VacPertagen

5 mL should be administered. 6). 3 Paediatric population The safety, immunogenicity and efficacy of VacPertagen in children less than 12 years of age have not yet been established. No data are available. Method of administration VacPertagen should be administered only by intramuscular injection, preferably in the deltoid region.

This vaccine must not be administered intravascularly, intradermally or subcutaneously. The content of VacPertagen pre-filled syringe should be well shaken before use. If resuspension does not occur after vigorous shaking or foreign particles or discoloration are observed, the vaccine should not be used.

4%). The majority of the reactions were mild in severity and resolved within a few days of onset. Tabulated list of adverse reactions The safety of a single dose of VacPertagen was evaluated in 2 508 individuals 12 years of age and older including 150 adolescents, 2 318 non-pregnant adults and 40 pregnant women based on data from randomised controlled clinical trials (Table 1).

Adverse reactions are listed according to the following frequency categories:

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) 6 Adverse reactions reported are listed per system organ class. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Table 1:

Adverse reactions System organ class Frequency Adverse reactions Blood and lymphatic system disorders Common Lymphadenitis, lymphadenopathy Nervous system disorders Very common Headache Cardiac disorders Rare Palpitations Gastrointestinal disorders Very common Nausea Common Vomiting, diarrhoea, enteritis Skin and subcutaneous tissue disorders Common Rash, urticaria Musculoskeletal and connective tissue disorders Very common Myalgia, arthralgia General disorders and administration site conditions Very common Injection site pain, fatigue, malaise Common Injection site pruritus, injection site induration, injection site haematoma, chills, pyrexia Uncommon Injection site erythema, injection site swelling Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

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. Prior to immunisation Vaccination should be preceded by a review of the medical history, in particular adverse reactions after past vaccinations.

Pertussis containing-vaccine If any of the following events have occurred after administration of a pertussis-containing vaccine, the decision to administer further doses of a pertussis-containing vaccine should be carefully considered: • Temperature of ≥ 40 °C within 48 hours, not attributable to another identifiable cause • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination • Persistent crying lasting ≥ 3 hours, occurring within 48 hours of vaccination • Convulsions with or without fever, occurring within 3 days of vaccination.

There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh the possible risks. 4 Hypersensitivity and anaphylaxis As with all injectable vaccines, appropriate medical care should be readily available in case of an anaphylactic event following the administration of the vaccine.

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. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.

Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia).

1 or formaldehyde. Hypersensitivity after previous administration of VacPertagen or any other pertussis vaccine. Vaccination with this vaccine is contraindicated if an individual has experienced in the past a severe allergic reaction or any encephalopathy with unknown aetiology within 7 days following previous vaccination with a pertussis containing vaccine.

Pertussis vaccine should not be administered to individuals with neurological disorders or uncontrolled epilepsy until treatment for the condition has been established, the condition has stabilised, and the benefit of vaccination clearly outweighs the risk.