FrancophonIA/ELRC3.0 huggingface dataset:
English: • have other side effects, most often blood disorders from taking MabCampath.
Slovenian: • imate druge neželene učinke, najpogosteje spremembe v krvi, zaradi jemanja zdravila MabCampath.
English: Lymphocyte depletion was rapidly reversible after cessation of dosing.
Slovenian: Izčrpanje limfocitov je bilo po prekinitvi uporabe hitro reverzibilno.
English: In the studies in first line and previously treated patients no substantial differences in safety and efficacy related to age were observed; however the
Slovenian: V študijah, ki so vključevale predhodno nezdravljene bolnike (zdravljenje prvega izbora) in pri že predhodno zdravljenih bolnikih ni mogoče opaziti znatnih razlik v varnosti ali učinkovitosti, povezanih s starostjo; vendar pa so podatki omejeni.
English: Also, you should not be vaccinated with live viral vaccines during treatment and for at least 12 months after you have finished your treatment.
Slovenian: Prav tako vas med zdravljenjem in vsaj še 12 mesecev po koncu zdravljenja ne smejo cepiti z živimi virusnimi cepivi.
English: Not Applicable
Slovenian: ni veljavno
English: Of the first-line patients (n=282) in whom baseline cytogenetic (FISH) data were available in Study 4, chromosomal aberrations were detected in 82%, while normal karyotype was detected in 18%.
Slovenian: Od predhodno nezdravljenih bolnikov (n=282), za katere so bili razpoložljivi osnovni citogenetski (FISH) podatki v študiji 4, je mogoče pri 82 % opaziti kromosomske spremembe, 18 % pa jih ima normalen kariotip.
English: Solutions may be stored at 15C-30C or refrigerated.
Slovenian: Raztopino lahko shranjujete pri temperaturi od 15 C - 30 C ali v hladilniku.
English: Concomitant medicinal products
Slovenian: Sočasno uporabljena zdravila
English: MabCampath should be used within 8 hours after dilution.
Slovenian: Zdravilo MabCampath je treba uporabiti v 8 urah po razredčenju.
English: It is not proposed that regular and systematic monitoring of CD52 expression should be carried out as routine clinical practice.
Slovenian: Reden in sistematičen nadzor ekspresije CD52 ni mišljen kot del vsakdanje klinične prakse.
English: As such, half-life was 8 hours (range: 2-32 hours) after the first 30 mg dose and was 6 days (range: 1-14 days) after the last 30 mg dose.
Slovenian: V teh okoliščinah je bil razpolovni čas 8 ur (razpon od 2 do 32 ur) po prvem 30-mg odmerku in 6 dni (razpon od 1 do 14 dni) po zadnjem 30-mg odmerku.
English: In first line patients, treated with either MabCampath or chlorambucil, there were 21 patients with the 17p deletion, 54 patients with 11q deletion, 34 patients with trisomy 12, 51 patients with normal karyotype and 67 patients with sole 13q deletion.
Slovenian: Izmed tako z zdravilom MabCampath kot s klorambucilom zdravljenih bolnikov je bilo 21 bolnikov z izbrisom 17p, 54 bolnikov z izbrisom 11q, 34 bolnikov s trisomijo 12, 51 bolnikov z normalnim kariotipom in 67 bolnikov izključno z izbrisom kariotipa 13q.
English: The cytogenetic profile of B-CLL has been increasingly recognized as providing important prognostic information and may predict response to certain therapies.
Slovenian: Citogenetski profil B-KLL je pomemben pri prognozi bolezni in glede na ta profil je mogoče predvideti odziv na določeno zdravljenje.
English: Profound lymphocyte depletion, an expected pharmacological effect of MabCampath, inevitably occurs and may be prolonged.
Slovenian: Hudo zmanjšanje števila limfocitov je pričakovan farmakološki učinek zdravila MabCampath; je neizogibno in je lahko dolgotrajno.
English: In this study, asymptomatic positive PCR only for CMV was reported in 77/147 (52.4%) of MabCampath-treated patients; symptomatic CMV infection was reported less commonly in 23/147 MabCampath treated patients (16%).
Slovenian: V tej študiji so poročali le o asimptomatsko pozitivnem PCR samo za CMV pri 77/147 (52,4 %) bolnikih, zdravljenimi z zdravilom MabCampath; simptomatska okužba s CMV je bila opažena manj pogosto pri 23/147 bolnikih, zdravljenimi z zdravilom MabCampath (16 %).
English: • have been treated in the past with chemotherapies or general medications that have a high risk of causing heart damage, your doctor may wish to monitor your cardiac function (ECG, heart rate, body weight) while receiving MabCampath.
Slovenian: • so vas v preteklosti zdravili s kemoterapijo ali z zdravili, pri katerih obstaja veliko tveganje za povzročitev okvare na srcu; vaš zdravnik bo med uporabo zdravila MabCampath nadzoroval delovanje vašega srca (npr. EKG, srčno frekvenco, telesno maso).
English: • The risk of infusion reactions o Need for premedication o That treatment for hypersensitivity reactions, including measures for resuscitation should be available during administration o That the risk of infusion reactions is highest in first week of therapy o That if the reaction is moderate or severe dosing should continue at the same level (ie no dose escalation) until each dose is well tolerated o That if therapy is withheld for more than 7 days then MabCampath should be reinstituted with gradual dose escalation
Slovenian: • tveganje reakcij po infundiranju o potreba po premedikaciji o da mora biti med uporabo zdravila na voljo zdravljenje preobčutljivostnih reakcij, vključno z ukrepi za reanimacijo o da je tveganje reakcij po infundiranju najvišje v prvem tednu zdravljenja o če je reakcija zmerna ali močna, se mora odmerna shema nadaljevati z enako stopnjo (to pomeni brez zvečanja odmerka), dokler bolnik odmerka ne prenese dobro o če je bilo zdravljenje prekinjeno za več kot 7 dni, je treba zdravilo MabCampath ponovno uvesti s postopnim stopnjevanjem odmerka.
English: Cardiac disorders: Congestive heart failure, cardiomyopathy, and decreased ejection fraction have been reported in patients previously treated with potentially cardiotoxic agents.
Slovenian: Srčne bolezni: poročali so o kongestivnem srčnem popuščanju, kardiomiopatiji ali znižanem iztisnem deležu pri bolnikih, ki so bili predhodno zdravljeni s potencialno kardiotoksičnimi zdravili.
English: WHAT MABCAMPATH IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO MABCAMPATH IN ZA KAJ GA UPORABLJAMO
English: There is no known specific antidote for MabCampath.
Slovenian: Za zdravilo MabCampath ni znanega specifičnega antidota.
English: It is not known whether MabCampath is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo MabCampath pri ljudeh izloča v materino mleko.
English: Clear type I glass vial, closed with a rubber stopper, containing 1 ml of concentrate.
Slovenian: Viala iz brezbarvnega stekla tipa I, zaprta z gumijastim zamaškom, vsebuje 1 ml koncentrata.
English: MabCampath was shown to be superior to chlorambucil as measured by the primary endpoint progression free survival (PFS) (see Figure 1).
Slovenian: Izkazalo se je, da je zdravilo MabCampath boljše kot klorambucil, kar je razvidno iz meritev v prvi končni točki merjenja preživetja brez napredovanja bolezni (PFS) (oglejte si sliko 1).
English: MabCampath contains no antimicrobial preservatives, therefore, it is recommended that MabCampath should be prepared for intravenous infusion using aseptic techniques and that the diluted solution for infusion should be administered within 8 hours after preparation and protected from light.
Slovenian: Zdravilo MabCampath ne vsebuje protimikrobnih konzervansov, zato ga je treba za intravensko infundiranje pripraviti v aseptičnih pogojih, razredčeno raztopino za infundiranje pa uporabiti v 8 urah po pripravi, zaščiteno pred svetlobo.
English: The antibody is produced in mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
Slovenian: Protitelo je pridobljeno iz suspenzije kulture celic sesalcev (jajčnik kitajskega hrčka) v hranilnem mediju.
English: In data available from first line patients treated with MabCampath, loss of CD52 expression was not observed around the time of disease progression or death.
Slovenian: Iz podatkov, ki so na voljo o bolnikih, pri katerih je bilo zdravljenje z zdravilom MabCampath zdravljenje prvega izbora, izgube ekspresije CD52 med napredovanjem bolezni ali ob smrti ni mogoče opaziti.
English: However, caution should be exercised as confusion and somnolence have been reported.
Slovenian: Potrebna je previdnost, ker so pri bolnikih poročali o pojavu zmedenosti in zaspanosti.
English: No apparent difference in pharmacokinetics between males and females was observed nor was any apparent age effect observed.
Slovenian: Med farmakokinetiko pri moških in ženskah ni bilo opaznih razlik; prav tako niso opazili razlik glede na starost.
English: If a patient improves (i.e. achieves a partial response or stable disease) and then reaches a plateau without further improvement for 4 weeks or more, then MabCampath should be discontinued and the patient monitored.
Slovenian: doseže delen odziv ali stabilno bolezen) in potem za 4 tedne ali več nastopi obdobje brez nadaljnjega izboljšanja, je treba uporabo zdravila MabCampath prekiniti in bolnika nadzorovati.
English: If these events are moderate to severe, then dosing should continue at the same level prior to each dose escalation, with appropriate premedication, until each dose is well tolerated.
Slovenian: Če so ti učinki zmerni do hudi, je treba zdravljenje pred nadaljnim stopnjevanjem odmerka nadaljevati z enakim odmerkom in ustrezno premedikacijo, dokler bolnik odmerka ne prenaša dobro.
English: Acute infusion reactions usually occur during the first week of therapy and substantially decline thereafter.
Slovenian: Akutne reakcije zaradi infundiranja se običajno pojavijo v prvem tednu zdravljenja in postopoma izzvenijo.
English: The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage.
Slovenian: Priporočljivo je uporabljati lateksne rokavice in zaščitna očala, da se prepreči izpostavljenost v primeru razbitja viale ali drugega naključnega razlitja.
English: In addition, testing indicating the presence of antibodies that may destroy red blood cells (Coombs test) has been reported.
Slovenian: Poročali so tudi o prisotnosti protiteles proti rdečim krvnim celicam (pozitiven Coombsov test).
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: Izobraževalno brošuro Povzetek lastnosti zdravila (SPC) z navodilom za uporabo in označbo
English: The frequency of infusion reactions was highest in the first week of therapy, and declined in the second or third week of treatment, in patients treated with MabCampath both as first line therapy and in previously treated patients.
Slovenian: Pogostnost učinkov zaradi infundiranja je bila največja v prvem tednu zdravljenja, v drugem ali tretjem tednu zdravljenja pa je neželenih učinkov manj pri bolnikih, ki so se z zdravilom MabCampath predhodno že zdravili ali pa so šele začeli z zdravljenjem z zdravilom MabCampath.
English: Each pack of MabCampath contains 3 vials.
Slovenian: Eno pakiranje zdravila MabCampath vsebuje 3 viale.
English: The required amount of the vial contents should be added to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Slovenian: Potrebno količino vsebine viale je treba dodati v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali 5 % raztopine glukoze za infundiranje.
English: If therapy is withheld for more than 7 days, MabCampath should be reinstituted with gradual dose escalation.
Slovenian: Če je zdravljenje prekinjeno za več kot 7 dni, je treba zdravljenje z zdravilom MabCampath ponovno začeti s postopnim povečevanjem odmerka.
English: As a result of this binding, the lymphocytes die, and this helps to control the CLL.
Slovenian: Posledica vezave je odmiranje limfocitov, kar pomaga pri zdravljenju KLL.
English: In the MabCampath arm 36/77 (46.8%) of patients with asymptomatic PCR positive CMV received antiviral therapy and 47/77 (61%) of these patients had MabCampath therapy interrupted.
Slovenian: 36/77 (46,8 %) od teh bolnikov, zdravljenih z zdravilom MabCampath, ki so bili PCR asimptomatsko pozitivni na CMV, je prejelo protivirusno zdravljenje, pri 47/77 (61 %) teh bolnikov pa so zdravljenje z zdravilom MabCampath prekinili.
English: Clear Type I glass ampoule, containing 3 ml of concentrate.
Slovenian: Ampula iz brezbarvnega stekla tipa I vsebuje 3 ml koncentrata.
English: Chest pain Influenza-like symptoms
Slovenian: • gripi podobni simptomi
English: It is recommended that MabCampath should be interrupted in patients whose platelet count falls to < 25,000/l or whose absolute neutrophil count (ANC) drops to < 250/l.
Slovenian: Uporabo zdravila MabCampath je priporočljivo prekiniti pri bolnikih, ki se jim število trombocitov zmanjša na < 25.000/l ali jim absolutno število nevtrofilcev (ANCabsolute neutrophil count) pade na < 250/l.
English: • tumour lysis syndrome (a metabolic disorder, which may begin with pains in the side and blood in the urine)
Slovenian: • sindrom razpada tumorja (presnovna motnja, ki se lahko začne z bolečinami v ledvenem predelu in prisotnostjo krvi v seču).
English: Treatment may be reinstituted following resolution of the haematological toxicity (see section 4.2).
Slovenian: Zdravljenje se lahko znova začne, ko hematološki toksični učinki minejo (glejte poglavje 4.2).
English: Patients may have allergic or hypersensitivity reactions to MabCampath and to murine or chimeric
Slovenian: Bolniki lahko doživijo alergijske ali preobčutljivostne reakcije na zdravilo MabCampath in na murina ali himerna monoklonska protitelesa.
English: - Active second malignancies.
Slovenian: • imate še kakšno drugo aktivno maligno bolezen
English: Figure 1: Progression free survival in first line study (by treatment group)
Slovenian: Slika 1: Preživetje brez napredovanja bolezni v študiji predhodno nezdravljenih bolnikov (zdravljenje prvega izbora) (glede na skupino zdravljenja)
English: In previously treated patients receiving MabCampath, the median time to reach a level of 200 cells/l is 2 months following last infusion with MabCampath but may take more than 12 months to approximate pretreatment levels.
Slovenian: Pri bolnikih, ki so že bili zdravljeni z zdravilom MabCampath, je srednja vrednost trajanja, da doseže raven 200 celic/l, 2 meseca po zadnji infuziji zdravila MabCampath, vendar lahko traja več kot 12 mesecev, da se število približa ravni pred zdravljenjem.
English: • unsteadiness, increased muscle tone
Slovenian: • motnje ravnotežja, povečana mišična napetost
English: Human IgG is known to cross the placental barrier; MabCampath may cross the placental barrier as well and thus potentially cause foetal B and T cell lymphocyte depletion.
Slovenian: Znano je, da človeški IgG prehajajo skozi placento; tudi zdravilo MabCampath lahko prehaja skozi placento ter tako povzroči izčrpanje limfocitov B in T pri plodu.
English: When you first receive MabCampath, you may experience side effects soon after the first infusions (see section 4 “Possible side effects”).
Slovenian: Ko prvič dobite zdravilo MabCampath, se vam lahko kmalu po prvih infundiranjih pojavijo neželeni učinki (glejte poglavje 4.
English: Do not use MabCampath if you notice any signs of particulate matter or discolouration prior to
Slovenian: Ne uporabljajte zdravila MabCampath, če pred uporabo opazite kakršnekoli znake delcev ali razbarvanja.
English: Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, nonmodulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages.
Slovenian: Alemtuzumab povzroči lizo limfocitov z vezavo na CD52, močno izražen nemodulacijski antigen, prisoten na površini skoraj vseh limfocitov B in T, pa tudi monocitov, timocitov in makrofagov.
English: • are pregnant or you think you may be pregnant, you should tell your doctor immediately.
Slovenian: • svojemu zdravniku takoj povedati, če ste noseči ali mislite, da ste noseči,
English: *Pearson chi-square test or Exact test *** log-rank test stratified by Rai group (Stage I-II vs III-IV)
Slovenian: *Pearsonov preskus korelacije ali preskus pomembnosti **Trajanje najboljšega odziva ***dnevnik stopenj, razvrščen glede na skupine po Raiju (stadij I-II vs. III-IV) ****glede na 4-barvni pretok
English: Each pack of MabCampath contains 3 ampoules.
Slovenian: Eno pakiranje zdravila MabCampath vsebuje 3 ampule.
English: In particular, you should not be given MabCampath within 3 weeks of taking any other anti-cancer
Slovenian: Zlasti pomembno je, da zdravila MabCampath ne dobite manj kot 3 tedne pred oz. po drugih zdravilih proti raku.
English: The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the ampoule or other accidental spillage.
Slovenian: Priporočljivo je uporabljati lateksne rokavice in zaščitna očala, da se prepreči izpostavljenost v primeru razbitja ampule ali drugega naključnega razlitja.
English: Patients should be premedicated with oral or intravenous steroids, an appropriate antihistamine and analgesic 30-60 minutes prior to each MabCampath infusion during dose escalation and as clinically indicated thereafter (see section 4.4).
Slovenian: Premedikacijo s peroralnimi ali intravenskimi steroidi, primernim antihistaminikom in analgetikom je treba izvesti 30 - 60 minut pred vsakim infundiranjem zdravila MabCampath med stopnjevanjem in kot je klinično indicirano v nadaljevanju (glejte poglavje 4.4).
English: België/Belgique/Belgien/ Luxemburg/ Luxembourg
Slovenian: België/Belgique/Belgien/ Luxemburg/Luxembourg Genzyme Belgium N.V.
English: More than 80% of previously treated patients may be expected to experience adverse reactions; the most commonly reported reactions usually occur during
Slovenian: Pri več kot 80 odstotkih predhodno zdravljenih bolnikov so bili neželeni učinki pričakovani; najpogosteje so se neželeni učinki pojavili v prvem tednu zdravljenja.
English: The required amount of the ampoule contents should be added, via a sterile, low-protein binding, non-fibre 5 μm filter, to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose (5%) solution for infusion.
Slovenian: Potrebno količino vsebine ampule je treba dodati prek sterilnega, nevlaknastega 5 μm filtra, ki malo veže beljakovine v 100 ml raztopine natrijevega klorida 9 mg/ml (0,9 %) za infundiranje ali 5 % raztopine glukoze za infundiranje.
English: MabCampath was administered as a 2 hour intravenous infusion, at the recommended dosing schedule, starting at 3 mg and increasing to 30 mg, 3 times weekly, for up to 12 weeks.
Slovenian: Zdravilo MabCampath so intravensko infundirali 2 uri po priporočeni odmerni shemi, tako da so začeli s 3 mg odmerkom in ga povečevali do 30 mg, trikrat na teden, do 12 tednov.
English: MabCampath may be reinstituted after the infection or toxicity has resolved.
Slovenian: Zdravljenje z zdravilom MabCampath se lahko ponovno začne, ko okužba ali toksični učinki minejo.
English: MabCampath is not recommended in children below 17 years of age or in patients who have kidney or
Slovenian: Uporaba zdravila MabCampath ni priporočljiva pri otrocih mlajših od 17 let in pri bolnikih z boleznimi ledvic ali jeter.
English: Patients should be monitored carefully (see
Slovenian: Bolnike je treba natančno nadzorovati (glejte poglavje 4.4).
English: No other findings, in the above toxicity studies, provide information of significant relevance to clinical
Slovenian: Omenjene študije toksičnosti niso pokazale drugih za klinično uporabo pomembnih informacij.
English: No short or long term animal studies have been conducted with MabCampath to assess carcinogenic
Slovenian: Kratkotrajnih ali dolgotrajnih študij zdravila MabCampath pri živalih za oceno kancerogenega in mutagenega potenciala niso izvedli.
English: You should
Slovenian: O tem vam bo
English: Significant Fab binding was also observed in the male reproductive tract (epididymis, sperm, seminal
Slovenian: Pomembno Fab vezavo so opažali tudi v moškem reproduktivnem sistemu (epididimisu, semenčicah, semenskih vrečkah) in koži.
English: Medicinal products for the treatment of hypersensitivity reactions, as well as preparedness to institute emergency measures in the event of reaction during administration is necessary (see section 4.2).
Slovenian: Za primer reakcij med uporabo zdravila morajo biti na razpolago zdravila za zdravljenje preobčutljivostnih reakcij kot tudi pripravljenost za izvajanje nujnih ukrepov (glejte poglavje 4.2).
English: In patients receiving MabCampath as first line therapy, the recovery of CD4+ counts to ≥200 cells/µl occurred by 6 months post-treatment, however, at 2 months post-treatment the median was 183 cells/l.
Slovenian: Pri bolnikih, ki dobivajo zdravilo MabCampath kot zdravilo prvega izbora, se je število celic CD4+ vrnilo na število 200 celic/µl v 6 mesecih po končanem zdravljenju, v 2 mesecih po zdravljenju pa se je povprečno število celic dvignilo na 183 celic/µl.
English: Systemic clearance decreased with repeated administration due to decreased receptor-mediated clearance (i.e. loss of CD52 receptors in the periphery).
Slovenian: Sistemski očistek se je z večkratno uporabo zmanjševal zaradi zmanjšanja receptorsko posredovanega očistka (t.j.
English: In the event that acute infusion reactions persist, the infusion time may be extended up to 8 hours from the time of reconstitution of MabCampath in solution for infusion.
Slovenian: Če akutna reakcija zaradi infundiranja ne izzveni, je možno čas infundiranja podaljšati do 8 ur od priprave raztopine zdravila MabCampath.
English: Store in the original packaging in order to protect from light.
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Caution should be exercised in the handling and preparation of the MabCampath solution.
Slovenian: Med pripravo in ravnanjem z raztopino MabCampath je potrebna previdnost.
English: MabCampath is used to treat patients with chronic lymphocytic leukaemia (CLL), a cancer of the lymphocytes (a type of white blood cell).
Slovenian: Zdravilo MabCampath se uporablja za zdravljenje bolnikov s kronično limfocitno levkemijo (KLL), kar je rak limfocitov (vrsta belih krvnih celic).
English: If treatment is needed, breast-feeding should be discontinued during treatment and for at least 4 weeks following MabCampath therapy.
Slovenian: Če je zdravljenje potrebno, je treba med zdravljenjem z zdravilom MabCampath in vsaj še 4 tedne po njem dojenje prekiniti.
English: Premedications
Slovenian: Premedikacija
English: Preclinical evaluation of alemtuzumab in animals has been limited to the cynomolgus monkey because of the lack of expression of the CD52 antigen on non-primate species.
Slovenian: Predklinično ocenjevanje alemtuzumaba pri živalih je bilo zaradi odsotnosti ekspresije antigena CD52 pri neprimatnih vrstah omejeno le na opice cynomolgus.
English: Median Age (Years)
Slovenian: Mediana starosti (leta)
English: The active substance in MabCampath, alemtuzumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila MabCampath, alemtuzumab, je monoklonsko protitelo.
English: Summary of first-line patient population and outcomes Independent review of response rate and duration MabCampath n=149
Slovenian: Pregled populacije in rezultatov predhodno ne zdravljenih bolnikov Neodvisen pregled stopnje odzivnosti in trajanje MabCampath n=149 Klorambucil n=148 Vrednost P
English: In the event of serious infection or severe haematological toxicity MabCampath should be interrupted until the event resolves.
Slovenian: V primeru resne okužbe ali hudih hematoloških toksičnih učinkov je treba zdravilo MabCampath prekiniti, dokler zaplet ne mine.
English: 53.4% Not Applicable N=82
Slovenian: 53,4 % ni veljavno