Registered Zambia · ZAMRA

Rotavac® 5.0ml Vaccine (10 doses)

Rotavirus 116E Live Attenuated+ Oral

What it does

Attenuated refers to a weakened form of a virus or bacteria used in vaccines to help the body build immunity.

Commonly used for: prevention of infectious diseases through vaccination

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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

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Sourcing - Kenya only

Registration & product details

Registration no.
233/006
Registration date
2026-01-15
Expiry date
2031-01-14
Status
Registered/Compliant
Active ingredient
Rotavirus 116E Live Attenuated+ Oral
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Bharat Biotech
Country of origin
India
Manufacturer location
BBIL, Genome Valley Rd, Shamirpet, Turkapally, Hyderabad, Telangana 500101, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:07:52 · updated 2026-09-17 03:39:56

Drug Interactions

5
Check interactions

Unknown (5)

Live - decreases efficacy

Aciclovir is predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live).

Unknown Theoretical

Live - affects response

COVID-19vaccinemightaffecttheresponsetolivevaccines (herpes-zostervaccine,live).UKHSAadvisesseparating administrationby7days.oTheoretical Cranberry

Unknown Theoretical

Live - decreases efficacy

Famciclovir is predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live). Theoretical Famotidine → see H2 receptor antagonists Fampridine

Unknown Theoretical

Live - decreases efficacy

Normal immunoglobulin is predicted to decrease the efficacy of live vaccines (Bacillus Calmette-Guérin vaccine, herpes-zoster vaccine, live, influenza vaccine (live), measles, mumps and rubella vaccin

Unknown Theoretical

Live - decreases efficacy

Valacicloviris predicted to decrease the efficacy of live vaccines (herpes-zoster vaccine, live).

Unknown Theoretical

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

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

About attenuated

Attenuated refers to a weakened form of a virus or bacteria used in vaccines to help the body build immunity.

What it treats

  • prevention of infectious diseases through vaccination

How it works

Attenuated vaccines stimulate the immune system to recognize and fight off the actual disease by using a weakened version of the germ.

Who it's for

People of various ages, depending on the specific vaccine, to help prevent certain infections.

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

About live

Live vaccines help your body build protection against certain diseases using weakened forms of the virus or bacteria.

What it treats

  • measles
  • mumps
  • rubella
  • chickenpox
  • yellow fever

How it works

Live vaccines stimulate your immune system to recognize and fight off infections by using a weakened version of the germ that causes the disease.

Who it's for

Live vaccines are typically given to children and adults to protect against specific infectious diseases.

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: attenuated

Attenuated vaccines contain live microorganisms that have been weakened (attenuated) so that they cannot cause disease in healthy individuals. These vaccines are designed to stimulate a robust immune response, leading to long-lasting immunity without causing the illness associated with the pathogen.

Indications

  • Measles
  • Mumps
  • Rubella
  • Yellow fever
  • Varicella (chickenpox)
  • Rotavirus

Dosage

Children: Refer to specific vaccine guidelines for paediatric dosing.

Adults: Refer to specific vaccine guidelines for adult dosing.

Mechanism of action

Attenuated vaccines work by mimicking a natural infection. The weakened pathogen replicates in the body, stimulating the immune system to produce a response against it, which includes the activation of T-cells and the production of antibodies. This prepares the immune system to recognize and fight off the pathogen if exposed in the future.

Pharmacodynamics

The pharmacodynamics of attenuated vaccines involve the interaction of the attenuated pathogen with the host's immune system. Upon administration, the vaccine induces both humoral (antibody-mediated) and cell-mediated immunity. This leads to the development of memory cells that ensure a faster and more effective response upon subsequent exposure to the actual pathogen.

Pharmacokinetics

Attenuated vaccines are generally administered via subcutaneous or intramuscular injection. The pharmacokinetics are characterized by the distribution of the vaccine components within the body, with the attenuated organisms replicating locally and inducing an immune response. The onset of immunity typically occurs within weeks, and the duration of immunity can vary depending on the specific vaccine.

Contra-indications

  • Severe immunodeficiency
  • Pregnant women (specific live attenuated vaccines)
  • Severe allergic reactions to vaccine components

Adverse effects

  • Injection site reactions (pain, swelling, redness)
  • Low-grade fever
  • Malaise
  • Rash
  • Rare neurological complications (e.g., Guillain-Barré syndrome)

Interactions

  • Immunosuppressive agents (may reduce vaccine efficacy)
  • Blood products (may interfere with immune response to vaccine)
  • Other live vaccines (timing may affect immune response)

Precautions

  • History of allergic reactions to previous vaccinations
  • Presence of active infections
  • Chronic illnesses that may affect immune response

Pregnancy

Live attenuated vaccines are generally contraindicated during pregnancy due to potential risks to the fetus.

Breast-feeding

Most live attenuated vaccines are considered safe during breastfeeding, but caution and consultation with a healthcare provider are advised.

Storage

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

Formulations

  • Injectable suspension
  • Oral suspension
  • Lyophilized powder for reconstitution

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: live

Live vaccines contain live attenuated forms of pathogens that are used to stimulate an immune response without causing the disease in healthy individuals. They are effective in preventing various infectious diseases by inducing long-lasting immunity. However, live vaccines are contraindicated in immunocompromised patients due to the risk of severe infections.

Indications

  • Measles
  • Mumps
  • Rubella
  • Varicella (chickenpox)
  • Yellow fever
  • Rotavirus
  • Intranasal influenza

Dosage

Children: Refer to the BNF for Children for specific dosing information based on age and vaccine type.

Adults: Refer to specific product guidelines for dosing information, as it can vary by vaccine type and brand.

Mechanism of action

Live vaccines work by introducing a weakened or attenuated form of a pathogen into the body. This stimulates the immune system to recognize and respond to the pathogen, leading to the production of antibodies and memory cells that provide long-term protection against future infections by the same pathogen.

Pharmacodynamics

The pharmacodynamics of live vaccines involve the activation of both humoral and cellular immunity. Following vaccination, the immune system generates a robust response, including the production of specific antibodies and the activation of T cells that can recognize and eliminate infected cells. This dual action helps establish long-term immunity.

Pharmacokinetics

The pharmacokinetics of live vaccines vary depending on the specific vaccine. Generally, the vaccine is administered via injection, allowing the live attenuated organisms to enter the bloodstream. The immune response typically begins within days and can last for years, depending on the vaccine. Live vaccines are usually stored under refrigeration to maintain their viability, and they should be administered within their expiration dates.

Interactions

  • livevaccines + abrocitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + baricitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + filgotinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + dexrazoxane: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + iron chelators: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + ozanimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + ponesimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + siponimod: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + upadacitinib: Severe (increases risk of generalised infection (possibly life-threatening))
  • livevaccines + diroximelfumarate: Moderate (increases risk of generalised infection (possibly life-threatening))

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.