FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of systemic injection reactions (e.g. rash, pruritus, flushing and oedema) was 1.2 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 2.1 per 100 patient-years in the Remsima intravenous group who switched to Remsima subcutaneous administration (from Week 30).
Danish: Forekomsten af systemiske injektionsreaktioner (fx udslæt, kløe, rødme og ødem) var 1,2 pr. 100 patientår i gruppen med subkutan Remsima (fra uge 6) og 2,1 pr. 100 patientår i gruppen med intravenøs Remsima, der skiftede til subkutan administration af Remsima (fra uge 30).
English: Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions when administered by intravenous infusion.
Danish: Antistoffer over for infliximab kan udvikles og har været forbundet med en øget frekvens af infusionsreaktioner, når infliximab administreres ved intravenøs infusion.
English: • Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever had it.
Danish: • Fortæl din læge, før du bruger Remsima, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det.
English: The proportions of patients with mucosal healing at week 26 were significantly greater in the infliximab plus AZA combination (43.9%, p<0.001) and infliximab monotherapy groups (30.1%, p=0.023) compared to the AZA monotherapy group (16.5%).
Danish: Andelen af patienter med slimhindeheling i uge 26 var signifikant større i grupperne, der fik infliximab plus AZA (43,9 %; p < 0,001) eller infliximab-monoterapi (30,1 %; p=0,023) sammenlignet med AZA-monoterapigruppen (16,5 %).
English: • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
Danish: • Lungehindebetændelse, der giver skape brystsmerter, som forværres ved vejrtrækning (pleuritis)
English: In addition:
Danish: Derudover gælder, at
English: From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration.
Danish: Hvis tegn og symptomer på sygdom vender tilbage, viser erfaring med intravenøs infliximab at, infliximab kan readministreres inden for 16 uger efter den seneste administration.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol and infusion rate may be slowed in order to decrease the risk of infusion-related reactions especially if infusion-related reactions have occurred previously (see section 4.4).
Danish: Patienter kan præmedicineres med fx et antihistamin, hydrocortison og/eller paracetamol og infusionshastigheden kan reduceres for at nedsætte risikoen for infusionsrelaterede reaktioner, især hvis infusionsrelaterede reaktioner er set tidligere (se pkt.
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Danish: 5.1): anæmi (10,7 %), blod i afføringen (9,7 %), leukopeni (8,7 %), rødmen (8,7 %), viral infektion (7,8 %), neutropeni (6,8 %), bakteriel infektion (5,8 %) og allergisk reaktion i luftvejene (5,8 %).
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima.
Danish: Fortæl straks din læge, hvis du får nye eller forværrede tegn på hjertesvigt under behandlingen med Remsima.
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Danish: • Hævelse af leveren (hepatitis) eller galdeblæren, leverskade
English: Infliximab has been associated with systemic injection reactions, anaphylactic shock and delayed hypersensitivity reactions (see section 4.8).
Danish: Infliximab har været forbundet med systemiske injektionsreaktioner, anafylaktisk shock samt forsinkede overfølsomhedsreaktioner (se pkt.
English: Keep the medicinal product in its outer carton in order to protect from light.
Danish: Opbevar lægemidlet i den originale ydre karton for at beskytte mod lys.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating infliximab therapy.
Danish: Det anbefales, at pædiatriske patienter bliver vaccineret i overensstemmelse med gældende vaccinationsvejledninger, før Remsima-behandling påbegyndes, hvis dette er muligt.
English: If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C, unless reconstitution/dilution has been taken place in controlled and validated aseptic conditions.
Danish: Hvis infusionsvæsken ikke anvendes straks, er opbevaringstiderne og -betingelserne efter anbrud indtil anvendelse brugerens ansvar, og bør normalt ikke overskride 24 timer ved 2°C - 8°C med mindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold (se pkt.
English: Remove the cap (see Figure D).
Danish: Fjern hætten (se Figur D).
English: Remsima 120 mg solution for injection in pre-filled syringe or in pre-filled pen are administered by subcutaneous injection only.
Danish: Remsima 120 mg injektionsvæske, opløsning i fyldt injektionssprøjte eller i fyldt pen administreres udelukkende ved subkutan injektion.
English: If serious reactions occur, symptomatic treatment must be given and further infliximab must not be administered (see section 4.8).
Danish: Hvis alvorlige reaktioner opstår, skal symptomatisk behandling gives, og der må ikke gives yderligere infliximab (se pkt.
English: b. Lift the pen from the injection site (see Figure H).
Danish: b. Løft pennen fra injektionsstedet (se Figur H).
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia
Danish: Hjerteinsufficiens (debuterende eller forværret), arytmi, besvimelse, bradykardi.
English: The incidence of localised injection site reactions (e.g. injection site erythema, pain, pruritus and swelling) was 17.6 per 100 patient-years in the Remsima subcutaneous group (from Week 6) and 21.4 per 100 patient-years in those who switched to Remsima subcutaneous administration (from Week 30).
Danish: Forekomsten af reaktioner på injektionsstedet (fx rødme på injektionsstedet, smerter, kløe og hævelse) var 17,6 pr. 100 patientår i gruppen med subkutan Remsima (fra uge 6) og 21,4 pr. 100 patientår hos dem, der skiftede til subkutan administration af Remsima (fra uge 30).
English: Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment (see section 5.1).
Danish: Fortsat behandling bør revurderes nøje hos patienter, som ikke viser tegn på klinisk fordel inden for de første 12 ugers behandling (se pkt.
English: SC
Danish: SDc
English: • Do not reuse the pen.
Danish: • Pennen må ikke genbruges.
English: Patients randomised
Danish: Randomisere de patienter
English: Finish the injection (see Figure G).
Danish: Færdiggør injektionen (se Figur G).
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤10 mg/day) and/or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
Danish: I begge studier var samtidig brug af konstante doser af folinsyre, orale kortikosteroider (≤ 10 mg/dag) og/eller nonsteroide anti-inflammatoriske stoffer (NSAIDs) tilladt.
English: About the Remsima syringe Parts of the syringe (see Figure A):
Danish: Om Remsima injektionssprøjte Injektionssprøjtens dele (se Figur A):
English: Psoriatic arthritis Plaque psoriasis 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Danish: Ankyloser ende spondylitis Psoriasis arthritis Psoriasis 281 1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
English: The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs. 14.0%, p<0.001; and 20.2% vs. 6.6%, p<0.001, respectively).
Danish: Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximab-behandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37,9 % mod 14,0 %, p < 0,001 og 20,2 % mod 6,6 %, p < 0,001).
English: How to use Remsima
Danish: Sådan skal du bruge Remsima
English: At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p <0.001).
Danish: I uge 4 efter indgivelse af en enkelt dosis opnåede 22/27 (81 %) af de infliximab-behandlede patienter, der fik 5 mg/kg dosen en klinisk virkning mod 4/25 (16 %) af placebopatienterne (p < 0,001).
English: Inspect the syringe.
Danish: Inspicér injektionssprøjten.
English: 2 Number of patients evaluated for ALT. 3 Median follow-up is based on patients treated.
Danish: 3 Medianopfølgning er baseret på behandlede patienter.
English: Studies with infliximab have not been performed in patients with liver or renal disease.
Danish: Der er ikke udført studier med infliximab hos patienter med lever- eller nyresygdom.
English: Myocardial ischaemia/myocardial infarction
Danish: Myokardieiskæmi/myokardieinfarkt.
English: Infliximab Placebo 5 mg/kg 10 mg/kg Combined
Danish: Infliximab 5 mg/kg 10 mg/kg Kombineret
English: Remsima 120 mg injection infliximab
Danish: Remsima 120 mg injektionsvæske Infliximab
English: Rheumatoid arthritis1 1 Placebo patients received methotrexate while infliximab patients received both infliximab and methotrexate.
Danish: 1 Placebo-patienter fik methotrexat, mens infliximab-patienter fik både infliximab og methotrexat.
English: b CDAI <150 at both Week 30 and 54 and not receiving corticosteroids in the 3 months prior to
Danish: b CDAI < 150 ved både uge 30 og 54.
English: Remsima may be stored at temperatures up to a maximum of 25°C for a single period of up to 6 months, but not exceeding the original expiry date.
Danish: Remsima kan opbevares ved temperaturer på op til højst 25 °C i en enkelt periode på op til 6 måneder, men den oprindelige udløbsdato må ikke overskrides.
English: Choose an injection site (see Figure C).
Danish: Vælg et injektionssted (se Figur C).
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p<0.001 and 46.1% vs. 18.2%, p<0.001, respectively).
Danish: Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34,6 % mod 16,5 %, p < 0,001 og 46,1 % mod 18,2 %, p < 0,001).
English: What you need to know before you use Remsima You must not use Remsima if
Danish: Det skal du vide, før du begynder at bruge Remsima Du må ikke bruge Remsima hvis
English: Week 22 137 (78.7%) 139 (84.2%) 90 (51.7%) 85 (51.5%) 49 (28.2%) 46 (27.9%)
Danish: Uge 6 103 (59,2 %) 107 (64,8 %) 45 (25,9 %) 47 (28,5 %) 18 (10,3 %) 19 (11,5 %) Uge 22 137 (78,7 %) 139 (84,2 %) 90 (51,7 %) 85 (51,5 %) 49 (28,2 %) 46 (27,9 %) Uge 54 125 (71,8 %)a 132 (80,0 %) 101 (58,0 %)a 108 (65,5 %) 68 (39,1 %)a 77 (46,7 %)
English: The pharmacokinetics of infliximab injected via subcutaneous route in elderly patients has not been studied.
Danish: Farmakokinetikken af infliximab injiceret subkutant hos ældre patienter er ikke undersøgt.
English: Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled pen.
Danish: Remsima er en klar til opaliserende, farveløs til lysebrun opløsning, som leveres som en fyldt pen til éngangsbrug.
English: Doing so may result in a needle stick injury.
Danish: Dette kan forårsage en kanylestikskade.
English: Do not recycle the injecting device.
Danish: Injektionsanordningen må ikke genbruges.
English: In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: "Infusion reactions and hypersensitivity").
Danish: Hos psoriasis patienter behandlet med infliximab som vedligeholdelsesbehandling uden samtidige immunmodulerende midler udviklede 28 % antistoffer mod infliximab (se pkt.
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Danish: Sikkerhed og virkning ved fornyet administration, udover hver 8. uge, er ikke klarlagt (se pkt.
English: • Some patients receiving infliximab have developed serious liver problems.
Danish: • Nogle patienter, der får Remsima, har udviklet alvorlige leverproblemer.
English: Endophthalmitis
Danish: Endoftalmitis.
English: • Tell your doctor before you are given Remsima if you are a carrier of hepatitis B or have ever had it.
Danish: • Fortæl din læge, før du får Remsima, hvis du er bærer af hepatitis B, eller hvis du nogensinde har haft det.
English: Do not recap the pen.
Danish: Du må ikke sætte hætten tilbage på pennen.
English: Placebo Maintenance (n=99)
Danish: ACCENT II (uge-14 responderende) Placebo Vedligeholdelse (n=99)
English: • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
Danish: • Andre hudproblemer såsom erythema multiforme, blærer og afskalning af huden eller bylder (furunkulose)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR PRE-FILLED PEN
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FYLDT PEN
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥220 ≤450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Danish: Infliximab med eller uden AZA blev vurderet i et randomiseret, dobbeltblindet studie med aktiv komparator (SONIC) hos 508 voksne patienter med moderat til svær Crohns sygdom (CDAI ≥ 220 ≤ 450).
English: • When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima.
Danish: • Behold det gamle kort som reference i 4 måneder efter din sidste Remsima-dosis, når du starter på et nyt kort.
English: Inspect the medicine (see Figure B).
Danish: Inspicér medicinen (se Figur B).
English: Consult your healthcare provider if you have questions about using the Remsima syringe.
Danish: Kontakt sundhedspersonalet, hvis du har spørgsmål om brug af Remsima injektionssprøjte.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med referencelægemidlet, som indeholder infliximab, i alle undergrupper af den pædiatriske population med reumatoid arthritis, juvenil idiopatisk arthritis, psoriasis arthritis, ankyloserende spondylitis og psoriasis (se pkt.
English: Remsima is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: Remsima er indiceret til behandling af moderat til svær, aktiv colitis ulcerosa hos voksne patienter, som har haft utilstrækkelig respons af konventionel behandling inklusive kortikosteroider og 6-mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kliniske kontraindikationer for sådanne behandlinger.
English: • Syringe
Danish: • Leversvigt
English: Other medicines and Remsima
Danish: Brug af anden medicin sammen med Remsima
English: Excipients: sucrose, polysorbate 80, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate.
Danish: Hjælpestoffer: Saccharose, polysorbat 80, natriumdihydrogen-phosphatmonohydrat og dinatriumphosphatdihydrat.
English: • Side effect due to an injection
Danish: • Bivirkninger i forbindelse med injektion
English: How to use Remsima Rheumatoid arthritis
Danish: Sådan skal du bruge Remsima Reumatoid arthritis
English: What you need to know before you use Remsima You must not be given Remsima if
Danish: Det skal du vide, før du begynder at bruge Remsima Du må ikke få Remsima hvis
English: The efficacy of infliximab intravenous formulation was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Danish: Virkningen af infliximab intravenøs formulering blev vurderet i to multicenter, randomiserede, dobbeltblindede, pivotale kliniske studier: ATTRACT og ASPIRE.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Danish: Patienter i gruppe 2, som havde en BASDAI ≥ 3 ved 2 på hinanden følgende konsultationer, fik 7,5 mg/kg infliximab hver 6. uge startende med uge 36 og frem til uge 96.
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Danish: • Tegn på lave blodtal såsom vedvarende feber, øget tendens til at få blå mærker eller til at bløde, små røde eller lilla pletter, der skyldes blødning under huden, eller bleghed.
English: Peripheral ischaemia, thrombophlebitis, haematoma
Danish: Perifer iskæmi, tromboflebitis, hæmatom.
English: Pack sizes of 1, 2, 3, 4, 5 vials.
Danish: Remsima findes i pakninger med 1, 2, 3, 4 eller 5 hætteglas.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima.
Danish: Hvis du er i tvivl, om noget af ovenstående gælder for dig, skal du tale med din læge, apotekspersonalet eller sygeplejersken, før du får Remsima.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL FOR PRE-FILLED SYRINGE WITH AUTOMATIC NEEDLE GUARD
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER ETIKET TIL FYLDT INJEKTIONSSPRØJTE MED AUTOMATISK KANYLEBESKYTTELSE
English: Remsima is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies.
Danish: Remsima er indiceret til behandling af svær, aktiv Crohns sygdom hos børn og unge mellem 6 og 17 år, som ikke har responderet på konventionel behandling inklusive kortikosteroid, immunmodulator og primær ernæringsbehandling, eller som er intolerante over for eller hvor der er kontraindikationer mod sådanne behandlinger.
English: Discontinuation of infliximab therapy should be considered in patients with confirmed significant haematologic abnormalities.
Danish: Seponering af Remsima-behandling bør overvejes hos patienter, hvor signifikante blodanormaliteter er bekræftet.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab intravenous administration (see section 4.4).
Danish: Efter markedsføring er tilfælde af anafylaktisk lignende reaktioner, inklusive strube/spiserørs ødemer og alvorlige bronkospasmer samt kramper blevet forbundet med intravenøs administration af infliximab (se pkt.
English: Note: Keep the pen and sharps disposal container out of the sight and reach of children.
Danish: Bemærk: Opbevar pennen og beholderen til skarpe genstande utilgængeligt for børn.
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remsima therapy.
Danish: Det anbefales, at patienterne, om muligt, bringes up to date med alle vaccinationer i overensstemmelse med gældende vaccinationsvejledninger før initiering af behandling med Remsima, Patienter, der får infliximab, kan få vaccinationer samtidigt, med undtagelse af levende vacciner (se pkt.
English: Powder for concentrate for solution for infusion (powder for concentrate) The powder is white.
Danish: Pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat).
English: “click” and the olive green plunger rod will begin to fill the window.
Danish: Bemærk: Når injektionen begynder, hører du det første høje ”klik” og den olivengrønne stempelstang begynder at fylde vinduet.
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Danish: Efter infliximab-behandling udviste patienter nedsat niveau af serum interleukin 6 (IL-6) og C-reaktivt protein (CRP).
English: Localised injection site reactions predominantly of mild to moderate in nature included the following reactions limited to injection site: erythema, pain, pruritus, swelling, induration, haematoma, oedema, bruising, coldness, irritation, paraesthesia, ulcer, urticaria, haemorrhage, rash and scab were reported to be associated with infliximab subcutaneous treatment.
Danish: Lokaliserede reaktioner på injektionsstedet, overvejende lette til moderate, omfattede følgende reaktioner begrænset til injektionsstedet: erytem, smerter, kløe, hævelse, induration, hæmatom, ødem, blå mærker, kulde, irritation, paræstesi, sår, urticaria, blødning, udslæt og sårskorpe rapporteredes at være forbundet med infliximab subkutan behandling.
English: Week 54 among patients who were receiving corticosteroids at baseline.
Danish: De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
English: The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies: ATTRACT and ASPIRE.
Danish: Virkningen af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblindede, pivotale kliniske studier: ATTRACT og ASPIRE.
English: • Adhesive bandage*
Danish: • Plaster*
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis
Danish: Nedre luftvejsinfektion (fx bronchitis, pneumoni), dyspnø, næseblod.
English: Patients received either 3 or 5 mg/kg infliximab or placebo infusions at weeks 0, 2 and 6.
Danish: Patienterne fik enten 3 eller 5 mg/kg infliximab eller placeboinfusioner i uge 0, 2 og 6.
English: EU/1/13/853/006 1 pre-filled syringe EU/1/13/853/009 1 pre-filled syringe with automatic needle guard EU/1/13/853/007 2 pre-filled syringes EU/1/13/853/010 2 pre-filled syringes with automatic needle guard EU/1/13/853/008 4 pre-filled syringes EU/1/13/853/011 4 pre-filled syringes with automatic needle guard
Danish: EU/1/13/853/006 1 fyldt injektionssprøjte EU/1/13/853/009 1 fyldt injektionssprøjte med automatisk kanylebeskyttelse EU/1/13/853/007 2 fyldte injektionssprøjter EU/1/13/853/010 2 fyldte injektionssprøjter med automatisk kanylebeskyttelse EU/1/13/853/008 4 fyldte injektionssprøjter EU/1/13/853/011 4 fyldte injektionssprøjter med automatisk kanylebeskyttelse
English: Remsima 100 mg powder for concentrate infliximab
Danish: Remsima 100 mg pulver til koncentrat infliximab i.v.