REMSIMA 40mg / ml concentrate for solution for infusion medication leaflet

L04AB02 infliximab • Antineoplastic and immunomodulating agents | Immunosuppressants | Tumor necrosis factor alpha (tnf-alpha) inhibitors

Infliximab is a monoclonal antibody used to treat autoimmune inflammatory diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, or ankylosing spondylitis. It works by blocking tumor necrosis factor-alpha (TNF-α), reducing inflammation and associated symptoms.

The medication is administered intravenously under the supervision of a specialist, usually at regular intervals.

Side effects may include infusion site reactions, infections, headaches, or fatigue. In rare cases, severe allergic reactions or serious infections may occur.

Patients should be closely monitored during treatment and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should consult a specialist before use.

General data about REMSIMA 40mg / ml

Substance: infliximab

Date of last drug list: 01-04-2026

Commercial code: W71779001

Concentration: 40mg / ml

Pharmaceutical form: concentrate for solution for infusion

Quantity: 1

Product type: generic

Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

Manufacturer: NUVISAN GMBH - GERMANIA

Holder: CELLTRION HEALTHCARE HUNGARY KFT. - UNGARIA

Number: 853/2013/18

Shelf life: 30 months

Concentrations available for infliximab

100mg, 120mg/ml, 40mg/ml