This medicinal product is subject to additional monitoring. Name: SIILTIBCY (0.5 microgram + 0.5 microgram)/mL solution for injection Mycobacterium tuberculosis derived antigens (rdESAT 6 and rCFP 10). Pharmaceutical form and composition: One dose (0.1 mL) contains 0.05 microgram of rdESAT 6* and 0.05 microgram of rCFP 10**. *Recombinant dimer of Mycobacterium tuberculosis early secretory antigenic target1; **Recombinant culture filtrate protein of Mycobacterium tuberculosis1; 1Produced in Lactococcus lactis cells. Multidose vial. One vial (1 mL) contains 10 doses of 0.1 mL. Therapeutic indication: SIILTIBCY is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. This medicinal product is for diagnostic use only. Posology and method of administration: Posology The dose is 0.1 mL of SIILTIBCY. Method of administration SIILTIBCY should be prepared and administered via intradermal injection by healthcare professionals trained for the Mantoux technique. The medicinal product should be administered with adequate hygiene of the hands and using aseptic technique, as follows: Withdraw 0.1 mL of SIILTIBCY using a 1 mL syringe with a short bevel needle. Before drawing SIILTIBCY from the multidose vial, expel any air from the syringe. If the vial was already opened, swab it with an alcohol swab and let it dry before use; Administer the 0.1 mL of SIILTIBCY intradermally in the middle-third of the forearm using the Mantoux technique. Therefore, stretch the skin slightly and hold the needle almost parallel to the skin surface with the bevel upwards. Insert the tip of the needle into the superficial layer of the dermis. Make sure the needle is visible through the epidermis during the injection. Do not apply the test in areas of scars, rashes, burn or tattoos; Inject the drawn 0.1 mL solution slowly. A small-blanched papule of 8-10 millimetres (mm) in diameter will appear, which should disappear after about 10 minutes. If the papule does not appear, repeat a new injection of 0.1 mL of SIILTIBCY on the other arm or on the same arm at least 4 cm away from the first injection site. The induration is measured 48 to 72 hours after the injection by a trained healthcare professional. Measure the diameter of the induration transversely to the long axis of the forearm with a ruler. To allow ease with measurement, a flexible (or easily bendable) ruler is suggested. An induration of ≥ 5 mm is considered as a positive test result, which indicates infection with Mycobacterium tuberculosis. Contra-indications: Hypersensitivity to the active substances or to any of the excipients disodium hydrogen phosphate dihydrate (E339), potassium dihydrogen orthophosphate (E340), potassium chloride (E508), sodium chloride, polysorbate 20 (E432) and phenol. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis derived products. Special warnings and precautions for use: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. General recommendations: Anaphylaxis Anaphylactic or other allergic type reactions are possible following administration of SIILTIBCY. Appropriate equipment for management of such reactions should always be available during the conduct of the test. Close observation for at least 15 minutes is recommended following the test. Route of administration Adherence to the Mantoux technique when administering SIILTIBCY is essential for obtaining reliable results, therefore avoid subcutaneous or intramuscular injection. Special populations The reactivity to SIILTIBCY can be lower or give false negative results in immunocompromised individuals, including those receiving immunosuppressant therapy and human immunodeficiency virus (HIV) positive individuals if cluster of differentiation 4 positive (CD4+) thymus cell (T cell) count is < 100 T cells/mm3. A positive test result indicates infection with Mycobacterium tuberculosis regardless of the CD4+ T cell count.  There may be an increased risk of false-negative results in the elderly population due to immunosenescence with age. Previous exposure to non-tuberculous mycobacteria SIILTIBCY does not identify subjects with previous exposure to non-tuberculous mycobacteria as well as those who received Bacillus Calmette-Guérin vaccine or therapy, and thus use for this purpose is not appropriate. Diagnosis of active tuberculosis SIILTIBCY cannot be used as stand-alone tool for diagnosis of active tuberculosis disease. In addition, risk assessment, radiography, and other diagnostic evaluations should be considered for subjects suspected to have active tuberculosis. Excipients This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. This medicinal product contains 0.011 mg of polysorbate 20 in each dose, which is equivalent to 0.11 mg/mL. Polysorbates may cause allergic reactions. Undesirable effects: Very common (≥ 1/10): Injection site pruritus. Common (≥ 1/100 to < 1/10): Headache, Injection site haematoma, Injection site vesicles, Injection site induration, Injection site swelling, Injection site pain, Injection site rash, Injection site erythema. Uncommon (≥ 1/1 000 to < 1/100): Gastroenteritis, Lymphadenopathy, Dizziness, Diarrhoea, Nausea, Rash, Pruritus, Pain in extremity, Injection site ulcer, Injection site haemorrhage, Pyrexia, Malaise, Fatigue, Injection site discolouration, Pain, Influenza-like illness. Rare (≥ 1/10 000 to < 1/1 000): Lymphadenitis, Eosinophilia, Head discomfort, Paraesthesia, Vomiting, Hepatitis, Jaundice, Transaminases increased, Night sweats, Urticaria, Myalgia, Arthritis, Axillary pain, Injection site inflammation, Injection site urticaria, Injection site nodule, Injection site papule, Chills, Injection site hypoaesthesia. Pharmacotherapeutic group: Tuberculosis diagnostics ATC code: V04CF Full product information: for the full product information, please consult the SmPC on www.ema.europa.eu. Date: March 2025. Marketing Authorisation Holder: Serum Life Science Europe GmbH, Ahrensburger Str. 1, 30659 Hannover, Germany, +49 511 169 90 80. For other information, Bilthoven Biologicals BV, PO Box 457, 3720 AL Bilthoven, The Netherlands, +31 (0)30 – 800 4800, info@bbio.nl. STBCY/EU/004-3/2025