(Tub/Vac/BCG (Perc))

(High Strength BCG Vaccine)

PLEASE READ THIS CAREFULLY before your child is 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 PERCUTANEOUS BCG VACCINE BP. It is one of a group of medicines called vaccines, which are used to protect people against infectious diseases.

PERCUTANEOUS BCG Vaccine is a freeze-dried powder of a live, weakened strain of Mycobactenum 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 vial of the vaccine contains the equivalent of not less than 50 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).

When your child is vaccinated with PERCUTANEOUS BCG Vaccine your child's body produces a response (called "cell-mediated immunity") against the weakened tuberculosis-causing bacteria. If your child later comes into contact with TB, this same response will again be produced to protect your child so that he or she does not catch the disease.

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

PERCUTANEOUS 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 is given to babies from birth and very young children.

Has your child had a skin test to check that they are not already immune to tuberculosis? (Anyone over 3 months old should have a skin test before BCG vaccination).

Has your child had Measles or German Measles recently? (This can affect the result of the skin test).

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

Does your child feel feverish or does your child have any type of infection?

Is your child receiving any treatment that lowers their resistance to disease, for example, steroids, radiotherapy, or drugs used for treating cancer, or does your child have a medical condition that affects

their resistance to infection (for instance, cancer leukaemia, HIV)?

Has your child had any other vaccinations in the last 3 weeks?

Does your child have a widespread infected skin condition?

Is your child taking any medicines for tuberculosis?

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

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

How will you be given the vaccine?

The vaccine is mixed with the sterile water or sodium chloride solution. A small amount of the vaccine will be transferred to the skin of your child and the treated area will then be immediately punctured using a multiple puncture apparatus with 18-20 needles.

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

The injection-site may swell and become painful. A blister or ulcer may develop 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 injectionsite or an allergic reaction may happen very soon after the injection. This may cause collapse and breathing difficulties.

If you think the vaccination has upset your child 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 PERCUTANEOUS BCG VACCINE BP for which it has been prepared .

Package Insert Patient Information Leaflet produced: May 1996.