Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

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, in persons with impaired immune system and persons undergoing immunosuppressive therapy 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.

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