ANTHRAX VACCINE (ALUM PRECIPITATED STERILE FILTRATE) - summary of medicine characteristics

Anthrax Vaccine (Alum precipitated sterile filtrate)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Anthrax antigens (Alum precipitated sterile filtrate): not less than 0.125mL per 0.5mL dose.

Aluminium potassium sulphate: 7.0 mg per 0.5mL dose (Equivalent to aluminium 0.4 mg per 0.5mL dose).

3 PHARMACEUTICAL FORM

Suspension for injection

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For prophylaxis in circumstances where exposure to Bacillus anthracis may be expected or anticipated.

4.2 Posology and method of administration

Posology

Primary immunisation: Four doses each 0.5ml

The first three doses should be administered at intervals of three weeks. The fourth dose should follow some six months after the third.

Booster injection: One dose of 0.5ml administered annually.

There is no evidence on which to recommend a different dose or doses for children or the elderly, although the vaccine will rarely be administered to these groups.

In cases where one or more of the recommended doses has been missed, it is recommended that expert advice is sought and/or official guidance is consulted regarding the appropriate dose regimen that should be followed in order to provide protection.

Method of Administration

Anthrax Vaccine should be administered by intramuscular injection, preferably into the deltoid muscle.

4.3 Contraindications Previous hypersensitivity reaction to an anthrax vaccine.

Known hypersensitivity to any of the ingredients in Anthrax Vaccine.

Vaccination should be postponed in subjects suffering from an acute severe febrile illness unless it is considered urgent to protect the individual. The presence of a minor infection is not a contra-indication for vaccination.

4.4 Special warnings and precautions for use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

Anthrax Vaccine contains thiomersal as a preservative, which may elicit hypersensitivity reactions. Anthrax vaccine must not be administered to subjects who are known to be hypersensitive to thiomersal (see sections 4.3 and 6.1).

In subjects with an impaired immune system, an adequate immune response may not be obtained. If possible, vaccination should be delayed until the completion of any immunosuppressive treatment. Subjects with chronic immunodeficiency may be vaccinated but the immune response may be impaired.

As with any vaccine, a protective immune response may not be elicited in all vaccinees.

4.5 Interaction with other medicinal products and other forms of interaction Anthrax Vaccine must not be mixed with any other vaccine or other medicinal product in the same syringe.

If necessary, Anthrax Vaccine may be given at the same time as other vaccines. Other injectable vaccines should be administered by separate injections into different anatomical sites and, ideally, into different limbs.

Subjects who are receiving immunosuppressive therapy, including high dose corticosteroids, may be given Anthrax Vaccine but may not mount an adequate immune response.

4.6 Pregnancy and lactation

Anthrax Vaccine should not be given to pregnant women unless the possible benefits of vaccination are considered to outweigh any potential risks to the fetus.

There is no information on administration of Anthrax Vaccine to breastfeeding women. Vaccination should be avoided unless it is considered esssential.

4.7 Effects on ability to drive and use machines

None known

4.8 Undesirable effects

Serious adverse events may occur but are rare. Local reactions and mild systemic reactions are more frequently reported.

Administration site reactions:

Common: Injection site inflammation, pain, erythema.

Reactions have occurred at the site of a previous injection of the vaccine following subsequent injections.

General disorders:

Common: Influenza-like symptoms, mild febrile reactions, malaise

Rare: Lymphadenopathy, fatique, asthenia

Immune system disorders:

Rare: Allergic reactions including urticaria, angioedema, pruritus

Isolated cases: Anaphylactic reactions, including bronchospasm, hypotension, circulatory collapse.

This medical product contains thiomersal (an organo-mercuric compound) as a preservative, and therefore, it is possible that sensitisation reactions may occur (see section 4.3).

Dermatological reactions (see Immune system disorders)

Rare: rash, sweating increased

Gastrointestinal disorders:

Rare: Nausea, vomiting

Musculoskeletal:

Common: Arthralgia, myalgia

Nervous system disorders:

Rare: Headache, paraesthesia, dizziness

4.9 Overdose

Product is available solely in the form of ampoules containing a single recommended dose. Accidental overdosage is therefore highly unlikely to occur.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Induction of active immunity by IgG antibody production.

5.2 Pharmacokinetic properties

None stated

5.3 Preclinical safety data

None stated

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium potassium sulphate

Thiomersal

Sodium chloride

Water for injections

6.2 Incompatibilities

None known

6.3 Shelf life

60 months.

6.4 Special precautions for storage

Store between 2° and 8°C. Do not freeze.

6.5 Nature and contents of container

Type 1 glass ampoule. Provided in pack sizes of 1, 5, 10, 25, 50 and 100 ampoules.

6.6 Special precautions for disposal

Contaminated waste and spillage should be dealt with in accordance with local documented procedures for handling waste.

Porton Biopharma Limited

Manor Farm Road

Porton Down

Salisbury Wiltshire SP4 0JG

8 MARKETING AUTHORISATION NUMBER

PL 44403/0001