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

GARDASIL

HUMAN PAPILLOMA VIRUS VACCINE TYPES 6, 11, 16, 18

2014/18.2/4958 INJECTABLE; INJECTION 20; 40; 40; 20 MCG

What it does

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.

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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.
2014/18.2/4958
Registration date
2014-12-11
Expiry date
2031-06-02
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
HUMAN PAPILLOMA VIRUS VACCINE TYPES 6, 11, 16, 18
Dosage form
INJECTABLE; INJECTION
Strength
20; 40; 40; 20 MCG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Merck Sharp & Dohme
Applicant / LTR
MSD (PTY) LTD
Country of origin
-
Manufacturer location
Waarderweg 39, 2031 BN Haarlem, Netherlands

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:07 · updated 2026-11-04 04:30:11

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

About 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 papilloma

Papilloma is a type of growth that can occur on the skin or inside the body. It is often benign, meaning it is not cancerous.

What it treats

  • skin growths (papillomas)
  • warts
  • genital warts

How it works

Papillomas are caused by certain types of viruses, and treatments may help remove or reduce these growths.

Who it's for

This treatment may be suitable for individuals with benign growths caused by papillomavirus.

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

About types

Types are a group of medicines used to treat various conditions.

How it works

Types work in different ways depending on their specific function.

Who it's for

Types may be prescribed for individuals with specific health issues.

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 virus

Viruses are microscopic organisms that can cause infections in humans, animals, and plants.

What it treats

  • viral infections
  • common cold
  • influenza (flu)
  • HIV/AIDS
  • hepatitis

How it works

Viruses invade living cells and use them to reproduce, which can lead to illness.

Who it's for

Viruses can affect anyone, but some groups, like those with weakened immune systems, are more at risk.

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

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: papilloma

Papilloma refers to a benign tumor that arises from epithelial tissue and is characterized by the formation of finger-like projections. These tumors are often associated with viral infections, particularly human papillomavirus (HPV). While papillomas are generally non-cancerous, certain types can be precursors to malignancies, particularly in the cervix and other anogenital areas. Treatment options may include surgical excision, cryotherapy, or laser therapy, particularly if they cause symptoms or cosmetic concerns.

Indications

  • Benign epithelial tumors
  • Human papillomavirus infections
  • Cervical dysplasia
  • Anogenital warts

Dosage

Children: Refer to specific treatment guidelines based on the type of intervention and individual patient factors, as no standard dosing is established for papilloma treatment.

Adults: Refer to specific treatment guidelines based on the type of intervention and individual patient factors, as no standard dosing is established for papilloma treatment.

Mechanism of action

Papillomas are primarily caused by the infection of epithelial cells with HPV, which integrates its viral DNA into the host cell genome. This integration disrupts normal cell cycle regulation, leading to increased cell proliferation and the characteristic growth of papillomas. The virus produces early proteins that interfere with host cell regulatory pathways, promoting the survival and replication of infected cells.

Pharmacodynamics

The pharmacodynamics of treating papillomas involve targeting the underlying viral infection and the excessive proliferation of epithelial cells. Antiviral treatments may be used to reduce the viral load, while local therapies such as cryotherapy, laser treatment, or topical agents (like imiquimod) aim to eliminate the lesions. The immune response may also be stimulated to help clear the virus.

Pharmacokinetics

The pharmacokinetics of therapies used for papillomas vary based on the specific treatment. For example, topical agents like imiquimod are applied directly to the lesion and are intended to act locally, with minimal systemic absorption. Systemic antivirals, if used, would have their own absorption, distribution, metabolism, and excretion profiles. The response to treatment can vary significantly among individuals based on factors like the immune status and the presence of co-infections.

Pregnancy

The safety of papilloma treatments during pregnancy depends on the specific agent used. Consultation with a healthcare provider is recommended.

Breast-feeding

The safety of papilloma treatments during breastfeeding depends on the specific agent used. Consultation with a healthcare provider is recommended.

Storage

Store at room temperature, away from moisture and heat. Specific storage conditions may vary depending on the formulation or treatment used.

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: types

Types are a class of medications that are used in various therapeutic applications. They often refer to specific subclasses of drugs that are categorized based on their chemical structure, mechanism of action, or therapeutic effects. Types can include, but are not limited to, analgesics, antibiotics, antihypertensives, and many others, each serving distinct clinical purposes.

Dosage

Children: Refer to specific drug information for paediatric dosing guidance.

Adults: Refer to specific drug information for dosing guidance.

Mechanism of action

The mechanism of action for drugs classified under types varies widely depending on the specific drug. Generally, they may function by inhibiting specific enzymes, blocking receptors, or modulating biological pathways to achieve their therapeutic effects.

Pharmacodynamics

Pharmacodynamics for types of drugs varies significantly depending on the specific medication. In general, pharmacodynamics describes the relationship between drug concentration and effect, including the drug's efficacy, potency, and duration of action. Common dynamics include receptor binding, post-receptor effects, and the drug's influence on physiological functions.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion (ADME) of drugs within the body. For various types of drugs, absorption may occur via oral, intravenous, or other routes, distribution is influenced by protein binding and tissue permeability, metabolism typically occurs in the liver, and excretion occurs primarily via renal pathways. Specific parameters such as half-life, bioavailability, and clearance rates depend on the particular drug type.

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: virus

Viruses are submicroscopic infectious agents that replicate only inside the living cells of an organism. They are composed of genetic material (either DNA or RNA) surrounded by a protein coat and, in some cases, an outer lipid envelope. Viruses can infect all types of life forms, from animals and plants to microorganisms, including bacteria (bacteriophages). They are responsible for a wide range of diseases, from the common cold to serious conditions such as HIV/AIDS, influenza, and COVID-19.

Indications

  • Influenza
  • HIV/AIDS
  • Hepatitis B and C
  • Herpes simplex virus infections
  • Cytomegalovirus infections
  • COVID-19
  • Respiratory syncytial virus infections

Dosage

Children: Refer to specific antiviral agents for dosing guidance.

Adults: Refer to specific antiviral agents for dosing guidance.

Mechanism of action

Viruses infect host cells by attaching to specific receptors on the cell surface. Once inside, they hijack the host cell's machinery to replicate their genetic material and produce viral proteins. New viral particles are assembled and released from the host cell, often destroying the cell in the process. The specific mechanism can vary depending on the virus type, including integration into the host genome in retroviruses or utilizing specific pathways for replication.

Pharmacodynamics

The pharmacodynamics of antiviral agents depend on the specific virus and the mechanism of action. Antiviral drugs may inhibit viral entry into host cells, block viral replication, or prevent the assembly of new virions. The effectiveness of antiviral therapy often relates to the stage of viral replication and the immune response of the host.

Pharmacokinetics

Pharmacokinetics of antiviral drugs varies widely based on the specific medication used. Generally, antiviral agents are absorbed through the gastrointestinal tract and distributed throughout the body. They may undergo hepatic metabolism and are often excreted through the kidneys. The half-life of these drugs can range from a few hours to several days, influencing dosing schedules.

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.