natgillin/translations-raw huggingface dataset:
DATO FOR ÆNDRING AF TEKSTEN &lt; {DD måned ÅÅÅÅ} &gt; [Udfyldes nationalt]
DATE OF REVISION OF THE TEXT &lt; {DD month YYYY} &gt; [To be completed nationally]
Af disse 110 patienter havde 23 (20,9 %) tidligere fået &lt; 30 mg orale morphinækvivalenter dagligt, 66 (60,0 %) havde fået 30 til 44 mg orale morphinækvivalenter dagligt, og 12 (10,9 %) havde fået mindst 45 mg orale morphinækvivalenter dagligt (der er ingen tilgængelige data for 9 forsøgspersoner [8,2 %]).
Of these 110 subjects, 23 (20.9%) had previously been receiving &lt; 30 mg of oral morphine equivalents per day, 66 (60.0%) had been receiving 30 to 44 mg of oral morphine equivalents per day, and 12 (10.9%) had been receiving at least 45 mg of oral morphine equivalents per day (data not available for 9 [8.2%] subjects).
DUROGESICs sikkerhed er blevet evalueret hos 289 pædiatriske patienter ( &lt; 18 år), som deltog i 3 kliniske studier vedrørende behandling af kroniske eller konstante smerter af malign eller non-malign oprindelse.
The safety of DUROGESIC was evaluated in 289 paediatric subjects ( &lt; 18 years) who participated in 3 clinical studies for the management of chronic or continuous pain of malignant or non-malignant origin.
Blandt de resterende 5 forsøgspersoner med en startdosis på mindst 25 mikrog/time, hvis tidligere opioiddosis var &lt; 45 mg orale morphinækvivalenter dagligt, havde 1 (0,6 %) tidligere fået &lt; 30 mg orale morphinækvivalenter dagligt, og 4 (2,2 %) havde fået 30 til 44 mg orale morphinækvivalenter dagligt (se pkt.
Among the remaining 5 subjects with a starting dosage of at least 25 mcg/h whose prior opioid doses were &lt; 45 mg of oral morphine equivalents per day, 1 (0.6%) had previously been receiving &lt; 30 mg of oral morphine equivalents per day and 4 (2.2%) had been receiving 30 to 44 mg of oral morphine equivalents per day (see section 4.8).
Denne indlægsseddel blev senest ændret &lt; {MM/ÅÅÅÅ} &gt; &lt; {måned ÅÅÅÅ}. &gt; [Udfyldes nationalt]
This leaflet was last revised in &lt; {MM/YYYY} &gt; &lt; {month YYYY} &gt; .
&lt; {Medlemslandets navn} &gt; &lt; {Lægemidlets navn} &gt;
&lt; {fax} &gt; &lt; {e-mail} &gt;
Signifikante niveauer var defineret som * p &lt; 0,05 **p &lt; 0,001, ***p &lt; 0,0001.
Significance levels were defined as * p &lt; 0.05, ** p &lt; 0.001, *** p &lt; 0.0001.
Størstedelen af patienterne (81 %) viste tegn på B-celleregenerering med &gt; 10 celler/mikroliter ved måned 12; dette steg til 87 % af patienterne ved måned 18.
The majority of patients (81%) showed signs of B cell return, with counts &gt; 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Antigenet udtrykkes på &gt; 95 % af alle B-celle non-Hodgkin-lymfomer.
The antigen is expressed on &gt; 95% of all B cell non-Hodgkin's lymphomas.
Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000) og meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000) and very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Gennemsnitsændring i SF-36 PHS % SF-36 PHS MCID Gennemsnitsændring i SF-36 MHS % SF-36 MHS MCID † Resultat ved uge 24 Signifikant forskel fra placebo ved det primære tidspunkt: * p &lt; 0,05, **p &lt; 0,001 ***p ≤ 0,0001 MCID HAQDI ≥ 0,22, MCID SF-36 PHS &gt; 5,42, MCID SF-36 MHS &gt; 6,33
% SF-36 PHS MCID Mean change in SF-36 MHS % SF-36 MHS MCID † Outcome at 24 weeks Significant difference from placebo at the primary time point: * p &lt; 0.05, ** p &lt; 0.001, *** p ≤ 0.0001 MCID HAQ-DI ≥ 0.22, MCID SF-36 PHS &gt; 5.42, MCID SF-36 MHS &gt; 6.33
For CLL-patienter, hvis lymfocyttal er &gt; 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med Rixathon for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
For CLL patients whose lymphocyte counts are &gt; 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with Rixathon to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
Median TTF: 2,6 år Ikke opnået p &lt; 0,001
Median TTF: 2.6 years Not reached p &lt; 0.001
Rituximab-vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder ( &lt; 60 år, ≥ 60 år), FLIPI-score (≤ 1, 2 eller ≥ 3), induktionsbehandling (R-CHOP, R-CVP eller R-FCM) og uanset kvaliteten af respons på induktionsbehandling (CR, CRu eller PR).
Rituximab maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age ( &lt; 60 years, &gt; = 60 years), FLIPI score ( &lt; =1, 2 or &gt; = 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
Forekomsten af symptomer på infusionsrelaterede reaktioner var højest under eller efter første infusion (9 %) og faldt med gentagne infusioner ( &lt; 4 %).
The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions ( &lt; 4%).
Rituximab-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p &lt; 0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p=0,0071).
Rituximab maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p &lt; 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden ( &lt; 1/10.000).
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100) and very rare ( &lt; 1/10,000).
I en subgruppeanalyse var den samlede responsrate højere hos patienter med histologisk subtype IWF B, C og D sammenlignet med subtype IWF A (58 % versus 12 %), højere hos patienter hvis største læsions længste diameter var &lt; 5 cm versus &gt; 7 cm (53 % versus 38 %) og højere hos patienter med kemoterapifølsomt relaps sammenlignet med kemoterapiresistent relaps (defineret som en responsvarighed &lt; 3 måneder) (50 % versus 22 %).
In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58% vs. 12%), higher in patients whose largest lesion was &lt; 5 cm vs. &gt; 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response &lt; 3 months) relapse (50% vs. 22%).
Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVPgruppen (p &lt; 0,0001), log rank test).
The median duration of response was 37.7 months in the R-CVP group and was 13.5 months in the CVP group (p &lt; 0.0001, log-rank test).
Infusionsrelaterede reaktioner i det kliniske studie, hvor man sÃ¥ pÃ¥ induktion af remission hos patienter med svÃ¦r, aktiv GPA eller MPA blev defineret som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som vÃ¦rende infusionsrelateret.
In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusionrelated by investigators in the safety population.
Median EFS: Ikke opnået p &lt; 0,0001
Median EFS: 36 Not reached p &lt; 0.0001
Infektioner og parasitÃ¦re sygdomme bakterielle og virale infektioner +bronkitis sepsis, +pneumoni, +febril infektion, +herpes zoster, +luftvejsinfektion er, svampeinfektione r, infektioner af ukendt Ã¦tiologi, +akut bronkitis, +sinusitis, hepatitis B1
Sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3/4 bivirkninger var ens hos ældre, sammenlignet med yngre ( &lt; 65 år).
The incidence of ADRs of all grades and grade 3 /4 ADR was similar in elderly patients compared to younger patients ( &lt; 65 years).
Hyppigheden af infusionsrelaterede bivirkninger aftog væsentligt med de efterfølgende infusioner og var under 1 % efter den ottende behandlingsserie med rituximab.
The incidence of infusion-related symptoms decreased substantially with subsequent infusions and is &lt; 1% of patients by the eighth cycle of rituximab (containing) treatment.
Median PFS: Ikke opnået p &lt; 0,0001
Median PFS: 28.8 Not reached p &lt; 0.0001
infusionsrelaterede reaktioner3 (generelt Ã¸dem, bronkospasm e, hiven efter vejret, larynxÃ¸dem angioÃ¸dem, generaliseret klÃ¸e, anafylaksi, anafylaktoide reaktioner)
Infusionrelated reactions3 (generalised oedema, bronchospas m, wheezing, laryngeal oedema, angioneuroti c oedema, generalised pruritus, anaphylaxis, anaphylactoi d reaction)
Vedligeholdelsesbehandling med rituximab gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p &lt; 0,0001 log rank test).
Maintenance treatment with rituximab led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p &lt; 0.0001 log-rank test).The median PFS was 42.2 months in the rituximab maintenance arm compared to 14.3 months in the observation arm.
Hos patienter med GPA eller MPA faldt antallet af B-celler i perifert blod til &lt; 10 celler/mikroliter efter 2 ugentlige infusioner af rituximab 375 mg/m2 og forblev på dette niveau hos de fleste patienter til måned 6.
&lt; 10 cells/μL after two weekly infusions of rituximab 375 mg/m2, and remained at that level in most patients up to the 6 month time point.
Infusionsrelaterede reaktioner hos patienter med GPA, MPA og PV var i overensstemmelse med dem, der sÃ¥s i kliniske studier med patienter med reumatoid artrit (se pkt.
IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with to those seen for rheumatoid arthritis patients in clinical trials (see section 4.8).
Infektioner og parasitÃ¦re sygdomme Ã¸vre luftvejsinfektioner, urinvejsinfektio n bronkitis, sinuitis gastroenteritis, fodsvamp
Upper respiratory tract infection, urinary tract infections
Informationsmaterialet til lÃ¦gen, informationsmaterialet til patienten samt patientkortet skal godkendes af den nationale sundhedsmyndighed, inden materialerne distribueres.
The Physician information, Patient information and Patient Alert Card must be agreed with the National Competent Authorities prior to distribution.
Den “primære” statistiske test for “respons” var trend-testen af CR versus PR versus non-respons (p &lt; 0,0001)
The “primary” statistical test for “response” was the trend test of CR versus PR versus non-response (p &lt; 0.0001)
Signifikante niveauer var defineret som * p &lt; 0,05 **p &lt; 0,001, ***p &lt; 0,0001.
Significance levels were defined as * p &lt; 0.05, **p &lt; 0.001, ***p &lt; 0.0001.
Antigen findes på &gt; 95 % af alle B-celle non-Hodgkin-lymfomer.
The antigen is expressed on &gt; 95 % of all B cell non-Hodgkin's lymphomas.
Ved måned 28 opstod der større recidiver (defineret som genkomsten af kliniske og/eller laboratorie tegn på vaskulitis-aktivitet ([BVAS] &gt; 0), der kunne føre til organsvigt eller skade eller være livstruende) hos 3 patienter (5 %) i MabThera-gruppen og 17 patienter (29 %) i azathioprin-gruppen (p=0,0007).
At month 28, major relapse (defined by the reappearance of clinical and/or laboratory signs of vasculitis activity ([BVAS] &gt; 0) that could lead to organ failure or damage or could be life threatening) occurred in 3 patients (5%) in the MabThera group and 17 patients (29%) in the azathioprine group (p=0.0007).
Dosisjustering er ikke nødvendig hos ældre patienter (alder &gt; 65 år).
No dose adjustment is required in elderly patients (aged &gt; 65 years).
Signifikant forskel fra placebo ved det primære tidspunkt: * p &lt; 0,05, **p &lt; 0,001 ***p ≤ 0,0001
Significant difference from placebo at the primary time point: * p &lt; 0.05, **p &lt; 0.001 ***p ≤ 0.0001
MabThera-vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP-induktionsbehandling (median PFS 37,5 måneder versus 11,6 måneder, p &lt; 0,0001) såvel som hos dem, der responderede på R-CHOP induktionsbehandling (median PFS 51,9 måneder versus 22,1 måneder, p=0,0071).
MabThera maintenance treatment significantly prolonged median PFS in patients responding to CHOP induction therapy (median PFS 37.5 months vs. 11.6 months, p &lt; 0.0001) as well as in those responding to R-CHOP induction (median PFS 51.9 months vs. 22.1 months, p=0.0071).
Andelen af patienter behandlet med MabThera, som viste minimal klinisk relevant ændring (MCID) i HAQ-DI (defineret som et fald i individuel total score på &gt; 0,22) var også højere end hos patienter, som fik methotrexat alene (tabel 14).
The proportions of MabThera treated patients showing a minimal clinically important difference (MCID) in HAQ-DI (defined as an individual total score decrease of &gt; 0.22) was also higher than among patients receiving methotrexate alone (Table 14).
For patienter, der vejer 60-90 kg og &lt; 60 kg, var den gennemsnitlige Ctrough værdi efter intravenøs dosering lavere, henholdsvis ca. 16 % og 34 %, sammenlignet med subkutan dosering.
For subjects weighing 60-90 kg and &lt; 60 kg, average Ctrough values following intravenous dosing were approximately 16% and 34% lower compared to the subcutaneous regimen, respectively.
Selvom MabThera ikke er myelosuppressivt ved monoterapi, bør der udvises forsigtighed, når det overvejes at behandle patienter med neutrofiltal på &lt; 1,5 x 109/l og/eller trombocyttal på &lt; 75 x 109/l, da kliniske erfaringer hos denne population er begrænsede.
Although MabThera is not myelosuppressive in monotherapy, caution should be exercised when considering treatment of patients with neutrophils &lt; 1.5 x 109/L and/or platelet counts &lt; 75 x 109/L as clinical experience in this population is limited.
I en subgruppeanalyse var den samlede responsrate højere hos patienter med histologisk subtype IWF B, C og D sammenlignet med subtype IWF A (58 % versus 12 %), højere hos patienter hvis største læsions længste diameter var &lt; 5 cm versus &gt; 7 cm (53 % versus 38 %) og højere hos patienter med kemoterapifølsomt relaps sammenlignet med kemoterapi-resistent relaps (defineret som en responsvarighed &lt; 3 måneder) (50 % versus 22 %).
In a subgroup analysis, the ORR was higher in patients with IWF B, C, and D histological subtypes as compared to IWF A subtype (58 % vs. 12%), higher in patients whose largest lesion was &lt; 5 cm vs. &gt; 7 cm in greatest diameter (53% vs. 38%), and higher in patients with chemosensitive relapse as compared to chemoresistant (defined as duration of response &lt; 3 months) relapse (50% vs. 22%).
Information til patienten om MabThera skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Patient information about MabThera should contain the following key elements:
Hyppigheden defineres som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000
Frequencies are defined as very common (≥1/10), common (≥1/100 to &lt; 1/10), uncommon (≥1/1,000 to &lt; 1/100), and very rare ( &lt; 1/10,000).
For patienter, der vejer &gt; 90 kg, var værdierne for Ctrough ens, for det subkutane og det intravenøse doserings-regime.
For subjects weighing &gt; 90 kg, Ctrough values were the same for the intravenous and subcutaneous regimens.
Hyppigheden af trombocytopeni var lav ( &lt; 1, grad 3/4), og der var ingen forskel mellem behandlingsarmene.
The incidence of thrombocytopenia was low ( &lt; 1 %, grade 3/4) and was not different between treatment arms.
Infusionsrelaterede reaktioner i det kliniske studie, hvor man sÃ¥ pÃ¥ induktion af remission hos patienter med svÃ¦r, aktiv GPA eller MPA blev defineret som enhver bivirkning, der opstod inden for 24 timer efter en infusion i sikkerhedspopulationen, og som af investigator blev anset som vÃ¦rende infusionsrelateret.
In the clinical trial studying induction of remission with severe active GPA and MPA, IRRs were defined as any adverse event occurring within 24 hours of an infusion and considered to be infusion-related by investigators in the safety population.
I kliniske studier med MabThera som vedligeholdelsesbehandling af recidiveret/ refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse ( &lt; 7 g/l) i både observationsgruppen og MabThera-gruppen efter induktionsbehandlingen.
In the clinical trial evaluating MabThera maintenance treatment in relapsed/refractory follicular lymphoma, median IgG levels were below the lower limit of normal (LLN) ( &lt; 7 g/L) after induction treatment in both the observation and the MabThera groups.
Størstedelen af patienterne (81 %) viste tegn på B-celleregenerering med &gt; 10 celler/mikroliter ved måned 12; dette steg til 87% af patienterne ved måned 18.
with counts &gt; 10 cells/μL by month 12, increasing to 87% of patients by month 18.
Andelen af patienter med tumorrespons (CR, Cru, PR) var signifikant højere (p &lt; 0,0001 chi square test) i R-CVP-gruppen (80,9 %) end i CVP-gruppen (57,2 %).
The proportion of patients with a tumour response (CR, CRu, PR) was significantly higher (p &lt; 0.0001 Chi-Square test) in the R-CVP group (80.9 %) than the CVP group (57.2 %).
Informationen til lÃ¦gen om MabThera skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Physician information about MabThera should contain the following key elements:
For CLL-patienter, hvis lymfocyttal er &gt; 25 x 109/l, anbefales det at administrere 100 mg prednison/prednisolon intravenøst kort før infusionen med MabThera for at reducere hastigheden og sværhedsgraden af akutte infusionsreaktioner og/eller cytokinfrigivelsessyndrom.
For CLL patients whose lymphocyte counts are &gt; 25 x 109/L it is recommended to administer prednisone/prednisolone 100 mg intravenous shortly before infusion with MabThera to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
R-CVP var signifikant bedre end CVP mht. det primære endepunkt, tid til behandlingssvigt (27 måneder versus 6,6 måneder), p &lt; 0,0001, log rank test).
R-CVP led to a significant benefit over CVP for the primary endpoint, time to treatment failure (27 months vs. 6.6 months, p &lt; 0.0001, log-rank test).
I det kliniske studie BO22334, blev effekt observeret imellem kropsstørrelse og eksponeringsratio i behandlingsserie 7, mellem rituximab subkutan formulering 1400 mg hver 3. uge og rituximab intravenøs formulering 375 mg/m2 hver 3. uge med Ctrough ratio på 2,29; 1,31 og 1,41 hos patienter med henholdsvis lavt, medium og højt legemsoverfladeareal (BSA) (lavt BSA ≤ 1,70 m2; 1,70 m2 &lt;
In clinical trial BO22334, an effect was observed between body size and exposure ratios reported in cycle 7, between rituximab subcutaneous formulation 1400 mg q3w and rituximab intravenous formulation 375 mg/m2 q3w with Ctrough ratios of 2.29, 1.31, and 1.41 in patients with low, medium and high BSA, respectively (low BSA ≤ 1.70 m2; 1.70 m2 &lt; medium BSA &lt; 1.90 m2; high BSA
Information som skal fremgÃ¥ pÃ¥ et aftageligt klistermÃ¦rke Lot
Information to appear on Peel-off sticker
Kardielle bivirkninger rapporteredes som alvorlige bivirkninger (inklusive atrieflimren, myokardieinfarkt, venstre ventrikelsvigt, myokardieiskæmi) hos 3 % af patienterne behandlet med MabThera sammenlignet med &lt; 1 % under observation.
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 &lt; 1% on observation.
MabThera-vedligeholdelsesbehandling gav konsekvent fordel i alle testede prædefinerede undergrupper: Køn (mand, kvinde), alder ( &lt; 60 år, ≥ 60 år), FLIPI-score (≤1, 2 eller ≥3),
MabThera maintenance treatment provided consistent benefit in all predefined subgroups tested: gender (male, female), age ( &lt; 60 years, &gt; = 60 years), FLIPI score ( &lt; =1, 2 or &gt; = 3), induction therapy (R-CHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR,CRu or PR).
medium BSA &lt; 1,90 m2; højt BSA ≥ 1,90 m2).
≥ 1.90 m2).
Infusionsrelaterede reaktioner hos patienter med GPA, MPA og PV var i overensstemmelse med dem, der sÃ¥s i kliniske studier med patienter med reumatoid artrit (se pkt.
IRRs for patients with granulomatosis with polyangiitis, microscopic polyangiitis and pemphigus vulgaris were consistent with those seen for rheumatoid arthritis patients in clinical trials (see section
Vedligeholdelsesbehandling med MabThera gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p &lt; 0,0001 log rank test).
Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p &lt; 0.0001 log-rank test).The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 76 %, når vurderet for &gt; 2-fold stigning i antistof -titeren).
In a non-randomised study, patients with relapsed low-grade NHL who received MabThera monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 76% when assessed for &gt; 2-fold increase in antibody titer).
Infektioner og parasitÃ¦re sygdomme Urinvejsinfektion
Infections and Infestations upper respiratory tract infection, urinary tract infections
Tabel 2 Effektresultater for SABRINA (BO22334) (ITT populationen)
Table 2 Efficacy results for SABRINA (BO22334) (Intent to Treat Population) Pooled Stages 1 &amp; 2 N = 410
Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16 % versus 81 %) og Keyhole Limet Haemocyanin (KLH) neoantigen (4 % versus 69 %, når vurderet for &gt; 2-fold stigning i antistof -titer).
In a non-randomized study, patients with relapsed low-grade NHL who received the MabThera intravenous formulation as monotherapy when compared to healthy untreated controls had a lower rate of response to vaccination with tetanus recall antigen (16% vs. 81%) and Keyhole Limpet Haemocyanin (KLH) neoantigen (4% vs. 69% when assessed for &gt; 2-fold increase in antibody titer).
Hyppigheden af bivirkninger, uanset sværhedsgrad, og hyppigheden af grad 3 og 4 bivirkninger var ens hos ældre sammenlignet med yngre ( &lt; 65 år) patienter.
The incidence of ADRs of all grades and grade 3/4 ADR was similar in elderly patients compared to younger patients ( &lt; 65 years).