Registered Botswana · BoMRA

BCG FREEZ DRIED VACCINE

BCG Vaccine 1 ml (0.05 mlx 20 dose/0.1 ml x 10 dose)

BOT0801139 POWDER FOR INJECTION 1 ml (0.05 mlx 20 dose/0.1 ml x 10 dose)

What it does

BCG is a vaccine used to help protect against tuberculosis (TB), a serious infectious disease that affects the lungs and other parts of the body.

Commonly used for: tuberculosis (TB), tuberculosis prevention

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
BOT0801139
Registration date
2008-03-27
Expiry date
2031-02-04
Status
Registered/Compliant
Active ingredient
BCG Vaccine 1 ml (0.05 mlx 20 dose/0.1 ml x 10 dose)
Dosage form
POWDER FOR INJECTION
Strength
1 ml (0.05 mlx 20 dose/0.1 ml x 10 dose)
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Serum Institute
Country of origin
India
Manufacturer location
Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Source: Botswana Medicines Regulatory Authority · fetched 2026-09-18 04:32:20

Disclaimer: This information is sourced from Botswana Medicines Regulatory Authority (Botswana). Always consult a qualified healthcare professional before using any medication.

About bcg

BCG is a vaccine used to help protect against tuberculosis (TB), a serious infectious disease that affects the lungs and other parts of the body.

What it treats

  • tuberculosis (TB)
  • tuberculosis prevention

How it works

BCG works by stimulating the immune system to recognize and fight off the bacteria that cause tuberculosis.

Who it's for

BCG is recommended for people who are at high risk of tuberculosis, especially in regions where TB is common.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About vaccine

Vaccines help protect against certain diseases by training your immune system to recognize and fight off specific germs.

What it treats

  • prevention of infectious diseases
  • immunization against viruses and bacteria

How it works

Vaccines stimulate your body's immune system to produce a response, creating memory cells that help fight off future infections.

Who it's for

Vaccines are for everyone, especially infants, children, and adults who need protection against certain diseases.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: vaccine

Vaccines are biological preparations that provide acquired immunity to a particular infectious disease. They contain antigens that stimulate the immune system to recognize and fight pathogens without causing the disease itself. Vaccines can be made from live attenuated pathogens, inactivated pathogens, subunit components, or mRNA. They are crucial in preventing infectious diseases and have significantly reduced morbidity and mortality worldwide.

Indications

  • Prevention of infectious diseases such as measles, mumps, rubella, hepatitis B, influenza, and human papillomavirus (HPV)
  • Travel vaccinations for diseases endemic to certain regions
  • Vaccination for at-risk populations, such as those with compromised immune systems or specific occupational exposures

Dosage

Children: Dosage varies by vaccine type and age; refer to the BNF for Children for specific dosing information.

Adults: Dosage varies by vaccine type and indication; refer to specific guidelines for each vaccine.

Mechanism of action

Vaccines work by mimicking an infection. They introduce a harmless component of a pathogen (antigen) to the immune system, prompting the body to produce an immune response. This includes the generation of antibodies and memory cells that provide long-term immunity. Upon subsequent exposure to the actual pathogen, the immune system is primed to respond more rapidly and effectively.

Pharmacodynamics

The pharmacodynamics of vaccines involves the activation of both humoral and cellular immunity. Vaccines stimulate B cells to produce antibodies against the pathogen, while T cells are activated to destroy infected cells. This dual response helps to establish immunological memory, which enables a faster and more robust response upon re-exposure to the pathogen.

Pharmacokinetics

Vaccines are administered via various routes, including intramuscular, subcutaneous, and oral. After administration, the antigens are presented to antigen-presenting cells, which activate T cells and stimulate B cell proliferation and differentiation. The half-life of vaccine-induced immunity varies depending on the type of vaccine, with some providing lifelong immunity and others requiring booster doses to maintain protection.

Contra-indications

  • Severe allergic reaction (anaphylaxis) to a component of the vaccine
  • Severe immunocompromised state for live attenuated vaccines

Adverse effects

  • Local reactions at the injection site (pain, redness, swelling)
  • Fever
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain
  • Nausea

Interactions

  • Immunosuppressive medications may reduce vaccine efficacy
  • Concurrent administration of some vaccines may require spacing to optimize immune response

Precautions

  • History of allergic reactions to vaccines or vaccine components
  • Pregnancy (specific vaccines may be contraindicated)
  • Moderate to severe acute illness with or without fever

Pregnancy

Consult healthcare provider. Some vaccines are contraindicated during pregnancy, while others are recommended.

Breast-feeding

Generally considered safe, but consult healthcare provider regarding specific vaccines.

Storage

Store in a refrigerator at 2-8°C. Do not freeze. Protect from light.

Formulations

  • Liquid suspension for injection
  • Lyophilized powder for reconstitution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.