natgillin/translations-raw huggingface dataset:
I studie III sås ACR 20- respons hos 70% af patienterne (118/ 167), ACR 50 hos 43% (73/ 168) og ACR 70 hos 22% (37/ 169) ved 18 måneder.
In study III, ACR 20 responses were observed in 70% (118/ 167) of patients, ACR 50 in 43% (73/ 168), and ACR 70 in 22% (37/ 169) at 18 months.
Der er set større forbedringer med abatacept end med placebo i andre målinger af sygdomsaktivitet af reumatoid arthritis, som ikke er inkluderede i ACR- responskriterierne fx morgenstivhed.
10 Greater improvements were seen with abatacept than with placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
DAS28- respons Sygdomsaktivitet blev også vurderet ved hjælp af DAS28 ESR (Disease Activity Score 28).
DAS28 response Disease activity was also assessed using the Disease Activity Score 28 (DAS28 ESR).
Der var signifikant forbedring af DAS i studie II, III og V sammenlignet med placebo.
There was a significant improvement of DAS in Studies II, III, and V as compared to placebo.
Studie V: abatacept eller infliximab versus placebo Der er gennemført et randomiseret dobbeltblindt studie med henblik på at vurdere sikkerhed og effekt af abatacept eller infliximab versus placebo hos patienter med utilstrækkeligt respons på methotrexat (studie V).
Study V: abatacept or infliximab versus placebo A randomized, double-blind study was conducted to assess the safety and efficacy of abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (Study V).
Det primære endpoint var gennemsnitlig ændring i sygdomsaktivitet hos abataceptbehandlede patienter sammenlignet med placebobehandlede ved 6 måneder med en efterfølgende dobbeltblind vurdering af sikkerhed og effekt af abatacept og infliximab ved 12 måneder.
The primary outcome was the mean change in disease activity in abatacept- treated patients compared to placebo-treated patients at 6 months with a subsequent double-blind assessment of safety and efficacy of abatacept and infliximab at 12 months.
Resultaterne for abatacept og infliximab var ensartede.
Greater improvement (p < 0.001) in DAS28 was observed with abatacept and with infliximab compared to placebo at six months in the placebo-controlled portion of the trial; the results between the abatacept and infliximab groups were similar.
ACR- respons i studie V var konsistent med hensyn til DAS28 - scoren.
The ACR responses in Study V were consistent with the DAS28 score.
Ved 6 måneder var hyppigheden af bivirkninger i form af infektioner henholdvis 48, 1% (75), 52, 1% (86) og 51, 8% (57) og hyppigheden af alvorlige bivirkninger var henholdsvis 1, 3% (2), 4, 2% (7) og 2, 7% (3) for abataceptgruppen, infliximabgruppen og placebogruppen.
At 6 months, the incidence of AE of infections were 48.1% (75), 52.1% (86), and 51.8% (57) and the incidence of serious AE of infections were 1.3% (2), 4.2% (7), and 2.7% (3) for abatacept, infliximab and placebo groups, respectively.
Ved 12 måneder var hyppigheden af bivirkninger, i form af infektioner, henholdsvis 59, 6% (93) og 68, 5% (113) og hyppigheden af alvorlige bivirkninger var henholdsvis 1, 9% (3) og 8, 5% (14) for abataceptgruppen og infliximabgruppen.
At 12 months, the incidence of AE of infections were 59.6% (93), 68.5% (113), and the incidence of serious AE of infections were 1.9% (3) and 8.5% (14) for abatacept and infliximab groups, respectively.
Radiografisk respons Studie 2 vurderede strukturel ledskade radiografisk over en periode på 2 år.
Radiographic response Structural joint damage was assessed radiographically over a two-year period in Study II.
Resultaterne blev målt ved hjælp af Genant- modificeret TSS (Total Sharp Score) og dets komponenter, erosionsscore og JSN - score (joint space narrowing).
The results were measured using the Genant-modified total Sharp score (TSS) and its components, the erosion score and joint space narrowing (JSN) score.
Middel- TSS ved baseline var 31, 7 hos de abataceptbehandlede patienter og 33, 4 hos de placebobehandlede patienter.
The baseline median TSS was 31.7 in abatacept-treated patients and 33.4 in placebo-treated patients.
Abatacept/ methotrexat reducerede efter 12 måneders behandling progressionshastigheden af strukturel skade sammenlignet med placebo/ methotrexat, vist i Tabel 4.
Abatacept/ methotrexate reduced the rate of progression of structural damage compared to placebo/ methotrexate after 12 months of treatment as shown in Table 4.
Progressionshastigheden af strukturel skade var signifikant mindre det andet år sammenlignet med det første år hos patienter, som var randomiseret til abatacept (p < 0, 0001).
The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomized to abatacept (p < 0.0001).
Gennemsnitlige radiografiske forandringer over 12 måneder i studie II Abatacept/ MTX Placebo/ MTX
Mean Radiographic Changes Over 12 Months in Study II Abatacept/ MTX Placebo/ MTX
Parameter TS- score Erosionsscore JSN- score a
Parameter Total Sharp score Erosion score JSN score a
n = 391 N = 195 P- værdia 1, 21 2, 32 0, 012 0, 63 1, 14 0, 029 0, 58 1, 18 0, 009
n = 391 n = 195 P-valuea 1.21 2.32 0.012 0.63 1.14 0.029 0.58 1.18 0.009
Baseret på non- parametrisk analyse.
Based on non-parametric analysis.
Ændring i fysisk funktion Forbedring i fysisk funktion blev målt ved HAQ- DI (Health Assessment Questionnaire Disability Index) i studie II, III, IV og V samt et modificeret HAQ- DI i studie I.
Physical function response Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in Studies II, III, IV and V and the modified HAQ-DI in Study I.
Resultater fra studie II og III angives i Tabel 5.
The results from Studies II and III are shown in Table 5.
Forbedring i fysisk funktion i placebokontrollerede Utilstrækkeligt respons på methotrexat Studie II Abatacepta Placebo
Improvement in Physical Function in Placebo-Controlled Trials Inadequate Response to Inadequate Response Methotrexate TNF Blocking Agent Study II Study III
HAQ- DI
to
+DMARDb +DMARDb
HAQc Disability
Baseline (middel)
Abatacepta Placebo Abatacepta
Gennemsnitlig forbedring fra baseline
Index Baseline (Mean) Mean Improvement from Baseline
Måned 12
Month 12 Proportion of patients with a clinically meaningful improvementd
= 130) NAe
NAe
Andel af patienter med klinisk betydningsfuld forbedringd ***
***
4. 2). b Samtidig DMARD dækker en eller flere af følgende: methotrexat, chloroquin/ hydroxychloroquin, sulfasalazin, leflunomid, azathioprin, guld og anakinra. c HAQ; 0 = bedst, 3 = værst; 20 spørgsmål; 8 kategorier: påklædning og soignering, stå op, spise, gå, hygiene, nå, gribe og aktiviteter. d Reduktion i HAQ- DI på ≥ 0, 3 enheder fra baseline. e Efter 6 måneder fik patienterne mulighed for at indgå i et åbent forsøg.
p < 0.001, abatacept vs. placebo. a Fixed dose approximating 10 mg/ kg (see section 4.2). b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/ hydroxychloroquine, sulfasalazine, leflunomide, azathioprine, gold, and anakinra. c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. d Reduction in HAQ-DI of ≥ 0.3 units from baseline. e After 6 months, patients were given the opportunity to enter into an open-label study.
I de åbne perioder i studie I, II og III opretholdt patienterne en forbedring i fysisk funktion gennem henholdsvis 48, 24 og 18 måneder.
During the open-label period of Studies I, II, and III, the improvement in physical function has been maintained through 48, 24, and 18 months, respectively.
Helbredsrelaterede endpoints og livskvalitet Helbredsrelateret livskvalitet vurderedes ved SF- 36- spørgeskemaet ved 6 måneder i studie I, II og III og ved 12 måneder i studie I og II.
Health-related outcomes and quality of life Health-related quality of life was assessed by the SF-36 questionnaire at 6 months in Studies I, II, and III and at 12 months in Studies I and II.
I disse studier sås klinisk og statistisk signifikant forbedring i abataceptgruppen sammenlignet med placebogruppen inden for alle 8 domæner i SF- 36 (4 fysiske domæner: fysisk funktion, fysisk betingede begrænsninger, fysiske smerter, alment helbred; og 4 psykiske domæner: energi, sociale activiteter, psykisk betingede begænsninger, psykisk velbefindende), såvel som i den fysiske totalscore og den psykiske totalscore.
In these studies, clinically and statistically significant improvement was observed in the abatacept group as compared with the placebo group in all 8 domains of the SF-36 (4 physical domains: physical function, role physical, bodily pain, general health; and 4 mental domains: vitality, social function, role emotional, mental health), as well as the Physical Component Summary and the Mental Component Summary.
Efter gentagne intravenøse infusioner (dag 1, 15, 30 og herefter hver 4. uge) har farmakokinetik for abatacept hos patienter med reumatoid artritis vist dosisproportionelle stigninger i Cmax og AUC over dosisområdet 2 mg/ kg til 10 mg/ kg.
After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics of abatacept in rheumatoid arthritis patients showed dose-proportional increases of Cmax and AUC over the dose range of 2 mg/ kg to 10 mg/ kg.
Ved 10 mg/ kg var den gennemsnitlige halveringstid 13, 1 dage, spændende fra 8 til 25 dage.
At 10 mg/ kg, the mean terminal half-life was 13.1 days, ranging from 8 to 25 days.
Det gennemsnitlige fordelingsvolumen (Vss) var 0, 07 l/ kg og spændte fra 0, 02 til 0, 13 l/ kg.
The mean distribution volume (Vss) was 0.07 l/ kg and ranged from 0.02 to 0.13 l/ kg.
0, 22 ml/ h/ kg.
The systemic clearance was approximately 0.22 ml/ h/ kg.
290 μg/ ml.
Mean steady-state trough concentrations were approximately 25 μ g/ ml, and mean Cmax concentrations were approximately 290 μ g/ ml.
Der var ingen systemisk akkumulering af abatacept ved gentagen behandling med 10 mg/ kg med månedlige intervaller hos patienter med reumatoid arthritis.
No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/ kg at monthly intervals in rheumatoid arthritis patients.
Alder og køn (korrigeret for kropsvægt) påvirkede ikke clearance.
Age and gender (when corrected for body weight) did not 12 affect clearance.
Der sås ingen påvirkning af methotrexat, NSAID, kortikosteroider og TNF- hæmmere på abatacepts clearance.
Methotrexate, NSAIDs, corticosteroids, and TNF blocking agents were not found to influence abatacept clearance.
12 Farmakokinetik for abatacept er ikke undersøgt hos børn og unge.
The pharmacokinetics of abatacept have not been studied in children and adolescents.
Der er ikke udført studier af betydningnen af nyre - og leverinsufficien på abatacepts farmakokinetik.
No studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of abatacept.
En række af in vitro- studier har ikke vist mutagenicitet eller clastogenicitet med abatacept.
No mutagenicity or clastogenicity was observed with abatacept in a battery of in vitro studies.
I et 1- årigt toksicitetsforsøg med cynomolgus- aber var abatacept ikke forbundet med signifikant toksicitet.
In a one-year toxicity study in cynomolgus monkeys, abatacept was not associated with any significant toxicity.
Reversible farmakologiske virkninger bestod af minimale, forbigående fald i serum- IgG og minimalt til svært lymfoidt tab i germinale centre i milten og/ eller lymfekirtler.
Reversible pharmacological effects consisted of minimal transient decreases in serum IgG and minimal to severe lymphoid depletion of germinal centres in the spleen and/ or lymph nodes.
Inden for forsøgets tidsramme sås ingen tegn på lymfomer eller præ- neoplastiske morfologiske forandringer på trods af tilstedeværelse af et virus, lymfocryptovirus, som vides at forårsage sådanne læsioner hos immunsupprimerede aber.
No evidence of lymphomas or preneoplastic morphological changes was observed, despite the presence of a virus, lymphocryptovirus, which is known to cause such lesions in immunosuppressed monkeys within the time frame of this study.
Relevansen af disse fund for den kliniske anvendelse af ORENCIA kendes ikke.
The relevance of these findings to the clinical use of ORENCIA is unknown.
Der er udført embryo- føtale udviklingsforsøg med abatacept på mus, rotter og kaniner i doser på op til 20- 30 gange den humane dosis på 10 mg/ kg, og der sås ingen bivirkninger hos afkommet.
Embryo-foetal development studies were conducted with abatacept in mice, rats, and rabbits at doses up to 20 to 30 times a human 10 mg/ kg dose and no undesirable effects were observed in the offspring.
Hos rotter og kaniner var optagelsen af abatacept på op til 29 gange den humane dosis på 10 mg/ kg, baseret på AUC.
In rats and rabbits, abatacept exposure was up to 29-fold a human 10 mg/ kg exposure based on AUC.
Dette udgør en dosis på 3 gange den humane dosis på 10 mg/ kg, baseret på AUC.
In a pre- and postnatal development study with abatacept in rats, no undesirable effects were observed in pups of dams given abatacept at doses up to 45 mg/ kg, representing 3-fold a human 10 mg/ kg exposure based on AUC.
Denne dosis svarede til en dosis på 11 gange den humane dosis på 10 mg/ kg, baseret på AUC.
At a dose of 200 mg/ kg, representing 11-fold a human exposure at 10 mg/ kg based on AUC, limited changes in immune function (a 9-fold increase in the mean T-cell-dependent antibody response in female pups and inflammation of the thyroid of 1 female pup out of 10 male and 10 female pups evaluated at this dose) were observed.
Maltose Natriumdihydrogenfosfatmonohydrat Natriumchlorid
Maltose Sodium dihydrogen phosphate monohydrate Sodium chloride
6. 6).
ORENCIA should NOT be used with siliconised syringes (see section 6.6).
Efter rekonstituering: der er vist kemisk og fysisk holdbarhed i 24 timer ved 2°C - 8°C.
After reconstitution: chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Af mikrobiologiske årsager bør den rekonstituerede opløsning fortyndes straks.
From a microbiological point of view, the reconstituted solution should be diluted immediately.
Efter fortynding: når den rekonstituerede opløsning fortyndes straks, er der vist kemisk og fysisk holdbarhed af den fortyndede infusionsopløsning i 24 timer ved 2°C - 8°C.
13 After dilution: when the reconstituted solution is diluted immediately, the chemical and physical in-use stability of the diluted infusion solution has been demonstrated for 24 hours at 2°C - 8°C.
Af mikrobiologiske årsager, bør den rekonstituerede opløsning anvendes straks.
From a microbiological point of view, the product should be used immediately.
13 6. 4 Særlige opbevaringsforhold
6.4 Special precautions for storage
250 mg pulver i hætteglas (Type 1 glas) med gummistopper (halobutylgummi) og forsegling (aluminium), der kan vippes af samt en silikonefri sprøjte (polyethylen).
250 mg powder in a vial (Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium) with a silicone-free syringe (polyethylene).
Pakker med 1, 2 eller 3 hætteglas (15 ml i hver) og henholdsvis 1, 2 eller 3 silikonfrie sprøjter.
Packs of 1, 2, or 3 vials (each 15 ml) and 1, 2, or 3 silicone-free syringes, respectively.
Rekonstituering og fortynding skal udføres i overensstemmelse med regler for god fremstillingspraksis særligt med hensyn til aseptisk fremstilling.
Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Rekonstituering 1.
Reconstitution 1.
4. 2).
Determine the dose and the number of ORENCIA vials needed (see section 4.2).
6. 2) og en 18- 21 gauge nål.
Under aseptic conditions, reconstitute each vial with 10 ml of water for injections, using the silicone free-disposable syringe provided with each vial (see section 6.2) and an 18-21 gauge needle.
- Fjern forseglingen fra hætteglasset, og tør toppen af med en alkohol- serviet.
- Remove the flip-top from the vial and wipe the top with an alcohol swab.
- Før nålen gennem midten af gummistopperen, og ret strålen af vand til injektionsvæsker mod siden
- Insert the syringe needle into the vial through the centre of the rubber stopper and direct the stream
af hætteglasset.
of water for injections to the glass wall of the vial.
- Fjern sprøjten og nålen, når de 10 ml vand til injektionsvæsker er injiceret i hætteglasset.
- Remove the syringe and needle after 10 ml of water for injections have been injected into the vial.
- For at minimere skumdannelse i ORENCIA- opløsningen, vendes hætteglasset med forsigtige,
- To minimise foam formation in solutions of ORENCIA, the vial should be rotated with gentle
roterende bevægelser, indtil indholdet er fuldstændig opløst.
swirling until the contents are completely dissolved.
- Når pulveret er fuldstændig opløst, udluftes hætteglasset med nålen, for at fjerne eventuelt skum.
- Upon complete dissolution of the powder, the vial should be vented with a needle to dissipate any
- Efter rekonstituering skal opløsningen være klar og farveløs til svagt gul.
- After reconstitution the solution should be clear and colourless to pale yellow.
Opløsningen må ikke
Do not use if opaque
bruges, hvis der ses uigennemsigtige partikler, misfarvning eller andre fremmedlegemer.
particles, discolouration, or other foreign particles are present.
Fortynding 3.
Dilution 3.
Umiddelbart efter rekonstituering fortyndes produktet yderligere til 100 ml med natriumchlorid 9 mg/ ml (0, 9%) opløsning til injektion.
Immediately after reconstitution, the product must be further diluted to 100 ml with sodium chloride 9 mg/ ml (0.9%) solution for injection.
- Fra en 100 ml infusionspose eller - flaske med 0, 9% natriumchlorid injektionsvæske udtrækkes et
- From a 100 ml infusion bag or bottle, withdraw a volume of sodium chloride 9 mg/ ml (0.9%)
volumen svarende til de rekonstituerede ORENCIA- hætteglas (for 2 hætteglas udtrækkes 20 ml, for 3 hætteglas udtrækkes 30 ml, for 4 hætteglas udtrækkes 40 ml).
solution for injection equal to the volume of the reconstituted vials (for 2 vials remove 20 ml, for 3 vials remove 30 ml, for 4 vials remove 40 ml).
- Tilsæt langsomt den rekonstituerede ORENCIA- opløsning fra hvert hætteglas til infusionsposen eller
- Slowly add the reconstituted ORENCIA solution from each vial to the infusion bag or bottle using
- flasken med samme silikonefrie éngangssprøjte, der leveres med hvert hætteglas.
the same silicone-free disposable syringe provided with each vial.
- Bland forsigtigt.
- Gently mix.
Koncentrationen af den fuldt fortyndede ORENCIA- opløsning i infusionsposen
The concentration of the fully diluted ORENCIA solution in the infusion bag or bottle
5 mg; 7, 5 mg eller 10 mg abatacept per ml opløsning afhængig af, om der er anvendt 2, 3 eller 4 hætteglas abatacept.
will be approximately 5, 7.5, or 10 mg of abatacept per ml of solution depending on whether 2, 3, or 4 vials of abatacept are used.
- Eventuelt ubrugt opløsning i hætteglasset skal straks bortskaffes i overensstemmelse med lokale
- Any unused portion in the vials must be immediately discarded in accordance with local
krav.
requirements.
Når rekonstituering og fortynding er udført under aseptiske forhold, kan ORENCIA - infusionsopløsningen anvendes straks eller inden for 24 timer, såfremt det opbevares i køleskab ved 2°C - 8°C.
When reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Inden administration skal ORENCIA- opløsningen efterses for partikelholdigt materiale og misfarvning.
Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Hele den færdigtilberedte ORENCIA- opløsning indgives over en periode på 30 minutter og
The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μ m).
- gem ikke ubrugt infusionsopløsning til senere brug.
- Do not store any unused portion of the infusion solution for reuse.
Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Storbritannien
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH United Kingdom
21, 05, 2007
21/ 05/ 2007
Contrada Fontana del Ceraso 03012 Anagni Italien
Contrada Fontana del Ceraso 03012 Anagni Italy
CHMP mente, at patienterne skal forsynes med et advarselskort, og det er inkluderet i annex III.
The CHMP considered that a Patient Alert Card should be provided and this is included in Annex III.
System for bivirkningsovervågning Markedsføringsindehaver må sikre, at et system for bivirkningsovervågning er tilgængeligt og at det fungerer inden produktet markedsføres.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance is in place and functioning before the product is placed on the market.
Plan for risikohåndtering MAH lover at udføre studier samt andre bivirkningsovervågningsaktiviteter som fremlagt detaljeret i planen for bivirkningsovervågning.
Risk Management plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan.
CHMP vejledning om systemer for risikohåndtering for lægemidler til human brug.
An updated Risk Management Plan should be provided as per CHMP Guideline on Risk Management Systems for medicinal products for human use.
ORENCIA 250 mg pulver til koncentrat til infusionsvæske, opløsning Abatacept
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept
Hjælpestoffer: maltose, natriumdihydrogenphosphat monohydrat og natriumchlorid
Excipients: maltose, sodium dihydrogen phosphate monohydrate and sodium chloride
1 hætteglas 1 steril silikonefri sprøjte
1 vial 1 sterile silicone-free syringe
2 hætteglas 2 sterile silikonefrie sprøjter
2 vials 2 sterile silicone-free syringes
3 hætteglas 3 sterile silikonefrie sprøjter
3 vials 3 sterile silicone-free syringes
Læs indlægssedlen inden rekonstituering og brug.
Intravenous use after reconstitution and dilution Read the package leaflet before reconstitution and use.
Til éngangsbrug.
For single use only.
Brug den medfølgende silikonefrie éngangssprøjte til rekonstituering.
Use the silicone-free disposable syringe included in the package for reconstitution.
20 Se indlægssedlen for holdbarhed af det rekonstituerede produkt.
20 Read the package leaflet for the shelf-life of the reconstituted product.
Smid eventuel ubrugt opløsning ud.
Discard any unused solution.
BAKKEETIKET
TRAY LABEL
ORENCIA 250 mg pulver til koncentrat til infusionsvæske, opløsning Abatacept Til intravenøs anvendelse
ORENCIA 250 mg powder for concentrate for solution for infusion Abatacept Intravenous use
250 mg abatacept
250 mg of abatacept
23 TEKST PÅ ADVARSELSKORT FOR PATIENTER
23 PATIENT ALERT CARD TEXT
Advarselskort
Orencia Patient Alert Card
for patienter i ORENCIA behandling
Infections
Infektion − Hvis du får symptomer, som tyder på
This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA. • Show this card to any doctor involved in
Dette
−
informationer om sikkerhed, som du bør være opmærksom på, inden du får ORENCIA og mens du er i behandling med ORENCIA.
If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Datoer for Start:
your treatment.
ORENCIA- behandling:
Dates of ORENCIA Treatment:
Infektion
Infections Start:
____________________
ORENCIA increases the risk of getting ____________________ infections.
ORENCIA øger risikoen for infektion.
Most recent:
Seneste behandling:
- You should not be treated with ORENCIA
- Du bør ikke behandles med ORENCIA ____________________
if you have severe infection. - You should be screened for certain infections prior to treatment with
hvis du har alvorlig infektion.
____________________
- Du bør undersøges for bestemte infektioner
ORENCIA, according to relevant guidelines.