FrancophonIA/ELRC3.0 huggingface dataset:
English: Thyroid disorders could be harmful to the baby (see section 2 Warnings and precautions - autoimmune conditions).
Slovenian: Bolezni ščitnice so lahko škodljive za otroka (glejte poglavje 2 Opozorila in previdnostni ukrepi - avtoimunske bolezni).
English: Pack size: carton with 1 vial.
Slovenian: Velikosti pakiranja: škatla z 1 vialo.
English: In most cases, these are mild but serious infections can occur.
Slovenian: V večini primerov so okužbe blage, vendar se lahko pojavijo tudi resne okužbe.
English: • kidney stones, excretion of ketone bodies in urine, kidney disease
Slovenian: • ledvični kamni, izločanje ketonskih teles v urinu, bolezni ledvic
English: The mechanism by which LEMTRADA exerts its therapeutic effects in MS is not fully elucidated.
Slovenian: Mehanizem, preko katerega zdravilo LEMTRADA doseže terapevtske učinke pri MS, ni povsem dognan.
English: Human IgG is known to cross the placental barrier; alemtuzumab may cross the placental barrier as well and thus potentially pose a risk to the foetus.
Slovenian: Človeška protitelesa IgG dokazano prehajajo placentarno bariero, zato lahko to bariero prehaja tudi alemtuzumab in zaradi tega potencialno predstavlja tveganje za plod.
English: (to diagnose all important serious side effects listed above)
Slovenian: krvna preiskava (za določitev vseh pomembnih resnih neželenih učinkov, ki so navedeni zgoraj)
English: Treatment-naïve patients Patients with inadequate response to prior therapy*
Slovenian: Bolniki z nezadostnim odzivom na predhodno zdravljenje*
English: In most cases these are mild but some serious reactions are possible.
Slovenian: V večini primerov so reakcije blage, vendar se lahko pojavijo tudi resne reakcije.
English: Doses of LEMTRADA greater than those tested in clinical studies may increase the intensity and/or duration of infusion-associated adverse reactions or its immune effects.
Slovenian: Odmerki zdravila LEMTRADA, ki so večji od preskušenih v kliničnih študijah, povečajo intenzivnost in/ali trajanje z infuzijo povezanih reakcij ali njihove imunske učinke.
English: • infection due to a virus known as Epstein-Barr virus
Slovenian: • okužba z virusom, imenovanim Epstein-Barrov virus
English: • abnormally heavy, prolonged or irregular menstruation
Slovenian: • nenormalno močna, dolga ali neredna menstrualna krvavitev
English: Patients with uncontrolled hypertension.
Slovenian: Bolniki z neurejeno hipertenzijo.
English: In RRMS patients experience relapses followed by periods of recovery.
Slovenian: Pri bolnikih z RRMS recidivom sledijo obdobja okrevanja.
English: Active and latent tuberculosis, including a few cases of disseminated tuberculosis, have been reported in 0.3% of the patients treated with LEMTRADA, most often in endemic regions.
Slovenian: Aktivno in latentno tuberkulozo, vključno s posameznimi primeri diseminirane tuberkuloze, so ugotovili pri 0,3 % bolnikov, zdravljenih z zdravilom LEMTRADA, najpogosteje v endemskih področjih.
English: Extended observation time (hospitalization) should be considered, as appropriate.
Slovenian: Razmisliti je treba o podaljšanem času opazovanja (hospitalizacije), če je potrebno.
English: It can also lead to damage of your lungs, which can result in coughing up blood.
Slovenian: Lahko pride tudi do poškodbe pljuč, kar se kaže kot izkašljevanje krvi.
English: However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the suckling newborn/infant.
Slovenian: Vendar lahko koristi imunosti, ki se prenaša z materinim mlekom, odtehtajo tveganje potencialne izpostavljenosti novorojenčka/dojenčka alemtuzumabu.
English: Fertility and reproduction
Slovenian: Plodnost in razmnoževanje
English: Skin papilloma
Slovenian: kožni papilom
English: Most patients in controlled clinical trials received antihistamines and/or antipyretics before at least one LEMTRADA infusion.
Slovenian: Večina bolnikov v kontroliranih kliničnih preskušanjih je prejela antihistaminike in/ali antipiretike vsaj pred eno infuzijo zdravila LEMTRADA.
English: Serum concentrations were low or undetectable within approximately 30 days following each treatment course.
Slovenian: Serumske koncentracije so bile nizke ali nezaznavne po približno 30 dneh po vsakem postopku zdravljenja.
English: In clinical studies, patients treated with LEMTRADA had fewer relapses and were less likely to experience worsening of their disability compared to patients treated with a beta-interferon injected multiple times per week.
Slovenian: V kliničnih študijah so imeli bolniki, zdravljeni z zdravilom LEMTRADA, manj recidivov in manjšo verjetnost poslabšanja njihove prizadetosti v primerjavi z bolniki, zdravljenimi z beta-interferonom, injiciranim večkrat na teden.
English: 3 years‡
Slovenian: 3 leta‡
English: • potassium chloride (E508)
Slovenian: • kalijev klorid (E508)
English: 4 years * Defined as patients having experienced at least 1 relapse during treatment with beta interferon or glatiramer acetate after having been on therapy with medicinal product for at least 6 months.
Slovenian: 4 leta * Opredeljeni kot bolniki, ki so imeli vsaj 1 recidiv med zdravljenjem z interferonom beta ali glatiramer acetatom po prejemanju zdravila, ki je trajalo vsaj 6 mesecev.
English: Water for injections
Slovenian: • voda za injekcije
English: These additional treatment courses may be adminisitered twelve months or more after the prior treatments.
Slovenian: Dodatne cikle zdravljenja se daje dvanajst mesecev ali več po predhodnem zdravljenju.
English: Patients with 6-month CDW (95% CI)
Slovenian: Bolniki s 6-mesečnim CDW (95-odstotni IZ)
English: Therefore, regular blood and urine tests are needed until 4 years after your last infusion.
Slovenian: Zato so potrebne preiskave krvi in urina še štiri leta po zadnji infuziji.
English: E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI E339, dinatrijev edetat , E508, E340, E433, natrijev klorid, voda za injekcije
English: The symptoms you experience are determined by which part of your central nervous system is affected.
Slovenian: Simptomi, ki se pojavijo, so odvisni od dela osrednjega živčnega sistema, ki je prizadet.
English: Resources for the management of anaphylaxis or serious reactions (see below) should be available.
Slovenian: Na voljo mora biti vse potrebno za obvladanje anafilaksije ali resnih reakcij (glejte spodaj).
English: LEMTRADA has not been administered for treatment of MS concomitantly with or following antineoplastic or immunosuppressive therapies.
Slovenian: Zdravilo LEMTRADA ni bilo uporabljeno za zdravljenje MS sočasno z ali po antineoplastičnih ali imunosupresivnih zdravljenjih.
English: • If non-compliant, patients may need further counseling to highlight the risks of missing scheduled monitoring tests.
Slovenian: • Če bolnik ne sodeluje, mu je morda treba dodatno svetovati glede tveganja zaradi izpuščenih preiskav.
English: It is unlikely that your dose would be missed since it is administered by a health care professional.
Slovenian: Ni verjetno, da bi pozabili vzeti odmerek, saj vam ga odmeri zdravstveni delavec.
English: Show the Patient Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Slovenian: Opozorilno kartico za bolnika in to navodilo za uporabo pokažite vsem zdravnikom, ki vas zdravijo, ne le svojemu nevrologu.
English: Most patients were treated conservatively with antibiotics and recovered without surgical intervention, whereas others underwent cholecystectomy.
Slovenian: Večino bolnikov so zdravili konzervativno z antibiotiki in so okrevali brez kirurškega posega, pri preostalih so opravili holecistektomijo.
English: Information from use of alemtuzumab prior to the marketing authorisation of LEMTRADA outside of company-sponsored studies
Slovenian: Informacije o uporabi alemtuzumaba, pridobljene pred pridobitvijo dovoljenja za promet z zdravilom LEMTRADA izven študij, ki jih je podprl izdelovalec
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V
English: Information on preparing to administer LEMTRADA and patient monitoring
Slovenian: Informacije o pripravah za dajanje zdravila LEMTRADA in spremljanju bolnika
English: There is no known antidote for alemtuzumab over dosage.
Slovenian: Ni znanega antidota za preveliko odmerjanje alemtuzumaba.
English: To help reduce the risk of some infections your doctor may consider giving you vaccination against chickenpox and/or other vaccinations that they think are necessary for you (see section 2: What you need to know before you are administered LEMTRADA - Vaccines).
Slovenian: Zaradi zmanjšanja tveganja nekaterih okužb bo vaš zdravnik presodil, ali morate prejeti cepivo proti noricam in/ali druga cepiva, za katera bo menil, da so pomembna za vas (glejte poglavje 2: Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA - cepiva).
English: The damage done to your nerves during this inflammation may be reversible, but as your disease progresses the damage may accumulate and become permanent.
Slovenian: Poškodbe živcev zaradi vnetja so lahko odpravljive, vendar se z napredovanjem bolezni poškodbe lahko kopičijo in postanejo trajne.
English: Terms marked with asterisk (*) in Table 1 include adverse reactions reported as Infusion Associated Reactions.
Slovenian: Izrazi v preglednici 1, označeni z zvezdico (*), so neželeni učinki, ki so poročani kot z infuzijo povezane reakcije.
English: CD3+ and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by 12months post-treatment.
Slovenian: Ravni limfocitov CD3+ in CD4+ rastejo počasneje proti normalnim vrednostim, vendar se običajno ne povrnejo na izhodiščne ravni v 12 mesecih po zdravljenju.
English: Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
Slovenian: Znotraj vsake kategorije pogostnosti so neželeni učinki navedeni s padajočo resnostjo.
English: In a controlled clinical trial in MS patients recently treated with beta interferon and glatiramer acetate were required to discontinue treatment 28 days before initiating treatment with LEMTRADA.
Slovenian: V kontroliranem kliničnem preskušanju pri bolnikih z MS so pri bolnikih, ki so se nedavno zdravili z interferonom beta in glatiramer acetatom, zahtevali prekinitev zdravljenja 28 dni pred uvedbo zdravljenja z zdravilom LEMTRADA.
English: If you have been diagnosed with cancer in the past, please inform your doctor about it.
Slovenian: • Predhodno postavljena diagnoza raka Če ste bili v preteklosti diagnosticirani z rakom, o tem obvestite svojega zdravnika.
English: Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism.
Slovenian: Če se hipotiroidizem med nosečnostjo ne zdravi, obstaja povečano tveganje splava ali učinkov na plod, kot sta umska zaostalost in pritlikavost.
English: If it is 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 2oC to 8oC, under protection from light.
Slovenian: Če se ne uporabi takoj, je za trajanje in pogoje hrambe pred uporabo odgovoren uporabnik, vendar hramba ne sme trajati več kot 8 ur pri 2 oC do 8 oC, zaščiteno pred svetlobo.
English: 1 Patient Alert Card: For the patient to present to other healthcare providers to alert them to the use of LEMTRADA in this patient.
Slovenian: 1 Opozorilna kartica za bolnika: ki jo bolnik pokaže drugim zdravstvenim delavcem, da jih opozori, da se zdravi z zdravilom LEMTRADA
English: Study population
Slovenian: Preučena populacija
English: It is not currently known if LEMTRADA confers a higher risk for developing thyroid malignancies, since thyroid autoimmunity may itself be a risk factor for thyroid malignancies.
Slovenian: Trenutno ni znano, ali zdravilo LEMTRADA povzroča večje tveganje za razvoj malignih bolezni ščitnice, saj je lahko avtoimunska bolezen ščitnice že sama dejavnik tveganja za maligne bolezni ščitnice.
English: There is a limited amount of data from the use of alemtuzumab in pregnant women.
Slovenian: Podatki o uporabi alemtuzumaba pri nosečnicah so omejeni.
English: If you become pregnant after treatment with LEMTRADA and experience a thyroid dirorder during pregnancy, extra caution is needed.
Slovenian: Če zanosite po zdravljenju z zdravilom LEMTRADA in se med nosečnostjo pojavi bolezen ščitnice, je potrebna posebna previdnost.
English: It is not known whether alemtuzumab can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity.
Slovenian: Ni znano, ali lahko alemtuzumab škoduje plodu, če se daje nosečnici oz. ali lahko vpliva na sposobnost razmnoževanja.
English: Having an untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.
Slovenian: Nezdravljena bolezen ščitnice lahko škoduje nerojenemu otroku ali otroku po rojstvu.
English: HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation.
Slovenian: HLH je življenjsko nevaren sindrom patološke imunske aktivacije, za katerega so značilni klinični znaki in simptomi skrajnega sistemskega vnetja.
English: These are described in section 4.4.
Slovenian: Ti neželeni učinki so opisani v poglavju 4.4..
English: - Alterations in the number, proportions, and properties of some lymphocyte subsets post-treatment - Increased representation of regulatory T cell subsets - Increased representation of memory T- and B-lymphocytes - Transient effects on components of innate immunity (i.e., neutrophils, macrophages, NK cells)
Slovenian: - spremembami v številu, deležih in lastnostih nekaterih podskupin limfocitov po zdravljenju - povečano zastopanostjo regulatornih podskupin celic T - povečano zastopanostjo spominskih podskupin celic T in B - prehodnimi učinki na komponente naravne imunosti (tj. nevtrofilci, makrofagi, celice ubijalke)
English: Follow-up of patients
Slovenian: Sledenje bolnikom
English: Store in a refrigerator (2°C-8°C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
Slovenian: Bolnike, ki se jim pojavijo zgodnji znaki patološke imunske aktivacije, je treba nemudoma ovrednotiti in upoštevati je treba možnost, da gre za HLH.
English: SANOFI BULGARIA EOOD
Slovenian: SANOFI BULGARIA EOOD Тел.
English: High titer anti-alemtuzumab antibodies observed in some patients were associated with incomplete lymphocyte depletion following a third or fourth treatment course, but there was no clear impact of anti-alemtuzumab antibodies on the clinical efficacy or safety profile of LEMTRADA.
Slovenian: Visok titer protiteles proti alemtuzumabu, opažen pri nekaterih bolnikih, je bil povezan z nepopolnim osiromašenjem limfocitov po tretjem ali četrtem ciklu zdravljenja, vendar ni bilo jasnega učinka protiteles proti alemtuzumabu na klinično učinkovitost in varnostni profil zdravila LEMTRADA.
English: Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Slovenian: Neželeni učinki so navedeni po organskih sistemih Medicinskega slovarja za regulativne zadeve (MedDRA - Medical Dictionary for Regulatory Activities) in prednostnih izrazih.
English: No data are available on the association of LEMTRADA with Hepatitis B virus (HBV) or Hepatitis C virus (HCV) reactivation as patients with evidence of active or chronic infections were excluded from clinical trials.
Slovenian: Podatkov o povezavi zdravila LEMTRADA in reaktivacijo okužbe z virusom hepatitisa B (HBV) ali C (HCV) ni na voljo, saj so bili bolniki s potrjenimi aktivnimi ali kroničnimi okužbami izključeni iz kliničnih preskušanj.
English: It is unknown if LEMTRADA can be transferred to a baby through breast milk, but there is a possibility that it could be.
Slovenian: Ni znano, ali se lahko zdravilo LEMTRADA z materinim mlekom prenese v dojenčka, vendar je to možno.
English: MS is an autoimmune disease that affects the central nervous system (brain and spinal cord).
Slovenian: MS je avtoimunska bolezen, ki prizadane osrednji živčni sistem (možgane in hrbtenjačo).
English: Treatment consists of discontinuation of the medicinal product and supportive therapy.
Slovenian: Ukrepanje obsega prekinitev zdravljenja in podporno terapijo.
English: What you need to know before you are administered LEMTRADA 3.
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo LEMTRADA 3.
English: Most cases occurred within the first month after treatment with LEMTRADA.
Slovenian: Večina primerov se je pojavila v prvem mesecu po zdravljenju z zdravilom LEMTRADA.
English: The majority of these may be due to cytokine release during infusion.
Slovenian: Večina teh primerov je bila lahko posledica sproščanja citokinov med infundiranjem.
English: Alemtuzumab binds to CD52, a cell surface antigen present at high levels on T (CD3+) and B (CD19+) lymphocytes, and at lower levels on natural killer cells, monocytes, and macrophages.
Slovenian: Alemtuzumab se veže na CD52, površinski antigen, ki je prisoten v velikih količinah na limfocitih T (CD3+) in B (CD19+), v manjših količinah pa na naravnih celicah ubijalkah, monocitih in makrofagih.
English: 1.5/1.3 years
Slovenian: 1,5/1,3 let
English: Alemtuzumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes.
Slovenian: Alemtuzumab je beljakovina, za katero je pričakovana presnovna pot razgradnja v majhne peptide in posamezne aminokisline zaradi splošno porazdeljenih proteolitičnih encimov.
English: As with other immunomodulating therapies, potential combined effects on the patient's immune system should be taken into account when considering administration of LEMTRADA.
Slovenian: Kot pri drugih imunomodulacijskih zdravljenjih je treba upoštevati morebitne kombinirane učinke na bolnikov imunski sistem, ko se namerava predpisati zdravilo LEMTRADA.
English: Cases of cervicocephalic arterial dissections, including multiple dissections, have been reported both within the first days after the LEMTRADA infusion or later on within the first month after the infusion.
Slovenian: O primerih disekcije cervikocefalnih arterij, tudi o več takšnih disekcijah, so poročali tako v prvih dneh po infundiranju zdravila LEMTRADA kot tudi pozneje, v prvem mesecu po infundiranju.
English: If you are a carrier of hepatitis B or hepatitis C infection (these affect the liver), extra caution is needed before you receive LEMTRADA treatment as it is unknown if treatment could lead to activation of the hepatitis infection which could subsequently damage your liver.
Slovenian: Če ste nosilec virusa hepatitisa B ali C (ki prizadeneta jetra), je potrebna dodatna previdnost pred zdravljenjem z zdravilom LEMTRADA, saj ni znano, ali lahko zdravljenje privede do aktivacije okužbe z virusom hepatitisa, ki bi posledično poškodovala jetra.
English: Administer within 8 hours after dilution.
Slovenian: Uporabite v 8 urah po redčenju.
English: There are no adequate clinical safety data on the effect of LEMTRADA on fertility.
Slovenian: Primernih podatkov o klinični varnosti zdravila LEMTRADA za plodnost ni.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with LEMTRADA in one or more subsets of the paediatric population in RRMS (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom LEMTRADA za eno ali več podskupin pediatrične populacije z RRMS (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Rate ratio (95% CI) Risk reduction
Slovenian: Razmerje stopenj (95-odstotni IZ) Zmanjšanje tveganja
English: The safety and efficacy of alemtuzumab in MS were evaluated in 3 randomised, rater-blinded, activecomparator clinical trials and 1 uncontrolled, rater-blinded extension study in patients with RRMS.
Slovenian: Varnost in učinkovitost alemtuzumaba pri MS so ocenjevali v 3 randomiziranih, za ocenjevalce enojno slepih kliničnih preskušanjih z aktivno primerjavo in 1 nekontrolirani podaljšani za ocenjevalce enojno slepi študiji pri bolnikih z RRMS.
English: Besides LEMTRADA, there are other treatments (including those for MS, or to treat other conditions) which could affect your immune system and so could affect your ability to fight infections.
Slovenian: Poleg zdravila LEMTRADA lahko tudi druga zdravila (za zdravljenje MS ali drugih bolezni) vplivajo na vaš imunski sistem in posledično vašo sposobnost obrambe pred okužbami.
English: o Platelet count should be obtained immediately after infusion on Days 3 and 5 of the first infusion course, as well as immediately after infusion on Day 3 of any subsequent course.
Slovenian: o Število trombocitov je treba določiti takoj po infundiranju, na 3. in 5. dan prvega ciklusa infuzij ter tudi takoj po infundiranju, na 3. dan vseh nadaljnjih ciklusov.
English: Patients had an EDSS from 0-3.0, at least 2 clinical episodes of MS in the prior 2 years, and ≥1 gadolinium-enhancing lesion at study entry.
Slovenian: Bolniki so imeli rezultat EDSS od 0 do 3,0, vsaj 2 klinični epizodi MS v preteklih 2 letih in ≥ 1 lezijo po gadolinijevem kontrastiranju ob vključitvi v študijo.
English: See LEMTRADA Health Care Professional Guide for more information, or read the summary of product characteristics available at the EMA website mentioned above.
Slovenian: Za več informacij preberite vodnik o zdravilu LEMTRADA za zdravstvene delavce ali preberite povzetek glavnih značilnosti zdravila, ki je na voljo na zgoraj omenjeni spletni strani agencije EMA.
English: In addition, you will be monitored during the infusion and for 2 hours after the infusion has been completed.
Slovenian: Poleg tega vas bodo spremljali med infuzijo in še dve uri po njej.
English: • During infusion: o Perform continuous/frequent (at least every hour) monitoring of heart rate, blood pressure and overall clinical status of the patients Discontinue the infusion
Slovenian: • Med infundiranjem: o Izvajajte stalen/pogost (vsaj vsako uro) nadzor srčne frekvence, krvnega tlaka in bolnikovega celotnega kliničnega stanja.
English: • feelings of anxiety, depression
Slovenian: • občutek tesnobe, depresija
English: If you are using such a medicine, your doctor may ask you to stop this medicine before starting treatment with LEMTRADA.
Slovenian: Če jemljete kakšno takšno zdravilo, vam bo zdravnik morda naročil prekinitev jemanja tega zdravila pred začetkom zdravljenja z zdravilom LEMTRADA.
English: SC IFNB-1a
Slovenian: alemtuzumab SC IFNB-1a
English: Clinically significant thrombocytopenia needs to be followed until resolution.
Slovenian: Klinično pomembno trombocitopenijo je treba spremljati, dokler ne mine.
English: Thyroid disease (see section 4.4 Thyroid Disorders) poses special risks in women who are pregnant.
Slovenian: Bolezni ščitnice (glejte poglavje 4.4 Bolezni ščitnice) so posebej nevarne za nosečnice.
English: The bag should be inverted gently to mix the solution.
Slovenian: Vrečko je treba previdno obračati, da se raztopina premeša.
English: The European Medicines Agency has waived the obligation to submit the results of studies with alemtuzumab in children from birth to less than 10 years in treatment of multiple sclerosis (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z alemtuzumabom za otroke od rojstva do manj kot 10 let starosti pri zdravljenju multiple skleroze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).