natgillin/translations-raw huggingface dataset:
De to første undersøgelser omfattede 991 patienter, hos hvem methotrexat ikke havde virket tilfredsstillende, mens den tredje omfattede 391 patienter, hos hvem TNF- hæmmere ikke havde virket tilfredsstillende.
The first two studies included 991 patients who had not had an adequate response to methotrexate, and the third included 391 patients who had not had an adequate response to TNF blockers in the past.
Denne medicin omfattede ikke TNF- hæmmere.
All three studies compared the effects of adding ORENCIA or placebo (a dummy treatment) to the other medicines that the patients were already taking for rheumatoid arthritis: these did not include a TNF blocker.
Virkningen blev hovedsagelig bedømt på mindskelsen af leddegigtsymptomerne efter seks måneders behandling, patienternes fysiske funktion og omfanget af ledskader (vurderet på røntgenbilleder).
The main measures of effectiveness were the reduction in symptoms of arthritis after 6 months of treatment, as well as physical function and the amount of damage to the joints (assessed using X rays).
I endnu en undersøgelse sammenlignedes virkningen af at anvende enten ORENCIA, infliximab (en TNF- hæmmer) eller placebo som tillægsbehandling til methotrexat.
An additional study compared the effects of adding ORENCIA, infliximab (a TNF blocker) or placebo to treatment containing methotrexate.
Denne undersøgelse omfattede 266 patienter, hos hvem methotrexat ikke havde virket tilfredsstillende.
This study included 266 patients who had not responded adequately to methotrexate.
Hvilken fordel viser undersøgelserne, at der er ved ORENCIA?
What benefit has ORENCIA shown during the studies?
ORENCIA var mere effektivt end placebo til at bevirke en bedring i symptomerne på leddegigt i alle undersøgelserne.
ORENCIA was more effective than placebo in improving the symptoms of rheumatoid arthritis in all studies.
I den første undersøgelse opnåede 70 (60, 9%) af de 115 patienter, der fik den godkendte dosis ORENCIA som tillægsbehandling til methotrexat, mindst 20% reduktion i symptomerne.
In the first study, 70 (60.9%) of the 115 patients adding the approved dose of ORENCIA to methotrexate had at least a 20% reduction in symptoms, compared to 42 (35.3%) of the 119 adding placebo.
I den anden undersøgelse sås en tilsvarende virkning af ORENCIA på leddegigtsymptomerne, foruden bedring i den fysiske funktion og mindsket ledbeskadigelse efter ét års behandling.
The second study showed a similar effect of ORENCIA on symptoms of rheumatoid arthritis, as well as improved physical function and a reduced rate of joint damage after a year of treatment.
I undersøgelsen af patienter, der ikke havde haft tilfredsstillende virkning af TNF- hæmmere, resulterede ORENCIA som tillægsbehandling til patientens eksisterende medicin i en reduktion af symptomerne på mindst 20% hos 129 (50, 4%) af de 256 patienter.
In the study of patients with an inadequate response to TNF blockers in the past, adding ORENCIA to existing treatment led to 129 (50.4%) of the 256 patients having at least a 20% reduction in symptoms, compared with 26 (19.5%) of the 133 patients adding placebo.
Patienter, der fik ORENCIA, opnåede desuden bedre fysisk funktion efter seks måneder.
Patients taking ORENCIA also had a greater improvement in physical function after 6 months.
Denne supplerende undersøgelse bekræftede, at ORENCIA giver bedring i symptomerne hos patienter, der ikke har haft tilfredsstillende virkning af methotrexat.
The additional study confirmed the improvement in symptoms with ORENCIA in patients who had not responded adequately to methotrexate.
Efter seks måneder sås en virkning svarende til virkningen af infliximab.
The response after 6 months was similar to that seen with infliximab.
Hvilken risiko er der forbundet med ORENCIA?
What is the risk associated with ORENCIA?
Den hyppigste bivirkning ved brug af ORENCIA (som ses hos flere end 1 ud af 10 patienter) er hovedpine.
The most common side effect when taking ORENCIA (seen in more than 1 patient in 10) is headache.
Den fuldstændige liste over de indberettede bivirkninger for ORENCIA fremgår af indlægssedlen.
For the full list of all side effects reported with ORENCIA, see the Package Leaflet.
ORENCIA bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for abatacept eller andre af indholdsstofferne.
ORENCIA should not be used in patients who may be hypersensitive (allergic) to abatacept or any of the other ingredients.
Det bør desuden ikke bruges hos patienter med svære, ukontrollerede infektioner, f. eks. blodforgiftning, eller "opportunistiske" infektioner (infektioner, der optræder hos patienter med nedsat immunforsvar).
It should also not be used in patients with severe and uncontrolled infections, such as sepsis (serious blood infection) or ‘ opportunistic’ infections (infections seen in patients with damaged immune systems).
Patienter, der er i behandling med ORENCIA, får udleveret et særligt informationskort, der forklarer denne begrænsning og instruerer dem om at kontakte lægen straks, hvis de får en infektion, mens de er i behandling med ORENCIA.
Patients who take ORENCIA are given a special alert card that explains this restriction, and instructs them to contact their doctor immediately if they develop an infection during a course of treatment with ORENCIA.
Hvorfor blev ORENCIA godkendt?
Why has ORENCIA been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at ORENCIA har en beskeden antiinflammatorisk virkning, og at det i kombination med methotrexat mindsker forværringen af ledbeskadigelsen og bedrer den fysiske funktion.
The Committee for Medicinal Products for Human Use (CHMP) concluded that ORENCIA had a modest anti-inflammatory effect, and in combination with methotrexate, led to a reduction in the worsening of joint damage and an improvement in physical function.
Udvalget fandt, at fordelene ved ORENCIA er større end risiciene til behandling af voksne patienter med moderat til svær, aktiv leddegigt, når andre sygdomsmodificerende gigtmidler, herunder mindst én TNF- hæmmer, ikke har virket tilfredsstillende eller ikke tåles af patienten.
The committee decided that ORENCIA’ s benefits are greater than its risks for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one TNF inhibitor.
Udvalget anbefalede udstedelse af markedsføringstilladelse for ORENCIA.
It recommended that ORENCIA be given marketing authorisation.
Andre oplysninger om ORENCIA:
Other information about ORENCIA:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ORENCIA til Bristol- Myers Squibb Pharma EEIG den 21. maj 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for ORENCIA to Bristol-Myers Squibb Pharma EEIG on 21 May 2007.
Den fuldstændige EPAR om ORENCIA findes her.
The full EPAR for ORENCIA can be found here.
Dette sammendrag blev sidst ajourført i 04- 2007.
This summary was last updated in 04-2007.
Pulver til koncentrat til infusionsvæske, opløsning
Pharmaceutical Form Powder for concentrate for solution for infusion
Hætteglas (glas)
Packaging Vial (glass)
1 hætteglas og 1 sprøjte
Package size 1 vial + 1 syringe
2 hætteglas og 2 sprøjter
2 vials + 2 syringes
3 hætteglas og 3 sprøjter
3 vials + 3 syringes
Hver ml indeholder 25 mg abatacept efter rekonstituering.
Each ml contains 25 mg of abatacept, after reconstitution.
Abatacept er et fusionsprotein fremstillet ved rekombinant DNA- teknologi i ovarieceller fra kinesiske hamstre.
Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells.
Hjælpestof: natrium:
Excipient: sodium:
0, 375 mmol per hætteglas.
0.375 mmol per vial
ORENCIA er i kombination med methotrexat indiceret til behandling af moderat til svær, aktiv reumatoid artritis hos voksne patienter, som har haft insufficient respons på eller er intolerante over for andre sygdomsmodificerende anti- reumatiske lægemidler, inklusive mindst én tumornekrosefaktor - hæmmer (TNF- hæmmer).
ORENCIA in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have had an insufficient response or intolerance to other disease-modifying anti-rheumatic drugs including at least one tumour necrosis factor (TNF) inhibitor.
Voksne Skal administreres som en 30- minutters intravenøs infusion i den dosis, som er specificeret i Tabel 1.
Adults To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.
Efter 1. infusion, gives ORENCIA efter 2 og 4 uger og herefter hver 4. uge. a
Following the initial administration, ORENCIA should be given 2 and 4 weeks after the first infusion, then every 4 weeks thereafter. a
ORENCIA- dosis
Dose of ORENCIA
Patientens vægt < 60 kg ≥ 60 kg til ≤ 100 kg > 100 kg Ca.
≥ 60 kg to ≤ 100 kg
10 mg/ kg.
> 100 kg
Dosis 500 mg 750 mg 1. 000 mg
1,000 mg
Antal hætteglasb 2 3 4
4
Hvert hætteglas giver 250 mg abatacept til administration.
Approximating 10 mg/ kg. b Each vial provides 250 mg of abatacept for administration.
Hvert hætteglas med ORENCIA 250 mg skal rekonstitueres med 10 ml vand til injektionsvæsker, ved hjælp af den medfølgende silikonefrie sprøjte.
Each vial of ORENCIA 250 mg must be reconstituted with 10 ml of water for injections, using the silicone-free syringe provided.
6. 6).
The reconstituted solution must then be diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection, before administration by intravenous infusion (see section 6.6).
2 Dosisjustering er ikke nødvendig ved samtidig behandling med andre DMARD, kortikosteroider, salicylater, non- steroide anti- inflammatoriske lægemidler (NSAID) eller analgetika.
2 No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
5. 1).
If a response to abatacept is not present within 6 months of treatment, the potential benefits of continuing treatment, known and potential risks, and therapeutic alternatives should be considered (see section 5.1).
Ældre patienter Dosisjustering ikke nødvendig.
Elderly patients No dose adjustment is required.
Børn Der er ingen erfaring med behandling af børn eller unge.
Paediatric patients There is no experience in children or adolescents.
ORENCIA bør derfor ikke bruges til børn og unge, før der foreligger yderligere data.
As a result, the use of ORENCIA in children or adolescents is not recommended until further data become available.
Nyre - og leverinsufficiens ORENCIA er ikke undersøgt i disse patientpopulationer.
Renal and hepatic impairment ORENCIA has not been studied in these patient populations.
4. 4).
Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
5. 1).
Combination with TNF blocking agents There is limited experience with use of abatacept in combination with TNF blocking agents (see section 5.1).
I placebo- kontrollerede kliniske forsøg oplevede de patienter, der fik TNF- hæmmende midler i kombination med abatacept, en samlet øgning i antal af infektioner og alvorlige infektioner sammenlignet med gruppen af patienter, som fik behandling med TNF- hæmmende midler og placebo (se pkt.
In placebo-controlled clinical trials, in comparison with patients treated with TNF blocking agents and placebo, patients who received combination TNF blocking agents with abatacept experienced an increase in overall infections and serious infections (see section 4.5).
Abatacept bør ikke bruges i kombination med TNF- hæmmende midler.
Abatacept is not recommended for use in combination with TNF blocking agents.
Patienter, der skifter fra behandling med et TNF- hæmmende middel til ORENCIA, skal overvåges for tegn på infektion.
While transitioning from TNF blocking agent therapy to ORENCIA therapy, patients should be monitored for signs of infection.
4. 8).
Allergic reactions Allergic reactions have been reported uncommonly with abatacept administration in clinical trials, where patients were not required to be pretreated to prevent allergic reactions (see section 4.8).
Der bør udvises særlig forsigtighed hos patienter, der tidligere har haft allergisk reaktion over for abatacept eller et eller flere hjælpestoffer.
Special caution should be exercised in patients with a history of allergic reactions to abatacept or to any of the excipients.
Hvis der opstår alvorlige allergiske eller anafylaktiske reaktioner, skal behandling med ORENCIA straks seponeres og relevant behandling påbegyndes.
If any serious allergic or anaphylactic reaction occurs, ORENCIA therapy should be discontinued immediately and appropriate therapy initiated.
Påvirkning af immunsystemet Lægemidler som påvirker immunsystemet, inklusive ORENCIA, kan påvirke forsvaret mod infektioner og maligniteter samt påvirke vaccinationsrespons.
Effects on the immune system Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.
Samtidig administration af ORENCIA og biologiske immunsuppressive eller immunmodulerende stoffer kan forstærke ORENCIAs effekt på immunsystemet.
Co-administration of ORENCIA with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of ORENCIA on the immune system.
Det er ikke tilstrækkelig evidens til vurdering af sikkerhed og effekt af ORENCIA i kombination med anakinra eller rituximab.
There is insufficient evidence to assess the safety and efficacy of ORENCIA in combination with anakinra or rituximab.
4. 8).
Infections Serious infections have been reported with abatacept (see section 4.8).
Patienter, som udvikler ny
Patients who develop a
3 infektion under behandling med ORENCIA, skal overvåges omhyggeligt.
3 new infection while undergoing treatment with ORENCIA should be monitored closely.
Der er ikke observeret øget forekomst af tuberkulose i de større, placebo- kontrollerede forsøg.
No increase of tuberculosis was observed in the pivotal placebo-controlled studies.
Ikke desto mindre bør patienter screenes for latent tuberkulose i henhold til de aktuelle medicinske retningslinjer, inden påbegyndelse af behandling med ORENCIA.
The available medical guidelines should also be taken into account.
Anti- reumatisk behandling er blevet associeret med reaktivering af hepatitis B.
Anti-rheumatic therapies have been associated with hepatitis B reactivation.
Der bør derfor udføres screening for viral hepatitis i overensstemmelse med publicerede retningslinjer forud for behandling med ORENCIA.
Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with ORENCIA.
4. 8).
Malignancies In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebo-treated patients were 1.4% and 1.1%, respectively (see section 4.8).
5. 3).
The clinical significance of this observation is unknown (see section 5.3).
ORENCIAs potentielle rolle i udviklingen af maligniteter inklusive lymfomer hos mennesker er ukendt.
The potential role of ORENCIA in the development of malignancies, including lymphoma, in humans is unknown.
Vaccinationer Levende vacciner bør ikke gives samtidig med ORENCIA eller inden for 3 måneder efter seponering.
Vaccinations Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation.
Der foreligger ingen data vedrørende sekundær transmission af infektion fra personer, der får levende vacciner til patienter i behandling med ORENCIA.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving ORENCIA.
Der er ikke tilstrækkelige data vedrørende effekt af vaccinationer hos patienter i behandling med ORENCIA.
Insufficient data are available on the effects of vaccinations in patients receiving ORENCIA.
Lægemidler der påvirker immunsystemet inklusive ORENCIA kan svække effekten af visse immuniseringer.
Medicinal products that affect the immune system, including ORENCIA, may blunt the effectiveness of some immunisations.
Ældre patienter I alt 323 patienter i aldersgruppen 65 år eller derover, inklusive 53 patienter i aldersgruppen 75 år eller derover, blev behandlet med abatacept i placebo- kontrollerede, kliniske forsøg.
Elderly patients A total of 323 patients 65 years of age and older, including 53 patients 75 years and older, received abatacept in placebo-controlled clinical trials.
Hyppigheden af alvorlig infektion og malignitet i forhold til placebo blandt abataceptbehandlede patienter over 65 år var højere end den der sås hos patienter under 65 år.
The frequencies of serious infection and malignancy relative to placebo among abatacept-treated patients over age 65 were higher than among those under age 65.
4. 8).
Because there is a higher incidence of infections and malignancies in the elderly in general, caution should be used when treating the elderly (see section 4.8).
Autoimmune processer Der er teoretiske overvejelser hvorvidt behandling med ORENCIA kan øge risiko for autoimmune processer fx forværring af dissimineret sklerose.
Autoimmune processes There is a theoretical concern that treatment with ORENCIA might increase the risk for autoimmune processes, for example deterioration of multiple sclerosis.
4. 8).
In the placebo-controlled clinical trials, abatacept treatment did not lead to increased autoantibody formation, such as antinuclear and anti- dsDNA antibodies, relative to placebo treatment (see section 4.8).
Test af blod- glukose Parenterale lægemidler, der indeholder maltose kan påvirke aflæsningen i blod- glukoseapparater, der anvender strips med glukosedehydrogenasepyrroloquinolinequinon (GDH- PQQ).
Blood glucose testing Parenteral medicinal products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).
GDH- PQQ- baserede glukosemonitoreringssystemer kan reagere på maltosen i ORENCIA, og dette kan medføre en falsk forhøjet blodglukosemåling på infusionsdagen.
The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Patienter med behov for kontrol af blod - glukoseniveauet bør under behandling med ORENCIA tilrådes anden metode, der ikke reagerer på maltose, fx en metode baseret på glukosedehydrogenase nikotinadenindinucleotid (GDH- NAD), glukoseoxidase eller glukosehexokinase.
When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Patienter på saltfattig diæt Dette lægemiddel indeholder 1, 5 mmol (eller 34, 5 mg) natrium per maksimal dosis af 4 hætteglas (0, 375 mmol eller 8, 625 mg natrium per hætteglas).
Patients on controlled sodium diet This medicinal product contains 1.5 mmol (or 34.5 mg) sodium per maximum dose of 4 vials (0.375 mmol or 8.625 mg sodium per vial).
5. 1).
Combination with TNF blocking agents There is limited experience with the use of abatacept in combination with TNF blocking agents (see section 5.1).
Selvom TNF- hæmmende midler ikke påvirkede abatacepts clearance i placebo- kontrollerede forsøg, oplevede den patientgruppe, der fik samtidig behandling med abatacept og TNF- hæmmende midler flere infektioner og alvorlige infektioner end de patienter der fik behandling med TNF - hæmmende midler alene.
While TNF blocking agents did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF blocking agents experienced more infections and serious infections than patients treated with only TNF blocking agents.
Samtidig behandling med ORENCIA og TNF- hæmmende middel frarådes derfor.
Therefore, concurrent therapy with ORENCIA and a TNF blocking agent is not recommended.
2).
Combination with other medicinal products Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Der er ikke identificeret øget riskio for bivirkninger i forbindelse med brug af abatacept i kombination med sulfasalazin, hydroxychloroquin eller leflunomid.
No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
4. 4 vedrørende kombination med andre lægemidler, der kan påvirke immunsystemet og med vaccinationer.
See section 4.4 regarding combination with other medicinal products that affect the immune system and with vaccinations.
Der er i embryo- føtale udviklingsstudier ikke observeret uønskede hændelser ved doser på op til 29 gange den humane dosis på 10 mg/ kg, baseret på AUC.
In embryo-foetal development studies no undesirable effects were observed at doses up to 29-fold a human 10 mg/ kg dose based on AUC.
5. 3).
In a pre- and postnatal development study limited changes in immune function were observed at 11-fold a human 10 mg/ kg dose based on AUC (see section 5.3).
ORENCIA bør ikke anvendes til gravide kvinder, med mindre dette er klart nødvendigt.
ORENCIA should not be used in pregnant women unless clearly necessary.
Fertile kvinder bør anvende effektiv antikonception under behandling med ORENCIA samt 14 uger efter sidste dosis af abatacept.
Women of child-bearing potential should use effective contraception during treatment with ORENCIA and up to 14 weeks after the last dose of abatacept treatment.
Brug under amning Abatacept er vist at udskilles i rottemælk.
Use during lactation Abatacept has been shown to be present in rat milk.
Det vides ikke, om abatacept udskilles i modermælk.
It is not known whether abatacept is excreted in human milk.
Kvinder bør ikke amme under behandling med ORENCIA samt 14 uger efter sidste dosis af abatacept.
Women should not breastfeed while treated with ORENCIA and for up to 14 weeks after the last dose of abatacept treatment.
Fertilitet Der er ikke udført formelle studier af ORENCIAs potentielle effekt på human fertilitet.
Fertility Formal studies of the potential effect of ORENCIA on human fertility have not been conducted.
5. 3).
In rats, abatacept had no undesirable effects on male or female fertility (see section 5.3).
Abatacept er undersøgt hos patienter med aktiv reumatoid artritis i placebo- kontrollerede, kliniske forsøg (1. 955 patienter behandlet med abatacept, 989 behandlet med placebo).
Abatacept has been studied in patients with active rheumatoid arthritis in placebo-controlled clinical trials (1,955 patients with abatacept, 989 with placebo).
Forsøgene indeholdt en dobbeltblind, placebo- kontrolleret periode på enten 6 måneder (258 patienter behandlet med abatacept, 133 med placebo) eller 1 år (1. 697 patienter behandlet med abatacept, 856 med placebo).
The trials had either a double-blind, placebo-controlled period of 6 months (258 patients with abatacept, 133 with placebo) or 1 year (1,697 patients with abatacept, 856 with placebo).
De fleste patienter i disse forsøg fik methotrexat (81, 9% med abatacept, 83, 3% med placebo).
Most patients in these trials were taking methotrexate (81.9% with abatacept, 83.3% with placebo).
Anden samtidig behandling omfattede:
Other concomitant medications included: