natgillin/translations-raw huggingface dataset:
Similar improvements in ARR, mean EDSS score, and T2 and gadolinium-enhancing lesions were seen after Course 4 when compared with the prior year.
Podobna izboljšanja AZT, povprečne ocene EDSS, T2-lezij in z gadolinijem poudarjenih lezij so zabeležili po 4. ciklusu v primerjavi s prejšnjim letom.
Concomitant use of LEMTRADA with any of these therapies could increase the risk of immunosuppression.
Sočasna uporaba zdravila LEMTRADA s katero od navedenih zdravljenj lahko poveča tveganje imunosupresije.
The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive days 12 months following the initial treatment course.
Farmakokinetika alemtuzumaba je bila ocenjena pri skupno 216 bolnikih z RRMS, ki so prejemali intravenske infuzije bodisi 12 mg/dan bodisi 24 mg/dan 5 zaporednih dni, 12 mesecev po prvem ciklu zdravljenja pa še 3 zaporedne dni.
Most events were mild to moderate in severity.
Večina pojavov je bila blagih do zmerno resnih.
Before treatment, patients must be informed about the risks and benefits, and the need to commit to follow-up from treatment initiation until at least 48 months after the last infusion of the second LEMTRADA treatment course.
Pred zdravljenjem je treba bolnike seznaniti s tveganji in koristmi ter jim povedati, da se morajo strinjati s spremljanjem, ki bo trajalo od uvedbe zdravljenja do najmanj 48 mesecev po zadnji infuziji drugega cikla zdravljenja z zdravilom LEMTRADA.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12.
Patients with a history of angina pectoris or myocardial infarction.
Bolniki z anamnezo angine pektoris ali miokardnega infarkta.
• hair loss
• izguba las
Patients who developed anti-alemtuzumab antibodies did so by 15 months from initial exposure.
Protitelesa proti alemtuzumabu so se pri bolnikih pojavila v 15 mesecih od prve izpostavljenosti.
No formal drug interaction studies have been conducted with LEMTRADA using the recommended dose in patients with MS.
Formalnih študij medsebojnega delovanja zdravila LEMTRADA v odmerkih, priporočenih za bolnike z MS, niso izvedli.
Alemtuzumab is an IgG1 kappa antibody with human variable framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal antibody.
Alemtuzumab je protitelo IgG1 kapa s humanim variabilnim okvirjem in konstantnimi področji ter področji iz podganjega monoklonskega protitelesa, ki določajo komplementarnost.
Acute acalculous cholecystitis
Akutni akalkulozni holecistitis
Cases of autoimmune hepatitis (including fatal cases and cases requiring liver transplantation) and hepatic injury related to infections have been reported in patients treated with LEMTRADA (see section 4.3).
Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o primerih avtoimunskega hepatitisa (vključno s smrtnimi primeri in primeri, v katerih je bila potrebna presaditev jeter) in okvare jeter v povezavi z okužbami (glejte poglavje 4.3).
If a cytopenia is confirmed, appropriate medical intervention should be promptly initiated, including referral to a specialist.
Če potrdite citopenijo, je treba takoj uvesti ustrezne medicinske postopke, vključno z napotitvijo k specialistu.
Resources for the management of cytokine release syndrome, hypersensitivity and/or anaphylactic reactions should be available.
Na voljo mora biti vse potrebno za obvladanje sindroma sproščanja citokinov, preobčutljivostnih in/ali anafilaktičnih reakcij.
• thyroid disorders (very common - may affect more than 1 in 10 people): may show as excessive sweating; unexplained weight-loss or gain; eye swelling; nervousness; fast heartbeat; feeling cold; worsening tiredness; or newly occurring constipation.
• bolezni ščitnice (zelo pogosti - pojavijo se lahko pri več kot 1 od 10 bolnikov): lahko se pokažejo kot čezmerno potenje; nepojasnjena izguba ali pridobivanje telesne mase; otekanje oči; živčnost; hitro bitje srca; mrazenje; stopnjevanje utrujenosti; ali nov pojav zapeke.
• Urinalysis with microscopy (prior to treatment initiation and at monthly intervals thereafter)
• Analiza urina z mikroskopijo (pred začetkom zdravljenja in nato v mesečnih presledkih)
• Together with your patient you need to plan and manage their periodic monitoring.
• Redno spremljanje načrtujte in uredite skupaj z bolnikom.
46.6% of the patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 received additional courses upon documented evidence of MS disease activity (relapse and/or MRI) and the treating physician's decision to retreat.
46,6 % bolnikov, uvodoma zdravljenih z 12 mg zdravila LEMTRADA na dan v 1. in 2. študiji, je po potrjeno dokazani aktivnosti MS (recidiv in/ali MR) ter odločitvi lečečega zdravnika za ponovno zdravljenje prejelo dodatne cikle.
In the majority of cases reactions occurred within 1-3 days of the infusion.
V večini primerov so se pojavili v 1 do 3 dneh po infundiranju.
Women of childbearing potential should use effective contraceptive measures during treatment and for 4 months following a course of LEMTRADA treatment (see section 4.6).
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med zdravljenjem in 4 mesece po zdravljenju z zdravilom LEMTRADA (glejte poglavje 4.6).
Symptoms of ITP could include (but are not limited to) easy bruising, petechiae, spontaneous mucocutaneous bleeding (e.g., epistaxis, haemoptysis), heavier than normal or irregular menstrual bleeding.
Simptomi ITP so lahko (a ne izključno) nagnjenost k pojavljanju podplutb, petehije, spontana mukokutana krvavitev (npr. epistaksa, hemoptiza), menstruacijska krvavitev, ki je intenzivnejša kot običajno ali neredna.
These can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Te je možno določiti s pomočjo krvnih preiskav, ki jih boste redno opravljali po zdravljenju z zdravilom LEMTRADA.
Get help right away if you have any of the following symptoms of bleeding in the lung: trouble breathing, coughing up blood, chest pain, facial drooping, sudden severe headache, weakness on one side of the body, difficulty with speech or neck pain.
Če se vam pojavi kateri od naslednjih simptomov krvavitve v pluča, takoj poiščite pomoč: težko dihanje, izkašljevanje krvi, bolečine v prsnem košu, povešenost delov obraza, nenaden hud glavobol, šibkost na eni strani telesa, težave z govorjenjem ali bolečine v vratu.
• vision problems, conjunctivitis, eye disease associated with thyroid disease
• težave z vidom, vnetje očesnih veznic (konjunktivitis), bolezen oči, povezana z boleznijo ščitnice
The study was declared successful if at least one of the two coprimary endpoint was met. 2 CDW was defined as an increase of at least 1 point on the expanded disability status scale (EDSS) from a baseline EDSS score ≥1.0 (1.5 point increase for patients with baseline EDSS of 0) that was sustained for 6 months.
2 CDW je bil opredeljen kot povečanje za vsaj 1 točko na lestvici prizadetosti (EDSS - Expanded Disability Status Scale) z izhodiščnega rezultata EDSS ≥1,0 (povečanje za 1,5 točke pri bolnikih z izhodiščnim rezultatom EDSS 0), ki se je ohranilo 6 mesecev.
• Administer LEMTRADA infusion solution via intravenous administration over approximately 4 hours.
• Infuzijska raztopina zdravila LEMTRADA se daje intravensko v obdobju približno štirih ur.
In clinical trials, patients were administered aciclovir 200 mg twice a day or equivalent.
V kliničnih preskušanjih so bolniki prejemali 200 mg aciklovirja dvakrat na dan ali enakovredno zdravilo.
Serious reactions occurred in 3% of patients and included cases of headache, pyrexia, urticaria, tachycardia, atrial fibrillation, nausea, chest discomfort, and hypotension.
Resne reakcije so se pojavile pri 3 % bolnikov, vključevale so primere glavobola, pireksije, urtikarije, tahikardije, atrijske fibrilacije, navzee, nelagodnega občutka v prsnem košu in hipotenzije.
After this period of time, testing should be performed based on clinical findings suggestive of ITP.
Po tem časovnem obdobju je treba preiskave opravljati na podlagi kliničnih ugotovitev, ki kažejo na ITP.
• autoimmune disorder characterized by bleeding (acquired haemophilia A)
• avtoimunska bolezen, za katero so značilne krvavitve (pridobljena hemofilija A)
EU/1/13/869/001
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/869/001
The most frequent side effects are infusion reactions (see below for information on how often patients experience these), which can happen at the time of the infusion or within 24 hours after the infusion.
Najpogostejši neželeni učinki so z infuzijo povezane reakcije (njihova pogostnost je navedena v nadaljevanju), ki se lahko pojavijo v času infuzije ali v 24 urah po infuziji.
• Patients should be premedicated with corticosteroids immediately prior to LEMTRADA infusion for the first 3 days on any treatment course.
• Bolnike je treba premedicirati s kortikosteroidi tik pred infuzijo zdravila LEMTRADA prve tri dni vsakega postopka zdravljenja.
You should also continue looking for signs and symptoms of side effects beyond four years as detailed in your patient guide, and you should continue carrying the Patient Alert Card with you.
Kot je določeno v vašem vodniku za bolnike, bodite tudi po štirih letih še naprej pozorni na znake in simptome stranskih učinkov ter še naprej s seboj nosite opozorilno kartico za bolnika.
Treatment with intravenous alemtuzumab at doses up to 10 mg/kg/day, administered for 5 consecutive days (AUC of 7.1 times the human exposure at the recommended daily dose) had no effect on fertility and reproductive performance in male huCD52 transgenic mice.
Intravensko prejemanje alemtuzumaba v odmerkih do 10 mg/kg/dan, ki so bili uporabljeni 5 zaporednih dni (vrednost AUC je bila 7,1-kratnik izpostavljenosti človeka pri priporočenem dnevnem odmerku), ni imelo vpliva na plodnost in sposobnost razmnoževanja pri samcih transgenih miših huCD52.
Positive samples were further evaluated for evidence of in vitro inhibition using a flow cytometry assay.
Pozitivne vzorce so dodano preiskali za dokaze zaviranja in vitro s testom na osnovi pretočne citometrije.
The treatment consists of stopping LEMTRADA administration and treating the symptoms.
Zdravljenje obsega prekinitev uporabe zdravila LEMTRADA in zdravljenje simptomov.
LEMTRADA 12 mg/day led to significantly lower EDSS scores (improved compared to baseline) through 2 years of follow up, compared with IFNB-1a (p<0.0001).
Zdravilo LEMTRADA v odmerku 12 mg/dan je pomembno zmanjšal rezultate EDSS (izboljšal v primerjavi z izhodiščem) v 2 letih sledenja v primerjavi z IFNB-1a (p<0,0001).
Forty-six patients received a third course of LEMTRADA treatment at 12 mg/day or 24 mg/day for 3 days at month 24.
Šestinštirideset bolnikov je prejelo tretji cikel zdravljenja z odmerkom zdravila LEMTRADA 12 mg/dan ali 24/mg/dan 3 dni v 24. mesecu.
If you develop one of these conditions your doctor will tell you, and take appropriate measures to treat it.
Zdravnik vam bo povedal, če se bo pri vas pojavila katera od teh bolezni, in vam svetoval glede ustreznih postopkov za zdravljenje.
Screening patients at high risk of HBV and/or HCV infection before initiation of LEMTRADA should be considered and caution should be exercised in prescribing LEMTRADA to patients identified as carriers of HBV and/or HCV as these patients may be at risk of irreversible liver damage relative to a potential virus reactivation as a consequence of their pre-existing status.
Pri predpisovanju zdravila LEMTRADA bolnikom, ki so dokazani nosilci HBV in/ali HCV, je potrebna previdnost, saj pri teh bolnikih obstaja tveganje ireverzibilnih poškodb jeter zaradi možne reaktivacije virusa kot posledice predhodnega stanja.
These are the side effects that you may experience:
Pojavijo se lahko naslednji neželeni učinki:
It was noted that in some of the patients, blood pressure and /or heart rate was temporarily abnormal during the infusion.
Zabeleženo je bilo, da so imeli nekateri bolniki med infundiranjem prehodno nenormalen krvni tlak in/ali srčno frekvenco.
For intravenous administration, withdraw 1.2 ml of LEMTRADA from the vial into a syringe using aseptic technique.
Za intravensko uporabo, iz viale z aseptično tehniko povlecite 1,2 ml zdravila LEMTRADA v brizgo.
In studies in mice, alterations in lymphocyte counts were observed in pups exposed to alemtuzumab during gestation at doses of 3 mg/kg/day for 5 consecutive days (AUC 0.6 times the human exposure at the recommended dose of 12 mg/day).
V študijah na miših so ugotovili spremenjeno število limfocitov pri mladičih, izpostavljenih alemtuzumabu med brejostjo v odmerku 3 mg/kg/dan 5 zaporednih dni (vrednost AUC je bila 0,6-kratnik izpostavljenosti človeka pri priporočenem odmerku 12 mg/dan).
LEMTRADA may increase the risk of acute acalculous cholecystitis.
Zdravilo LEMTRADA lahko poveča tveganje za akutni akalkulozni holecistitis.
• pain in the back, the neck, or in arms or legs, muscle pain, muscle spasms, joint pain, painful mouth or throat
• bolečina v hrbtu, vratu ali v rokah ali nogah, mišične bolečine, mišični krči, bolečine v sklepih,
Specialists and equipment required for the timely diagnosis and management of adverse reactions, especially myocardial ischaemia and myocardial infarction, cerebrovascular adverse reactions, autoimmune conditions, and infections, should be available.
Na voljo morajo biti specialisti in oprema, potrebni za pravočasno odkritje in obvladanje neželenih učinkov, zlasti ishemije miokarda in miokardnega infarkta, cerebrovaskularnih neželenih učinkov, avtoimunskih stanj in okužb.
Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with LEMTRADA (see also under ‘Infections' in section 4.4).
Na prvi dan obeh stopenj zdravljenja z zdravilom LEMTRADA je treba pri vseh bolnikih uvesti peroralno profilakso pred herpesno okužbo, ki mora trajati vsaj 1 mesec po zdravljenju z zdravilom LEMTRADA (glejte tudi razdelek "Okužbe" v poglavju 4.4).
After having a course of treatment with LEMTRADA you may be at greater risk of developing other autoimmune conditions, or experiencing serious infections.
Po postopku zdravljenja z zdravilom LEMTRADA je pri vas lahko povečano tveganje za pojav drugih avtoimunskih bolezni ali resnih okužb.
Patients should be informed about symptoms of HLH and time to onset.
Bolnike je treba seznaniti s simptomi HLH in časom do njihovega pojava.
• heart attack
• srčna kap
Details about the signs and symptoms, testing, and actions you need to take are described in sections 2 and 4autoimmune conditions.
Podrobnosti o znakih in simptomih, preiskavah in vaših ukrepih najdete v poglavjih 2 in 4 - avtoimunske bolezni.
Thyroid endocrine disorders including autoimmune thyroid disorders have been observed in 36.8% of patients treated with LEMTRADA 12 mg in clinical trials in MS with a median of 6.1 years (maximum 12 years) of follow- up from the first LEMTRADA exposure.
Ščitnične endokrine motnje, vključno z avtoimunskimi boleznimi ščitnice so bile ugotovljene pri 36,8 % bolnikih, zdravljenih z odmerkom zdravila LEMTRADA 12 mg v kliničnih preskušanjih pri MS, med spremljanjem, ki je mediano trajalo 6,1 leta (največ 12 let)od prve izpostavljenosti zdravilu LEMTRADA.
If you have not completed the standard required vaccinations, your doctor will consider whether you should have them before your LEMTRADA treatment.
Če niste prejeli vseh obveznih cepiv, bo vaš zdravnik presodil, ali se morate pred začetkom zdravljenja z zdravilom LEMTRADA cepiti.
Serious endocrine events occurred in 4.4% of patients, with Basedow's disease (also known as Graves' disease), hyperthyroidism, hypothyroidism, autoimmune thyroiditis, and goitre occurring in more than 1 patient.
Resni endokrini neželeni dogodki so se pojavili pri 4,4 % bolnikov, pri čemer so se pri več kot 1 bolniku pojavile Basedowova bolezen (prej imenovana Gravesova bolezen), hipertiroidizem, hipotiroidizem, avtoimunski tiroiditis in golša.
LEMTRADA contains the active substance alemtuzumab, which is used to treat a form of multiple sclerosis (MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
Zdravilo LEMTRADA vsebuje zdravilno učinkovino alemtuzumab, ki se uporablja za zdravljenje oblike multiple skleroze (MS) pri odraslih bolnikih, ki ji pravimo recidivno-remitentna multipla skleroza (RRMS).
Through 6 years from initial LEMTRADA treatment, patients continuing in follow-up showed rates of MS relapse, brain lesion formation on MRI, and brain volume loss consistent with LEMTRADA's treatment effects during Studies 1 and 2 as well as predominantly stable or improved disability scores.
V 6-letnem obdobju od uvodnega zdravljenja z zdravilom LEMTRADA so se pri bolnikih, vključenih v nadaljnje spremljanje, deleži recidivov MS, nastajanje možganskih lezij na MR in izguba možganskega volumna skladali z učinki zdravila LEMTRADA, ugotovljenimi v študijah 1 in 2; bolniki so imeli tudi pretežno stabilne ocene prizadetosti ali so se jim te ocene izboljšale.
Patients treated with LEMTRADA are also at a higher risk of developing listeria infection (a bacterial infection caused by ingestion of contaminated foods).
Bolniki, ki se zdravijo z zdravilom LEMTRADA, imajo večje tveganje za razvoj okužbe z listerijo (bakterijska okužba, do katere pride z uživanjem okužene hrane).
• Complete blood count with differential, serum transaminases and serum creatinine levels (prior to treatment initiation and at monthly intervals thereafter).
• Celotna in diferencialna krvna slika, raven serumskih transaminaz (pred uvedbo zdravljenja in nato v mesečnih presledkih)
Patients receiving LEMTRADA should be instructed to report symptoms of infections to a physician.
Bolnikom, ki prejemajo zdravilo LEMTRADA, je treba naročiti, da morajo o simptomih okužbe obvestiti zdravnika.
The diluted solution should be administered by intravenous infusion over a period of approximately 4 hours.
Razredčena raztopina se daje z intravensko infuzijo v obdobju približno 4 ur.
Patients treated with LEMTRADA must be given the Package Leaflet, the Patient Alert Card and the Patient Guide.
Bolniki, ki se zdravijo z zdravilom LEMTRADA, morajo prejeti navodilo za uporabo, opozorilno kartico za bolnika in vodnik za bolnike.
Patients treated with LEMTRADA are at a higher risk of getting a serious infection (see section 4infections).
Pri bolnikih, ki se zdravijo z zdravilom LEMTRADA, je večje tveganje za resne okužbe (glejte poglavje 4Okužbe).
Uncommonly, patients have experienced autoimmune conditions involving red blood cells or white blood cells.
Občasno so se pri bolnikih pojavile avtoimunske bolezni, ki prizadanejo rdeče in bele krvničke.
Patients with active MS, defined as at least 2 relapses within the prior 2 years and 1 or more contrastenhancing lesions
Bolniki z aktivno MS, opredeljeno kot vsaj 2 recidiva v preteklih 2 letih in 1 ali več lezij s povečanjem kontrasta.
There is no LEMTRADA treatment between the two courses.
Med obema postopkoma se ne boste zdravili z zdravilom LEMTRADA.
• trembling, loss of sensation, burning or prickling sensation
• tresavica, izguba čutov, pekoč občutek ali ščemenje
Educational programme Prior to launch in each Member State the MAH shall agree an educational programme for HCPs and patients with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora pred prihodom zdravila na trg s pristojnim nacionalnim organom v vsaki državi članici dogovoriti o izobraževalnem programu za zdravstvene delavce in bolnike.
LEMTRADA is a clear, colourless to slightly yellow concentrate for solution for infusion (sterile concentrate) that comes in a glass vial with stopper.
Zdravilo LEMTRADA je bister, brezbarven do rahlo rumen koncentrat za raztopino za infundiranje (sterilni koncentrat) v stekleni viali z zamaškom.
Patients with a history of arterial dissection of the cervicocephalic arteries.
Bolniki z anamnezo arterijske disekcije cervikocefalnih arterij.
Information about some specific conditions that have been seen in MS patients who have been treated with LEMTRADA is provided below.
V nadaljevanju sledijo informacije o določenih boleznih, ki so jih ugotovili pri bolnikih z MS, ki so bili zdravljeni z zdravilom LEMTRADA.
The incidence of thyroid events was higher in patients with a medical history of thyroid disorders both in the LEMTRADA and interferon beta 1a (IFNB1a) treatment groups.
Pojavnost dogodkov, povezanih s ščitnico, je bila večja pri bolnikih z anamnezo bolezni ščitnice, tako v skupini, zdravljeni z zdravilom LEMTRADA, kot v skupini, zdravljeni z interferonom beta 1a (IFNB-1a).
In clinical trials, patients were pre-treated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.
V kliničnih preskušanjih so bili bolniki premedicirani s 1.000 mg prednizolona prve 3 dni obeh ciklov zdravljenja z zdravilom LEMTRADA.
The incidence of IARs was higher in course 1 than in subsequent courses.
Incidenca z infundiranjem povezanih reakcij je bila v 1. ciklu večja kot v nadaljnjih ciklih.
Patients were treated with LEMTRADA 12 mg/day (N=108) or 24 mg/day (N=108) administered once per day for 5 days at month 0 and for 3 days at month 12 or subcutaneous IFNB-1a 44 µg (N=107) administered 3 times per week for 3 years.
Bolniki predhodno niso bili zdravljeni za MS. Bolniki so bili zdravljeni z odmerkom zdravila LEMTRADA 12 mg/dan (N=108) ali 24 mg/dan (N=108), ki so ga prejeli enkrat dnevno 5 dni v 0. mesecu in 3 dni v 12. mesecu, ali subkutanim IFNB-1a 44 µg (N=107), ki so ga prejemali 3-krat tedensko 3 leta.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/PACK
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA/PAKIRANJE
Patients with Gadolinium enhancing lesions through Year 2
Bolniki z lezijo po gadolinijevem kontrastiranju v 2. letu
Patients who develop autoimmunity should be assessed for other autoimmune mediated conditions (see section 4.3).
Bolnike, ki se jim pojavi kakšna avtoimunska motnja, je treba oceniti tudi glede drugih avtoimunskih motenj (glejte poglavje 4.3).
Data reflect the percentage of patients whose test results were considered positive for antibodies to alemtuzumab using an enzyme-linked immunosorbent assay (ELISA) and confirmed by a competitive binding assay.
Podatki odražajo odstotek bolnikov z rezultati preiskav, ki so se šteli za pozitivne za protitelesa proti alemtuzumabu z encimsko imunskim testom
Including follow-up in Study 4, patients originally treated with LEMTRADA in Studies 1 and 2, respectively, had ARRs 0.17 and 0.23, CDW was seen in 22.3% and 29.7%, while 32.7% and 42.5% achieved CDI.
Upoštevaje tudi spremljevalno študijo 4 so imeli bolniki, zdravljeni z zdravilom LEMTRADA v študiji 1 oziroma v študiji 2 AZT 0,17 oziroma 0,23, potrjeno poslabšanje prizadetosti (CDW) se pojavilo pri 22,3 % oziroma 29,7 % bolnikov, potrjeno izboljšanje prizadetosti (CDI) pa pri 32,7 % oziroma 42,5 % bolnikov.
The vast majority (approximately 80%) of patients who presented with a thyroid event after treatment were anti-TPO antibody negative at baseline.
Večina bolnikov (približno 80 %), pri katerih so se po zdravljenju pojavili neželeni dogodki, povezani s ščitnico, je bila na začetku zdravljenja negativna na antiTPO protitelesa.
Patients typically present with spontaneous subcutaneous haematomas and extensive bruising although haematuria, epistaxis, gastrointestinal or other types of bleeding may occur.
Klinična slika praviloma obsega spontane podkožne hematome in obsežne podplutbe, lahko pa se pojavijo tudi hematurija, epistaksa, gastrointestinalne krvavitve in druge vrste krvavitev.
Blood and lymphatic system disorders Severe bleeding reactions have been reported in non-MS patients.
Bolezni krvi in limfatičnega sistema Pri bolnikih, ki niso imeli MS, so poročali o hudih reakcijah s krvavitvijo.
• A test of thyroid function, such as thyroid stimulating hormone level (prior to treatment initiation and every 3 months thereafter).
• Preiskava delovanja ščitnice, kot je določanje ravni tirotropina (pred uvedbo zdravljenja in nato vsake
• disodium phosphate dihydrate (E339)
• dinatrijev fosfat dihidrat (E339)