VARILRIX VACCINE

**Indications** Healthy subjects VARILRIX is indicated for active immunisation against varicella of healthy subjects from the age of 12 months onwards. High-risk patients and healthy close contacts VARILRIX is also indicated for active immunisation against varicella of susceptible high-risk patients and their susceptible healthy close contacts. _Patients with acute leukaemia_ Patients suffering from leukaemia have been recognised to be at special risk when they develop varicella, and should receive vaccine if they have no history of the disease or are found to be seronegative. When immunising patients in the acute phase of leukaemia, maintenance chemotherapy should be withheld one week before and one week after immunisation. Patients under radiotherapy should normally not be immunised during the treatment phase. _Patients under immunosuppressive treatment_ Patients under immunosuppressive treatment (including corticosteroid therapy) for malignant solid tumour or for serious chronic diseases (such as chronic renal failure, auto-immune diseases, collagen diseases, severe bronchial asthma) are predisposed to severe varicella. Generally, patients are immunised when they are in complete haematological remission from the disease. It is advised that the total lymphocyte count should be at least 1,200 per mm3 or no other evidence of lack of cellular immune competence exists. _Patients with planned organ transplantation_ If organ transplantation (e.g., kidney transplant) is being considered, immunisation should be carried out a few weeks before the administration of the immunosuppressive treatment. _Patients with chronic diseases_ Other chronic diseases, such as metabolic and endocrine disorders, chronic pulmonary and cardiovascular diseases, mucoviscidosis and neuromuscular abnormalities may also predispose to severe varicella. _Healthy close contacts_ Susceptible healthy close contacts should be immunised in order to reduce the risk of transmission of virus to high-risk patients. These include parents and siblings of high-risk patients, medical, paramedical personnel and other people who are in close contact with varicella patients or high-risk patients.

**Contraindications** VARILRIX is contraindicated in individuals with severe humoral or cellular immunodeficiency such as: - patients with primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3; - patients presenting other evidence of lack of cellular immune competence (e.g., patients with leukaemias, lymphomas, blood dyscrasias, clinically manifest HIV infection); - patients receiving immunosuppressive therapy including high dose of corticosteroids. See also “ _Warnings and Precautions_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. VARILRIX is contraindicated in individuals with known hypersensitivity to neomycin, or to any other component of the vaccine (see “ _Qualitative and Quantitative Composition_” and “ _List of Excipients_” – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), or to any other varicella vaccine. VARILRIX is contraindicated in individuals having shown signs of hypersensitivity after previous administration of varicella vaccine. VARILRIX is contraindicated in pregnant women. Pregnancy should be avoided for one month after vaccination (see _“Pregnancy”_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

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