natgillin/translations-raw huggingface dataset:
Therefore patients with a history of cardiac disease should be monitored closely (see Infusion-related reactions, above).
Bolnike z anamnezo bolezni srca je zato treba natančno opazovati (glejte Reakcije, povezane z infuzijo, zgoraj).
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake Uporabno do/EXP.
Pneumocystis jirovecii pneumonia prophylaxis was required for all patients with CD4+ T-lymphocyte counts less than 250 per cubic millimeter.
Profilaksa proti pljučnici zaradi Pneumocystis jirovecii je bila zahtevana za vse bolnike, ki so imeli število limfocitov T CD4+ manj kot 250 na kubični milimeter.
For mixing the solution, gently invert the bag in order to avoid foaming.
Za mešanje raztopine vrečko rahlo obrnemo, tako da preprečimo penjenje.
Patients with a history of pulmonary insufficiency or those with pulmonary tumour infiltration may be at greater risk of poor outcome and should be treated with increased caution.
Bolniki z anamnezo pljučne insuficience ali tisti s pljučno tumorsko infiltracijo imajo lahko večje tveganje za slab izid in jih je treba zdraviti posebno pazljivo.
This is because Ritemvia may pass into breast milk.
Zdravilo Ritemvia namreč lahko prehaja v materino mleko.
Prednisone N=36
prednizon n = 36
Treatment start date and contact details
Začetek zdravljenja in podatki za stik
Ritemvia may be used for the treatment of several different conditions in adults.
Zdravilo Ritemvia se uporablja za zdravljenje več različnih bolezni pri odraslih.
• taste problems - such as changes in the way things taste
motnje okušanja - na primer spremenjen okus stvari,
The majority of patients were ANCApositive at diagnosis or during the course of their disease; had histologically confirmed necrotizing small-vessel vasculitis with a clinical phenotype of GPA/MPA, or renal limited ANCA-associated vasculitis; or both.
Večina bolnikov je bila ob postavitvi diagnoze ali med potekom bolezni ANCA-pozitivnih; imeli so histološko potrjen nekrotizirajoč vaskulitis malih žil s kliničnim fenotipom GPA/MPA, ledvično omejen z ANCA povezan vaskulitis ali oboje.
No pharmacokinetic data are available in patients with hepatic or renal impairment.
Farmakokinetičnih podatkov pri bolnikih z jetrno in ledvično okvaro ni na voljo.
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 rituximab 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 rituksimab prejemali kot samostojno zdravljenje ali v kombinaciji z metotreksatom.
Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
Od bolnikov, ki so prvotno dobivali samo metotreksat, jih je 81% dobilo rituksimab kot rešilno zdravilo (rescue) med 16. in 24. tednom ali v okviru nadaljevalne študije pred 56. tednom.
Neutropenic events, including severe late onset and persistent neutropenia, have been rarely reported in the post-marketing setting, some of which were associated with fatal infections.
O dogodkih nevtropenije, vključno s hudo obliko pozne in dolgotrajne nevtropenije, so po prihodu zdravila na trg poročali redko, nekateri dogodki pa so bili povezani z usodnimi okužbami.
2Details on infusion related reactions are provided in the description of selected adverse drug reactions section.
Podrobnosti o reakcijah, povezanih z infundiranjem, so navedene v opisu v poglavju o izbranih neželenih učinkih zdravila.
Patients in a severely immunocompromised state.
Bolniki, ki so hudo imunsko oslabeli.
Efficacy outcomes in rituximab treated patients were analysed based on autoantibody status prior to commencing treatment.
Izide učinkovitosti so pri bolnikih, zdravljenih z rituksimabom, analizirali na podlagi stanja protiteles pred začetkom zdravljenja.
During or within the first 24 hours of the infusion you may develop fever, chills and shivering.
Med infuzijo ali v prvih 24 urah po njej se lahko pojavijo zvišana telesna temperatura, mrazenje in drgetanje.
IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
Reakcije, povezane z infuzijo, se lahko pojavijo kot rezultat preobčutljivosti in/ali mehanizma delovanja.
Measure blood neutrophils prior to each course of rituximab, 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 rituksimab in redno do 6 mesecev po končanem zdravljenju ter pri znakih ali simptomih okužbe (glejte poglavje 4.8).
For each term, the frequency count was based on reactions of all grades (from mild to severe), except for terms marked with "+" where the frequency count was based only on severe (≥ grade 3 NCI common toxicity criteria) reactions.
Pri vsakem izrazu so pri določitvi pogostnosti upoštevali neželene učinke vseh stopenj (od blage do hude), razen za izraze, označene s "+", kjer so pri določitvi pogostnosti upoštevali le hude neželene učinke (≥ 3. stopnja po lestvici skupnih meril toksičnosti Nacionalnega inštituta za raka (NCI common toxicity criteria)).
Mean change in DAS † Outcome at 24 weeks
† Izid po 24 tednih
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.
Specific studies to determine the effects of rituximab on fertility have not been performed.
Specifičnih študij za ugotavljanje učinkov rituksimaba na plodnost niso izvedli.
Prednisone tapering was to be completed by 6 months from the start of study treatment.
Postopno zmanjševanje prednizona so morali končati do 6 mesecev po začetku raziskovanega zdravljenja.
From month 12 to month 18, 8 relapses were observed in the rituximab group compared with four in the cyclophosphamide group.
Od 12. do 18. meseca so v skupini z rituksimabom zabeležili 8 ponovitev in v skupini s ciklofosfamidom 4.
Also please tell your doctor if you had a lot of infections in the past or suffer from severe infections.
Zdravniku povejte tudi, če imate pogoste ali hude okužbe;
Population pharmacokinetic analysis of the same data gave similar mean values for systemic clearance and half-life, 0.26 L/day and 20.4 days, respectively.
Populacijska farmakokinetična analiza istih podatkov je dala podobne povprečne vrednosti za sistemski očistek in razpolovni čas, 0,26 L/dan in 20,4 dni.
Cytokine release syndrome may be clinically indistinguishable from acute hypersensitivity reactions.
Sindrom sproščanja citokinov je lahko klinično nerazločljiv od akutnih preobčutljivostnih reakcij.
A diagnosis of PRES/RPLS requires confirmation by brain imaging.
Diagnozo PRES/RPLS je treba potrditi s slikanjem možganov.
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of IRRs (see sections 4.2 and 4.4).
Premedikacija z intravenskimi glukokortikoidi je pomembno znižala incidenco in resnost z infuzijo povezanih reakcij (glejte poglavji 4.2 in 4.4).
• an increase in the amount of potassium in the blood
povečanje količine kalija v krvi,
The antibody is produced by mammalian (Chinese hamster ovary) cell suspension culture and purified by affinity chromatography and ion exchange, including specific viral inactivation and removal procedures.
Protitelo je pridobljeno iz suspenzije kulture celic sesalcev (ovarij kitajskega hrčka) in očiščeno z afinitetno kromatografijo ter ionsko izmenjavo, vključno s specifičnimi postopki inaktivacije in odstranjevanja virusov.
The proportions of patients experiencing cardiac reactions (all or serious) did not increase over multiple courses.
Delež bolnikov, pri katerih so se pojavili neželeni učinki, povezani s srcem (vsi ali resni), se z nadaljnjimi cikli zdravljenja ni povečeval.
These patients were treated either with rituximab monotherapy (as induction treatment or maintenance treatment following induction treatment) or in combination with chemotherapy.
Ti bolniki so prejemali rituksimab kot samostojno zdravljenje (kot indukcijsko zdravljenje ali vzdrževalno zdravljenje po indukcijskem zdravljenju) ali v kombinaciji s kemoterapijo.
Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Število odzivnih (delež odziva [%]) aVrednost p je vrednost iz Fisherjevega eksaktnega testa s sredinskim popravkom p. b 95-% interval zaupanja je korigiran Newcombov interval.
Of the 99 patients treated with rituximab, 12 (12%) experienced at least one IRR.
Od 99 bolnikov, zdravljenih z rituksimab, se je pri 12 (12%) pojavila vsaj ena IRR.
Respiratory system Cases of interstitial lung disease, some with fatal outcome, have been reported.
Poročali so o primerih intersticijske bolezni pljuč, nekateri so bili smrtni.
This is because there is not much information about the use of Ritemvia in children and young people.
O uporabi zdravila Ritemvia pri otrocih in mladostnikih namreč ni veliko informacij.
INFORMATION IN BRAILLE <Justification for not including Braille accepted.>
PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna
However, because maternal IgG is excreted in human milk, and rituximab was detectable in milk from lactating monkeys, women should not breastfeed while treated with rituximab and for 12 months following rituximab treatment.
A zaradi dejstva, da se materini IgG izločajo v materino mleko, in da so rituksimab našli v mleku doječih opic, ženske med zdravljenjem z zdravilom rituksimab in 12 mesecev po njem ne smejo dojiti.
in the blood which help protect against infection
(IgG), v krvi; ta protitelesa pomagajo pri zaščiti proti okužbam.
In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
V primerjavi s sindromom sproščanja citokinov se prave preobčutljivostne reakcije praviloma pojavijo že v nekaj minutah po začetku infundiranja.
The incidence of thrombocytopenia was low (<1%, grade 3/4) and was not different between treatment arms.
Incidenca trombocitopenije je bila nizka (< 1% 3. ali 4. stopnje) in se med zdravljenima skupinama ni razlikovala.
PK parameters for rituximab were comparable over the two treatment courses.
Farmakokinetični parametri za rituksimab so bili med dvema cikloma zdravljenja primerljivi.
For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Zaradi podobnosti med boleznima sklepamo, da bi bili rezultati za bolnike s KLL podobni, a tega niso preučili v kliničnem preskušanju.
Corticosteroids given by mouth may be started at any time by your doctor to treat your condition.
Kortikosteroide, ki jih boste uživali, pa vam zdravnik lahko za zdravljenje vaše bolezni uvede kadar koli.
For patients who may be at higher risk for relapse, physicians should consider a longer duration of Ritemvia maintenance therapy, up to 5 years.
Pri bolnikih z večjim tveganjem za recidiv je treba razmisliti o dolgotrajnejšem vzdrževalnem zdravljenju z zdravilom Ritemvia, do 5 let.
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with rituximab, however patients should be closely observed for signs of infection if biologic agents and/or DMARDs are used following rituximab 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 rituksimabom, vendar jih moramo skrbno opazovati glede znakov okužbe, če po zdravljenju z zdravilom rituksimab prejmejo biološka zdravila in/ali DMARD.
Premedication and prophylactic medications
Premedikacijainprofilaktičnazdravila
No long-term animal studies have been performed to establish the carcinogenic potential of rituximab.
Dolgoročnih študij na živalih za ugotavljanje kancerogenega potenciala rituksimaba niso izvedli.
Treatment with rituximab in combination with methotrexate over multiple courses resulted in sustained improvements in the clinical signs and symptoms of RA, as indicated by ACR, DAS28ESR and EULAR responses which was evident in all patient populations studied (Figure 2).
Dolgotrajna učinkovitost z več cikli zdravljenja Zdravljenje z rituksimabom v kombinaciji z metotreksatom v več ciklih je prineslo stalno izboljšanje kliničnih znakov in simptomov RA, kot so pokazali odzivi po ACR, DAS28-ESR in EULAR; to je bilo opazno v vseh raziskovanih populacijah bolnikov (slika 2).
Talk to your doctor, pharmacist or nurse before you are given this medicine if you, or your child, are under 18 years of age.
Preden boste dobili to zdravilo, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če ste vi ali vaš otrok mlajši od 18 let.
In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings.
Pri vseh bolnikih z infuzijo nadaljujemo šele po prenehanju vseh simptomov, vzpostavitvi normalnih laboratorijskih vrednosti in rentgenskih izvidov prsnega koša.
Trial 1 evaluated 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Preskušanje 1 je ocenilo 517 bolnikov, ki so nezadovoljivo odgovorili na eno ali več zdravljenj z zaviralci TNF ali jih niso prenašali.
Vaccination should be completed at least 4 weeks prior to first administration of rituximab.
Cepljenje naj bo zaključeno najmanj 4 tedne pred prvo aplikacijo zdravila rituksimab.
This set of reactions which includes syndrome of cytokine release, tumour lysis syndrome and anaphylactic and hypersensitivity reactions are described below.
Ta skupina reakcij, ki vključuje sindrom sproščanja citokinov, sindrom razpada tumorja in anafilaktične ter preobčutljivostne reakcije, je opisana spodaj.
• Detailed information on the risk of PML, the need for timely diagnosis of PML and appropriate measures to diagnose PML
• podrobne podatke o tveganju za PML, informacije o nujnosti njene pravočasne diagnoze in ustreznih ukrepov za diagnosticiranje te bolezni,
Prednisone dose tapering and the decision to stop prednisone treatment after month 18 were left at the investigator's discretion.
Zmanjševanje odmerka prednizona in odločitev za prenehanje zdravljenja s prednizonom po 18 mesecih sta bila prepuščena raziskovalčevi presoji.
All IRRs were CTC Grade 1 or 2.
Vse reakcije, povezane z infuzijo, so bile 1. ali 2. stopnje po CTC.
This is mostly accounted for by IRRs (most frequent during the first treatment course), RA exacerbation and infections all of which were more frequent in the first 6 months of treatment.
To gre v glavnem pripisati reakcijam, povezanim z infuzijo (ki se najpogosteje pojavljajo v prvem ciklu zdravljenja), poslabšanju revmatoidnega artritisa in okužbam; vse našteto se je pogosteje pojavljalo v prvih 6 mesecih zdravljenja.
The projected median time to progression (TTP) for responding patients was 13.0 months.
Mediana časa do napredovanja bolezni (TTP, time to progression) je pri odzivnih bolnikih znašala 13,0 meseca.
The transient IgM increase usually returned to at least baseline level within 4 months.
Prehodna zvišanja IgM so se običajno vrnila vsaj na raven pred zdravljenjem v 4
Azathioprine 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
Število preskušancev s hujšim recidivom azatioprin 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 rituksimab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Število preskušancev s tveganjem azatioprin 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 rituksimab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
The safety information collected during post-marketing experience reflects the expected adverse reaction profile as seen in clinical trials for rituximab (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 rituksimabom (glejte poglavje 4.4).
Animal studies did not reveal deleterious effects of rituximab on reproductive organs.
Študije na živalih niso pokazale škodljivih učinkov rituksimaba na reproduktivne organe.
Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Ker lahko uvodnemu izboljšanju kliničnih simptomov sledi poslabšanje, je treba takšne bolnike skrbno spremljati, dokler sindrom razpada tumorja in pljučna infiltracija ne mineta oziroma dokler nista izključena.
• 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.
Three of the patients had received two courses of rituximab before enrolment and thus were given a third course in the study.
Trije od teh bolnikov so bili dvakrat zdravljeni z rituksimabom pred vključitvijo, tako so v študiji prejeli tretje zdravljenje z rituksimabom.
Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/dL).
Klinično in statistično značilno izboljšanje je bilo opaženo tudi v vseh posameznih komponentah odziva ACR (število bolečih in oteklih sklepov, bolnikova in zdravnikova splošna ocena, ocena glede na indeks nezmožnosti (HAQ), ocena bolečine in C-reaktivnega proteina (CRP) (mg/dl).
Placebo+MTX
Placebo + metotreksat
What Ritemvia is and what it is used for What you need to know before you use Ritemvia How to use Ritemvia
Kaj je zdravilo Ritemvia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ritemvia Kako uporabljati zdravilo Ritemvia
This finding was not supported by a stepwise logistic regression analysis in which the following factors were identified as prognostic factors: histological type, bcl-2 positivity at baseline, resistance to last chemotherapy and bulky disease.
Te ugotovitve niso podprli s stopenjsko logistično regresijsko analizo, s katero so ugotovili naslednje prognostične dejavnike: histološki tip, izraženost bcl-2 na začetku zdravljenja, neodzivnost na zadnjo kemoterapijo in obsežna bolezen.
This is because Ritemvia can across the placenta and may affect your baby.
Zdravilo Ritemvia namreč prehaja skozi posteljico (placento) in lahko škoduje otroku.
Peripheral B cell counts declined below normal following completion of the first dose of rituximab.
Število perifernih celic B se je po dokončanju prvega odmerka rituksimaba zmanjšalo pod normalno vrednost.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Ob sumu na PML je treba zdravljenje prekiniti, dokler PML ni izključena.
Table 14 Physical function and quality of life outcomes at week 24 in Trial 1
Funkcijska zmogljivost in vpliv na kakovost življenja po 24 tednih v preskušanju
Prednisone treatment was tapered and then kept at a low dose (approximately 5 mg per day) for at least 18 months after randomisation.
Zdravljenje s prednizonom so postopoma zmanjšali in ga nato vzdrževali v majhnem odmerku (približno 5 mg na dan) vsaj 18 mesecev po randomizaciji.
Severe (grade 3/4) neutropenia was reported in 4.2%, anaemia in 1.1% and thrombocytopenia in 1.7% of the patients.
Huda nevtropenija (3. ali 4. stopnje) se je pojavila pri 4,2% bolnikov, anemija pri 1,1% in trombocitopenija pri 1,7% bolnikov.
Study Treatment, N
Zdravljenje (n)
• you are allergic to rituximab, other proteins which are like rituximab, or any of the other ingredients of this medicine (listed in section 6)
• ste alergični na rituksimab, druge podobne beljakovine ali katero koli sestavino tega zdravila
How Ritemvia is given How it is given
Kako se daje zdravilo Ritemvia Kako se zdravilo daje
Your doctor may need to take special care of you during your treatment with Ritemvia.
Zdravnik bo morda moral biti med zdravljenjem z zdravilom Ritemvia posebej poskrbeti za vas.
However, the higher incidence of neutropenia in patients treated with rituximab 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 rituksimab v kombinaciji s kemoterapijo, ni spremljala višja incidenca infekcijskih in parazitskih bolezni kot pri bolnikih, zdravljenih samo s kemoterapijo.
Your doctor may prescribe Ritemvia for the treatment of:
Zdravnik vam lahko zdravilo Ritemvia predpiše za zdravljenje:
The ADRs identified only during post-marketing surveillance, and for which a frequency could not be estimated, are listed under “not known”.
Neželeni učinki, ki so jih opazili samo po prihodu zdravila na trg in za katere pogostnosti ni mogoče oceniti, so navedeni v ni znano.
Binet stage A Binet stage B Binet stage C CI: Confidence Interval
Stopnja po Binetu A Stopnja po Binetu B Stopnja po Binetu C
Frequencies are defined as very common (≥ 1/10), common
Pogostnost je opredeljena kot zelo pogosta (≥ 1/10), pogosta
Currently, there are limited data on possible drug interactions with rituximab.
Trenutno je le malo podatkov o mogočih medsebojnih učinkih zdravil pri uporabi zdravila rituksimab.
This is because some people have a fall in their blood pressure while they are being given Ritemvia.
Nekaterim ljudem se namreč med prejemanjem zdravila Ritemvia krvni tlak zniža;
• general discomfort or feeling uneasy or tired, shaking, signs of flu
splošno nelagodje, neprijetno počutje ali utrujenost, tresenje, znaki gripe,
The emergence of ADA was not associated with clinical deterioration or with an increased risk of reactions to subsequent infusions in the majority of patients.
Pojav ADA pri večini bolnikov ni bil povezan s kliničnim poslabšanjem ali povečanim tveganjem za reakcije pri nadaljnjih infuzijah.
Table 16 Percentage of patients who achieved complete remission at 6 months (Intent-to-treat population*)
Odstotek bolnikov, ki so po 6 mesecih dosegli popolno remisijo (populacija, ki so jo nameravali zdraviti*).
Figure 2: ACR responses for 4 treatment courses (24 weeks after each course (within patient, within visit) in patients with an inadequate response to TNF-inhibitors (n=146)
Slika 2: Odzivi ACR za 4 cikle zdravljenja (24 tednov po vsakem ciklu (intraindividualno, znotraj pregledov) pri bolnikih, ki niso zadostno odgovorili zdravljenje z zaviralci TNF (n = 146).
Infections were predominately mild to moderate.
Okužbe so bile v glavnem blage do zmerne.
Treatment difference (Rituximabcyclophosphamide)
Razlika zdravljenj (rituksimabciklofosfamid)
The incidence of infusion-related symptoms decreases substantially with subsequent infusions and is less than 1% after eight doses of rituximab.
Incidenca simptomov, povezanih z infuzijo, se z nadaljnjimi infuzijami bistveno zmanjšuje in je po osmih odmerkih rituksimaba manjša kot 1%.
Ritemvia can be given alone or with other medicines called “chemotherapy”.
Zdravilo Ritemvia lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
The primary outcome measure was the rate of major relapse at month 28.
Primarno merilo izida je bil delež hujših recidivov po 28 mesecih.
No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would have no or negligible influence on the ability to drive and use machines.
Študij o vplivu zdravila rituksimab na sposobnost za vožnjo in upravljanje s stroji niso izvedli, čeprav opisano farmakološko delovanje in neželeni učinki kažejo, da vpliva na to ni ali je le zanemarljiv.