VARILRIX VACCINE [SIN09001P]

Product Info

VARILRIX VACCINE

[SIN09001P]

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.

Dosage and Administration

Powder and solvent for solution for injection

0.5 ml of reconstituted vaccine contains one immunising dose.

Posology

The immunisation schedules for VARILRIX should be based on official recommendations.

Healthy individuals

• Children 12 months up to and including 12 years of age
  Children from the age of 12 months up to and including 12 years of age should receive 2 doses of VARILRIX to ensure optimal protection against varicella (see “Pharmacodynamics” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

  It is preferable to administer the second dose at least 6 weeks after the first dose but in no circumstances less than 4 weeks.

  [Note: Applicable official recommendations may vary regarding the interval between doses and the need for one or two doses of varicella-containing vaccines in children aged 12 months to 12 years].

• Adolescents and adults from 13 years of age and above
  From 13 years of age and above: 2 doses.
  It is preferable to administer the second dose at least 6 weeks after the first dose but in no circumstances less than 4 weeks.

Individuals at high risk of severe varicella

The same schedule described for healthy individuals should be applied for individuals at high-risk of severe varicella (see “Pharmacodynamic effects” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
In these individuals, periodic measurement of varicella antibodies after vaccination may be indicated in order to identify those who may benefit from re-vaccination. Under no circumstances should the interval between the doses be less than 4 weeks.

Interchangeability

• A single dose of VARILRIX may be administered to those who have already received a single dose of another varicella-containing vaccine.

• A single dose of VARILRIX may be administered followed by a single dose of another varicella-containing vaccine.

Method of administration

VARILRIX is to be injected subcutaneously (SC) or intramuscularly (IM) in the deltoid region or in the anterolateral area of the thigh.

VARILRIX should be administered subcutaneously in individuals with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder).

For instructions on reconstitution of the medicinal product before administration, see “Use and Handling” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

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).