natgillin/translations-raw huggingface dataset:
− if you have any of the following conditions: o other autoimmune disease besides multiple sclerosis o uncontrolled high blood pressure o history of tears in blood vessels supplying the brain o history of stroke o history of heart attack or chest pain o history of bleeding disorder
- če imate katero od naslednjih bolezni ali stanj: o druge avtoimunske bolezni poleg multiple skleroze, o neurejen visok krvni tlak, o ste imeli v preteklosti pretrganje žile, ki oskrbuje možgane, o ste imeli v preteklosti možgansko kap, o ste imeli v preteklosti srčni infarkt ali bolečine v prsih, o ste imeli v preteklosti kakšno motnjo strjevanja krvi.
Supportive analyses from Study 2 (CAMMS32400507) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (48% reduction, p=0.0121), and significantly fewer relapses that led to steroid treatment (56% reduction, p<0.0001) or to hospitalization (55% reduction, p=0.0045) compared to IFNB-1a.
Podporne analize 2. študije (CAMMS32400507) so pokazale, da je odmerek zdravila LEMTRADA 12 mg/dan pomembno zmanjšal število hudih recidivov (48-odstotno zmanjšanje, p=0,0121) in pomembno zmanjšal število recidivov, ki so privedli do zdravljenja s steroidi (56-odstotno zmanjšanje, p<0,0001) ali hospitalizacije (55-odstotno zmanjšanje, p<0,0045) v primerjavi z IFNB-1a.
Alemtuzumab is a monoclonal antibody produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium by recombinant DNA technology.
Alemtuzumab je monoklonsko protitelo pridobljeno s tehniko rekombinantne DNA iz suspenzijske kulture celic sesalca (jajčnika kitajskega hrčka) v hranljivem gojišču.
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of infusion associated reactions, but would tend to be more severe or potentially life-threatening.
Lahko se pojavijo klinični znaki anafilaksije, podobni kliničnim znakom neželenih reakcij zaradi infuzije, ki pa so ponavadi bolj resni in so lahko življenjsko ogrožujoči.
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What LEMTRADA looks like and contents of the pack
Izgled zdravila LEMTRADA in vsebina pakiranja
An additional 12 serious events of ITP has been observed through a median of 6.1 years (maximum 12 years) of follow-up (cumulative annualised rate of 2.8 events/1000 patient years).
Med spremljanjem, ki je mediano trajalo 6,1 leta (in največ 12 let), so zabeležili dodatnih 12 resnih primerov ITP (kumulativni na leto preračunani delež 2,8 dogodka/1000 bolnik-let).
Administration of 12 mg/day resulted in a mean Cmax of 3014 ng/ml on day 5 of the initial treatment course, and 2276 ng/ml on day 3 of the second treatment course.
Dajanje odmerka 12 mg/dan je privedlo do povprečne Cmax 3014 ng/ml 5. dan prvega cikla zdravljenja in 2276 ng/ml 3. dan drugega cikla zdravljenja.
Some patients have developed liver inflammation after receiving LEMTRADA.
Nekaterim bolnikom se je po prejemanju zdravila LEMTRADA pojavilo vnetje jeter.
Tuberculosis has been reported for patients treated with LEMTRADA and IFNB-1a in controlled clinical trials.
Pri bolnikih, zdravljenih z zdravilom LEMTRADA in IFNB-1a v kontroliranih kliničnih preskušanjih, so poročali o tuberkulozi.
Listeriosis/Listeria meningitis has been reported in LEMTRADA treated patients, generally within one month of LEMTRADA infusion.
Pri bolnikih zdravljenih z zdravilom LEMTRADA, so poročali o listeriozi/listerijskemu meningitisu, običajno v roku enega meseca po prejetju infuzije.
A reproductive toxicity study in pregnant mice exposed to intravenous doses of alemtuzumab up to 10 mg/kg/day (AUC 2.4 times the human exposure at the recommended dose of 12 mg/day) for 5 consecutive days during gestation resulted in significant increases in the number of dams with all conceptuses dead or resorbed, along with a concomitant reduction in the number of dams with viable foetuses.
Študija reproduktivne toksičnosti pri brejih miših, ki so bile izpostavljene intravenskim odmerkom alemtuzumaba do 10 mg/kg/dan (vrednost AUC je bila 2,4-kratnik izpostavljenosti človeka pri priporočenem odmerku 12 mg/kg) 5 zaporednih dni med brejostjo, je pokazala pomembno povečanje števila samic z mrtvimi ali resorbiranimi vsemi konceptusi ter sočasno zmanjšanje števila samic z živimi plodovi.
Educate patients on the signs and symptoms of acquired haemophilia A and to seek immediate medical attention, if any of these symptoms are observed.
Bolnike seznanite z znaki in simptomi pridobljene hemofilije A in jim naročite, naj nemudoma poiščejo zdravniško pomoč, če opazijo katerega od teh simptomov.
It is recommended that patients be premedicated to ameliorate the effects of infusion reactions (see section
Priporočljiva je premedikacija, da se ublažijo učinki z infuzijo povezanih reakcij (glejte poglavje 4.2).
In the post-marketing setting several patients who developed biopsy proven AIH had previously developed autoimmune thyroid disorders.
V obdobju po prihodu zdravila na trg je pri več bolnikih, ki se jim je razvil z biopsijo dokazan AIH, predhodno prišlo do avtoimunskih bolezni ščitnice.
• inflammation of the mouth/gums/tongue
• vnetje ust/dlesni/jezika
Symptoms of acquired hemophilia A are described in section 4.
Simptomi pridobljene hemofilije A so opisani v poglavju 4.
Intravenous use.
intravenska uporaba
Study design
Zasnova študije
Through all available follow-up, including patients who received additional treatment courses, the most common IARs included headache, rash, pyrexia, nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnoea, dysgeusia, chest discomfort, generalised rash, tachycardia, bradycardia, dyspepsia, dizziness, and pain.
Med celotnim spremljanjem, ki je na voljo, vključno z bolniki, ki so prejeli dodatne cikle zdravljenja, so najpogostejše z infundiranjem povezane reakcije vključevale glavobol, izpuščaj, pireksijo, navzeo, urtikarijo, srbenje, nespečnost, mrazenje, pordevanje, utrujenost, dispnejo, disgevzijo, nelagoden občutek v prsnem košu, generaliziran izpuščaj, tahikardijo, bradikardijo, dispepsijo, omotico in bolečine.
Renal or hepatic impairment LEMTRADA has not been studied in patients with renal or hepatic impairment.
Okvarjeno delovanje ledvic ali jeter Zdravilo LEMTRADA ni bilo preučeno pri bolnikih z okvarjenim delovanjem ledvic ali jeter.
Cytokine release syndrome*, hypersensitivity including anaphylaxis*
Bolezni imunskega sistema sindrom sproščanja citokinov*, preobčutljivost, vključno z anafilaksijo*
Patients with clinical symtoms suggesting development of a serious adverse event temporarily associated with the infusion (myocardial ischemia, haemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage) should be closely monitored until complete resolution of the symptoms.
Bolnike s kliničnimi simptomi, ki kažejo na razvoj resnega neželenega učinka, časovno povezanega z infundiranjem (ishemija miokarda, hemoragična možganska kap, disekcija cervikocefalne arterije ali pljučna alveolarna krvavitev), je treba natančno nadzorovati, dokler ti simptomi povsem ne minejo.
Commonly, patients have developed a bleeding disorder caused by a low level of blood platelets, called immune thrombocytopenic purpura (ITP).
o Imunska trombocitopenična purpura (ITP) Pogosto se je pri bolnikih pojavila motnja krvavitve, ki jo je povzročilo nizko število krvnih ploščic in jo imenujemo imunska trombocitopenična purpura (ITP).
During post-marketing use, additional cases of acute acalculous cholecystitis have been reported in LEMTRADA-treated patients.
Med uporabo po prihodu zdravila na trg so pri bolnikih, zdravljenih z zdravilom LEMTRADA, poročali o dodatnih primerih akutnega akalkuloznega holecistitisa.
Your doctor will explain to you how LEMTRADA will be given.
Zdravnik vam bo pojasnil, kako se daje zdravilo LEMTRADA.
Infections that occurred more often in LEMTRADA -treated patients than IFNB 1a patients included nasopharyngitis, urinary tract infection, upper respiratory tract infection, sinusitis, oral herpes, influenza, and bronchitis.
Okužbe, ki so se pojavljale pogosteje pri bolnikih, zdravljenih z zdravilom LEMTRADA, kot pri bolnikih, zdravljenih z IFNB 1a, so vključevale nazofaringitis, okužbe sečil, okužbe zgornjih dihal, sinusitis, herpes v ustih, gripo in bronhitis.
To reduce the risk of infection, patients receiving LEMTRADA should avoid ingestion of uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks prior to, during, and for at least one month after LEMTRADA infusion.
Za zmanjšanje tveganja za okužbo se morajo bolniki, ki prejemajo zdravilo LEMTRADA, dva tedna pred, med ali vsaj še mesec dni po infuziji zdravila LEMTRADA izogibati uživanju nekuhanega ali premalo kuhanega mesa, mehkim sirom in izdelkom iz nepasteriziranega mleka.
There were no external, soft tissue, or skeletal malformations or variations observed at doses up to 10 mg/kg/day.
Pri odmerkih do 10 mg/kg/dan niso opazili malformacij ali sprememb zunanjosti, mehkih tkiv ali skeleta.
Each vial contains 12 mg alemtuzumab in 1.2 ml.
Ena viala vsebuje 12 mg alemtuzumaba v 1,2 ml.
Reactions attributed to anaphylaxis have been reported rarely in contrast to infusion associated reactions.
V primerjavi z neželenimi reakcijami zaradi infuzije so z anafilaksijo povezane neželene reakcije ugotovili redko.
91.8% of the patients treated with LEMTRADA 12 mg in Studies 1 and 2 entered Study 4.
V 4. študijo je vstopilo 91,8 % bolnikov, zdravljenih z 12 mg zdravila LEMTRADA v 1. in 2. študiji.
LEMTRADA is supplied in a clear, 2 ml glass vial, with a butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Zdravilo LEMTRADA je dobavljeno v brezbarvni, 2 ml stekleni viali z zamaškom iz butilne gume in aluminijevo zaporko s plastičnim poteznim pokrovčkom.
You should report to your doctor if you have symptoms such as stomach pain or discomfort, fever, nausea or vomiting.
Zdravniku morate poročati, če imate znake, kot so bolečine ali nelagodje v želodcu, zvišana telesna temperatura, slabost ali bruhanje.
In clinical trials, infusion associated reactions (IARs) were defined as any adverse event occurring during or within 24 hours of LEMTRADA infusion.
V kliničnih preskušanjih so z infuzijo povezane reakcije opredelili kot vse neželene dogodke v 24 urah po infundiranju zdravila LEMTRADA.
• autoimmune over-active or under-active thyroid gland, thyroid antibodies or goitre (swelling of the thyroid gland in the neck)
• avtoimuno čezmerno ali premalo delovanje ščitnice, ščitnična protitelesa ali golšavost (otekanje ščitnice v vratu)
• Thyroid disorders such as over-active or under-active thyroid gland
• Bolezni ščitnice, kot so prekomerno ali nezadostno delovanje ščitnice
Do not use if particulate matter is present or the concentrate is discoloured.
V primeru prisotnosti delcev ali spremembe barve koncentrata zdravila ne uporabite.
LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis in a hospital with ready access to intensive care.
Zdravljenje z zdravilom LEMTRADA sme uvesti in nadzorovati le nevrolog, ki ima izkušnje z zdravljenjem bolnikov z multiplo sklerozo, v bolnišnicah s takojšnjim dostopom do intenzivne nege.
This includes any possible side-effects not listed in this leaflet.
Posvetujte se tudi, če opazite neželene učinke, ki niso navedeni v tem navodilu.
Potassium chloride (E508) Potassium dihydrogen phosphate (E340) Polysorbate 80 (E433) Sodium chloride
6.1 Seznam pomožnih snovi dinatrijev fosfat dihidrat (E339) dinatrijev edetat kalijev klorid (E508) kalijev dihidrogenfosfat (E340) polisorbat 80 (E 433) natrijev klorid voda za injekcije
LEMTRADA treatment should only be initiated and supervised by a neurologist experienced in the treatment of patients with multiple sclerosis (MS) in a hospital with ready access to intensive care.
Zdravljenje z zdravilom LEMTRADA sme uvesti in nadzorovati le nevrolog, ki ima izkušnje z zdravljenjem bolnikov z multiplo sklerozo (MS), v bolnišnicah s takojšnjim dostopom do intenzivne nege.
In some patients there was increased blood pressure from baseline before the haemorrhage.
Nekaterim bolnikom se je pred krvavitvijo krvni tlak zvišal v primerjavi z izhodiščem.
After this period of time, testing should be performed based on clinical findings suggestive of nephropathies.
Po tem obdobju naj se testiranje opravlja glede na klinične ugotovitve, ki kažejo na nefropatije.
Additional course(s) of LEMTRADA were administered at 12 mg/day for 3 consecutive days (36 mg total dose) at least 12 months after the prior treatment course.
Dodatno zdravljenje z zdravilom LEMTRADA v odmerku 12 mg/dan je trajalo 3 zaporedne dni (skupni odmerek 36 mg) in sicer vsaj 12 mesecev po predhodnem zdravljenju.
In female mice dosed with intravenous alemtuzumab up to 10 mg/kg/day (AUC of 4.7 times the human exposure at the recommended daily dose) for 5 consecutive days prior to cohabitation with wild-type male mice, the average number of corpora lutea and implantation sites per mouse were significantly reduced as compared to vehicle treated animals.
Pri samicah miši, ki so intravensko prejemale alemtuzumab v odmerkih do 10 mg/kg/dan (vrednost AUC je bila 4,7-kratnik izpostavljenosti človeka pri priporočenem dnevnem odmerku) 5 zaporednih dni pred skupno naselitvijo s samci divjega tipa, je bilo povprečno število rumenih telesc in implantacijskih mest na žival pomembno manjše kot pri živalih, ki so prejemale vehikel.
The cumulative annualised rate of infections was 0.99 through a median of 6.1 years (maximum 12 years) of follow-up from the first LEMTRADA exposure, as compared to 1.27 in controlled clinical trials.
Kumulativni na leto preračunani delež okužb med spremljanjem, ki je mediano trajalo 6,1 leta (in največ 12 let) od prve izpostavljenosti zdravilu LEMTRADA, je bil 0,99; v kontroliranih kliničnih preskušanjih pa
Myocardial ischaemia and myocardial infarction
Ishemija miokarda in miokardni infarkt
Serious varicella zoster virus infections, including primary varicella and varicella zoster re-activation, have occurred more often in patients treated with LEMTRADA 12 mg (0.4%) in clinical trials as compared to IFNB-1a (0%).
Resni primeri okužb z virusom varicella zoster, vključno s primarnimi noricami in reaktivacijo herpes zostra, so bili v kliničnih preskušanjih pogostejši pri bolnikih, ki so prejemali zdravilo LEMTRADA v odmerku 12 mg (0,4 %), kot pri bolnikih, ki so prejemali IFNB-1a (0 %).
In controlled clinical studies, 0.2% of LEMTRADA-treated MS patients developed acute acalculous cholecystitis, compared to 0% of patients treated with INFB-1a.
V kontroliranih kliničnih študijah se je akutni akalkulozni holecistitis pojavil pri 0,2 % bolnikov z MS, zdravljenih z zdravilom LEMTRADA, in pri 0 % bolnikov, zdravljenih z INFB-1a.
1 Herpes virus infections include PTs: Oral herpes, Herpes simplex, Genital herpes, Herpes virus infection, Genital herpes simplex, Herpes dermatitis, Ophthalmic herpes simplex, Herpes simplex serology positive.
okužba s herpes virusom, genitalni herpes simpleks, herpetični dermatitis, oftalmični herpes simpleks, serološko pozitivni herpes simpleks.
Hypotension*, hypertension*
Žilne bolezni pordevanje* hipotenzija*, hipertenzija*
Continue to test the patient every month for autoimmune conditions, until 4 years after last infusion.
Bolnik naj opravlja preiskave za avtoimunske bolezni vsak mesec še štiri leta po zadnji infuziji.
Mean EDSS score at baseline
Povprečna ocena EDSS v izhodišču
Rarely, patients have experienced autoimmune related problems with their kidneys, such as antiglomerular basement membrane disease (anti-GBM disease).
V redkih primerih so se pri bolnikih pojavile z avtoimunostjo povezane ledvične težave, kot je anti-GBM bolezen.
29% of patients treated with LEMTRADA reached CDI in Study 2, while only 13% of subcutaneous IFNB1a treated patiets reached this endpoint.
V študiji 2 je CDI doseglo 29 % bolnikov, zdravljenih zdravilom LEMTRADA, in samo 13 % bolnikov, zdravljenih s subkutanim IFNB-1a.
LEMTRADA is indicated as a single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups:
Zdravilo LEMTRADA je indicirano kot samostojno imunomodulirajoče zdravilo za zdravljenje odraslih z zelo aktivno recidivno-remitentno multiplo sklerozo (RRMS) v naslednjih skupinah bolnikov:
• Second treatment course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
• Drugi cikel zdravljenja: 12 mg/dan 3 zaporedne dni (skupni odmerek 36 mg), ki se daje 12 mesecev po prvem ciklu zdravljenja.
Other serious reactions temporally associated with LEMTRADA infusion
Drugi resni neželeni učinki, časovno povezani z infundiranjem zdravila LEMTRADA
Sanofi Tel +44 (0)845 372 7101
Tel +44 (0) 845 372 7101
Time to onset of CDI was defined as a decrease of at least one point on the EDSS from a baseline EDSS score ≥ 2 that was sustained for at least 6 months.
Potrjeno izboljšanje prizadetosti (confirmed disability improvement - CDI) Čas do nastopa CDI je bil opredeljen kot zmanjšanje za vsaj eno točko na lestvici EDSS z izhodiščnega rezultata EDSS ≥ 2, ki se je ohranilo vsaj 6 mesecev.
Therefore, breast-feeding should be discontinued during each course of treatment with LEMTRADA and for 4 months following the last infusion of each treatment course.
Zato je treba dojenje prekiniti pred vsakim ciklom zdravljenja z zdravilom LEMTRADA in 4 mesece po zadnjem infundiranju le-tega.
Prophylaxis with an oral anti-herpes agent should be initiated starting on the first day of LEMTRADA treatment and continuing for a minimum of 1 month following each course of treatment.
Na prvi dan zdravljenja z zdravilom LEMTRADA je treba uvesti profilakso s peroralnim zdravilom proti herpesu, ki mora trajati vsaj 1 mesec po vsaki stopnji zdravljenja.
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Ena viala vsebuje 12 mg alemtuzumaba v 1,2 ml (10 mg/ml).
infections, gastroenteritis, oral candidiasis, vulvovaginal candidiasis, influenza, ear infection, pneumonia, vaginal infection, tooth infection tonsillitis, acute sinusitis, cellulitis, pneumonitis, tuberculosis, cytomegalovirus infection virus (EBV) reactivation
okužba s herpes zostrom2, okužba spodnjih dihal, gastroenteritis, oralna kandidoza, vulvovaginalna kandidoza, gripa, okužba ušesa, pljučnica, vaginalna okužba, zobna okužba onihomikoza, gingivitis, glivična okužba kože, tonzilitis, akutni sinusitis, celulitis, pnevmonitis, tuberkuloza, okužba s citomegaloviruso m listerioza/listeri jski meningitis, reaktivacija EpsteinBarrovega virusa (EBV)
If an additional course is administered, safety-follow up should be continued until at least 48 months after the last infusion.
Če bolnik dobi dodaten cikel zdravljenja, je treba varnostno spremljanje nadaljevati še vsaj 48 mesecev po zadnji infuziji.
Patients should be advised to seek immediate medical attention if any of these symptoms occur and be informed on the potential for delayed onset.
Naročiti jim je treba, naj nemudoma poiščejo zdravniško pomoč, če se jim pojavi kateri od teh simptomov; seznaniti jih je treba z možnostjo zapoznelega pojava takšnih simptomov.
• difficulty swallowing, throat irritation, productive cough
• oteženo požiranje, draženje grla, produktivni kašelj
Epstein-Barr Virus-associated lymphoproliferative disorders Epstein-Barr Virus-associated lymphoproliferative disorders have been observed outside company-sponsored studies.
Limfoproliferativne bolezni, povezane z virusom Epstein-Barr Izven študij, ki jih je podprl izdelovalec, so ugotovili limfoproliferativne bolezni, povezane z virusom Epstein-Barr.
You should report to your doctor symptoms like shortness of breath, cough, wheezing, chest pain or tightness and coughing up blood, as these could be caused by pneumonitis.
O simptomih, kot so težko dihanje, kašelj, piskajoče dihanje, bolečina ali tiščanje v prsih ali izkašljevanje krvi, morate obvestiti zdravnika, kajti lahko so posledica pnevmonitisa.
A total of 1,486 patients treated with LEMTRADA (12 mg or 24 mg) constituted the safety population in a pooled analysis of MS clinical studies with a median follow-up of 6.1 years (maximum 12 years), resulting in 8,635 patient-years of safety follow-up.
Populacijo za oceno varnosti je v združeni analizi kliničnih študij multiple skleroze z mediano sledenja 6,1 let (največ 12 let) sestavljalo 1.486 bolnikov, ki so bili zdravljeni z zdravilom LEMTRADA (12 mg ali 24 mg), kar pomeni 8.635 bolnik-let sledenja varnosti.
MS relapse, dizziness*, hypoaesthesia, paraesthesia, tremor, dysgeusia*, migraine*
možganska kap **, disekcija hipestezija, parestezija, tremor, paragevzija*, migrena*
Therefore, women of childbearing potential have to use effective contraception when receiving a course of treatment with LEMTRADA and up to 4 months after each course of treatment.
Zato morajo ženske v rodni dobi uporabljati učinkovito kontracepcijo med postopkom zdravljenja z zdravilom LEMTRADA in do 4 mesece po vsakem takšnem postopku.
Weight decreased, weight increased, red blood cell count decreased, bacterial test positive, blood glucose increased, mean cell volume increase
Preiskave zvišanje kreatinina v krvi zmanjšanje telesne mase, povečanje telesne mase, zmanjšanje števila rdečih krvnih celic, pozitivno bakterijsko testiranje, zvišanje glukoze v krvi, povečanje povprečnega volumna celic
Pulmonary alveolar haemorrhage
Pljučna alveolarna krvavitev
Most patients treated with LEMTRADA will experience side-effects at the time of the infusion or within 24 hours after the infusion.
Pri večini bolnikov, zdravljenih z zdravilom LEMTRADA, se neželeni učinki pojavijo v času infuzije ali v 24 urah po infuziji.
Summary of tests you will have for autoimmune conditions: Test
Povzetek preiskav, ki jih boste potrebovali zaradi avtoimunskih bolezni:
Haemophagocytic lymphohistiocytosis (HLH)
Hemofagocitna limfohistiocitoza (HLH)
In addition, infections which can result in abnormalities of the cervix (the neck of the womb) are possible.
Možne so tudi okužbe, ki privedejo do nenormalnosti materničnega vratu.
Patients treated with LEMTRADA are at a higher risk of developing herpes infection (e.g. a cold sore).
Bolniki, ki se zdravijo z zdravilom LEMTRADA, imajo večje tveganje za razvoj herpesne okužbe (npr. herpes na ustnicah).
Rare (may affect up to 1 in 1000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
• Infections: airway infections such as colds and sinus infections, urinary tract infections, herpes infections
• Okužbe: okužbe dihal, kot je prehlad ali okužba sinusov, okužbe sečil, okužbe s herpes virusom
Among patients who received one or two additional LEMTRADA treatment courses, improvements were seen in relapse rate, MRI activity and mean disability scores following a first or second LEMTRADA retreatment (Courses 3 and 4) when compared with outcomes in the preceding year.
Pri bolnikih, ki so prejeli enega ali dva dodatna cikla zdravila LEMTRADA, so po prvem ali drugem ponovnem zdravljenju z zdravilom LEMTRADA (3. in 4. cikel) opažali izboljšanje deleža recidivov, aktivnosti po MR in povprečnih ocen invalidnosti v primerjavi z izidi v letu pred tem.
Most patients treated with LEMTRADA in clinical trials in MS experienced mild to moderate IARs during and/or up to 24 hours after LEMTRADA 12 mg administration.
Pri večini bolnikov v kliničnih preskušanjih pri MS, zdravljenih z zdravilom LEMTRADA v odmerku 12 mg, so se pojavile blage do zmerne z infuzijo povezane reakcije med in/ali v 24 urah po dajanju zdravila LEMTRADA.
This medicine contains less than 1 mmol potassium (39 mg) per infusion, i.e. it is essentially ‘potassiumfree'.
To zdravilo vsebuje manj kot 1 mmol kalija (39 mg) na infuzijo, kar v bistvu pomeni „brez kalija“.
Autoimmune hepatitis and hepatic injury
Avtoimunski hepatitis in okvara jeter