International reference: 6 US FDA recalls for this ingredient

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (prepared)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (prepared)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (prepared)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (prepared)

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. (prepared)

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. (prepared)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

Registered Kenya · PPB

INDIRAB

PURIFIED INACTIVATED LYOPHILIZED RABIES VACCINE PREPARED ON VERO CELLS

H2008/19253/620 2.5 I.U.

What it does

Cells are the basic building blocks of all living organisms, playing a crucial role in growth, repair, and maintenance of the body.

Commonly used for: general health, tissue repair, growth and development

Read more in plain English ↓

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

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Registration & product details

Registration no.
H2008/19253/620
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
PURIFIED INACTIVATED LYOPHILIZED RABIES VACCINE PREPARED ON VERO CELLS
Dosage form
2.5 I.U.
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Phillips Therapeutics
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
Embakasi South, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:58:53 · updated 2026-03-23 04:44:01

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About cells

Cells are the basic building blocks of all living organisms, playing a crucial role in growth, repair, and maintenance of the body.

What it treats

  • general health
  • tissue repair
  • growth and development

How it works

Cells function by carrying out various biological processes that support life, such as energy production, nutrient absorption, and waste removal.

Who it's for

Everyone, as all living beings are made up of cells.

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

About inactivated

Inactivated vaccines help your body build protection against certain diseases without causing the disease itself.

What it treats

  • prevention of infectious diseases

How it works

Inactivated vaccines contain viruses or bacteria that have been killed or inactivated, so they cannot cause disease. They stimulate your immune system to recognize and fight off the real infection if you are exposed in the future.

Who it's for

These vaccines are generally given to people of all ages, based on specific health recommendations.

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

About lyophilized

Lyophilized refers to a method of freeze-drying substances, often used to preserve medicines for better stability and longer shelf life.

How it works

Lyophilization removes moisture from a substance, keeping its properties intact, making it easier to store and use.

Who it's for

This process is used for various pharmaceutical products, but specific applications depend on the individual medicine.

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

About prepared

Prepared is used to treat various health conditions, but specific details about its class and interactions are not provided.

How it works

Information on how Prepared works is not available.

Who it's for

Prepared may be 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 purified

Purified ingredients are often used in various medicines to ensure safety and effectiveness by removing impurities.

What it treats

  • various medical conditions

How it works

Purified ingredients help in delivering the intended effects of the medicine without the risk of contaminants.

Who it's for

People who need medications with safe and effective ingredients.

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

About rabies

Rabies is a viral infection that affects the brain and spinal cord, usually transmitted through animal bites.

What it treats

  • protection against rabies after exposure
  • post-exposure prophylaxis for rabies

How it works

Rabies vaccines help your body build immunity against the rabies virus.

Who it's for

This treatment is for anyone who has been bitten by an animal that may carry rabies.

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

About vaccine

Vaccines help protect against certain diseases by training your immune system to recognize and fight off specific germs.

What it treats

  • prevention of infectious diseases
  • immunization against viruses and bacteria

How it works

Vaccines stimulate your body's immune system to produce a response, creating memory cells that help fight off future infections.

Who it's for

Vaccines are for everyone, especially infants, children, and adults who need protection against certain diseases.

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

About vero

Vero is a medication used to treat various health conditions.

How it works

Vero helps to improve health by acting on specific pathways in the body.

Who it's for

Vero is for individuals who are prescribed this medication by their healthcare provider.

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

Clinical monograph: cells

Cells are the basic structural and functional units of all living organisms. They serve various roles depending on their type, including energy production, metabolism, and response to stimuli. Cells can be classified into prokaryotic and eukaryotic cells, with eukaryotic cells further divided into animal, plant, and fungal cells. Each type of cell has distinct organelles and functions.

Dosage

Children: Refer to pharmacological literature for specific dosing guidelines based on the drug and condition being treated.

Adults: Refer to pharmacological literature for specific dosing guidelines based on the drug and condition being treated.

Mechanism of action

Cells perform their functions through complex biochemical processes including signal transduction, gene expression, and energy metabolism. These processes are regulated by various molecules such as enzymes, hormones, and signaling pathways that facilitate communication within and between cells.

Pharmacodynamics

Pharmacodynamics in the context of cells refers to how cells respond to various drugs or stimuli. This includes receptor activation, intracellular signaling cascades, and modifications of cellular behavior such as proliferation, differentiation, or apoptosis. The response can vary greatly depending on the cell type and the specific conditions.

Pharmacokinetics

Pharmacokinetics involves how substances are absorbed, distributed, metabolized, and excreted by cells. For drugs, this includes how they enter cells, their distribution within cellular compartments, metabolic conversion to active or inactive forms, and ultimate removal from the body. Each of these processes significantly influences the efficacy and safety of pharmacological interventions.

Pregnancy

Cell therapy and manipulation during pregnancy require caution. The effects on fetal development depend on the type of cells used and the intended application.

Breast-feeding

The implications of cell therapy during breastfeeding are not well studied, and caution is advised.

Storage

Cells should be stored in controlled environments, typically at low temperatures to maintain viability, such as liquid nitrogen for cryopreserved cells.

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: inactivated

Inactivated vaccines are a type of immunization that use pathogens that have been killed or inactivated through physical or chemical processes. Unlike live vaccines, inactivated vaccines do not replicate in the host but still stimulate an immune response. These vaccines are generally considered safe and are commonly used to prevent various infectious diseases.

Indications

  • Hepatitis A
  • Hepatitis B
  • Influenza
  • Polio
  • Rabies
  • Typhoid fever

Dosage

Children: Refer to specific product guidelines for paediatric dosing, as it varies by vaccine type and indication.

Adults: Refer to specific product guidelines for adult dosing, as it varies by vaccine type and indication.

Mechanism of action

Inactivated vaccines work by introducing a form of the pathogen that cannot cause disease into the body. This stimulates the immune system to produce antibodies and memory cells specific to the pathogen, allowing for a robust immune response upon future exposure. The immune system recognizes the inactivated pathogen as foreign, leading to the activation of T-cells and B-cells, which are crucial for long-term immunity.

Pharmacodynamics

The pharmacodynamics of inactivated vaccines involve the generation of an adaptive immune response. After vaccination, the body produces specific antibodies against the inactivated pathogen. The response typically includes both humoral immunity, characterized by antibody production, and cellular immunity, involving T-cell activation. The duration of immunity can vary, and booster doses may be required to maintain adequate protection.

Pharmacokinetics

Inactivated vaccines do not have a pharmacokinetic profile like traditional drugs since they do not enter systemic circulation in the same manner. Following administration, the vaccine components are taken up by antigen-presenting cells, which process and present the antigens to T-cells. The immune response is initiated locally at the site of injection and can be influenced by factors such as the route of administration and the presence of adjuvants that enhance the immune response.

Adverse effects

  • Injection site reactions (pain, swelling, redness)
  • Fever
  • Fatigue
  • Headache
  • Myalgia
  • Chills

Precautions

  • Assess for allergies to vaccine components
  • Monitor for allergic reactions post-administration
  • Consider underlying health conditions that may affect immune response

Pregnancy

Inactivated vaccines are generally considered safe during pregnancy, but individual risk-benefit assessment is recommended.

Breast-feeding

Inactivated vaccines can be administered during breastfeeding without concern for adverse effects in the infant.

Storage

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

Formulations

  • Inactivated viral vaccines
  • Inactivated bacterial vaccines

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: lyophilized

Lyophilized drugs refer to pharmaceutical compounds that have undergone the freeze-drying process, resulting in a stable, powdered form that can be reconstituted for administration. This method enhances the stability and shelf-life of sensitive compounds, such as proteins, peptides, and vaccines. Lyophilization is commonly used for biologics and some antibiotics, allowing for easier storage and transport without the need for refrigeration.

Indications

  • Vaccination
  • Antibiotic therapy
  • Hormone replacement therapy
  • Enzyme replacement therapy
  • Immunotherapy

Dosage

Children: Refer to specific drug information for dosing guidelines, as this varies widely based on the active ingredient and indication.

Adults: Refer to specific drug information for dosing guidelines, as this varies widely based on the active ingredient and indication.

Mechanism of action

Lyophilization itself does not have a mechanism of action, as it is a preservation technique rather than a pharmacologically active process. The mechanism of action of the lyophilized drug will depend on the specific active pharmaceutical ingredient (API) that has been lyophilized. For example, if the lyophilized drug is a vaccine, its mechanism may involve the stimulation of the immune response through the introduction of antigens.

Pharmacodynamics

The pharmacodynamics of a lyophilized drug will vary based on the specific formulation and active ingredients. Generally, once reconstituted, the pharmacodynamic properties will reflect those of the non-lyophilized form. Factors such as bioavailability, receptor binding, and the drug's effects on physiological systems will be determined by the specific drug's characteristics.

Pharmacokinetics

The pharmacokinetics of a lyophilized drug will also depend on the specific API. Once reconstituted, the drug's absorption, distribution, metabolism, and excretion (ADME) profile will align with that of the non-lyophilized version. The freeze-drying process is designed to minimize degradation, maintaining the pharmacokinetic properties of the drug post-reconstitution.

Pregnancy

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

Breast-feeding

Caution is advised when administering during breastfeeding. The effects on a nursing infant are not known.

Storage

Store in a cool, dry place. Protect from light and moisture. Follow specific storage recommendations for individual formulations.

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: prepared

Prepared refers to a class of substances that are processed or formulated for specific therapeutic uses, often in the context of pharmaceutical preparations. These preparations can include various forms such as tablets, capsules, syrups, and injections, tailored to deliver active ingredients effectively to patients.

Dosage

Children: Refer to the specific preparation’s guidelines for paediatric dosing information.

Adults: Refer to the specific preparation’s guidelines for dosing information.

Mechanism of action

The mechanism of action varies widely depending on the specific active ingredients within the prepared formulation. Generally, these mechanisms involve interactions with biological targets such as receptors, enzymes, or cellular processes to elicit a desired therapeutic effect.

Pharmacodynamics

Pharmacodynamics of prepared substances depend on their active components. They may exhibit actions ranging from agonistic or antagonistic effects on receptors, modulation of enzyme activity, or alteration of cellular signaling pathways. The specific dynamics will determine the onset, intensity, and duration of therapeutic effects.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of the drug. For prepared drugs, absorption can be influenced by the formulation type, with some forms being rapidly absorbed while others are designed for slow release. Distribution is often determined by the lipophilicity of the drug and its ability to cross biological membranes. Metabolism typically occurs in the liver, and excretion may happen through the kidneys or bile, depending on the drug's chemical properties.

Pregnancy

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

Breast-feeding

Caution is advised. The effects on a nursing infant are unknown; consider the importance of the drug to the mother.

Storage

Store in a cool, dry place away from light. Ensure the container is tightly closed.

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: purified

Purified refers to a substance that has been processed to remove impurities, contaminants, or unwanted substances, resulting in a more concentrated and effective form of the original compound. In pharmacology, purified compounds are often used to enhance therapeutic efficacy and reduce adverse effects. The purification process can apply to a variety of substances, including drugs, biological products, and chemical compounds.

Dosage

Children: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Adults: Refer to specific drug formulations and product labels as purified substances can vary widely in their use and dosing.

Mechanism of action

The mechanism of action for purified compounds varies widely depending on the specific substance. Generally, purified drugs exert their effects by interacting with specific biological targets, such as receptors, enzymes, or ion channels, leading to a desired therapeutic effect. This interaction can involve binding to receptors to activate or inhibit signaling pathways, modulating enzymatic activity, or altering physiological processes.

Pharmacodynamics

Pharmacodynamics describes the effects of a drug on the body and the relationship between drug concentration and effect. For purified drugs, this can involve dose-response relationships and the time course of their action. The purified form often enhances potency and reduces variability in response among patients, which can lead to more predictable therapeutic outcomes. The overall effect is determined by the drug's affinity for its target, the efficacy of the drug-receptor interaction, and the downstream signaling pathways activated as a result of this interaction.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of a drug. For purified substances, absorption can be more efficient due to the absence of impurities that may affect solubility or stability. Distribution may also be enhanced, leading to higher bioavailability. Metabolism can be influenced by the structure of the purified compound, as it may be metabolized more readily by liver enzymes. Excretion typically occurs through the kidneys or liver, depending on the molecular characteristics of the purified drug.

Pregnancy

Consult with a healthcare professional, as the safety of purified forms of medications during pregnancy may vary depending on the specific substance.

Breast-feeding

Consult with a healthcare professional, as the safety of purified forms of medications during breastfeeding may vary depending on the specific substance.

Storage

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

Rabies is a viral disease caused by the rabies virus, which primarily affects mammals, including humans. It is transmitted through the saliva of infected animals, commonly via bites. The disease is characterized by encephalitis and can lead to severe neurological symptoms, and is often fatal if not treated promptly. Vaccination is a critical preventive measure, particularly for individuals at high risk of exposure, such as veterinary staff and travelers to endemic areas.

Indications

  • Rabies prevention in individuals at high risk of exposure
  • Post-exposure prophylaxis following potential rabies exposure
  • Vaccination for travelers to endemic regions

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations for pediatric patients.

Adults: Refer to the BNF for specific dosing guidelines, as it varies based on exposure risk and vaccination history.

Mechanism of action

The rabies vaccine works by stimulating the immune system to produce antibodies against the rabies virus. This is achieved through the introduction of inactivated or attenuated virus particles, which mimic the infection without causing the disease. The immune response generated helps to prevent the virus from causing illness upon subsequent exposure.

Pharmacodynamics

The rabies vaccine induces an adaptive immune response, leading to the production of neutralizing antibodies specific to the rabies virus. This immune memory protects against future infections. The vaccine is typically administered in a series of doses to ensure adequate immune response and long-term protection.

Pharmacokinetics

The pharmacokinetics of the rabies vaccine involve absorption at the injection site, followed by systemic distribution of the antigens. The onset of immunity generally occurs within two weeks after the initial vaccination, with peak antibody levels typically reached within one to two months. The duration of immunity can vary, necessitating booster doses in certain populations.

Interactions

  • chloroquine+rabiesvaccine: Severe (decreases efficacy)

Pregnancy

Rabies vaccination is generally considered safe during pregnancy. However, the risks and benefits should be carefully evaluated.

Breast-feeding

Rabies vaccine is not known to cause any adverse effects in breastfeeding. However, consult with a healthcare provider for individual assessments.

Storage

Store the rabies vaccine in a refrigerator at 2-8 degrees Celsius. 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: vaccine

Vaccines are biological preparations that provide acquired immunity to a particular infectious disease. They contain antigens that stimulate the immune system to recognize and fight pathogens without causing the disease itself. Vaccines can be made from live attenuated pathogens, inactivated pathogens, subunit components, or mRNA. They are crucial in preventing infectious diseases and have significantly reduced morbidity and mortality worldwide.

Indications

  • Prevention of infectious diseases such as measles, mumps, rubella, hepatitis B, influenza, and human papillomavirus (HPV)
  • Travel vaccinations for diseases endemic to certain regions
  • Vaccination for at-risk populations, such as those with compromised immune systems or specific occupational exposures

Dosage

Children: Dosage varies by vaccine type and age; refer to the BNF for Children for specific dosing information.

Adults: Dosage varies by vaccine type and indication; refer to specific guidelines for each vaccine.

Mechanism of action

Vaccines work by mimicking an infection. They introduce a harmless component of a pathogen (antigen) to the immune system, prompting the body to produce an immune response. This includes the generation of antibodies and memory cells that provide long-term immunity. Upon subsequent exposure to the actual pathogen, the immune system is primed to respond more rapidly and effectively.

Pharmacodynamics

The pharmacodynamics of vaccines involves the activation of both humoral and cellular immunity. Vaccines stimulate B cells to produce antibodies against the pathogen, while T cells are activated to destroy infected cells. This dual response helps to establish immunological memory, which enables a faster and more robust response upon re-exposure to the pathogen.

Pharmacokinetics

Vaccines are administered via various routes, including intramuscular, subcutaneous, and oral. After administration, the antigens are presented to antigen-presenting cells, which activate T cells and stimulate B cell proliferation and differentiation. The half-life of vaccine-induced immunity varies depending on the type of vaccine, with some providing lifelong immunity and others requiring booster doses to maintain protection.

Contra-indications

  • Severe allergic reaction (anaphylaxis) to a component of the vaccine
  • Severe immunocompromised state for live attenuated vaccines

Adverse effects

  • Local reactions at the injection site (pain, redness, swelling)
  • Fever
  • Fatigue
  • Headache
  • Muscle pain
  • Joint pain
  • Nausea

Interactions

  • Immunosuppressive medications may reduce vaccine efficacy
  • Concurrent administration of some vaccines may require spacing to optimize immune response

Precautions

  • History of allergic reactions to vaccines or vaccine components
  • Pregnancy (specific vaccines may be contraindicated)
  • Moderate to severe acute illness with or without fever

Pregnancy

Consult healthcare provider. Some vaccines are contraindicated during pregnancy, while others are recommended.

Breast-feeding

Generally considered safe, but consult healthcare provider regarding specific vaccines.

Storage

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

Formulations

  • Liquid suspension for injection
  • 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: vero

Vero is a brand name that may refer to various medications. However, without specific context, it is essential to clarify the exact active ingredient. Generally, the name may be associated with products such as Vero-Dexamethasone or other formulations. Dexamethasone is a synthetic glucocorticoid used for its anti-inflammatory and immunosuppressive properties. It is commonly administered in conditions requiring corticosteroid therapy, including severe allergies, skin conditions, and certain types of cancer.

Indications

  • Allergic conditions
  • Autoimmune diseases
  • Inflammatory conditions
  • Certain cancers
  • Asthma exacerbations
  • Chronic obstructive pulmonary disease (COPD)

Dosage

Children: Refer to the BNF for Children for pediatric dosing recommendations, as these will depend on the child's age, weight, and specific clinical condition.

Adults: Refer to the specific BNF for appropriate dosing information based on the condition being treated. Dosage varies widely depending on the severity of the condition and the specific formulation used.

Mechanism of action

Dexamethasone binds to glucocorticoid receptors in the cytoplasm of target cells, leading to the formation of a receptor-hormone complex that translocates to the nucleus. This complex then modulates gene expression, resulting in the inhibition of pro-inflammatory cytokines and mediators, thus exerting potent anti-inflammatory and immunosuppressive effects.

Pharmacodynamics

Dexamethasone exhibits anti-inflammatory properties by reducing the migration of leukocytes and the production of cytokines. It suppresses the immune response and decreases capillary permeability, which helps in alleviating symptoms associated with inflammation. Its effects can be observed in various conditions, including autoimmune disorders, asthma, and as part of anti-cancer regimens.

Pharmacokinetics

Dexamethasone is rapidly absorbed when administered orally and reaches peak plasma concentrations within 1 to 2 hours. It has a high protein binding rate, primarily to albumin and corticosteroid-binding globulin. The drug is metabolized predominantly in the liver and has a half-life of approximately 3 to 4 hours. It is excreted mainly through urine as metabolites.

Pregnancy

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

Breast-feeding

It is unknown whether vero is excreted in human milk. Caution should be exercised when administered to nursing women.

Storage

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