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ANTHRAX VACCINE (ALUM PRECIPITATED STERILE FILTRATE)

Active substance(s): ANTHRAX ANTIGEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
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.

7

MARKETING AUTHORISATION HOLDER
Porton Biopharma Limited
Manor Farm Road
Porton Down
Salisbury
Wiltshire
SP4 0JG

8

MARKETING AUTHORISATION NUMBER
PL 44403/0001

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Reviewed product licence granted 25 September 1991. Prior to that date this
was a product licence of right.

10

DATE OF REVISION OF THE TEXT
08/05/2015

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