Registered Rwanda · Rwanda FDA

POLIOMYELITIS VACCINE (ORAL) BIVALENT TYPE 1 AND 3 20 DOSE

Monovalent Bulk of Poliomyelitis Type 1 and 3,

Rwanda FDA-HBP-MA-0118 Solution for Oral administration Type 1 and 3 - 20 Dose

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

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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-0118
Registration date
21/04/2024
Expiry date
20/04/2029
Status
Registered
Active ingredient
Monovalent Bulk of Poliomyelitis Type 1 and 3,
Strength
Type 1 and 3 - 20 Dose
Pack size
50 vials of 2ml
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 22:07:18 · 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 monovalent

Monovalent is a type of medication used in various treatments.

What it treats

  • prevention of specific diseases
  • support for immune response

How it works

Monovalent works by targeting a specific disease-causing organism, helping the body to build immunity against it.

Who it's for

This medication is generally for individuals who need protection against certain infections.

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

About poliomyelitis

Poliomyelitis is a viral disease that can cause paralysis. Vaccination is key to prevention.

What it treats

  • poliomyelitis (polio)

How it works

Vaccines stimulate the immune system to recognize and fight the poliovirus, preventing infection.

Who it's for

The vaccine is recommended for children and individuals at risk of exposure to the virus.

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: monovalent

Monovalent vaccines are designed to provide immunity against a single strain of a specific pathogen. They are often used in immunization protocols to prevent infections caused by particular bacteria or viruses. These vaccines can be crucial in controlling outbreaks of diseases that are prevalent in certain regions, including Kenya.

Indications

  • Prevention of specific infectious diseases caused by a single strain of a pathogen
  • Vaccination campaigns targeting specific outbreaks
  • Routine immunization programs

Dosage

Children: Refer to specific vaccine guidelines for paediatric dosing based on the vaccine used.

Adults: Refer to specific vaccine guidelines for adult dosing based on the vaccine used.

Mechanism of action

Monovalent vaccines work by introducing a harmless component of a pathogen, such as an inactivated virus, live attenuated virus, or a subunit of the pathogen, into the body. This exposure stimulates the immune system to recognize and mount a response against the specific pathogen strain, leading to the production of neutralizing antibodies and memory cells that provide long-term immunity.

Pharmacodynamics

The pharmacodynamics of monovalent vaccines involve the activation of the adaptive immune system. Upon administration, dendritic cells present antigens from the vaccine to T cells, which then help stimulate B cells to produce antibodies. This process also generates memory T and B cells that enable a rapid and robust immune response upon subsequent exposure to the pathogen.

Pharmacokinetics

As vaccines, monovalent formulations do not have traditional pharmacokinetic profiles, as they do not follow the same absorption, distribution, metabolism, and excretion pathways typical of pharmaceutical drugs. Instead, their efficacy is influenced by factors like the route of administration (intramuscular, subcutaneous), vaccine stability, and the immune response of the individual receiving the vaccine.

Pregnancy

Monovalent vaccines are generally considered safe during pregnancy; however, it is important to consult a healthcare professional for specific recommendations based on the type of vaccine and individual circumstances.

Breast-feeding

Monovalent vaccines can typically be administered during breastfeeding without any special precautions; consult a healthcare professional for personalized advice.

Storage

Store monovalent vaccines according to the manufacturer's guidelines, usually in a refrigerator at temperatures between 2°C and 8°C. Protect from light and do not freeze.

Formulations

  • Inactivated monovalent vaccine
  • Live attenuated monovalent 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: poliomyelitis

Poliomyelitis, commonly known as polio, is an infectious disease caused by the poliovirus. It primarily affects children under five years of age and can lead to paralysis, respiratory issues, and in severe cases, death. The virus is transmitted through the fecal-oral route or, less commonly, through contaminated water or food. Vaccination has significantly reduced the incidence of polio worldwide. The disease can manifest in various forms, including asymptomatic, non-paralytic, and paralytic poliomyelitis.

Indications

  • Prevention of poliomyelitis infection
  • Vaccination in children and high-risk populations

Dosage

Children: Refer to the BNF for Children for specific dosages and recommendations for vaccination schedules.

Adults: Refer to specific vaccination guidelines for adults, as dosages may vary based on risk factors and prior vaccination history.

Mechanism of action

Poliovirus enters the body through the oral route, replicating in the oropharynx and gastrointestinal tract before spreading to the central nervous system via the bloodstream. Once inside the CNS, the virus selectively infects motor neurons in the anterior horn of the spinal cord, leading to cell lysis and resulting in muscle weakness or paralysis. The immune response to the virus contributes to inflammation and further neuronal damage.

Pharmacodynamics

The poliovirus's pathogenicity is primarily due to its ability to evade the host's immune response and its selective neurotropism. The destruction of motor neurons leads to flaccid paralysis, with recovery possible in some cases as the motor neurons may regenerate. The severity of the disease correlates with the extent of neuronal involvement, which can vary widely among individuals.

Pharmacokinetics

Poliovirus is an RNA virus that does not undergo traditional pharmacokinetic processes as it is not treated with drugs. Instead, the prevention of polio relies on vaccination strategies. The inactivated poliovirus vaccine (IPV) and the oral poliovirus vaccine (OPV) are used to induce immunity. After administration, the vaccines promote the development of antibodies against the virus without causing disease.

Contra-indications

  • Hypersensitivity to the vaccine component
  • Severe immunodeficiency
  • Acute febrile illness

Adverse effects

  • Pain at injection site
  • Fever
  • Fatigue
  • Headache
  • Nausea
  • Allergic reactions

Interactions

  • Immunosuppressive therapies may reduce vaccine efficacy
  • Concomitant administration with other vaccines may affect immune response

Precautions

  • Use with caution in individuals with moderate to severe acute illness
  • Consider history of allergic reactions
  • Monitor for signs of anaphylaxis after administration

Pregnancy

Poliomyelitis vaccination is generally considered safe during pregnancy, but consult a healthcare professional.

Breast-feeding

The vaccine is considered safe for breastfeeding mothers.

Storage

Store at 2 to 8 degrees Celsius. Do not freeze. Protect from light.

Formulations

  • Inactivated poliovirus vaccine (IPV)
  • Oral poliovirus vaccine (OPV)

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.

South Africa 1 product