Data Sheet

CHOLERA VACCINE

Cholera Vaccine is a heat-killed, phenol-preserved suspension of classical biotypes of V. cholerae (Inaba and Ogawa). The vaccine conforms with the requirements of the British Pharmacopoeia, each millilitre containing 8,000 million organisms. Phenol 0.5% w/v is added as a preservative.

Cholera Vaccine affords protection against both the classical and the El Tor biotypes.

Indications

Cholera Vaccine protects about 60% of those immunized and is used primarily to facilitate foreign travel.

Cholera Immunisation as a Travel Requirement

Australia no longer requires a certificate of vaccination against cholera for in-coming travellers. A number of countries, however, require such vaccination (See W.H.O. publication "Vaccination Certificate Requirements for International Travel" published annually). A single dose, normally the same as that used for boosting (see schedule below), meets the normal requirements of travel of most of these countries. The International Certificate is valid for 6 months, starting 6 days after one dose of vaccine. Cholera vaccination certificates are normally not required for infants under 6 months of age.

Contraindications

Infections: Defer administration in the presence of acute respiratory or other active infections.

Immune deficiency conditions: Administration of vaccine to a patient taking corticosteroids or other immunosuppressive agents may result in an altered immune response and should be avoided if possible.

Revaccination is not advisable if a person has experienced a serious reaction to the vaccine.

Use in Pregnancy: Category B2

There is no convincing evidence of risk to the foetus from immunization of pregnant women using inactivated virus vaccines, bacterial vaccines or toxoids.

Precautions

A careful history prior to injection is essential to determine any possible sensitivity to the vaccine, such as anaphylaxis, rash, fever etc.

As with other injectable vaccines, appropriate medical treatment and supervision should always be available in case of anaphylactic reactions. Adrenalin should always be readily available whenever the injection is given.

Adverse Reactions

The reactions listed below may begin soon after injection or may be delayed for 3 to 10 days. They usually subside within 24 to 48 hours.

Local reactions: Transitory soreness occurring on the first day or so following injection of the vaccine is common. Reactions at the site of the injection may occasionally occur, usually within 5 to 7 days. These include erythema, swelling, pain, tenderness or induration.

Systemic reactions: Malaise, low-grade fever, headache, generalized aches and pains, flushing, generalized urticaria, tachycardia and hypotension may occur.

Dosage and Administration

To provide maximum protection, the primary immunization course should consist of 2 doses of vaccine subcutaneously at an interval of 7 to 28 days. The longer interval is to be preferred.

The following age-dosage schedule is recommended:

Children under 6 months of age are usually not given Cholera Vaccine, as with adequate maternal care the risk of exposure to infection should be very small. However, if under special circumstances it is desired to immunize infants of this age, doses as for the under 5 years group may be given.

Note: The container should be shaken vigorously before use.

Duration of Immunity and the Need for Reimmunisation

Immunity following vaccination against cholera is of short duration, and booster doses are required every 6 months while an individual is at continual risk. One dose is sufficient for booster immunization irrespective of the interval since the last dose. The size of this dose should correspond to the first immunizing dose of the schedule given above. Alternatively, 0.1 mL could be injected intradermally; this method of giving boosters is often used in persons giving a history of severe systemic reactions to previous cholera inoculations.

Mode of Issue

Cholera Vaccine is issued in 1 mL and 10 mL containers.

Storage

Cholera Vaccine should be protected from light and stored at 2° to 8°C. It must not be frozen.

Medicine Classification

Prescription Medicine.

NOTE:

In general, inactivated vaccines can be administered simultaneously at separate sites. It should be noted, however, that when vaccines commonly associated with local or systemic side effects (such as cholera, typhoid, and plague vaccines) are given simultaneously, the side effects theoretically might be accentuated. When practical, these vaccines should be given on separate occasions.

Name and Address

Distributed by:

CSL (New Zealand) Limited
Level 4, Building 10
Central Park
666 Great South Road
Auckland
NEW ZEALAND

Telephone: 09 579 8105

Manufactured by:

CSL Limited ACN 051 588 348
45 Poplar Road
Parkville 3052 VICTORIA AUSTRALIA

Date of Preparation

25 June 1999