Registered Kenya · PPB

ROTAVAC 5D

ROTAVIRUS 116E BULK

H2026/CTD10815/21651 NLT 105.0 FFU / 0.5 ML NEW/INNOVATOR

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.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Hard to find? We help patients in Kenya source rare medicines. We don't sell or dispense medicines - licensed pharmacies do.

Source this medicine

Registration & product details

Registration no.
H2026/CTD10815/21651
Registration date
-
Expiry date
2031 July 28
Status
Registered
Active ingredient
ROTAVIRUS 116E BULK
Strength
-
Pack size
0.5 ML (SINGLE DOSE) VIAL, 2.5 ML (MULTI-DOSE) VIAL & 0.5 ML PFS
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Phillips Therapeutics Limited
Country of origin
FOREIGN
Manufacturer location
Embakasi South, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-08-02 06:35:51 · updated 2026-09-18 02:05:22

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). 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 rotavirus

Rotavirus is a virus that can cause severe diarrhea, especially in young children. Vaccination helps protect against this infection.

What it treats

  • diarrhea caused by rotavirus
  • gastroenteritis (stomach flu)

How it works

The rotavirus vaccine helps the body build immunity against the virus, reducing the risk of infection and severe symptoms.

Who it's for

It is recommended for infants and young children to prevent rotavirus infections.

Cautions

  • • Not suitable for individuals with severe allergic reactions to the vaccine components.
  • • Consult a healthcare professional if the child has a weakened immune system.

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: rotavirus

Rotavirus is a virus that primarily causes gastroenteritis, particularly in infants and young children. It is a leading cause of severe diarrhea and dehydration in children worldwide. The virus is transmitted via the fecal-oral route, often through contaminated hands, surfaces, or food. Vaccination is the primary preventive measure, which significantly reduces the incidence of rotavirus infections and associated complications.

Indications

  • Rotavirus gastroenteritis
  • Prevention of rotavirus-related diarrhea in infants and children

Dosage

Children: Refer to the BNF for Children for specific vaccination schedules and dosing information related to rotavirus vaccination.

Mechanism of action

Rotavirus infects and replicates in the epithelial cells of the small intestine. The virus disrupts the normal function of these cells, leading to malabsorption of nutrients and water. The infection triggers an inflammatory response, resulting in increased intestinal permeability, secretion of electrolytes and water into the intestinal lumen, and subsequent diarrhea.

Pharmacodynamics

The body's immune response plays a crucial role in controlling rotavirus infections. The production of antibodies against rotavirus is stimulated by natural infection and vaccination. These antibodies help neutralize the virus and prevent future infections. The severity of the disease is often related to the host's immune status and the age of the child at the time of infection.

Pharmacokinetics

As a virus, rotavirus does not follow traditional pharmacokinetic profiles like absorption, distribution, metabolism, and excretion seen with drugs. Instead, the focus is on the replication cycle of the virus within the host's intestinal cells and the resultant immune response. The stability of rotavirus outside the host is significant for transmission, as it can survive on surfaces for long periods.

Contra-indications

  • Severe allergic reaction to any component of the vaccine
  • History of intussusception
  • Severe combined immunodeficiency (SCID)
  • Moderate or severe acute illness

Adverse effects

  • Diarrhea
  • Vomiting
  • Fever
  • Irritability
  • Intussusception (rarely)
  • Allergic reactions (rare)

Interactions

  • Immunosuppressive therapies may reduce vaccine efficacy
  • Other live vaccines should generally be given at the same visit or separated by at least 4 weeks

Precautions

  • Monitor for signs of intussusception after vaccination
  • Use with caution in individuals with a history of gastrointestinal disorders
  • Pregnant women should not receive the vaccine

Pregnancy

The vaccine is not recommended during pregnancy due to lack of safety data.

Breast-feeding

Safe to use during breastfeeding; no contraindications.

Storage

Store in a refrigerator (2°C to 8°C). Do not freeze.

Formulations

  • Oral suspension for vaccination

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.