FrancophonIA/ELRC3.0 huggingface dataset:
English: Before treatment starts and every month after treatment
Slovenian: pred začetkom zdravljenja in vsak mesec po zdravljenju štiri leta po zadnji infuziji zdravila LEMTRADA
English: • Review the LEMTRADA Patient Guide and Package Leaflet with your patient.
Slovenian: • Skupaj z bolnikom preglejte opozorilno kartico za bolnika in vodnik za bolnike, ki jemljejo zdravilo LEMTRADA.
English: In controlled clinical trials two MS patients accidentally received up to 60 mg LEMTRADA (i.e. total dose for initial treatment course) in a single infusion and experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia).
Slovenian: V kontroliranih kliničnih preskušanjih sta dva bolnika z MS prejela do 60 mg zdravila LEMTRADA (tj. skupni odmerek za prvo stopnjo zdravljenja) v eni infuziji.
English: Cytomegalovirus infections (CMV) including cases of CMV reactivation have been reported in LEMTRADA-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o okužbah s citomegalovirusom (CMV), vključno z reaktivacijo virusa CMV.
English: A positive Coombs test has been reported in an alemtuzumab-treated oncology patient.
Slovenian: Pri onkološkem bolniku, zdravljenem z alemtuzumabom, so poročali tudi opozitivnem Coombsovem testu.
English: • An oral anti-herpes agent should be administered to all patients during and for 1 month following treatment.
Slovenian: • Med zdravljenjem in še en mesec po njem je treba vsem bolnikom dajati peroralna zdravila proti herpesu.
English: Referral to a haematologist for management should be considered.
Slovenian: V poštev pride napotitev k hematologu za vodenje te motnje.
English: • Complete baseline tests and screening as decribed in SmPC section 4.
Slovenian: • Opravite vse preiskave in presejanja v izhodišču, kot so opisana v poglavju 4 povzetka glavnih značilnosti zdravila.
English: Neutrophils, monocytes, eosinophils, basophils, and natural killer cells are only transiently affected by LEMTRADA.
Slovenian: Zdravilo LEMTRADA samo prehodno učinkuje na nevtrofilce, monocite, eozinofilce, bazofilce in naravne ubijalke.
English: Haemorrhagic stroke
Slovenian: • otekle bezgavke
English: Serious and sometimes fatal autoimmune phenomena including autoimmune haemolytic anaemia, autoimmune thrombocytopenia, aplastic anaemia, Guillain-Barré syndrome, and chronic inflammatory demyelinating polyradiculoneuropathy have been reported in alemtuzumab-treated non-MS patients.
Slovenian: Pri bolnikih, zdravljenih z alemtuzumabom, ki niso imeli MS, so poročali o resnih in v nekaterih primerih smrtnih avtoimunskih pojavih, vključno z avtoimunsko hemolitično anemijo, avtoimunsko trombocitopenijo, aplastično anemijo, Guillain-Barréjevim sindromom in kronično vnetno demielinizirajočo poliradikulonevropatijo.
English: Infections with a virus called cytomegalovirus have been reported in patients treated with LEMTRADA.
Slovenian: Pri bolnikih, ki so se zdravili z zdravilom LEMTRADA, so poročali o okužbah z virusom, imenovanim citomegalovirus.
English: HLH is characterized by fever, hepatomegaly and cytopenias.
Slovenian: Značilnost HLH so zvišana telesna temperatura, hepatomegalija in citopenije.
English: Also, tell your doctor if you are suffering from a serious infection before the start of your LEMTRADA
Slovenian: Povejte svojemu zdravniku, če imate resno okužbo pred začetkom zdravljenja z zdravilom LEMTRADA, saj mora vaš zdravnik odložiti zdravljenje, dokler okužba ni pozdravljena.
English: • LEMTRADA Health Care Professional Guide
Slovenian: • vodnik o zdravilu LEMTRADA za zdravstvene delavce,
English: Neoplasms benign, malignant and unspecified (incl.
Slovenian: Benigne, maligne in neopredelje ne novotvorbe (vključno s cistami in polipi)
English: LEMTRADA 12 mg sterile concentrate alemtuzumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE LEMTRADA 12 mg sterilni koncentrat alemtuzumab i.v.
English: o Liver inflammation
Slovenian: o Vnetje jeter
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih kontuzija, z infuzijo povezana reakcija
English: Remind the patient to remain vigilant for symptoms they may experience and to seek immediate medical help if they have any concerns.
Slovenian: Opozorite bolnike, naj bodo pozorni na simptome, ki se lahko pojavijo, in naj v primeru kakršnih koli pomislekov takoj poiščejo zdravniško pomoč.
English: The following information is intended for healthcare professionals only: Information on risk minimisation - autoimmune conditions
Slovenian: Informacije o zmanjšanju tveganja - avtoimunske bolezni
English: In the majority of cases time to onset was within 1-3 days of the LEMTRADA infusion.
Slovenian: Večinoma so se pojavili v 1 do 3 dneh po infuziji zdravila LEMTRADA.
English: Conjunctivitis, endocrine ophthalmopathy, vision blurred
Slovenian: Očesne bolezni konjuktivitis, endokrina oftalmopatija, zamegljen vid diplopija
English: The alpha half-life approximated 4-5 days and was comparable between courses leading to low or undetectable serum concentrations within approximately 30 days following each treatment course.
Slovenian: Alfa razpolovna doba se je približala 45 dnem in je bila primerljiva med cikli zdravljenja.
English: Signs and symptoms of thyroid disorders are described in section 4.
Slovenian: Znaki in simptomi bolezni ščitnice so opisani v poglavju 4.
English: Autoimmune thyroiditis including thyroiditis subacute, goitre, anti-thyroid antibody positive
Slovenian: Basedowova bolezen, hipertiroidizem , hipotiroidizem avtoimunski tiroiditis,vključno s tiroidizmom, golšavost, pozitivna preiskava na protitelesa proti ščitnici
English: Most patients experience IARs which occur during or within 24 hours after treatment with LEMTRADA.
Slovenian: Pri večini bolnikov se pojavijo z infuzijo povezane reakcije med zdravljenjem ali v 24 urah po zdravljenju z zdravilom LEMTRADA.
English: • exaggerated immune response
Slovenian: • pretiran imunski odziv
English: therapy (≥1 drug used)
Slovenian: Povprečno trajanje predhodnega zdravljenja MS (uporabljeno ≥ 1 zdravilo)
English: (additional test to diagnose kidney disorders)
Slovenian: urinska preiskava (dodatna preiskava za določitev bolezni ledvic)
English: Patients in clinical trials in MS had serum samples collected 1, 3, and 12 months after each treatment course for determination of antialemtuzumab antibodies.Approximately 85% of patients receiving LEMTRADA tested positive for antialemtuzumab antibodies during the study, with ≥90% of these patients testing positive also for antibodies that inhibited alemtuzumab binding in vitro.
Slovenian: Približno 85 % bolnikov, ki je prejelo zdravilo LEMTRADA v študiji, je imelo pozitiven rezultat določitve protiteles proti alemtuzumabu, 90 % od njih pa je imelo tudi pozitiven rezultat za protitelesa, ki so zavirala vezavo alemtuzumaba in vitro.
English: A description of the sign and symptoms of autoimmune risks A description of the best course of action if sign and symptoms of those risks present themselves (e.g. How to reach your doctors) Recommendations for the planning of the monitoring schedule The patient alert card shall contain the following key messages: A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient has been treated with LEMTRADA That LEMTRADA treatment may increase the risk of: Immune mediated reactions such as thyroid disorders, Immune Thrombocytopenic Purpura (ITP).
Slovenian: Opozorilna kartica za bolnika vsebuje naslednja ključna sporočila: opozorilo za zdravstvene delavce, ki kadar koli zdravijo bolnika, tudi v nujnih primerih, da je bil bolnik zdravljen z zdravilom LEMTRADA; zdravljenje z zdravilom LEMTRADA lahko poveča tveganje za: imunske reakcije, na primer bolezni ščitnice, imunsko trombocitopenično purpuro (ITP); nefropatije, vključno z anti-GBM boleznijo; avtoimunski hepatitis (AIH), pridobljena hemofilija A in HLH.
English: indigestion, chest discomfort, pain, dizziness, altered taste, difficulty sleeping, difficulty breathing or shortness of breath, low blood pressure, infusion site pain.
Slovenian: • Z infuzijo povezane reakcije, ki se lahko pojavijo v času infuzije ali v 24 urah po infuziji: slaba prebava, nelagoden občutek v prsnem košu, bolečine, omotica, spremenjeno okušanje, nespečnost, oteženo dihanje ali zasoplost, nizek krvni tlak, bolečina na mestu infundiranja
English: Autoimmune disease
Slovenian: Bolezni ščitnice
English: Myalgia, muscle weakness, arthralgia, back pain, pain in extremity, muscle spasms, neck pain, musculoskeletal pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva mialgija, šibkost mišic, artralgija, bolečine v hrbtenici, bolečine v okončinah, mišični spazmi,
English: Genzyme Ltd.
Slovenian: Genzyme Europe B.V.
English: Patients should be pre-treated with corticosteroids immediately prior to LEMTRADA administration on each of the first 3 days of any treatment course.
Slovenian: Premedikacijo s kortikosteroidi je treba izvesti tik pred vsakim dajanjem zdravila LEMTRADA vsak dan prve 3 dni obeh ciklov zdravljenja.
English: Sanofi AB Tel: +46 (0)8 634 50 00
Slovenian: Tel: +46 (0)8 634 50 00
English: Your doctor will perform blood tests before you start treatment with LEMTRADA.
Slovenian: Preden se začnete zdraviti z zdravilom LEMTRADA, bodo pri vas opravili krvne preiskave.
English: Cases of acquired haemophilia A (anti-factor VIII antibodies) have been reported in both clinical trial and post-marketing setting.
Slovenian: V kliničnih preskušanjih in po prihodu zdravila na trg so poročali o primerih pridobljene hemofilije A (protitelesa proti faktorju VIII).
English: • Haemophagocytic lymphohistiocytosis
Slovenian: • Hemofagocitna limfohistiocitoza
English: The vial contents should be inspected for particulate matter and discoloration prior to administration.
Slovenian: Vsebino viale morate pred uporabo pregledati, da ne vsebuje delcev ali da ni spremenila barve.
English: Epstein-Barr virus (EBV) reactivation, including severe EBV hepatitis cases, has been reported in LEMTRADA-treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o reaktivaciji Epstein-Barrovega virusa (EBV), vključno s hudimi primeri hepatitisa zaradi EBV.
English: Signs and symptoms of ITP are described in section 4.
Slovenian: Znaki in simptomi ITP so opisani v poglavju 4.
English: • muscular and bone pain, chest discomfort
Slovenian: • bolečine v mišicah in kosteh, bolečine v mišicah v predelu prsnega koša
English: Observation for infusion reactions is recommended during and for at least 2 hours after LEMTRADA infusion.
Slovenian: Priporočljivo je opazovanje bolnikov glede z infuzijo povezanih reakcij med infundiranjem zdravila LEMTRADA in še vsaj 2 uri po njem.
English: Endocrine disorders
Slovenian: Bolezni endokrineg a sistema
English: • Inflammation of the gallbladder
Slovenian: • Vnetje žolčnika
English: Relapse severity
Slovenian: Resnost recidiva
English: What you need to know before you are administered LEMTRADA Do not use LEMTRADA:
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA
English: • Infections: stomach flu, inflammation of the gums, nail fungus, tonsil inflammation, acute sinusitis,
Slovenian: • Okužbe: trebušna gripa, vnetje dlesni, glivice na nohtih, vnetje mandljev (tonzil), akutno vnetje sinusov, bakterijska okužba kože, pljučnica (pnevmonitis), okužba s citomegalovirusom
English: Pneumonitis (inflammation of lung tissue) has been reported in LEMTRADA treated patients.
Slovenian: Pri bolnikih, zdravljenih z zdravilom LEMTRADA, je bil opisan pnevmonitis (vnetje pljučnega tkiva).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 8 hours at 2°C - 8°C, under protection from light.
Slovenian: Do uporabe ne sme preteči več kot 8 ur, če je zdravilo hranjeno pri 2°C do 8 °C in zaščiteno pred svetlobo.
English: − if you are allergic to alemtuzumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila LEMTRADA: - če ste alergični na alemtuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste okuženi z virusom človeške imunske pomanjkljivosti (HIV); - če imate resno okužbo
English: Controlled, randomised, rater and dose-blinded
Slovenian: Kontrolirana, randomizirana, za ocenjevalca enojno slepa z zakritim odmerkom
English: Initiation of treatment with LEMTRADA should be delayed in patients with severe active infection until resolution.
Slovenian: Pri bolnikih s hudo aktivno okužbo je treba uvedbo zdravila LEMTRADA odložiti, dokler okužba ne mine.
English: Reduced gestational weight gain relative to the vehicle controls was observed in pregnant mice dosed with 10 mg/kg/day.
Slovenian: Pri brejih miših, ki so prejemale odmerke 10 mg/kg/dan, so opazili manjšo pridobivanje gestacijske teže v primerjavi z živalmi, ki so prejemale vehikel.
English: Placental transfer and potential pharmacologic activity of LEMTRADA were observed in mice during gestation and following delivery.
Slovenian: Pri miših sta bila ugotovljena prehajanje skozi posteljico in možna farmakološka dejavnost zdravila LEMTRADA med brejostjo in po kotitvi.
English: Complete blood count results (see above under ITP) should be used to monitor for cytopenias, including neutropenia.
Slovenian: Za spremljanje citopenije, vključno z nevtropenijo, naj se uporabljajo rezultati celotne krvne slike (glejte razdelek o ITP).
English: Sanofi S.p.A. Tel: 800536389
Slovenian: Tel: 800536389
English: Pneumonitis has been reported in patients who received LEMTRADA infusions.
Slovenian: Pri bolnikih, ki so prejemali infuzije zdravila LEMTRADA, so poročali o pnevmonitisu.
English: Nephropathies
Slovenian: United Kingdom Sanofi
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: • athlete's foot
Slovenian: • dinatrijev edetat
English: o Other autoimmune conditions
Slovenian: o Druge avtoimunske bolezni
English: Suomi/Finland
Slovenian: Suomi/Finland Sanofi Oy
English: Pre-treatment
Slovenian: Premedikacija
English: Patients treated with LEMTRADA must be given the Patient Alert Card and Patient Guide and be informed about the risks of LEMTRADA (see also package leaflet).
Slovenian: Obvestiti jih je treba o tveganjih zdravila LEMTRADA (glejte tudi navodilo za uporabo).
English: Listeriosis/listeri a meningitis, Epstein-Barr infection, herpes virus infection,1
Slovenian: Infekcijske in parazitske bolezni okužba zgornjih dihal, okužba sečil, okužba s herpes virusom1
English: Clinical endpoints
Slovenian: Klinični opazovani dogodki
English: Posology
Slovenian: Avtoimunost
English: Suspected autoimmune cytopenias such as neutropenia, haemolytic anaemia and pancytopenia have been infrequently reported in clinical trials in MS.
Slovenian: V kliničnih preskušanjih pri MS so občasno ugotavljali sume na avtoimunsko citopenijo, kot so nevtropenija, hemolitična anemija in pancitopenija.
English: • stroke
Slovenian: • udarnina
English: • Third or fourth course: 12 mg/day on 3 consecutive days (36 mg total dose) administered at least
Slovenian: • Tretji ali četrti cikel: 12 mg/dan 3 dni zapored (celotni odmerek 36 mg), uporabljen vsaj 12 mesecev po prejšnjem ciklu zdravljenja (glejte poglavje 4.1, 5.1).
English: changes in heart rate, headache, rash, rash over your body, fever, hives, chills, itching, reddening of the face and neck, feeling tired, nausea
Slovenian: • Z infuzijo povezane reakcije, ki se lahko pojavijo v času infuzije ali v 24 urah po infuziji: spremembe srčnega ritma, glavobol, izpuščaj, izpuščaji po celem telesu, zvišana telesna temperatura, koprivnica, mrazenje, srbenje, pordelost obraza in vratu, utrujenost, slabost
English: Until 4 years after your last LEMTRADA infusion
Slovenian: Te preiskave boste opravljali še štiri leta po vaši zadnji infuziji.
English: Uncommon (may affect up to 1 in 100 people)
Slovenian: Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Serum creatinine levels should be obtained prior to initiation of treatment and at monthly intervals thereafter until at least 48 months after the last infusion.
Slovenian: Pred uvedbo zdravljenja in nato v mesečnih presledkih do najmanj 48 mesecev po zadnjem infundiranju je treba določati serumske ravni kreatinina.
English: VZV vaccination of antibody-negative patients should be considered prior to treatment initiation with LEMTRADA.
Slovenian: Pri bolnikih, ki nimajo zadostne ravni protiteles, je treba pred uvedbo zdravljenja z zdravilom LEMTRADA preučiti možnost cepljenja proti virusu varicella zoster.
English: In particular, your doctor will consider vaccinating you against chickenpox if you have never had it. Any vaccination will need to be given to you at least 6 weeks before starting a LEMTRADA treatment course.
Slovenian: Vsa cepiva boste morali prejeti vsaj šest tednov pred začetkom zdravljenja z zdravilom LEMTRADA.
English: Pyrexia*, fatigue*, chills*
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija*, utrujenost*, mrazenje*
English: • LEMTRADA Prescriber's Check-list
Slovenian: • kontrolni seznam za zdravnike, ki predpisujejo zdravilo LEMTRADA.
English: Animal data have shown effects on fertility in humanised mice (see section 5.3), however a potential impact on human fertility during the period of exposure is unknown based on the available data.
Slovenian: Znano je, da je CD52 prisoten v tkivih človeških reproduktivnih organov in reproduktivnih organov glodalcev.Podatki na živalih so pokazali učinke na plodnost humaniziranih miši (glejte poglavje 5.3).
English: Cervical human papilloma virus (HPV) infection, including cervical dysplasia and anogenital warts, has also been reported in patients treated with LEMTRADA 12 mg (2%).
Slovenian: Pri bolnicah, zdravljenih z odmerkom zdravila LEMTRADA 12 mg (2 %), so ugotovili tudi okužbo materničnega vratu s človeškim papiloma virusom (HPV), vključno z displazijo materničnega vratu in anogenitalnimi bradavicami.
English: Neutropenia Cases of severe (including fatal) neutropenia have been reported within 2 months of LEMTRADA infusion.
Slovenian: V 2 mesecih po infundiranju zdravila LEMTRADA so poročali o primerih hude nevtropenije (vključno s smrtnim izidom).
English: • LEMTRADA Training Module
Slovenian: • modul usposabljanja za zdravilo LEMTRADA,
English: o Acquired haemophilia A
Slovenian: o Pridobljena hemofilija A
English: While not observed in clinical trials, alveolar haemorrhage manifested as haemoptysis may occur with anti-GBM disease.
Slovenian: Skupaj z anti-GBM boleznijo se lahko pojavi alveolarna krvavitev, ki se kaže kot hemoptiza, vendar tega v kliničnih preskušanjih niso opazili.
English: • If the patient shows clinical symptoms suggesting development of a serious adverse event associated with the infusion (myocardial ischemia, hemorrhagic stroke, cervico-cephalic arterial dissection or pulmonary alveolar haemorrhage
Slovenian: • če se bolniku pojavijo klinični simptomi, ki kažejo na razvoj resnega z infundiranjem povezanega neželenega učinka (ishemija miokarda,
English: Placental transfer and potential pharmacologic activity of alemtuzumab were observed during gestation and following delivery in mice.
Slovenian: Pri miših sta bila ugotovljena prehajanje skozi posteljico in možna farmakološka dejavnost alemtuzumaba med brejostjo in po kotitvi.
English: Disease history
Slovenian: Avtoimunska bolezen
English: Patients with a history of stroke.
Slovenian: Bolniki z anamnezo možganske kapi.
English: Autoimmune hepatitis
Slovenian: Hemoragična možganska kap
English: • rectal bleeding
Slovenian: • rektalna krvavitev
English: Thyroid disorders
Slovenian: Trombocitopenija
English: Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in alemtuzumab-treated non-MS patients previously treated with potentially cardiotoxic agents.
Slovenian: Pri bolnikih, ki niso imeli MS in so bili zdravljeni z alemtuzumabom, predhodno pa s potencialno kardiotoksičnimi zdravili, so ugotovili srčno popuščanje, kardiomiopatijo in zmanjšan iztisni delež.
English: • heartburn
Slovenian: • bradavice
English: Duration
Slovenian: Dojenje
English: • Infections: cough, ear infection, flu-like illness, bronchitis, pneumonia, oral thrush or vaginal thrush,
Slovenian: • Okužbe: kašelj, okužba ušesa, gripi podobna bolezen, bronhitis, pljučnica, kandidoza v ustih ali nožnici, pasovec (herpes zoster), herpes na ustnicah, otekle ali povečane bezgavke, gripa, vključno z okužbami s pasovcem (herpes zostrom), okužba zoba
English: Urticaria*, rash*, pruritus*,
Slovenian: recidiv MS, omotica*,
English: Lymphadenopath y, immune thrombocytopeni c purpura, thrombocytopeni a, anaemia haematocrit decreased, leukocytosis
Slovenian: Bolezni krvi in limfatičneg a sistema limfopenija, levkopenija, vključno z nevtropenijo limfadenopatija, imunska trombocitopeničn a purpura, trombocitopenija, anemija, znižana vrednost hematokrita, , levkocitoza pancitopenija, hemolitična anemija, pridobljena hemofilija A
English: During your treatment course and for 4 months afterwards, you may have LEMTRADA in your body.
Slovenian: Zdravilo LEMTRADA imate lahko v svojem telesu med postopkom zdravljenja in še štiri mesece po njem.
English: Nephropathies, including anti-glomerular basement membrane (anti-GBM) disease, have been observed in 6 (0.4%) patients in clinical trials in MS through a median of 6.1 years (maximum 12 years) of follow-up and generally occurred within 39 months following the last administration of LEMTRADA.
Slovenian: Nefropatije, vključno z anti-GBM boleznijo, so ugotovili pri 6 (0,4 %) bolnikov z MS v kliničnih preskušanjih.
English: Complete blood counts with differential should be obtained prior to initiation of treatment and at monthly intervals thereafter until at least 48 months after the last infusion.
Slovenian: Pred uvedbo zdravljenja in nato v mesečnih presledkih do najmanj 48 mesecev po zadnjem infundiranju je treba določati celotno in diferencialno krvno sliko.
English: Please refer to the LEMTRADA Patient Guide for more information about these events.
Slovenian: Za več informacij o teh dogodkih glejte vodnik za bolnike, ki jemljejo zdravilo LEMTRADA.
English: • swelling of arms and/or legs
Slovenian: • otekanje rok in/ali nog
English: people): may show as spontaneous bruising, nose bleeds, painful or swollen joints, other types of bleeding, or bleeding from a cut that may take longer than usual to stop.
Slovenian: • Pridobljena hemofilija A (posebna motnja strjevanja krvi) (občasno - pojavi se lahko pri največ 1 od 100 bolnikov): kaže se lahko s spontanimi podplutbami, krvavitvami iz nosu, bolečimi ali oteklimi sklepi, drugimi vrstami krvavitev ali krvavitvijo iz ureznine, ki se ustavi pozneje kot običajno.
English: nephropathies, including anti-Glomerular Basement Membrane (anti-GBM) disease, autoimmune hepatitis (AIH), acquired haemophilia A, and HLH Serious infections Serious reactions temporally associated with LEMTRADA infusion, including myocardial ischaemia, haemorrhagic stroke, cervico-cephalic arterial dissection and pulmonary alveolar haemorrhage .
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvišana raven aspartataminotransferaze, zvišana raven alaninaminotransferaze holecistitis, vključno z akalkuloznim holecistitisom in akutnim akalkuloznim holecistitisom
English: • bleeding of gums
Slovenian: • krvavitev iz dlesni
English: Serious and sometimes fatal IARs including bronchospasm, hypoxia, syncope, pulmonary infiltrates, acute respiratory distress syndrome , respiratory arrest, myocardial infarction, arrhythmias, acute cardiac insufficiency, and cardiac arrest have been observed in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS.
Slovenian: Pri bolnikih, ki niso imeli MS in so bili zdravljeni z alemtuzumabom v večjih in pogostejših odmerkih, kot se uporabljajo za zdravljenje MS, so ugotovili resne in v nekaterih primerih smrtne, z infuzijo povezane reakcije, vključno z bronhospazmom, hipoksijo, sinkopo, pljučnimi infiltrati, akutno srčno insuficienco in srčnim zastojem.