natgillin/translations-raw huggingface dataset:
These reactions led to unscheduled termination of 6/36 animals treated with obinutuzumab during dosing and recovery phases; these changes were partially reversible.
Te reakcije so povzročile nenačrtovano prekinitev pri 6/36 živali, ki so prejemale obinutuzumab med fazo odmerjanja in okrevanja; spremembe so bile delno reverzibilne.
· A typical schedule is shown below.
• Tipičen razpored je prikazan spodaj.
This is because treatment with Gazyvaro may affect yours or the baby's health.
Zdravljenje z zdravilom Gazyvaro namreč lahko vpliva na vaše ali otrokovo zdravje.
followed by 48 hours (including infusion time) at ≤ 30°C.
8 °C, čemur sledi 48 ur (vključno s časom infundiranja) pri temperaturi ≤ 30 °C.
When these symptoms go away, or improve, the infusion can be continued.
Ko ti simptomi minejo ali se izboljšajo, je infundiranje mogoče nadaljevati.
From a microbiological point of view, the prepared infusion solution should be used immediately.
Z mikrobiološkega stališča je treba pripravljeno raztopino za infundiranje uporabiti takoj.
The majority of the patients in study GAO4753g had FL (81.1%).
Večina bolnikov v študiji GAO4753g je imela FL (81,1 %).
However, if you get an infusion related reaction, (see section 4), do not drive, cycle or use any tools or machines until the reaction stops.
Če pa se vam pojavi reakcija, povezana z infuzijo (glejte poglavje 4), ne upravljajte vozil, ne kolesarite in ne uporabljajte kakršnih koli orodij ali strojev, dokler reakcija ne mine.
Patients should continue to receive repeated prophylaxis prior to each subsequent infusion, if deemed appropriate.
Bolniki morajo nadaljevati z jemanjem ponovnih profilaks pred vsako nadaljnjo infuzijo, če se smatra, da je to primerno.
Do not increase the infusion rate.
Ne povečajte hitrosti infundiranja.
· you are allergic to obinutuzumab or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na obinutuzumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Gastro-Intestinal Perforation
Gastro-intestinalne perforacije
However, no notable differences in quality of life during follow up have been identified to date.
Vendar do zdaj med spremljanjem niso ugotovili pomembnih razlik v kakovosti življenja.
Clearly label each infusion bag.
Obe infuzijski vrečki jasno označite.
Due to the open label design the patient reported outcomes should be interpreted with caution.
Zaradi odprte zasnove študije je treba izide po navedbi bolnika razlagati previdno.
If treatment is necessary it should be administered in accordance with local guidelines and the administration of granulocyte-colony stimulating factors (G-CSF) should be considered.
Če je potrebno zdravljenje, ga je treba uporabiti v skladu z lokalnimi smernicami in razmisliti o uporabi granulocitne kolonije stimulirajočih faktorjev (granulocyte-colony stimulating factor - G-CSF).
In addition these patients should be hydrated with caution in order to prevent a potential fluid overload.
Poleg tega je treba pri teh bolnikih hidracijo izvajati previdno, da bi preprečili možno preobremenitev s tekočino.
Antibodies are mostly cleared by catabolism.
Protitelesa se večinoma odstranijo s katabolizmom.
While the clinical significance of HAHA is not known, a potential correlation between HAHA and clinical course cannot be ruled out.
Čeprav klinični pomen protiteles HAHA ni znan, možne povezave med protitelesi HAHA in kliničnim potekom ni mogoče izključiti.
There are no data from the use of obinutuzumab in pregnant women.
Podatkov o uporabi obinutuzumaba pri nosečnicah ni.
Gazyvaro is available in a pack containing 1 glass vial.
Zdravilo Gazyvaro je na voljo v pakiranju, ki vsebuje 1 stekleno vialo.
This includes medicines obtained without a prescription and herbal medicines.
To velja tudi za zdravila, ki ste jih dobili brez recepta, in zdravila rastlinskega izvora.
The patient should be referred to a neurologist for the evaluation and treatment of PML.
Bolnika je treba napotiti k nevrologu za ovrednotenje in zdravljenje PML.
The median age was 73 years, with 44% being 75 years or older.
Mediana starosti je bila 73 let in 44 % oseb je bilo starih 75 let ali več.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Če ni uporabljena takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas po navadi ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če je bilo razredčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
The symptoms of PML are nonspecific and can vary depending on the affected region of the brain.
Simptomi PML so nespecifični in se lahko razlikujejo glede na prizadet možganski predel.
Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines.
Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
This decreasing trend continued during maintenance therapy with Gazyvaro alone.
Ta trend zmanjševanja se je nadaljeval med vzdrževalnim zdravljenjem s samim z zdravilom Gazyvaro.
Fatal infections have been reported.
Poročali so o okužbah s smrtnim izidom.
The safety and timing of vaccination should be discussed with the infant's physician (see section 4.6).
O varnosti in časovni shemi cepljenja se je treba pogovoriti z dojenčkovim zdravnikom (glejte poglavje 4.6).
Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their anti-hypertensive medicine.
Pri bolnikih z akutnim tveganjem za hipertenzivno krizo je treba oceniti tveganja in koristi zadržanja njihovih antihipertenzivnih zdravil.
In such instances, all subsequent visits and the start of Cycle 2 will be shifted to accommodate for the delay in Cycle 1.
V takšnih primerih naj bodo vsi nadaljnji obiski in začetek 2. cikla zdravljenja prestavljeni glede na odlog v 1. ciklu.
The demographics data and baseline characteristics were well balanced between the treatment arms.
Demografski podatki in izhodiščne značilnosti so bili med skupinama dobro uravnoteženi.
Gazyvaro should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Zdravila Gazyvaro se pri nosečnicah ne sme uporabljati, razen če možna korist odtehta možno tveganje.
Gazyvaro can cause some serious side effects that you need to tell your doctor or nurse about straight away.
Zdravilo Gazyvaro lahko povzroči nekatere resne neželene učinke, o katerih morate takoj povedati zdravniku ali medicinski sestri.
Medicines given before each infusion
Zdravila, uporabljena pred vsakim infundiranjem
No definitive conclusions could be drawn on efficacy in the MZL and SLL sub-populations.
Dokončni sklepi o učinkovitosti pri subpopulacijah z MZL in SLL niso bili mogoči.
Every 2 months for 2 years or until disease progression (whichever occurs first)
Vsaka 2 meseca v obdobju 2 let ali do napredovanja bolezni (glede na to, kar se zgodi prej)
Patients with positive hepatitis B serology should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation.
Bolniki s pozitivnimi serološkimi izvidi za hepatitis B se morajo pred začetkom zdravljenja posvetovati s specialistom za jetrne bolezni; treba jih je nadzorovati in voditi v skladu z lokalnimi zdravstvenimi standardi, da bi preprečili reaktivacijo hepatitisa.
Pay attention to the following side effects
Bodite pozorni na naslednje neželene učinke
The safety and efficacy of Gazyvaro in children and adolescents aged below 18 years has not been established.
Varnost in učinkovitost zdravila Gazyvaro pri otrocih in mladostnikih, mlajših od 18 let, nista ugotovljeni.
Hydrocortisone should not be used as it has not been effective in reducing rates of IRR.
Hidrokortizona se ne sme uporabiti, ker ni bil učinkovit za zmanjšanje deleža reakcij, povezanih z infuzijo.
#with a higher incidence (difference of ≥ 2% between the treatment arms).
# Z večjo incidenco (razlika ≥ 2 % med skupinama).
Exposure in utero to obinutuzumab and vaccination of infants with live virus vaccines
Izpostavljenost obinutuzumabu in utero in cepljenje dojenčkov z živimi virusnimi cepivi
Patients with active hepatitis B disease should not be treated with Gazyvaro.
Bolnikov z aktivnim hepatitisom B se ne sme zdraviti z zdravilom Gazyvaro.
Transfusion of blood products (i.e. platelet transfusion) according to institutional practice is at the discretion of the treating physician.
Transfuzija krvnih pripravkov (tj. transfuzije trombocitov) je v skladu s prakso v ustanovi prepuščena presoji lečečega zdravnika.
· If you get an infusion related reaction, you may require additional treatment, or the infusion may need to be slowed down or stopped.
• Če dobite reakcijo, povezano z infuzijo, boste morda potrebovali dodatno zdravljenje ali bo infundiranje morda treba upočasniti ali ustaviti.
NR (22.5,-)
ND (22,5; -)
Obinutuzumab is administered intravenously, therefore absorption is not applicable.
Obinutuzumab se uporablja intravensko, zato podatek o absorpciji ni relevanten.
Do not give Gazyvaro to children or young people under 18 years of age.
Zdravila Gazyvaro ne smemo dati otrokom ali osebam, mlajšim od 18 let.
Patients with FL Grade 3b were excluded from the study.
Bolniki s folikularnim limfomom gradusa 3b so bili iz študije izključeni.
All patients considered at risk should be carefully monitored during the initial days of treatment with a special focus on renal function, potassium, and uric acid values.
Vse bolnike s tveganjem je treba pozorno spremljati med prvimi dnevi zdravljenja s posebno pozornostjo na ledvično delovanje, vrednosti kalija in sečne kisline.
Late onset neutropenia (occurring >28 days after the end of treatment) or prolonged neutropenia (lasting more than 28 days after treatment has been completed/stopped) may occur.
Pojavi se lahko zapoznela nevtropenija (ki nastopi > 28 dni po koncu zdravljenja) ali dolgotrajna nevtropenija (ki traja več kot 28 dni po dokončanju/prenehanju zdravljenja).
The majority of patients were Caucasian (95%) and male (61%).
Večina bolnikov je bila belcev (95 %) in 61 % je bilo moških.
At a minimum this should include hepatitis B surface antigen (HBsAg) status and hepatitis B core antibody (HBcAb) status.
To mora obsegati vsaj določitev stanja površinskega antigena hepatitisa B (HBsAg) in stanja središčnega protitelesa proti hepatitisu B (HBcAb).
This is indicative of target mediated drug disposition (TMDD), where the initial abundance of CD20 cells causes a rapid removal of obinutuzumab from the circulation.
To kaže na ciljno posredovano odstranjevanje zdravila (target mediated drug disposition - TMDD), pri katerem začetna količina CD20+ celic povzroči hitro odstranjevanje obinutuzumaba iz obtoka.
Therefore, no pharmacokinetic interaction is expected with medicinal products known to be metabolised by these enzyme systems.
Zato ni pričakovati farmakokinetičnih medsebojnih delovanj z zdravili, ki se presnavljajo s temi encimskimi sistemi.
In patients treated with G+ B, 79.4% received all six treatment cycles compared to 66.7% of patients in the B arm.
Med bolniki, zdravljenimi z G + B, jih je 79,4 % prejelo vseh šest ciklov zdravljenja; v skupini, ki je prejemala B, je bilo takšnih 66,7 %.
HR (95% CI)
HR (95-% IZ)
Recovery of B-cells was observed within 12-18 months of follow up in 35% (14 out of 40) of patients without progressive disease and 13% (5 out of 40) with progressive disease.
Okrevanje celic B so opažali v 12 do 18 mesecih spremljanja pri 35 % (14 od 40) bolnikov brez napredujoče bolezni in pri 13 % (5 od 40) z napredujočo boleznijo.
● a hole in the stomach or intestines (gastrointestinal perforation, especially in cases where the cancer affects the gastrointestinal tubes)
• luknja v želodcu ali črevesju (predrtje prebavil, še posebej v primerih, ko rak prizadane prebavno cev)
· Full dose (1,000 mg) once every 2 months for up to 2 years as long as your disease does not progress.
• Celoten odmerek (1000 mg) enkrat na vsaka 2 meseca naslednji 2 leti, dokler vaša bolezen ne napreduje.
A therapy choice for these patients should carefully consider the overall safety profile of Gazyvaro plus chemotherapy and the patient-specific situation.
Pri izbiri zdravljenja za te bolnike je treba skrbno pretehtati celokupni varnostni profil zdravila Gazyvaro v kombinaciji s kemoterapijo ter specifično situacijo bolnika.
· Store in a refrigerator (2 °C-8 °C).
• Shranjujte v hladilniku (2-8 °C).
The diagnosis of PML should be considered in any patient presenting with new-onset or changes to pre-existing neurologic manifestations.
Na diagnozo PML je treba pomisliti pri vsakem bolniku z novonastalimi nevrološkimi spremembami ali spremembi že obstoječih nevroloških stanj.
While fatal haemorrhagic events occurred in less than 1% of patients; none of the fatal adverse events occurred in Cycle 1.
Hemoragični dogodki s smrtnim izidom so se pojavili pri manj kot 1 % bolnikov, nobeden od neželenih učinkov s smrtnim izidom pa se ni pojavil v 1. ciklu.
· Tell your doctor or nurse if you are pregnant, think you might be pregnant or are planning to have a baby.
Nosečnost • Zdravniku ali medicinski sestri povejte, če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev.
If toxicity occurs before Cycle 1 Day 8 or Cycle 1 Day 15, requiring delay of treatment, these doses should be given after resolution of toxicity.
Če se pred 8. dnem 1. cikla ali pred 15. dnem 1. cikla pojavi toksičnost, ki zahteva odlog zdravljenja, se mora te odmerke aplicirati potem, ko toksični učinek izzveni.
· CLL and FL are types of cancer that affect white blood cells called “B-lymphocytes”.
• KLL in FL sta dve vrsti raka, ki prizadeneta vrsto belih krvnih celic, imenovanih limfociti B.
Gazyvaro is not likely to affect your ability to drive, cycle or use any tools or machines.
Ni verjetno, da bi zdravilo Gazyvaro vplivalo na vašo sposobnost za vožnjo, kolesarjenje ali uporabo orodij ali strojev.
Antiviral and antifungal prophylaxis should also be considered (see section 4.2).
Razmisliti je treba tudi o protivirusni in protiglivični profilaksi (glejte poglavje 4.2).
No studies have been performed to establish the carcinogenic potential of obinutuzumab.
Študij za oceno kancerogenega potenciala obinutuzumaba niso izvedli.
This subgroup comprised 21% (253/1202) of the FL ITT population and experienced 16.3% (40/245) of the PFS events.
Ta podskupina je predstavljala 21 % (253/1202) populacije folikularnega limfoma z namenom zdraviti in je imela 16,3 % (40/245) primerov PFS.
The median time from initial diagnosis was 3 years and the median number of prior therapies was 2 (range 1 to 10); 44% of patients had received 1 prior therapy and 34% of patients had received 2 prior therapies.
Mediani čas od prve diagnoze je bil 3 leta in mediano število predhodnih zdravljenj 2 (razpon: od 1 do 10); eno predhodno zdravljenje je prejelo 44 % bolnikov in dve predhodni zdravljenji 34 % bolnikov.
Health-related quality of life assessments, specific to fatigue through treatment period, show no statistically significant difference suggesting that the addition of Gazyvaro to a chlorambucil regimen does not increase the experience of fatigue for patients.
Ocene kakovosti življenja, specifične za utrujenost med obdobjem zdravljenja, ne kažejo statistično značilne razlike; to kaže, da dodatek zdravila Gazyvaro shemi s klorambucilom bolnikom ne poveča utrujenosti.
No significant difference was observed in the pharmacokinetics of obinutuzumab among patients < 65 years (n=375), patients between 65-75 years (n=265) and patients > 75 years (n=171).
Farmakokinetika obinutuzumaba se ni bistveno razlikovala med bolniki, starimi < 65 let (n = 375), bolniki, starimi od 65 do 75 let (n = 265), in bolniki, starimi > 75 let (n = 171).
This is because there is no information about its use in these age groups.
O njegovi uporabi v teh starostnih skupinah namreč ni podatkov.
Therefore patients with a history of cardiac disease should be monitored closely.
Zato je treba bolnike z anamnezo srčne bolezni natančno nadzirati.
As treatment continues, the impact of this pathway diminishes and the linear clearance pathway predominates.
Med nadaljevanjem zdravljenja pa se pomen te poti zmanjšuje in prevlada pot linearnega očistka.
The incidence and intensity of adverse reactions reported in these studies did not appear to be dose dependent.
Incidenca in izrazitost neželenih učinkov, opisanih v teh študijah, po vsem sodeč nista odvisni od odmerka.
However, once the majority of CD20 cells are bound with obinutuzumab, the impact of TMDD on PK is minimised.
Ko pa je večina CD20+ celic vezana z obinutuzumabom, se vpliv TMDD na farmakokinetiko minimizira.
Obinutuzumab elimination comprises two parallel pathways which describe clearance, a linear clearance pathway and a non-linear clearance pathway which changes as a function of time.
Obinutuzumab se odstranjuje po dveh vzporednih poteh, ki opisujeta očistek: pot linearnega očistka in pot nelinearnega očistka, ki se spreminja v odvisnosti od časa.
The profile of adverse reactions in patients with FL was consistent with the overall iNHL population in both studies.
Profil neželenih učinkov pri bolnikih s FL je bil v obeh študijah skladen s celokupno populacijo iNHL.
Gazyvaro will be stored by the healthcare professionals at the hospital or clinic.
Shranjevanje zdravila Gazyvaro Zdravilo Gazyvaro bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
Dose modifications during treatment (all indications) No dose reductions of Gazyvaro are recommended.
Prilagoditev odmerka med zdravljenjem (vse indikacije) Zmanjšanja odmerka zdravila Gazyvaro niso priporočljiva.
During the initial treatment, the non-linear time-varying clearance pathway is dominant and is consequently the major clearance pathway.
Med začetnim zdravljenjem prevladuje pot nelinearnega časovno spremenljivega očistka, ki je posledično glavna pot očistka.
Infusion related reactions
Reakcije, povezane z infuzijo
Gazyvaro has no or negligible influence on the ability to drive and use machines.
Zdravilo Gazyvaro ne vpliva ali pa ima zanemarljiv vpliv na sposobnost za vožnjo in upravljanje strojev.
Infusion related reactions can happen during the infusion or up to 24 hours after the infusion.
Reakcije, povezane z infuzijo, se lahko pojavijo med infundiranjem ali v 24 urah po njem.
The incidence of thrombocytopenia was 14%.
Incidenca trombocitopenije je bila 14 %.
Fifty-seven percent received bendamustine, 33% received CHOP, and 10% received CVP chemotherapy.
Sedeminpetdeset % bolnikov je prejelo bendamustin, 33 % kemoterapijo CHOP in 10 % kemoterapijo
Gazyvaro should be prepared by a healthcare professional using aseptic technique.
Zdravilo Gazyvaro mora pripraviti zdravstveni delavec z uporabo aseptične tehnike.
Based on the FACT-Lym questionnaire and EQ-5D index scale collected during the treatment and during follow-up periods, health-related quality of life was generally maintained in the pivotal study with no meaningful difference between the arms.
Na podlagi vprašalnika FACT-Lym in indeksne lestvice EQ-5D, uporabljenih med zdravljenjem in obdobjem spremljanja, se je zdravstvena kakovost življenja v ključni študiji na splošno ohranila; med skupinama ni bilo pomembnih razlik.
These may include:
Med takšnimi so lahko:
Gazyvaro should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available.
Dajanje zdravila Gazyvaro mora potekati pod natančnim nadzorom izkušenega zdravnika in v okolju, kjer je takoj na voljo vse potrebno za oživljanje.
Gazyvaro can then be used on its own for up to 2 years as a “maintenance treatment”.
Zdravilo Gazyvaro lahko do 2 leti uporabljamo samostojno kot vzdrževalno zdravljenje.
Following intravenous administration, the volume of distribution of the central compartment (2.98 L in patients with CLL and 2.97 in patients with iNHL), approximates serum volume, which indicates distribution is largely restricted to plasma and interstitial fluid.
Po intravenski uporabi je volumen porazdelitve centralnega razdelka (2,98 l pri bolnikih s KLL in 2,97 l pri bolnikih z iNHL) blizu volumna seruma; to kaže, da je porazdelitev v veliki meri omejena na plazmo in intersticijsko tekočino.
The demographic data and baseline characteristics were well balanced between the treatment arms (median age 63 years, the majority were Caucasian [88%] and male [58%]).
Demografski podatki in izhodiščne značilnosti so bili med zdravljenima skupinama dobro uravnoteženi (mediana starost 63 let, večina je bila belcev [88 %] in moških [58 %]).
The reduction in the risk of disease progression or death seen in the iNHL population is driven by the subset of patients with FL.
Zmanjšanje tveganja za napredovanje bolezni ali smrt, ki so ga opazili v skupini bolnikov z iNHL, temelji na podskupini bolnikov s FL.
Discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy should also be considered.
V poštev pride tudi prenehanje ali zmanjšanje morebitne sočasne kemoterapije ali imunosupresivnega zdravljenja.
No specific studies in animals have been performed to evaluate the effect of obinutuzumab on fertility.
Pri živalih niso izvedli specifičnih študij za oceno vpliva obinutuzumaba na plodnost.
It specifically targets the extracellular loop of the CD20 transmembrane antigen on the surface of non-malignant and malignant pre-B and mature B-lymphocytes, but not on haematopoietic stem cells, pro-B-cells, normal plasma cells or other normal tissue.
Je specifično usmerjeno na zunajcelično zanko transmembranskega antigena CD20 na površini nemalignih in malignih pre-B in zrelih B-limfocitov, ne pa na krvotvorne matične celice, celice pro-B, zrele plazmatke ali druga normalna tkiva.
Therefore, in order to provide the most comprehensive safety information, the analysis of ADRs presented in the following has been performed on the entire study population (i.e. iNHL).
vključno s FL. Da bi zagotovili kar najbolj celovite varnostne informacije, je bila analiza neželenih učinkov, predstavljenih v nadaljevanju, izvedena na celotni študijski populaciji (tj. iNHL).
Instructions on the rate of infusion are shown in Tables 4 and 5.
Navodila glede hitrosti infundiranja so prikazana v preglednicah 4 in 5.
Use of any concomitant therapies which could possibly worsen thrombocytopenia-related events, such as platelet inhibitors and anticoagulants, should also be taken into consideration, especially during the first cycle.
Upoštevati je treba tudi sočasno uporabo katerih koli zdravil, ki lahko poslabšajo s trombocitopenijo povezane dogodke, na primer zaviralcev trombocitov in antikoagulantov; to je treba še zlasti upoštevati v prvem ciklu.
· On Day 1 of your first cycle, you will be given part of your first Gazyvaro dose of 100 milligrams (mg) very slowly.
• Prvi dan prvega cikla boste zelo počasi dobili del prvega odmerka zdravila Gazyvaro, ki znaša 100 miligramov (mg).
In the follicular lymphoma studies, a high incidence of infections was observed in all phases of the studies, including follow-up, with the highest incidence seen in the maintenance phase.
V študijah folikularnega limfoma so v vseh fazah, vključno z obdobjem spremljanja, opazili visoko incidenco okužb; najvišjo incidenco so zaznali pri bolnikih v vzdrževalni fazi.
It should be given as an intravenous infusion through a dedicated line after dilution (see section 6.6).
Po razredčenju ga je treba dati kot intravensko infuzijo po posebni liniji (glejte poglavje 6.6).
· If you do not have an infusion related reaction following the small part of your first dose, you may be given the rest of your first dose (900 mg) on the same day.
• Če se vam po infundiranju majhne količine prvega odmerka ne pojavi reakcija, povezana z infuzijo, lahko dobite preostanek prvega odmerka (900 mg) še isti dan.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2-8 °C).
Standard dosing of CHOP and CVP was given.
Za CHOP in CVP so uporabili standarno odmerjanje.