanian: c.588A>T arba c.588A>C
English: c.C525G or c.C525A
Lithuanian: c.525C>G arba c.525C>A c.C525G arba c.C525A
English: c.861G>C or c.861G>T
Lithuanian: c.861G>C arba c.861G>T
English: Mean annualised rate of change in eGFRCKD-EPI was -0.40 mL/min/1.73 m
Lithuanian: Chronic Kidney Disease Epidemiology Collaboration, CKD-EPI) pokyčio vidurkis buvo -0,40 ml/min/1,73 m
English: You should only take Galafold once every other day.
Lithuanian: Galafold reikia vartoti tik kas antrą dieną.
English: In the ERT- naïve trial, Galafold showed statistically significant reductions in plasma lyso-Gb3 concentrations and kidney interstitial capillary GL-3 inclusions in patients with amenable mutations.
Lithuanian: Atliekant PFT vaistiniais preparatais negydytų pacientų tyrimą, vartojant Galafold, lizo-Gb3 koncentracija pacientų, kuriems buvo nustatytos gydymui pasiduodančios mutacijos, kraujo plazmoje ir GL-3 inkliuzų kiekis jų inkstų intersticinio audinio kapiliaruose sumažėjo statistiškai reikšmingai.
English: c.936G>T or c.936G>C
Lithuanian: c.936G>T arba c.936G>C
English: c.G963C or c.G963T
Lithuanian: c.G963C arba c.G963T
English: c.A868C or c.A868T
Lithuanian: c.A868C arba c.A868T
English: c.837G>C or c.837G>T
Lithuanian: c.837G>C arba c.837G>T
English: Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP.
Lithuanian: Ant dėžutės po „Tinka iki“ ir lizdinės pokštelės po „EXP“ nurodytam tinkamumo laikui pasibaigus, šio vaisto vartoti negalima.
English: c.A712C or c.T714A or c.T714G S238R
Lithuanian: c.A712C arba c.T714A arba c.T714G
English: c.1019G>A or c.1020G>A c.G1019A or c.G1020A
Lithuanian: W340R c.1019G>A arba c.1020G>A c.G1019A arba c.G1020A W340X c.1019G>C
English: p.N298X
Lithuanian: N298X
English: c.486G>C or c.486G>T
Lithuanian: c.486G>C arba c.486G>T
English: c.484T>C or c.484T>A
Lithuanian: c.484T>C arba c.484T>A
English: c.C279G or c.C279A
Lithuanian: c.279C>G arba c.279C>A c.C279G arba c.C279A
English: c.G978C or c.G978T
Lithuanian: c.G978C arba c.G978T
English: Torticollis Pain in extremity
Lithuanian: Tortikolis Galūnių skausmas
English: c.978G>C or c.978G>T
Lithuanian: c.978G>C arba c.978G>T
English: c.72G>C or c.72G>T
Lithuanian: c.72G>C arba c.72G>T
English: UNKNOWN (del Exon3_7?)
Lithuanian: NEŽINOMA (del Exon3_7?)
English: c.720G>C or c.720G>T
Lithuanian: c.720G>C arba c.720G>T
English: p.V390fs*9
Lithuanian: V390fs*9
English: c.T706C or c.T706A
Lithuanian: c.T706C arba c.T706A
English: c.G936T or c.G936C
Lithuanian: c.G936T arba c.G936C
English: c.963G>C or c.963G>T
Lithuanian: c.963G>C arba c.963G>T
English: c.C159G or c.C159A
Lithuanian: c.159C>G arba c.159C>A c.C159G arba c.C159A
English: c.G720C or c.G720T
Lithuanian: c.G720C arba c.G720T
English: c.676T>C or c.676T>A
Lithuanian: c.676T>C arba c.676T>A
English: p.Y365fs*7
Lithuanian: Y365fs*7
English: p.E71X
Lithuanian: E71X
English: Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed.
Lithuanian: Taikant gydymą visomis migalastato dozėmis, žiurkių patinams pasireiškė laikinas ir visiškai praeinantis nevaisingumas.
English: C]-migalastat hydrochloride in the concentration range between 1 and
Lithuanian: C]-migalastato hidrochlorido, nustatyta, kad maždaug 77 proc.
English: c.729G>C or c.729G>T
Lithuanian: c.729G>C arba c.729G>T
English: c.667T>A or c.668G>C
Lithuanian: c.667T>A arba c.668G>C
English: c.678G>T or c.678G>C
Lithuanian: c.678G>T arba c.678G>C
English: c.G708C or c.G708T
Lithuanian: c.G708C arba c.G708T
English: c.G126A or c.G126C or c.G126T M42I
Lithuanian: c.G126A arba c.G126C arba c.G126T
English: c.G228C or c.G228A or c.G228T M76I
Lithuanian: c.G228C arba c.G228A arba c.G228T
English: c.G72C or c.G72T
Lithuanian: c.G72C arba c.G72T
English: UNKNOWN (del Exon2_3?)
Lithuanian: NEŽINOMA (del Exon2_3?)
English: c.706T>C or c.706T>A
Lithuanian: c.706T>C arba c.706T>A
English: (dyspnoea)
Lithuanian: (dispepsija)
English: c.G729C or c.G729T
Lithuanian: c.G729C arba c.G729T
English: Approximately 9% of the total radioactivity was unassigned.
Lithuanian: bendrojo radioaktyvumo nepriskirta konkrečioms medžiagoms.
English: c.139T>C or c.139T>A
Lithuanian: Baltymų sekos pakitimas c.139T>C arba c.139T>A
English: c.G678T or c.G678C
Lithuanian: c.G678T arba c.G678C
English: c.868A>C or c.868A>T
Lithuanian: c.868A>C arba c.868A>T
English: c.G561T or c.G561A or c.G561C M187I
Lithuanian: c.G561T arba c.G561A arba c.G561C
English: c.A886T or c.A886C
Lithuanian: c.A886T arba c.A886C
English: Do not take this medicine if you are breast-feeding, until you have spoken with your doctor, pharmacist, or nurse.
Lithuanian: Jeigu jūs žindote, nevartokite šio vaisto nepasitarę su savo gydytoju, vaistininku arba slaugytoju.
English: c.A442C or c.T444A or c.T444G S148R
Lithuanian: c.A442C arba c.T444A arba c.T444G
English: p.V339fs*5
Lithuanian: V339fs*5
English: Protein Sequence change p.T412Sfs*37
Lithuanian: p.T412Sfs*37
English: Do not take Galafold if you:
Lithuanian: Kas žinotina prieš vartojant Galafold Galafold vartoti negalima:
English: c.886A>T or c.886A>C
Lithuanian: c.886A>T arba c.886A>C
English: c.G786C or c.G786T
Lithuanian: c.G786C arba c.G786T
English: c.C305G or c.C305A
Lithuanian: c.305C>G arba c.305C>A c.C305G arba c.C305A
English: c.G153A or c.G153T or c.G153C M51I
Lithuanian: c.G153A arba c.G153T arba c.G153C
English: c.A1023C or c.A1023T
Lithuanian: c.1023A >C arba c.1023A>T c.A1023C arba c.A1023T
English: Muscle spasms Myalgia
Lithuanian: Raumenų spazmai Mialgija
English: c.786G>C or c.786G>T
Lithuanian: c.786G>C arba c.786G>T
English: c.G888A or c.G888T or c.G888C M296I
Lithuanian: c.G888A arba c.G888T arba c.G888C
English: p.V339fs*7
Lithuanian: V339fs*7
English: c.C747G or c.C747A
Lithuanian: c.747C>G arba c.747C>A c.C747G arba c.C747A
English: If you are planning to have a baby, ask your doctor, pharmacist, or nurse for advice.
Lithuanian: Jeigu planuojate pastoti, pasitarkite su savo gydytoju, vaistininku arba slaugytoju.
English: El. paštas: MedInfo@amicusrx.com
Lithuanian: paštas: MedInfo@amicusrx.com
English: c.G288A or c.G288T or c.G288C M96I
Lithuanian: c.G288A arba c.G288T arba c.G288C
English: c.1034C>G or c.1034C>A c.C1034G or c.C1034A
Lithuanian: L344P c.1034C>G arba c.1034C>A c.C1034G arba c.C1034A S345X c.1042G>C
English: (95% CI: -2.653, -0.782; n=31).
Lithuanian: -0,782; n=31).
English: Similar findings have been noted pre-clinically following treatment with other iminosugars (see section 5.3).
Lithuanian: Panašūs rezultatai nustatyti atlikus ikiklinikinius tyrimus po gydymo kitais iminosacharidais (žr.
English: • Diarrhoea
Lithuanian: • Galūnių dilgčiojimas
English: c.G870A or c.G870C or c.G870T M290I
Lithuanian: c.G870A arba c.G870C arba c.G870T
English: c.T258G or c.T258A
Lithuanian: c.258T>G arba c.258T>A c.T258G arba c.T258A
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
Lithuanian: Po kontrolinio laikotarpio AGM tyrimo tęsinyje pacientams, kuriems gydymo pradžioje diagnozuota kairiojo skilvelio hipertrofija, vidutinis KSMi pokytis nuo gydymo pradžios iki 36-o mėnesio buvo30,0 (95 proc. PI: -57,9, -2,2; n=4), o iki 48-o mėnesio buvo -33,1 (PI:-60,9, -5,4; n=4).
English: c.C207A or c.C207G
Lithuanian: c.207C>A arba c.207C>G c.C207A arba c.C207G
English: (torticollis)
Lithuanian: (mialgija)
English: c.C897G or c.C897A
Lithuanian: c.897C>G arba c.897C>A c.C897G arba c.C897A
English: Disease Substrate
Lithuanian: Ligos pagrindas
English: Galafold 123 mg hard capsules migalastat
Lithuanian: Galafold 123 mg kietosios kapsulės Migalastatas
English: Protein sequence change c.126G>A or c.126G>C or c.126G>T
Lithuanian: c.126G>A arba c.126G>C arba c.126G>T
English: c.G284A or c.G285A
Lithuanian: c.284G>A arba c.285G>A c.G284A arba c.G285A
English: c.1046G>A or c.1047G>A c.G1046A or c.G1047A
Lithuanian: W349R c.1046G>A arba c.1047G>A c.G1046A arba c.G1047A W349X c.1048G>C
English: Galafold 123 mg hard capsules
Lithuanian: galafold 123 mg kietosios kapsulės
English: galafold 123 mg hard capsules
Lithuanian: Galafold 123 mg kietosios kapsulės
English: c.552T>A or c.552T>G
Lithuanian: c.552T>A arba c.552T>G c.T552A arba c.T552G
English: Abdominal pain Constipation Dry mouth
Lithuanian: Pilvo skausmas Vidurių užkietėjimas Išsausėjusi burna Staigiai atsiradęs poreikis tuštintis
English: c.C453G or c.C453A
Lithuanian: c.453C>G arba c.453C>A c.C453G arba c.C453A
English: c.C233G or c.C233A
Lithuanian: c.233C>G arba c.233C>A c.C233G arba c.C233A
English: c.1065C>A or c.1065C>G c.C1065A or c.C1065G
Lithuanian: c.456C>A arba c.456C>G c.C456A arba c.C456G
English: c.C816A or c.C816G
Lithuanian: c.816C>A arba c.816C>G c.C816A arba c.C816G
English: c.G485A or c.G486A
Lithuanian: c.485G>A arba c.486G>A c.G485A arba c.G486A
English: c.T102G or c.T102A
Lithuanian: c.102T>G arba c.102T>A c.T102G arba c.T102A
English: c.3G>A or c.3G>T or c.3G>C c.G3A or c.G3T or c.G3C
Lithuanian: c.3G>A arba c.3G>T arba c.3G>C
English: c.1081G>A or c.1081G>C
Lithuanian: c.1081G>A arba c.1081G>C c.G1081A arba c.G1081C
English: c.C519A or c.C519G
Lithuanian: c.519C>A arba c.519C>G c.C519A arba c.C519G
English: c.T960G or c.T960A
Lithuanian: c.960T>G arba c.960T>A c.T960G arba c.T960A
English: • Reduced sense of touch or sensation
Lithuanian: • Sumažėjęs odos jautrumas (hipestezija)
English: c.T402G or c.T402A
Lithuanian: c.402T>G arba c.402T>A c.T402G arba c.T402A
English: c.T881G or c.T881A
Lithuanian: c.881T>G arba c.881T>A c.T881G arba c.T881A
English: c.G131A or c.G132A
Lithuanian: c.131G>A arba c.132G>A c.G131A arba c.G132A
English: Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat - The other ingredients are: Capsule contents: Pregelatinised maize starch and magnesium stearate Capsule shell: Gelatin, titanium dioxide, and indigotine Printing ink: Shellac, black iron oxide, and potassium hydroxide
Lithuanian: Spausdinimo rašalas: šelakas, juodasis geležies oksidas ir kalio hidroksidas.
English: c.G830A or c.G831A
Lithuanian: c.830G>A arba c.831G>A c.G830A arba c.G831A
English: Dyspnoea Epistaxis
Lithuanian: Inkstų veikla
English: c.C966A or c.C966G
Lithuanian: c.966C>A arba c.966C>G c.C966A arba c.C966G
English: c.G1074T or c.G1074C
Lithuanian: c.1074G>T arba c.1074G>C c.G1074T arba c.G1074C
English: c.G785A or c.G786A
Lithuanian: c.785G>A arba c.786G>A c.G785A arba c.G786A
English: c.G860A or c.G861A
Lithuanian: c.860G>A arba c.861G>A c.G860A arba c.G861A
English: c.108G>C or c.108G>T
Lithuanian: Baltymų sekos pakitimas c.108G>C arba c.108G>T
English: c.T369G or c.T369A
Lithuanian: c.369T>G arba c.369T>A c.T369G arba c.T369A
English: c.T702G or c.T702A
Lithuanian: c.702T>G arba c.702T>A c.T702G arba c.T702A
English: c.465T>A or c.465T>G
Lithuanian: c.465T>A arba c.465T>G c.T465A arba c.T465G
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).
Lithuanian: PI: -8,9, 1,3; n=28), o vidutinis KSMi pokytis nuo gydymo pradžios pacientams, kuriems gydymo pradžioje diagnozuota kairiojo skilvelio hipertrofija, buvo -10,0 (95 proc. PI: -16,6, -3,3; n=10).
English: c.T894G or c.T894A
Lithuanian: c.894T>G arba c.894T>A c.T894G arba c.T894A
English: c.T834G or c.T834A
Lithuanian: c.834T>G arba c.834T>A c.T834G arba c.T834A
English: c.408T>A or c.408T>G
Lithuanian: c.408T>A arba c.408T>G c.T408A arba c.T408G
English: c.648T>A or c.648T>G
Lithuanian: c.648T>A arba c.648T>G c.T648A arba c.T648G
English: c.G707A or c.G708A
Lithuanian: c.707G>A arba c.708G>A c.G707A arba c.G708A
English: c.G778C or c.G778A
Lithuanian: c.778G>C arba c.778G>A c.G778C arba c.G778A
English: c.G103C or c.G103A
Lithuanian: c.103G>C arba c.103G>A c.G103C arba c.G103A
English: c.C666A or c.C666G
Lithuanian: c.666C>A arba c.666C>G c.C666A arba c.C666G
English: c.G734A or c.G735A
Lithuanian: c.734G>A arba c.735G>A c.G734A arba c.G735A
English: c.G772C or c.G772A
Lithuanian: c.772G>C arba c.772G>A c.G772C arba c.G772A
English: c.G242A or c.G243A
Lithuanian: c.242G>A arba c.243G>A c.G242A arba c.G243A
English: c.798T>A or c.798T>G
Lithuanian: c.798T>A arba c.798T>G c.T798A arba c.T798G
English: c.789T>A or c.789T>G
Lithuanian: c.789T>A arba c.789T>G c.T789A arba c.T789G
English: (95% CI: -2.272,
Lithuanian: (95 proc.
English: c.677G>A or c.678G>A
Lithuanian: c.677G>A arba c.678G>A c.G677A arba c.G678A
English: c.687T>A or c.687T>G
Lithuanian: c.687T>A arba c.687T>G c.T687A arba c.T687G
English: Further information on Halimatoz can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Lithuanian: Daugiau informacijos apie Halimatoz rasite Agentūros tinklalapyje adresu: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Halimatoz (adalimumab)
Lithuanian: Halimatoz (adalimumabas)
English: This means that Halimatoz is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Lithuanian: Tai reiškia, kad Halimatoz yra labai panašus į kitą biologinį vaistą („referencinį vaistą“), kuris jau registruotas ES.
English: What measures are being taken to ensure the safe and effective use of Halimatoz?
Lithuanian: Kokios priemonės taikomos siekiant užtikrinti saugų ir veiksmingą Halimatoz vartojimą?
English: Other information about Halimatoz
Lithuanian: Kita informacija apie 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.
Lithuanian: Vaisto dozė ir injekcijų dažnumas priklauso nuo ligos, kurią numatoma gydyti, o vaikams skiriama dozė paprastai apskaičiuojama pagal vaiko svorį; kadangi Halimatoz tiekiamas tik 40 mg dozėmis, jis netinkamas vaikams, kuriems reikia mažesnės nei 40 mg dozės.
English: The reference medicine for Halimatoz is Humira.
Lithuanian: Referencinis Halimatoz vaistas yra Humira.
English: What is Halimatoz and what is it used for?
Lithuanian: Kas yra Halimatoz ir kam jis vartojamas?
English: Side effects reported with Halimatoz are carefully evaluated and any necessary action taken to protect patients.
Lithuanian: Halimatoz šalutinis poveikis yra kruopščiai vertinamas ir imamasi visų reikiamų priemonių pacientams apsaugoti.
English: Why is Halimatoz authorised in the EU?
Lithuanian: Kodėl Halimatoz buvo registruotas ES?
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.
Lithuanian: Kadangi Halimatoz yra panašus biologinis vaistas, visų su Humira atliktų adalimumabo veiksmingumo ir saugumo tyrimų nereikia kartoti su Halimatoz.
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.
Lithuanian: Kaip ir kiti šios klasės vaistai, Halimatoz gali pakenkti imuninės sistemos gebėjimui kovoti su infekcijomis ir vėžiu - adalimumabą vartojusiems pacientams nustatyta keletas sunkių infekcijų ir kraujo vėžio atvejų.
English: Therefore, the Agency's view was that, as for Humira, the benefits of Halimatoz outweigh the identified risks and it can be authorised.
Lithuanian: Todėl Agentūra laikėsi nuomonės, kad, kaip ir Humira, Halimatoz nauda persveria nustatytą riziką ir jį galima registruoti.
English: Halimatoz is mostly used in adults when their conditions are severe, moderately severe or getting worse, or when patients cannot use other treatments.
Lithuanian: Halimatoz daugiausia skiriamas suaugusiesiems, kurių būklė sunki, vidutinio sunkumo arba sunkėja, arba kai pacientai negali vartoti kitų vaistų.
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.
Lithuanian: Halimatoz galima įsigyti tik pateikus receptą, o gydymą turi pradėti ir prižiūrėti ligų, kurios gydomos Halimatoz, gydymo patirties turintis gydytojas.
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.
Lithuanian: Po 16 gydymo savaičių simptomai bent 75 proc.
English: As for all medicines, data on the use of Halimatoz are continuously monitored.
Lithuanian: Kaip ir visų vaistų, Halimatoz vartojimo duomenys yra nuolatos stebimi.
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.
Lithuanian: Europos vaistų agentūra nusprendė, kad atsižvelgiant į panašiems biologiniams vaistams keliamus ES reikalavimus, savo struktūra, grynumu ir biologiniu aktyvumu Halimatoz labai panašus į Humira ir taip pat, kaip šis vaistas, pasiskirsto žmogaus organizme.
English: For more information on the use of Halimatoz in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Lithuanian: Daugiau informacijos apie tai, kaip vartoti Halimatoz pagal visas indikacijas, įskaitant tai, kokiais atvejais šį vaistą galima skirti vaikams, rasite pakuotės lapelyje arba teiraukitės savo gydytojo arba vaistininko.
English: Halimatoz is a medicine that acts on the immune system and is used to treat the following conditions:
Lithuanian: Halimatoz - tai imuninę sistemą veikiantis vaistas, kuriuo gydomos šios ligos:
English: An overview of Halimatoz and why it is authorised in the EU
Lithuanian: Halimatoz apžvalga ir kodėl jis buvo registruotas Europos Sąjungoje (ES)
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (a serious skin condition).
Lithuanian: Kiti reti sunkūs šalutinio poveikio reiškiniai (galintys pasireikšti ne daugiau kaip 1 žmogui iš 1 000)sutrikusi raudonųjų kraujo ląstelių gamyba kaulų čiulpuose, nervų sutrikimai, vilkligė ir į ją panašios ligos (kuriomis sergant imuninė sistema „atakuoja“ paties paciento audinius, taip sukeldama uždegimą ir pažeisdama organus) ir Stivenso-Džonsono sindromas (sunki odos liga).
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).
Lithuanian: Halimatoz negalima vartoti sergant aktyvia tuberkulioze ar kitomis sunkiomis infekcinėmis ligomis arba esant vidutinio sunkumo ar sunkiam širdies nepakankamumui (kai širdis negali išvarinėti pakankamai kraujo po organizmą).
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).
Lithuanian: Veiklioji Halimatoz medžiaga adalimumabas yra monokloninis antikūnas (tam tikros rūšies baltymas), kuris sumodeliuotas taip, kad atpažintų žmogaus kūne gaminamą medžiagą, vadinamą naviko nekrozės faktoriumi (NNF), ir prie jos jungtųsi.
English: For the full list of side effects and restrictions with Halimatoz, see the package leaflet.
Lithuanian: Išsamų visų Halimatoz šalutinio poveikio reiškinių ir apribojimų sąrašą galima rasti pakuotės lapelyje.
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.
Lithuanian: Halimatoz tiekiamas užpildytame švirkšte arba švirkštiklyje, po oda švirkščiamo tirpalo forma; paprastai jis švirkščiamas kas 2 savaites.
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.
Lithuanian: Nuspręsta, kad visų šių duomenų pakanka, kad būtų galima padaryti išvadą, jog pagal patvirtintas indikacijas vartojamas Halimatoz toks pat veiksmingas ir saugus kaip Humira.