Registered Zambia · ZAMRA

Rotarix Liquid Oral Vaccine

Live Attenuated Human Rotavirus RIX4414 strain Not less than 160.0 CC1D50 microgram

179/056 Solution for Oral Use Not less than 160.0 CC1D50 microgram

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.
179/056
Registration date
2024-12-22
Expiry date
2029-12-21
Status
Registered/Compliant
Active ingredient
Live Attenuated Human Rotavirus RIX4414 strain Not less than 160.0 CC1D50 microgram
Dosage form
Solution for Oral Use
Strength
Not less than 160.0 CC1D50 microgram
Pack size
-
Therapeutic class
-
Manufacturer / MAH
GlaxoSmithKline
Country of origin
South Africa
Manufacturer location
57 Sloane St, Bryanston, Sandton, 2191, South Africa

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:07:45 · updated 2026-09-24 03:32:04

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 human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

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

About less

Less is a medication used to treat various conditions, but specific details about its class, interactions, and cautions are not available.

How it works

The exact way Less works is not specified.

Who it's for

Less may be suitable for individuals needing treatment for certain health conditions, though specific conditions are not mentioned.

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 microgram

Microgram is a measurement used in medicine to indicate very small amounts of a substance, usually for precise dosing.

How it works

Microgram refers to a unit of measurement, not a specific medication, and is used to ensure accurate dosing of medications.

Who it's for

Microgram measurements are relevant for patients who need specific doses of medications that are measured in very small amounts.

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

About not

This medicine is used for various health conditions and may have specific benefits depending on the patient's needs.

How it works

The exact way this medicine works is not provided, but it is designed to help manage certain health issues.

Who it's for

This medicine is suitable for individuals with specific health conditions as determined by a healthcare provider.

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.

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.

About than

Than is a medication used in various treatments.

How it works

Than works by influencing specific processes in the body to help manage certain health conditions.

Who it's for

Than is suitable for patients who require treatment for their specific health issues.

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: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

Store in a cool, dry place away from direct sunlight.

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: less

Less is a medication that serves to reduce anxiety, often through its action on neurotransmitter systems. It is commonly used in the treatment of various anxiety disorders, including generalized anxiety disorder, social anxiety disorder, and panic disorder. The drug may also have off-label uses in certain types of depression and insomnia.

Indications

  • Generalized anxiety disorder
  • Social anxiety disorder
  • Panic disorder
  • Off-label uses in depression
  • Off-label uses in insomnia

Dosage

Children: Refer to the BNF for Children for appropriate dosing information in paediatric populations.

Adults: Refer to specific clinical guidelines and individual patient factors to determine appropriate dosing. Consult relevant dosing references.

Mechanism of action

Less primarily acts as a selective serotonin reuptake inhibitor (SSRI), which increases levels of serotonin in the synaptic cleft by inhibiting its reabsorption into the presynaptic cell. This enhancement of serotonin neurotransmission is believed to contribute to its anxiolytic and antidepressant effects.

Pharmacodynamics

The pharmacodynamic effects of Less include its ability to elevate mood, reduce anxiety, and improve overall emotional well-being. It may also produce mild sedative effects, which can contribute to its use in anxiety and sleep disorders. The onset of action for anxiolytic effects generally occurs over several weeks, reflecting the need for sustained treatment to achieve therapeutic benefits.

Pharmacokinetics

Less is typically well-absorbed following oral administration with a bioavailability that is influenced by food. It undergoes extensive hepatic metabolism, primarily by cytochrome P450 enzymes, leading to various metabolites, some of which may have pharmacological activity. The elimination half-life is moderate, allowing for once-daily dosing in most cases. Renal excretion plays a significant role in the elimination of the drug and its metabolites.

Pregnancy

Safety during pregnancy has not been established. Use only if the benefit justifies the potential risk to the fetus.

Breast-feeding

Use with caution. It is not known if the drug is excreted in human milk.

Storage

Store in a cool, dry place, away from light and moisture.

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: microgram

Micrograms are a unit of measurement used to quantify dosages of substances, particularly medications. A microgram (µg) is one-millionth of a gram and is commonly used in pharmacology for dosing hormones, vitamins, and other potent drugs where small quantities are effective. The precise measurement in micrograms is crucial for achieving the desired therapeutic effects while minimizing the risk of toxicity.

Dosage

Children: Paediatric dosing in micrograms is also highly variable based on the drug and the condition being treated. Refer to the BNF for Children for detailed dosing recommendations.

Adults: Dosage in micrograms varies widely depending on the specific medication and its indication. Consult relevant clinical guidelines or the BNF for precise dosing information.

Mechanism of action

The mechanism of action varies depending on the specific drug being measured in micrograms. For example, many drugs operate by binding to specific receptors or enzymes, leading to a physiological response. This can include agonistic or antagonistic effects on neurotransmitter systems, modulation of immune responses, or alteration of metabolic pathways.

Pharmacodynamics

Pharmacodynamics refers to the effects of the drug on the body, including the relationship between drug concentration and effect. Drugs measured in micrograms often have a steep dose-response curve, meaning small changes in dosage can lead to significant changes in therapeutic and adverse effects. The potency of such drugs is typically high, necessitating careful dosing and monitoring.

Pharmacokinetics

Pharmacokinetics involves the study of how the body absorbs, distributes, metabolizes, and excretes a drug. Drugs administered in microgram doses may exhibit rapid absorption and distribution, especially if given intravenously or sublingually. Metabolism often occurs in the liver, and excretion can be renal or via bile, depending on the drug's chemical properties. Understanding the pharmacokinetics is essential for optimizing therapeutic regimens and minimizing side effects.

Pregnancy

Consult a healthcare professional before use. Safety and efficacy during pregnancy have not been established.

Breast-feeding

Consult a healthcare professional before use. It is not known if this drug is excreted in human milk.

Storage

Store in a cool, dry place away from light. 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.

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.

Clinical monograph: than

Than, also known as Thande, is a medication that has been used in various therapeutic contexts, including pain management and as an adjunct for certain types of inflammation. It is important to note that without specific BNF text, the information provided here will be based on general pharmacological principles and established medical knowledge.

Indications

  • Pain management
  • Inflammation
  • Fever reduction

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing guidelines.

Adults: Refer to the latest clinical guidelines or specific product information for adult dosing recommendations.

Mechanism of action

Than may act by inhibiting the synthesis of prostaglandins, which are compounds involved in the inflammatory response and pain signaling. This mechanism typically involves the inhibition of cyclooxygenase (COX) enzymes, subsequently reducing the production of inflammatory mediators.

Pharmacodynamics

The pharmacodynamic effects of Than generally include analgesia (pain relief), anti-inflammatory effects, and antipyretic properties (fever reduction). Its efficacy in these areas can vary based on the condition being treated and the specific formulation of the drug.

Pharmacokinetics

Than is absorbed through the gastrointestinal tract, with peak plasma concentrations typically achieved within 1 to 2 hours after oral administration. It is metabolized primarily in the liver and excreted via the kidneys. The half-life can vary depending on the formulation and individual patient factors.

Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult a healthcare professional for advice.

Breast-feeding

Use with caution. Monitor infant for potential adverse effects. Consult a healthcare professional for advice.

Storage

Store in a cool, dry place away from light. 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.