FrancophonIA/ELRC3.0 huggingface dataset:
English: • Decrease in white blood cell numbers (lymphocytes, leukocytes, neutrophils)
Slovenian: • Znižanje števila belih krvničk (limfocitov, levkocitov, nevtrofilcev)
English: • Increase in white blood cells counts such as neutrophils, eosinophils (different types of white blood cells) anaemia, decrease in percentage of red blood cells, easy or excessive bruising or bleeding,
Slovenian: • povečanje števila belih krvnih celic, kot so nevtrofilci, eozinofilci (različne vrste belih krvnih celic), anemija, zmanjšanje odstotka rdečih krvničk, hiter nastanek ali pretirane modrice ali krvavitve, otekanje bezgavk
English: Data from clinical trials in MS has shown that adherence to the blood monitoring requirements and education relative to signs and symptoms of ITP has led to early detection and treatment of ITP with most cases responding to first-line medical therapy.
Slovenian: Podatki iz kliničnih preskušanj pri MS kažejo, da upoštevanje zahtev glede krvnih preiskav in izobraževanje glede znakov in simptomov ITP vodita do zgodnjega odkrivanja in zdravljenja ITP, ki se v večini primerov odzove na zdravljenje prve izbire.
English: Reported cases of temporally associated events were not related to anti-GBM disease (Goodpasteurs syndrome).
Slovenian: Opisani primeri časovno povezanih dogodkov niso bili povezani z boleznijo s protitelesi proti glomerulni bazalni membrani (Goodpasturov sindrom).
English: Study name
Slovenian: Ime študije
English: It is unknown whether alemtuzumab is excreted in human milk.
Slovenian: Ni znano, ali se alemtuzumab izloča v materino mleko pri ljudeh.
English: 2.0/1.6 years
Slovenian: 2/1,6 let
English: Monitoring for side effects and regular testing must continue for 4 years after the last infusion.
Slovenian: Spremljanje neželenih učinkov in redne preiskave je treba nadaljevati še štiri leta po zadnji infuziji.
English: Your doctor will monitor vital signs, including blood pressure, before and during the infusion.
Slovenian: Zdravnik vam bo pred infundiranjem in med njim kontroliral vitalne znake, vključno s krvnim tlakom.
English: Your doctor can also prescribe a medicine for cold sores (see section 2: What you need to know before you are administered LEMTRADA - Infections).
Slovenian: Zdravnik vam lahko predpiše tudi zdravilo za herpes na ustnicah (glejte poglavje 2: Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA - okužbe).
English: Talk to your doctor if you are thinking about trying to become pregnant.
Slovenian: Posvetujte se z zdravnikom, če načrtujete zanositev.
English: One patient developed ITP that went unrecognised prior to implementation of monthly blood monitoring requirements and died from intracerebral haemorrhage.
Slovenian: Pri enem bolniku se je pojavila ITP, ki je bila pred uvedbo obveznih mesečnih krvnih preiskav neprepoznana; bolnik je umrl zaradi intracerebralne krvavitve.
English: You will be given a Patient Alert Card and a Patient Guide with further information.
Slovenian: Prejeli boste bolnikovo kartico in vodnik za bolnike z dodatnimi informacijami.
English: In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing foetus and can cause transient neonatal Graves' disease.
Slovenian: Pri materah z Gravesovo boleznijo se lahko materina protitelesa proti receptorju za tirotropin prenesejo na razvijajoč se plod in povzročijo prehodno neonatalno Gravesovo bolezen.
English: • bleeding in lungs
Slovenian: • krvavitev v pljučih
English: The reduction in the level of circulating B and T cells by LEMTRADA and subsequent repopulation, may reduce the potential for relapse, which ultimately delays disease progression.
Slovenian: Zdravilo LEMTRADA povzroči zmanjšanje ravni krožečih celic B in T in naknadno ponovno naselitev, kar morda zmanjša možnost recidiva in odloži napredovanje bolezni.
English: Alemtuzumab, is a recombinant DNA-derived humanised monoclonal antibody directed against the 21-28 kD cell surface glycoprotein CD52.
Slovenian: Alemtuzumab je s tehniko rekombinantne DNA pridobljeno humanizirano monoklonsko protitelo, usmerjeno proti 21-28 kD površinskemu glikoproteinu CD52.
English: Therefore, regardless of pretreatment anti-TPO antibody status patients may develop a thyroid adverse reaction and must have all tests periodically performed as described above.
Slovenian: Torej lahko ne glede na status anti-TPO protiteles pred začetkom zdravljenja bolniki razvijejo na ščitnico vezane neželene dogodke in jim je treba periodično opraviti vse teste, kot je opisano zgoraj.
English: Most thyroid events were managed with conventional medical therapy however some patients required surgical intervention.
Slovenian: Večina dogodkov, povezanih s ščitnico, je bila obravnavanih z običajnim zdravljenjem, vendar so nekateri bolniki potrebovali kirurški poseg.
English: It is very important that you are properly treated for a thyroid disorder, especially if you become pregnant after using LEMTRADA.
Slovenian: Zelo pomembno je, da se bolezen ščitnice pravilno zdravi, zlasti če zanosite po uporabi zdravila LEMTRADA.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 C do 8 C).
English: Patients with new or enlarging T2 lesions through Year 2
Slovenian: Bolniki z novo ali povečano lezijo T2 v 2. letu
English: Alemtuzumab was detected in the milk and offspring of lactating female mice.
Slovenian: Alemtuzumab so zaznali v mleku in mladičih doječih miši.
English: It is not known if LEMTRADA will have an effect on fertility during this period.
Slovenian: Ni znano, ali ima zdravilo LEMTRADA v tem obdobju učinek na plodnost.
English: In general, once a patient has had a herpes infection, they have an increased risk of developing another one.
Slovenian: Na splošno velja, da je pri bolnikih, ki so imeli herpesno okužbo, tveganje za razvoj ponovne okužbe večje.
English: Patients with severe active infection until complete resolution.
Slovenian: Bolniki s hudo aktivno okužbo, do njenega popolnega izginotja.
English: Clinical examination and laboratory tests should be conducted at periodic intervals until at least 48 months following the last treatment course of LEMTRADA in order to monitor for early signs of autoimmune diseases:
Slovenian: Klinični pregled in laboratorijske preiskave je treba opravljati v rednih presledkih še vsaj 48 mesecev po zadnjem zdravljenju z zdravilom LEMTRADA, da bolnike spremljate glede zgodnjih znakov avtoimunskih bolezni:
English: What LEMTRADA is and what it is used for 2.
Slovenian: Kaj je zdravilo LEMTRADA in za kaj ga uporabljamo 2.
English: • sodium chloride
Slovenian: • natrijev klorid
English: • pain in ear
Slovenian: • bolečine v ušesu
English: This medicinal product must not be diluted with other solvents.
Slovenian: Zdravila ne smete redčiti z drugimi topili.
English: In each year of Study 4, patients from both studies continued to show a low risk of forming new T2 (27.4% to 33.2%) or gadolinium-enhancing lesions (9.4% to 13.5%), and the median annual percent change in brain parenchymal fraction ranged from 0.19% to -0.09%.
Slovenian: V vsakem letu študije 4 so imeli bolniki iz obeh študij še naprej majhno tveganje za nastanek novih T2-lezij (27,4 % do 33,2 %) ali z gadolinijem poudarjenih lezij (9,4 % do 13,5 %) in mediani letni odstotek spremembe v deležu možganskega parenhima je segal od 0,19 % do -0,09 %.
English: It is important that you keep the Patient Alert Card with you during treatment and for 4 years after your last infusion with LEMTRADA, because side effects may occur many years after treatment.
Slovenian: Pomembno je, da med zdravljenjem in še štiri leta po zadnji infuziji zdravila LEMTRADA pri sebi hranite opozorilno kartico bolnika, ker se lahko neželeni učinki pojavijo več let po zdravljenju.
English: The table below is based on the pooled safety data on all LEMTRADA 12 mg-treated patients during all available follow up in clinical trials.
Slovenian: Spodnja preglednica temelji na združenih podatkih o varnosti pri vseh bolnikih, zdravljenih z 12 mg zdravila LEMTRADA med celotnim spremljanjem v kliničnih preskušanjih, ki je na voljo.
English: You will also find this information in the Patient Alert Card and Patient Guide that you have been given by your doctor.
Slovenian: Te informacije so tudi v opozorilni kartici za bolnika in vodniku za bolnike, ki ste ju prejeli od zdravnika.
English: The therapy is recommended as an initial treatment of 2 courses with up to 2 additional treatment courses if needed (see posology) with safety follow-up of patients from initiation of the first treatment course and for at least 48 months after the last infusion of the second treatment course.
Slovenian: Zdravljenje se priporoča v obliki 2 ciklov začetnega zdravljenja z do 2 dodatnima cikloma zdravljenja, če je potrebno, (glejte poglavje o odmerjanju) z varnostnim sledenjem bolnikov od uvedbe prvega cikla zdravljenja do najmanj 48 mesecev po zadnji infuziji drugega cikla zdravljenja.
English: The type of adverse reactions including seriousness and severity observed in LEMTRADA treatment groups through all available follow-up including patients who received additional treatment courses were similar to those in the active-controlled studies.
Slovenian: Vrsta neželenih učinkov (vključno z njihovo resnostjo in izrazitostjo) v terapevtskih skupinah z zdravilom LEMTRADA je bila med celotnim spremljanjem, ki je na voljo - vključno z bolniki, ki so prejeli dodatne cikle zdravljenja - podobna kot v študijah, kontroliranih z učinkovino.
English: The safety of immunisation with live viral vaccines following a course of LEMTRADA treatment has not been formally studied in controlled clinical trials in MS and should not be administered to MS patients who have recently received a course of LEMTRADA.
Slovenian: Varnost cepljenja z živimi virusnimi cepivi po zdravljenju z zdravilom LEMTRADA v kontroliranih kliničnih preskušanjih pri MS formalno ni bila preučena, zato se ta cepiva ne smejo dajati bolnikom z MS, ki so jih nedavno zdravili z zdravilom LEMTRADA.
English: If you develop a thyroid disorder, in most cases you will need to be treated for the rest of your life with medicines to control your thyroid disorder, and in some cases your thyroid gland may have to be removed.
Slovenian: Če se pri vas pojavi bolezen ščitnice, je v večini primerov potrebno zdravljenje z zdravili za obvladovanje bolezni ščitnice do konca življenja, v nekaterih primerih pa je treba ščitnico odstraniti.
English: The observation of clinically significant changes from baseline in serum creatinine, unexplained haematuria, and/or proteinuria, should prompt further evaluation for nephropathies including immediate referral to a specialist.
Slovenian: Ugotovitvi klinično pomembnih sprememb serumske ravni kreatinina glede na izhodiščno stanje, nepojasnjeni hematuriji in/ali proteinuriji morajo takoj slediti preiskave za nefropatije, vključno s takojšnjo napotitvijo k specialistu.
English: Patients with active MS, defined as at least 2 relapses within the prior 2 years.
Slovenian: Bolniki z aktivno MS, opredeljeno kot vsaj 2 recidiva v preteklih 2 letih.
English: The percentage of patients with new or enlarging T2 lesions declined from 50.8% the year prior to Course 3 to 35.9% one year after, and new gadolinium-enhancing lesions from 32.2% to 11.9%.
Slovenian: Odstotek bolnikov z novo T2-lezijo ali povečanjem takšne lezije se je zmanjšal s 50,8 % v letu pred 3. ciklusom na 35,9 % leto pozneje, z novimi z gadolinijem poudarjenimi lezijami pa z 32,2 % na 11,9 %.
English: • listeriosis/listeria meningitis
Slovenian: • listerioza/listerijski meningitis (vnetje možganskih ovojnic)
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: What LEMTRADA is and what it is used for
Slovenian: Kaj je zdravilo LEMTRADA in za kaj ga uporabljamo
English: If an additional third or fourth course is administered, continue safety follow-up for at least 48 months after the last infusion (see section 4.4).
Slovenian: Če bolnik dobi dodaten tretji ali četrti cikel zdravljenja, je treba varnostno spremljanje nadaljevati še vsaj 48 mesecev po zadnji infuziji (glejte poglavje 4.4).
English: For these patients, the ARR declined from 0.79 in the year prior to Course 3 to 0.18 one year after, and the mean EDSS score from 2.89 to 2.69.
Slovenian: Pri teh bolnikih je AZT upadlo z 0,79 v letu pred 3. ciklusom na 0,18 leto potem in povprečna ocena EDSS se jim je zmanjšala z 2,89 na 2,69.
English: LEMTRADA should be administered during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Slovenian: Zdravilo LEMTRADA smete pri nosečnici uporabiti le, če pričakovani koristni učinki odtehtajo potencialno tveganje za plod.
English: Once you have received LEMTRADA, you will need to undergo regular tests to ensure that any potential side effects can be diagnosed and treated promptly.
Slovenian: Ko prejmete zdravilo LEMTRADA, boste morali opraviti običajne preiskave, da se zagotovita hitra diagnostika in zdravljenje možnih neželenih učinkov.
English: A clear, colourless to slightly yellow concentrate with pH 7.0 - 7.4.
Slovenian: FARMACEVTSKA OBLIKA koncentrat za raztopino za infundiranje (sterilni koncentrat) Bister, brezbarven do rahlo rumen koncentrat s pH 7,0 - 7,4.
English: Relapse Rate1
Slovenian: Stopnja recidivov1
English: LEMTRADA has minor influence on the ability to drive and use machines.
Slovenian: Zdravilo LEMTRADA ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: If ITP is suspected a complete blood count should be obtained immediately.
Slovenian: Če sumite na pojav ITP, je treba nemudoma določiti celotno krvno sliko.
English: It is recommended that the diluted product be administered immediately.
Slovenian: Priporočljivo je, da se razredčeno zdravilo uporabi nemudoma.
English: It is recommended that patients have completed local immunisation requirements at least 6 weeks prior to treatment with LEMTRADA.
Slovenian: Priporočljivo je, da bolniki opravijo cepljenja po lokalnem programu vsaj 6 tednov pred zdravljenjem z zdravilom LEMTRADA.
English: The autoimmune conditions can occur many years after treatment with LEMTRADA.
Slovenian: Avtoimunske bolezni se lahko pojavijo več let po zdravljenju z zdravilom LEMTRADA.
English: In a sub-study in 13 male LEMTRADA-treated patients (treated with either 12 mg or 24 mg), there was no evidence of aspermia, azoospermia, consistently depressed sperm count, motility disorders or an increase in sperm morphological abnormalities.
Slovenian: V podštudiji s 13 moškimi bolniki, zdravljenimi z zdravilom LEMTRADA (zdravljenimi bodisi z 12 mg bodisi s 24 mg), ni bilo dokazov aspermije, azoospermije, stalno zmanjšanega števila spermijev, motenj gibljivosti ali povečanja morfoloških nenormalnosti semenčic.
English: • red and white blood cells disorders (uncommon - may affect up to 1 in 100 people): diagnosed from your blood tests.
Slovenian: • bolezni rdečih in belih krvničk (občasni - pojavijo se lahko pri največ 1 od 100 bolnikov), ki se določijo na podlagi krvnih preiskav.
English: Patients with known coagulopathy, on anti-platelet or anti-coagulant therapy.
Slovenian: Bolniki z znano koagulopatijo, na antiagregacijskem ali antikoagulantnem zdravljenju.
English: Observed autoimmune thyroid disorders included hyperthyroidism or hypothyroidism.
Slovenian: Ugotovljene avtoimunske bolezni ščitnice so vključevale hipertiroidizem in hipotiroidizem.
English: The rate of thyroid adverse reactions was highest in year three and declined thereafter.
Slovenian: Delež neželenih učinkov povezan s ščitnico je bil največji tretje leto in se je nato zmanjševal.
English: • tears in carotid or vertebral arteries (blood vessels supplying the brain)
Slovenian: • pretrganje vratnih (karotidnih) ali vretenčnih (vertebralnih) arterij (to so žile, ki oskrbujejo možgane)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: LEMTRADA depletes circulating T and B lymphocytes after each treatment course with the lowest observed values occurring 1 month after a course of treatment (the earliest post-treatment time point in phase 3 studies).
Slovenian: Zdravilo LEMTRADA po vsaki stopnji zdravljenja osiromaši krožeče limfocite T in B, najnižje ravni pa se pa so opazne 1 mesec po zdravljenje (najbolj zgodnja časovna točka po zdravljenju v študijah 3. faze).
English: Serious events of ITP have been observed in 12 (1%) patients treated in controlled clinical trials in MS (corresponding to an annualised rate 4.7 events/1000 patient years).
Slovenian: Resne pojave ITP so opazili pri 12 (1 %) bolnikih, zdravljenih v kontroliranih kliničnih preskušanjih pri MS (to ustreza na leto preračunanemu deležu 4,7 dogodkov/1000 bolnik-let).
English: Annualised Relapse rate (ARR) (95% CI)
Slovenian: Letna stopnja recidivov (Annualised Relapse rate - ARR) (95-odstotni IZ)
English: Read the summary of product characteristics (available at the EMA website mentioned above) for more information.
Slovenian: Za več informacij preberite povzetek glavnih značilnosti zdravila (na voljo na zgoraj omenjeni spletni strani agencije EMA).
English: Reactions may occur following any of the doses during the treatment course.
Slovenian: Učinki se lahko pojavijo po katerem koli odmerku med ciklusom zdravljenja.
English: Very Common Common
Slovenian: Zelo pogosti
English: Pharmacotherapeutic group: Immunosuppressants, Selective immunosuppressants, ATC code: L04AA34
Slovenian: Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA34.
English: Approximately 40% of patients had total lymphocyte counts reaching the lower limit of normal (LLN) by 6 months after each treatment course, and approximately 80% of patients had total lymphocyte counts reaching the LLN by 12 months after each course.
Slovenian: Pri približno 40 % bolnikov je skupno število limfocitov doseglo spodnjo mejo normalnih vrednosti v 6 mesecih po vsaki stopnji zdravljenja, pri približno 80 % bolnikov pa je skupno število limfocitov doseglo spodnjo mejo normalnih vrednosti v 12 mesecih po vsakemzdravljenju.
English: DO NOT SHAKE VIALS PRIOR TO USE.
Slovenian: VIALE PRED UPORABO NE PRETRESITE.
English: Infections were generally of typical duration and resolved following conventional medical treatment.
Slovenian: Okužbe so trajale kot običajno in so po standardnem zdravljenju izzvenele.
English: • kidney disorders, (rare - may affect up to 1 in 1,000 people): may show as blood in the urine (your urine may be red or tea-coloured), or as swelling in your legs or feet.
Slovenian: • bolezni ledvic (redki - pojavijo se lahko pri največ 1 od 1.000 bolnikov): lahko se pokažejo kot kri v urinu (urin je rdeče barve ali barve čaja) ali kot otekanje nog ali stopal.
English: • excessive activation of white blood cells associated with inflammation (haemophagocytic lymphohistiocytosis)
Slovenian: • prekomerna aktivacija belih krvnih celic, povezanih z vnetjem (hemofagocitna limfohistiocitoza)
English: It is recommended that your doctor prescribes a medicine to reduce the chance of developing a herpes infection, which should be taken on the days that you receive LEMTRADA treatment, and for one month following the treatment.
Slovenian: Priporočljivo je, da vam zdravnik za zmanjševanje možnosti za razvoj herpesne okužbe predpiše zdravilo, ki ga morate jemati tiste dni, ko se zdravite z zdravilom LEMTRADA, in še en mesec po zdravljenju.
English: If untreated it can cause kidney failure requiring dialysis or transplantation, and may lead to death.
Slovenian: Če ni zdravljena, lahko povzroči ledvično odpoved z dializo ali presaditvijo in lahko vodi v smrt.
English: Carcinogenesis and mutagenesis
Slovenian: Kancerogenost in mutagenost
English: If you notice any of these signs or symptoms, call your doctor right away to report them.
Slovenian: Če opazite katerega od teh znakov ali simptomov, nemudoma pokličite svojega zdravnika in jih navedite.
English: Most cases occurred within two months of alemtuzumab dosing.
Slovenian: Večina primerov se je pojavila v dveh mesecih po odmerku alemtuzumaba.
English: % receiving ≥2 prior MS
Slovenian: % oseb, ki so opravile ≥ 2 predhodni zdravljenji MS
English: o Perform laboratory tests (complete blood count with differential, serum transaminases, serum creatinine, test of thyroid function and urinanalysis with microscopy).
Slovenian: o Opraviti je treba laboratorijske preiskave (celotno krvno sliko z diferencialno krvno sliko, serumske transaminaze, kreatinin v serumu, preiskave delovanja ščitnice in analizo urina, vključno z mikroskopskim pregledom).
English: Patients with new T1 hypointense lesions through Year 2
Slovenian: Bolniki z novo hipointenzivno lezijo T1 v 2. letu
English: • Pre-infusion evaluations: o Obtain a baseline ECG and vital signs, including heart rate and blood pressure measurement.
Slovenian: • Ovrednotenje pred infundiranjem: o Opraviti je treba EKG in preveriti vitalne znake, vključno z meritvijo srčne frekvence in krvnega tlaka.
English: Non-interventional post-authorisation safety study (PASS): In order to investigate the incidence of mortality in patients treated with Lemtrada compared to a relevant patient population, the MAH shall submit the results of a post-authorisation safety study
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za proučitev pojavnosti umrljivosti med bolniki, zdravljenimi z zdravilom Lemtrada, v primerjavi z relevantno populacijo bolnikov bo imetnik dovoljenja za promet z zdravilom predložil neintervencijsko študijo o varnosti zdravila
English: The most important side effects are the autoimmune conditions described in section 2 which include:
Slovenian: Najpomembnejši resni neželeni učinki so avtoimunske bolezni, ki so opisane v poglavju 2 in obsegajo:
English: Inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Slovenian: Vbrizgajte v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze (5 %) za infundiranje.
English: Through 2 treatment courses, there was no association of the presence of anti-alemtuzumab or inhibitory anti-alemtuzumab antibodies with a reduction in efficacy, change in pharmacodynamics, or the occurrence of adverse reactions, including infusion associated reactions.
Slovenian: V dveh ciklih zdravljenja prisotnosti protiteles proti alemtuzumabu ali zaviralnih protiteles proti alemtuzumabu nista bili povezani z z zmanjšanjem učinkovitosti, spremembo farmakodinamike ali pojavnostjo neželenih učinkov, vključno z reakcijami, povezanimi z infuzijo.
English: Terms marked with two asterisks (**) in Table 1 include adverse reactions observed in the post marketing setting which have occurred in the majority of cases with time to onset within 1-3 days of LEMTRADA infusion, following any of the doses during the treatment course.
Slovenian: Izrazi, ki so v preglednici 1 označeni z dvema zvezdicama (**), vključujejo neželene učinke, zabeležene v obdobju po prihodu zdravila na trg, ki so se v večini primerov pojavili v 1 do 3 dneh po infundiranju zdravila LEMTRADA in po katerem koli odmerku med ciklusom zdravljenja.
English: Table 1: Adverse reactions in study 1, 2, 3 and 4 observed in LEMTRADA 12 mg treated patients and post-marketing surveillance
Slovenian: Preglednica 1: Neželeni učinki v študijah 1, 2, 3 in 4, opaženi pri bolnikih, zdravljenih z 12 mg odmerkom zdravila LEMTRADA in v okviru spremljanja po prihodu zdravila na trg