FrancophonIA/ELRC3.0 huggingface dataset:
English: Some of the IARs (e.g. dizziness) could temporarily impact the patient's ability to drive or use machines and caution should be exercised until these are resolved.
Slovenian: Nekatere z infuzijo povezane reakcije (npr. omotica) lahko začasno vplivajo na bolnikovo sposobnost vožnje in upravljanja s stroji, zato je treba biti do prenehanja teh učinkov previden.
English: Study 4, was a Phase 3, multicenter, open-label, rater-blinded, efficacy and safety extension study for patients with RRMS who participated in Study 1, 2, or 3 (prior phase 3 and 2 studies) to assess long-term efficacy and safety of LEMTRADA.
Slovenian: 4. študija je bila multicentrično podaljšanje študije učinkovitosti in varnosti 3. faze z načrtom odprtega zdravljenja in slepljenim ocenjevalcem; zajela je bolnike z RRMS, ki so sodelovali v 1., 2. ali 3. študiji (predhodne študije 2. in 3. faze), in je bila namenjena oceni dolgoročne učinkovitosti in varnosti zdravila LEMTRADA.
English: It is recommended that HPV screening be completed annually for female patients.
Slovenian: Pri bolnicah je priporočljivo izvajanje presejanja za HPV vsako leto.
English: Thyroid disease poses special risks in women who are pregnant (see section 4.6).
Slovenian: Bolezni ščitnice so posebej nevarne za nosečnice (glejte poglavje 4.6).
English: Non-interventional post-authorisation safety study (PASS): In order to assess compliance with the therapeutic indication and effectiveness of measures to minimise the risk of cardiovascular and cerebrovascular adverse events in close temporal association with Lemtrada infusion and immune-mediated adverse reactions, the MAH shall submit the results of a drug utilisation study.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za oceno kompliance s terapevtsko indikacijo in učinkovitosti ukrepov za zmanjšanje tveganja za srčno-žilne in možganskožilne neželene učinke, časovno tesno povezane z infundiranjem zdravila Lemtrada, in imunsko pogojenih neželenih učinkov bo imetnik dovoljenja za promet predložil rezultate študije uporabe zdravila.
English: The recommended dose of alemtuzumab is 12 mg/day administered by intravenous infusion for 2 initial treatment courses, with up to 2 additional treatment courses if needed.
Slovenian: Priporočeni odmerek alemtuzumaba je 12 mg/dan in se daje z intravensko infuzijo v 2 začetnih ciklih zdravljenja z do 2 dodatnima cikloma zdravljenja, če je potrebno.
English: • First treatment course: 12 mg/day on 5 consecutive days (60 mg total dose)
Slovenian: • Prvi cikel zdravljenja: 12 mg/dan 5 zaporednih dni (skupni odmerek 60 mg)
English: Time to onset of symptoms ranged from less than 24 hours to 2 months after LEMTRADA infusion.
Slovenian: Simptomi so se pojavili v razponu od manj kot 24 ur do 2 meseca po infuziji zdravila LEMTRADA.
English: All of these serious side effects can start many years after you have received LEMTRADA.
Slovenian: Vsi ti resni neželeni učinki lahko nastopijo več let po prejemu zdravila LEMTRADA.
English: Your doctor will also want to make sure that you do not have certain medical conditions or disorders before you start your treatment with LEMTRADA.
Slovenian: Vaš zdravnik se bo želel tudi prepričati, da pred začetkom zdravljenja z zdravilom LEMTRADA nimate določenih bolezni ali motenj.
English: To try to reduce infusion reactions, your doctor will give you medicine (corticosteroids) before each of the first 3 infusions of a LEMTRADA course.
Slovenian: Vaš zdravnik bo poskušal zmanjšati z infuzijo povezane reakcije tako, da vam bo dal zdravilo (kortikosteroide) pred vsako od prvih treh infuzij v postopku zdravljenja z zdravilom LEMTRADA.
English: The most common adverse reactions with LEMTRADA (in ≥20% of patients) were rash, headache, pyrexia, and respiratory tract infections.
Slovenian: Najpogostejši neželeni učinki zdravila LEMTRADA (pri ≥ 20 % bolnikov) so bili izpuščaj, glavobol, pireksija in okužbe dihal.
English: To assist in the education of patients regarding potential side-effects and instructions on what to do in case of certain side-effects, the following risk minimisation materials are available:
Slovenian: V pomoč pri izobraževanju bolnikov o možnih neželenih učinkih in ukrepih v primeru pojava določenih neželenih učinkov je na voljo naslednje gradivo za zmanjšanje tveganja:
English: As with other immunomodulatory therapies, caution should be exercised in initiating LEMTRADA therapy in patients with pre-existing and/or an on-going malignancy.
Slovenian: Kot pri drugih imunomodulacijskih zdravljenjih je treba previdno začeti zdravljenje z zdravilom LEMTRADA pri bolnikih, ki so že imeli in/ali še prebolevajo maligno bolezen.
English: Clinical manifestations of nephropathy may include elevation in serum creatinine, haematuria, and/or proteinuria.
Slovenian: Klinične manifestacije nefropatije lahko vključujejo zvišanje serumske ravni kreatinina, hematurijo in/ali proteinurijo.
English: Approximately half (51.2%) of patients initially treated with LEMTRADA 12 mg/day in Study 1 or 2 who enrolled in Study 4, received only the initial 2 courses of LEMTRADA and no other disease modifying treatment throughout 6 years of follow-up.
Slovenian: Približno polovica (51,2 %) bolnikov, uvodoma zdravljenih z 12 mg zdravila LEMTRADA na dan v 1. in 2. študiji, ki so bili vključeni v 4. študijo, je prejela le uvodna 2 cikla zdravila LEMTRADA in nobenih drugih imunomodulirajočih zdravil med 6-letnim spremljanjem.
English: You will also have regular blood and urine tests to ensure that if you develop any of these conditions, they are treated promptly.
Slovenian: Redno boste opravljali preiskave krvi in urina, da se zagotovi hitro zdravljenje, če se pri vas pojavi katera od omenjenih bolezni.
English: Nevertheless, please note that in case of missed dose, this should not be given on the same day as a scheduled dose.
Slovenian: Vendar si zapomnite, da pozabljenega odmerka ne smete vzeti na isti dan, kot naj bi vzeli predhodno planiran odmerek.
English: Treatment may result in the formation of autoantibodies and increase the risk of autoimmune mediated conditions which may be serious and life threatening.
Slovenian: Zdravljenje lahko povzroči nastanek avtoprotiteles in poveča tveganje za avtoimunske motnje, ki so lahko resne in življenjsko nevarne.
English: Haemoptysis may also be indicative of ITP or acquired haemophilia A (see above), and an appropriate differential diagnosis has to be undertaken.
Slovenian: Hemoptiza lahko kaže tudi na ITP ali na pridobljeno hemofilijo A (glejte zgoraj), zato je treba opraviti ustrezno diferencialno diagnostiko.
English: Infusion instructions to reduce serious reactions temporally associated with LEMTRADA infusion
Slovenian: Navodila za infundiranje za zmanjšanje resnih reakcij, časovno povezanih z infundiranjem zdravila LEMTRADA
English: Cardiac disorders Tachycardia* Bradycardia*, palpitations*
Slovenian: Srčne bolezni tahikardija* bradikardija*, palpitacije*
English: Screening for tuberculosis will be arranged by your doctor.
Slovenian: Vaš zdravnik bo uredil presejalno preiskavo za tuberkulozo.
English: Another side effect is an increased risk of infections (see below for information on how often patients experience infections).
Slovenian: Pomemben neželeni učinek je tudi povečano tveganje okužb (podatki o pogostosti okužb pri bolnikih so v nadaljevanju).
English: To allow for the full effect of the VZV vaccination to occur, treatment with LEMTRADA should be postponed for 6 weeks following vaccination.
Slovenian: Da cepljenje proti virusu varicella zoster doseže polni učinek, odložite zdravljenje z zdravilom LEMTRADA za 6 tednov po cepljenju.
English: Several of the patient reported were below 50 years of age and had no history of hypertension, bleeding disorders or concomitant anticoagulants or platelet inhibitors.
Slovenian: Več bolnikov, o katerih so poročali, je bilo mlajših od 50 let in v anamnezi niso imeli hipertenzije ali motenj strjevanja krvi in niso sočasno uporabljali antikoagulantnih ali antiagregacijskih zdravil.
English: o Immune Thrombocytopenic Purpura (ITP)
Slovenian: Imunska trombocitopenična purpura (ITP)
English: Myocardial ischaemia**, myocardial infarction**
Slovenian: ishemija miokarda**, miokardni infarkt**
English: Alemtuzumab acts through antibody-dependent cellular cytolysis and complement-mediated lysis following cell surface binding to T and B lymphocytes.
Slovenian: Alemtuzumab deluje preko od protiteles odvisne celične citolize in s komplementom posredovane lize po vezavi na površino limfocitov T in B.
English: There is no relevant use of alemtuzumab in children aged from birth to less than 10 years for the treatment of multiple sclerosis.
Slovenian: Pri otrocih od rojstva do manj kot 10 let starosti uporaba alemtuzumaba za zdravljenje multiple skleroze ni smiselna.
English: • Use aseptic techniques to withdraw 1.2 ml of LEMTRADA from the vial and inject into 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Slovenian: • Z aseptičnimi tehnikami povlecite 1,2 ml zdravila LEMTRADA iz viale in ga vbrizgajte v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali raztopine glukoze (5 %) za infundiranje.
English: Additionally, the observed incidence of antibody (including inhibitory antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medicines, and underlying disease.
Slovenian: Poleg tega na ugotovljeno pojavnost pozitivnosti testa za protitelesa (vključno z zaviralnimi protitelesi) lahko vpliva več dejavnikov, vključno z metodologijo testa, postopki ravnanja z vzorci, časom odvzema vzorca, sočasno uporabljenimi zdravili in osnovno boleznijo.
English: • ITP (bleeding disorders), (common - may affect up to 1 in 10 people): may show as small scattered red, pink or purple spots on your skin; easy bruising; bleeding from a cut that is harder to stop; heavier, longer or more frequent menstrual periods than normal; bleeding between menstrual periods; bleeding from your gums or nose that is new or takes longer than usual to stop; or coughing up blood.
Slovenian: • ITP (motnja strjevanja krvi) (pogosti - pojavijo se lahko pri največ 1 od 10 bolnikov): lahko se pokaže kot majhne razpršene rdeče, rožnate ali vijolične pike na koži; nagnjenost k pojavljanju podplutb; krvavitev iz ureznine, ki jo je težje ustaviti; menstrualna krvavitev, ki je močnejša, daljša ali pogostejša kot običajno; krvavitev med menstruacijami; krvavitev iz dlesni ali nosu, ki se še ni pojavila ali traja dlje kot običajno; ali izkašljevanje krvi.
English: Patients should be informed about the risk of autoimmune hepatitis, hepatic injury and related symptoms.
Slovenian: Bolnike je treba seznaniti s tveganjem za avtoimunski hepatitis, okvaro jeter in s simptomi, ki so s tem povezani.
English: Severe anaphylaxis and other hypersensitivity reactions, including anaphylactic shock and angioedema have also been reported.
Slovenian: Poročali so tudi o hudi anafilaksi in drugih preobčutljivostnih reakcijah, vključno z anafilaktičnim šokom in angioedemom.
English: Anti-GBM disease may lead to renal failure requiring dialysis and/or transplantation if not treated rapidly and can be life-threatening if left untreated.
Slovenian: Bolezen protiteles proti glomerulni bazalni membrani lahko vodi v ledvično odpoved, ki zahteva dializo in/ali presaditev, če se ne pozdravi hitro, ter je lahko življenjsko nevarna, če je ne zdravimo.
English: Patients and physicians should be made aware of the potential later onset of autoimmune disorders after the 48 months monitoring period.
Slovenian: Poskrbeti je treba, da se bolniki in zdravniki zavedajo možnosti za zapoznel pojav avtoimunskih motenj tudi po koncu 48-mesečnega obdobja nadzora.
English: If ITP onset is confirmed, appropriate medical intervention should be promptly initiated, including immediate referral to a specialist.
Slovenian: Če potrdite pojav ITP, je treba takoj uvesti ustrezne medicinske postopke, vključno s takojšnjo napotitvijo k specialistu.
English: • It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Slovenian: • Priporočljivo je, da zdravilo uporabite nemudoma po redčenju zaradi možnosti mikrobne kontaminacije.
English: Haemoptysis may also be indicative of anti-GBM disease (see below), and an appropriate differential diagnosis has to be undertaken.
Slovenian: Hemoptiza lahko kaže tudi na bolezen protiteles proti glomerulni bazalni membrani (glejte spodaj), zato je treba opraviti ustrezno diferencialno diagnostiko.
English: Liver inflammation can be diagnosed from the blood tests that you will be having regularly after LEMTRADA treatment.
Slovenian: Vnetje jeter je mogoče ugotoviti na podlagi izvidov preiskav krvi, ki jih boste redno opravljali po zdravljenju z zdravilom LEMTRADA.
English: After this time, if you have symptoms of ITP, kidney or thyroid disorders, your doctor will perform more tests.
Slovenian: Če boste po tem času imeli simptome ITP, bolezni ledvic ali ščitnice, bo zdravnik opravil dodatne preiskave.
English: It is recommended that the product is used immediately after dilution, due to a possible risk for microbial contamination.
Slovenian: Priporočljivo je, da se zdravilo uporabi nemudoma po redčenju zaradi možnosti mikrobnega onesnaženja.
English: To try to reduce infusion reactions, your doctor will give you other medicine(s) (see section 4 - infusion reactions).
Slovenian: Vaš zdravnik bo poskušal zmanjšati z infuzijo povezane reakcije tako, da vam bo dal drugo zdravilo ali zdravila (glejte poglavje 4 - Z infuzijo povezane reakcije).
English: In clinical trials, there were 2 cases of anti-GBM disease.
Slovenian: V kliničnih preskušanjih sta bila 2 primera bolezni protiteles proti glomerulni bazalni membrani.
English: There is no evidence that LEMTRADA has an impact on male fertility.
Slovenian: Ni dokazov, da bi zdravilo LEMTRADA vplivalo na moško plodnost.
English: Any spillage or waste material should be disposed of in accordance with local requirements.
Slovenian: Razlito zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: After each infusion, the patient should be observed for 2 hours for infusion associated reactions.
Slovenian: • Po infundiranju zdravila je treba bolnika še dve uri opazovati zaradi z infuzijo povezanih reakcij.
English: • constipation, acid reflex, dry mouth
Slovenian: • zapeka, refluks želodčne kisline, suha usta
English: The patients should be educated on the potential for delayed onset of infusion associated reactions and instructed to report symptoms and seek appropriate medical care.
Slovenian: Bolnike je treba seznaniti z možnostjo za zapoznel pojav z infundiranjem povezanih reakcij in jim naročiti, da morajo o simptomih poročati in poiskati ustrezno zdravniško pomoč.
English: Recommendations on how to mitigate these risks through appropriate patient counselling, monitoring and management.
Slovenian: priporočila o zmanjševanju teh tveganj z ustreznim svetovanjem, spremljanjem in obravnavo bolnika; poglavje „Pogosta vprašanja“.
English: After this period of time testing should be performed based on clinical findings suggestive of thyroid dysfunction or in case of pregnancy.
Slovenian: Po tem časovnem obdobju je treba opraviti testiranje, če klinični izsledki kažejo na moteno delovanje ščitnice ali v primeru nosečnosti.
English: LEMTRADA adjusts your immune system to limit its attacks on your nervous system.
Slovenian: Kako zdravilo LEMTRADA deluje Zdravilo LEMTRADA uravnava vaš imunski sistem in omejuje napade na živčni sistem.
English: Patients who are relapse free at Year 2 (95% CI)
Slovenian: Bolniki, ki so brez recidiva po 2. letih (95-odstotni IZ)
English: The reported thrombocytopenia occurred within the first days after the infusion (unlike ITP).
Slovenian: Trombocitopenija, o kateri so poročali, se je pojavila v prvih dneh po infundiranju (v nasprotju z ITP).
English: In patients continuing from controlled clinical studies and who did not receive any additional LEMTRADA after the initial 2 treatment courses, the rate (events per person-year) of most adverse reactions was comparable to or reduced in years 3-6 as compared to years 1 and 2.
Slovenian: Pri bolnikih, ki so nadaljevali iz kontroliranih kliničnih študij in po uvodnih 2 ciklih zdravljenja niso več prejeli zdravila LEMTRADA, je bil delež (učinki na bolnik-leto) večine neželenih učinkov v obdobju od 3. do 6. leta podoben ali zmanjšan kot v obdobju 1. in 2. leta.
English: Patients in the extension study (Study 4) were eligible to receive additional as-needed LEMTRADA treatment course(s) upon documentation of resumed disease activity, defined as the occurrence of ≥1 MS relapse and/or ≥2 new or enlarging brain or spinal lesions on magnetic resonance imaging (MRI).
Slovenian: Bolniki v podaljšani študiji (4. študija) so lahko prejeli dodaten cikel/dodatne cikle zdravljenja z zdravilom LEMTRADA po potrebi glede na dokumentirano ponovno aktivnost bolezni, ki je bila opredeljena kot pojav ≥ 1 recidiva MS in/ali ≥ 2 novih ali povečanih lezij v možganih ali hrbtnem mozgu na magnetnoresonančnem slikanju (MR).
English: Patients treated with LEMTRADA have had infections due to a virus called Epstein-Barr virus (EBV), including cases with severe liver inflammation.
Slovenian: Bolniki, ki so prejemali zdravilo LEMTRADA, so imeli okužbe z virusom, imenovanim Epstein-Barrov virus (EBV), vključno s primeri hudega vnetja jeter.
English: Follow-up after treatment with LEMTRADA
Slovenian: Sledenje po zdravljenju z zdravilom LEMTRADA
English: Results for Studies 1 and 2 are shown in Table 3.
Slovenian: V preglednici 3 so prikazani rezultati študije 1 in 2.
English: Patients should be advised to report symptoms of pneumonitis, which may include shortness of breath, cough, wheezing, chest pain or tightness and hemoptysis.
Slovenian: Bolnikom je treba naročiti, naj zdravnika obvestijo o simptomih pnevmonitisa, med katerimi so lahko težko dihanje, kašelj, piskajoče dihanje, bolečina ali tiščanje v prsih in hemoptiza.
English: Investigations
Slovenian: Preiskava
English: If you notice any of these signs or symptoms for bleeding or kidney disorders, call your doctor immediately to report the symptoms.
Slovenian: Če opazite katerega od teh znakov ali simptomov krvavitve ali bolezni ledvic, nemudoma pokličite svojega zdravnika in mu navedite simptome.
English: Do not use this medicine after the expiry date which is stated on the outer carton and the vial label after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Rok uporabnosti se izteče na zadnji dan navedenega meseca.
English: Patients should be informed about the signs and symptoms and on the time to onset of the events.
Slovenian: Bolnike je treba seznaniti z znaki in simptomi ter časom do pojava teh učinkov.
English: • Infections
Slovenian: • Okužbe
English: ‡ Study primary endpoint was scored at 3 years.
Slovenian: ‡ Primarni opazovani dogodek študije so ocenili po 3 letih.
English: Other medicines and LEMTRADA
Slovenian: Druga zdravila in zdravilo LEMTRADA
English: • increased sensation, sensory disturbance such as numbness, tingling and pain, tension headache
Slovenian: • povečana občutljivost, senzorične motnje, kot so otrplost, mravljinčenje in bolečina, tenzijski glavobol
English: Very commonly, patients have experienced an autoimmune disorder of the thyroid gland affecting its ability to make or control hormones that are important for your metabolism.
Slovenian: Zelo pogosto se je pri bolnikih pojavila avtoimunska bolezen ščitnice, ki vpliva na sposobnost nastajanja ali uravnavanja hormonov, ki so pomembni za presnovo.
English: Similar improvements in ARR, mean EDSS score, and T2 and gadolinium-enhancing lesions were seen after Course 4 when compared with the prior year.
Slovenian: Podobna izboljšanja AZT, povprečne ocene EDSS, T2-lezij in z gadolinijem poudarjenih lezij so zabeležili po 4. ciklusu v primerjavi s prejšnjim letom.
English: Concomitant use of LEMTRADA with any of these therapies could increase the risk of immunosuppression.
Slovenian: Sočasna uporaba zdravila LEMTRADA s katero od navedenih zdravljenj lahko poveča tveganje imunosupresije.
English: The pharmacokinetics of alemtuzumab were evaluated in a total of 216 patients with RRMS who received intravenous infusions of either 12 mg/day or 24 mg/day on 5 consecutive days, followed by 3 consecutive days 12 months following the initial treatment course.
Slovenian: Farmakokinetika alemtuzumaba je bila ocenjena pri skupno 216 bolnikih z RRMS, ki so prejemali intravenske infuzije bodisi 12 mg/dan bodisi 24 mg/dan 5 zaporednih dni, 12 mesecev po prvem ciklu zdravljenja pa še 3 zaporedne dni.
English: Most events were mild to moderate in severity.
Slovenian: Večina pojavov je bila blagih do zmerno resnih.
English: Before treatment, patients must be informed about the risks and benefits, and the need to commit to follow-up from treatment initiation until at least 48 months after the last infusion of the second LEMTRADA treatment course.
Slovenian: Pred zdravljenjem je treba bolnike seznaniti s tveganji in koristmi ter jim povedati, da se morajo strinjati s spremljanjem, ki bo trajalo od uvedbe zdravljenja do najmanj 48 mesecev po zadnji infuziji drugega cikla zdravljenja z zdravilom LEMTRADA.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12.
English: Patients with a history of angina pectoris or myocardial infarction.
Slovenian: Bolniki z anamnezo angine pektoris ali miokardnega infarkta.
English: • hair loss
Slovenian: • izguba las
English: Patients who developed anti-alemtuzumab antibodies did so by 15 months from initial exposure.
Slovenian: Protitelesa proti alemtuzumabu so se pri bolnikih pojavila v 15 mesecih od prve izpostavljenosti.
English: No formal drug interaction studies have been conducted with LEMTRADA using the recommended dose in patients with MS.
Slovenian: Formalnih študij medsebojnega delovanja zdravila LEMTRADA v odmerkih, priporočenih za bolnike z MS, niso izvedli.
English: Alemtuzumab is an IgG1 kappa antibody with human variable framework and constant regions, and complementary-determining regions from a murine (rat) monoclonal antibody.
Slovenian: Alemtuzumab je protitelo IgG1 kapa s humanim variabilnim okvirjem in konstantnimi področji ter področji iz podganjega monoklonskega protitelesa, ki določajo komplementarnost.
English: Acute acalculous cholecystitis
Slovenian: Akutni akalkulozni holecistitis
English: Cases of autoimmune hepatitis (including fatal cases and cases requiring liver transplantation) and hepatic injury related to infections have been reported in patients treated with LEMTRADA (see section 4.3).
Slovenian: Pri bolnikih, zdravljenih z zdravilom LEMTRADA, so poročali o primerih avtoimunskega hepatitisa (vključno s smrtnimi primeri in primeri, v katerih je bila potrebna presaditev jeter) in okvare jeter v povezavi z okužbami (glejte poglavje 4.3).
English: None
Slovenian: Brez
English: If a cytopenia is confirmed, appropriate medical intervention should be promptly initiated, including referral to a specialist.
Slovenian: Če potrdite citopenijo, je treba takoj uvesti ustrezne medicinske postopke, vključno z napotitvijo k specialistu.
English: Resources for the management of cytokine release syndrome, hypersensitivity and/or anaphylactic reactions should be available.
Slovenian: Na voljo mora biti vse potrebno za obvladanje sindroma sproščanja citokinov, preobčutljivostnih in/ali anafilaktičnih reakcij.