Registered Tanzania · TMDA

Diphtheria Antitoxin

Diptheria Toxoid 10000 IU/10ml

TAN 21 HM 0427 Liquid 10000

What it does

Diphtheria is a serious bacterial infection that mainly affects the throat and nose. It can lead to difficulty breathing and other severe complications if not treated promptly.

Commonly used for: diphtheria (a bacterial infection), respiratory infections

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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.
TAN 21 HM 0427
Registration date
2021-08-20
Expiry date
2026-08-19
Status
Registered/Compliant
Active ingredient
Diptheria Toxoid 10000 IU/10ml
Dosage form
Liquid
Strength
10000
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Vins Bioproducts
Applicant / LTR
Vins Bioproducts Ltd
Country of origin
INDIA
Manufacturer location
8-2-248/B/31/A, beside Bhramhakumaris Building, VST Colony, Punjagutta, Hyderabad, Telangana 500082, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:35:50 · updated 2026-08-17 03:00:39

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About diptheria

Diphtheria is a serious bacterial infection that mainly affects the throat and nose. It can lead to difficulty breathing and other severe complications if not treated promptly.

What it treats

  • diphtheria (a bacterial infection)
  • respiratory infections

How it works

The body responds to the diphtheria bacteria by producing antibodies that help fight the infection.

Who it's for

Diphtheria primarily affects unvaccinated children, but can also occur in adults.

Cautions

  • • Diphtheria can be life-threatening, so vaccination is important for prevention.
  • • Seek medical attention if you suspect an infection.

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

About toxoid

A toxoid is a type of vaccine that helps protect against diseases caused by toxins produced by bacteria.

What it treats

  • diphtheria
  • tetanus

How it works

Toxoids work by stimulating the immune system to recognize and fight off the bacteria that produce harmful toxins.

Who it's for

Toxoids are generally given to people of all ages, especially children, to help prevent serious infections.

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

Clinical monograph: diptheria

Diphtheria is an acute bacterial infection caused by the bacterium Corynebacterium diphtheriae, characterized by the formation of a pseudomembrane in the throat and systemic complications due to toxin production. It primarily spreads through respiratory droplets or direct contact with infected lesions. Vaccination has significantly reduced its incidence in many parts of the world, but outbreaks can occur, particularly in areas with low vaccination coverage.

Indications

  • Diphtheria prevention through vaccination
  • Management of diphtheria infections
  • Treatment of complications arising from diphtheria toxin

Dosage

Children: Refer to established guidelines for the management of diphtheria in children. Treatment typically includes administration of diphtheria antitoxin and antibiotics.

Adults: Refer to established guidelines for the management of diphtheria. Treatment typically includes administration of diphtheria antitoxin and antibiotics.

Mechanism of action

Corynebacterium diphtheriae produces diphtheria toxin, which is a potent exotoxin that inhibits protein synthesis in host cells. The toxin binds to the heparin-binding epidermal growth factor (HB-EGF) receptor on cell membranes, facilitating its entry into cells. Once inside, it catalyzes the ADP-ribosylation of elongation factor-2 (EF-2), halting protein synthesis and leading to cell death.

Pharmacodynamics

The toxicity of diphtheria is primarily due to the action of its exotoxin. The severity of the disease is correlated with the amount of toxin produced, which can lead to local tissue necrosis in the throat, systemic effects such as myocarditis and neuropathy, and can be fatal if untreated. The immune response to the toxin plays a crucial role in recovery, as patients who have been previously vaccinated may exhibit milder disease due to pre-existing immunity.

Pharmacokinetics

The pharmacokinetics of diphtheria toxin involve its release into the bloodstream after local infections in the throat. The toxin can disseminate to various tissues, including the heart and nervous system, leading to systemic manifestations. The half-life of the toxin is not well established, but it is rapidly cleared from circulation following the development of antibodies in the host, which neutralize the toxin's effects.

Adverse effects

  • Local reactions at the injection site
  • Fever
  • Fatigue
  • Allergic reactions
  • Anaphylaxis (rare)

Precautions

  • History of severe allergic reactions to diphtheria toxoid or any component of the vaccine
  • Use with caution in individuals with immunocompromised conditions

Pregnancy

Diphtheria vaccination is generally considered safe during pregnancy and is recommended to protect both the mother and fetus from potential exposure.

Breast-feeding

Diphtheria vaccination is safe during breastfeeding and is recommended as it helps to protect the infant.

Storage

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

Formulations

  • Diphtheria toxoid vaccine (inactivated)
  • Diphtheria-tetanus-pertussis (DTP) combination vaccine

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: toxoid

Toxoids are inactivated toxic compounds produced by certain bacteria that are used as vaccines to induce immunity against the corresponding toxin. They are commonly used in immunization programs to prevent diseases caused by bacterial toxins, such as diphtheria and tetanus. The process of toxoid preparation involves the detoxification of the bacterial toxin through chemical or heat treatment while preserving its immunogenic properties.

Indications

  • Diphtheria prophylaxis
  • Tetanus prophylaxis
  • Pertussis prophylaxis (when combined with other vaccines)

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for pediatric immunization with toxoids.

Adults: Refer to specific guidelines for each toxoid vaccine, as dosing may vary based on the type of vaccine and individual patient factors.

Mechanism of action

Toxoids work by stimulating the immune system to produce antibodies against the toxin without causing disease. When administered, the immune system recognizes the toxoid as a foreign substance and generates a specific immune response. This includes the production of immunoglobulin G (IgG) antibodies that can neutralize the active toxin if the individual is exposed to the bacteria in the future.

Pharmacodynamics

The pharmacodynamics of toxoids involve the activation of the adaptive immune response. After vaccination, dendritic cells present the antigen to T cells, which then help B cells differentiate into plasma cells that produce specific antibodies. The presence of these antibodies provides immunity against the toxin by neutralizing its effects, thereby preventing the disease associated with the original bacterial toxin.

Pharmacokinetics

Toxoids are typically administered via intramuscular or subcutaneous injection. Following administration, they are gradually taken up by antigen-presenting cells, which then process and present the toxoid to T cells. The immunogenic response can develop over several weeks. The duration of immunity can vary, necessitating booster doses to maintain adequate antibody levels over time.

Adverse effects

  • Local reactions at the injection site, such as pain, swelling, or redness.
  • Fever.
  • Fatigue.
  • Headache.
  • Allergic reactions in rare cases.

Precautions

  • Use with caution in individuals with a history of severe allergic reactions to a vaccine component.
  • Monitor patients for allergic reactions post-vaccination.

Pregnancy

Toxoids are generally considered safe during pregnancy; however, consultation with a healthcare provider is recommended.

Breast-feeding

Toxoids are considered safe for use during breastfeeding.

Storage

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

Formulations

  • Diphtheria toxoid
  • Tetanus toxoid
  • Pertussis toxoid

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.