(Dried Tub/Vac/BCG)

PLEASE READ THIS CAREFULLY before you (or your child) are vaccinated. This leaflet provides a summary of the information available on the vaccine. If you have any questions or are not sure about anything, ask your doctor.

The name of this product is INTRADERMAL BCG VACCINE, BP. It is one of a group of medicines called vaccines, which are used to protect people against infectious diseases.

INTRADERMAL BCG Vaccine is a freeze-dried powder of a live, weakened strain of Mycobacterium bovis (the same type of bacteria that causes the infectious disease tuberculosis (TB), except that the weakened bacteria cannot cause the disease). The powder is mixed with sterile water or sodium chloride solution before use.

When mixed with the sterile water or sodium chloride solution, each ml of the vaccine contains the equivalent of not less than 8 million units of the weakened strain of the bacteria. The vaccine also contains dextran, glucose, Triton WR 1339 and water.

The vaccine is supplied as a freeze-dried powder in 10 dose containers (in packs of 10 or in packs of 5 with 5 containers of sterile water). The vaccine is also supplied in 50 dose containers (in packs of 5 with 5 containers of sodium chloride solution).

When you are vaccinated with INTRADERMAL BCG Vaccine your body produces a response (called "cell-mediated immunity") against the weakened tuberculosis-causing bacteria. If you later come into contact with TB, this same response will again be produced to protect you so that you do not catch the disease.

Evans Medical Limited, Regent Park, Leatherhead, KT22 7PQ, England.

INTRADERMAL BCG Vaccine is used to protect people against tuberculosis, a serious infectious disease which may affect any part of the body. The disease most commonly affects the lungs (chest). The vaccine can be given to babies, children, adults and elderly. Children are usually vaccinated while at school.

Have you had a skin test to check that you are not already immune to tuberculosis? (Anyone over 3 months old should have the skin test before BCG vaccination).

Have you had Measles or German Measles recently? (This can affect the result of the skin test).

Do you think you may be allergic/sensitive to any of the ingredients in the vaccine which are listed above?

Do you feel feverish or do you have any type of infection?

Are you receiving any treatment that lowers your resistance to disease, for example, steroids, radiotherapy, or drugs used for treating cancer, or do you have a medical condition that affects your resistance to infection (for instance, cancer, leukaemia, HIV)?

Do you have a widespread infected skin condition?

Are you pregnant or breast-feeding?

Are you taking any medicines for tuberculosis?

Have you had any other vaccinations in the last 3 weeks?

If the answer to any of these questions is YES, TELL YOUR DOCTOR. Vaccination may need to be delayed or may not be recommended.

You must not have another vaccination (injection) against infectious diseases in the same arm as your BCG vaccination for at least 3 months. This is because it could produce inflammation in the local lymph glands.

The vaccine will be made up and a dose withdrawn into a syringe.

For babies under three months of age your doctor will inject a single 0.05 ml dose of the vaccine into the skin. For children aged 3 months or over, adults and elderly the doctor will inject a single 0.1 ml dose of vaccine into the skin.

A small, white bleb will appear at the injection site. The injection site should be left uncovered.

Your doctor will write down the name, dose and lot number of the vaccine, and the date it was given, in your (or your child's) medical records. However, it may help you to remember what vaccines you have received if you also make note of the name and dose of the vaccines, and the date on which they were given.

A small swelling appears within 2-6 weeks and this may develop into a blister or ulcer, about 10 mm in diameter. It heals in 6-12 weeks, and a dry dressing can be used if the ulcer oozes. Be careful not to let tight clothing rub the ulcer.

Some people feel feverish, get a rash or have swollen glands after the vaccination. Small babies occasionally get swollen glands in their arm-pits.

Very rarely, an abscess may form at the injection site or an allergic reaction may happen very soon after the injection. This may cause collapse and breathing difficulties.

If you (or your child) think the vaccination has upset you in any way, TELL YOUR DOCTOR.

The freeze-dried powder should be refrigerated between 2-8 C. It should be protected from light. The sterile water and sodium chloride solution for mixing with the vaccine should be stored below 25 C (at room temperature),it should not be frozen. Once the powder and sterile water have been mixed, the mixture should be kept cool, protected from light and used within 4 hours.

The vaccine should not be used after the "Use-by" date on the label.

This leaflet does not contain the complete information about this vaccine. If you have any questions or are unsure of anything, ask your doctor, who has access to additional information.

This leaflet only applies to the product INTRADERMAL BCG VACCINE, BP for which it has been prepared.

Package Insert Patient Information Leaflet produced: May 1996.