natgillin/translations-raw huggingface dataset:
Når MabThera anvendes til behandling af ikke- Hodgkins lymfom, er de hyppigste bivirkninger (som optræder hos flere end 1 ud af 10 patienter) bakterieinfektioner, virusinfektioner, bronkitis (betændelse i luftvejene i lungerne), neutropeni (lavt antal hvide blodlegemer (neutrofiler)), leukopeni (lavt antal leukocytter, en anden type hvide blodlegemer), febril neutropeni (neutropeni med feber), reaktioner i forbindelse med infusionen (hovedsagelig feber, kulderystelser og rysten), angioødem (hævelser under huden), kvalme, pruritus (kløe), udslæt, hårtab, feber, kulderystelser, asteni (kraftesløshed), hovedpine og faldende IgG- niveauer (en type antistof).
When used to treat non-Hodgkin’ s lymphoma, the most common side effects with MabThera (seen in more than 1 patient in 10) are bacterial infections, viral infections, bronchitis (inflammation of the airways in the lungs), neutropenia (low levels of neutrophils, a type of white blood cell), leucopenia (low levels of leucocytes, another type of white blood cell), febrile neutropenia (neutropenia with fever), reactions related to the infusion (mainly fever, chills and shivering), angioedema (swelling beneath the skin), nausea (feeling sick), pruritus (itching), rash, alopecia (hair loss), fever, chills, asthenia (weakness), headache and decreased levels of IgG (a type of antibody).
Ved anvendelse til behandling af reumatoid arthritis er den hyppigste bivirkning (som optræder hos flere end 1 ud af 10 patienter) infektion.
When used to treat rheumatoid arthritis, the most common side effect (seen in more than 1 patient in 10) is infection.
Den fuldstændige liste over de indberettede bivirkninger ved MabThera fremgår af indlægssedlen.
For the full list of all side effects reported with MabThera, see the Package Leaflet.
2/ 3 MabThera må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for rituximab, museproteiner eller et eller flere af de øvrige indholdsstoffer.
MabThera should not be used in people who may be hypersensitive (allergic) to rituximab, mouse proteins, or any of the other ingredients.
Desuden bør MabThera ikke gives til patienter med reumatoid arthritis, hvis de har en aktiv, svær infektion, svær hjerteinsufficiens eller svær hjertesygdom.
In addition, patients with rheumatoid arthritis should not receive MabThera if they have an active severe infection, severe heart failure or severe heart disease.
Hvorfor blev MabThera godkendt?
2/ 3 Why has MabThera been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved MabThera er større end risiciene ved behandling af non- Hodgkins lymfom og reumatoid arthritis.
The Committee for Medicinal Products for Human Use (CHMP) decided that MabThera’ s benefits are greater than its risks for the treatment of non-Hodgkin’ s lymphoma and rheumatoid arthritis.
Udvalget anbefalede udstedelse af markedsføringstilladelse for MabThera.
The Committee recommended that MabThera be given marketing authorisation.
Andre oplysninger om MabThera:
Other information about MabThera:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for MabThera til Roche Registration Limited den 2. juni 1998.
The European Commission granted a marketing authorisation valid throughout the European Union for MabThera to Roche Registration Limited on 2 June 1998.
Markedsføringstilladelsen blev fornyet den 2. juni 2003 og den 2. juni 2008.
The marketing authorisation was renewed on 2 June 2003 and on 2 June 2008.
Den fuldstændige EPAR for MabThera findes her.
The full EPAR for MabThera is available here.
EU/ 1/ 98/ 067/ 001 EU/ 1/ 98/ 067/ 001
EU/ 1/ 98/ 067/ 001
MABTHERA MABTHERA
EU/ 1/ 98/ 067/ 002
100 mg 500 mg
500 mg
Koncentrat til infusion, opløsning Intravenøs anvendelse Koncentrat til infusion, opløsning Intravenøs anvendelse
Concentrate for solution for infusion
Ampul (glas) Ampul (glas)
Vial (glass)
10 ml (10mg/ ml) 2 hætteglas 50 ml (10mg/ ml) 1 hætteglas
50 ml (10 mg/ ml)
MabThera 100 mg/ ml (10 mg/ ml) koncentrat til infusionsvæske, opløsning
MabThera 100 mg (10 mg/ ml) concentrate for solution for infusion
Opløsningen indeholder 10 mg rituximab pr. ml.
Each solution contains 10 mg/ ml of Rituximab.
Et hætteglas til engangsbrug indeholder 100 mg rituximab.
Each single-use vial containing 100 mg of Rituximab.
Rituximab er et gensplejset chimerisk muse/ humant monoklonalt antistof der repræsenterer et glycosyleret immunoglobulin med humane IgG1 konstante regioner og murine light- chain og heavy - chain variable regionssekvenser.
Rituximab is a genetically engineered chimeric mouse/ human monoclonal antibody representing a glycosylated immunoglobulin with human IgG1 constant regions and murine light-chain and heavy- chain variable region sequences.
Non- Hodgkin lymfom (NHL)
Non-Hodgkin’ s lymphoma (NHL)
MabThera er indiceret til behandling af tidligere ubehandlede patienter med stadium III- IV follikulært lymfom i kombination med kemoterapi.
MabThera is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy.
MabThera vedligeholdelsesbehandling er indiceret til patienter med relaps/ refraktært follikulært lymfom, der responderer på induktionsbehandling med kemoterapiregimer med eller uden MabThera.
MabThera maintenance therapy is indicated for patients with relapsed/ refractory follicular lymphoma responding to induction therapy with chemotherapy with or without MabThera.
MabThera monoterapi er indiceret til behandling af patienter med grad III- IV follikulært lymfom, som er resistente overfor kemoterapi eller som er i deres andet eller efterfølgende relaps efter kemoterapi.
MabThera monotherapy is indicated for treatment of patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
MabThera er, i kombination med CHOP- kemoterapi (cyclophosphamid, doxorubicin, vincristin og prednisolon), indiceret til behandling af patienter med CD20 positivt, diffust storcellet B- celle non - Hodgkin lymfom.
MabThera is indicated for the treatment of patients with CD20 positive diffuse large B cell non- Hodgkin’ s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
MabThera er indiceret som 1. linje behandling til patienter med kronisk lymfatisk leukæmi (CLL) i kombination med kemoterapi.
MabThera is indicated for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
5. 1 for yderligere information.
See section 5.1 for further information.
MabThera er, i kombination med methotrexat, indiceret til behandling af voksne patienter med svær aktiv reumatoid arthritis, som har haft utilstrækkeligt respons med eller er intolerante over for andre
MabThera in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-
2 disease- modifying anti- rheumatic drugs (DMARD) inklusive en eller flere tumor nekrosis faktor (TNF) hæmmere.
2 modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.
MabThera- infusioner bør anvendes på hospitaler, hvor komplet genoplivningsudstyr er umiddelbart tilgængeligt og under tæt kontrol af en erfaren læge.
MabThera infusions should be administered under the close supervision of an experienced physician, and in an environment where full resuscitation facilities are immediately available.
Non Hodgkin lymfom
Non-Hodgkin’ s lymphoma
Justering af dosis under behandling Der foreligger ingen anbefalinger for dosisreduktion af MabThera.
Dosage adjustments during treatment No dose reductions of MabThera are recommended.
Når MabThera gives i kombination med kemoterapi, bør de kemoterapeutiske lægemidler reduceres i henhold til standard doseringsreduktioner.
When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied.
Follikulær non- Hodgkin lymfom Kombinationsbehandling Den anbefalede dosis af MabThera i kombination med kemoterapi til induktionsbehandling af tidligere ubehandlet eller recidiveret / refraktær NHL hos patienter er:
Combination therapy The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory patients with follicular NHL is:
375 mg/ m2 kropsoverflade pr behandlingsserie i op til 8 serier.
375 mg/ m2 body surface area per cycle, for up to 8 cycles.
MabThera bør gives på dag 1 i hver kemoterapiserie, efter intravenøs indgift af glucocorticoidkomponenten, hvis det anvendes.
Mabthera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
Monoterapi/ Vedligeholdelsesbehandling Den anbefalede dosis af MabThera som vedligeholdelsesbehandling til patienter til behandling af recidiveret/ refraktær follikulær NHL, som har responderet på induktionsbehandling med kemoterapi med eller uden MabThera er:
Monotherapy/ Maintenance The recommended dose of MabThera used as a maintenance treatment for patients with relapsed/ refractory follicular NHL who have responded to induction treatment with chemotherapy, with or without MabThera is:
375 mg/ m2 kropsoverflade hver 3. måned indtil sygdomsprogression eller i maksimalt to år.
375 mg/ m2 body surface area once every 3 months until disease progression or for a maximum period of two years.
Den anbefalede dosis af MabThera monoterapi anvendt som induktionsbehandling til voksne patienter med grad III- IV follikulært lymfom, som er resistente overfor behandling med kemoterapi eller som er i deres anden eller efterfølgende recidiv efter kemoterapi er:
The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy is:
375 mg/ m2 kropsoverflade, givet som intravenøs infusion en gang ugentligt i fire uger.
375 mg/ m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
Til genbehandling med MabThera monoterapi til patienter, som har responderet på tidligere behandling med MabThera monoterapi for recidiveret/ refraktær follikulær NHL, er den anbefalede dosis:
For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for relapsed/ refractory follicular NHL, the recommended dose is:
5. 1).
375 mg/ m2 body surface area, administered as an intravenous infusion once weekly for four weeks (see section 5.1).
Diffust storcellet B- celle non- Hodgkin lymfom MabThera bør anvendes i kombination med CHOP kemoterapi.
Diffuse large B cell non-Hodgkin's lymphoma MabThera should be used in combination with CHOP chemotherapy.
Den anbefalede dosis er 375 mg/ m² legemsoverflade, administreret på dag 1 i hver kemoterapiserie i 8 serier efter intravenøs infusion af glukokortikoid- komponenten i CHOP.
The recommended dosage is 375 mg/ m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles after intravenous infusion of the glucocorticoid component of CHOP.
Sikkerhed og effekt af MabThera er ikke påvist i kombination med andre kemoterapiregimer til behandling af diffust storcellet B- celle non- Hodgkin lymfom.
Safety and efficacy of MabThera have not been established in combination with other chemotherapies in diffuse large B cell non- Hodgkin’ s lymphoma.
For at nedsætte risikoen for tumorlysesyndrom hos CLL patienter bør der gives forebyggende behandling med adækvat hydrering og administration af urikosurika 48 timer før behandlingens start.
Prophylaxis with adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome.
Til patienter med lymfocyttal > 25 x 109/ l bør der gives 100 mg prednison eller prednisolon intravenøst kort tid før infusionen med MabThera for at nedsætte antallet og sværhedsgraden af akutte infusionsreaktioner og/ eller cytokine release syndrome.
For CLL patients whose lymphocyte counts are > 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.
3 Den anbefalede dosis af MabThera i kombination med kemoterapi er 375 mg/ m2 legemsoverflade gives på første dag af første behandlingsserie efterfulgt af 500 mg/ m2 legemsoverflade på dag 1 af hver af de følgende serier, i alt 6 serier.
3 The recommended dosage of MabThera in combination with chemotherapy is 375 mg/ m2 body surface area administered on day 1 of the first treatment cycle followed by 500 mg/ m2 body surface area administered on day 1 of each subsequent cycle for 6 cycles in total.
En behandling med MabThera består af to 1000 mg intravenøse infusioner.
A course of MabThera consists of two 1000 mg intravenous infusions.
Den anbefalede dosering af MabThera er 1000 mg ved intravenøs infusion efterfulgt af endnu en 1000 mg intravenøs infusion to uger senere.
The recommended dosage of MabThera is 1000 mg by intravenous infusion followed by a second 1000 mg intravenous infusion two weeks later.
Sygdomsaktiviteten bør monitoreres regelmæssigt.
Disease activity should be regularly monitored.
Der er begrænsede kliniske data om sikkerhed og effekt af gentagne behandlingsforløb med MabThera.
There are limited clinical data on the safety and efficacy of further courses of therapy with MabThera.
I en lille observationsgruppe fik cirka 600 patienter med tegn på tilbagevendende sygdomsaktivitet yderligere 2- 5 behandlingsforløb 6- 12 måneder efter det tidligere behandlingsforløb.
In a small observational cohort, approximately 600 patients with evidence of continued disease activity received 2-5 repeated courses of treatment 6- 12 months after the previous course.
4. 8 og 5. 1).
(See sections 4.8 and 5.1).
Hos nogle patienter udvikles humane anti- kimære antistoffer (HACA) efter den første behandling med MabThera (se pkt.
Human anti chimeric antibodies (HACA) develop in some patients after the first course of MabThera (see section 5.1).
Forekomst af HACA kan være forbundet med en forværring af infusionsreaktioner eller allergiske reaktioner efter den anden eller senere infusioner.
The presence of HACA may be associated with the worsening of infusion or allergic reactions after the second infusion of subsequent courses.
Derudover er der i et tilfælde med HACA observeret mangel på B- celle depletion efter gentagne behandlinger.
Furthermore, in one case with HACA, failure to deplete B-cells after receipt of further treatment courses has been observed.
Derfor bør forholdet mellem risici og fordele af behandling med MabThera nøje overvejes, før der gives gentagne behandlinger med MabThera.
Thus, the benefit/ risk balance of therapy with MabThera should be carefully considered before administering subsequent courses of Mabthera.
Hvis et efterfølgende behandlingsforløb overvejes, bør det ikke gives i et interval på mindre end 16 uger.
If a repeat course of treatment is considered it should not be given at an interval less than 16 weeks.
Øvrig behandling med glukokortikoider, salicylater, non- steroid antiinflammatoriske lægemidler eller analgetika kan fortsætte under behandlingen med MabThera.
Background therapy with glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with MabThera.
Dette bør gøres for at nedsætte risikoen for og alvorligheden af akutte infusionsreaktioner (se indgivelsesmåde).
Rheumatoid arthritis patients should receive treatment with 100 mg intravenous methylprednisolone 30 minutes prior to MabThera to decrease the rate and severity of acute infusion reactions (see method of administration).
Første infusion i hver behandling Den anbefalede initiale infusionshastighed er 50 mg/ time, som efter de første 30 minutter kan øges med 50 mg/ time hver halve time, til en maksimal hastighed på 400 mg/ time.
First infusion of each course The recommended initial rate for infusion is 50 mg/ hr; after the first 30 minutes, it can be escalated in 50 mg/ hr increments every 30 minutes, to a maximum of 400 mg/ hr.
Anden infusion i hver behandling Efterfølgende doser af MabThera kan infunderes med en initial infusionshastighed på 100 mg/ time, som kan øges med 100 mg/ time hver halve time, til en maksimal hastighed på 400 mg/ time.
Second infusion of each course Subsequent doses of MabThera can be infused at an initial rate of 100 mg/ hr, and increased by 100 mg/ hr increments at 30 minutes intervals, to a maximum of 400 mg/ hr.
Pædiatrisk anvendelse MabThera bør ikke bruges til børn og unge på grund af mangel på data vedrørende sikkerhed og effekt.
Paediatric use MabThera is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Indgivelsesmåde Til behandling af non- Hodgkin lymfom og kronisk lymfatisk leukæmi bør det overvejes at give præmedicinering med glukokortikoider, hvis MabThera ikke gives i kombination med kemoterapi, som indeholder glukokortikoider.
Method of Administration Premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy for treatment of non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia.
Der bør altid gives præmedicinering med et antipyretikum og et antihistamin, såsom paracetamol og diphenhydramin før hver infusion med MabThera.
Premedication consisting of an anti-pyretic and an antihistaminic, e. g. paracetamol and diphenhydramine, should always be administered before each infusion of MabThera.
Efter de første 30 minutter kan den øges med 50 mg/ time hvert 30. minut til højst 400 mg/ time.
First infusion The recommended initial rate for infusion is 50 mg/ hr; after the first 30 minutes, it can be escalated in 50 mg/ hr increments every 30 minutes, to a maximum of 400 mg/ hr.
4 Efterfølgende infusioner Efterfølgende MabThera- doser kan infunderes med 100 mg/ time initialt og øges med 100 mg/ time hvert 30. minut til højst 400 mg/ time.
4 Subsequent infusions Subsequent doses of MabThera can be infused at an initial rate of 100 mg/ hr, and increased by 100 mg/ hr increments at 30 minutes intervals, to a maximum of 400 mg/ hr.
Den tilberedte MabThera- opløsning skal gives som en intravenøs infusion gennem en separat anlagt intravenøs adgang.
The prepared MabThera solution should be administered as an intravenous infusion through a dedicated line.
4. 4).
Patients should be closely monitored for the onset of cytokine release syndrome (see section 4.4).
Hos patienter, som udvikler tegn på alvorlige reaktioner, især alvorlig dyspnø, bronchospasme eller hypoxi, skal infusionen straks afbrydes.
Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
Patienterne bør ligeledes undersøges for lungeinfiltration med røntgen af thorax.
Patients with non-Hodgkin’ s lymphoma should then be evaluated for evidence of tumour lysis syndrome including appropriate laboratory tests and, for pulmonary infiltration, with a chest x-ray.
For alle patienter gælder, at infusionen ikke bør startes igen, før alle symptomer er forsvundet, og laboratorieværdier og røntgenfund er normaliserede.
In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest x-ray findings.
4. 8) responderer sædvanligvis på en reduktion af infusionshastigheden.
Mild or moderate infusion-related reactions (section 4.8) usually respond to a reduction in the rate of infusion.
Kontraindikationer for anvendelse til non- Hodgkin lymfom og kronisk lymfatisk leukæmi
Contraindications for use in non-Hodgkin’ s lymphoma and chronic lymphocytic leukaemia
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne eller over for murine proteiner.
Hypersensitivity to the active substance or to any of the excipients or to murine proteins.
4. 4).
Active, severe infections (see section 4.4).
Kontraindikationer for anvendelse til reumatoid arthritis
Contraindications for use in rheumatoid arthritis
Alvorlig hjerteinsufficiens (New York Heart Association klasse IV) eller alvorlig, ukontrolleret hjertesygdom.
Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease.
Progressiv multifokal leukoencephalopati
Progressive Multifocal Leukoencephalopathy
Anvendelse af MabThera kan være forbundet med forøget risiko for progressiv multifokal leukoencefalopati (PML).
Use of MabThera maybe associated with an increased risk of Progressive Multifocal Leukoencephalopathy (PML).
Hvis der er mistanke om PML, skal behandling seponeres, indtil PML- diagnosen er udelukket.
If PML is suspected, further dosing must be suspended until PML has been excluded.
Såfremt der er tvivl, bør yderligere undersøgelser overvejes, såsom MRI scanning, helst med kontrast, CSF test for JC viral DNA og gentagne neurologiske vurderinger.
If any doubt exists, further evaluation, including MRI scan preferably with contrast, CSF testing for JC Viral DNA and repeat neurological assessments, should be considered.
Patienten bør
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e. g. cognitive, neurological or psychiatric symptoms).
5 også rådes til at informere deres pårørende eller plejepersonale om behandlingen, idet de måske opdager symptomer, som patienten ikke selv er klar over.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Efter rekonstituering af immunsystemet hos immunkomprimerede patienter med PML er der set stabilisering eller forbedret tilstand.
5 Following reconstitution of the immune system in immunocompromised patients with PML, stabilisation or improved outcome has been seen.
Det er uvist, om tidlig erkendelse af PML og seponering af MabThera- behandlingen kan føre til lignende stabilisering eller forbedret tilstand.
It remains unknown if early detection of PML and suspension of MabThera therapy may lead to similar stabilisation or improved outcome.
Non- Hodgkin lymfom og kronisk lymfatisk leukæmi
Non-Hogkin’ s lymphoma and chronic lymphocytic leukaemia
Patienter med stor tumorbyrde eller med et højt antal (≥ 25x 109/ l) af cirkulerende maligne celler som fx patienter med CLL, som måske har forøget risiko for især alvorligt cytokin frigivelsessyndrom, må kun behandles med yderste forsigtighed.
Patients with a high tumour burden or with a high number (≥ 25 x 109/ l) of circulating malignant cells such as patients with CLL, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution.
Disse patienter skal monitoreres tæt gennem hele den første infusion.
These patients should be very closely monitored throughout the first infusion.
Det bør overvejes at give disse patienter første infusion med nedsat infusionshastighed eller at fordele dosis over to dage i første serie.
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.
Alvorligt cytokin frigivelsessyndrom er karakteriseret ved alvorlig dyspnø ofte sammen med bronchospasme og hypoxi, foruden feber, kulderystelser, rigor, urticaria og angioødem.
Severe cytokine release syndrome is characterised by severe dyspnea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema.