Registered Rwanda · Rwanda FDA

RABIVAX-S

Purified Rabies Antigen

RWANDA-FDA25/HM/0237/0008 Lyophilized powder for injection 1 dose of 2.5 IU

What it does

Antigens are substances that trigger an immune response in the body, helping to fight infections and diseases.

Commonly used for: to help the body recognize and fight infections, to assist in vaccine development

Read more in plain English ↓

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

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Sourcing - Kenya only

Registration & product details

Registration no.
RWANDA-FDA25/HM/0237/0008
Registration date
05/02/2026
Expiry date
04/02/2031
Status
Registered
Active ingredient
Purified Rabies Antigen
Strength
1 dose of 2.5 IU
Pack size
5.0ml x 5 vials in single carton
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 22:07:02 · updated 2026-09-17 02:30:42

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

About antigen

Antigens are substances that trigger an immune response in the body, helping to fight infections and diseases.

What it treats

  • to help the body recognize and fight infections
  • to assist in vaccine development

How it works

Antigens stimulate the immune system to produce antibodies, which are proteins that help protect the body from diseases.

Who it's for

Antigens are used for people needing vaccinations or treatments that enhance immune response.

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

About purified

Purified ingredients are often used in various medicines to ensure safety and effectiveness by removing impurities.

What it treats

  • various medical conditions

How it works

Purified ingredients help in delivering the intended effects of the medicine without the risk of contaminants.

Who it's for

People who need medications with safe and effective ingredients.

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

About rabies

Rabies is a viral infection that affects the brain and spinal cord, usually transmitted through animal bites.

What it treats

  • protection against rabies after exposure
  • post-exposure prophylaxis for rabies

How it works

Rabies vaccines help your body build immunity against the rabies virus.

Who it's for

This treatment is for anyone who has been bitten by an animal that may carry rabies.

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

Clinical monograph: antigen

Antigens are substances that can induce an immune response in the body. They are typically proteins or polysaccharides found on the surface of pathogens such as bacteria, viruses, and fungi, as well as on non-infectious substances like pollen and transplanted tissues. The immune system recognizes these antigens as foreign, leading to the production of antibodies and activation of immune cells.

Indications

  • Vaccination against infectious diseases
  • Allergy testing and immunotherapy
  • Monoclonal antibody production
  • Transplantation to prevent organ rejection

Dosage

Children: Dosing of antigens in children also depends on the specific antigen and the clinical indication. For pediatric vaccinations, refer to the BNF for Children.

Adults: Dosing of antigens is highly variable and depends on the specific antigen and the clinical indication. For vaccine administration, refer to national immunization guidelines.

Mechanism of action

Antigens work by binding to specific receptors on the surface of immune cells, such as B cells and T cells. This binding triggers a cascade of immune responses, including the proliferation of specific immune cell populations and the production of antibodies that target the antigen. This process is crucial for the development of adaptive immunity, allowing the body to remember and respond more effectively to future encounters with the same antigen.

Pharmacodynamics

The pharmacodynamics of antigens involve the interaction with the immune system to elicit a response. The magnitude and quality of this response can vary based on several factors, including the nature of the antigen, the route of exposure, and the host's immune status. Antigens can be classified as T-cell dependent or T-cell independent, influencing the type of immune response generated.

Pharmacokinetics

Antigens are processed by antigen-presenting cells (APCs) that present peptide fragments to T cells. The pharmacokinetics of antigens can vary widely depending on their form (e.g., live attenuated, inactivated, or subunit vaccines). Generally, once introduced into the body, antigens are taken up by APCs, which then migrate to lymph nodes to activate T and B cells. The duration of immune response can be influenced by the type of antigen and the presence of adjuvants.

Pregnancy

Safety during pregnancy depends on the specific type of antigen. Consult relevant guidelines for specific antigens.

Breast-feeding

Safety during breastfeeding varies by antigen type. Consult relevant guidelines for specific antigens.

Storage

Store at controlled room temperature, away from light and moisture. Specific storage conditions may vary based on the type of antigen.

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: purified

Purified refers to a substance that has been processed to remove impurities, contaminants, or unwanted substances, resulting in a more concentrated and effective form of the original compound. In pharmacology, purified compounds are often used to enhance therapeutic efficacy and reduce adverse effects. The purification process can apply to a variety of substances, including drugs, biological products, and chemical compounds.

Dosage

Children: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Adults: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Mechanism of action

The mechanism of action for purified compounds varies widely depending on the specific substance. Generally, purified drugs exert their effects by interacting with specific biological targets, such as receptors, enzymes, or ion channels, leading to a desired therapeutic effect. This interaction can involve binding to receptors to activate or inhibit signaling pathways, modulating enzymatic activity, or altering physiological processes.

Pharmacodynamics

Pharmacodynamics describes the effects of a drug on the body and the relationship between drug concentration and effect. For purified drugs, this can involve dose-response relationships and the time course of their action. The purified form often enhances potency and reduces variability in response among patients, which can lead to more predictable therapeutic outcomes. The overall effect is determined by the drug's affinity for its target, the efficacy of the drug-receptor interaction, and the downstream signaling pathways activated as a result of this interaction.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. For purified substances, absorption can be more efficient due to the absence of impurities that may affect solubility or stability. Distribution may also be enhanced, leading to higher bioavailability. Metabolism can be influenced by the structure of the purified compound, as it may be metabolized more readily by liver enzymes. Excretion typically occurs through the kidneys or liver, depending on the molecular characteristics of the purified drug.

Pregnancy

Consult with a healthcare professional, as the safety of purified forms of medications during pregnancy may vary depending on the specific substance.

Breast-feeding

Consult with a healthcare professional, as the safety of purified forms of medications during breastfeeding may vary depending on the specific substance.

Storage

Store in a cool, dry place, away from light and moisture, and 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: rabies

Rabies is a viral disease caused by the rabies virus, which primarily affects mammals, including humans. It is transmitted through the saliva of infected animals, commonly via bites. The disease is characterized by encephalitis and can lead to severe neurological symptoms, and is often fatal if not treated promptly. Vaccination is a critical preventive measure, particularly for individuals at high risk of exposure, such as veterinary staff and travelers to endemic areas.

Indications

  • Rabies prevention in individuals at high risk of exposure
  • Post-exposure prophylaxis following potential rabies exposure
  • Vaccination for travelers to endemic regions

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for pediatric patients.

Adults: Refer to the BNF for specific dosing guidelines, as it varies based on exposure risk and vaccination history.

Mechanism of action

The rabies vaccine works by stimulating the immune system to produce antibodies against the rabies virus. This is achieved through the introduction of inactivated or attenuated virus particles, which mimic the infection without causing the disease. The immune response generated helps to prevent the virus from causing illness upon subsequent exposure.

Pharmacodynamics

The rabies vaccine induces an adaptive immune response, leading to the production of neutralizing antibodies specific to the rabies virus. This immune memory protects against future infections. The vaccine is typically administered in a series of doses to ensure adequate immune response and long-term protection.

Pharmacokinetics

The pharmacokinetics of the rabies vaccine involve absorption at the injection site, followed by systemic distribution of the antigens. The onset of immunity generally occurs within two weeks after the initial vaccination, with peak antibody levels typically reached within one to two months. The duration of immunity can vary, necessitating booster doses in certain populations.

Interactions

  • chloroquine+rabiesvaccine: Severe (decreases efficacy)

Pregnancy

Rabies vaccination is generally considered safe during pregnancy. However, the risks and benefits should be carefully evaluated.

Breast-feeding

Rabies vaccine is not known to cause any adverse effects in breastfeeding. However, consult with a healthcare provider for individual assessments.

Storage

Store the rabies vaccine in a refrigerator at 2-8 degrees Celsius. Do not freeze.

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.