FrancophonIA/ELRC3.0 huggingface dataset:
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (study HS-I).
Danish: Sammenlignet med placebo blev der ved uge 12 påvist større forbedringer i forhold til baseline i hudspecifik sundhedsrelateret livskvalitet målt ved “Dermatology Life Quality Index“ (DLQI; HS-studie I og II), globale patienttilfredshed med lægemiddelbehandlingen målt ved ”Treatment Satisfaction Questionnaire - medication” (TSQM; HS-studie I og II) og fysisk helbred målt ved ”physical component summary score” af SF-36 (HS-studie I).
English: On rare occasions, a specific and severe type of lymphoma has been observed in patients taking Imraldi.
Danish: I sjældne tilfælde er der set en alvorlig type af lymfom hos patienter, som tog Imraldi.
English: -56.2a a p<0.001, adalimumab vs. placebo
Danish: -56,2a a p < 0,001; adalimumab versus placebo
English: Maintenance of remission and response rates are presented in Table 23.
Danish: Rater for vedligeholdelse af remission- og respons er vist i tabel 23.
English: Patients treated with Imraldi should be given the Patient Reminder Card.
Danish: Patienter i Imraldibehandling skal have udleveret Patientkortet.
English: Placebo (treatment withdrawal) N = 73
Danish: Placebo (behandlingen afbrydes) N = 73
English: Imraldi is injected under the skin (subcutaneous use).
Danish: Imraldi injiceres under huden (subkutan anvendelse).
English: • Tell your doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of contracting HBV.
Danish: • Fortæl lægen, hvis dit barn er bærer af hepatitis B-virus (HBV), hvis dit barn har aktiv HBVinfektion, eller hvis du tror, dit barn kan have risiko for at få HBV.
English: After you push the plunger all the way down, the needle will retract to help prevent needle stick injury.
Danish: Når du har presset stemplet helt i bund, vil kanylen trække sig tilbage, så stikskade af kanylen forhindres.
English: RA study IIa**
Danish: RA-studie IIa**
English: It is important to tell your doctor if your child has had or has a serious heart condition.
Danish: Det er vigtigt at informere lægen, hvis dit barn har eller har haft en alvorlig hjertesygdom.
English: In RA studies I-IV, adalimumab -treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I RA-studierne I-IV opnåede adalimumab-behandlede patienter statistisk signifikant ACR 20- og 50respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 %, 26.4 % (92/349) and 37.8 % (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Danish: I et åbent forlængelsesstudie med patienter, hvis dosis blev trappet op fra 40 mg hver anden uge til 40 mg ugentlig på grund af PASI-respons under 50 %, opnåede 26,4 % (92/349) og 37,8 % (132/349) af patienterne PASI 75-respons ved henholdsvis uge 12 og 24.
English: It is important that you tell your baby's doctors and other health care professionals about your Imraldi use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Danish: Det er vigtigt, at du fortæller dit spædbarns læge og andre sundhedspersoner, at du fik Imraldi under graviditeten, før ditspæd barn får nogen vaccinationer (for mere information om vacciner, se afsnittet ”Advarsler og forsigtighedsregler”).
English: Week 26 Week 52 p value for Standard Dose versus Low Dose comparison 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion 3 Defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Danish: 2 Immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten opfyldte det kliniske respons-kriterium 3 Defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline-besøget
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Danish: 673 patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [BASDAI] var 7,0), som havde utilstrækkeligt respons på ≥ 2 NSAID, eller var intolerante over for eller havde en kontraindikation mod NSAID deltog i den åbne periode af studie nr-axSpA II, hvor de fik adalimumab
English: • increased lipids in the blood;
Danish: • forhøjede lipider i blodet;
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥3 × ULN occurred in 2.6 % (5/192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Danish: I fase 3-studiet med adalimumab hos patienter med pædiatrisk Crohns sygdom, der evaluerede effekten og sikkerheden af to vedligeholdelsesdosisregimer tilpasset legemsvægt (efter induktionsbehandling tilpasset legemsvægt) i op til 52 ugers behandling, forekom ALAT-stigninger ≥ 3 × ULN hos 2,6 % (5/192) af patienterne, hvoraf 4 havde fået samtidig behandling med immunsuppressiva ved baseline.
English: • leukaemia (cancer affecting the blood and bone marrow);
Danish: • leukæmi (kræft som påvirker blod og knoglemarv);
English: Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Danish: Figur 2 Kaplan-Meier-kurver, opsummerer tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: Very common Lipids increased Common
Danish: Meget almindelig Forhøjede leverenzymer
English: In Psoriasis studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15).
Danish: I Psoriasis-studierne I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75-respons i forhold til baseline ved uge 16 (se tabel 14 og 15).
English: Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Danish: Erythema multiforme1), Stevens-Johnsons syndrom1), angioødem1), kutan vaskulitis1), lichenoid hudreaktion1)
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Imraldi.
Danish: Fortæl din læge, hvis du får azathioprin eller mercaptopurin sammen med Imraldi.
English: It is important to tell your doctor if you have had or have a serious heart condition.
Danish: Det er vigtigt at informere lægen, hvis du har eller har haft en alvorlig hjertesygdom.
English: Clinical remission Clinical response
Danish: Klinisk remission Klinisk respons
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Danish: Hvis du har ankyloserende spondylitis eller aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis, vil du først få andre lægemidler.
English: • fever;
Danish: • feber;
English: The recommended Imraldi induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Danish: Det anbefalede Imraldi induktions-dosis-regime til voksne patienter med moderat til svær aktiv Crohns sygdom er 80 mg i uge 0 efterfulgt af 40 mg i uge 2.
English: Talk to your doctor or pharmacist before using Imraldi.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Imraldi.
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til < 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat.
English: Imraldi is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Danish: Imraldi bruges til behandling af Crohns sygdom hos børn i alderen 6-17 år.
English:  Avoid skin that's sore, bruised, scarred, scaly, or has red patches.
Danish:  Undgå hudområder, der er ømme, blåfarvede, arrede, skællende eller har røde pletter.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Imraldi therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Danish: Hvis du har reumatoid artrit og ikke får methotrexat i kombination med din Imraldi-behandling, kan lægen vælge at ordinere 40 mg adalimumab hver uge eller 80 mg hver anden uge.
English: Method and route of administration
Danish: Anvendelsesmåde og administrationsvej
English: • Tell your doctor if your child resides or travels in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic.
Danish: • Fortæl lægen, hvis dit barn har fast bopæl eller rejser i områder, hvor svampeinfektioner som histoplasmose, kokcidioidomykose eller blastomykose erudbredte.
English: Table 16 Ps Study IV Efficacy Results at 16, 26 and 52 Weeks
Danish: Tabel 16 Ps studie IV Effektresultater ved 16, 26 and 52 uger
English: Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in Period B.
Danish: Patienter, som var randomiseret til placebo i periode A, blev tildelt adalimumab 40 mg hver uge i periode B.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia, hyperglycaemia, hypophosphatemia, dehydration
Danish: Hypokaliæmi, forhøjet urinsyre, unormal blod-natrium, hypokalcæmi hyperglykæmi, hypofosfatæmi, dehydrering
English: • sicca syndrome (including dry eyes and dry mouth);
Danish: • Sjøgrens syndrom (inklusive tørre øjne og tør mund);
English: • Pull the needle package off, but DO NOT remove the clear needle cap.
Danish: • Tag emballagen af kanylen men fjern IKKE den klare kanylehætte.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and
Danish: PASI 75 og PGA clear eller minimal steg med stigende adalimumab-koncentration, begge med sammenlignelig tilsyneladende EC50 på omkring 4,5 μg/ml (henholdsvis 95% CI 0,4-47,6 og
English: • Do not give Imraldi to children with polyarticular juvenile idiopathic arthritis below the age of
Danish: • Giv ikke Imraldi til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Danish: RA-studie II evaluerede 544 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel.
English: 6 months 12 months a RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Danish: 12 måneder a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg adalimumab givet hver anden uge c MTX = methotrexat
English: Imraldi is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Danish: Imraldi bruges til at behandle Crohns sygdom hos voksne og børn i alderen 6-17 år.
English: • If your child has mild heart failure and is being treated with Imraldi, his/her heart failure status must be closely monitored by your doctor.
Danish: • Hvis dit barn har let hjertesvigt og bliver behandlet med Imraldi, skal status for dit barns hjertesvigt følges nøje af lægen.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system), and leukaemia (a cancer that affects the blood and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfom (kræft som påvirker lymfesystemt) og leukæmi (kræft som påvirker blod og knoglemarv).
English: DO NOT touch the vial stopper after wiping with the alcohol pad.
Danish: Rør IKKE ved hætteglassets prop efter den er tørret af med spritservietten.
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51 %) were in remission at week 52.
Danish: I studie UC-II var 21/41 (51 %) af de adalimumab-behandlede patienter, der var i remission i uge 8, også i remission i uge 52.
English: If these medicines do not work well enough, you will be given Imraldi to treat your rheumatoid arthritis.
Danish: Hvis disse lægemidler ikke har tilstrækkelig effekt, vil du få Imraldi til behandling af din reumatoide artrit.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Danish: Alvorlige infektioner, inklusive sepsis, forårsaget af bakterier, mykobakterier, invasive svampe, parasittereller virus eller andre opportunistiske infektioner såsom listeriose, legionellose og pneumocystis er blevet rapporteret hos patienter, som fik adalimumab.
English: 40 mg given every other week starting one week after the initial dose
Danish: 40 mg givet hver anden uge startende en uge efter den initiale dosis
English: Table 24 Time to Treatment Failure in Studies UV I and UV II
Danish: Tabel 24 Tid til behandlingssvigt i studie UV I og UV II
English: Table 14 Efficacy Response in Placebo-Controlled Study nr-axSpA I
Danish: Tabel 14 Effekt-respons i placebo-kontrolleret studie nr-axSpA I
English: Disease flare criteria were defined as a worsening of ≥30% from baseline in ≥3 of 6 Paediatric ACR core criteria, ≥2 active joints,
Danish: Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på > 30 % i ikke mere end 1 af de 6 kriterier.
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p<0.001) in the adalimumab group (at week 48).
Danish: Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ± 1,9 i adalimumab-gruppen (ved uge 48) (p < 0,001).
English: In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
Danish: PASI 75- og PGA clear eller minimal respons blev vedligeholdt i op til yderligere 52 uger uden nye sikkerhedsfund i den åbne del af studiet.
English: Children and adolescents with plaque psoriasis
Danish: Børn og unge med plaque psoriasis
English: • respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);
Danish: • luftvejsinfektioner (inklusive forkølelse, løbende næse, bihulebetændelse, lungebetændelse);
English: Time to Treatment Failure At or After Week 2 in Study UV II
Danish: Tid til behandlingssvigt i eller efter uge 2 i studie UV II
English: EU/1/17/1216/001 1 pre-filled syringe EU/1/17/1216/002 2 pre-filled syringes EU/1/17/1216/003 4 pre-filled syringes EU/1/17/1216/004 6 pre-filled syringes
Danish: EU/1/17/1216/001 1 fyldt injektionssprøjte EU/1/17/1216/002 2 fyldte injektionssprøjter EU/1/17/1216/003 4 fyldte injektionssprøjter EU/1/17/1216/004 6 fyldte injektionssprøjter
English: Based on the observed data approach, 222 (80.4 %) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 222 (80,4 %) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Danish: Tilgængelige data tyder på, at klinisk respons sædvanligvis opnås inden for 12 uger.
English: In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.
Danish: Der er ingen erfaring med behandling med adalimumab uden samtidig behandling med methotrexat ved pædiatrisk uveitis.
English:  < 40 kg: 20 mg every week  ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Danish: • ≥ 40 kg: 40 mg hver uge eller 80 mg hver anden uge Fortsat behandling skal overvejes nøje hos patienter, som ikke responderer inden for 12 uger.
English: No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 × ULN i fase 3-studier af adalimumab hos pædiatriske patienter med plaque-psoriasis.
English: Clinical remission Clinical response (CR-100) Patients in steroid-free remission for >=90 daysa
Danish: Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥ 90 dagea
English: Table 17 Efficacy Results at 12 Weeks, HS Studies I and II
Danish: Tabel 17 Effektresultater ved uge 12, HS-Studie I og II
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Imraldi.
Danish: • Hvis du har eller udvikler demyeliniserende sygdom (en sygdom, der angriber det isolerende lag omkring nerverne, såsom dissemineret sklerose), vil din læge afgøre om du skal have eller fortsætte med at få Imraldi.
English: PASI 75b PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimalc a MTX = methotrexat b p = 0,027; adalimumab 0,8 mg/kg versus MTX c p = 0,083; adalimumab 0,8 mg/kg versus MTX
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Danish: Adalimumab 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt-blinde placebo-kontrollerede studier med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Danish: I CD-studie I og CD-studie II blev der i uge 4 opnået statistisk signifikante forbedringer i total score i det sygdoms-specifikke inflammatorisk tarmsygdoms-spørgeskema (IBDQ) hos patienter randomiseret til adalimumab 80/40 mg og 160/80 mg sammenlignet med placebo, og i CD-studie III blev det også set ved uge 26 og 56 hos de adalimumab-behandlede-grupper sammenlignet med placebo-gruppen.
English: RA study IIIa**
Danish: RA-studie IIIa**
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Danish: Adalimumabs sikkerhed og virkning blev undersøgt i randomiserede, dobbeltblinde, placebokontrollerede studier og et åbent forlængelsesstudie hos voksne patienter med moderat til svær hidrosadenitis suppurativa (HS), som var intolerante, havde en kontraindikation eller et utilstrækkeligt respons på mindst 3 måneders forsøg med systemisk antibiotikabehandling.
English: Imraldi 40 mg solution for injection in pre-filled pen EU/1/17/1216/005
Danish: Imraldi 40 mg injektionsvæske, opløsning i fyldt pen EU/1/17/1216/005
English: • Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton.
Danish: • Tag en æske indeholdende en sprøjte, en hætteglasadapter, et hætteglas, to spritservietter og en kanyle ud af kartonen.
English: • hidradenitis suppurativa,
Danish: • hidrosadenitis suppurativa,
English: Table 21 Efficacy Results at 12 Weeks, HS Studies I and II
Danish: Tabel 21 Effektresultater ved uge 12, HS-Studie I og II
English: • Adults with non-infectious uveitis with inflammation affecting the back of the eye
Danish: • Voksne med ikke-infektiøs uveitis (regnbuehindebetændelse), som påvirker den bagerste del af øjet.
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Danish: Fortæl straks din læge, hvis du får symptomer som ændringer i dit syn, svaghed i arme eller ben eller følsesløshed eller en snurrende fornemmelse et sted i kroppen.
English: Patients demonstrating a Paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Danish: Patienter, der udviste pædiatrisk ACR 30-respons ved uge 16, var egnede til randomisering i den dobbeltblindede fase og fik enten adalimumab 24 mg/m2 op til maksimalt 40 mg eller placebo hver anden uge i yderligere 32 uger eller indtil opblussen af sygdommen.
English: Methotrexate should be continued during treatment with Imraldi.
Danish: Der fortsættes med methotrexat under behandling med Imraldi.
English: A 40 mg pre-filled pen and a 40 mg pre-filled syringe are also available for patients to administer a full 40 mg dose.
Danish: En 40 mg fyldt pen og en 40 mg fyldt injektionssprøjte er også tilgængelige til patienter til administration af en fuld dosis på 40 mg.