Registered South Africa · SAHPRA

ROTAVIRUS VACCINE ASPEN

LIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT G1 , FFU REASSORTANT G2 , FFU REASSORTANT G3 , FFU REASSORTANT G4 , FFU REASSORTANT G9

59/30.2/0066

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.

Ask about this medicine

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

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
59/30.2/0066
Registration date
2025/12/02
Expiry date
-
Status
Registered
Active ingredient
LIVE ATTENUATED BOVINE - HUMAN ROTAVIRUS REASSORTANT G1 , FFU REASSORTANT G2 , FFU REASSORTANT G3 , FFU REASSORTANT G4 , FFU REASSORTANT G9
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:30:16 · updated 2026-10-18 04:02:35

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 South African Health Products Regulatory Authority (South Africa). 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 bovine

Bovine is derived from cattle and is often used in various treatments.

What it treats

  • wound healing
  • tissue repair
  • certain infections

How it works

Bovine works by providing essential nutrients and proteins that help in the healing and repair processes of the body.

Who it's for

This treatment is suitable for individuals needing support for healing injuries or infections.

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

About ffu

Ffu is a medication used to treat certain health conditions.

How it works

Ffu works by affecting the body in a specific way to help manage your condition.

Who it's for

Ffu is prescribed for individuals with specific health issues as determined by a healthcare professional.

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 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 reassortant

Reassortant is a type of medication that may be used in specific treatments.

How it works

The exact way reassortant works is not specified, but it is generally involved in modifying viral components.

Who it's for

This medication is for individuals requiring targeted treatments related to viral infections.

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: bovine

Bovine refers to cattle and is not a specific drug but rather a category of livestock that can be used in various medicinal contexts. Products derived from bovine sources, such as insulin or certain immunoglobulins, have significant therapeutic applications in human medicine. Bovine-derived products are utilized for their biological activity and can be integral in treating various conditions.

Indications

  • Diabetes mellitus
  • Hypoglycemia
  • Certain immunodeficiencies
  • Replacement therapy for hormone deficiencies

Dosage

Children: Refer to the specific product guidelines for dosing, as it varies widely based on the type of bovine-derived treatment.

Adults: Refer to the specific product guidelines for dosing, as it varies widely based on the type of bovine-derived treatment.

Mechanism of action

Bovine-derived products, such as insulin from bovine pancreas, function by mimicking the action of human hormones or proteins in the body. For example, insulin facilitates glucose uptake by cells, thereby lowering blood glucose levels in diabetic patients. The mechanism of action is largely dependent on the specific bovine product in question.

Pharmacodynamics

The pharmacodynamics vary widely depending on the specific bovine product. For insulin, the pharmacodynamics involve promoting the transport of glucose into cells, inhibiting hepatic glucose production, and enhancing lipid storage. Other bovine-derived products may have different effects based on their biological functions.

Pharmacokinetics

Pharmacokinetics also depend on the specific bovine product. For bovine insulin, absorption occurs rapidly after subcutaneous administration, with a peak effect typically seen within a few hours. The half-life can vary; for example, regular insulin has a short half-life, while long-acting formulations can provide sustained effects. Distribution and elimination will also depend on the specific product and formulation.

Pregnancy

There is limited data on the use of bovine-derived products during pregnancy. Caution is advised.

Breast-feeding

Limited data available; consult healthcare provider before use.

Storage

Store in a cool, dry place away from direct sunlight. Specific storage conditions may vary based on the formulation.

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: 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: reassortant

Reassortant vaccines are a type of vaccine that utilize reassorted viruses, typically created by mixing genes from two different viruses to produce a new strain. These vaccines are primarily used in the prevention of viral infections, particularly influenza, by inducing an immune response that protects against circulating viral strains. The process of reassortment allows for the generation of viruses that can effectively mimic the pathogenic strains, thus eliciting an appropriate immune response in the host.

Indications

  • Influenza prevention
  • Viral respiratory infections
  • Pediatric vaccination programs

Dosage

Children: Refer to specific guidelines based on the type of reassortant vaccine used, as dosing can vary.

Adults: Refer to specific guidelines based on the type of reassortant vaccine used, as dosing can vary.

Mechanism of action

Reassortant viruses work by introducing specific genes from a virulent strain into a backbone of a less virulent or attenuated strain. When administered, the vaccine stimulates the immune system to recognize and respond to the surface antigens of the virus, particularly hemagglutinin and neuraminidase, leading to the production of neutralizing antibodies. This prepares the immune system to respond more effectively to natural infections by the wild-type virus.

Pharmacodynamics

The pharmacodynamics of reassortant vaccines involve the interaction between the vaccine and the immune system, leading to the activation of both humoral and cellular immunity. Following vaccination, the body produces specific antibodies against the reassorted viral antigens, enhancing the immunological memory. This results in a quicker and more robust immune response upon subsequent exposure to the actual virus, reducing the severity and duration of the disease.

Pharmacokinetics

Reassortant vaccines are typically administered via intramuscular or subcutaneous injection. After administration, the vaccine components are processed by antigen-presenting cells, leading to T-cell activation and subsequent antibody production. The onset of immunity usually occurs within a few weeks, with the duration of protective immunity varying based on the specific vaccine and population factors. Clearance of the vaccine components is primarily through normal metabolic pathways, with no specific half-life defined due to the nature of vaccines.

Pregnancy

The safety of reassortant vaccines during pregnancy is not fully established. Pregnant individuals should consult healthcare providers before vaccination.

Breast-feeding

Reassortant vaccines are generally considered safe during breastfeeding, but it is advisable to consult a healthcare professional.

Storage

Reassortant vaccines should be stored in a refrigerator at 2-8 degrees Celsius, protected from light. Do not freeze.

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.