Bcg Vaccine Ajv freeze-dried Injection

This medicinal product is a vaccine and is used for the prevention of tuberculosis in infants, children and adults but does not ensure complete immunity. Babies should be immunised as soon as possible after birth.

Do not use BCG VACCINE AJV:

• if you are hypersensitive (allergic) to any of the ingredients of BCG VACCINE AJV,
• if you have a weakened resistance towards infections due to a disease in/of your immune system,
• if you are receiving medical treatment that affects the immune response e.g. corticosteroids, radiotherapy or other immunosuppressive treatment; infants who are exposed to immunosuppressive therapy while in utero or via breastfeeding must not be vaccinated with BCG VACCINE AJV for as long as a postnatal influence of the immune status of the infant remains possible. (e.g. maternal treatment with TNF α antagonists),
• if your immune status is in question,
• if you are infected with HIV; however, BCG VACCINE AJV may be given where benefits outweigh risks for vaccination such as infants born to HIV-infected women, but
• whose HIV infection is negative (i.e. laboratory confirmed), or
• whose HIV infection is unknown and demonstrate no clinical signs or symptoms suggestive of HIV infection;
• in patients suffering from an acute illness, high fever and in serous skin disease, vaccination should be postponed,
• if you are suffering from a malignant condition (e.g. lymphoma, leukaemia, Hodgkin’s disease or other tumours of the reticulo-endothelial system),
• if you are already receiving medicines that are active against the bacteria that cause tuberculosis, and
• in infants who are born to mothers who are taking medicines that are active against the bacteria that cause tuberculosis.

Take special care with BCG VACCINE AJV:

• if BCG vaccination is deemed necessary after an individual has received immunosuppressive agents, such as antineoplastic chemotherapy for cancer or high dose systemic corticosteroid therapy, the advice of a specialist must be sought before the vaccination is performed due to the risk of a disseminated BCG infection,
• if you or your child has eczema. BCG VACCINE AJV can still be given into an area of normal skin if the eczema in other areas is not infected, and
• if you or your child had a skin test for Tuberculosis infection that has come up positive. BCG VACCINE AJV is not helpful in such people and there can be problems at the injection site if it is given.

Pregnancy and breast-feeding

Safety in pregnancy has not been established. BCG vaccination during lactation is believed to pose no risk to the breast-feeding child.

Important information about some of the ingredients of BCG VACCINE AJV:

Using other medicines with BCG VACCINE AJV: Other vaccines can be given at the same time as BCG VACCINE AJV, but must be given in different areas of the body. Other live vaccines must either be given at the same time or normally not less than 4 weeks after BCG vaccination. No other vaccines should be injected into the arm or leg where BCG VACCINE AJV was given for 3 months afterwards. If you are pregnant or breast feeding your baby, please consult your doctor, pharmacist or other health care professional for advice before being vaccinated. Always tell your healthcare professional if you are taking any other medicine.

Your doctor, pharmacist or other healthcare professional will immunise you as follows: Children below 1 year of age: 0,05 ml of the reconstituted vaccine by intradermal injection. 0,1 ml of the reconstituted vaccine should be given to children 1 year or older, and adults. The injection should be given slowly, strictly intradermally, into the upper layer of skin of the right arm in the region over the distal insertion of the deltoid muscle (about one-third down the upper arm). Use a sterile fine short needle for each injection (25 G/0,50 mm or 26 G/0,45 mm). Alcohol or disinfectant used to clean the skin must be allowed to evaporate before injection to prevent inactivation of the vaccine.

Reconstitution: Only Diluted Sauton Medium may be used for reconstitution of BCG VACCINE AJV. The rubber stopper must not be wiped with antiseptic or detergent. If alcohol is used to swab the rubber stopper of the vial, it must be allowed to evaporate before the stopper is penetrated with the syringe needle. The vaccine should be visually inspected before and after reconstitution for any foreign particles before administration. The Reconstituting fluid for BCG VACCINE AJV must be cooled to < 8 °C before use. Transfer 1 ml Reconstituting fluid for BCG VACCINE AJV with a sterile syringe with a long needle into the vial containing the vaccine. Carefully invert the vial a few times to resuspend the freeze-dried BCG thoroughly, which will produce a homogenous, slightly opaque and colourless suspension. Gently swirl the vial of resuspended vaccine before drawing up each subsequent dose. Avoid vigorous shaking. Thoroughly mixed the vaccine is a homogenous, slightly opaque and colourless suspension. For the multidose vial a separate sterile syringe and needle must be used for each injection.

BCG VACCINE AJV can have side effects. Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen when immunised with this medicine or if you experience any untoward effects after vaccination, please consult your doctor, pharmacist or other health care professional for advice.

More frequent: A local reaction is normal after BCG. A small tender red swelling appears at the site of the injection which gradually changes to a small vesicle. An ulcer may appear 2 to 4 weeks after vaccination. An adherent dressing is not recommended. The reaction usually subsides within two to five months and in practically all children leaves a superficial scar 2-10 mm in diameter. In a minority of neonates, a scar may not be seen, due to the immaturity of the immune system.

Less frequent: Enlargement of the lymph nodes under your arms ( ˂ 1 cm) may appear following immunisation.

If you have swelling at the injection site that does not settle or seems to be getting bigger, or an ulcer that gets bigger and seems very slow to heal, or if you notice swellings in your armpit that are larger than one centimeter across, you should tell your doctor or nurse. These are not normal reactions to the vaccine.

Other side effects

Less frequent: several allergic reactions (such as redness of the face and neck, swelling of the face, throat or neck, skin rash, breathing difficulties and collapse) can occur. These often start very soon after injection, and may happen while you are still in the clinic. If the symptoms start after leaving the clinic, it is important that you contact a doctor urgently or visit the nearest hospital emergency department.

Less frequent:

• headache,
• fever,
• swelling of gland in the armpit to more than 1 cm across, and
• an ulcer that lets out fluid at the injection site. If this happens, the ulcer should be allowed to dry and tight clothes should be avoided. If the ulcer seems very slow to heal, contact your doctor, pharmacist or nurse for advice.

Other less frequent side effects:

• inflammation of gland, sometimes with abscesses and release of fluid from the swellings; inadvertent subcutaneous injection produces abscess formation and may lead to ugly retracted scars,
• infection with the bacteria in the vaccine (Mycobacterium bovis BCG) can occur, that can spread through the body, including to the bones; this does not usually happen in people who are otherwise healthy but it has been reported. These infections need to be treated in a similar way to the treatment of TB,
• osteitis, lupus types of reaction and keloid formation may occur, and
• osteomyelitis.

Keep all medicines out of the reach and sight of children. During storage in refrigerator (between 2-8 °C) the product is stable until indicated date of expiration. Reconstituted vaccine may be kept cold for up to six hours, protected from light. Reconstituting fluid for BCG VACCINE AJV may be kept at room temperature or cold, but should not be frozen.