natgillin/translations-raw huggingface dataset:
Tabel 11 Behandling af relapsed/refraktær kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for rituximab plus FC versus FC alene (median observationstid: 25,3 måneder)
Table 11 Treatment of relapsed/refractory chronic lymphocytic leukaemia - overview of efficacy results for rituximab plus FC vs. FC alone (25.3 months median observation time)
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 Rixathon.
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 Rixathon.
I CLL 1. linjestudiet oplevede Binet C patienter i R-FC-armen flere bivirkninger sammenlignet med patienter i FC-armen (R-FC 83 % versus FC 71 %).
In the CLL first-line study, Binet stage C patients experienced more adverse events in the R-FC arm compared to the FC arm (R-FC 83% vs. FC
Hvis du er i tvivl, skal du kontakte lægen, apotekspersonalet eller sundhedspersonalet, inden du får Rixathon.
If you are not sure, talk to your doctor, pharmacist or nurse before you are given Rixathon.
Granulomatose med polyangiitis og mikroskopisk polyangiitis Patienter behandlet med Rixathon skal have udleveret patientkortet ved hver infusion.
Granulomatosis with polyangiitis and microscopic polyangiitis Patients treated with Rixathon must be given the patient alert card with each infusion.
Natriumcitrat, polysorbat 80, natriumchlorid, natriumhydroxid, saltsyre, vand til injektionsvæsker.
Sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.
Du kan have behov for ekstra overvågning under din behandling med Rixathon.
Your doctor may need to take special care of you during your treatment with Rixathon.
e) Hvis du behandles for pemfigus vulgaris
e) If you are being treated for pemphigus vulgaris
Hvis en sådan bivirkning skulle opstå med formodet relation til Rixathon, skal behandlingen seponeres permanent.
In case of such an event with a suspected relationship to Rixathon, treatment should be permanently discontinued.
1 hætteglas indeholder 10 mg/ml rituximab.
1 vial contains 10 mg/mL rituximab.
Det skal du vide, før du begynder at få Rixathon Du må ikke få Rixathon, hvis
What you need to know before you are given Rixathon Do not take Rixathon if
Hepatitis B-reaktivering
Hepatitis-B reactivation
• Rixathon gives samme dag som kemoterapien.
• Rixathon will be given to you on the same day as your chemotherapy.
Rixathon skal administreres som to 500 mg intravenøse infusioner, med to ugers mellemrum, efterfulgt af en 500 mg intravenøs infusion hver 6. måned.
Rixathon should be administered as two 500 mg IV infusions separated by two weeks, followed by a 500 mg IV infusion every 6 months thereafter.
Baseret på den farmakokinetiske populationsanalyse af data fra 97 patienter med GPA eller MPA, der fik 375 mg/m2 rituximab én gang ugentligt i 4 uger, var den estimerede mediane terminale halveringstid 23 dage (9-49 dage).
Based on the population pharmacokinetic analysis of data in 97 patients with granulomatosis with polyangiitis and microscopic polyangiitis who received 375 mg/m2 rituximab once weekly for four doses, the estimated median terminal elimination half-life was 23 days (range, 9 - 49 days).
Nervesystemet paræstesi, hypoæstesi, agitation, insomni, vasodilatation, svimmelhed, angst
Paraesthesia, hypoaesthesia, agitation, insomnia, vasodilatation, dizziness, anxiety
Alle læger, som kan forventes at udskrive Rixathon mod ikke-onkologiske indikationer, har modtaget følgende: - Produktresuméet - Undervisningsbrochure til sundhedspersonale - Undervisningsbrochure til patienter
All physicians who are expected to prescribe Rixathon for non-oncology indications are provided with the following: - Product information - HCP educational leaflet - Patient educational leaflet
I det kliniske studie med vedligeholdelsesbehandling oplevede 7 ud af 57 (12 %) patienter i rituximab-armen mindst én infusionsrelateret reaktion.
In the maintenance therapy clinical trial, 7/57 (12%) patients in the rituximab arm experienced at least one infusion-related reaction.
I det kliniske studie med induktion af remission blev kardielle bivirkninger rapporteret med en hyppighed på ca. 273 pr. 100 patientår (95 % konfidensinterval 149-470) ved det primære endepunkt ved måned 6.
In the clinical trial on induction of remission, cardiac events occurred at a rate of approximately 273 per 100 patient years (95% CI 149 - 470) at the 6-month primary endpoint.
c) Hvis du behandles for reumatoid artrit
c) If you are being treated for rheumatoid arthritis
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 rituximab.
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 rituximab.
Kemoterapien skal gives efter infusionen med Rixathon.
The chemotherapy should be given after the Rixathon infusion.
+myokardieinfark t4 og 6, arytmier, +atrieflimren, takykardi, +hjertesygdom
+Myocardial infarction4 and 6, arrhythmia, +atrial fibrillation, tachycardia, +cardiac disorder
Antallet af patienter uden kortikosteroid-behandling eller behandlet med minimalt kortikosteroid (≤ 10 mg/dag) over tid
Figure 4: Number of patients who were off or on minimal corticosteroid (≤10mg/day) therapy over time
Andelen af patienter, der rapporterede bivirkninger efter genbehandling med flere rituximab-serier var sammenlignelig med andelen af patienter, der rapporterede bivirkninger efter induktionsbehandling (alle bivirkninger og bivirkninger af grad 3/4).
The percentage of patients reporting ADRs upon re-treatment with further courses of rituximab was similar to the percentage of patients reporting ADRs upon initial exposure (any grade and grade 3/4 ADRs).
I begge arme fik patienterne intravenøs pulsbehandling med 1.000 mg methylprednisolon (eller andet glukokortikoid i ækvivalent dosis) pr. dag i 1-3 dage efterfulgt af oral prednison (1 mg/kg/dag, dog højst 80 mg/dag).
Patients in both arms received 1,000 mg of pulse intravenous methylprednisolone (or another equivalent-dose glucocorticoid) per day for 1 to 3 days, followed by oral prednisone (1 mg/kg/day, not exceeding 80 mg/day).
Den anbefalede dosis af Rixathon er 1.000 mg ved intravenøs infusion efterfulgt af endnu en 1.000 mg intravenøs infusion to uger senere.
The recommended dosage of Rixathon is 1,000 mg by intravenous infusion followed by a second 1,000 mg intravenous infusion two weeks later.
Tabel 1 Sammenfatning af bivirkninger, som blev rapporteret i kliniske studier eller under post-marketing overvågning, hos patienter med NHL og CLL, som fik rituximab monoterapi eller vedligeholdelsesbehandling med rituximab, eller i kombination med kemoterapi
Table 1 ADRs reported in clinical trials or during postmarketing surveillance in patients with NHL and CLL disease treated with rituximab monotherapy/maintenance or in combination with chemotherapy
Infusionsrelaterede reaktioner i det kliniske studie, hvor man så på induktion af remission hos patienter med svær, 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 værende 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.
Følgende reaktioner blev indberettet som bivirkninger under de kliniske studier, men blev rapporteret med samme eller lavere hyppighed i rituximab-armen, sammenlignet med kontrolarmene: hæmatotoksicitet, infektioner hos neutropene patienter, urinvejsinfektioner, sensoriske forstyrrelser og pyreksi.
The following terms have been reported as adverse events during clinical trials, however, were reported at a similar or lower incidence in the rituximab arms compared to control arms: haematotoxicity, neutropenic infection, urinary tract infection, sensory disturbance, pyrexia.
Tabel 9 Vedligeholdelsesfase: Oversigt over effektdata for rituximab versus observation (28 måneders median observationstid)
Table 9 Maintenance phase: overview of efficacy results rituximab vs. observation (28 months median observation time)
kraniel neuropati, tab af andre sanser5
Cranial neuropathy, loss of other senses5
Disse symptomer er sædvanligvis reversible, når rituximab-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 rituximab infusion and administration of an anti-pyretic, an antihistaminic and occasionally oxygen, intravenous saline or bronchodilators, and glucocorticoids if required.
Efter to intravenøse infusioner af rituximab i en dosis på 1.000 mg med to ugers interval, var den gennemsnitlige halveringstid 20,8 dage (i intervallet 8,58 dage til 35,9 dage), den gennemsnitlige systemiske clearance var 0,23 l/dag (i intervallet 0,091 til 0,67 l/dag) og det gennemsnitlige steady-state fordelingsvolumen var 4,6 l (i intervallet 1,7 til 7,51 l).
Following two intravenous infusions of rituximab at a dose of 1,000 mg, two weeks apart, the mean terminal half-life was 20.8 days (range, 8.58 to 35.9 days), mean systemic clearance was 0.23 L/day (range, 0.091 to 0.67 L/day), and mean steady-state distribution volume was 4.6 L (range, 1.7 to 7.51 L).
Hos patienter med non-Hodgkin-lymfom og CLL bør det overvejes at give præmedicinering med glukokortikoider, hvis Rixathon ikke gives i kombination med et kemoterapiregime, som indeholder glukokortikoid.
In patients with non-Hodgkin's lymphoma and chronic lymphocytic leukaemia, premedication with glucocorticoids should be considered if Rixathon is not given in combination with glucocorticoid-containing chemotherapy.
b) Hvis du behandles for kronisk lymfatisk leukæmi
b) If you are being treated for chronic lymphocytic leukaemia
I det kliniske studie med induktion af remission var malignitetshyppigheden blandt rituximabbehandlede patienter i det kliniske studie med patienter med GPA eller MPA 2,00 pr. 100 patientår ved studiets slutning (da sidste patient havde gennemført opfølgningsperioden).
In the clinical trial on induction of remission, the incidence of malignancy in rituximab treated patients in the granulomatosis with polyangiitis and microscopic polyangiitis clinical study was 2.00 per 100 patient years at the study common closing date (when the final patient had completed the follow-up period).
2 hætteglas a 10 ml 3 hætteglas a 10 ml
2 vials of 10 mL 3 vials of 10 mL
Der er observeret progression af Kaposis sarkom hos rituximabeksponerede patienter med Kaposis sarkom.
Progression of Kaposi's sarcoma has been observed in rituximab-exposed patients with pre-existing Kaposi's sarcoma.
• Feber eller vedvarende hoste
• Fever or persistent cough
• Yderligere risikominimeringsforanstaltninger For indikationerne non-Hodgkin-lymfom (NHL) og kronisk lymfatisk leukæmi (CLL):
• Additional risk minimisation measures For the indications non-Hodgkin´s lymphoma (NHL) and Chronic lymphocytic leukaemia
Brug af anden medicin sammen med Rixathon
Other medicines and Rixathon
• Infusionsrelaterede reaktioner (herunder cytokinfrigivelsessyndrom, tumorlysesyndrom), se pkt.
• IRRs (including cytokine-release syndrome, tumour-lysis syndrome), see section 4.4.
Hos patienter med GPA eller MPA anbefales det at give methylprednisolon intravenøst i 1-3 dage i en dosis på 1.000 mg pr. dag inden den første Rixathon-infusion (sidste dosis methylprednisolon kan gives samme dag som første Rixathon-infusion).
In patients with granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis, methylprednisolone given intravenously for 1 to 3 days at a dose of 1,000 mg per day is recommended prior to the first infusion of Rixathon (the last dose of methylprednisolone may be given on the same day as the first infusion of Rixathon).
Infusionsrelaterede reaktioner2
Infusion-related reactions2
Median TTF/PFS/ EFS måneder
ORR, % CR, % Median TTF/PFS/ EFS mo
Ca. 2.400 patienter fik to eller flere behandlingsserier, heraf fik over 1.000 patienter fem eller flere behandlingsserier.
In clinical trials more than 3,100 patients received at least one treatment course and were followed for periods ranging from 6 months to over 5 years; approximately 2,400 patients received two or more courses of treatment with over 1,000 having received 5 or more courses.
Eftersom hypotension kan forekomme under administration af rituximab, bør det overvejes at afbryde behandling med antihypertensive lægemidler 12 timer før infusion med Rixathon.
Since hypotension may occur during rituximab administration, consideration should be given to withholding anti-hypertensive medicinal product 12 hours prior to the Rixathon infusion.
Under vedligeholdelsesbehandlingen var hyppigheden af hjertesygdomme af grad 3/4 sammenlignelig mellem patienter behandlet i rituximab-gruppen og i observationsgruppen.
During maintenance treatment, the incidence of grade 3/4 cardiac disorders was comparable between patients treated with rituximab and observation.
Under kliniske studier har infektioner i de nedre luftveje (inklusive pneumoni) været rapporteret med en forekomst i rituximab-armene svarende til forekomsten i kontrolarmene.
Lower respiratory tract infections (including pneumonia) have been reported during clinical trials, at a similar incidence in the rituximab arms compared to control arms.
• infektioner i blodet (sepsis), lungebetændelse, helvedesild, forkølelse, infektion i bronkierne, svampeinfektioner, infektioner af ukendt oprindelse, bihulebetændelse, leverbetændelse (hepatitis B)
• infections of the blood (sepsis), pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B
Rixathon er indiceret til behandling af patienter med moderat til svær pemfigus vulgaris (PV).
Rixathon is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).
Hvis behandlingen virker, kan Rixathon gives som vedligeholdelsesbehandling i 2 år efter, den første behandling er givet.
In patients where the treatment is working, Rixathon may be used as a maintenance treatment for 2 years after completing the initial treatment.
Rixathon leveres i sterile, pyrogenfri hætteglas uden konserveringsmiddel til engangsbrug.
Rixathon is provided in sterile, preservative-free, non-pyrogenic, single use vials.
Hvis du behandles for reumatoid artritis, granulomatose med polyangiitis, mikroskopisk polyangiitis eller pemfigus vulgaris vil du også finde denne information i patientkortet, som du har fået af lægen.
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor.
I alt 197 patienter i alderen 15 år og derover med svær, aktiv GPA (75 %) eller MPA (24 %) blev inkluderet og behandlet i et randomiseret, dobbeltblindet, placebokontrolleret, non-inferioritetsmulticenterstudie med aktiv kontrolgruppe.
A total of 197 patients aged 15 years or older with severely, active granulomatosis with polyangiitis (75%) and microscopic polyangiitis (24%) were enrolled and treated in an active-comparator, randomised, double-blind, multicenter, non-inferiority trial.
Kronisk lymfatisk leukæmi (CLL)
Chronic lymphocytic leukaemia (CLL)
Kardiale hændelser (herunder atrieflimren, myokardieinfarkt, venstre ventrikulært svigt og myokardieiskæmi) blev rapporteret som alvorlige bivirkninger hos 3 % af patienterne, som fik rituximab sammenlignet med < 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 < 1% on observation.
18-måneder p=0,016
18-months p=0.016
Det er vigtigt, fordi Rixathon i enkelte tilfælde har forårsaget, at en tidligere leverbetændelse (hepatitis B) er blevet aktiv igen.
This is because in a few cases, Rixathon could cause hepatitis B to become active again, which can be fatal in very rare cases.
Da hypotension kan forekomme under infusion med rituximab, bør det overvejes at seponere antihypertensiva i 12 timer før Rixathoninfusionen.
Since hypotension may occur during rituximab infusion, consideration should be given to withholding anti-hypertensive medicinal products 12 hours prior to the Rixathon infusion.
• ændringer i blodtryk, kvalme, udslæt, feber, en følelse af kløe, løbende eller stoppet næse og nysen, rysten, hurtig hjerterytme (puls) og træthed
• Changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
Alvorlige infusionsrelaterede reaktioner med dødelig udgang er rapporteret hos patienter med reumatoid artrit efter markedsføring.
Severe IRRs with fatal outcome have been reported in rheumatoid arthritis patients in the postmarketing setting.
Efter den femte 500 mg/m2 infusion var den gennemsnitlige Cmax (N=15) 408 µg/ml (spændvidde 97-764 µg/ml), og den gennemsnitlige terminale halveringstid var 32 dage (spændvidde 14-62 dage).
The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
• sammensnøring af musklerne i luftvejene, som forårsager hvæsende vejrtrækning (bronkospasme), inflammation (betændelseslignende reaktion), irritation i lungerne, halsen eller bihulerne, åndenød, løbende næse
• tightening of the muscles in the airways which causes wheezing (bronchospasm), inflammation, irritation in the lungs, throat or sinuses, being short of breath, runny nose
48-måneder p=0,0096
48-months p=0.0096
Natriumchlorid Natriumhydroxid Saltsyre
Sodium chloride Sodium hydroxide Hydrochloric acid Water for injections
Koncentrat til infusionsvæske, opløsning 100 mg/10 ml
Concentrate for solution for infusion 100 mg / 10 mL
Koncentrat til infusionsvæske, opløsning 500 mg/50 ml
Concentrate for solution for infusion 500 mg / 50 mL
CTC og af IRR, som førte til seponering, faldt med antal behandlingsserier og var sjældne fra 3. behandlingsserie og frem.
The proportion of CTC Grade 3 events and of IRRs leading to withdrawal decreased by course and were rare from course 3 onwards.
Det er vist, at rituximab i kombination med methotrexat reducerer hastigheden af ledskadeprogression, målt ved hjælp af røntgen, samt forbedrer fysisk funktionsevne.
Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg på dag 1 og 15 i fire studier.
The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg on days 1 and 15 in four studies.
Alle infusionsrelaterede reaktioner var lette eller moderate, og de fleste af dem blev rapporteret under systemorganklasserne; Luftveje, thorax og mediastinum og Hud og subkutane væv.
All IRR symptoms were mild or moderate and most of them were reported from the SOCs Respiratory, Thoracic and Mediastinal Disorders and Skin and Subcutaneous Tissue disorders.
Hætteglasset med 50 ml indeholder 500 mg rituximab (10 mg/ml).
The 50 mL vial contains 500 mg of rituximab (10 mg/mL).
Patienter behandlet med Rixathon skal have udleveret patientkortet ved hver infusion.
Patients treated with Rixathon must be given the patient alert card with each infusion.
Gastrointestinale sygdomme
Gastrointestinal Disorders
Rixathon 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.
Rixathon 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.
I skal fortsætte med sikker prævention i 12 måneder efter din sidste behandling med Rixathon.
You must also do this for 12 months after your last treatment with Rixathon.
Baseret på en populationsfarmakokinetisk undersøgelse af 298 patienter med NHL, som fik enkelte eller flere infusioner af rituximab alene eller i kombination med CHOP-kemoterapi (anvendte rituximabdoser varierede fra 100 til 500 mg/m2), vurderedes den non-specifikke clearance (CL1), den specifikke clearance (CL2), hvor B-celler eller tumor sandsynligvis bidrager, og det centrale kompartments distributionsvolumen til (V1) til at være henholdsvis 0,14 l/dag, 0,59 l/dag og 2,7 l. Den estimerede mediane terminale eliminationshalveringstid af rituximab var 22 dage (spændvidde 6, 1-52 dage).
Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied rituximab doses ranged from 100 to 500 mg/m2), the typical population estimates of nonspecific clearance (CL1), specific clearance (CL2) likely contributed by B cells or tumour burden, and central compartment volume of distribution (V1) were 0.14 L/day, 0.59 L/day, and 2.7 L, respectively.
Tabel 10a Førstelinjebehandling af kronisk lymfatisk leukæmi - sammenfatning af resultaterne for effekt for rituximab plus FC versus FC alene - median observationstid: 48,1 måneder
Table 10a First-line treatment of chronic lymphocytic leukaemia Overview of efficacy results for rituximab plus FC vs. FC alone - 48.1 months median observation time
Rixathon anvendes til behandling af patienter med moderat til svær pemfigus vulgaris.
Rixathon is used for the treatment of patients with moderate to severe pemphigus vulgaris.
Farmakokinetikken for rituximab blev vurderet efter to i.v.-doser på 500 mg og 1.000 mg efter genbehandling i den anden behandlingsserie.
The pharmacokinetics of rituximab were assessed following two intravenous doses of 500 mg and 1,000 mg upon re-treatment in the second course.
+venstre ventrikulær t svigt, +supraventrikulær takykardi, +ventrikulæ r takykardi, +angina, +myokardie -iskæmi, bradykardi alvorlige kardielle sygdomme
+Left ventricular failure, +supraventri cular tachycardia, +ventricular tachycardia, +angina, +myocardial ischaemia, bradycardia
Antal af patienter med større recidiv
Number of patients
53-måneder p=0,029
53-months p=0.029
Ved CLL var incidensen af sygdomme fra nervesystemet af grad 3 eller 4 lav både i 1. linjestudiet (4 % R-FC, 4 % FC) og i relaps/refraktær studiet (3 % R-FC, 3 % FC).
In CLL, the overall incidence of grade 3 or 4 nervous system disorders was low both in the first-line study (4% R-FC, 4% FC) and in the relapsed/refractory study (3% R-FC, 3% FC).
Alle patienter bør screenes for hepatitis B-virus (HBV) før påbegyndelse af behandling med Rixathon.
Hepatitis B virus (HBV) screening should be performed in all patients before initiation of treatment with Rixathon.
Toksisk epidermal nekrolyse (Lyells syndrom) og Stevens-Johnsons syndrom, nogle med dødelig udgang, har været rapporteret meget sjældent.
Toxic Epidermal Necrolysis (Lyell syndrome) and Stevens-Johnson syndrome, some with fatal outcome, have been reported very rarely.
Der er meget sjældent blevet rapporteret om reaktivering af hepatitis B-infektion hos RA-patienter, som får rituximab (se pkt.
Reactivation of hepatitis B infection has also been very rarely reported in RA patients receiving rituximab (see section 4.4).