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

ROTAVAC

ROTAVIRUS, STRAIN 116E

2023/18.2/6387 VACCINE 10^5.0 FFU/0.5ML

What it does

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

Commonly used for: diarrhea caused by rotavirus, gastroenteritis (stomach flu)

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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.
2023/18.2/6387
Registration date
2023-03-17
Expiry date
2028-03-17
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
ROTAVIRUS, STRAIN 116E
Dosage form
VACCINE
Strength
10^5.0 FFU/0.5ML
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Bharat Biotech
Country of origin
-
Manufacturer location
BBIL, Genome Valley Rd, Shamirpet, Turkapally, Hyderabad, Telangana 500101, India

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

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). Always consult a qualified healthcare professional before using any medication.

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.

About strain

Strain is a type of medicine used to help with various health conditions.

What it treats

  • muscle pain
  • injuries
  • sports injuries

How it works

Strain helps relieve pain and reduce inflammation in the affected areas.

Who it's for

It is suitable for people experiencing muscle pain or injuries.

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

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.

Clinical monograph: strain

Strain refers to a specific variant of a microorganism, such as bacteria or viruses, that has distinct genetic characteristics. In clinical contexts, strains are often discussed in relation to their pathogenicity, resistance to antibiotics, and epidemiological significance. Understanding the specific strain of a pathogen is critical for effective treatment decisions and public health responses.

Indications

  • Bacterial infections
  • Viral infections
  • Epidemiological studies
  • Antibiotic resistance monitoring

Dosage

Children: Refer to specific antimicrobial treatment guidelines based on the strain identified and the infection site.

Adults: Refer to specific antimicrobial treatment guidelines based on the strain identified and the infection site.

Mechanism of action

The mechanism of action for a strain depends on the type of microorganism it represents. For pathogenic bacteria, the strain may produce toxins, evade the host's immune response, or possess resistance mechanisms that allow it to survive in the presence of antibiotics. For viruses, strains may exhibit mutations that alter their ability to infect host cells or evade antiviral therapies.

Pharmacodynamics

Pharmacodynamics in the context of strains involves the interaction between the strain and the host's immune system, as well as the effects of specific antimicrobial agents on the strain. These interactions can influence the efficacy of treatments and the development of resistance.

Pharmacokinetics

Pharmacokinetics is not directly applicable to strains themselves but rather to the drugs used to treat infections caused by specific strains. Factors such as absorption, distribution, metabolism, and excretion of antimicrobial agents can vary depending on the strain's characteristics and the site of infection.

Pregnancy

There is limited information on the safety of strain in pregnancy. It is advisable to consult healthcare professionals for guidance.

Breast-feeding

Safety during breastfeeding is not well established. It is recommended to seek medical advice before use.

Storage

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

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.