TICOVAC Suspension for injection in a pre-filled syringe Ref.[27959] Active ingredients: Encephalitis, tick borne

As with all vaccines that are administered by injection, appropriate emergency treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Non-severe allergy to egg protein does not usually constitute a contraindication to vaccination with TicoVac 0.5 ml. Nevertheless, such persons should only be vaccinated under appropriate supervision and facilities for emergency management of hypersensitivity reactions should be available.

The levels of potassium and sodium are at less than 1 mmol per dose, i.e., essentially “potassium and sodium-free”.

Intravascular administration must be avoided as this might lead to severe reactions, including hypersensitivity reactions with shock.

The recommended route of administration is intramuscular. However, this may not be appropriate in subjects with a bleeding disorder or subjects receiving prophylactic anticoagulation. Limited data in healthy adults suggest comparable immune response for subcutaneous booster vaccinations when compared to intramuscular booster vaccinations. However, subcutaneous administration might lead to an increased risk for local adverse reactions. No data are available for subjects 60 years of age and older. Furthermore, no data are available for primary immunisation via the subcutaneous route.

A protective immune response may not be elicited in persons undergoing immunosuppressive therapy.

Whenever serological testing is considered necessary in order to determine the need for sequential doses, assays should be performed in an experienced, qualified laboratory. This is because cross reactivity with pre-existing antibodies due to natural exposure or previous vaccination against other flaviviruses (e.g. Japanese encephalitis, Yellow fever, Dengue virus) may give false positive results.

In case of a known or suspected auto-immune disease in the intended recipient, the risk of TBE infection must be weighed against the risk that TicoVac 0.5 ml might have an adverse effect on the course of the auto-immune disease.

Caution is required when considering the need for vaccination in persons with pre-existing cerebral disorders such as active demyelinating disorders or poorly controlled epilepsy.

There is no data concerning post exposure prophylaxis with TicoVac 0.5 ml.

As with all vaccines, TicoVac 0.5 ml may not completely protect all vaccinees against the infection that it is intended to prevent. For details on product administration in persons 60 years of age and older and persons with impaired immune system please see section 4.2.

Tick bites may transmit infections other than TBE, including certain pathogens that can sometimes cause a clinical picture that resembles tick-borne encephalitis. TBE vaccines do not provide protection against Borrelia infection. Therefore, the appearance of clinical signs and symptoms of possible TBE infection in a vaccinee should be thoroughly investigated for the possibility of alternative causes.

No interaction studies with other vaccines or medicinal products have been performed. The administration of other vaccines at the same time as TicoVac 0.5 ml should be performed only in accordance with official recommendations. If other injectable vaccines are to be given at the same time, administrations should be into separate sites and, preferably, into separate limbs.

Pregnancy

There are no data from the use of TicoVac 0.5 ml in pregnant women.

Breast-feeding

It is unknown whether TicoVac 0.5 ml is excreted in human milk.

Therefore, TicoVac 0.5 ml should only be administered during pregnancy and to breastfeeding women when it is considered urgent to achieve protection against TBE infection and after careful consideration of the risk-benefit relationship.

TicoVac 0.5 ml is unlikely to affect a person’s ability to drive and use machines. It should be taken into account, however, that impaired vision or dizziness may occur.

The frequencies provided in the table below are per vaccination and have been calculated based on a pooled analysis of adverse reactions from 7 clinical studies conducted with TicoVac 0.5 mL (2.4 µg) in subjects aged 16 through 65 years receiving 3 vaccinations (3512 subjects after the first vaccination, 3477 after the second vaccination, and 3274 after the third vaccination).

The ADRs listed in this section are given according to the recommended frequency convention:

Adverse Reactions from clinical trials:

Adverse reactions from post-marketing surveillance:

The following additional adverse reactions have been reported in post-marketing experience.

^* The upper limit of the 95% confidence interval of the event frequency is calculated with 3/n, with n representing the number of subjects included in all clinical trials with TicoVac 0.5 ml. Therefore, the calculated frequency “rare” represents the theoretical maximum frequency for these events

In a small comparative study on the immune response after intramuscular and subcutaneous administration of TicoVac in healthy adults, the subcutaneous route led to a higher local reactogenicity profile, particularly in women.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

¹ The frequency of vertigo is based on the rate reported after the first vaccination (n=3512). Vertigo was not reported after the second or third vaccinations.

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.