natgillin/translations-raw huggingface dataset:
Hæmatologisk toksicitet - ≥ Grad 3-neutropeni med feber, grad 4neutropeni, som varer mere end 7 dage, trombocyttal &lt; 10 x 109 celler/l
Haematological toxicity - ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count &lt; 10,000 cells/μl
Denne interimanalyse viste en TTP-risikoreduktion på 45 % (95 % CI, 29-57 %, p &lt; 0,0001) for patienter behandlet med kombinationsbehandlingen bortezomib og pegyleret liposomal doxorubicin.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p &lt; 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
HRb(95 % CI)=0,63 p-værdid &lt; 0.001
HRb (95% CI)=0.63 p-valued &lt; 0.001
Median for investigatorbedømt PFS var 30,7 måneder i BzmbR-CAP-gruppen og 16,1 måneder i RCHOP-gruppen (hazard-ratio [HR]=0,51; p &lt; 0,001).
Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p &lt; 0.001).
a Intent to Treat (ITT)-population b p-værdi fra den stratificerede log-rank-test; analyse ud fra behandling udelukker opdeling på tidligere behandling;
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p &lt;
&gt; 3 x ULN Alle
&gt; 3 x ULN
Patienter med ≥ grad 2 perifer neuropati ved baseline eller trombocyttal &lt; 50 x 109/l indgik ikke.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts &lt; 50,000/μl were excluded.
ORe (95 % CI)=1,688 p-værdig &lt; 0,007
ORe (95% CI)=1.688 p-valueg=0.007
Det er uvist, om bortezomibs farmakokinetik bliver påvirket hos patienter med svært nedsat nyrefunktion (CrCl &lt; 20 ml/min/1,73 m2), som ikke er i dialyse.
It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL &lt; 20 ml/min/1.73 m2).
Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: For trombocyttal ved baseline &lt; 75 x 109/l havde 90 % af 21 patienter et tal på ≤ 25 x 109/l under studiet, herunder 14 % &lt; 10 x 109/l.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts &lt; 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% &lt; 10,000/μl; in contrast, with a baseline platelet count &gt; 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
- Hvis trombocyttallet er &lt; 25 x 109 celler/l, eller ANC er &lt; 0,75 x 109 celler/l på en dag med Bortezomib SUN-dosering (undtagen dag 1 i hver cyklus)
- If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib SUN dosing day (other than day 1)
Normal (CrCl ≥ 60 ml/min/1,73 m2, n=12), Mild (CrCl = 40-59 ml/min/1,73 m2, n=10), Moderat (CrCl = 20-39 ml/min/1,73 m2, n=9) og Alvorlig (CrCl &lt; 20 ml/min/1,73 m2, n=3).
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL &lt; 20 ml/min/1.73 m2, n=3).
Behandlingen med bortezomib skal indstilles, når trombocyttallet er &lt; 25 x 109/l eller, ved kombinationsbehandling med melphalan og prednison, når trombocyttallet er ≤ 30 x 109/l (se pkt.
Bortezomib therapy should be withheld when the platelet count is &lt; 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2).
&gt; 1,5-3 x ULN Alle
&gt; 1.5 x - 3 x ULN Any
Nedsat nyrefunktion Bortezomibs farmakokinetik påvirkes ikke hos patienter med let til moderat nedsat nyrefunktion (kreatininclearance [CrCl] &gt; 20 ml/min/1,73 m2).
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] &gt; 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
ANC-værdien ≤ 0,75 x 109/l på en Bortezomib SUN-dosisdag (bortset fra dag 1)
or ANC &lt; 750 cells/μl on a Bortezomib SUN dosing day (other than Day 1 of each cycle)
&gt; 1,0-1,5 x ULN Alle
&gt; 1.0 x - 1.5 x ULN Any
dissemineret og oftalmisk), herpesvirusinfektion*, bakterieinfektion*, øvre/nedre luftvejsinfektion*, svampeinfektion*, herpes simplex*
Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated &amp; ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia
&gt; 1 tidligere behandling tidligere behandli nger
&gt; 1 prior line of therapy
{DD / MM / ÅÅÅÅ}
&lt; {DD/MM/YYYY} &gt;
A. &lt; FREMSTILLER &lt; (E) &gt; AF DE(T) BIOLOGISK AKTIVE STOF &lt; (FER) &gt; OG &gt; FREMSTILLER &lt; (E) &gt; ANSVARLIG FOR BATCHFRIGIVELSE
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Infektioner forÃ¥rsaget af bakterien P. aeruginosa er almindelige ved cystisk fibrose.
Bacterial lung infection with P. aeruginosa is frequent in cystic fibrosis patients.
Tiden til indsætten var mellem 1 og 3 uger hos 14 af patienterne, mens der i 9 tilfælde blev angivet kortere tid til indsætten ( &lt; 7 dage), heraf 6 med meget kort tid til indsætten (1-3 dage).
Time to onset ranged from 1 to 3 weeks in 14 patients, while 9 cases were reported with a shorter time to onset ( &lt; 7 days) including 6 cases with a very short time to onset between 1- 3 days.
Infektioner Kontakt straks lÃ¦gen, hvis du fÃ¥r tegn pÃ¥ infektion, f.eks.:
Infections Tell your doctor immediately if you get signs of an infection including:
Eksplorative analyser af fordelen ved vedligeholdelsesbehandling viste en mindre udtalt effekt hos ældre patienter ( &gt; 70 år), dog var stikprøvestørrelserne små.
Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients ( &gt; 70 years of age), however sample sizes were small.
Informationen til lÃ¦gen og informationen til patienten skal godkendes af den nationale sundhedsmyndighed, inden materialerne distribueres, og patientkortet skal inkluderes som en del af den indre emballage.
The Physician information and Patient information must be agreed with the National Competent Authorities prior to distribution and Patient Alert Card should be included as part of inner packaging.
Infusionsrelaterede reaktioner kan forekomme som fÃ¸lge af hypersensitivitet og/eller virkningsmekanismen.
IRRs may occur as a result of hypersensitivity and/or to the mechanism of action.
Selvom rituximab ikke er myelosuppressivt ved monoterapi, bør forsigtighed udvises, når det overvejes at behandle patienter med neutrofiltal på &lt; 1,5 x 109/l og/eller trombocyttal på &lt; 75 x 109/l, fordi de kliniske erfaringer hos denne population er begrænsede.
Although rituximab 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.
Antigenet udtrykkes på &gt; 95 % af alle B-celle nonHodgkin-lymfomer.
The antigen is expressed on &gt; 95% of all B cell non-Hodgkin's lymphomas.
Forekomsten af symptomer på infusionsrelaterede reaktioner var højest under eller efter første infusion (9 %) og faldt med gentagende infusioner ( &lt; 4 %).
The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions ( &lt; 4%).
150 patienter, som oprindeligt var randomiseret til placebo + MTX i studie 1, fik mindst en behandlingsserie af rituximab + MTX ved 1 år * p &lt; 0,05, ** p &lt; 0,001.
150 patients originally randomised to placebo + MTX in Trial 1 received at least one course of RTX + MTX by one year * p &lt; 0.05, ** p &lt; 0.001.
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.
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 rituximab-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 rituximab group and 17 patients (29%) in the azathioprine group (p=0.0007).
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, ≥ 60 years), FLIPI score (≤1, 2 or ≥ 3), induction therapy (RCHOP, R-CVP or R-FCM) and regardless of the quality of response to induction treatment (CR, CRu or PR).
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).
Median EFS: 36 Ikke opnået p &lt; 0,0001
Median EFS: 36 Not reached p &lt; 0.0001
Median PFS: 28,8 Ikke opnået p &lt; 0,0001
Median PFS: 28.8 Not reached p &lt; 0.0001
Andelen af patienter behandlet med rituximab, 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 rituximab 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).
Hyppigheden af grad 3/4 bivirkninger i blod og lymfesystemet var højere hos ældre patienter med tidligere ubehandlet eller relaps/refraktær CLL, sammenlignet med hos yngre patienter ( &lt; 65 år).
The incidence of grade 3/4 blood and lymphatic adverse events was higher in elderly patients compared to younger patients ( &lt; 65 years), with previously untreated or relapsed/refractory CLL.
Det bør overvejes at give disse patienter første infusion med nedsat infusionshastighed eller at fordele dosis over to dage i første serie og hver af de efterfølgende serier, hvis lymfocyttallet stadig er &gt; 25 x 109/l.
Consideration should be given to the use of a reduced infusion rate for the first infusion in these patients or a split dosing over two days during the first cycle and any subsequent cycles if the lymphocyte count is still &gt; 25 x 109/L.
Ældre Dosisjustering er ikke nødvendig hos ældre patienter (alder &gt; 65 år).
Elderly No dose adjustment is required in elderly patients (aged &gt; 65 years).
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%).
Den mediane responsvarighed var 37,7 måneder i R-CVP-gruppen, og den var 13,5 måneder i CVP-gruppen (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).
Dosisjustering er ikke nødvendig hos ældre patienter (alder &gt; 65 år).
Elderly No dose adjustment is required in elderly patients (aged &gt; 65 years).
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), 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; 1/1000), very rare ( &lt; 1/10,000) and not known (cannot be estimated from the available data).
Information til patienten om Ritemvia skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Patient information about Ritemvia should contain the following key elements:
I kliniske studier med rituximab som vedligeholdelsesbehandling af recidiveret/ refraktært follikulært lymfom var de mediane IgG-niveauer under nedre referencegrænse ( &lt; 7 g/l) i både observationsgruppen og rituximab-gruppen efter induktionsbehandlingen.
In the clinical trial evaluating rituximab 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 rituximab groups.
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%).
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).
Hos patienter med granulomatose med polyangiitis eller mikroskopisk polyangiitis 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.
In patients with granulomatosis with polyangiitis or microscopic polyangiitis, the number of peripheral blood B cells decreased to &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.
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
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
Behandling med R-CVP forlængede signifikant tiden til sygdomsprogression eller død, sammenlignet med CVP; 33,6 måneder i forhold til 14,7 måneder (p &lt; 0,0001, log-rank test).
Treatment with R-CVP significantly prolonged the time to disease progression or death compared to CVP, 33.6 months and 14.7 months, respectively (p &lt; 0.0001, log-rank test).
Efter en median observationstid på 48,1 måneder i 1. linje-studiet var medianen for progressionsfri overlevelse 55 måneder i R-FC-gruppen og 33 måneder i FC-gruppen (p &lt; 0,0001, log-rank test).
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 &lt; 0.0001, log-rank test).
Signifikante niveauer var defineret som * p &lt; 0,05 **p &lt; 0,001, ***p &lt; 0,0001.
Mean change DAS28-ESR ‐1.97** Significance levels were defined as * p &lt; 0.05, **p &lt; 0.001, ***p &lt; 0.0001.
Informationen til lÃ¦gen om Ritemvia skal indeholde fÃ¸lgende nÃ¸gle-elementer:
The Physician information about Ritemvia should contain the following key elements:
almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til ≤ 1/100) og meget sjælden ( &lt; 1/10.000).
(≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1000 to &lt; 1/100) and very rare ( &lt; 1/10000).
Median TTF: 2,6 år Ikke opnået p &lt; 0,001
Median TTF: years Not reached p &lt; 0.001
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).
Influenzalignende symptomer Perifert Ã¸dem
Influenza-like illness Oedema peripheral
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.
cell return, with counts &gt; 10 cells/μL by month 12, increasing to 87% of patients by month 18.
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.
Infusion-related reactions 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.
Frekvenserne er defineret som meget almindelig (≥ 1/10), 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).
Kardiale hændelser (herunder atrieflimren, myokardieinfarkt, venstre ventrikulært svigt og myokardieiskæmi) blev rapporteret som alvorlige bivirkninger hos 3 % af patienterne, som fik rituximab sammenlignet med &lt; 1 % i observationsgruppen.
Cardiac events were reported as serious adverse events (including atrial fibrillation, myocardial infarction, left ventricular failure, myocardial ischaemia) in 3% of patients treated with rituximab compared to &lt; 1% on observation.
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.
Infektionerne var hovedsageligt lette til moderate og var som regel Ã¸vre luftvejsinfektioner, herpes zoster og urinvejsinfektioner.
Infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections, herpes zoster and urinary tract infections.
Den “primære” statistiske undersøgelse af “respons” var test for trend af CR versus PR versus ingen 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) Abbreviations: NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
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).
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 rituximab 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).
Infusionsrelaterede reaktioner (IRR) 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.
Infektioner og parasitÃ¦re sygdomme bakterielle og virale infektioner +bronkitis sepsis, +pneumoni, +febril infektion, +herpes zoster, +luftvejsinfektioner, svampeinfektioner, infektioner af ukendt Ã¦tiologi, +akut bronkitis, +sinusitis, hepatitis B1
Infections and infestations bacterial infections, viral infections, +bronchitis sepsis, +pneumonia, +febrile infection, +herpes zoster, +respiratory tract infection, fungal infections, infections of unknown aetiology, +acute bronchitis, +sinusitis, hepatitis B1
infusions-relaterede reaktioner3 (generelt Ã¸dem, bronkospasme, hiven efter vejret, larynxÃ¸dem angioÃ¸dem, generaliseret klÃ¸e, anafylaksi, anafylaktoide reaktioner)
3infusion-related reactions (generalised oedema, bronchospasm, wheezing, laryngeal oedema, angioneurotic oedema, generalised pruritis, anaphylaxis, anaphylactoid reaction)
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 4.8).
Information til lÃ¦gen
Physician information
Infektionerne var hovedsageligt lette til moderate og var som regel lokaliseret i de Ã¸vre luftveje eller urinvejene.
The infections were predominately mild to moderate and consisted mostly of upper respiratory tract infections and urinary tract infections.
Forskellen i OS mellem de to behandlingsarme var statistisk signifikant (p &lt; 0,001).
The difference in OS between the two treatment arms was statistically significant (p &lt; 0.001).
Infektion var den mest almindelige ikke-hÃ¦matologiske toksicitet.
Infection was the most common non haematological toxicity.
Der var ingen metabolitter med &gt; 10 % i forhold til udgangsstoffet eller total radioaktivitet i plasma.
No metabolites were present at &gt; 10% relative to parent or total radioactivity in plasma.
Der foreligger ingen data for administration af pomalidomid til pædiatriske patienter ( &lt; 18 år).
No data are available on administration of pomalidomide to paediatric patients ( &lt; 18 years of age).