natgillin/translations-raw huggingface dataset:
Both cases were serious, were identified early through clinical and laboratory monitoring, and had a positive outcome after treatment.
V obeh primerih je bila bolezen resna in je bila odkrita s kliničnimi in laboratorijskimi preiskavami, po zdravljenju pa je bil izid pozitiven.
LEMTRADA does not cure MS, but it can reduce the number of MS relapses.
Zdravilo LEMTRADA ne ozdravi MS, vendar lahko zmanjša število recidivov MS.
4.5/3.8 years
4,5/3,8 let
Patients with other concomitant autoimmune diseases (besides MS).
Bolniki z drugimi sočasnimi avtoimunskimi boleznimi (poleg MS).
Mean Age (years) Mean/Median Disease duration
Izhodiščne lastnosti Povprečna starost (leta) Povprečno/mediano trajanje bolezni
Several of the patients reported were below 40 years of age and had no risk factors for ischemic heart disease.
Več bolnikov, o katerih so poročali, je bilo mlajših od 40 let in niso imeli dejavnikov tveganja za ishemično srčno bolezen.
He/She will advise you what is right for you and your baby.
Zdravnik/zdravnica vam bo svetoval(a) o najboljši izbiri za vas in vašega otroka.
1 Co-primary endpoints: ARR & CDW.
1 Sočasni primarni končni točki: ARR in CDW.
The number of normal sperm was significantly reduced (<10%) relative to controls and the percent abnormal sperm (detached heads or no heads) were significantly increased (up to 3%).
Število normalnih semenčic se je pomembno zmanjšalo (<10 %) v primerjavi s kontrolnimi živalmi, odstotek nenormalnih semenčic (z odstranjenimi glavicami ali brez njih) pa je bil pomembno povečan (do 3 %).
However, there may be benefits of breast milk (which can help protect a baby from infections), so talk to your doctor if you are planning to breast-feed your baby.
Vendar ima materino mleko lahko koristne učinke (ki lahko zaščitijo otroka pred okužbami), zato se posvetujte z zdravnikom, če nameravate svojega otroka dojiti.
• inflammation of the gallbladder with or without gallstones
• vnetje žolčnika z ali brez žolčnih kamnov
However, research suggests immunomodulatory effects through the depletion and repopulation of lymphocytes, including:
Vendar raziskave kažejo na imunomodulatorne učinke preko osiromašenja in ponovne naselitve limfocitov, vključno s:
Do not freeze or shake.
Ne zamrzujte ali stresajte.
When you have medical treatment, even if it is not for your MS, show the Patient Alert Card to the doctor.
Če se boste zdravili, tudi če ne zaradi MS, zdravniku pokažite opozorilno kartico za bolnika.
During post-marketing use, rare, serious, sometimes fatal and unpredictable adverse events from various organ systems have been reported.
V obdobju po prihodu zdravila na trg so poročali o redkih, resnih, včasih smrtnih in nepredvidljivih neželenih učinkih na različne organske sisteme.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden prejmete to zdravilo.
In MS your immune system mistakenly attacks the protective layer (myelin) around the nerve fibres, causing inflammation.
Pri MS vaš imunski sistem zmotno napada zaščitno ovojnico (mielin) okoli živčnih vlaken in povzroči vnetje.
Each infusion will take approximately 4 hours.
Ena infuzija traja približno štiri ure.
Study 3 (phase 2 study CAMMS223) evaluated the safety and efficacy of LEMTRADA in patients with RRMS over the course of 3 years.
V študiji 3 (študija 2. faze CAMMS223) so ocenjevali varnost in učinkovitost zdravila LEMTRADA pri bolnikih z RRMS v obdobju 3 let.
When the inflammation causes symptoms this is often called an “attack” or a “relapse”.
Pojav, ko vnetje povzroči simptome, običajno imenujemo „napad“ ali „recidiv“.
Median % Change in Brain Parenchymal Fraction
Mediana % sprememba v deležu možganskega parenhima
Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.
Pred začetkom uporabe zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Missed doses should not be given on the same day as a scheduled dose.
Zamujenih odmerkov se ne sme dajati na isti dan kot načrtovani odmerek.
Early detection and treatment of nephropathies may decrease the risk of poor outcomes.
Zgodnje odkrivanje in zdravljenje nefropatij lahko zmanjša tveganje slabega izida.
Patients who participated in CAMMS223, CAMMS323, or CAMMS32400507 (see baseline characteristics above)
Bolniki, ki so sodelovali v CAMMS223, CAMMS323 ali CAMMS32400507 (glejte izhodiščne značilnosti zgoraj)
The initial treatment you will receive will consist of one infusion per day for 5 days (course 1) and one infusion per day for 3 days one year later (course 2).
Začetno zdravljenje bo zajemalo eno infuzijo na dan 5 dni (1. postopek) in eno infuzijo na dan 3 dni eno leto kasneje (2. postopek).
The study provides efficacy and safety through a median of 6 years from entry into Studies 1 and 2.
Študija je zagotovila podatke o učinkovitost in varnosti za mediano 6 let od vključitve bolnikov v 1. in 2. študijo.
CB9 8PU United Kingdom
CB9 8PU Velika Britanija
This analysis includes data from Phase 3 studies only (CAMMS324 and CAMMS323) due to differences in the MRI acquisition algorithms between the Phase 2 and Phase 3 studies.
Ta analiza vključuje le podatke iz študij 3. faze (CAMMS324 in CAMMS323), ker se algoritmi pridobivanja MRposnetkov med študijami 2. in 3. faze razlikujejo.
LEMTRADA is used if your MS is highly active despite that you have been treated with at least one other medicine for MS or if your MS is rapidly evolving.
Zdravilo LEMTRADA se uporablja, če imate zelo aktivno MS, čeprav ste prejemali že vsaj eno drugo zdravilo za MS, ali če se vam MS razvija hitro.
Disability1 (Confirmed Disability Worsening [CDW] 2
Prizadetost2 (Potrjeno poslabšanje prizadetosti [confirmed disability worsening - CDW]
Symptoms have been reported to occur within a few months to four years following the initiation of treatment.
Poročali so, da se simptomi pojavijo od nekaj mesecev do štiri leta po začetku zdravljenja.
Before initiation of therapy, evaluation of immune serostatus could be considered according to local guidelines.
Pred začetkom zdravljenja lahko v skladu z lokalnimi smernicami pride v poštev ocena imunskega serološkega statusa.
For these reasons, comparison of the incidence of antibodies to LEMTRADA with the incidence of antibodies to other products may be misleading.
Zaradi tega je primerjava pojavnosti protiteles proti zdravilu LEMTRADA s pojavnostjo protiteles proti drugim zdravilom lahko zavajajoča.
LEMTRADA is not recommended for patients with inactive disease or those stable on current therapy.
Zdravilo LEMTRADA ni priporočljivo za bolnike z neaktivno boleznijo ali bolnike, ki so stabilni s trenutnim zdravljenjem.
Doses higher than the recommended dose may result in more serious or longer lasting infusion reactions (see section 4) or a stronger effect on the immune system.
Odmerki, ki so večji od priporočenih, lahko privedejo do resnejših ali dalj časa trajajočih z infuzijo povezanih reakcij (glejte poglavje 4) ali močnejšega učinka na imunski sistem.
From a microbiological point of view, it is recommended that the product should be used immediately.
Z mikrobiološkega vidika je treba zdravilo nemudoma uporabiti.
Human Immunodeficiency Virus (HIV) infection.
Okužba z virusom človeške imunske pomanjkljivosti (HIV).
Other treatments to limit these reactions can also be given before the infusion or when you experience symptoms.
Za omejevanje teh reakcij se lahko pred infuzijo ali ob pojavu simptomov dajejo tudi druga zdravila.
The observation time should be extended (hospitalisation) as appropriate.
Čas opazovanja (hospitalizacijo) je treba podaljšati, če je potrebno.
Your doctor will explain to you what tests you will need.
Zdravnik vam bo pojasnil, katere preiskave je treba opraviti pri vas.
The ability to generate an immune response to any vaccine following LEMTRADA treatment has not been studied.
Sposobnost imunskega odziva na katero koli cepivo po zdravljenju z zdravilom LEMTRADA ni bila preučena.
The pharmacokinetics of alemtuzumab in RRMS has not been studied in patients aged 55 years and older.
Farmakokinetika alemtuzumaba pri RRMS ni bila preizkušena na bolnikih, starih 55 let in več.
• sensation of spinning or loss of balance, migraine
• občutek vrtenja ali izguba ravnotežja, migrena
2 Patient Guide:
2 Vodnik za bolnike:
• tuberculosis
• tuberkoloza
Excipients with known effect
Pomožna snov z znanim učinkom
Therefore, it is recommended that all female patients have an annual screening performed, such as a cervical smear.
Zato je priporočljivo, da vse ženske opravljajo letne presejalne preglede, kot je bris materničnega vratu.
It is not known if LEMTRADA affects your response to a vaccine.
Ni znano, ali zdravilo LEMTRADA vpliva na vaš odziv na cepivo.
Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
Conclusions cannot be made with available data on the effect of race and gender on the pharmacokinetics of alemtuzumab.
Na podlagi razpoložljivih podatkov ne moremo sklepati na vpliv rase in spola na farmakokinetiko alemtuzumaba.
Before initiation of therapy, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection, according to local guidelines.
Pred uvedbo zdravljenja je treba v skladu z lokalnimi smernicami vse bolnike pregledati glede aktivne in neaktivne ("latentne") okužbe s tuberkulozo.
Thyroid disorders could be harmful to the baby (see section 2 Warnings and precautions - autoimmune conditions).
Bolezni ščitnice so lahko škodljive za otroka (glejte poglavje 2 Opozorila in previdnostni ukrepi - avtoimunske bolezni).
Pack size: carton with 1 vial.
Velikosti pakiranja: škatla z 1 vialo.
In most cases, these are mild but serious infections can occur.
V večini primerov so okužbe blage, vendar se lahko pojavijo tudi resne okužbe.
• kidney stones, excretion of ketone bodies in urine, kidney disease
• ledvični kamni, izločanje ketonskih teles v urinu, bolezni ledvic
The mechanism by which LEMTRADA exerts its therapeutic effects in MS is not fully elucidated.
Mehanizem, preko katerega zdravilo LEMTRADA doseže terapevtske učinke pri MS, ni povsem dognan.
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.
Človeška protitelesa IgG dokazano prehajajo placentarno bariero, zato lahko to bariero prehaja tudi alemtuzumab in zaradi tega potencialno predstavlja tveganje za plod.
(to diagnose all important serious side effects listed above)
krvna preiskava (za določitev vseh pomembnih resnih neželenih učinkov, ki so navedeni zgoraj)
Treatment-naïve patients Patients with inadequate response to prior therapy*
Bolniki z nezadostnim odzivom na predhodno zdravljenje*
In most cases these are mild but some serious reactions are possible.
V večini primerov so reakcije blage, vendar se lahko pojavijo tudi resne reakcije.
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.
Odmerki zdravila LEMTRADA, ki so večji od preskušenih v kliničnih študijah, povečajo intenzivnost in/ali trajanje z infuzijo povezanih reakcij ali njihove imunske učinke.
• infection due to a virus known as Epstein-Barr virus
• okužba z virusom, imenovanim Epstein-Barrov virus
• abnormally heavy, prolonged or irregular menstruation
• nenormalno močna, dolga ali neredna menstrualna krvavitev
Patients with uncontrolled hypertension.
Bolniki z neurejeno hipertenzijo.
In RRMS patients experience relapses followed by periods of recovery.
Pri bolnikih z RRMS recidivom sledijo obdobja okrevanja.
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.
Aktivno in latentno tuberkulozo, vključno s posameznimi primeri diseminirane tuberkuloze, so ugotovili pri 0,3 % bolnikov, zdravljenih z zdravilom LEMTRADA, najpogosteje v endemskih področjih.
Extended observation time (hospitalization) should be considered, as appropriate.
Razmisliti je treba o podaljšanem času opazovanja (hospitalizacije), če je potrebno.
It can also lead to damage of your lungs, which can result in coughing up blood.
Lahko pride tudi do poškodbe pljuč, kar se kaže kot izkašljevanje krvi.
However, benefits of conferred immunity through breast-milk may outweigh the risks of potential exposure to alemtuzumab for the suckling newborn/infant.
Vendar lahko koristi imunosti, ki se prenaša z materinim mlekom, odtehtajo tveganje potencialne izpostavljenosti novorojenčka/dojenčka alemtuzumabu.
Fertility and reproduction
Plodnost in razmnoževanje
Skin papilloma
kožni papilom
Most patients in controlled clinical trials received antihistamines and/or antipyretics before at least one LEMTRADA infusion.
Večina bolnikov v kontroliranih kliničnih preskušanjih je prejela antihistaminike in/ali antipiretike vsaj pred eno infuzijo zdravila LEMTRADA.
Serum concentrations were low or undetectable within approximately 30 days following each treatment course.
Serumske koncentracije so bile nizke ali nezaznavne po približno 30 dneh po vsakem postopku zdravljenja.
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.
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.
3 years‡
3 leta‡
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.
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.
These additional treatment courses may be adminisitered twelve months or more after the prior treatments.
Dodatne cikle zdravljenja se daje dvanajst mesecev ali več po predhodnem zdravljenju.
Patients with 6-month CDW (95% CI)
Bolniki s 6-mesečnim CDW (95-odstotni IZ)
Therefore, regular blood and urine tests are needed until 4 years after your last infusion.
Zato so potrebne preiskave krvi in urina še štiri leta po zadnji infuziji.
E339, disodium edetate, E508, E340, E433, sodium chloride, water for injections
SEZNAM POMOŽNIH SNOVI E339, dinatrijev edetat , E508, E340, E433, natrijev klorid, voda za injekcije
The symptoms you experience are determined by which part of your central nervous system is affected.
Simptomi, ki se pojavijo, so odvisni od dela osrednjega živčnega sistema, ki je prizadet.
Resources for the management of anaphylaxis or serious reactions (see below) should be available.
Na voljo mora biti vse potrebno za obvladanje anafilaksije ali resnih reakcij (glejte spodaj).
LEMTRADA has not been administered for treatment of MS concomitantly with or following antineoplastic or immunosuppressive therapies.
Zdravilo LEMTRADA ni bilo uporabljeno za zdravljenje MS sočasno z ali po antineoplastičnih ali imunosupresivnih zdravljenjih.
• If non-compliant, patients may need further counseling to highlight the risks of missing scheduled monitoring tests.
• Če bolnik ne sodeluje, mu je morda treba dodatno svetovati glede tveganja zaradi izpuščenih preiskav.
It is unlikely that your dose would be missed since it is administered by a health care professional.
Ni verjetno, da bi pozabili vzeti odmerek, saj vam ga odmeri zdravstveni delavec.
Show the Patient Alert Card and this package leaflet to any doctor involved with your treatment, not only to your neurologist.
Opozorilno kartico za bolnika in to navodilo za uporabo pokažite vsem zdravnikom, ki vas zdravijo, ne le svojemu nevrologu.
Most patients were treated conservatively with antibiotics and recovered without surgical intervention, whereas others underwent cholecystectomy.
Večino bolnikov so zdravili konzervativno z antibiotiki in so okrevali brez kirurškega posega, pri preostalih so opravili holecistektomijo.
Information from use of alemtuzumab prior to the marketing authorisation of LEMTRADA outside of company-sponsored studies
Informacije o uporabi alemtuzumaba, pridobljene pred pridobitvijo dovoljenja za promet z zdravilom LEMTRADA izven študij, ki jih je podprl izdelovalec
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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
Information on preparing to administer LEMTRADA and patient monitoring
Informacije o pripravah za dajanje zdravila LEMTRADA in spremljanju bolnika
There is no known antidote for alemtuzumab over dosage.
Ni znanega antidota za preveliko odmerjanje alemtuzumaba.
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).
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).
The damage done to your nerves during this inflammation may be reversible, but as your disease progresses the damage may accumulate and become permanent.
Poškodbe živcev zaradi vnetja so lahko odpravljive, vendar se z napredovanjem bolezni poškodbe lahko kopičijo in postanejo trajne.
Terms marked with asterisk (*) in Table 1 include adverse reactions reported as Infusion Associated Reactions.
Izrazi v preglednici 1, označeni z zvezdico (*), so neželeni učinki, ki so poročani kot z infuzijo povezane reakcije.
CD3+ and CD4+ lymphocyte counts rise more slowly towards normal, but generally do not return to baseline by 12months post-treatment.
Ravni limfocitov CD3+ in CD4+ rastejo počasneje proti normalnim vrednostim, vendar se običajno ne povrnejo na izhodiščne ravni v 12 mesecih po zdravljenju.
Within each frequency grouping, adverse reactions have been presented in order of decreasing seriousness.
Znotraj vsake kategorije pogostnosti so neželeni učinki navedeni s padajočo resnostjo.
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.
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.
If you have been diagnosed with cancer in the past, please inform your doctor about it.
• Predhodno postavljena diagnoza raka Če ste bili v preteklosti diagnosticirani z rakom, o tem obvestite svojega zdravnika.
Without treatment of hypothyroidism during pregnancy, there is an increased risk for miscarriage and foetal effects such as mental retardation and dwarfism.
Če se hipotiroidizem med nosečnostjo ne zdravi, obstaja povečano tveganje splava ali učinkov na plod, kot sta umska zaostalost in pritlikavost.
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.
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.
1 Patient Alert Card: For the patient to present to other healthcare providers to alert them to the use of LEMTRADA in this patient.
1 Opozorilna kartica za bolnika: ki jo bolnik pokaže drugim zdravstvenim delavcem, da jih opozori, da se zdravi z zdravilom LEMTRADA
Study population
Preučena populacija
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.
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.
There is a limited amount of data from the use of alemtuzumab in pregnant women.
Podatki o uporabi alemtuzumaba pri nosečnicah so omejeni.
If you become pregnant after treatment with LEMTRADA and experience a thyroid dirorder during pregnancy, extra caution is needed.
Če zanosite po zdravljenju z zdravilom LEMTRADA in se med nosečnostjo pojavi bolezen ščitnice, je potrebna posebna previdnost.
It is not known whether alemtuzumab can cause foetal harm when administered to pregnant women or whether it can affect reproductive capacity.
Ni znano, ali lahko alemtuzumab škoduje plodu, če se daje nosečnici oz. ali lahko vpliva na sposobnost razmnoževanja.
Having an untreated thyroid disorder could harm your unborn baby, or harm your baby after birth.
Nezdravljena bolezen ščitnice lahko škoduje nerojenemu otroku ali otroku po rojstvu.
HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation.
HLH je življenjsko nevaren sindrom patološke imunske aktivacije, za katerega so značilni klinični znaki in simptomi skrajnega sistemskega vnetja.
These are described in section 4.4.
Ti neželeni učinki so opisani v poglavju 4.4..
- 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)
- 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)
Follow-up of patients
Sledenje bolnikom
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2 C - 8 C).
Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered.
Bolnike, ki se jim pojavijo zgodnji znaki patološke imunske aktivacije, je treba nemudoma ovrednotiti in upoštevati je treba možnost, da gre za HLH.
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.
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.
Adverse reactions are listed by Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT).
Neželeni učinki so navedeni po organskih sistemih Medicinskega slovarja za regulativne zadeve (MedDRA - Medical Dictionary for Regulatory Activities) in prednostnih izrazih.