Imvanex · 4.6 Fertility, pregnancy and lactation · 1

HOS-216244 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The safety of IMVANEX has been assessed in 22 clinical trials (21 completed and 1 ongoing clinical trial [POX-MVA-045]) in which more than 6 000 vaccinia-naïve individuals received two doses of no less than 5 x 107 Inf.U four weeks apart while 534 vaccinia- and IMVANEX-experienced individuals received a single booster dose. The most common adverse reactions observed in clinical trials were injection site reactions and common systemic reactions typical for vaccines which were mild to moderate in intensity and resolved without intervention within seven days following vaccination. Adverse reaction rates reported after either vaccination dose (1st, 2nd or booster) were similar. Tabulated list of adverse reactions Adverse reactions from all clinical trials 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) Unknown (cannot be estimated from the available data) Table 1 Adverse reactions reported in clinical trials (N = 7 992 subjects) and post-authorisation experience with IMVANEX MedDRA Very Common Uncommon Rare Unknown System Organ common (≥1/100 to (≥1/1 000 to (≥1/10 000 to (cannot be Class (≥1/10) <1/10) <1/100) <1/1 000) estimated from the available data) Infections and - - Nasopharyngitis Sinusitis - infestations Upper respiratory Influenza tract infection Conjunctivitis Pharyngitis Blood and - - Lymphadenopathy - - lymphatic system disorders Metabolism and - Appetite disorder - Decreased - nutrition appetite disorders Psychiatric - - Sleep disorder - - disorders

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HOS-216240 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or trace residues (chicken protein, benzonase, gentamicin and ciprofloxacin).

HOS-216239 · has-indication-information · PDF-Seite 2

Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 2 years of age and older (see sections 4.4 and 5.1). The use of this vaccine should be in accordance with official recommendations.

HOS-216242 · has-interaction-information · PDF-Seite 4

No interaction studies with other vaccines or medicinal products have been performed. Therefore, concomitant administration of IMVANEX with other vaccines should be avoided. The concomitant administration of the vaccine with any immunoglobulin including vaccinia immune globulin (VIG) has not been studied and should be avoided.

HOS-216243 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are limited data (less than 300 pregnancy outcomes) from the use of IMVANEX in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of IMVANEX during pregnancy. Administration of IMVANEX in pregnancy should only be considered when the potential benefits outweigh any potential risk to the mother and foetus. Breast-feeding It is not known whether IMVANEX is excreted in human milk. As a precautionary measure, it is preferable to avoid the use of IMVANEX during breast-feeding. Administration of IMVANEX during breast-feeding should only be considered when the potential benefits outweigh any potential risks to the mother and baby. Fertility Animal studies did not reveal any evidence of impaired female and male fertility.

HOS-216241 · has-warning-information · PDF-Seite 3

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. Hypersensitivity and anaphylaxis As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine. Concurrent illness Immunisation should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not result in the deferral of vaccination. General recommendations IMVANEX should not be administered by intravascular injection. Limitations of vaccine effectiveness The protective efficacy of IMVANEX against smallpox, monkeypox, and disease caused by vaccinia virus has not been studied in humans, see section 5.1. A protective immune response may not be elicited in all vaccinees. There are inadequate data to determine the appropriate timing of booster doses. Prior vaccination with IMVANEX may modify the cutaneous response (‘take’) to subsequently administered replication-competent smallpox vaccine resulting in a reduced or absent take, see section 5.1. 3 Individuals with atopic dermatitis Individuals with atopic dermatitis developed more local and systemic symptoms after vaccination (see section 4.8) Immunocompromised individuals Data have been generated in HIV infected individuals with CD4 counts ≥ 100 cells/µl and ≤ 750 cells/µl. Lower immune response data have been observed in HIV infected individuals compared to healthy individuals (see section 5.1). There are no data on the immune response to IMVANEX in other immunosuppressed individuals. Two doses of IMVANEX given at a 7-day interval showed lower immune responses and slightly more local reactogenicity than two doses given at a 28-day interval. Therefore, dose intervals of less than 28 days should be avoided. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ’sodium-f

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