natgillin/translations-raw huggingface dataset:
Dette syndrom kan ligne kliniske fund på tumor lyse syndrom som hyperuricæmi, hyperkaliæmi, hypocalcæmi, hyperphosphatæmi, akut nyresvigt, forhøjet laktatdehydrogenase (LDH) og kan medføre akut respirationssvigt og død.
This syndrome may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, hyperphosphaetemia, acute renal failure, elevated Lactate dehydrogenase (LDH) and may be associated with acute respiratory failure and death.
Det akutte respirationssvigt kan ledsages af f. eks. interstitiel lungeinfiltration eller lungeødem som kan ses på røntgen af thorax.
The acute respiratory failure may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray.
4. 2) og modtage kraftig symptomatisk behandling.
Patients who develop severe cytokine release syndrome should have their infusion interrupted immediately (see section 4.2) and should receive aggressive symptomatic treatment.
Da en initial forbedring kan følges af forværring, bør disse patienter monitoreres tæt indtil tumor lyse syndrom og lunge infiltration er forsvundet eller udelukket.
Since initial improvement of clinical symptoms may be followed by deterioration, these patients should be closely monitored until tumour lysis syndrome and pulmonary infiltration have been resolved or ruled out.
Yderligere behandling af patienter efter fuldstændig ophør af kliniske fund og symptomer har sjældent resulteret i gentagelse af alvorligt cytokin frigivelsessyndrom.
Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome.
4. 8) ledsaget af hypotension og bronchospasme er set hos 10% af patienter behandlet med MabThera.
Infusion related adverse reactions including cytokine release syndrome (see section 4.8) accompanied by hypotension and bronchospasm have been observed in 10% of patients treated with MabThera.
Disse symptomer er sædvanligvis reversible, når MabThera infusionen afbrydes, og der administreres et antipyretikum, et antihistamin og undertiden oxygen, intravenøst saltvand eller bronchodilaterende midler og glukokortikoider om nødvendigt.
These symptoms are usually reversible with interruption of MabThera infusion and administration of an anti-pyretic, an antihistaminic, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Ved alvorlige reaktioner se venligst cytokin frigivelsessyndrom ovenfor.
Please see cytokine release syndrome above for severe reactions.
I modsætning til cytokin frigivelsessyndromet optræder egentlige allergiske reaktioner typisk indenfor minutter efter påbegyndelse af infusionen.
In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes after starting infusion.
Lægemidler til behandling af overfølsomhedsreaktioner, såsom epinephrin (adrenalin), antihistamin og glukokortikoid bør være tilgængelige til umiddelbar anvendelse i tilfælde af en allergisk reaktion under indgift af MabThera.
Medicinal products for the treatment of hypersensitivity reactions, e. g., epinephrine (adrenaline), antihistamines and glucocorticooids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
Kliniske fund ved anafylaksi kan ligne de kliniske fund på cytokin frigivelsessyndrom (beskrevet ovenfor).
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above).
Eftersom hypotension kan forekomme under infusion af MabThera, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med MabThera.
Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medicines 12 hours prior to the MabThera infusion.
Angina pectoris eller hjertearrytmier, såsom atrieflimren og atrieflagren, hjertesvigt eller myokardieinfarkt er forekommet hos patienter behandlet med MabThera.
Angina pectoris, or cardiac arrhythmias such as atrial flutter and fibrillation heart failure or myocardial infarction have occurred in patients treated with MabThera.
Derfor bør patienter med hjertelidelse og/ eller tidligere kardiotoksisk kemoterapi i anamnesen monitoreres nøje.
Therefore patients with a history of cardiac disease and/ or cardiotoxic chemotherapy should be monitored closely.
Selvom MabThera ikke er myelosuppressivt som monoterapi, bør forsigtighed udvises når det overvejes at behandle patienter med neutrofiltal på < 1, 5 x 109/ l og/ eller thrombocyttal på < 75 x 109/ l, fordi de kliniske erfaringer på denne population er begrænsede.
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.
MabThera er blevet anvendt til 21
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.
Behovet for regelmæssig fuldstændig blodtælling, inklusive trombocyttællinger, under monoterapi med MabThera, bør overvejes.
6 Consideration should be given to the need for regular full blood counts, including platelet counts, during monotherapy with MabThera.
Hvis MabThera gives i kombination med CHOP - eller CVP – kemoterapi (cyclophosphamid, vincristin og prednisolon), skal der foretages regelmæssig fuldstændig blodtælling i henhold til sædvanlig medicinsk praksis.
When MabThera is given in combination with CHOP or CVP (cyclophosphamide, vincristine, and prednisone) chemotherapy, regular full blood counts should be performed according to usual medical practice.
Alvorlige infektioner, herunder dødelige, kan forekomme under behandlingen med MabThera (se pkt.
Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
4. 8) MabThera bør ikke administreres til patienter med en aktiv og/ eller alvorlig infektion (som f. eks. tuberkulose, sepsis og opportunistiske infektioner, se pkt.
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3).
4. 8).
Physicians should exercise caution when considering the use of MabThera in patients with a history of recurring or chronic infections or with underlying conditions which may further predispose patients to serious infection (see section 4.8).
Meget sjældne tilfælde af hepatitis B reaktivering, herunder tilfælde af fulminant hepatitis med dødelig udgang, er blevet rapporteret hos patienter, der har fået rituximab.
Very rare cases of hepatitis B reactivation have been reported in subjects receiving rituximab including fulminant hepatitis with fatal outcome.
Hovedparten af disse patienter var også udsat for cytotoksisk kemoterapi.
The majority of these subjects were also exposed to cytotoxic chemotherapy.
Disse tilfælde er forvekslet med både den tilgrundliggende sygdom samt cytotoksisk kemoterapi.
The reports are confounded by both the underlying disease state and the cytotoxic chemotherapy.
Patienter, der tidligere har haft en hepatitis B infektion skal kontrolleres omhyggeligt for tegn på aktiv hepatitis B infektion, når rituximab anvendes sammen med cytotoksisk kemoterapi.
Patients with a history of hepatitis B infection should be carefully monitored for signs of active hepatitis B infection when rituximab is used in association with cytotoxic chemotherapy.
4. 8).
Very rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported during post-marketing use of MabThera in NHL and CLL (see section 4.8).
Hovedparten af patienterne havde fået rituximab i kombination med kemoterapi eller som en del af en hæmatopoietisk stamcelletransplantation.
The majority of patients had received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant.
Sikkerheden for vaccination med levende, virale vacciner efter MabThera behandling er ikke undersøgt hos NHL og CLL patienter, og vaccination med levende, virale vacciner kan ikke anbefales.
The safety of immunization with live viral vaccines, following MabThera therapy has not been studied for NHL and CLL patients and vaccination with live virus vaccines is not recommended.
Patienter, som behandles med MabThera, kan vaccineres med ikke- levende vacciner.
Patients treated with MabThera may receive non-live vaccinations.
Dog kan responsrater efter vaccination med ikke- levende vacciner være nedsat.
However with non-live vaccines response rates may be reduced.
I et ikke- randomiseret studie blev patienter med relaps af low- grade NHL, som fik MabThera monoterapi, sammenlignet med raske, ubehandlede kontroller.
In a non-randomized 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.
Patienterne havde en lavere responsrate over for vaccination med tetanus recall antigen (16% vs 81%) og Keyhole Limet Haemocyanin (KLH) neoantigen (4% vs 69%, når vurderet for > 2- fold stigning i antistof - titeren).
69% when assessed for > 2-fold increase in antibody titer).
Hos CLL patienter forventes lignede resultater, når lighederne mellem sygdommene tages i betragtning, men det er ikke undersøgt i kliniske studier.
For CLL patients similar results are assumable considering similarities between both diseases but that has not been investigated in clinical trials.
Gennenmsnittet af præterapeutiske antistoftitere for et udvalg af antigener (Streptococcus pneumoniae, influenza A, mæslinger, røde hunde, skoldkopper) blev bibeholdt i mindst 6 måneder efter behandling med MabThera.
Mean pre-therapeutic antibody titers against a panel of antigens (Streptococcus pneumoniae, influenza A, mumps, rubella, varicella) were maintained for at least 6 months after treatment with MabThera.
Infusionsreaktioner MabThera er forbundet med infusionsreaktioner, som kan være relaterede til frigivelse af cytokiner og/ eller andre kemiske mediatorer.
Infusion reactions MabThera is associated with infusion reactions, which may be related to release of cytokines and/ or other chemical mediators.
4. 8).
Premedication with intravenous glucocorticoid significantly reduced the incidence and severity of these events (see section 4.8).
De fleste rapporterede infusionshændelser var af mild til moderat sværhedsgrad.
Most infusion events reported were mild to moderate in severity.
Andelen af påvirkede patienter faldt i de efterfølgende infusioner.
The proportion of affected patients decreases with subsequent infusions.
De rapporterede reaktioner var som regel reversible efter reduktion af hastigheden, eller afbrydelse, af MabThera- infusionen og administration af et antipyretikum, et antihistamin og, lejlighedsvis oxygen, intravenøs saltvandsopløsning eller bronchodilatorer, samt glukokortikoider, hvis det var påkrævet.
The reactions reported were usually reversible with a reduction in rate, or interruption, of MabThera infusion and administration of an anti-pyretic, an antihistamine, and, occasionally, oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
I de fleste tilfælde kan infusionen genoptages med en 50% reduktion i hastigheden (for eksempel fra 100 mg/ time til 50 mg/ time), når symptomerne er fuldstændigt forsvundet.
In most cases, the infusion can be resumed at a 50% reduction in rate (e. g. from 100 mg/ h to 50 mg/ h) when symptoms have completely resolved.
7 Anafylaktiske og andre hypersensitivitetsreaktioner er blevet rapporteret efter intravenøs administration af proteiner, inklusive MabThera, til patienter.
Anaphylactic and other hypersensitivity reactions have been reported following the intravenous administration of proteins, including MabThera, to patients.
Lægemidler til behandling af hypersensitivitetsreaktioner, for eksempel epinephrin (adrenalin), antihistaminer og glukokortikoider, bør være tilgængelige til øjeblikkelig anvendelse, i tilfælde af en allergisk reaktion under administration af MabThera.
Medicinal products for the treatment of hypersensitivity reactions, e. g., epinephrine (adrenaline), antihistamines and glucocorticoids, should be available for immediate use in the event of an allergic reaction during administration of MabThera.
5. 1).
The presence of HACA may be associated with worsening infusion or allergic reactions after the second infusion of subsequent courses (see section 5.1).
4. 8).
7 In clinical studies 10/ 990 (1%) patients with rheumatoid arthritis who received a first infusion of MabThera at any dose experienced a serious reaction during the infusion (see section 4.8).
Patienten skal nøje overvåges under administration.
Therefore, in patients with a known cardiac history, the risk of cardiovascular complications resulting from infusion reactions should be considered before treatment with MabThera and patients closely monitored during administration.
Da hypotension kan forekomme under infusion med MabThera, bør det overvejes at seponere antihypertensiva i 12 timer før MabThera- infusionen.
Since hypotension may occur during MabThera infusion, consideration should be given to withholding anti-hypertensive medications 12 hours prior to the MabThera infusion.
Infektioner Alvorlige infektioner, inklusive fatale tilfælde, kan forekomme under behandlingsforløbet med MabThera (se pkt.
Infections Serious infections, including fatalities, can occur during therapy with MabThera (see section 4.8).
4. 3) eller til alvorligt immunokompromitterede patienter (for eksempel ved hypogammaglobulinæmi eller hvor CD4 eller CD8 niveauerne er meget lave).
MabThera should not be administered to patients with an active and/ or severe infection (e. g. tuberculosis, sepsis and opportunistic infections, see section 4.3) or severely immunocompromised patients (e. g. in hypogammaglobulinemia or where levels of CD4 or CD8 are very low).
Patienter bør evalueres for enhver potentiel risiko for infektioner, før der gives efterfølgende behandlinger med MabThera.
Before giving a subsequent course of MabThera treatment, patients should be re-evaluated for any potential risk for infections.
Progressiv multifokal leukoencefalopati (PML) er i meget sjældne tilfælde set efter behandling med MabThera for reumatoid arthritis og autoimmune sygdomme, inklusive systemisk lupus erythematosus (SLE) og vaskulitis.
Very rare cases of Progressive Multifocal Leukoencephalopathy (PML) have been reported following use of MabThera for the treatment of rheumatoid arthritis and autoimmune diseases including Systemic Lupus Erythematosus (SLE) and Vasculitis.
Disse tilfælde vedrørte patienter med flere risikofaktorer for PML, såsom den underliggende sygdom, langvarig behandling med immunsuppresiva eller behandling med kemoterapi.
These cases involved patients with multiple risk factors for PML, including the underlying disease and long-term immunosuppressive therapy or chemotherapy.
Hos patienter med non- Hodgkin lymfom, der fik rituximab i kombination med cytotoksisk kemoterapi, er der i meget sjældne tilfælde rapporteret om reaktivering af hepatitis B (se non- Hodgkin lymfom).
In patients with non-Hodgkin’ s lymphoma receiving rituximab in combination with cytotoxic chemotherapy, very rare cases of hepatitis B reactivation have been reported (see non-Hodgkin’ s lymphoma).
Vaccination Lægen bør gennemgå patientens vaccinationsstatus og følge gældende vaccinationsvejledninger inden igangsætning af MabThera behandling.
Immunization Physicians should review the patient’ s vaccination status and follow current immunization guidelines prior to MabThera therapy.
Sikkerheden ved vaccination med levende, virale vacciner efter behandling med MabThera er ikke undersøgt.
The safety of immunization with live viral vaccines following MabThera therapy has not been studied.
Derfor kan vaccination med levende, virale vacciner ikke anbefales samtidig med MabThera behandling, eller mens der er perifer B- celle depletion.
Therefore vaccination with live virus vaccines is not recommended whilst on MabThera or whilst peripherally B cell depleted.
Patienter, som behandles med MabThera, kan vaccineres med ikke- levende vacciner, men responsraterne kan være nedsat.
Patients treated with MabThera may receive non-live vaccinations.
I et randomiseret studie blev RA patienter behandlet med MabThera og methotrexat eller med methotrexat alene.
However, response rates to non- live vaccines may be reduced.
Responsraterne var sammenlignelige ved vaccination med tetanus recall antigen (39% vs.
In a randomized study, patients with RA treated with MabThera and methotrexate had comparable response rates to tetanus recall antigen (39% vs.
42%), der var reduceret respons over for pneumokok polysaccharid vaccine (43% vs.
42%), reduced rates to pneumococcal polysaccharide vaccine (43% vs.
82% over for mindst to pneumokokantistof serotyper) og over for KLH neoantigen (47% vs.
82% to at least 2 pneumococcal antibody serotypes), and KLH neoantigen (47% vs.
93%), når vaccinationen blev givet 6 måneder efter MabThera- behandling.
93%), when given 6 months after MabThera/ Rituxan as compared to patients only receiving methotrexate.
Hvis vaccination med ikke levende vacciner er nødvendig samtidig med behandling med MabThera, bør vaccinationerne være gennemført mindst 4 uger inden næste behandling med MabThera.
Should non-live vaccinations be required whilst receiving MabThera therapy, these should be completed at least 4 weeks prior to commencing the next course of MabThera
8 Ved gentagen behandling med MabThera gennem et år er den samlede erfaring, at andelen af patienter med positive antistoftitere over for S. pneumoniae, influenza, mæslinger, røde hunde, skoldkopper og tetanustoksoid generelt var sammenlignelige til andelen ved baseline.
In the overall experience of MabThera repeat treatment over one year, the proportions of patients with positive antibody titers against S. pneumoniae, influenza, mumps, rubella, varicella and tetanus toxoid were generally similar to the proportions at baseline.
Samtidig/ fortløbende anvendelse af andre DMARDs Samtidig anvendelse af MabThera og andre antireumatiske behandlinger, end dem der er specificeret under reumatoid arthritis- indikation og dosering, anbefales ikke.
8 Concomitant/ sequential use of other DMARDs The concomitant use of MabThera and antirheumatic therapies other than those specified under the rheumatoid arthritis indication and posology is not recommended.
4. 5).
There are limited data from clinical trials to fully assess the safety of the sequential use of other DMARDs (including TNF inhibitors and other biologics) following MabThera (see section 4.5).
Sådanne patienter skal imidlertid observeres tæt for tegn på infektion, hvis biologiske lægemidler og/ eller DMARDs anvendes efter MabThera behandling.
The available data indicate that the rate of clinically relevant infection is unchanged when such therapies are used in patients previously treated with MabThera, however patients should be closely observed for signs of infection if biologic agents and/ or DMARDs are used following MabThera therapy.
Maligne sygdomme Immunomodulerende lægemidler kan øge risikoen for maligne sygdomme.
Malignancy Immunomodulatory drugs may increase the risk of malignancy.
4. 8) kan en mulig risiko for udvikling af solide tumorer ikke udelukkes på nuværende tidspunkt, selv om tilgængelige data ikke tyder på nogen øget risiko.
On the basis of limited experience with MabThera in rheumatoid arthritis patients (see section 4.8) a possible risk for the development of solid tumours cannot be excluded at this time, although present data do not seem to suggest any increased risk.
Samtidig administration med methotrexat påvirkede ikke farmakokinetikken af MabThera hos patienter med reumatoid arthritis.
Co-administration with methotrexate had no effect on the pharmacokinetics of MabThera in rheumatoid arthritis patients.
Patienter med humant anti- mus antistof eller humant anti- kimært antistof titere (HAMA/ HACA) kan få allergiske eller overfølsomhedsreaktioner, når de behandles med andre diagnostiske eller terapeutiske monoklonale antistoffer.
Patients with human anti-mouse antibody or human anti-chimeric antibody (HAMA/ HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.
I en lille observationsgruppe fik 280 patienter med reumatoid arthritis efterfølgende behandling med andre DMARDs, og deraf fik 185 patienter et biologisk DMARD efter MabThera behandling.
In a small cohort of patients with rheumatoid arthritis, 280 patients received subsequent therapy with other DMARDs of whom 185 received a biologic DMARD following MabThera.
Hos disse patienter var andelen af patienter, som fik klinisk relevant infektion under MabThera - behandling, 6, 99 per 100 patientår i forhold til 5, 49 per patientår efter behandling med biologiske DMARD.
In these patients the rate of clinically relevant infection while on MabThera only was 6.99 per 100 patient years compared to 5.49 per 100 patients years following treatment with the biologic DMARD.
Graviditet Det vides, at IgG- immunoglobuliner kan passere placentabarrieren.
Pregnancy IgG immunoglobulins are known to cross the placental barrier.
B- celle niveauer i spædbørn efter moderen havde været eksponeret for MabThera, er ikke undersøgt i kliniske forsøg.
B cell levels in human neonates following maternal exposure to MabThera have not been studied in clinical trials.
Der foreligger ingen adækvate og velkontrollerede data fra studier hos gravide kvinder, men der er dog beskrevet forbigående B- celle depletion og lymfocytopeni hos børn af mødre, som har været eksponeret for rituximab under graviditeten.
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
Derfor bør MabThera/ Rituxan ikke gives til gravide kvinder medmindre den potentielle gevinst opvejer den potentielle risiko.
For these reasons MabThera should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
På grund af den lange retentionstid hos B- celle reducerede patienter, bør kvinder i den fødedygtige alder anvende sikker antikonception under behandling og i 12 måneder efter afsluttet behandling med MabThera.
Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during treatment and for 12 months following MabThera therapy.
Toksicitetsforsøg om reproduktion, der blev udført på cynomolgusaber, viste ingen tegn på embryotoksicitet in utero.
Developmental toxicity studies performed in cynomolgus monkeys revealed no evidence of embryotoxicity in utero.
Nyfødte unger af dyremødre, der havde været eksponeret for MabThera, sås at have B- celle depletion i den postnatale fase.
New born offspring of maternal animals exposed to MabThera were noted to have depleted B cell populations during the post natal phase.
9 Amning Det vides ikke om rituximab udskilles i modermælk.
Lactation Whether rituximab is excreted in human milk is not known.
Eftersom maternelt IgG imidlertid udskilles i modermælk, og rituximab blev detekteret i mælk fra diegivende aber, bør kvinder ikke amme, når de behandles med MabThera og i 12 måneder efter afsluttet MabThera behandling.
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.