Registered Rwanda · Rwanda FDA

BCG VACCINE (FREEZE-DRIED)

LIVE ATTENUATED STRAINS OF MYCOBACTERIUM BOVIS

Rwanda FDA-HBP-MA-003 LYOPHILIZED INJECTION 2 X 105 AND 8 X 105 C.F.U.

What it does

Attenuated refers to a weakened form of a virus or bacteria used in vaccines to help the body build immunity.

Commonly used for: prevention of infectious diseases through vaccination

Read more in plain English ↓

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HBP-MA-003
Registration date
08/09/2021
Expiry date
08/09/2026
Status
Registered
Active ingredient
LIVE ATTENUATED STRAINS OF MYCOBACTERIUM BOVIS
Dosage form
LYOPHILIZED INJECTION
Strength
2 X 105 AND 8 X 105 C.F.U.
Pack size
50X1ML
Therapeutic class
-
Manufacturer / MAH
Serum Institute Of India
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: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:39 · updated 2026-09-21 02:30:20

Drug Interactions

5
Check interactions

Unknown (5)

Live - decreases efficacy

Aciclovir is predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live).

Unknown Theoretical

Live - affects response

COVID-19vaccinemightaffecttheresponsetolivevaccines (herpes-zostervaccine,live).UKHSAadvisesseparating administrationby7days.oTheoretical Cranberry

Unknown Theoretical

Live - decreases efficacy

Famciclovir is predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live). Theoretical Famotidine → see H2 receptor antagonists Fampridine

Unknown Theoretical

Live - decreases efficacy

Normal immunoglobulin is predicted to decrease the efficacy of live vaccines (Bacillus Calmette-Guérin vaccine, herpes-zoster vaccine, live, influenza vaccine (live), measles, mumps and rubella vaccin

Unknown Theoretical

Live - decreases efficacy

Valacicloviris predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About attenuated

Attenuated refers to a weakened form of a virus or bacteria used in vaccines to help the body build immunity.

What it treats

  • prevention of infectious diseases through vaccination

How it works

Attenuated vaccines stimulate the immune system to recognize and fight off the actual disease by using a weakened version of the germ.

Who it's for

People of various ages, depending on the specific vaccine, to help prevent certain infections.

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

About bovis

Bovis is a medication used to treat various health conditions.

What it treats

  • joint pain (arthritis)
  • muscle pain (myalgia)
  • inflammation

How it works

Bovis helps reduce pain and swelling in the body.

Who it's for

Bovis is for adults and children who need relief from pain and inflammation.

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

About live

Live vaccines help your body build protection against certain diseases using weakened forms of the virus or bacteria.

What it treats

  • measles
  • mumps
  • rubella
  • chickenpox
  • yellow fever

How it works

Live vaccines stimulate your immune system to recognize and fight off infections by using a weakened version of the germ that causes the disease.

Who it's for

Live vaccines are typically given to children and adults to protect against specific infectious diseases.

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

About mycobacterium

Mycobacterium is a type of bacteria used in certain treatments, particularly for tuberculosis (TB) and other mycobacterial infections.

What it treats

  • tuberculosis (TB)
  • mycobacterial infections

How it works

Mycobacterium is used in therapies that help stimulate the immune system or directly combat infections caused by these bacteria.

Who it's for

This treatment is for individuals diagnosed with tuberculosis or other related infections.

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

About strains

Strains are specific types of bacteria or yeast that are used in various health products, often for digestive health and overall wellness.

What it treats

  • digestive issues
  • irritable bowel syndrome (IBS)
  • preventing diarrhea
  • boosting immune health

How it works

Strains help maintain a healthy balance of good bacteria in the gut, which can improve digestion and support the immune system.

Who it's for

Strains are suitable for people looking to improve their gut health or those experiencing digestive problems.

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

Clinical monograph: attenuated

Attenuated vaccines contain live microorganisms that have been weakened (attenuated) so that they cannot cause disease in healthy individuals. These vaccines are designed to stimulate a robust immune response, leading to long-lasting immunity without causing the illness associated with the pathogen.

Indications

  • Measles
  • Mumps
  • Rubella
  • Yellow fever
  • Varicella (chickenpox)
  • Rotavirus

Dosage

Children: Refer to specific vaccine guidelines for paediatric dosing.

Adults: Refer to specific vaccine guidelines for adult dosing.

Mechanism of action

Attenuated vaccines work by mimicking a natural infection. The weakened pathogen replicates in the body, stimulating the immune system to produce a response against it, which includes the activation of T-cells and the production of antibodies. This prepares the immune system to recognize and fight off the pathogen if exposed in the future.

Pharmacodynamics

The pharmacodynamics of attenuated vaccines involve the interaction of the attenuated pathogen with the host's immune system. Upon administration, the vaccine induces both humoral (antibody-mediated) and cell-mediated immunity. This leads to the development of memory cells that ensure a faster and more effective response upon subsequent exposure to the actual pathogen.

Pharmacokinetics

Attenuated vaccines are generally administered via subcutaneous or intramuscular injection. The pharmacokinetics are characterized by the distribution of the vaccine components within the body, with the attenuated organisms replicating locally and inducing an immune response. The onset of immunity typically occurs within weeks, and the duration of immunity can vary depending on the specific vaccine.

Contra-indications

  • Severe immunodeficiency
  • Pregnant women (specific live attenuated vaccines)
  • Severe allergic reactions to vaccine components

Adverse effects

  • Injection site reactions (pain, swelling, redness)
  • Low-grade fever
  • Malaise
  • Rash
  • Rare neurological complications (e.g., Guillain-Barré syndrome)

Interactions

  • Immunosuppressive agents (may reduce vaccine efficacy)
  • Blood products (may interfere with immune response to vaccine)
  • Other live vaccines (timing may affect immune response)

Precautions

  • History of allergic reactions to previous vaccinations
  • Presence of active infections
  • Chronic illnesses that may affect immune response

Pregnancy

Live attenuated vaccines are generally contraindicated during pregnancy due to potential risks to the fetus.

Breast-feeding

Most live attenuated vaccines are considered safe during breastfeeding, but caution and consultation with a healthcare provider are advised.

Storage

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

Formulations

  • Injectable suspension
  • Oral suspension
  • 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.

Clinical monograph: bovis

Bovis refers to a class of medications derived from bovine sources, often used in traditional medicine practices. These preparations may contain various components, including hormones, enzymes, and minerals, which are believed to have therapeutic effects. However, specific pharmacological profiles and clinical data are limited in modern medical references.

Indications

  • Diabetes mellitus (for bovine insulin)
  • Hormonal deficiencies
  • Certain metabolic disorders
  • Growth hormone deficiencies

Dosage

Children: Refer to BNF for Children or specific product guidelines for pediatric dosing information.

Adults: Refer to specific product guidelines or clinical protocols, as dosing can vary widely among different bovine-derived products.

Mechanism of action

The mechanism of action for bovine-derived products can vary significantly depending on the specific component involved. For example, bovine insulin acts by facilitating glucose uptake in tissues, thereby lowering blood glucose levels. Other bovine-derived compounds may exert effects through different pathways, such as modulating immune responses or influencing metabolic processes.

Pharmacodynamics

Pharmacodynamics of bovine products largely depend on the active ingredients present. For instance, bovine insulin’s primary effect is to stimulate glucose uptake and inhibit hepatic glucose production. Other bovine-derived hormones may impact various physiological processes, such as growth, metabolism, and immune function.

Pharmacokinetics

The pharmacokinetics of bovine-derived medications can vary widely. Generally, proteins and peptides derived from bovine sources are subject to enzymatic degradation in the gastrointestinal tract, which may limit oral bioavailability. However, when administered via injection (as with insulin), the pharmacokinetics can be more predictable, with onset of action, peak times, and duration of effect influenced by formulation and route of administration.

Pregnancy

There is limited information on the safety of bovis during pregnancy. It is advised to use caution and consult healthcare professionals before use.

Breast-feeding

Due to insufficient data, it is recommended to consult a healthcare professional before using bovis while breastfeeding.

Storage

Store at room temperature, away from direct light and moisture. Keep out of reach of children.

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

Clinical monograph: live

Live vaccines contain live attenuated forms of pathogens that are used to stimulate an immune response without causing the disease in healthy individuals. They are effective in preventing various infectious diseases by inducing long-lasting immunity. However, live vaccines are contraindicated in immunocompromised patients due to the risk of severe infections.

Indications

  • Measles
  • Mumps
  • Rubella
  • Varicella (chickenpox)
  • Yellow fever
  • Rotavirus
  • Intranasal influenza

Dosage

Children: Refer to the BNF for Children for specific dosing information based on age and vaccine type.

Adults: Refer to specific product guidelines for dosing information, as it can vary by vaccine type and brand.

Mechanism of action

Live vaccines work by introducing a weakened or attenuated form of a pathogen into the body. This stimulates the immune system to recognize and respond to the pathogen, leading to the production of antibodies and memory cells that provide long-term protection against future infections by the same pathogen.

Pharmacodynamics

The pharmacodynamics of live vaccines involve the activation of both humoral and cellular immunity. Following vaccination, the immune system generates a robust response, including the production of specific antibodies and the activation of T cells that can recognize and eliminate infected cells. This dual action helps establish long-term immunity.

Pharmacokinetics

The pharmacokinetics of live vaccines vary depending on the specific vaccine. Generally, the vaccine is administered via injection, allowing the live attenuated organisms to enter the bloodstream. The immune response typically begins within days and can last for years, depending on the vaccine. Live vaccines are usually stored under refrigeration to maintain their viability, and they should be administered within their expiration dates.

Interactions

  • livevaccines + abrocitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + baricitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + filgotinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + dexrazoxane: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + iron chelators: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + ozanimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + ponesimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + siponimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + upadacitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + diroximelfumarate: Moderate (increases risk of generalised infection (possibly life-threatening))

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

Clinical monograph: mycobacterium

Mycobacterium refers to a genus of bacteria, some of which are pathogenic and responsible for diseases such as tuberculosis and leprosy. The most well-known species, Mycobacterium tuberculosis, is the causative agent of tuberculosis (TB), a serious infectious disease primarily affecting the lungs but can also involve other parts of the body. Treatment typically involves a combination of antibiotics over an extended period to effectively eliminate the bacteria and prevent resistance.

Indications

  • Tuberculosis (TB)
  • Leprosy
  • Mycobacterial infections
  • Nontuberculous mycobacterial infections

Dosage

Adults: Refer to specific treatment guidelines for dosing and duration of therapy, as it varies based on the drug and the severity

Mechanism of action

Mycobacterium species possess a unique cell wall structure rich in mycolic acids, which is crucial for their virulence. Antibiotics that target Mycobacterium, such as isoniazid and rifampicin, work by inhibiting cell wall synthesis or interfering with RNA synthesis, respectively. Isoniazid is a prodrug that becomes activated by the bacterial catalase-peroxidase enzyme, leading to the inhibition of mycolic acid synthesis. Rifampicin inhibits bacterial DNA-dependent RNA polymerase, preventing RNA transcription and bacterial replication.

Pharmacodynamics

The pharmacodynamics of Mycobacterium-targeting drugs relate to their ability to penetrate the bacterial cell wall and exert their effects. The efficacy of these drugs often depends on the growth phase of the bacteria, as some agents are more effective against actively dividing bacteria while others can target dormant forms. The immune response also plays a significant role in controlling mycobacterial infections, with the host's cellular immunity being crucial for clearing the infection.

Pharmacokinetics

Pharmacokinetics varies among different drugs used to treat Mycobacterium infections. For instance, isoniazid is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1 to 2 hours. It is metabolized in the liver through acetylation, and its half-life can vary significantly among individuals. Rifampicin also shows good oral bioavailability and is extensively metabolized in the liver, with a half-life of approximately 2 to 5 hours. Both drugs can penetrate well into tissues, including lung tissue, making them effective in treating pulmonary tuberculosis.

Adverse effects

  • Hypersensitivity reactions
  • Gastrointestinal disturbances
  • Hepatotoxicity
  • Peripheral neuropathy
  • Rash
  • Fever

Interactions

  • Anticonvulsants may reduce efficacy
  • Rifampicin may decrease serum concentrations of other drugs

Precautions

  • Monitor liver function tests regularly
  • Assess for signs of peripheral neuropathy
  • Use with caution in patients with a history of liver disease

Pregnancy

Use in pregnancy only if the benefit justifies the potential risk to the fetus. Some agents may be teratogenic.

Breast-feeding

Excreted in breast milk. Use with caution and consider the risk-benefit ratio.

Storage

Store in a cool, dry place away from light. Specific storage conditions depend on the formulation.

Formulations

  • Tablets
  • Injectable solutions
  • Suspensions

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

Clinical monograph: strains

Strains are injuries to muscles or tendons that occur when they are overstretched or torn. They commonly result from physical activity, including sports, and can cause pain, swelling, and limited mobility. The severity of strains can vary from mild to severe, and they typically affect the lower back, neck, shoulder, and hamstring areas.

Indications

  • Muscle strain
  • Tendon strain
  • Acute pain management
  • Inflammation control

Dosage

Children: Refer to specific medication guidelines as dosing varies by drug used for pain management.

Adults: Refer to specific medication guidelines as dosing varies by drug used for pain management.

Mechanism of action

The mechanism of injury in strains involves the disruption of muscle fibers or tendons due to excessive tension or force. This can lead to inflammation, pain, and impaired function. Inflammatory mediators are released at the site of injury, resulting in local vasodilation, increased permeability of blood vessels, and recruitment of immune cells which contribute to the healing process.

Pharmacodynamics

The pharmacodynamics of treating strains often involve the use of analgesics and anti-inflammatory medications, which work by inhibiting cyclooxygenase (COX) enzymes, leading to decreased production of prostaglandins. This reduces pain and inflammation associated with muscle or tendon injury. Physical therapy may also play a significant role in enhancing recovery and restoring function.

Pharmacokinetics

The pharmacokinetics of medications used for strains, such as NSAIDs, vary depending on the specific drug. Generally, these agents are absorbed rapidly from the gastrointestinal tract, peak in plasma concentration within a few hours, and have a half-life that varies widely. Metabolism typically occurs in the liver, and excretion is primarily via the kidneys. Individual responses can vary based on age, weight, and overall health.

Pregnancy

Consult healthcare provider before use.

Breast-feeding

Consult healthcare provider before use.

Storage

Store in a cool, dry place, away from direct sunlight.

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.