natgillin/translations-raw huggingface dataset:
A peel--off sticker is included on the vials which specifies the strength, route of administration and indication.
Na viali je nalepka, na kateri je navedena jakost zdravila, način uporabe in indikacija.
Results from three other randomised trials using MabThera in combination with chemotherapy regimen other than CVP (CHOP, MCP, CHVP/Interferon-α) have also demonstrated significant improvements in response rates, time-dependent parameters as well as in overall survival.
Rezultati treh drugih randomiziranih preskušanj z uporabo zdravila MabThera v kombinaciji z drugimi shemami kemoterapije (CHOP, MCP, CHVP/interferon alfa), in ne CVP, so prav tako pokazali značilna izboljšanja deležev odgovora, od časa odvisnih parametrov in celokupnega preživetja.
The pharmacokinetics of rituximab were assessed following two intravenous (IV) doses of 500 mg and 1000 mg on Days 1 and 15 in four studies.
Farmakokinetiko rituksimaba so ocenili po dveh 500 mg in 1000 mg intravenskih odmerkih ob dnevih 1 in 15 v štirih preskušanjih.
The complete response rate after cycle 8 was 76.2 % in the R-CHOP group and 62.4 % in the CHOP group (p=0.0028).
Po 8 ciklih zdravljenja je bil popolni odgovor v skupini R-CHOP 76,2 %, v skupini CHOP pa 62,4 % (p = 0,0028).
In clinical trials fewer than 1% (17/3189) of patients experienced a serious IRR.
V kliničnih preskušanjih se je resna z infuzijo povezana reakcija pojavila pri manj kot 1 % bolnikov (17/3.189).
Mean terminal elimination half-life after the second infusion, following the second course, was 19 days for 2 x 500 mg dose and ranged from 21 to 22 days for the 2 x 1000 mg dose.
Povprečni končni razpolovni čas izločanja po drugi infuziji, po drugem ciklu zdravljenja, je bil 19 dni za 2 x 500 mg odmerek ter 21 do 22 dni za 2 x 1000 mg odmerek.
In a prospective, open label, international, multi-centre, phase III trial 1193 patients with previously untreated advanced follicular lymphoma received induction therapy with R-CHOP (n=881), R-CVP (n=268) or R-FCM (n=44), according to the investigators' choice.
V prospektivnem, odprtem, mednarodnem, multicentričnem preskušanju III. faze je 1.193 bolnikov s predhodno nezdravljenimi folikularnimi limfomi prejelo indukcijsko zdravljenje z R-CHOP (n = 881), R-CVP (n = 268) ali R-FCM (n = 44) po presoji raziskovalca.
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 MabThera and for 12 months following MabThera 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
body surface area once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years (8 infusions in total).
1400 mg enkrat na 3 mesece (z začetkom 3 mesece po zadnjem odmerku indukcijskega zdravljenja) do napredovanja bolezni ali največ dve leti (skupaj 8 aplikacij).
Ninety-nine patients were treated for induction of remission of GPA and MPA in a clinical trial with MabThera (375 mg/m2, once weekly for 4 weeks) and glucocorticoids (see section 5.1).
Devetindevetdeset bolnikov so za indukcijo remisije GPA in MPA zdravili z zdravilom MabThera (375 mg/m2 enkrat na teden 4 tedne) in z glukokortikoidi (glejte poglavje 5.1).
In these patients the rate of clinically relevant infection while on MabThera was 6.01 per 100 patient years compared to 4.97 per 100 patient years following treatment with the biologic DMARD.
6,01 na 100 bolnik-let, ko so se zdravili z zdravilom MabThera, v primerjavi s 4,97 na 100 bolnik-let po tem, ko so prejeli nadaljnje zdravljenje z biološkim DMARD.
Metabolism and nutrition disorders hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
Presnovne in prehranske motnje hiperglikemija, zmanjšanje telesne mase, periferni edem, edem obraza, zvišanje LDH, hipokalciemija
Infusion related adverse reactions of all kinds have been observed in 77% of patients treated with MabThera intravenous formulation (including cytokine release syndrome accompanied by hypotension and bronchospasm in 10 % of patients) see section 4.8.
Z infuzijo povezane neželene reakcije vseh vrst so opazili pri 77 % bolnikov, ki so se zdravili z intravensko obliko zdravila MabThera (vključno s sindromom sproščanja citokinov, ki sta ga spremljala hipotenzija in bronhospazem pri 10 % bolnikov), glejte poglavje 4.8.
• Allergic reactions that are most likely to occur during an infusion, but can occur up-to
· alergijske reakcije, ki se najverjetneje pojavijo med infuzijo.
Ctrough values at pre-dose cycle 8
Ctrough, vrednosti pred odmerkom 8. cikel µg/ml
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Če zdravilo MabThera uporabimo v kombinaciji s kemoterapijo, je treba uporabiti standardno zmanjšanje odmerkov citostatikov.
Median PFS: 28.8 Not reached p < 0.0001
Mediana PFS: 28,8 ni doseženo p < 0,0001
The highest intravenous dose of MabThera tested in humans to date is 5000 mg (2250 mg/m2), tested in a dose escalation study in patients with CLL.
Največji do zdaj preizkušen intravenski odmerek zdravila MabThera pri človeku je 5000 mg (2250 mg/m2), preizkušen v študiji povečevanja odmerka pri bolnikih s kronično limfocitno levkemijo.
The clinical relevance of ADA formation in MabThera-treated PV patients is unclear.
Klinični pomen nastanka ADA pri bolnikih z navadnim pemfigusom, zdravljenih z zdravilom MabThera, ni jasen.
In the PV population, 5 (13%) patients in the MabThera group and 3 (8%) patients in the standard prednisone group had moderate disease and 33 (87%) patients in the MabThera group and 33 (92%) patients in the standard-dose prednisone group had severe disease according to disease severity defined by Harman's criteria.
Glede na izrazitost bolezni, določeno po Harmanovih merilih, je imelo v populaciji z navadnim pemfigusom zmerno bolezen 5 (13 %) bolnikov v skupini z zdravilom MabThera in 3 (8 %) bolnikov v skupini s standardnim prednizonom, hudo bolezen pa 33 (87 %) bolnikov v skupini z zdravilom MabThera in 33 (92 %) bolnikov v skupini s standardnim prednizonom.
• A feeling of fullness or a throbbing pain behind the nose, cheeks and eyes (sinusitis), pain in the abdomen, vomiting and diarrhoea, breathing problems
· občutek zamašenosti ali utripajoča bolečina za nosom, lici in očmi (sinuzitis), bolečina v trebuhu, bruhanje in driska, težave z dihanjem,
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
Zdravilo MabThera je indicirano za zdravljenje predhodno nezdravljenih bolnikov s III. in IV. stadijem folikularnih limfomov v kombinaciji s kemoterapijo.
What MabThera is and what it is used for What you need to know before you use MabThera How to use MabThera
Kaj je zdravilo MabThera in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo MabThera Kako uporabljati zdravilo MabThera
• lower immunity - because of lower levels of anti-bodies called “immunoglobulins” (IgG) in the blood which help protect against infection
· zmanjšana imunost - zaradi manjše koncentracije protiteles, imenovanih imunoglobulin (IgG), v krvi; ta protitelesa pomagajo pri zaščiti proti okužbam
MabThera intravenous formulation was used at the standard dose of 375 mg/m2.
Intravenska oblika zdravila MabThera je bila uporabljena v standardnem odmerku 375 mg/m2.
Median EFS: 36 Not reached p < 0.0001
Mediana EFS: 36 ni doseženo p < 0,0001
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients (<65 years), with previously untreated or relapsed/refractory CLL.
Incidenca neželenih dogodkov krvi in limfatičnega sistema 3. ali 4. stopnje je bila pri bolnikih s KLL, ki predhodno še niso bili zdravljeni ali pri katerih se je bolezen ponovila oziroma se na predhodno zdravljenje niso odzvali, višja pri starejših bolnikih v primerjavi z mlajšimi bolniki (< 65 let).
A longer period may be appropriate in patients with an increased risk of hypersensitivity reactions.
Pri bolnikih, ki imajo večje tveganje za preobčutljivostne reakcije, je morda primeren daljši čas opazovanja.
The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1600 mg irrespective of the patient's body surface area.
Priporočeni odmerek podkožne oblike zdravila MabThera za odrasle bolnike je podkožna injekcija fiksnega odmerka 1600 mg ne glede na bolnikovo telesno površino.
Hazard ratio (95% CI)
Število bolnikov Razmerje ogroženosti (95-% CI)
The most common local cutaneous reactions in the MabThera subcutaneous arm were injection site erythema (13%), injection site pain (7%), and injection site oedema (4%).
Najpogostejše lokalne kožne reakcije v skupini bolnikov, ki so prejemali podkožno obliko zdravila MabThera, so bile eritem na mestu injiciranja (13 %), bolečina na mestu injiciranja (7 %) in edem na mestu injiciranja (4 %).
Following two intravenous infusions of MabThera at a dose of 1000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 l (range, 1.7 to 7.51 L).
Revmatoidni artritis Po dveh intravenskih infuzijah zdravila MabThera v odmerku 1000 mg v razmiku dveh tednov je bil povprečni končni razpolovni čas 20,8 dni (razpon 8,58 do 35,9 dni), povprečni sistemski očistek je bil 0,23 l/dan (razpon 0,091 do 0,67 l/dan), povprečen volumen distribucije v stanju dinamičnega ravnovesja pa 4,6 l (razpon 1,7 do 7,51 l).
The Patient information about MabThera should contain the following key elements:
Izobraževalno gradivo za bolnika o zdravilu MabThera mora vsebovati naslednje ključne vsebine:
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
pogosti (³ 1/100 do < 1/10), občasni (³ 1/1000 do < 1/100), redki (³ 1/10.000 do < 1/1000), zelo redki
• low mood and loss of interest or enjoyment in doing things, feeling nervous
· slabo razpoloženje in izguba zanimanja ali veselja za početje stvari, živčnost · motnje okušanja - na primer spremenjen okus stvari
• Feeling generally unwell or listless.
· splošno slabo počutje ali brezvoljnost.
In the first-line study, after a median observation time of 48.1 months, the median PFS was 55 months in the R-FC group and 33 months in the FC group (p < 0.0001, log-rank test).
V študiji pri bolnikih v prvi liniji zdravljenja po mediani opazovanja 48,1 meseca je bila mediana preživetja brez napredovanja bolezni 55 mesecev v skupini R-FC in 33 mesecev v skupini FC (p < 0,0001, test log-rang).
Mean pre-therapeutic antibody titres against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Povprečni predterapevtski titri protiteles proti naboru antigenov (Streptococcus pneumoniae, influenca A, mumps, rdečke, norice) so se ohranili najmanj 6 mesecev po zdravljenju z zdravilom
• Pain in the tummy, back, muscles and/or joints
· bolečina v trebuhu, hrbtu, mišicah in/ali sklepih.
Patients were randomised in a 1:1 ratio to receive either oral cyclophosphamide daily (2mg/kg/day) for 3-6 months or MabThera (375 mg/m2) once weekly for 4 weeks.
Bolnike so v razmerju 1:1 randomizirali na zdravljenje s peroralnim ciklofosfamidom (2 mg/kg/dan) vsak dan od 3 do 6 mesecev ali z zdravilom MabThera (375 mg/m2) enkrat na teden 4 tedne.
Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50 % of patients in clinical trials involving MabThera intravenous formulation, and were predominantly seen during the first infusion, usually in the first one to two hours.
O znakih in simptomih, ki bi lahko nakazovali reakcije, povezane z infuzijo, so poročali pri več kot 50 % bolnikov v kliničnih preskušanjih, v katerih so uporabljali intravensko obliko zdravila MabThera; večinoma so jih opazili med prvo infuzijo, po navadi v prvih dveh urah.
The use of MabThera subcutaneous formulation as monotherapy in patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy cannot be recommended as the safety of the once weekly subcutaneous administration has not been established.
Uporabe podkožne oblike zdravila MabThera v monoterapiji pri bolnikih s III. in IV. stadijem folikularnih limfomov, ki so neodzivni na kemoterapijo ali se jim je bolezen po kemoterapiji drugič ali že večkrat ponovila, ni mogoče priporočiti, ker varnosti podkožnega dajanja enkrat na teden niso ugotavljali.
These include: pain, swelling, bruising, bleeding, skin redness, itching and rash.
Med njimi so bolečina, oteklost, podplutba, krvavitev, pordelost kože, srbenje in izpuščaj.
Store in a refrigerator (2 °C to 8 °C).
Shranjujte v hladilniku (2 do 8 °C).
The safety of immunisation with live viral vaccines following MabThera therapy has not been studied.
Varnosti imunizacije z živimi virusnimi cepivi po zdravljenju z zdravilom MabThera niso proučevali.
The 1400 mg strength is intended for subcutaneous use in non Hodgkin lymphoma (NHL) only.
Jakost zdravila 1400 mg je namenjena podkožni uporabi le za zdravljenje ne-Hodgkinovega limfoma (NHL).
The difference between the treatment groups with respect to overall survival showed a significant clinical difference (p=0.029, log-rank test stratified by centre): survival rates at 53 months were 80.9% for patients in the R-CVP group compared to 71.1% for patients in the CVP group.
Razlika med terapevtskima skupinama glede celokupnega preživetja je pokazala značilno klinično razliko (p = 0,029, log-rang test s stratifikacijo po centru): po 53 mesecih je bil delež preživetja v skupini z R-CVP 80,9 % in v skupini s CVP 71,1 %.
For subjects weighing 60-90 kg and < 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Pri bolnikih s telesno maso 60-90 kg in < 60 kg so bile povprečne Ctrough po intravenskem odmerjanju v primerjavi s podkožnim manjše: približno 16 % manjše v skupini s telesno maso 60-90 kg in približno 34 % manjše v skupini s telesno maso < 60 kg.
What MabThera is and what it is used for What you need to know before you are given MabThera How MabThera is given
Kaj je zdravilo MabThera in za kaj ga uporabljamo Kaj morate vedeti, preden boste dobili zdravilo MabThera Kako se daje zdravilo MabThera
• inflammation of blood vessels including those leading to skin symptoms
· srčno popuščanje · simptomi vnetja žil, vključno s tistimi, ki vodijo v kožo
Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils < 1.5 x 109/L and/or platelet counts < 75 x 109/L as clinical experience in this population is limited.
Čeprav zdravilo MabThera pri samostojnem zdravljenju ne deluje mielosupresivno, je potrebna previdnost pri bolnikih, ki imajo število nevtrofilcev < 1,5 x 109/l in/ali trombocitov < 75 x 109/l.
An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
Analiza celokupnega preživetja je potrdila pomembno korist vzdrževalnega zdravljenja z zdravilom MabThera v primerjavi z opazovano skupino (p = 0,0039, test log-rang).
In the NHL phase 3 trial SABRINA (BO22334), local cutaneous reactions were reported in up to 20% of patients receiving subcutaneous MabThera.
V kliničnem preskušanju faze III SABRINA (BO22334) je do 20 % bolnikov, ki so prejemali podkožno obliko zdravila MabThera, navedlo lokalne kožne reakcije.
asthma, too little oxygen reaching the body organs
astma, telesne organe doseže premalo kisika, · oteklost trebuha.
Mean Cmax was 16 to 19% higher following second infusion compared to the first infusion for both doses.
večja po drugi infuziji v primerjavi s prvo infuzijo pri obeh odmerkih.
The reported cases had recognised risk factors for PRES/RPLS, including the patients' underlying disease, hypertension, immunosuppressive therapy and/or chemotherapy.
so bili prisotni znani dejavniki tveganja za PRES/RPLS, vključno z bolnikovo osnovno boleznijo, hipertenzijo, imunosupresivnim zdravljenjem in/ali kemoterapijo.
The recommended dose of MabThera subcutaneous formulation used for adult patients is a subcutaneous injection at a fixed dose of 1400 mg irrespective of the patient's body surface area.
Priporočeni odmerek podkožne oblike zdravila MabThera za odrasle bolnike je podkožna injekcija fiksnega odmerka 1400 mg ne glede na bolnikovo telesno površino.
The safety profile of MabThera in patients with moderate to severe rheumatoid arthritis (RA) is summarised in the sections below.
Varnostni profil zdravila MabThera pri bolnikih z zelo aktivnim revmatoidnim artritisom je povzet v spodnjem besedilu.
The overall safety profile of MabThera in non-Hodgkin's lymphoma and CLL is based on data from patients from clinical trials and from post-marketing surveillance.
Celotni varnostni profil zdravila MabThera pri ne-Hodgkinovem limfomu in kronični limfocitni levkemiji (KLL) temelji na podatkih bolnikov iz kliničnih preskušanj in iz nadzora med obdobjem trženja.
ORR was 57% (95% Confidence interval (CI); 41% - 73%; CR 14%, PR 43%) with a projected median TTP for responding patients of 19.4 months (range 5.3 to 38.9 months).
Celokupen odgovor je znašal 57 % (95-% interval zaupanja 41 %-73 %; popoln odgovor 14 %, delni odgovor 43 %), mediana časa do napredovanja bolezni je bila pri odzivnih bolnikih 19,4 meseca (razpon 5,3 do 38,9 meseca).
MabThera has been used in 21 patients who underwent autologous bone marrow transplantation and other risk groups with a presumable reduced bone marrow function without inducing myelotoxicity.
Zdravilo MabThera so uporabili pri 21 bolnikih po avtologni transplantaciji kostnega mozga in pri drugih rizičnih skupinah, pri katerih je pričakovano zmanjšano delovanje kostnega mozga, ne da bi se pojavila mielotoksičnost.
MabThera intravenous formulation was used at the standard dose of 375 mg/m2
Intravenska oblika zdravila MabThera je bila uporabljena v standardnem odmerku 375 mg/m2
Excipients: This medicinal product contains 2.3 mmol (or 52.6 mg) sodium per 10 mL vial and 11.5 mmol (or 263.2 mg) sodium per 50 mL vial.
Pomožne snovi: To zdravilo vsebuje 2,3 mmol (ali 52,6 mg) natrija na 10-ml vialo in 11,5 mmol (ali 263,2 mg) natrija na 50-ml vialo.
• high blood sugar level, weight loss, swelling in the face and body, high levels of the enzyme “LDH” in the blood, low calcium levels in the blood
· velika koncentracija krvnega sladkorja, hujšanje, oteklost obraza in telesa, visoka raven encima LDH v krvi, majhna koncentracija kalcija v krvi
c) If you are being treated for rheumatoid arthritis Each course of treatment is made up of two separate infusions which are given 2 weeks apart.
Če se zdravite zaradi navadnega pemfigusa Vsak cikel zdravljenja obsega dve ločeni infuziji, ki ju boste dobili v presledku 2 tednov.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu.
The Physician information about MabThera should contain the following key elements:
Izobraževalno gradivo za zdravnika o zdravilu MabThera mora vsebovati naslednje ključne vsebine:
During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with MabThera and observation.
Med vzdrževalnim zdravljenjem je bila incidenca srčnih bolezni 3. ali 4. stopnje med bolniki, zdravljenimi z zdravilom MabThera, in opazovano skupino primerljiva.
MabThera subcutaneous formulation
MabThera podkožna oblika
− * Worst case imputation a Non-inferiority was demonstrated since the lower bound ( − 3.2%) was higher than the pre-determined non-inferiority margin ( − 20%).
* Imputacija za najslabši primer a Neinferiornost je bila dokazana, ker je bila spodnja meja (-3,2 %) višja od vnaprej opredeljene meje neinferiornosti b 95,1-% interval zaupanja vključuje dodatni 0,001 alfa na račun vmesne analize učinkovitosti.
Table 8: Distribution/Elimination - Pharmacokinetic parameters of MabThera subcutaneous compared to MabThera intravenous Trial BP22333 (SparkThera) Geometric mean Ctrough
Porazdelitev/izločanje - farmakokinetični parametri zdravila MabThera podkožno v primerjavi z zdravilom MabThera intravensko Preskušanje BP22333 (SparkThera)
• tightening of the muscles in the airways which causes wheezing (bronchospasm),
· skrčenje mišic v dihalih, ki povzroči piskajoče dihanje (bronhospazem), vnetje, draženje pljuč,
Cases of posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) have been reported.
Poročali so o primerih sindroma posteriorne reverzibilne encefalopatije (posterior reversible encephalopathy syndrome - PRES) oziroma sindroma reverzibilne posteriorne levkoencefalopatije (reversible posterior leukoencephalopathy syndrome - RPLS).
MabThera 1400 mg can be given alone or with other medicines called “chemotherapy”.
Zdravilo MabThera 1400 mg lahko uporabljamo samostojno ali skupaj z drugimi zdravili, ki jih imenujemo kemoterapija.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the MabThera arms compared to control arms.
V kliničnih preskušanjih so o okužbah spodnjih dihal (vključno s pljučnico) v skupini z zdravilom MabThera poročali s podobno incidenco kot v kontrolnih skupinah.
• Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heart beat, and tiredness
· spremembe krvnega tlaka, slabost, kožni izpuščaji, zvišana telesna temperatura, srbenje, smrkav ali zamašen nos ter kihanje, drgetanje, hitro bitje srca in utrujenost, · glavobol,
Table 3 Summary of key results from four phase III randomized trials evaluating the benefit of MabThera with different chemotherapy regimens in follicular lymphoma
Povzetek ključnih rezultatov štirih randomiziranih preskušanj III. faze, ki so ocenjevala korist zdravila MabThera v kombinaciji z različnimi shemami kemoterapije pri folikularnih limfomih
The final analysis confirmed that R-CHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Končna analiza je potrdila, da je bilo zdravljenje z R-CHOP povezano s klinično pomembnim in statistično značilnim podaljšanjem trajanja preživetja brez dogodkov (primarni parameter učinkovitosti; dogodki so bili smrt, ponovitev bolezni ali napredovanje limfoma ali uvedba novega protilimfomskega zdravljenja) (p = 0,0001).
MabThera is a ready to use, clear to opalescent, colourless to yellowish liquid, supplied as a solution for subcutaneous injection in a colourless glass vial with a butyl rubber stopper with aluminium over seal and a blue plastic flip-off disk.
Zdravilo MabThera je za uporabo pripravljena, bistra do opalescenčna, brezbarvna do rumenkasta tekočina, ki je na voljo kot raztopina za podkožno injiciranje v brezbarvni stekleni viali z zamaškom iz butilne gume, z aluminijsko prekrivno zaporo in plastično modro snemno ploščico.
Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61 % with MabThera maintenance treatment when compared to observation (95 % CI; 45 %-72 %).
Tveganje za napredovanje bolezni ali smrt je bilo zmanjšano za 61 % z vzdrževalnim zdravljenjem z zdravilom MabThera v primerjavi z opazovano skupino (Coxova regresijska analiza, 95-% interval zaupanja: 45-72 %).
• The active ingredient is rituximab.
· Zdravilna učinkovina je rituksimab.