natgillin/translations-raw huggingface dataset:
In the event of relapse, patients may receive 1000 mg IV.
V primeru recidiva lahko bolniki dobijo 1000 mg intravensko.
• If you respond well to treatment, you may be given MabThera as a maintenance treatment every 2 or 3 months for two years.
· Če se boste dobro odzvali na zdravljenje, boste lahko zdravilo MabThera dobivali kot vzdrževalno zdravljenje na dva meseca ali tri, in sicer dve leti.
The hypodermic injection needle must only be attached to the syringe immediately prior to administration to avoid potential needle clogging.
Hipodermično injekcijsko iglo je treba namestiti na brizgo šele tik pred dajanjem zdravila, da bi preprečili možno zamašitev igle.
METHOD OF ADMINISTRATION Only for subcutaneous use
POSTOPEK UPORABE Samo za subkutano uporabo
In embryofetal developmental studies in mice, rHuPH20 caused reduced fetal weight and loss of implantations at systemic exposures sufficiently in excess of human therapeutic exposure.
V študijah embrio-fetalnega razvoja pri miših je rHuPH20 povzročil manjšo telesno maso in izgubo implantatov pri sistemskih izpostavljenostih, ki so občutno presegale terapevtsko izpostavljenost pri človeku.
The primary objective for the study was complete remission (complete epithelialisation and absence of new and/or established lesions) at month 24 without the use of prednisone therapy for two months or more (CRoff for ≥2 months).
Primarni cilj študije je bila popolna remisija (CR - complete remission) (popolna epitelizacija in odsotnost novih in/ali razvitih lezij) po 24 mesecih brez uporabe prednizonskega zdravljenja v obdobju dveh mesecev ali več (CRoff za ³ 2 meseca).
This should be followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day, and tapered as rapidly as possible based on clinical need) during and after the 4 week induction course of MabThera treatment.
1 mg/kg/dan prednizona peroralno (odmerek ne sme preseči 80 mg/dan in ga je treba zmanjšati, kolikor hitro je mogoče glede na klinične potrebe) med in po 4-tedenskem indukcijskem zdravljenju z zdravilom MabThera.
As typical for monoclonal antibodies, rituximab PK parameters depended on body size measures.
Kot je značilno za monoklonska protitelesa, so farmakokinetični parametri rituksimaba odvisni od telesne velikosti.
The MAH must ensure that all physicians who are expected to prescribe MabThera are provided with the following:
Imetnik dovoljenja za promet mora zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali zdravilo MabThera, prejeli:
At Week 24, patients who were seropositive to RF and/or anti-CCP at baseline had a significantly increased probability of achieving ACR20 and 50 responses compared to seronegative patients (p=0.0312 and p=0.0096) (Table 15).
Po 24 tednih so imeli bolniki, ki so bili izhodiščno seropozitivni za RF in/ali anti-CCP, značilno večjo verjetnost, da dosežejo odziv ACR20 in 50, v primerjavi s seronegativnimi bolniki (p = 0,0312 in p = 0,0096) (preglednica 15).
This is because side effects can develop several months after you have had treatment.
ker se lahko neželeni učinki pojavijo več mesecev po zdravljenju.
Of the 99 patients treated with MabThera, 12 (12%) experienced at least one IRR.
Od 99 bolnikov, zdravljenih z zdravilom MabThera, se je pri 12 (12 %) pojavila vsaj ena IRR.
The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Končna analiza učinkovitosti je vključevala vse randomizirane bolnike (197 CHOP, 202 R-CHOP); mediano sledenje bolnikov je trajalo približno 31 mesecev.
Patients should be observed for at least 15 minutes following MabThera subcutaneous administration.
Bolnika je treba opazovati vsaj 15 minut po podkožni uporabi zdravila MabThera.
Your doctor may need to take special care of you during your treatment with MabThera.
Zdravnik bo morda moral med zdravljenjem z zdravilom MabThera posebej poskrbeti za vas.
Significance levels were defined as * p<0.05, **p<0.001, ***p<0.0001.
Ravni signifikantnosti so bile opredeljene kot *p < 0,05; **p < 0,001; ***p < 0,0001.
The safety and efficacy of MabThera in children below 18 years has not been established.
Pediatrična populacija Varnost in učinkovitost zdravila MabThera pri otrocih do 18. leta starosti nista dokazani.
MabThera is indicated in adults for the following indications:
Zdravilo MabThera je pri odraslih indicirano za naslednje indikacije:
MabThera slows down the damage to your joints caused by rheumatoid arthritis and improves your ability to do normal daily activities.
Zdravilo MabThera upočasni nastanek okvar sklepov, ki so posledica revmatoidnega artritisa, ter izboljša vašo sposobnost za opravljanje običajnih dnevnih aktivnosti.
Other rarely-reported side-effects due to MabThera include a decreased number of white cells in the blood (neutrophils) that help to fight against infection.
Drugi neželeni učinki zdravila MabThera, o katerih so poročali redko, vključujejo zmanjšano število belih krvnih celic (nevtrofilcev), ki pomagajo v boju proti okužbam.
Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and very rare (<1/10,000).
Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta (≥ 1/100 do < 1/10), občasna (> 1/1000 do ≤ 1/100) in zelo redka (≤ 1/10.000).
Measure blood neutrophils prior to each course of MabThera, and regularly up to 6-months after cessation of treatment, and upon signs or symptoms of infection (see section 4.8).
Število nevtrofilcev v krvi je treba določiti pred vsakim ciklom zdravila MabThera in redno do 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
MabThera in combination with chemotherapy destroys these cells which are gradually removed from the body by biological processes.
Zdravilo MabThera v kombinaciji s kemoterapijo uniči te celice, ki se postopno odstranijo iz telesa z biološkimi procesi.
Rarely MabThera can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Redko lahko zdravilo MabThera povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.
This sticker should be removed from the vial and stuck onto the syringe prior to use.
To nalepko morate z viale odlepiti in jo pred uporabo nalepiti na brizgo.
Additionally, no effects on semen quality were shown for rHuPH20.
Poleg tega so ugotovili, da rHuPH20 ni vplival na kakovost semena.
Patient subpopulations - MabThera combination therapy Elderly patients (≥ 65 years)
Podskupine bolnikov - kombinirano zdravljenje z zdravilom MabThera Starejši bolniki (³ 65 let)
Some vaccines should not be given at the same time as MabThera or in the months after you receive MabThera.
Nekatera cepiva se ne smejo dajati sočasno z zdravilom MabThera ali nekaj mesecev po prejetju tega zdravila.
Initial treatment in combination with chemotherapy
Začetno zdravljenje v kombinaciji s kemoterapijo
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed and subsequent updates of the RMP.
Načrt za obvladovanje tveganja (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Table 17 Complete remission at 6-months by disease status MabThera
Popolna remisija po 6 mesecih glede na stanje bolezni MabThera
From month 12 to month 18, 8 relapses were observed in the MabThera group compared with four in the cyclophosphamide group.
Od 12. do 18. meseca so v skupini z zdravilom MabThera zabeležili 8 ponovitev in v skupini s ciklofosfamidom 4.
Immunomodulatory drugs may increase the risk of malignancy.
Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
Initiate at a rate of 250mg/hour for the first 30 minutes and then 600 mg/hour for the next 90 minutes.
Začetna hitrost infundiranja je 250 mg/h prvih 30 minut in nato 600 mg/h naslednjih 90 minut.
Of 67 patients evaluated for HAMA, no responses were noted.
Pri 67 bolnikih, pri katerih so analizirali prisotnost HAMA, teh niso opazili.
A small proportion of patients had prolonged peripheral B cell depletion lasting 2 years or more after their last dose of MabThera.
Pri majhnem deležu bolnikov je bil upad števila perifernih celic B dolgotrajen, trajal je 2 leti ali več po zadnjem odmerku zdravila
• Place all used needles and syringes into a sharps container (puncture-proof disposable container).
· Vse uporabljene igle in brizge zavrzite v vsebnik za ostre odpadke (proti prebadanju varen vsebnik za enkratno uporabo).
In a further clinical study, a total of 57 severe, active GPA and MPA patients in disease remission were treated with MabThera for the maintenance of remission (see section 5.1).
V nadaljnji klinični študiji so skupno 57 bolnikov s hudo aktivno GPA in MPA v remisiji bolezni zdravili z zdravilom MabThera za vzdrževanje remisije (glejte poglavje 5.1).
The safety information collected during post marketing experience reflects the expected adverse reaction profile as seen in clinical trials for MabThera (see section 4.4).
Podatki o varnosti, zbrani v obdobju po prihodu zdravila na trg, odražajo pričakovani profil neželenih učinkov, kot so ga opazili v kliničnih preskušanjih z zdravilom MabThera (glejte poglavje 4.4).
Kaplan-Meier Estimate of Median Time to Event (Months)
Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
Vaccination should be completed at least 4 weeks prior to first administration of MabThera.
Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo zdravila MabThera.
Many patients get some local side effects where MabThera is injected.
Številnim bolnikom se pojavijo nekateri lokalni neželeni učinki na mestu, kjer je bilo injicirano zdravilo MabThera.
There was no evidence of clinically relevant dependencies of rituximab pharmacokinetics on age and sex.
Ni bilo dokazov, da bi bila farmakokinetika rituksimaba klinično pomembno odvisna od starosti in spola.
Efficacy outcomes in MabThera treated patients were analysed based on autoantibody status prior to commencing treatment.
Izide učinkovitosti so pri bolnikih, zdravljenih z zdravilom MabThera, analizirali na podlagi stanja protiteles pred začetkom zdravljenja.
This is because MabThera may pass into breast milk.
Zdravilo MabThera namreč lahko prehaja v materino mleko.
• taste problems - such as changes in the way things taste
· motnje okušanja - na primer spremenjen okus stvari,
Peripheral blood B cell counts begin to increase from week 24 and evidence for repopulation is observed in the majority of patients by week 40, whether MabThera was administered as monotherapy or in combination with methotrexate.
Število perifernih celic B se je začelo povečevati od 24. tedna in znake ponovne populacije so opazili pri večini bolnikov do 40. tedna ne glede na to, ali so zdravilo MabThera prejemali kot samostojno zdravljenje ali v kombinaciji z metotreksatom.
These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70.
48. teden, ko je seropozitivnost prav tako značilno povečala verjetnost za doseganje odziva ACR70.
Ask your pharmacist how to throw away medicines that you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
All clearance and volume parameters increased with BSA.
Vsi očistki in volumski parametri so se povečevali s telesno površino.
Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Slika 4: Število bolnikov brez kortikosteroidnega zdravljenja ali z minimalnim kortikosteroidnim zdravljenjem (≤ 10mg/dan) glede na čas zdravljenja
serious viral infection2
resna virusna okužba2
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following MabThera therapy.
Podatki, ki so na voljo, nakazujejo, da je pojavnost klinično pomembnih okužb nespremenjena, ko ta zdravila uporabimo pri bolnikih, ki so jih prej zdravili z zdravilom MabThera, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z zdravilom MabThera prejmejo biološka zdravila in/ali DMARD.
• The other ingredients are recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, α,α-trehalose dihydrate, L-methionine, polysorbate 80 and water for injections.
· Druge sestavine zdravila so rekombinantna humana hialuronidaza (rHuPH20), L-histidin, L-histidin-klorid monohidrat, a,a-trehaloza-dihidrat, L-metionin, polisorbat 80 in voda za injekcije.
If a patient develops PML, the dosing of MabThera must be permanently discontinued.
Če se pri bolniku razvije PML, je treba uporabo zdravila MabThera dokončno ukiniti.
• Signs of PML include: - Confusion, memory loss or problems thinking - Loss of balance or a change in the way you walk or talk - Decreased strength or weakness on one side of your body - Blurred vision or loss of vision.
- zmedenost, izgubo spomina ali težave pri mišljenju, - izgubo ravnotežja ali spremembo v načinu govora ali hoje, - zmanjšano moč ali šibkost na eni strani telesa, - zamegljen vid ali izgubo vida.
Your doctor may prescribe MabThera for the treatment of:
Zdravnik vam lahko zdravilo MabThera predpiše za zdravljenje:
The rate of serious cardiac events was 2.1 per 100 patient years (95% CI 3 -15).
Delež resnih srčnih dogodkov je bil 2,1 na 100 bolnik-let (95-% interval zaupanja, 3-15).
MabThera + low-dose prednisone (n = 38)
MabThera + majhen odmerek prednizona (n = 38)
In placebo-controlled periods of clinical trials, 0.94% (13/1382) of MabThera treated patients and 0.27% (2/731) of placebo patients developed severe neutropenia.
V kliničnih preskušanjih nadzorovanih s placebom, je pri 0,94 % (13/1382) bolnikov zdravljenih z zdravilom MabThera in pri 0,27 % (2/731) bolnikov, ki so prejemali placebo, prišlo do razvoja hude nevtropenije.
• After aseptic dilution in D-glucose solution
· Po aseptični razredčitvi z raztopino D-glukoze
Some cases of late neutropenia occurring more than four weeks after the last infusion of MabThera were reported.
Poročali so o posameznih primerih pozne nevtropenije, ki se je pojavila več kot 4 tedne po zadnji infuziji zdravila MabThera.
Currently, there are limited data on possible drug interactions with MabThera.
Trenutno je le malo podatkov o mogočih medsebojnih učinkih zdravil pri uporabi zdravila MabThera.
Patients in the MabThera group who relapsed could receive an additional infusion of MabThera 1000 mg in combination with reintroduced or escalated prednisone dose.
Bolniki v skupini z zdravilom MabThera, ki se jim je pojavil recidiv, so lahko prejeli dodatno infuzijo 1000 mg zdravila MabThera v kombinaciji s ponovno uvedenim prednizonom ali povečanjem odmerka prednizona.
Beginning the therapy with MabThera intravenous infusion would allow a better handling of the administration reactions by slowing or stopping the intravenous infusion.
Začetek zdravljenja z intravensko infuzijo zdravila MabThera omogoča boljše obvladanje takšnih reakcij, ker je intravensko infuzijo mogoče upočasniti ali končati.
As with the intravenous formulation, MabThera subcutaneous formulation should be administered in an environment where full resuscitation facilities are immediately available and under the close supervision of an experienced healthcare professional.
Tako kot intravensko obliko je treba tudi podkožno obliko zdravila MabThera dajati v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo, ter pod natančnim nadzorom izkušenega zdravnika.
These studies support the use of MabThera with any chemotherapy.
Te študije podpirajo uporabo zdravila MabThera s katero koli kemoterapijo.
• pain in the muscles or in the hands or feet
· bolečina v mišicah ali dlaneh ali stopalih,
Names and addresses of the manufacturers of the biological active substance
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine
• you have ever had or might now have a hepatitis infection.
· če ste kdaj imeli okužbo z virusom hepatitisa, ali če menite, da jo imate zdaj.
MabThera subcutaneous formulation is not intended for intravenous administration and should be given via subcutaneous injection only.
Podkožna oblika zdravila MabThera ni namenjena intravenski uporabi in se lahko daje le s podkožno injekcijo.
Minor relapses (not life threatening and not involving major organ damage) occurred in seven patients in the MabThera group (12%) and eight patients in the azathioprine group (14%).
Blažji recidivi (takšni, ki niso bili življenjsko ogrožajoči in niso vključevali okvare pomembnega organa) so se pojavili pri sedmih bolnikih v skupini z zdravilom MabThera (12 %) in pri osmih bolnikih v skupini z azatioprinom (14 %).
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Iz kliničnih preskušanj ni zadostnih podatkov za popolno oceno varnosti uporabe drugih DMARD (vključno z zaviralci TNF in drugimi biološkimi zdravili), ki sledijo zdravljenju z zdravilom MabThera (glejte poglavje 4.5).
L-histidine hydrochloride monohydrate α,α-trehalose dihydrate L-methionine
L-histidin-klorid monohidrat a,a-trehaloza-dihidrat
This is because there is not much information about the use of MabThera in children and young people.
O uporabi zdravila MabThera pri otrocih in mladostnikih namreč ni veliko informacij.
These patients were treated either with MabThera monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Ti bolniki so prejemali zdravilo MabThera kot samostojno zdravljenje (kot indukcijsko zdravljenje ali vzdrževalno zdravljenje po indukcijskem zdravljenju) ali v kombinaciji s kemoterapijo.
Unopened vial 36 months
6.3 Rok uporabnosti Neodprta viala 36 mesecev
MabThera is usually taken together with another medicine called methotrexate.
Zdravilo MabThera se običajno jemlje skupaj z zdravilom, imenovanim metotreksat.
They are not specifically related to the route of administration of MabThera and can be observed with both formulations.
Reakcije niso specifično povezane s potjo uporabe zdravila MabThera in se lahko pojavijo pri obeh oblikah zdravila.
MabThera may be used for the treatment of several different conditions in adults.
Zdravilo MabThera se uporablja za zdravljenje več različnih bolezni pri odraslih.
Neutropenia was not associated with an observed increase in serious infection in MabThera-treated patients.
Nevtropenija ni bila povezana z opaznim povečanjem resnih okužb med bolniki, ki so prejemali zdravilo MabThera.
However, the higher incidence of neutropenia in patients treated with MabThera and chemotherapy was not associated with a higher incidence of infections and infestations compared to patients treated with chemotherapy alone.
Toda višje incidence nevtropenije pri bolnikih, ki so prejemali zdravilo MabThera v kombinaciji s kemoterapijo, ni spremljala višja incidenca infekcijskih in parazitskih bolezni kot pri bolnikih, zdravljenih samo s kemoterapijo.
Severe infusion-related reactions (such as bronchospasm, hypotension) occurred in up to 12 % of the cases.
Hude reakcije, povezane z infuzijo (npr. bronhospazem, hipotenzija), so se pojavile pri do 12 % bolnikov.
(see section 5.1).
(glejte poglavje 4.4).
Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving MabThera (see Section 4.4).
O reaktivaciji okužbe z virusom hepatitisa B so zelo redko poročali tudi pri bolnikih z revmatoidnim artritisom, ki so prejemali zdravilo MabThera (glejte poglavje 4.4).
The proportion of patients with IgG levels below the LLN was about 60% in the MabThera group throughout the 2 year treatment period, while it decreased in the observation group (36% after 2 years).
Delež bolnikov s koncentracijo IgG pod spodnjo mejo normalne vrednosti je bil med 2-letnim zdravljenjem približno 60 % v skupini, ki je prejemala zdravilo MabThera, v opazovani skupini pa se je zmanjšal (36 % po dveh letih).
Of 356 patients evaluated for anti-drug antibody (ADA), 1.1 % (4 patients) were positive.
Od 356 bolnikov, pri katerih so ocenjevali prisotnost protiteles proti zdravilu (anti-drug antibody -ADA), so bili pozitivni 4 bolniki (1,1 %).
All patients were followed until month 28 (10 or 6 months, respectively, after the last MabThera infusion or azathioprine dose).
Vse bolnike so spremljali do 28. meseca (10 mesecev po zadnji infuziji zdravila MabThera ali 6 mesecev po zadnjem odmerku azatioprina).
For patients who may be at higher risk for relapse, physicians should consider a longer duration of MabThera maintenance therapy, up to 5 years.
Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom MabThera, do 5 let.
Use of MabThera may be associated with an increased risk of progressive multifocal leukoencephalopathy (PML).
Uporaba zdravila MabThera je lahko povezana z večjim tveganjem za progresivno multifokalno levkoencefalopatijo (PML).
Table 2 Efficacy results for SAWYER (BO25341) (Intent to Treat Population)
Rezultati učinkovitosti za preskušanje SAWYER (BO25341) (populacija, ki so jo nameravali zdraviti)
• Severe vision loss (sign of brain nerves damage).
· ledvična odpoved · hudo poslabšanje vida (znak poškodbe možganskih živcev)
• you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems.
· če ste kdaj imeli težave s srcem (npr. angino pektoris, razbijanje srca ali srčno popuščanje) ali težave z dihanjem.
Some local cutaneous reactions occurred more than 24 hours after the MabThera subcutaneous administration.
Nekatere lokalne kožne reakcije so se pojavile več kot 24 ur po podkožni uporabi zdravila MabThera.
Trials of MabThera in patients with early arthritis (patients without prior methotrexate treatment and patients with an inadequate response to methotrexate, but not yet treated with TNF-alpha inhibitors) have met their primary endpoints.
V preskušanjih z zdravilom MabThera pri bolnikih z zgodnjim artritisom (bolniki, ki se še niso zdravili z metotreksatom in bolniki z nezadostnim odzivom na metotreksat, ki se še niso zdravili z zaviralci TNF-alfa) so bili primarni cilji doseženi.
It is important to check the medicinal product labels to ensure that the appropriate formulation (intravenous or subcutaneous formulation) is being given to the patient, as prescribed.
Pomembno je preveriti nalepke na zdravilu in tako zagotoviti, da bolnik dobi ustrezno obliko (intravensko ali podkožno), ki mu je bila predpisana.
This is because in a few cases, MabThera could cause hepatitis B to become active again, which can be fatal in very rare cases.
V maloštevilnih primerih namreč lahko bolezen zaradi zdravila MabThera ponovno izbruhne; to je lahko v zelo redkih primerih smrtno.
MabThera should not be administered to patients with an active, severe infection (e.g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e.g. where levels of CD4 or CD8 are very low).
Zdravila MabThera se ne sme dajati bolnikom z aktivno, hudo okužbo (npr. tuberkulozo, sepso ali oportunističnimi okužbami, glejte poglavje 4.3) ali hudo imunokompromitiranim bolnikom (npr. pri zelo nizkih vrednostih CD4 ali CD8).