PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) Zimbabwe · MCAZ

SII HEPATITIS-B (RDNA) (PAEDIATRIC)

HEPATITIS B SURFACE ANTIGEN

2005/18.1/4394 VACCINE 10MCG

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.
2005/18.1/4394
Registration date
2005-09-23
Expiry date
2027-12-31
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
HEPATITIS B SURFACE ANTIGEN
Dosage form
VACCINE
Strength
10MCG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Serum Institute Of India
Country of origin
-
Manufacturer location
Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:11 · updated 2026-09-16 04:30:10

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). 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 hepatitis

Hepatitis is an inflammation of the liver that can be caused by viral infections, alcohol use, or other factors. It can affect liver function and health.

What it treats

  • hepatitis (liver inflammation)
  • viral hepatitis
  • alcoholic hepatitis

How it works

Hepatitis can occur when the liver is damaged by viruses or toxins, leading to inflammation and impaired liver function.

Who it's for

Anyone can develop hepatitis, but certain groups, like those who consume alcohol excessively or are exposed to infected blood, are at higher risk.

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

About surface

Surface is a medication used for various conditions, primarily to treat skin issues.

What it treats

  • skin conditions
  • dermatitis
  • eczema

How it works

Surface works by forming a protective layer on the skin, helping to keep it moisturized and preventing irritation.

Who it's for

This medication is suitable for individuals experiencing skin problems, including children and adults.

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: hepatitis

Hepatitis refers to an inflammatory condition of the liver, which can be caused by viral infections (such as hepatitis A, B, C, D, and E), alcohol consumption, certain medications, and autoimmune diseases. The condition can be acute or chronic, leading to liver damage, cirrhosis, or liver cancer over time. The management of hepatitis depends on its etiology, severity, and the overall health of the patient.

Indications

  • Acute viral hepatitis
  • Chronic hepatitis B
  • Chronic hepatitis C
  • Autoimmune hepatitis
  • Alcoholic hepatitis
  • Non-alcoholic fatty liver disease

Dosage

Children: Paediatric dosing also varies significantly based on the specific condition and medication. As with adult dosing, it is important to refer to the BNF for Children for specific recommendations.

Adults: Dosing for adult patients varies widely depending on the specific antiviral agent used and the type of hepatitis. It is essential to refer to specific guidelines or the BNF for precise dosing.

Mechanism of action

In viral hepatitis, the viruses typically enter liver cells and replicate, leading to cellular injury and inflammation. The immune response to the infection contributes to liver damage. Antiviral therapies aim to inhibit viral replication, either by directly targeting viral enzymes or by modulating the host immune response.

Pharmacodynamics

The pharmacodynamics of antiviral agents used in hepatitis treatment involve the inhibition of viral replication, reduction of viral load, and improvement of liver function. This can lead to a decrease in serum liver enzymes (ALT and AST) and an improvement in clinical symptoms. In chronic hepatitis B and C, sustained virologic response is the goal, indicating effective viral suppression.

Pharmacokinetics

The pharmacokinetics of antiviral medications used for hepatitis can vary significantly depending on the specific drug. Generally, these agents are absorbed from the gastrointestinal tract, metabolized in the liver, and excreted through urine or feces. The half-lives of these drugs can vary, influencing dosing schedules.

Pregnancy

Consult medical guidelines as hepatitis can pose risks during pregnancy; specific management depends on the type of hepatitis.

Breast-feeding

Consult healthcare providers, as the safety of certain hepatitis medications during breastfeeding varies.

Storage

Store in a cool, dry place away from direct sunlight; specific storage conditions may vary based on the medication used.

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: surface

Surface is a term that generally refers to the outermost layer or boundary of an object, material, or substance. In a pharmacological context, surface interactions can pertain to drug formulations, such as topical agents that act on the skin or mucosal surfaces. These agents may include creams, ointments, and gels that deliver medication directly to the site of action, enhancing local effects while minimizing systemic absorption.

Indications

  • Topical treatment of skin conditions
  • Emulsifying agents in pharmaceutical formulations
  • Wound healing applications
  • Delivery of poorly soluble drugs

Dosage

Children: Refer to specific product guidelines and BNF for appropriate dosing regimens.

Adults: Refer to specific product guidelines and BNF for appropriate dosing regimens.

Mechanism of action

Surface-active agents, or surfactants, lower the surface tension between two substances, such as between a liquid and a solid or between two liquids. This property enables them to spread easily and improve the solubility of drugs in various formulations. In the context of drug delivery, surfactants can facilitate the absorption of medications across biological membranes by disrupting lipid bilayers, thus enhancing bioavailability.

Pharmacodynamics

Pharmacodynamics refers to the effects of drugs on the body and their mechanisms of action. For surface-active agents, the pharmacodynamic properties include their ability to alter surface tension and enhance wetting, spreading, and emulsification. These properties allow for improved penetration of active ingredients into tissues and can enhance the therapeutic effects of topically applied drugs.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of drugs. Surface-active agents typically exhibit limited systemic absorption when applied topically, leading to localized effects. The rate of absorption can be influenced by the formulation, the presence of other excipients, and the condition of the skin or mucosal surface. Metabolism may occur to a minimal extent, and excretion primarily happens through the skin or via the lymphatic system.

Pregnancy

Consult healthcare professional before use.

Breast-feeding

Consult healthcare professional 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.