natgillin/translations-raw huggingface dataset:
Det vides ikke om rituximab udskilles i modermælk.
Whether rituximab is excreted in human milk is not known.
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
36 4.7 Effects on ability to drive and use machines
Erfaringer fra non- Hodgkin lymfom og kronisk lymfocytiks leukæmi
Experience from non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
MabThera’ s sikkerhedsprofil ved non- Hodgkin lymfom og kronisk lymfocytiks leukæmi er baseret på data fra patienter fra kliniske studier og fra post- marketing overvågning.
The overall safety profile of MabThera in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia is based on data from patients from clinical trials and from post-marketing surveillance.
30 – 55% af patienterne i de kliniske studier hos patienter med NHL og hos 30 – 50% af patienterne i de kliniske studier med CLL.
Infectious events (predominantly bacterial and viral) occurred in approximately 30-55% of patients during clinical trials in patients with NHL and in 30-50% of patients during clinical trial in patients with CLL.
Indenfor hver hyppighedsgruppe er bivirkningerne anført efter aftagende sværhedsgrad.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Hyppigheden defineres som meget almindelig (≥ 1/ 10, almindelig (≥ 1/ 100 til < 1/ 10),, ikke almindelig (≥ 1/ 1. 000 til < 1/ 100), og sjælden (≥ 1/ 10. 000 til < 1/ 1000).
Frequencies are defined as very common (≥ 1/ 10), common (≥ 1/ 100 to < 1/ 10) and uncommon (≥ 1/ 1,000 to < 1/ 100) and rare (≥ 1/ 10,000 to < 1/ 1000).
38 Tabel 1
Table 1
Sammenfatning af bivirkninger, som blev rapporteret i kliniske studier eller under post marketing overvågning, hos patienter med NHL, som fik MabThera monoterapi eller vedligeholdelsesbehandling med MabThera, eller i kombination med kemoterapi
ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with MabThera monotherapy/ maintenance or in combination with chemotherapy
anæmi, trombocytopeni,
neutropenia, anaemia, leucopenia, thrombocytopenia +febrile +
infusions - relaterede reaktioner, angioødem
infusion related reactions, angioedema
hypersensitivitet
hypersensitivity
hyperglykæmi, vægttab, perifert ødem, ansigtsødem, øget LDH, hypocalcæmi
hyperglycaemia, weight decrease, peripheral oedema, face oedema, increased LDH, hypocalcaemia
dysgeusi
dysgeusia
svære kardiale
arrhythmia, + atrial fibrillation,
atrieflimren,
tachycardia, + ventricular tachycardia, +
hændelser 3 og 5
tachycardia, +
takykardi, +
angina, +myocardial
supraventriku -
cardiac disorder
hjertesygdom
ischaemia, bradycardia,
39 Vaskulære sygdomme
Vascular disorders
hypertension, orthostatisk hypotension, hypotension
hypertension, orthostatic hypotension, hypotension
vasculitis (fortrinsvis kutan), leukocytoclastisk vasculitis
vasculitis (predominately cutaneous), leukocytoclastic vasculitis
bronkospasmer3, luftvejssygdomme, brystsmerter, dyspnø, øget hoste, rhinitis
bronchospasm3, respiratory disease, chest pain, dyspnoea, increased cough, rhinitis
astma, bronchiolitis obliterans, lungesygdomme, hypoksi
asthma, bronchiolitis obliterans, lung disorder, hypoxia
respirationssvigt3, lungeinfiltrater, interstitiel pneumonitis
respiratory failure3, pulmonary infiltrates, interstitial pneumonitis
Mave- tarmkanalen
System Organ
opkastning, diarre, mavesmerter, dysfagi, stomatitis, obstipation, dyspepsi, anoreksi, halsirritation
Uncommon
forstørret abdomen
Unknown
gastro- intestinal perforation6
Gastrointestinal disorders
Hud og subkutane væv
nausea
pruritis, udslæt, +
vomiting, diarrhoea, abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation
urticaria, svedtendens,
abdominal enlargement
svære bulløse hudreaktioner,
gastro-intestinal perforation6
alopeci
Skin and subcutaneous
nattesved, +
pruritis, rash, +
toksisk epidermal
urticaria, sweating, night
Knogler, led, muskler og bindevæv
severe bullous skin reactions,
hudsygdomme hypertoni, myalgier, artralgier, rygsmerter, nakkesmerter, smerter
tissue disorders Musculoskeletal, connective tissue and bone disorders
nekrolyse6
alopecia
Nyre - og urinvejssygdommer
sweats, +skin disorder hypertonia, myalgia, arthralgia, back pain, neck pain, pain
nyresvigt3
toxic epidermal necrolysis6
Almene symptomer
Renal and urinary disorders
feber
renal failure3
,
General disorders and administration
De optrådte fortrinsvis under den første infusion, normalt under de første én til to
Infusion-related reactions Signs and symptoms suggestive of an infusion-related reaction were reported in more than 50% of patients in clinical trials, and were predominantly seen during the first infusion, usually in the first one to two hours.
Exacerbationer af hjertelidelser som angina pectoris, kongestiv hjertesygdom eller svære hjertetilfælde (hjertestop, myokardieinfarkt og atrieflimren), lungeødem, multiorgansvigt, tumorlysesyndrom, cytokin frigivelsessyndrom, nyresvigt og respirationssvigt blev rapporteret med lavere eller ukendt hyppighed.
39 events (heart failure, myocardial infarction, atrial fibrillation), pulmonary oedema, multi-organ failure, tumour lysis syndrome, cytokine release syndrome, renal failure, and respiratory failure were reported at lower or unknown frequencies.
I studier med MabThera i kombination med kemoterapi blev der rapporteret hyppigere om leukopenia grad 3/ 4 R- CHOP 88% versus CHOP 79%, R- FC 23% vs 12% FC), neutropeni (R- CVP 24% versus CVP 14%; R- CHOP 97% versus CHOP 88%), R- FC 30% vs.
CHOP 79%, R-FC 23% vs.
Kardiovaskulære bivirkninger Kardiovaskulære bivirkninger blev rapporteret hos 18, 8% af patienterne i behandlingsperioden.
Cardiovascular reactions Cardiovascular reactions during clinical trials with MabThera monotherapy were reported in 18.8% of patients with the most frequently reported events being hypotension and hypertension.
De hyppigst rapporterede bivirkninger var hypotension og hypertension.
Cases of grade 3 or 4 arrhythmia (including ventricular and supraventricular tachycardia) and angina pectoris during infusion were reported.
Under infusionen blev der rapporteret om arytmier af grad 3 eller 4 (herunder ventrikulær og supraventrikulær takykardi) og
During maintenance treatment, the incidence of grade 3/ 4 cardiac disorders was comparable between patients treated with MabThera and observation.
Under vedligeholdelsesbehandlingen var hyppigheden af hjertesygdomme af grad 3/ 4 / sammenlignelig mellem patienter behandlet i MabThera- gruppen og i observationssgruppen.
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischemia) in 3% of patients treated with MabThera compared to < 1% on observation.
I studier, som evaluerede MabThera i kombination med kemoterapi var hyppigheden af arytmier af grad 3 og 4, fortrinsvis supraventrikulære arytmier, som fx takykardi og atrieflagren/ atrieflimren, højere i R- CHOP- gruppen (14 patienter, 6, 9%) sammenlignet med CHOP- gruppen (3 patienter, 1, 5%).
40 grade 3 and 4 cardiac arrhythmias, predominantly supraventricular arrhythmias such as tachycardia and atrial flutter/ fibrillation, was higher in the R-CHOP group (14 patients, 6.9%) as compared to the CHOP group (3 patients, 1.5%).
Gastrointestinale sygdomme Hos patienter, der er behandlet med MabThera for non- Hodgkin lymfom, er der i nogle tilfælde set gastrointestinal perforation og i nogle tilfælde med døedelig udgang.
Gastrointestinal Disorders Gastrointestinal perforation in some cases leading to death has been observed in patients receiving MabThera for treatment of non Hodgkin lymphoma.
Ældre patienter (≥ 65 år):
Patient subpopulations (MabThera monotherapy) Elderly patients(≥ 65 years):
Erfaringer med reumatoid arthritis
Experience from rheumatoid arthritis
42 Den kliniske effekt af MabThera i kombination med methotrexat blev undersøgt i tre dobbeltblindede, kontrollerede kliniske forsøg (et fase- III, to fase- II forsøg) hos patienter med reumatoid arthritis.
The clinical efficacy of MabThera, given together with methotrexate was studied in three double blind controlled clinical trials (one phase III two phase II trials) in patients with rheumatoid arthritis.
Patienterne fik 2 x 1000 mg MabThera med to ugers interval, derudover methotrexat (10- 25 mg/ uge).
41 Patients received 2 x 1000 mg of MabThera separated by an interval of two weeks; in addition to methotrexate (10-25 mg/ week).
Indenfor hver hyppighedsgruppe er bivirkningerne angivet efter faldende alvorlighed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Infusionsrelaterede reaktioner kan forekomme i forbindelse med hypersensitivitet og/ eller virkningsmekanismen
Infusion related reactions may occur as a result of hypersensitivity and/ or to the mechanism of action.
Følgende hændelser er blevet rapporteret som bivirkninger, set i kliniske forsøg, og med samme frekvens i MabThera- armen som i kontrolarmen: nedre luftvejsinfektioner/ pneumoni, smerter i øvre del af abdomen, muskelkramper og astenia.
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar incidence in the MabThera-arms compared to control arms: lower respiratory tract infections/ pneumonia, abdominal pain upper, muscle spasms and asthenia.
43 Gentagne behandlinger De begrænsede kliniske data fra gentagen behandling af RA- patienter synes at vise en bivirkningsprofil, som ligner den ved første behandling.
Multiple Courses The limited clinical trial data on multiple courses of treatment of RA patients seem to be associated with a similar ADR profile to that observed following first exposure.
I et forsøg, der sammenlignede effekten af glukokortikoidbehandling, blev disse hændelser observeret hos 5/ 149 (3%) af patienterne efter deres første infusion med rituximab- placebo og hos 42/ 192 (22%) af patienterne, der modtog deres første infusion med 1000 mg rituximab.
42 Infusion-related reactions Symptoms suggesting an acute infusion reaction (e. g. pruritis, fever, urticaria/ rash, chills, pyrexia, rigors, sneezing, angioneurotic edema, throat irritation, cough and bronchospasm, with or without associated hypotension or hypertension) were observed in 79/ 540 (15%) patients following their first exposure to MabThera; In a study comparing the effect of glucocorticoid regimen, these events were observed in 5/ 149 (3%) of patients following their first rituximab placebo infusion and 42/ 192 (22%) of patients receiving their first infusion of 1000 mg rituximab.
Tilfælde af progressiv multifokal leukoencephalopati med dødelig udgang er rapporteret efter anvendelse af MabThera i forbindelse med behandling for autoimmune sygdomme, som inkluderer reumatoid arthritis og ikke- godkendte indikationer som systemisk lupus erythematosus (SLE) og vaskulitis.
This includes Rheumatoid Arthritis and off-label autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and Vasculitis.
44 Rituximab bindes specifikt til det transmembrane antigen, CD20, et non- glycosyleret phosphoprotein som findes på præ- B og modne B lymfocytter.
Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated phosphoprotein, located on pre-B and mature B lymphocytes.
Rituximabs Fab domæne bindes til CD20 antigenet på B lymfocytter og Fc domainet kan rekruttere immuneffektor funktioner til at mediere B- celle lysis.
43 The Fab domain of rituximab binds to the CD20 antigen on B lymphocytes and the Fc domain can recruit immune effector functions to mediate B cell lysis.
Klinisk erfaring ved non- Hodgkin lymfom og kronisk lymfatisk leukæmi
Clinical Experience in Non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia
5, 3 til 38, 9 måneder).
The 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).
To patienter blev genbehandlet to gange under studiet.
44 in the study.
Resultaterne fra tre andre randomiserede studier, hvor MabThera/ Rituxan blev anvendt i kombination med andre kemoterapibehandlinger end CVP (CHOP, MCP, CHVP/ Interferon- α), har også vist signifikante forbedringer i responsrater, tidsafhængige parametre samt samlet overlevelse.
Results from three other randomized 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.
46 Tabel 3
Table 3
Behandling, Median ORR,% CR, Median OS rates, n FU,% TTF/ PFS /% måneder EFS måneder CVP, 159 53 57 10 Median 53- måneder R- CVP, 162 81 41 TTP:
FU, ORR,% TTF/ PFS/ EFS rates, n% months mo% Median TTP:
71. 1
53-months CVP, 159 57 10 14.7 71.1
14. 7 80. 9 33. 6 p=0. 029 P < 0. 0001
53 33.6 80.9 R-CVP, 162 81 41 P < 0.0001 p=0.029
EFS – Eventfri overlevelse TTP – Tid til progression eller død PFS – Progressionsfri overlevelse TTF – Tid til behandlingssvigt OS rates – Overlevelsesrater ved analysetiden
45 TTP – Time to progression or death PFS – Progression-Free Survival TTF – Time to Treatment Failure OS rates – survival rates at the time of the analyses
47 Tabel 4
Table 4
48 Tabel 5
46 Table 5
Kaplan- Meier estimat af den
Median Time to Event (Months)
Risiko -
Reduction
14, 3 42, 2
14.3 42.2
En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R- CHOP behandlingen i forhold til CHOP behandlingen (p=0, 0071), hvilket svarer til en risikoreduktion på 32%.
47 A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
I alle patientundergrupper (køn, alder, aldersjusteret IPI, Ann Arbor stadie, ECOG, β2- mikrobuglobulin, LDH, albumin, B- symptomer, udbredt sygdom, ekstranodale lymfomer, knoglemarvspåvirkning) var risikoratioen for hændelsesfri overlevelse og samlet overlevelse (R- CHOP sammenlignet med CHOP) mindre end henholdsvis 0, 83 og 0, 95.
In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β 2 microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
Medianen for det primære endepunkt, progressionsfri overlevelse, var 40 måneder i R- FC- gruppen og 32 måneder i FC- gruppen (p < 0, 0001, log- rank test).
The primary endpoint of progression-free survival was 40 months in median in the R-FC group and 32 months in the FC group (p < 0.0001, log-rank test).
Det er dog nødvendigt med en længere follow- up- periode for at bekræfte denne observation.
The analysis of overall survival showed an improved survival in favour of the R-FC arm (p=0.0427, log-rank test), however longer follow-up is needed to confirm this observation.
Førstelinjebehandling af kronisk lymfatisk leukæmi – sammenfatning af resultaterne for effekt for MabThera plus FC versus FC alene (median observationstid:
First-line treatment of chronic lymphocytic leukaemia
20, 7 måneder)
Overview of observation
Effektparameter
FC alone (20.7 months median time)
Kaplan- Meier estimat for
Efficacy Parameter
Risiko
Kaplan-Meier Estimate of
Responsrate (CR, nPR eller PR)
Response rate (CR, nPR,
Responsvarighed *
Duration of response*
Sygdomsfri overlevelse (DFS) **
Disease free survival (DFS)**
mediane tid til hændelsen FC R- FC
Time to new lymphoma treatment
Responsrate og CR- rater er analyseret med χ2- test.
Response rate and CR rates analysed using Chi-squared Test.
NR: ikke nået; n. a.: ikke relevant *: gælder kun for patienter, som opnåede CR, nPR eller PR **: gælder kun for patienter, som opnåede CR
only applicable to patients achieving a CR, nPR, PR; applicable
Progressionsfri overlevelse ifølge Binet stage (ITT)
Progression-Free Survival according to Binet stage (ITT)
Kliniske erfaringer med reumatoid arthritis
Clinical experience in rheumatoid arthritis
Forsøg 1 var et dobbeltblindet sammenlignende forsøg, der omfattede 517 patienter, som havde oplevet utilstrækkeligt respons eller intolerans over for behandling med en eller flere TNF- hæmmere.
Study 1 was a double blind comparative study which included 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Forsøg 2 var et randomiseret, dobbeltblindet, double- dummy, kontrolleret, 3 x 3 multifaktorielt forsøg, som sammenlignede to forskellige doser af rituximab med eller uden en af to kortikosteriodregimer i kombination med ugentlig methotrexat hos patienter med aktiv reumatoid arthritis og som ikke havde responderet på behandling med 1- 5 andre DMARDs.
Study 2 was a randomized, double-blind, double-dummy, controlled, 3 x 3 multifactorial study which compared two different dose levels of rituximab given with or without one of two peri infusional corticosteroid regimens in combination with weekly methotrexate in patients with active rheumatoid arthritis which had not responded to treatment with 1 to 5 other DMARDs.
51 Resultat for sygdomsaktivitet I alle tre forsøg, øgede rituximab 2 x 1000 mg signifikant andelen af patienter, der opnåede mindst 20% forbedring i ACR score, sammenlignet med patienter behandlet med methotrexat alene (tabel 6).
Disease activity outcomes In all three studies, rituximab 2 x 1000 mg significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone
Sammenligning mellem studierne af ACR respons ved uge 24 (ITT populationen)
Cross-Study Comparison of
ACR Respons Placebo+MTX Rituximab+MTX
ACR Responses at Week 24 (ITT Population)
p ≤ 0, 0001; 2 p ≤ 0, 001; 3 p < 0, 05 MTX – methotrexat
p ≤ 0.0001; 2 p ≤ 0.001; 3 p < 0.05 MTX – Methotrexate
Patienter behandlet med rituximab havde en signifikant større reduktion i sygdomsaktivitetsscore (DAS28) end patienter behandlet med methotrexat alene (gennemsnitlig ændring i DAS28 fra baseline var henholdsvis - 1, 9 versus - 0, 4; p < 0, 0001).
Rituximab treated patients had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Mean change in DAS28 from baseline -1.9 vs. -0.4, p < 0.0001, respectively).
Et godt til moderat European League Against Rheumatism (EULAR) respons blev opnået af signifikant flere patienter behandlet med rituximab sammenlignet med patienter behandlet med methotrexat alene (tabel 8).
A good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients compared to patients treated with methotrexate alone (Table 9).
Af de patienter, der i starten udelukkende fik methotrexat, fik 81% rituximab
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.
Tabel 8
50 Table 8
Gennemsnitlige radiologiske forandringer over 56 uger i forsøg 1
Radiographic mean changes over 56 weeks in Study 1
Forekomst af HACA kan være forbundet med forværring af infusions - eller allergiske reaktioner efter det andet af efterfølgende behandlingsforløb.
The presence of HACA may be associated with worsening of infusion or allergic reactions after the second infusion of subsequent courses.
53 Hyperurikæmi (grad 3/ 4) forekom hos 143/ 950 (15%) patienter, med størstedelen efter infusion på dagene 1 og/ eller 15.
Hyperuricemia (grade 3/ 4) occurred in 143/ 950 (15%) patients, with the majority post-infusion on days 1 and/ or 15.
De totale immunoglobulinniveauer i plasma, totalt lymfocyttal, og hvide blodlegemer forblev generelt inden for normalværdierne efter behandling med MabThera, med undtagelse af et forbigående fald i antallet af hvide blodlegemer i de første fire uger efter behandlingen.
51 Plasma total immunoglobulin concentrations, total lymphocytes counts, and white cells generally remained within normal limits following MabThera treatment, with the exception of a transient drop in white cells counts over the first four weeks following therapy.
Efter hver infusion steg den gennemsnitlige Cmax, fra et gennemsnit på 243 µg/ ml (spændvidde 16- 582 µg/ ml) efter den første infusion til 550 µg/ ml (spændvidde 171 – 1177 µg/ ml) efter den ottende infusion.
Upon administration of rituximab at a dose of 375 mg/ m2 as an intravenous infusion at weekly intervals for 8 doses to 37 patients with NHL, the mean Cmax increased with each successive infusion, spanning from a mean of 243 µg/ mL (range, 16 – 582 µg/ mL) after the first infusion to 550 µg/ mL (range, 171 – 1177 µg/ mL) after the eighth infusion.
54 Reumatoid arthritis
Rheumatoid arthritis
Efter to intravenøse infusioner af rituximab i en dosis på 1000 mg med to ugers interval, var den gennemsnitlige halveringstid 20, 8 dage (i intervallet 8, 58 dage til 35, 9 dage), den gennemsnitlige systemiske clearance var 0, 23 l/ dag (i intervallet 0, 091 til 0, 67 l/ dag) og det gennemsnitlige steady - state fordelingsvolumen var 4, 6 l (i intervallet 1, 7 til 7, 51 l).
Following two intravenous infusions of rituximab 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).
Farmakokinetisk analyse af populationen af de samme data gav sammenlignelige gennemsnitlige værdier for systemisk clearance og halveringstid; henholdsvis 0, 26 l/ dag og 20, 4 dage.
Population pharmacokinetic analysis
Farmakokinetisk analyse af populationen viste, at legemsoverflade og køn var de mest signifikante co- variable, til forklaring af inter- individuel variation i farmakokinetiske parametre.
52 revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters.
55 6. 3 Opbevaringstid
6.3 Shelf life
6. 4 Særlige opbevaringsforhold
53 6.4 Special precautions for storage
Hætteglas, af klart type I glas med butyl gummi prop, indeholdende 100 mg rituximab i 10 ml.
Clear Type I glass vials with butyl rubber stopper containing 500 mg of rituximab in 50 ml.
Pakninger med 2 hætteglas.
Packs of 1 vials.
EU/ 1/ 98/ 067/ 001
EU/ 1/ 98/ 067/ 002
De kan finde yderligere information om {navn} på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu.
DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
57 BILAG II
54 ANNEX II
FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
55 A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
1 D- 79639, Grenzach- Wyhlen Tyskland
1 D-79639 Grenzach-Wyhlen Germany
• BETINGELSER ELLER BEGRÆNSINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Indehaveren af markedsføringstilladelsen vil fortsætte med at indsende årlige PSURer, medmindre andet bliver fastlagt af CHMP.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
59 BILAG III
57 ANNEX III
60 A.
58 A.
61 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
MabThera 100 mg, koncentrat til infusionsvæske, opløsning
MabThera 100 mg concentrate for solution for infusion
Rituximab
Rituximab 100 mg / 10 ml
1 hætteglas indeholder 10 mg/ ml rituximab.
1 vial contains 10 mg/ ml rituximab.
Koncentrat til infusionsvæske, opløsning Pakning med 2 hætteglas á 10 ml
Concentrate for solution for infusion 2 vials of 10 ml
62 10.
60 10.