FrancophonIA/ELRC3.0 huggingface dataset:
English: Tuberculosis (TB): You should be screened for TB prior to ORENCIA treatment.
Danish: Tuberkulose: Du bør undersøges for tuberkulose, før du begynder behandling med ORENCIA.
English: If you miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule on your chosen day.
Danish: Hvis du har glemt din dosis mindre end tre dage efter den planlagte dato, skal du tage din dosis, så snart du kommer i tanke om det, og tage din næste dosis på den valgte behandlingsdag.
English: In SC-III, increased rates of immunogenicity were observed in subjects tested during 6 months of complete drug withdrawal in the abatacept+MTX and abatacept monotherapy groups (37.7% [29/77] and 44.1% [27/59], respectively) with generally low titer antibody responses.
Danish: I SC-III blev der observeret en øget forekomst af immunogenicitet hos forsøgspersoner, som blev testet i løbet af en 6 måneders periode med komplet lægemiddelseponering i abatacept+MTX- og abatacept-monoterapigrupperne (henholdsvis 37,7% [29/77] og 44,1% [27/59]) med antistofrespons i generelt lav titer.
English: Note: It is normal to see a drop of fluid leaving the needle.
Danish: Bemærk: Det er normalt, at der sidder en dråbe væske på spidsen af kanylen.
English: Children weighing 75 kg or more should be administered ORENCIA powder for concentrate for solution for infusion following the adult dosing regimen.
Danish: Børn, der vejer 75 kg eller derover, bør følge voksendoseringen for ORENCIA pulver til koncentrat til infusionsvæske, opløsning.
English: The Type 1 glass syringe has a coated stopper and fixed stainless steel needle covered with a rigid needle shield.
Danish: Injektionssprøjten af Type 1 glas har en coated stopper og en fast nål af rustfri stål dækket af en stiv kanylehætte.
English: ORENCIA can also be used with methotrexate to treat highly active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: ORENCIA kan også anvendes sammen med methotrexat til at behandle meget aktiv og fremadskridende leddegigt hos patienter, der ikke tidligere er blevet behandlet med methotrexat.
English: Gather supplies for your injection on a clean, flat surface (only the ClickJect Pre-filled Pen is included in the package): Alcohol swab
Danish: Tag de ting frem, du skal bruge, og læg dem på et rent, plant underlag (pakningen indeholder kun den fyldte ClickJect-pen): Renseserviet
English: The proportion of patients who discontinued treatment due to ARs was 3.0% for abatacept-treated patients and 2.0% for placebo-treated patients.
Danish: Andelen af patienter som seponerede behandling på grund af bivirkninger, var 3,0% for abatacept-behandlede patienter og 2,0% for placebobehandlede.
English: From a microbiological point of view, the reconstituted solution should be diluted immediately.
Danish: Af mikrobiologiske årsager bør den rekonstituerede infusionsvæske fortyndes straks.
English: There is limited experience with use of abatacept in combination with TNF-inhibitors (see section 5.1).
Danish: Der er begrænset erfaring med brug af abatacept i kombination med TNF-hæmmere (se pkt.
English: Immunogenicity in patients with pJIA treated with subcutaneous abatacept
Danish: Immunogenicitet hos patienter med pJIA behandlet med subkutan abatacept
English: The mean change was, 0.41 and 0.74 from year 1 to year 2 (n=290, 130), 0.37 and 0.68 from year 2 to year 3 (n=293, 130), 0.34 and 0.43 from year 3 to year 4 (n=290, 128) and the change was 0.26 and 0.29 (n=233, 114) from year 4 to year 5 for patients originally randomised to abatacept plus MTX and placebo plus MTX respectively.
Danish: Den gennemsnitlige ændring var 0,41 og 0,74 fra år 1 til år 2 (n = 290, 130), 0,37 og 0,68 fra år 2 til år 3 (n = 293, 130), 0,34 og 0,43 fra år 3 til år 4 (n = 290, 128), og ændringen var 0,26 og 0,29 (n = 233, 114) fra år 4 til år 5 for patienter, som oprindeligt var randomiseret til henholdsvis abatacept plus MTX og placebo plus MTX.
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary gland tumours (in females) occurred.
Danish: Der er i et carcinogenicitetsstudie med mus set stigninger i forekomsten af maligne lymfomer og mammatumorer (hos hunmus).
English: The respective values for ACR 20 at 24 months were 59.7% (190/318) for the abatacept SC group and 60.1% (197/328) for the adalimumab SC group.
Danish: De respektive værdier for ACR-20 ved 24 måneder var 59,7% (190/318) for abatacept s.c.-gruppen og 60,1% (197/328) for adalimumab s.c.-gruppen.
English: Lymphoma, lung neoplasm malignant, squamous cell carcinoma
Danish: Lymfom, maligne lungetumorer, spinocellulært karcinom
English: Get to know your Pre-filled Syringe There are 3 types of pre-filled syringes:
Danish: FØR DU BEGYNDER Lær den fyldte injektionssprøjte at kende Der er 3 typer af fyldt injektionssprøjte
English: One serious adverse reaction of infection (limb abscess) was reported in the 2 to 5 year age cohort during the 20-month extension period of the pJIA SC study.
Danish: Én alvorlig bivirkning, infektion (bylder på ekstremitet), blev indberettet i aldersgruppen 2-5 år i løbet af 20-måneders forlængelsesperioden i pJIA s.c.-studiet.
English: Population pharmacokinetic analyses did not detect any effect of methotrexate, NSAIDs, and corticosteroids on abatacept clearance (see section 5.2).
Danish: Farmakokinetiske populationsanalyser har ikke påvist, at methotrexat, NSAID eller kortikosteroider har effekt på abatacepts clearance (se pkt.
English: Major Clinical Responsec
Danish: Primær klinisk responsc
English: The COPD patients treated with abatacept developed adverse reactions more frequently than those treated with placebo (51.4% vs. 47.1%, respectively).
Danish: KOLpatienter behandlet med abatacept udviklede hyppigere bivirkninger end dem, der blev behandlet med placebo (henholdsvis 51,4% og 47,1%).
English: The abatacept + MTX group had less progression in structural damage compared with MTX group as reflected by mean treatment difference of the abatacept + MTX group versus MTX group (Table 5).
Danish: I abatacept + MTX-gruppen sås mindre progression i strukturel ledskade sammenlignet med MTX-gruppen, udtrykt som gennemsnitlig behandlingsforskel i abatacept + MTX-gruppen versus MTX-gruppen (Tabel 5).
English: Patients on controlled sodium diet
Danish: Patienter på saltfattig diæt
English: † p < 0.05, abatacept plus MTX vs MTX plus placebo a Fixed dose approximating 10 mg/kg (see section 4.2).
Danish: †† p < 0,05, abatacept plus MTX vs MTX plus placebo a Fast dosis, ca. 10 mg/kg (se pkt 4.2).
English: A significantly higher proportion of patients achieved an ACR 20 response after treatment with abatacept 10 mg/kg intravenous in PsA-I or 125 mg subcutaneous in PsA-II compared to placebo at Week 24 in the overall study populations.
Danish: En signifikant højere andel af patienterne opnåede et ACR 20-respons efter behandling med abatacept 10 mg/kg intravenøst i PsA-I eller 125 mg subkutant i PsA-II sammenlignet med placebo ved uge 24 i den samlede studiepopulation.
English: Remove the needle cover by holding the body of the pre-filled syringe with one hand and pulling the cover straight off with your other hand.
Danish: Fjern kanylehætten ved at holde på cylinderen på den fyldte injektionssprøjte med én hånd og træk hætten lige op med den anden hånd.
English: Study I patients were randomised to receive abatacept 2 or 10 mg/kg or placebo for 12 months.
Danish: Patienterne i studie I randomiseredes til abatacept 2 eller 10 mg/kg eller placebo i 12 måneder.
English: Remove the flip-top from the vial and wipe the top with an alcohol swab.
Danish: Fjern forseglingen fra hætteglasset, og tør toppen af med en alkohol-serviet.
English: During the 24-week placebo-controlled period in the larger study PsA-II, the proportion of patients with adverse reactions was similar in the abatacept and placebo treatment groups (15.5% and 11.4%, respectively).
Danish: Under den 24-ugers placebokontrollerede periode i det større PsA-II studie var andelen af patienter med bivirkninger sammenlignelig mellem den abatacept-behandlede og den placebobehandlede gruppe (henholdsvis 15,5% og 11,4%).
English: In the 6 to 17 year age cohort, the overall rate of seropositivity during the cumulative period including post abatacept follow-up was 4.7% (8/172): 2.3% (4/172) on treatment and 13.6% (6/44) after discontinuation of abatacept (≥ 28 days after the last dose).
Danish: I aldersgruppen 6-17 år var den samlede forekomst af seropositivitet under den kumulative periode inklusive opfølgning efter abatacept 4,7% (8/172): 2,3% (4/172) under behandlingen og 13,6% (6/44) efter seponering af abatacept (≥ 28 dage efter sidste dosis).
English: In this study children and adolescents with moderately to severely active pJIA, ages 2 to 17 years (46 patients in the 2 to 5 year age cohort and 173 patients in the 6 to 17 year age cohort) with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents, were treated.
Danish: I dette studie blev børn og unge med moderat til svær aktiv pJIA i alderen 2 til 17 år (46 patienter i aldersgruppen 2-5 år og 173 patienter i aldersgruppen 6-17 år) med utilstrækkeligt respons eller intolerance overfor mindst en DMARD, som kan have inkluderet biologiske lægemidler, behandlet.
English: Remove the pre-filled syringe from the injection site and let go of the pinched skin.
Danish: Fjern den fyldte injektionssprøjte fra injektionsstedet og slip den sammenklemte hud.
English: 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.
Danish: Ved 6 måneder var hyppigheden af bivirkninger i form af infektioner henholdsvis 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.
English: If any serious allergic or anaphylactic reaction occurs, intravenous or subcutaneous ORENCIA therapy should be discontinued immediately and appropriate therapy initiated, and the use of ORENCIA should be permanently discontinued (see section 4.8).
Danish: Hvis der opstår alvorlige allergiske eller anafylaktiske reaktioner, skal intravenøs eller subkutan behandling med ORENCIA straks afbrydes og relevant behandling påbegyndes, og ORENCIA skal seponeres permanent (se pkt.
English: After proper training in subcutaneous injection technique, a patient may self-inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.
Danish: Efter at have fået behørig undervisning i subkutan injektionsteknik kan patienten selv injicere ORENCIA, hvis lægen beslutter, at det er hensigtsmæssigt.
English: Serious infections at least possibly related to treatment were reported in 1.5% of abatacept-treated patients and 1.1% of placebo-treated patients.
Danish: Alvorlige infektioner, der som minimum muligvis var relateret til behandling, rapporteredes hos 1,5% af de abataceptbehandlede patienter og hos 1,1% af de placebobehandlede.
English: During the initial double blind 6 months period (short term period), the overall immunogenicity frequency to abatacept was 1.1% (8/725) and 2.3% (16/710)for the subcutaneous and intravenous groups, respectively.
Danish: I den initiale 6 måneder lange dobbeltblinde periode (korttidsperioden) var den samlede forekomst af immunogenicitet ved abatacept henholdsvis 1,1% (8/725) og 2,3% (16/710) i den subkutane og intravenøse gruppe.
English: - Remove the flip-top from the vial and wipe the top with an alcohol swab.
Danish: - Fjern forseglingen fra hætteglasset, og tør toppen af med en alkohol-serviet.
English: Discontinuation due to an acute infusion-related reaction occurred in 0.3% of patients receiving abatacept and in 0.1% of placebo-treated patients.
Danish: Seponering på grund af akut infusionsrelateret reaktion forekom hos 0,3% af de abatacept-behandlede patienter og hos 0,1% af de placebobehandlede.
English: One mL pre-filled syringe (Type 1 glass) in a pre-filled pen.
Danish: En ml fyldt injektionssprøjte (Type 1 glas) i en fyldt pen.
English: Population pharmacokinetic analyses revealed that there was a trend toward higher clearance of abatacept with increasing body weight.
Danish: Farmakokinetiske populationsanalyser viste en tendens til højere clearance af abatacept med stigende kropsvægt.
English: Excipient with known effect sodium: 0.375 mmol (8.625 mg) per vial
Danish: Hjælpestof, som behandleren skal være opmærksom på natrium: 0,375 mmol (8,625 mg) per hætteglas.
English: Transparent Tip
Danish: Gennemsigtig spids
English: In the placebo-controlled clinical trials with abatacept, infections at least possibly related to treatment were reported in 22.7% of abatacept-treated patients and 20.5% of placebo-treated patients.
Danish: I de placebo-kontrollerede kliniske studier med abatacept rapporteredes infektioner, der som minimum var muligt relateret til behandling hos 22,7% af de abatacept-behandlede patienter og hos 20,5% af de placebobehandlede.
English: Participants in Period C at day 1765 included 33 of the 58 Period B abatacept recipients, 30 of the 59 Period B placebo recipients, and 13 of the 36 Period A non-responders.
Danish: Patienterne ved dag 1.765 i periode C omfattede 33 af de 58 abatacept-modtagere fra periode B, 30 af de 59 placebo-modtagere fra periode B og 13 af de 36 patienter fra periode A, der ikke responderede.
English: If you miss receiving ORENCIA when you are supposed to, ask your doctor when to schedule your next dose.
Danish: Hvis du ikke har fået ORENCIA, som du skulle have haft, skal du spørge lægen, hvornår du næste gang skal have en dosis.
English: 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.
Danish: Ved en dosis på 200 mg/kg sås der begrænsede forandringer af immunfunktionen (en 9 gange stigning i gennemsnitligt T-celleafhængigt antistofrespons hos hun-unger, og inflammation af thyroidea hos 1 hun-unge ud af 10 han- og 10 hun-unger evalueret ved denne dosis).
English: The incidence rates (95% CI) for serious infections was 3.0 (2.3, 3.8) per 100 patient-years for abatacept-treated patients and 2.3 (1.5, 3.3) per 100 patient-years for placebo-treated patients in the double-blind studies.
Danish: Incidensraterne (95% CI) for alvorlige infektioner var 3,0 (2,3, 3,8) pr. 100 patientår hos abataceptbehandlede patienter og 2,3 (1,5, 3,3) pr. 100 patientår hos placebobehandlede patienter i de dobbeltblinde studier.
English: Women of childbearing potential have to use effective contraception during treatment and up to 14 weeks after the last dose of abatacept.
Danish: Kvinder i den fertile alder skal anvende effektiv kontraception under behandling samt op til 14 uger efter sidste dosis af abatacept.
English: b Each vial provides 250 mg of abatacept for administration.
Danish: b Hvert hætteglas giver 250 mg abatacept til administration.
English: B. Prepare your injection site Wipe your injection site with an alcohol swab in a circular motion.
Danish: B. Klargør injektionsstedet Aftør huden på injektionsstedet i cirklende bevægelser med en spritserviet.
English: They had active disease, with baseline mean active joint count of 16 and a mean number of joints with loss of motion of 16; and elevated C-reactive protein (CRP) levels (mean, 3.2 mg/dl) and ESRs (mean, 32 mm/h).
Danish: Deres sygdom var aktiv, ved baseline var det gennemsnitlige antal aktive led 16 og det gennemsnitlige antal led med manglende bevægelighed var 16; de havde forhøjet C-reaktivt proteinniveau (CRP) (gennemsnitlig 3,2 mg/dl) og ESR (gennemsnitlig 32 mm/t).
English: Patients in the sub-study (n=117) of the open-label extension of study SC-I received 125 mg of subcutaneous abatacept administered weekly via the pre-filled syringe for at least 4 months, and were then switched to receive 125 mg SC abatacept administered weekly via the pre-filled pen for 12 weeks.
Danish: Patienterne i sub-studiet (n=117) i den åbne forlængelse af studie SC-I fik 125 mg subkutan (s.c.) abatacept administreret ugentligt med den fyldte injektionssprøjte i mindst 4 måneder og blev derefter skiftet til 125 mg abatacept s.c. ugentligt med den fyldte pen i 12 uger.
English: The safety and efficacy of ORENCIA solution for injection in pre-filled pen for subcutaneous administration in children below 18 years of age have not been established.
Danish: Sikkerhed og virkning af subkutan administration af ORENCIA injektionsvæske, opløsning, i fyldt pen hos børn under 18 år er ikke klarlagt.
English: DO NOT replace the cap on the Pen.
Danish: DU MÅ IKKE sætte hætten tilbage på pennen.
English: Choose your injection site in either the abdomen or front of the thigh.
Danish: Udvælg et injektionssted enten på maven eller foran på låret.
English: The side effects experienced in children and adolescents with polyarticular juvenile idiopathic arthritis are similar to those experienced in adults as described above, with the following differences:
Danish: De bivirkninger, der er observeret hos børn og unge med børnegigt, svarer til dem, der er set hos voksne som beskrevet ovenfor, med følgende undtagelser:
English: Study SC-I compared the immunogenicity to abatacept following subcutaneous or intravenous administration as assessed by ELISA assay.
Danish: Studie SC-I sammenlignede abatacepts immunogenicitet efter henholdsvis subkutan og intravenøs administration ved ELISA-analyse.
English: Clinical efficacy and safety in adult rheumatoid arthritis
Danish: Klinisk virkning og sikkerhed hos voksne med reumatoid artritis
English: The mean (range) for cmin and cmax at steady state observed after 85 days of treatment was 32.5 mcg/mL (6.6 to 113.8 mcg/mL) and 48.1 mcg/mL (9.8 to 132.4 mcg/mL), respectively.
Danish: Gennemsnitlig (interval) Cmin og Cmax ved steady state observeret efter 85 dages behandling var henholdsvis 32,5 mikrog/ml (6,6-113,8 mikrog/ml) og 48,1 mikrog/ml (9,8-132,4 mikrog/ml).
English: DO NOT use the Pen if it is dropped after the cap is removed.
Danish: DU MÅ IKKE bruge pennen, hvis du taber den, efter du har fjernet hætten.
English: During the extension period of the pJIA studies (20 months in the pJIA ongoing SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Danish: Under forlængelsesperioden af pJIA-studiet (20 måneder i det igangværende pJIA s.c.-studie og 5 år i pJIA IV-studiet), var sikkerhedsprofilen hos pJIA patienterne i alderen 6-17 år sammenlignelig med den set hos voksne patienter.
English: MRI Synovitis Score
Danish: Synovitisscore ved MR-scanning
English: Uncommon Thrombocytopenia, leukopenia
Danish: Trombocytopeni, leukopeni
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium per dosis, dvs. det er i det væsentligste natriumfrit.
English: ORENCIA solution for injection in pre-filled pen has not been studied in children and adolescents under the age of 18 years.
Danish: ORENCIA injektionsvæske, i fyldt pen, er ikke undersøgt hos børn og unge under 18 år.
English: During the extension period of the pJIA studies (20 months in the pJIA SC study and 5 years in the pJIA IV study), the safety profile in the pJIA patients aged 6 to 17 years was comparable to that seen in adult patients.
Danish: Under forlængelsesperioden af pJIA-studierne (20 måneder i pJIA s.c.-studiet og 5 år i pJIA IVstudiet), var sikkerhedsprofilen hos pJIA patienterne i alderen 6-17 år sammenlignelig med den set hos voksne patienter.
English: 125 mg, solution for injection subcutaneous use
Danish: 125 mg, injektionsvæske subkutan anvendelse
English: EU/1/07/389/002 2 vials and 2 silicone-free syringes (2 packs of 1) EU/1/07/389/003 3 vials and 3 silicone-free syringes (3 packs of 1)
Danish: EU/1/07/389/002 2 hætteglas og 2 silikonefrie sprøjter (2 pakninger med hver én) EU/1/07/389/003 3 hætteglas og 3 silikonefrie sprøjter (3 pakninger med hver én)
English: The adjusted geometric mean of abatacept at steady state trough concentration (Cminss) was 25.3 mcg/mL for the subcutaneous pre-filled pen and 27.8 mcg/mL for the subcutaneous pre-filled syringe with a ratio of 0.91 [90% CI: 0.83, 1.00].
Danish: Den justerede geometriske middelværdi af den laveste koncentration af abatacept ved steady state (Cminss) var 25,3 mikrog/ml for den fyldte pen subkutant og 27,8 mikrog/ml for den fyldte injektionssprøjte subkutant (ratio 0,91 [90% CI: 0,83; 1,00]).
English: Preparation of infusion: immediately after reconstitution, dilute the concentrate to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Tilberedning af infusion: umiddelbart efter rekonstituering fortyndes koncentratet til 100 ml med natriumchlorid 9 mg/ml (0,9%) opløsning til injektion.
English: ORENCIA should be given to you again, 2 and then 4 weeks after the first infusion.
Danish: ORENCIA skal gives igen 2 og 4 uger efter første infusion.
English: Similar inhibition was observed in both treatment groups up to 24 months (mTSS (mean ± standard deviation [SD] = 0.89 ± 4.13 vs 1.13 ±8.66), erosion score (0.41 ± 2.57 vs 0.41 ±5.04), and JSN score (0.48 ±2.18 vs 0.72 ±3.81)) for the abatacept (n=257) and adalimumab (n=260) groups, respectively.
Danish: Sammenlignelig hæmning blev observeret i begge behandlingsgrupper efter 24 måneder (mTSS (gennemsnitlig ± standardafvigelse [SD] = 0,89 ± 4,13 versus 1,13 ±8,66), erosionsscore (0,41 ± 2,57 versus 0,41 ±5,04) og JSN-score (0,48 ±2,18 versus 0,72 ±3,81)) for henholdsvis abatacept (n=257) og adalimumab (n=260) grupperne.
English: Comprehensive instructions for the preparation and administration of ORENCIA in a pre-filled pen are given in the package leaflet and "Important instructions for use".
Danish: Detaljeret vejledning om klargøring og indgivelse af ORENCIA i en fyldt pen findes i indlægssedlen og ”Vigtig brugervejledning”.
English: EU/1/07/389/011 4 pre-filled pens
Danish: EU/1/07/389/011 4 fyldte penne
English: Remove one pre-filled syringe from the refrigerator and wait 30 minutes to allow it to reach room temperature.
Danish: Fjern en fyldt injektionssprøjte fra køleskabet, og vent 30 minutter for at lade den opnå stuetemperatur.
English: During period A, 74% were taking methotrexate (mean dose at study entry, 13.2 mg/m2/week) thus, 26% of patients received abatacept monotherapy in Period A. Of the 190 patients entering the study, 57 (30%) had previously been treated with TNF-inhibitor therapy.
Danish: I periode A tog 74% methotrexat (gennemsnitlig dosis ved indtræden i studiet, 13,2 mg/m2/uge), og 26% af patienterne fik således abatacept som monoterapi i periode A. Af de 190 patienter, der deltog i studiet, havde 57 (30%) tidligere været i TNF-hæmmerbehandling.
English: - Do not store any unused portion of the infusion solution for reuse.
Danish: - Gem ikke ubrugt infusionsvæske til senere brug.
English: ORENCIA solution for injection in pre-filled syringe has not been studied in children and adolescents under 2 years of age.
Danish: ORENCIA injektionsvæske i fyldt injektionssprøjte er ikke undersøgt hos børn og unge under 2 år.
English: Please refer to the ORENCIA powder for concentrate for solution for infusion 250 mg and ORENCIA solution for injection in prefilled syringe 125 mg, 87.5 mg and 50 mg SmPCs.
Danish: Se venligst produktresuméerne for ORENCIA pulver til koncentrat til infusionsvæske, opløsning 250 mg og ORENCIA injektionsvæske, opløsning, fyldt injektionssprøjte 125 mg, 87,5 mg og 50 mg.
English: Patients should be screened for latent tuberculosis prior to initiating ORENCIA.
Danish: Patienter bør screenes for latent tuberkulose i henhold til de aktuelle kliniske retningslinjer inden påbegyndelse af behandling med ORENCIA.