Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
BCG Vaccine AJV
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Bacillus calmette-guerin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for BCG Vaccine AJV contains bacteria of the type Mycobacterium bovis BCG and is used for protection against tuberculosis (TB).
2. What you need to know before you are vaccinated with BCG Vaccine AJV You should not be vaccinated with BCG Vaccine AJV
- if you are allergic to Mycobacterium bovis or any of the other ingredients in this vaccine (listed in section 6)
- if you are suffering from an acute severe febrile illness or generalised skin infection. In these cases vaccination should be postponed
- if you have a weakened resistance toward infections due to a disease in/of your immune system
- if you are receiving medical treatment that affects the immune response, e.g. corticosteroids or radiotherapy
- if you have been exposed to immunosuppressive treatment in utero or via breast-feeding, (e.g. treatment with TNF-α antagonists)
- if you are suffering from any malignant conditions, (e.g. lymphoma, leukaemia or Hodgkin's disease)
- if your immune status is in question
- if you are infected with HIV
- if you are receiving medical treatment against TB
Warnings and precautions Talk to your doctor, pharmacist or nurse before you are vaccinated with BCG Vaccine AJV. The doctor or nurse will be extra cautious about vaccinating you with BCG Vaccine AJV: •
if you have eczema. The vaccination can be given in an eczema-free area
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•
if you have been skin tested for TB infection and the test was found positive vaccination is not required. Vaccination may cause a severe local reaction in that case
Other medicines and BCG Vaccine AJV Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines Other vaccines can be given at the same time as BCG Vaccine AJV at different injection sites Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being vaccinated with BCG Vaccine AJV. Vaccination is not recommended during pregnancy or breast-feeding, although no harmful effects to the unborn or breastfed child have been associated with BCG Vaccine AJV. Driving and using machines BCG Vaccine AJV has no influence on the ability to drive and use machines.
BCG Vaccine AJV contains potassium and sodium BCG Vaccine AJV contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially 'potassium-free'. BCG Vaccine AJV contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 'sodiumfree'. 3. How you are vaccinated with BCG Vaccine AJV The doctor or nurse will give the vaccination by injection into the upper layer of the skin. The recommended dose is 0.05 ml for children under 12 months of age and 0.1 ml for adults and children aged 12 months or more. The injection site is best left uncovered to facilitate healing. The expected reactions to the vaccination include:
- a slight swelling, redness and tenderness at the injection site followed by a local lesion
- some weeks later this lesion evolves into a small ulcer
- after some months this ulcer will heal leaving a small, flat scar
- a slight swelling of the lymph nodes in the armpit may be experienced These are common reactions to the vaccination.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Possible side effects
Like all medicines, BCG Vaccine AJV can cause side effects, although not everybody gets them. Severe allergic reactions (such as redness of the face and neck, swelling of the face, throat or neck, skin rash, breathing difficulties and collapse) may occur in rare cases (less than 1 in 1,000 people). If you observe any of the above reactions contact your doctor immediately.
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Other side effects include: Uncommon side effects: may affect up to 1 in 100 people
- fever
- swelling of lymph nodes in the armpit larger than 1 cm across
- inflammation of lymph nodes, sometimes with oozing ulcers and pus
- an oozing ulcer at the injection site
- headache Rare side effects: may affect up to 1 in 1,000 people
- abscess at the injection site
- infection with the bacteria from the vaccine can occur. The infection can spread throughout the body, including the bones Fainting, seizures and convulsions among patients receiving injections have been observed. In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
BCG Vaccine AJV Keep this vaccine out of the sight and reach of children. Store in a refrigerator (2oC – 8oC). Store in the original package in order to protect from light. Do not freeze. Do not use the vaccine after the expiry date which is stated on the carton as "EXP". The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What BCG Vaccine AJV contains
- The active substance is: Freeze-dried powder containing live attenuated bacteria of the type Mycobacterium bovis BCG (Bacillus Calmette-Guérin), Danish strain 1331. 1 ml vaccine contains between 2-8 million bacteria. •
The other ingredients are: Sodium glutamate, magnesium sulphate heptahydrate, dipotassium phosphate, L-asparagine monohydrate, ferric ammonium citrate, glycerol 85%, citric acid monohydrate and water for injections.
What BCG Vaccine AJV looks like and contents of the pack
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BCG Vaccine AJV consists of a powder and solvent for suspension for injection (2-8 x 105 bacteria/0.1 ml dose or 1-4 x 105 bacteria/0.05 ml dose). Pack sizes of 1, 5, or 10 vials and pack size of 1 vial with one syringe and two injection needles (one long for adding solvent and one short for intradermal injection). The powder in the amber vial is white and crystalline. The powder might be difficult to see due to the small amount of powder in the vial. The solvent in the clear vial is a colourless solution without visible particles. The mixed vaccine should appear as a homogenous, slightly opalescent, colourless suspension. Pack sizes: 1, 5 and 10-vial packages and 1 vial enclosed in a 1-dose injection kit. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer AJ Vaccines A/S 5, Artillerivej DK-2300 Copenhagen S Denmark tel.: +45 7229 7000 e-mail: [email protected] This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: DK: BCG Vaccine "AJ Vaccines" EL, FI: BCG Vaccine AJVaccines FR: VACCIN BCG AJVaccines NO: BCG-vaksine AJVaccines PL: BCG Szczepionka AJVaccines SE: BCG-vaccin AJVaccines UK: BCG Vaccine AJV This leaflet was last revised in 10/2023
The following information is intended for medical and healthcare professionals only Special warnings and precautions for use The vaccine should be administered strictly by the intradermal route. The vaccine should preferably be administered by personnel trained in the intradermal vaccination technique. Inadequate administered injections, e.g. subcutaneously or intramuscularly increase the risk of lymphadenitis and abscess formation. Tuberculin skin test positive persons should not be vaccinated as this may result in an aggravated locoregional reaction. Although anaphylactic reactions are rare, facilities for its management should always be available during vaccination. Whenever possible, persons should be kept under observation for 15-20 minutes after vaccination, in case an allergic reaction should occur. BCG vaccination may be given concurrently with inactivated or live vaccines, including combined measles, mumps and rubella vaccines. If not given concurrently, a period of not less than 4 weeks must pass before giving another live vaccine. There must be an interval of at least 3 months before a vaccination in the same arm can take place.
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Handling The rubber stopper must not be wiped with any antiseptic or detergent. If alcohol is used to swab the rubber stopper, it must be allowed to evaporate before the stopper is penetrated with the syringe needle. Using a syringe fitted with a long needle, transfer to the vial the volume of solvent stated on the label. Do not use other diluents as these may damage the vaccine. Carefully invert the vial a few times to the resuspend the lyophilised BCG completely. Do not shake the vial. Gently swirl the vial with the reconstituted vaccine before drawing up each subsequent dose. When drawn up into the syringe, the reconstituted vaccine should appear homogeneous, slightly opaque and colourless. When reconstituted, the vaccine should be used within 4 hours. Method of administration The vaccine should be administered by personnel trained in the intradermal technique. The injection site should be clean and dry. If antiseptics (such as alcohol) are applied to swab the skin, it must be allowed to evaporate before injection. The vaccine must be given strictly intradermally, approximately one third down the upper arm corresponding to the area of the distal insertion of the deltoid muscle, as follows: − − − − −
The skin is stretched between thumb and forefinger The needle should be almost parallel with the skin surface and slowly inserted (bevel upwards), approximately 2 mm into the superficial layers of the dermis. The needle should be visible through the epidermis during insertion The vaccine should be given slowly A raised, blanched papule at the needle point is a sign of correct injection The injection site is best left uncovered to facilitate healing
The mixed vaccine should be administered with a syringe of 1 ml graduated into hundredths of millilitre (1/100) fitted with a short bevel syringe needle (25G or 26G). Jet injectors or multiple puncture devices should not be used to administer the vaccine. Over dosage or incorrect administration Overdose increases the risk of suppurative lymphadenitis and may lead to excessive scar formation. Gross over dosage increases the risk of undesirable BCG complications. Administering the vaccine too deep increases the risk of discharging ulcer, lymphadenitis and abscess formation. Treatment of complications after vaccination with BCG Vaccine AJV
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Expert advice should be sought regarding the appropriate treatment regimen for the management of systemic infections or persistent local infections following vaccination with BCG Vaccine AJV. Antibiotic sensitivity of the BCG strain: The table below indicates the minimum inhibitory concentrations (MIC) for selected anti-tuberculous drugs towards the BCG Danish strain 1331 [as determined by Bactec 460]. The MIC for isoniazid is 0.4 mg/l. There is no consensus as to whether Mycobacterium bovis BCG should be classified as susceptible, intermediately susceptible or resistant to isoniazid when the MIC is 0.4 mg/l. However, based on criteria set for Mycobacterium tuberculosis, the strain could be considered to be of intermediate susceptibility. Drug Isoniazid Streptomycin Rifampicin Ethambutol
Minimum Inhibitory Concentration (MIC) 0.4 mg/l 2.0 mg/l 2.0 mg/l 2.5 mg/l
BCG Danish strain 1331 is resistant to pyrazinamide.
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Frequently asked questions about BCG Vaccine AJV
What is the active substance in BCG Vaccine AJV?
The active substance in BCG Vaccine AJV is bacillus calmette-guerin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for BCG Vaccine AJV, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get BCG Vaccine AJV without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: bacillus calmette-guerin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Active immunisation against tuberculosis.
BCG Vaccine AJV is to be used on the basis of national official recommendations.
4.2. Posology and method of administration
Posology:
Adults and children aged 12 months and over:
A dose of 0.1 ml of the reconstituted vaccine is injected strictly by the intradermal route.
Infants under 12 months of age:
A dose of 0.05 ml of the reconstituted vaccine is injected strictly by the intradermal route.
National recommendations should be consulted regarding the need for tuberculin testing prior to administration of BCG Vaccine AJV.
Method of Administration:
The injection site should be clean and dry. If antiseptics (such as alcohol) are applied to swab the skin, they should be allowed to evaporate completely before the injection is made.
BCG Vaccine AJV should be administered by personnel trained in the intradermal technique.
The vaccine should be injected strictly intradermally in the arm, over the distal insertion of the deltoid muscle onto the humerus (approx. one third down the upper arm), as follows:
• The skin is stretched between thumb and forefinger.
• The needle should be almost parallel with the skin surface and slowly inserted (bevel upwards), approximately 2 mm into the superficial layers of the dermis.
• The needle should be visible through the epidermis during insertion.
• The injection is given slowly.
• A raised, blanched bleb is a sign of correct injection.
• The injection site is best left uncovered to facilitate healing.
For information on the expected reaction following successful vaccination with BCG Vaccine AJV, see section 4.8.
BCG Vaccine AJV should be administered with a syringe of 1 ml subgraduated into hundredths of ml (1/100 ml) fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm). Jet injectors or multiple puncture devices should not be used to administer the vaccine.
For instructions on reconstitution of the vaccine before administration, see section 6.6.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Vaccination should be postponed in persons suffering from acute severe febrile illness or with generalised infected skin conditions. Eczema is not a contraindication, but the vaccine site should be lesion free.
BCG Vaccine AJV should not be administered to persons in treatment with systemic corticosteroids or other immunosuppressive treatment including radiotherapy. This also includes infants exposed to immunosuppressive treatment in utero or via breastfeeding, for as long as a postnatal influence of the immune status of the infant remains possible (e.g. maternal treatment with TNF-α antagonists).
Furthermore BCG Vaccine AJV should not be given to persons suffering from malignant conditions (e.g. lymphoma, leukaemia, Hodgkin's disease or other tumours of the reticulo-endothelial system), those with primary or secondary immune-deficiencies, those with HIV-infection, including infants born to HIV-positive mothers.
In persons whose immune status is in question, the BCG vaccination should be postponed until the immune status has been evaluated.
The effect of BCG vaccination may be exaggerated in immunosuppressed patients, and a generalised BCG-infection is possible.
BCG Vaccine AJV should not be given to patients who are receiving anti-tuberculosis drugs.
4.4. Special warnings and precautions for use
Although anaphylaxis is rare, facilities for its management should always be available during vaccination. Whenever possible, patients should be observed for an allergic reaction for up to 15-20 minutes after receiving immunization.
Tuberculin positive persons (consult national recommendations for the definition of a positive tuberculin reaction) do not require the vaccine. Administration of the vaccine to such persons may result in a severe local reaction.
Administering the vaccine too deep increases the risk of discharging ulcer, lymphadenitis and abscess formation. See section 4.2 for method of administration.
BCG Vaccine AJV should under no circumstances be administered intravascularly.
Regarding undesirable effects caused by BCG-infection and the susceptibility of the strain to anti-tuberculous drugs refer to section 4.8.
The potential risk of apnoea and the need for respiratory monitoring for 48–72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Cases of Immune reconstitution inflammatory syndrome (IRIS) have been reported after the onset of antiretroviral therapy in HIV-infected children or after initiating treatment for other severe immune deficiencies in children who had prior BCG vaccination. Adenitis, suppurative adenitis, purulent discharge, skin ulceration, skin abscesses, fever, have been reported in association with IRIS, appearing within weeks to months after initiation of immune therapy. Clinicians should be aware of this syndrome when treating patients with primary or secondary immunodeficiency who had prior BCG vaccination.
BCG Vaccine AJV contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose and is essentially free of potassium and sodium.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
4.5. Interaction with other medicinal products and other forms of interaction
Intradermal BCG vaccination may be given concurrently with inactivated or live vaccines, including combined measles, mumps and rubella vaccines.
Other vaccines to be given at the same time as BCG Vaccine AJV should not be given into the same arm. If not given at the same time an interval of not less than four weeks should normally be allowed to lapse between the administrations of any two live vaccines.
It is advisable not to give further vaccination in the arm used for BCG vaccination for 3 months because of the risk of regional lymphadenitis.
4.6. Fertility, pregnancy and lactation
Pregnancy
Although no harmful effects to the foetus have been associated with BCG Vaccine AJV, vaccination is not recommended during pregnancy.
Breastfeeding
Although no harmful effects to the breastfed child have been associated with BCG Vaccine AJV, vaccination of the mother is not recommended during lactation.
However, in areas with high risk of tuberculosis infection, BCG Vaccine AJV may be given during pregnancy or lactation if the benefit of vaccination outweighs the risk.
Fertility
No clinical or non-clinical data are available on the possible effects of BCG Vaccine AJV on male or female fertility.
4.7. Effects on ability to drive and use machines
BCG Vaccine AJV has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The expected reaction to successful vaccination with BCG Vaccine AJV includes induration at the injection site followed by a local lesion that may ulcerate some weeks later and heal over some months leaving a small, flat scar.
A local site reaction may include erythema and tenderness.
It also may include enlargement of a regional lymph node to < 1 cm.
Undesirable effects of the vaccine include the following:
Uncommon
(≥1/1000 to <1/100)
Rare
(≥1/10000 to <1/1000)
Blood and lymphatic system disorder
• Enlargement of regional lymph node > 1 cm
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Nervous system disorder
• Headache
-
Musculoskeletal and connective tissue disorders
-
• Osteitis
Infections and infestations
• Suppurative lymphadenitis
• Osteomyelitis
• Injection site abscess
General disorders and administration site conditions
• Fever
• Injection site ulceration
• Injection site discharge
-
Immune system disorders
-
• Anaphylactic reaction
• Allergic reaction
Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see section 4.4).
During post-marketing safety surveillance syncope among patients receiving injections have been reported. Also seizures and convulsions have been reported.
An excessive response to the BCG Vaccine AJV may result in a discharging ulcer. This may be attributable to inadvertent subcutaneous injection or to excessive dosage. The ulcer should be encouraged to dry and abrasion (by tight clothes, for example) avoided.
Expert advice should be sought regarding the appropriate treatment regimen for the management of systemic infections or persistent local infections following vaccination with BCG Vaccine AJV.
Antibiotic sensitivity of the BCG strain:
Section 5.1 includes a table with minimum inhibitory concentrations (MIC) for selected anti-tuberculous drugs towards the BCG Danish strain 1331 [as determined by Bactec 460].
The MIC for isoniazid is 0.4 mg/l. There is no consensus as to whether Mycobacterium bovis should be classified as susceptible, intermediately susceptible or resistant to isoniazid when the MIC is 0.4 mg/l. However, based on criteria set for Mycobacterium tuberculosis, the strain could be considered to be of intermediate susceptibility.
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 at: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdose increases the risk of suppurative lymphadenitis and may lead to excessive scar formation.
Gross overdosage increases the risk of undesirable BCG complications.
For treatment of disseminated infections with BCG, refer to section 4.8.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Onko BCG 50Prątki BCG (Bacillus Calmette-Guerin) podszczep brazylijski Moreau 50 mg (nie mn
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about BCG Vaccine AJV. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.