International reference: 5 US FDA recalls for this ingredient

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point. (particle)

Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes. (particle)

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing (particle)

Presence of Particulate Matter: Complaint received of a glass particle in the vial. (particle)

Presence of Particulate Matter: Presence of glass particle. (particle)

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

Registered Rwanda · Rwanda FDA

GARDASIL 9

Human Pappilomavirus L1 Virus Like Particle Type 6, 11, 16, 18, 31, 33, 45, 52, 58

Rwanda FDA-HBP-MA-0140 Suspension for injection Each 0.5 ml dose contains approximately: 30 ?g HPV Type 6 L1 protein, 40 ?g HPV Type 11 L1 protein, 60 ?g HPV Type 16 L1 protein, 40 ?g HPV Type 18 L1 protein, 20 ?g HPV Type 31 L1 protein, 20 ?g HPV Type 33 L1 protein, 20 ?g HPV Type 45 L1 protein, 20 ?g HPV Type 52 L1 protein, and 20 ?g HPV Type 58 L1 protein.

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.

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.
Rwanda FDA-HBP-MA-0140
Registration date
18/10/2024
Expiry date
17/10/2029
Status
Registered
Active ingredient
Human Pappilomavirus L1 Virus Like Particle Type 6, 11, 16, 18, 31, 33, 45, 52, 58
Strength
Each 0.5 ml dose contains approximately: 30 ?g HPV Type 6 L1 protein, 40 ?g HPV Type 11 L1 protein, 60 ?g HPV Type 16 L1 protein, 40 ?g HPV Type 18 L1 protein, 20 ?g HPV Type 31 L1 protein, 20 ?g HPV Type 33 L1 protein, 20 ?g HPV Type 45 L1 protein, 20 ?g HPV Type 52 L1 protein, and 20 ?g HPV Type 58 L1 protein.
Pack size
10 vials
Therapeutic class
-
Manufacturer / MAH
Merck Sharp & Dohme
Applicant / LTR
MSD Morocco
Country of origin
USA
Manufacturer location
Levelingstraße 4a, 81673 München, Germany

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:03 · updated 2026-09-17 02:30:43

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). 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 like

Like is a medication used to treat various conditions. It helps improve health and manage symptoms effectively.

What it treats

  • general health improvement
  • symptom management

How it works

Like works by supporting the body's functions and helping to maintain balance.

Who it's for

This medication is suitable for individuals seeking to improve their health or manage specific symptoms.

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

About pappilomavirus

Pappilomavirus is associated with certain viral infections that can cause warts and other related conditions.

What it treats

  • warts
  • human papillomavirus (HPV) infections

How it works

Pappilomavirus affects the skin and mucous membranes, leading to the development of warts and other lesions.

Who it's for

This treatment is for individuals with warts or HPV-related conditions.

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

About particle

Particle is a medication used to treat various health conditions. It is important to understand how it works and any precautions to take when using it.

How it works

The exact mechanism of action for Particle is not specified, but it is designed to help manage certain health issues.

Who it's for

Particle may be prescribed for individuals with specific medical conditions 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 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: like

Like, also known as a selective serotonin reuptake inhibitor (SSRI), is used primarily in the treatment of depression and anxiety disorders. It enhances mood and emotional well-being by increasing serotonin levels in the brain. Like is commonly prescribed for conditions such as major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and panic disorder.

Indications

  • Major depressive disorder
  • Generalized anxiety disorder
  • Obsessive-compulsive disorder
  • Panic disorder

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing information.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Like works by selectively inhibiting the reuptake of serotonin (5-HT) in the presynaptic neurons, leading to an increase in serotonin levels in the synaptic cleft. This increase enhances serotonergic neurotransmission, which is thought to contribute to its antidepressant and anxiolytic effects.

Pharmacodynamics

The pharmacodynamic effects of Like include increased levels of serotonin in the central nervous system, which improves mood, reduces anxiety, and alleviates symptoms of depression. The onset of therapeutic effects may take several weeks, as the drug facilitates neuronal adaptation and changes in receptor sensitivity over time.

Pharmacokinetics

Like is absorbed well from the gastrointestinal tract, with peak plasma concentrations typically occurring within 4 to 6 hours post-dose. It is extensively metabolized in the liver, primarily by cytochrome P450 enzymes, and has a half-life that allows for once-daily dosing in most cases. Excretion occurs mainly via urine, with metabolites being eliminated in both urine and feces.

Pregnancy

Data on the use of this drug in pregnancy is limited. Its use should be carefully considered against potential risks.

Breast-feeding

Caution is advised when using this drug during breastfeeding. It is recommended to assess the benefits and risks before use.

Storage

Store in a cool, dry place away from direct sunlight. Ensure it is kept 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: pappilomavirus

Papillomavirus, particularly human papillomavirus (HPV), is a group of more than 200 related viruses, some of which are known to cause warts, while others are associated with various cancers, including cervical, anal, and oropharyngeal cancers. HPV is primarily transmitted through direct skin-to-skin contact, including sexual contact. Vaccination can prevent many of the HPV types that cause disease, and screening programs are essential for early detection and management of HPV-related conditions.

Indications

  • Prevention of HPV-related diseases through vaccination
  • Screening for cervical cancer
  • Management of genital warts

Dosage

Children: Refer to specific vaccination guidelines or treatment protocols for management of HPV-related conditions.

Adults: Refer to specific vaccination guidelines or treatment protocols for management of HPV-related conditions.

Mechanism of action

HPV infects epithelial cells, where it can integrate into the host genome. The E6 and E7 viral proteins interfere with host cell cycle regulation, leading to uncontrolled cell proliferation and potential malignancy. E6 binds to and promotes degradation of p53, a key tumor suppressor protein, while E7 binds to the retinoblastoma protein (Rb), disrupting the regulation of the cell cycle.

Pharmacodynamics

The clinical effects of HPV are related to its ability to induce hyperproliferation of epithelial cells, leading to the formation of benign lesions such as warts, or precancerous lesions which may progress to cancer. The immune response plays a critical role in controlling HPV infections, and persistent infection with high-risk HPV types is a significant risk factor for the development of HPV-related cancers.

Pharmacokinetics

The pharmacokinetics of HPV are not traditionally measured like conventional drugs since it is a virus. However, the viral lifecycle involves initial infection of keratinocytes followed by replication within the host cells. The clinical manifestations depend on the host immune response and can vary widely from benign warts to malignant lesions over time.

Adverse effects

  • Local irritation
  • Itching
  • Burning sensation
  • Inflammation at the application site

Precautions

  • Use with caution in individuals with sensitive skin
  • Avoid application on broken skin
  • Consult a healthcare professional before use in immunocompromised patients

Pregnancy

Consult a healthcare professional before use, as safety during pregnancy has not been fully established.

Breast-feeding

Consult a healthcare professional before use, as safety during breastfeeding has not been fully established.

Storage

Store in a cool, dry place away from direct sunlight, and keep out of reach of children.

Formulations

  • Topical solution
  • Cream
  • Gel

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: particle

Particle refers to a small localized object to which can be ascribed physical properties. In pharmacology, this term can relate to drug formulations that utilize particle size to enhance the pharmacokinetics and pharmacodynamics of a drug. For instance, nanoparticles are often used in drug delivery systems to improve bioavailability, targeting, and controlled release of therapeutics.

Dosage

Children: Refer to specific formulation guidelines or literature for dosage recommendations, as this varies widely depending on the drug and its formulation.

Adults: Refer to specific formulation guidelines or literature for dosage recommendations, as this varies widely depending on the drug and its formulation.

Mechanism of action

The mechanism of action of particles in drug formulations often involves enhancing solubility, stability, and absorption of the active pharmaceutical ingredient. Nanoparticles can facilitate cellular uptake through endocytosis, allowing for targeted delivery to specific tissues or cells, which can improve therapeutic efficacy and reduce side effects.

Pharmacodynamics

Pharmacodynamics of particle-based drug delivery systems can vary widely depending on the size, surface properties, and composition of the particles. Generally, smaller particles may have increased surface area leading to enhanced interaction with biological membranes. This can result in improved drug release profiles, increased cellular uptake, and sustained drug action.

Pharmacokinetics

Pharmacokinetics of drug particles is influenced by their size, shape, and surface characteristics. Smaller particles may exhibit faster absorption rates and higher bioavailability compared to larger particles. The distribution of drug particles in the body can be affected by their ability to evade the immune system, their clearance rates, and their interaction with plasma proteins. Metabolism and excretion pathways can also differ based on the formulation of the drug particle.

Pregnancy

The safety of particle administration during pregnancy has not been established. Consultation with a healthcare professional is advised.

Breast-feeding

It is unclear whether particles are excreted in breast milk. A healthcare professional should be consulted.

Storage

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