Summary of Product Characteristics (SmPC) - Anthrax vaccine (Alum Precipitated Sterile Filtrate)
1 NAME OF THE MEDICINAL PRODUCT
Anthrax Vaccine (Alum precipitated sterile filtrate).
Suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Anthrax antigens (Alum precipitated sterile filtrate): not less than 0.125 mL per 0.5 mL dose.
Aluminium potassium sulphate: 7.0 mg per 0.5 mL dose (Equivalent to aluminium 0.4 mg per 0.5 mL dose).
Excipients with known effect: sodium chloride 1.7 mg per 0.5mL dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
The product is a white suspension, contained in a clear glass ampoule with two coloured rings (red and blue).
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
Primary Immunisation: Four doses each 0.5 mL.
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 0.5 mL administered annually.
Paediatric population
The safety and efficacy of Anthrax Vaccine in children has not been established. No data are available.
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 listed in
- Vaccination should be postponed in subjects suffering from 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 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
No interaction studies have been performed.
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 Fertility, Pregnancy and Lactation
Pregnancy
Anthrax Vaccine should not be given to pregnant women unless the possible benefits of vaccination are considered to outweigh any potential risks to the foetus.
Breast-feeding
There is no information on administration of Anthrax Vaccine to breast-feeding women.
Vaccination should be avoided unless it is considered essential.
Fertility
No studies have been conducted on the effect of the Anthrax Vaccine on fertility.
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, fatigue, asthenia.
Immune system disorders:
Rare: Allergic reactions including urticaria, angioedema, pruritus.
Isolated cases: Anaphylactic reactions, including bronchospasm, hypotension, circulatory collapse.
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.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
This product is available solely in the form of ampoules containing a single recommended dose. Accidental overdosage is therefore highly unlikely.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: anthrax vaccine, ATC code: J07AC
Induction of active immunity by IgG antibody production.
5.2 Pharmacokinetic Properties
Not applicable.
5.3 Preclinical Safety Data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Aluminium potassium sulphate.
Thiomersal.
Sodium chloride.
Water for injection.
6.2 Incompatibilities
Not applicable.
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
0.5 mL suspension in a type 1 glass ampoule. Provided in pack sizes of 1, 5, 10, 25, 50 and 100 ampoules.
6.6 Special precautions for disposal and other handling
The suspension should be inspected visually for any foreign particulate matter and/or discolouration before administration. Discard if the content appears to have changed. 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
Date of first authorisation: 06 January 1994
10 DATE OF REVISION OF THE TEXT
19/03/2021