Siiltibcy

HOS-100656 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile 5 The safety profile presented below is based on data obtained from 7 clinical trials (TESEC-01 to TESEC-07), where SIILTIBCY was administered to 2 960 subjects (aged 32 days to 76 years) (Table 1). The most common adverse reactions were injection site pruritus (20%), injection site pain (8%) and injection site hematoma (6%). Tabulated list of adverse reactions Adverse reactions reported are listed according to the following frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000) and not known (cannot be estimated from the available data). Adverse drug reactions (ADRs) are organised by MedDRA System Organ Class (SOC). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1: Adverse reactions reported with SIILTIBCY (infants, children, adolescents and adults combined) System organ class Frequency Adverse reactions category Infections and infestations Uncommon Gastroenteritis Blood and lymphatic system disorders Uncommon Lymphadenopathy Rare Lymphadenitis Eosinophilia Nervous system disorders Common Headache Uncommon Dizziness Rare Head discomfort Paraesthesia Gastrointestinal disorders Uncommon Diarrhoea Nausea Rare Vomiting Hepatobiliary disorders Rare Hepatitis Jaundice Transaminases increased Skin and subcutaneous tissue disorders Uncommon Rash

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100652 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis derived products.

HOS-100651 · has-indication-information · PDF-Seite 2

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.

HOS-100654 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Similar to other Mycobacterium tuberculosis skin tests, reactivity to SIILTIBCY may be decreased in persons who are receiving corticosteroids or immunosuppressive agents. Reduced reactivity may be observed when SIILTIBCY is used after vaccination with live vaccines (e.g. vaccines against measles, mumps and rubella). This decreased reactivity may result in false- negative reactions. Therefore, SIILTIBCY should be administered either before or at the same time of the vaccination or should be postponed for 4 weeks after vaccination. Regardless of the concomitant use of other medicinal products a positive test result indicates infection with Mycobacterium tuberculosis.

HOS-100655 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no or limited data from the use of SIILTIBCY in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). No effects during pregnancy are anticipated, since systemic exposure to SIILTIBCY is negligible. SIILTIBCY can be used during pregnancy. Breast-feeding No effects on the breast-fed newborns/infants are anticipated since the systemic exposure of the breast-feeding mother to SIILTIBCY is negligible. The skin test can be carried out during breast-feeding. Fertility No animal studies have been conducted on the effects of SIILTIBCY on fertility. Considering the negligible human systemic exposure to SIILTIBCY, no effects on fertility in male and female subjects is anticipated.

HOS-100653 · has-warning-information · PDF-Seite 4

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 4 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.