FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommonly, patients developed a bleeding disorder caused by antibodies that work against factor VIII (a protein needed for normal clotting of blood), called acquired hemophilia A. This condition must be diagnosed and treated immediately.
Slovenian: Občasno se je bolnikom pojavila motnja strjevanja krvi zaradi nastanka protiteles proti faktorju VIII (faktor VIII je beljakovina, potrebna za normalno strjevanje krvi).
English: Patients who were accidentally given too much LEMTRADA in one infusion have experienced serious reactions, such as headache, rash, low blood pressure or increased heart rate.
Slovenian: Če ste prejeli večji odmerek zdravila LEMTRADA, kot bi smeli Pri bolnikih, ki so nenamerno prejeli preveč zdravila LEMTRADA v eni infuziji, so se pojavile resne reakcije, kot so glavobol, izpuščaj, nizek krvni tlak ali pospešeno bitje srca.
English: o Kidney disease (such as anti-GBM disease)
Slovenian: o Bolezen ledvic (kot je bolezen zaradi prisotnih protiteles proti glomerulni bazalni membrani - »anti-GBM bolezen«)
English: If you experience multiple symptoms such as fever, swollen glands, bruising, or skin rash, contact your doctor immediately.
Slovenian: Če opazite več simptomov, na primer zvišano telesno temperaturo, otekle bezgavke, podplutbe ali izpuščaj na koži, se nemudoma posvetujte z zdravnikom.
English: This medicine contains less than 1 mmol sodium (23 mg) per infusion, i.e. it is essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na infuzijo, kar v bistvu pomeni „brez natrija“.
English: Justification for not including Braille accepted
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
English: • nose bleeds, bruises
Slovenian: • krvavitve iz nosu, podplutbe
English: • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.
Slovenian: • za bolnike s hitro razvijajočo se, hudo recidivno-remitentno multiplo sklerozo, opredeljeno kot 2 ali več onesposabljajočih recidivov v enem letu ter z 1 ali več z gadolinijem poudarjenih lezij na magnetnoresonančnem slikanju (MR) možganov ali s pomembnim povečanjem bremena T2-lezij v primerjavi z zadnjim nedavnim MR-posnetkom.
English: To reduce this risk, you should avoid eating uncooked or undercooked meats, soft cheeses and unpasteurized dairy products two weeks before treatment, during the treatment and for at least one month after LEMTRADA treatment.
Slovenian: Da zmanjšate to tveganje, se dva tedna pred zdravljenjem, med zdravljenjem ali vsaj mesec dni po zdravljenju z zdravilom LEMTRADA izogibajte uživanju nekuhanega ali premalo kuhanega mesa, mehkim sirom in izdelkom iz nepasteriziranega mleka.
English: Table 3: Key Clinical and MRI Endpoints from Studies 1 and 2 Study 1
Slovenian: Preglednica 3: Ključni klinični opazovani dogodki in opazovani dogodki na MRS v študijah1 in 2
English: • abnormal liver test
Slovenian: • nenormalni rezultati preiskav jeter
English: Dissection of the cervicocephalic arteries
Slovenian: Disekcija cervikocefalnih arterij
English: Autoimmune events reported in alemtuzumab-treated patients include neutropenia, haemolytic anaemia (including a fatal case), acquired haemophilia, anti-GBM disease, and thyroid disease.
Slovenian: Avtoimunski neželeni učinki, ugotovljeni pri bolnikih, zdravljenih z alemtuzumabom, so vključevali nevtropenijo, hemolitično anemijo (vključno z enim smrtnim izidom), pridobljeno hemofilijo, anti-GBM bolezen in bolezen ščitnice.
English: These tests are done to see whether you may take LEMTRADA.
Slovenian: Te preiskave bodo pokazale, ali smete jemati zdravilo LEMTRADA.
English: Contusion, infusion related reaction
Slovenian: Z infuzijo povezane reakcije
English: • fever and/or chills
Slovenian: • zvišana telesna temperatura in/ali mrzlica
English: It is recommended that you do not breast-feed during each course of treatment with LEMTRADA and for 4 months after each treatment course.
Slovenian: Priporočljivo je, da med nobenim postopkom zdravljenja z zdravilom LEMTRADA in še štiri mesece po vsakem postopku zdravljenja ne dojite.
English: Reported autoimmune conditions, include thyroid disorders, immune thrombocytopenic purpura (ITP), nephropathies (e.g. anti-glomerular basement membrane disease), autoimmune hepatitis (AIH), and acquired haemophilia A. In the post-marketing setting, patients developing multiple autoimmune disorders after LEMTRADA treatment have been observed.
Slovenian: Avtoimunske motnje, o katerih so poročali, obsegajo bolezni ščitnice, imunsko trombocitopenično purpuro (ITP), nefropatije (npr. bolezen s protitelesi proti glomerulni bazalni membrani), avtoimunski hepatitis (AIH) in pridobljeno hemofilijo A. V obdobju po prihodu zdravila na trg so poročali o bolnikih, ki se jim je po zdravljenju z zdravilom LEMTRADA pojavilo več avtoimunskih bolezni.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL/VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA VIALI
English: • MS relapse
Slovenian: • recidiv MS
English: A “Frequently asked questions” section The prescriber checklist shall contain the following key messages: Lists of tests to be conducted for the initial screening of the patient Vaccination course to be completed 6 weeks before treatment
Slovenian: Kontrolni seznam za zdravnike, ki predpisujejo zdravilo, vsebuje naslednja ključna sporočila: seznam preiskav, ki jih je treba opraviti za izhodiščne presejalne preglede bolnika; program cepljenj, ki jih je treba zaključiti 6 tednov pred zdravljenjem; pregledi glede premedikacije, splošnega zdravja ter nosečnosti in kontracepcije tik pred zdravljenjem;
English: LEMTRADA may cause different types of thyroid disorders, including: Over-active thyroid gland (hyperthyroidism) when the thyroid produces too much hormone Under-active thyroid gland (hypothyroidism) when the thyroid does not produce enough hormone.
Slovenian: čezmerno aktivno ščitnico (hipertiroidizem), ko v ščitnici nastaja preveč hormona premalo aktivno ščitnico (hipotiroidizem), ko v ščitnici nastaja premalo hormona.
English: Treatment with LEMTRADA may increase the risk for autoimmune conditions.
Slovenian: Zdravljenje z zdravilom LEMTRADA lahko poveča vaše tveganje za avtoimunske bolezni.
English: Some patients, if they have symptoms or signs of MS disease after the initial two courses, may receive one or two additional treatment courses consisting of one infusion per day for 3 days .
Slovenian: Nekateri bolniki lahko dobijo en ali dva dodatna cikla zdravljenja s po eno infuzijo na dan 3 dni zapored, če imajo po uvodnih dveh ciklih simptome ali znake MS.
English: Symptomatic treatment can be initiated if needed - see SmPC.
Slovenian: Po potrebi uvedite simptomatično zdravljenje - glejte povzetek glavnih značilnosti zdravila.
English: Pretreatment with antihistamines and/or antipyretics prior to LEMTRADA administration may also be considered.
Slovenian: Poleg tega pride v poštev tudi premedikacija z antihistaminiki in/ali antipiretiki pred dajanjem zdravila LEMTRADA.
English: irregular or abnormal heart beat, high blood pressure, impaired kidney function, white blood cells in urine
Slovenian: • nenormalni rezultati preiskav: kri ali beljakovine v urinu, upočasnjeno bitje srca, nepravilno ali nenormalno bitje srca, visok krvni tlak, poslabšanje ledvične funkcije, bele krvničke v urinu
English: More helpful information about these autoimmune conditions (and the testing for them) can be found in the
Slovenian: Več koristnih informacij o teh avtoimunskih boleznih (in preiskavah zanje) najdete v vodniku za bolnike, ki jemljejo zdravilo LEMTRADA.
English: You must NOT receive certain types of vaccines (live viral vaccines) if you have recently received LEMTRADA.
Slovenian: Če ste pred kratkim prejeli zdravilo LEMTRADA, NE SMETE prejeti določenih vrst cepiv (živa virusna cepiva).
English: The MAH shall ensure that, following agreement with the National Competent Authorities in each Member State where LEMTRADA is marketed, at launch and after launch, all physicians who intend to prescribe LEMTRADA are provided with an updated physician educational pack containing the following elements: The Summary of Product Characteristics HCP guide Prescriber checklist Patient guide Patient alert card The HCP guide shall contain the following key messages: 1.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo LEMTRADA, po dogovoru z nacionalnimi pristojnimi organi v vsaki državi članici, kjer se trži zdravilo LEMTRADA, pred in po začetku trženja prejeli posodobljen paketa izobraževalnih gradiv za zdravnike, ki vsebuje naslednje elemente:
English: • acne, redness of the skin, excessive sweating, skin discoloration, skin lesion, dermatitis
Slovenian: • akne, pordelost kože, čezmerno potenje, razbarvanje kože, spremembe na koži (kožne lezije),
English: Erythema*, ecchymosis, alopecia, hyperhidrosis, acne, skin lesion, dermatitis
Slovenian: Eritem *, ekhimoza, alopecija, hiperhidroza, akne, kožna lezija, dermatitis mehurji, nočno potenje, otekanje obraza, ekcem,
English: Concentrate for solution for infusion 1 vial
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Koncentrat za raztopino za infundiranje 1 viala
English: • Post-infusion: o Observation for infusion reactions is recommended for a minimum of 2 hours after LEMTRADA infusion.
Slovenian: • Po infundiranju: o Bolnike je priporočljivo vsaj 2 uri po infundiranju zdravila LEMTRADA opazovati glede pojava z infuzijo povezanih reakcij.
English: Symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, and vomiting.
Slovenian: Med simptomi akutnega akalkuloznega holecistitisa so bolečine v trebuhu, občutljivost trebuha, zvišana telesna temperatura, slabost in bruhanje.
English: Remind the patient to remain vigilant for symptoms related to autoimmune conditions, and to seek medical help if they have any concerns.
Slovenian: Bolnika opomnite, naj bo pozoren na simptome, povezane z avtoimunskimi boleznimi, ter naj poišče zdravniško pomoč, če je negotov.
English: Women who are able to conceive have to use effective contraception during each treatment course with LEMTRADA and for 4 months after each course of treatment.
Slovenian: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo med vsakim postopkom zdravljenja z zdravilom LEMTRADA in še štiri mesece po vsakem postopku zdravljenja.
English: Acute acalculous cholecystitis is a condition that may be associated with high morbidity and mortality rates if not diagnosed early and treated.
Slovenian: Če akutni akalkulozni holecistitis ni zgodaj diagnosticiran in zdravljen, je lahko povezan z veliko obolevnostjo in umrljivostjo.
English: Name and address of the manufacturers responsible for batch release
Slovenian: Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
English: If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom.
English: Cognitive, physical, and sexual development of pups exposed to alemtuzumab during lactation were not affected at doses up to 10 mg/kg/day alemtuzumab.
Slovenian: Pri odmerkih alemtuzumaba do 10 mg/kg/dan ni bilo vpliva na kognitivni, telesni in spolni razvoj mladičev, ki so bili alemtuzumabu izpostavljeni med laktacijo.
English: LEMTRADA must be diluted before infusion.
Slovenian: Zdravilo LEMTRADA je treba pred infundiranjem redčiti.
English: LEMTRADA 12 mg concentrate for solution for infusion alemtuzumab
Slovenian: LEMTRADA 12 mg koncentrat za raztopino za infundiranje alemtuzumab
English: If acute acalculous cholecystitis is suspected, evaluate and treat promptly.
Slovenian: V primeru suma na akutni akalkulozni holecistitis bolnika nemudoma ocenite in zdravite.
English: Study design/demographics for Studies 1, 2, 3 and 4 are shown in Table 2 Table 2: Study Design and Baseline Characteristics for Studies 1, 2, 3 and 4 Study 1
Slovenian: V preglednici 2 je prikazana zasnova študije in demografija za študije 1, 2, 3 in 4.
English: In alignment with the effect on relapse rate, supportive analyses from Study 1 (CAMMS323) showed that LEMTRADA 12 mg/day led to significantly fewer LEMTRADA -treated patients experiencing severe relapses (61% reduction, p=0.0056) and signficantly fewer relapses that led to steroid treatment (58%
Slovenian: Podporne analize 1. študije (CAMMS323) so vzporedno z učinkom na stopnjo recidivov pokazale, da je odmerek zdravila LEMTRADA 12 mg/dan pomembno zmanjšal število bolnikov s hudimi recidivi (61odstotno zmanjšanje, p=0,0056) in pomembno zmanjšal število recidivov, ki so privedli do zdravljenja s steroidi (58-odstotno zmanjšanje, p<0,0001) v primerjavi z IFNB-1a.
English: Some patients have had serious or life-threatening reactions after LEMTRADA infusion, including bleeding in the lung, heart attack, stroke or tears in blood vessels supplying the brain.
Slovenian: • Druge resne reakcije, ki se pojavijo kmalu po infundiranju zdravila LEMTRADA Nekaterim ljudem so se po infundiranju zdravila LEMTRADA pojavile resne ali življenjsko nevarne reakcije, vključno s krvavitvijo v pljučih, srčnim infarktom, možgansko kapjo ali pretrganjem žil, ki oskrbujejo možgane.
English: Infections occurred in 71% of patients treated with LEMTRADA 12 mg as compared to 53% of patients treated with subcutaneous interferon beta-1a [IFNB 1a](44mcg 3-times weekly) in controlled clinical trials in MS up to 2 years in duration and were predominantly mild to moderate in severity.
Slovenian: V kontroliranih kliničnih preskušanjih pri MS, ki so trajala 2 leti, so se okužbe pojavile pri 71 % bolnikov, zdravljenih z odmerkom zdravila LEMTRADA 12 mg, in pri 53 % bolnikov, zdravljenih s subkutanim odmerkom interferona beta-1a [IFNB 1a](44 mcg 3-krat tedensko).
English: A coagulopathy panel including aPTT must be obtained in all patients that present with such symptoms.
Slovenian: Pri vseh bolnikih, ki se jim pojavijo takšni simptomi, je treba opraviti vse preiskave za koagulopatije, vključno z aPTČ.
English: If you develop one or more of the following symptoms report this to your doctor: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, or bleeding or bruising more easily than normal.
Slovenian: Če se vam pojavijo eden ali več simptomov, kot so slabost v želodcu (siljenje na bruhanje), bruhanje, bolečine v trebuhu, utrujenost, izguba apetita, porumenelost kože ali očesnih beločnic, temen urin, ali če ste bolj nagnjeni h krvavitvam ali podplutbam kot po navadi, morate o tem obvestiti zdravnika.
English: Superficial fungal infections, especially oral and vaginal candidiasis, occurred more commonly in LEMTRADA -treated patients (12%) than in patients treated with IFNB-1a (3%) in controlled clinical trials in MS.
Slovenian: V kontroliranih kliničnih preskušanjih pri MS so se površinske glivične okužbe, zlasti oralna in vaginalna kandidoza, pojavljale pogosteje pri bolnikih, zdravljenih z zdravilom LEMTRADA (12 %), kot pri bolnikih, zdravljenih z IFNB-1a (3 %).
English: Hazard ratio (95% CI)
Slovenian: Razmerje ogroženosti (95-odstotni IZ)
English: The frequency of PML in BCLL patients treated with alemtuzumab is no greater than the background frequency.
Slovenian: O progresivni multifokalni levkoencefalopatiji (PML) so poročali pri bolnikih z B-KLL, ki so se zdravili z alemtuzumabom ali ne. Pogostnost PML pri bolnikih z B-KLL, zdravljenih z alemtuzumabom, ni večja od osnovne pogostnosti.
English: • The vial contents should be inspected for particulate matter and discolouration prior to administration.
Slovenian: • Vsebino viale morate pred uporabo pregledati, da ne vsebuje delcev ali da ni spremenila barve.
English: • general discomfort, weakness, vomiting, diarrhoea, abdominal pain, gastric flu, hiccups
Slovenian: • splošno nelagodje, šibkost, bruhanje, driska, trebušne bolečine, gastroenteritis, kolcanje
English: The most important adverse reactions are autoimmunity (ITP, thyroid disorders, nephropathies, cytopenias), IARs, and infections.
Slovenian: Najpomembnejši neželeni učinki so avtoimunost (ITP, bolezni ščitnice, nefropatije, citopenije), z infuzijo povezane reakcije in okužbe.
English: • Infusion reactions
Slovenian: • Z infuzijo povezane reakcije
English: A fatal event of transfusion associated graft versus host disease has been reported in an alemtuzumab-treated oncology patient.
Slovenian: Pri onkološkem bolniku, zdravljenem z alemtuzumabom, so poročali o s transfuzijo povezani bolezni presadka proti gostitelju s smrtnim izidom.
English: Contact details of the prescriber of LEMTRADA
Slovenian: kontaktni podatki zdravnika, ki predpisuje zdravilo LEMTRADA.
English: Treatment with LEMTRADA may increase the risk of excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis), which can be fatal if not diagnosed and treated early.
Slovenian: Zdravljenje z zdravilom LEMTRADA lahko poveča tveganje za prekomerno aktivacijo belih krvnih celic, povezanih z vnetjem (hemofagocitna limfohistiocitoza).
English: Controlled, randomised, raterblinded
Slovenian: Kontrolirana, randomizirana, za ocenjevalca enojno slepa
English: In the subgroup of RRMS patients with 2 or more relapses in the prior year and at least 1 Gd-enhanced T1 lesion at baseline, the annualised relapse rate was 0.26 (95% CI: 0.20, 0.34) in the Lemtrada treated group (n
Slovenian: V podskupini bolnikov z RRMS, ki so imeli v preteklem letu 2 recidiva ali več in izhodiščno vsaj 1 z Gdojačano T1-lezijo, je bil na leto preračunani delež recidivov v skupini z zdravilom Lemtrada 0,26 (95 % IZ: 0,20; 0,34) (n = 206) in v skupini z IFNB-1a 0,51 (95 % IZ: 0,40; 0,64) (n = 102) (p < 0,0001).
English: Signs and symptoms of kidney disease are described in section 4.
Slovenian: Znaki in simptomi bolezni ledvic so opisani v poglavju 4.
English: Constipation, gastrooesophageal reflux disease, gingival bleeding, dry mouth, dysphagia, gastrointestinal disorder, haematochezia
Slovenian: bolečine v trebuhu, bruhanje, driska, dispepsija*, stomatitis zapeka, gastroezofagealna refluksna bolezen, gingivalna krvavitev, suha usta, disfagija, gastrointestinalna motnja, hematohezija avtoimunski hepatitis
English: Liver function tests should beperformed before initial treatment and at monthly intervals until at least 48 months after the last infusion.
Slovenian: Preiskave delovanja jeter je treba opraviti pred začetkom zdravljenja in jih nato izvajati v enomesečnih presledkih vsaj še 48 mesecev po zadnji infuziji.
English: The following adverse reactions were identified prior to registration of LEMTRADA during use of alemtuzumab for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL), as well as for the treatment of other disorders, generally at higher and more frequent doses (e.g. 30 mg) than that recommended in the treatment of MS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to alemtuzumab exposure.
Slovenian: Naslednji neželeni dogodki so bili ugotovljeni pred pridobitvijo dovoljenja za promet z zdravilom LEMTRADA med uporabo alemtuzumaba za zdravljenje B-celične kronične limfocitne levkemije (B-KLL) ter za zdravljenje drugih bolezni, običajno z večjimi in pogostejšimi odmerki (npr. 30 mg), kot so priporočeni za zdravljenje MS.
English: Insomnia*, anxiety, depression
Slovenian: Psihiatrične motnje nespečnost*, tesnoba, depresija
English: Nephrolithiasis, ketonuria, nephropathies including antiGBM disease
Slovenian: Bolezni sečil proteinurija, hematurija nefrolitiaza, ketonurija, nefropatije, vključno z antiGBM boleznijo
English: How to store LEMTRADA
Slovenian: Kako se daje zdravilo LEMTRADA
English: Uncontrolled, rater-blinded extension study
Slovenian: Nekontrolirana, podaljšana za ocenjevalca enojno slepa študija
English: LEMTRADA contains potassium and sodium
Slovenian: Zdravilo LEMTRADA vsebuje natrij in kalij
English: Serum concentrations increased with each consecutive dose within a treatment course, with the highest observed concentrations occurring following the last infusion of a treatment course.
Slovenian: Med zdravljenjem so se serumske koncentracije povečevale po vsakem zaporednem odmerku.
English: The patient should be reminded to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns.
Slovenian: Bolnike je treba opozoriti, naj bodo pozorni na simptome, ki se lahko pojavijo, in naj v primeru kakršnih koli pomislekov takoj poiščejo zdravniško pomoč.
English: In clinical trials, 74% of patients with positive anti-thyroid peroxidase (anti-TPO) antibodies at baseline developed a thyroid event compared with 38% of patients with a baseline negative status.
Slovenian: V kliničnih preskušanjih se je neželen učinek na ščitnici pojavil pri 74 % bolnikov, ki so izhodiščno imeli protitelesa proti ščitnični peroksidazi (anti-TPO-protitelesa) v primerjavi z 38 % bolnikov, ki so imeli izhodiščno negativen izvid za ta protitelesa.
English: Treatment- naïve patients
Slovenian: Nezdravljeni bolniki
English: As for any immune modulating medicinal product, before initiating a course of LEMTRADA treatment, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV.
Slovenian: Določanje protiteles in cepljenje proti virusu varicella zoster Kot pri vsakem zdravilu, ki spremeni imunski odziv, je treba pred zdravljenjem z zdravilom LEMTRADA bolnikom brez noric ali cepljenja proti virusu varicella zoster v anamnezi določiti raven protiteles proti temu virusu.
English: 2 Herpes zoster infections include PTs: Herpes zoster, Herpes zoster cutaneous disseminated, Ophthalmic herpes zoster, Herpes ophthalmic, Herpes zoster infection neurological, Herpes zoster meningitis.
Slovenian: oftalmični herpes zoster, oftalmični herpes zoster, nevrološka okužba s herpes-zostrom, herpes zoster meningitis.
English: 0.545], p<0.0006) and reduced the ARR by 67% (rate ratio 0.33 [95% CI: 0.196, 0.552], p<0.0001) as compared to subcutaneous IFNB-1a.
Slovenian: Po 3 letih je zdravilo LEMTRADA zmanjšalo tveganje 6-mesečnega CDW za 76 % (razmerje ogroženosti 0,24 [95-odstotni IZ: 0,110; 0,545], p<0,0006) in zmanjšalo stopnjo ARR za 67 % (razmerje stopenj 0,33 [95-odstotni IZ: 0,196; 0,552], p<0,0001) v primerjavi s subkutanim IFNB-1a.
English: There is little or no CD52 detected on neutrophils, plasma cells, or bone marrow stem cells.
Slovenian: Na nevtrofilcih, plazmatkah in matičnih celicah v kostnem mozgu je zaznati malo ali pa nič CD52.
English: • decreased weight, weight increase, red blood cell decrease, blood glucose increase, increase in red blood cell size
Slovenian: • zmanjšana telesna masa, povečanje telesne mase, zmanjšanje eritrocitov, zvišanje glukoze v krvi,
English: LEMTRADA may increase your chance of getting inflammation of the gallbladder.
Slovenian: Zdravilo LEMTRADA lahko poveča možnosti za vnetje žolčnika.
English: How LEMTRADA will be administered 4.
Slovenian: Kako se daje zdravilo LEMTRADA 4.
English: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Slovenian: België/Belgique/Belgien/ Luxemburg/Luxembourg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: LEMTRADA 12 mg concentrate for solution for infusion
Slovenian: IME ZDRAVILA LEMTRADA 12 mg koncentrat za raztopino za infundiranje
English: IARs may occur in patients despite pretreatment.
Slovenian: Z infuzijo povezane reakcije se lahko pojavijo kljub premedikaciji.
English: Alemtuzumab
Slovenian: Malignost
English: During post-marketing use, HLH (including fatal cases) has been reported in patients treated with LEMTRADA.
Slovenian: V obdobju po prihodu zdravila na trg so pri bolnikih, ki so prejemali zdravilo LEMTRADA, poročali o HLH (vključno s smrtnimi primeri).
English: Haemophagocytic lymphohistiocytos is (HLH)
Slovenian: hemofagocitna limfohistiocitoz a (HLH)