Registered Rwanda · Rwanda FDA

TETGLOB 250 I.U

TETANUS IMMUNOGLOBULIN BULK POWDER 250 IU

What it does

Bulk is a natural ingredient that helps improve bowel movements by increasing the amount of water in the stool, making it easier to pass.

Commonly used for: constipation, irregular bowel movements, hemorrhoids, diverticular disease

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 FDA-HBP-MA- 009
Registration date
25/01/2023
Expiry date
24/01/2028
Status
Registered
Active ingredient
TETANUS IMMUNOGLOBULIN BULK POWDER 250 IU
Strength
250 IU
Pack size
2 ML TUBULAR FLINT GLASS VIAL
Therapeutic class
-
Manufacturer / MAH
Bharat Serums & Vaccines
Country of origin
INDIA
Manufacturer location
3RD Floor, Liberty Tower, Plot No. K-10, behind Reliable Plaza, Kalwa Industrial Estate, Gavate Wadi, MIDC, Airoli, Navi Mumbai, Maharashtra 400708, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:36 · updated 2026-09-21 02:30:20

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

About bulk

Bulk is a natural ingredient that helps improve bowel movements by increasing the amount of water in the stool, making it easier to pass.

What it treats

  • constipation
  • irregular bowel movements
  • hemorrhoids
  • diverticular disease

How it works

It works by absorbing water in the intestine, which helps to soften the stool and promote regular bowel movements.

Who it's for

It is suitable for adults and children who need help with constipation or have conditions that affect their bowel health.

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

About immunoglobulin

Immunoglobulin is a treatment that helps boost the immune system by providing antibodies. It is often used to help people with weakened immune systems.

What it treats

  • weakened immune system
  • certain autoimmune diseases
  • infections

How it works

Immunoglobulin provides antibodies to the body, which help fight off infections and support the immune response.

Who it's for

This treatment is suitable for individuals with conditions that cause a low level of antibodies or those who have autoimmune disorders.

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

About tetanus

Tetanus is a serious bacterial infection that affects the nervous system and can cause muscle stiffness and spasms.

What it treats

  • tetanus infection
  • lockjaw

How it works

Tetanus is caused by a toxin produced by the bacteria Clostridium tetani, which interferes with nerve signals to muscles.

Who it's for

Tetanus can affect anyone, especially those who are not vaccinated or have not received booster shots.

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

Clinical monograph: bulk

Bulk-forming agents, commonly referred to as bulk laxatives, are substances that increase the bulk of the stool, facilitating bowel movements. They are usually derived from natural sources such as psyllium, methylcellulose, and bran. These agents work by absorbing water in the intestines, which helps to soften the stool and promote its passage. Bulk-forming agents are often used in the management of constipation and are considered a first-line therapy due to their safety profile and efficacy.

Indications

  • Constipation
  • Irritable bowel syndrome
  • Diverticular disease
  • Prevention of straining during defecation post-surgery
  • Management of stool consistency in patients with fecal incontinence

Dosage

Children: Refer to specific product guidelines for dosing information, as doses may vary depending on the formulation and the child's age and condition.

Adults: Refer to specific product guidelines for dosing information, as doses may vary depending on the formulation and the patient's condition.

Mechanism of action

Bulk-forming agents function by absorbing water in the intestinal lumen, which increases the stool volume. This mechanical effect stretches the intestinal walls, stimulating peristalsis and facilitating bowel movement. Additionally, the hydrated bulk can help to improve stool consistency and reduce the incidence of straining during defecation.

Pharmacodynamics

The pharmacodynamic effects of bulk-forming agents are primarily localized to the gastrointestinal tract. They increase stool bulk and moisture content, which can help to alleviate constipation. The onset of action typically occurs within 12 to 72 hours after ingestion, depending on the specific agent and individual patient factors.

Pharmacokinetics

Bulk-forming agents are not absorbed into the bloodstream and remain within the gastrointestinal tract. They exert their effects locally and are eliminated in the feces. The hydration of the bulk-forming agent occurs within the intestinal lumen, which helps to form a gel-like substance that enhances stool passage without systemic absorption.

Adverse effects

  • Gastrointestinal discomfort
  • Bloating
  • Flatulence
  • Diarrhea
  • Nausea

Precautions

  • Ensure adequate fluid intake to prevent gastrointestinal obstruction.
  • Monitor for signs of allergic reactions in sensitive individuals.
  • Use cautiously in patients with gastrointestinal disorders.

Pregnancy

Generally considered safe, but consult a healthcare provider for individual assessment.

Breast-feeding

Considered safe, but consult a healthcare provider for individual assessment.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Powder
  • Capsules
  • Tablets
  • Granules

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: immunoglobulin

Immunoglobulin is a preparation of antibodies derived from human plasma, used for passive immunization and to modulate immune responses. It is composed of a mixture of immunoglobulin G (IgG) antibodies and is administered to prevent infections in immunocompromised patients, treat various autoimmune disorders, and manage conditions like chronic inflammatory demyelinating polyneuropathy (CIDP).

Indications

  • Primary immunodeficiency disorders
  • Secondary immunodeficiency (e.g. due to HIV infection)
  • Chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Immune thrombocytopenic purpura (ITP)
  • Kawasaki disease
  • Prevention of infections in at-risk populations (e.g. following bone marrow transplant)

Dosage

Children: Refer to the BNF for Children for age-appropriate dosing guidelines; specific doses depend on the clinical condition and patient age.

Adults: Refer to specific guidelines for dosing based on indication; typically varies based on clinical scenario and patient condition.

Mechanism of action

Immunoglobulin exerts its effects primarily through the neutralization of pathogens and toxins, opsonization, and the activation of the complement system. It modulates immune responses by influencing the activity of various immune cells, including B cells, T cells, and macrophages, thereby enhancing antibody production and regulating inflammation.

Pharmacodynamics

The pharmacodynamics of immunoglobulin involve its ability to bind to specific antigens, effectively neutralizing them and facilitating their clearance. It also plays a crucial role in modulating the immune response, providing immediate passive immunity and promoting the establishment of active immunity over time. The diverse mechanisms through which immunoglobulin operates include antibody-dependent cell-mediated cytotoxicity (ADCC) and inhibition of pro-inflammatory cytokines.

Pharmacokinetics

Immunoglobulin is typically administered intravenously or subcutaneously. After administration, it is distributed throughout the extracellular space. The half-life of immunoglobulin varies but is generally in the range of 21 to 30 days, depending on the specific formulation and the patient's individual characteristics. It is primarily eliminated through the reticuloendothelial system, with catabolism occurring in various tissues.

Contra-indications

  • Hypersensitivity to immunoglobulin preparations
  • Selective IgA deficiency with a history of hypersensitivity
  • Severe hyperprolinemia

Adverse effects

  • Headache
  • Nausea
  • Fever
  • Chills
  • Fatigue
  • Rash
  • Anaphylactic reactions
  • Thromboembolic events

Interactions

  • Live attenuated vaccines may be less effective if administered concurrently with immunoglobulin therapy
  • Caution is advised when administering with other blood products

Precautions

  • Monitor for signs of anaphylaxis during and after administration
  • Use with caution in patients with renal impairment
  • Hydrate adequately to prevent renal dysfunction
  • Consider the risk of thrombosis in patients with a history of thromboembolic events

Pregnancy

Immunoglobulin can be used during pregnancy if indicated, as it is considered safe based on available data.

Breast-feeding

Immunoglobulin is excreted in breast milk, but is generally considered safe during breastfeeding.

Storage

Store at 2-8 degrees Celsius. Do not freeze. Protect from light. Use before expiry date.

Formulations

  • Intravenous immunoglobulin (IVIG)
  • Subcutaneous immunoglobulin (SCIG)
  • Intramuscular immunoglobulin (IMIG)

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: tetanus

Tetanus is a serious bacterial infection caused by the bacterium Clostridium tetani, which produces a potent toxin affecting the nervous system. The disease is characterized by muscle stiffness and spasms, often beginning in the jaw and neck. It can lead to severe complications and can be fatal if left untreated. Vaccination is the primary method of prevention, and treatment typically involves antitoxins, antibiotics, and supportive care.

Indications

  • Tetanus prophylaxis
  • Treatment of tetanus infection
  • Management of tetanus symptoms

Dosage

Children: Refer to the specific guidelines for tetanus immunoglobulin and other supportive treatments as per clinical protocols.

Adults: Refer to the specific guidelines for tetanus immunoglobulin and other supportive treatments as per clinical protocols.

Mechanism of action

The tetanus toxin binds to the presynaptic membrane of motor neurons and is transported retrogradely to the spinal cord, where it interferes with neurotransmitter release, particularly inhibiting the release of glycine and gamma-aminobutyric acid (GABA), leading to unopposed motor neuron activity and resultant muscle rigidity and spasms.

Pharmacodynamics

Tetanus toxin is one of the most potent toxins known, with effects that can manifest within hours of exposure. The toxin's ability to block inhibitory neurotransmitter release results in a state of continuous muscle contraction, known as tetany. The clinical presentation of tetanus includes trismus (lockjaw), muscle rigidity, and autonomic instability, among others.

Pharmacokinetics

The pharmacokinetics of tetanus toxin are complex due to its high potency and the nature of its action. Following entry into the body, the toxin binds to nerve endings and is internalized, leading to its effects on neurotransmitter release. The half-life of the toxin is not well defined as it does not circulate freely in the bloodstream but acts locally at the neuromuscular junction. Recovery from the effects of the toxin may take weeks to months, depending on the severity of the infection and the treatment provided.

Adverse effects

  • Pain at the injection site
  • Fever
  • Fatigue
  • Headache
  • Nausea

Precautions

  • Ensure patient is up to date with vaccinations
  • Monitor for allergic reactions post-vaccination
  • Consider history of neurological disorders

Pregnancy

Tetanus vaccination is considered safe during pregnancy and is recommended to protect both the mother and the newborn.

Breast-feeding

Tetanus vaccination is safe during breastfeeding and does not affect the nursing infant.

Storage

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

Formulations

  • Tetanus toxoid 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.

This drug in other countries

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