International reference: 3 US FDA recalls for this ingredient

Failed impurities/degradation specifications: Purity readings for oxygen were out of specification. (respiratory)

Defective Delivery System: There is a potential for some units in certain lots of Qnasl Nasal Aerosol 80 mcg metered spray to have clogged stem valves. (respiratory)

Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol (respiratory)

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

3 months to expiry Ghana · FDA Ghana

ABRYSVO

RESPIRATORY SYNCYTIAL VIRUS VACCINE [BIVALENT, RECOMBINANT]

What it does

Recombinant medicines are made using DNA technology. They can help treat various conditions by providing the body with proteins it may be lacking.

Commonly used for: certain genetic disorders, some types of cancer, hormonal imbalances

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.
FDA/HVC/251-04010
Registration date
2025-04-28
Expiry date
2026-05-26
Status
3 months to expiry
Active ingredient
RESPIRATORY SYNCYTIAL VIRUS VACCINE [BIVALENT, RECOMBINANT]
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Pfizer
Country of origin
BELGIUM
Manufacturer location
Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium

Source: Food and Drugs Authority · fetched 2026-04-18 08:45:56 · updated 2026-05-23 02:53:22

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About recombinant]

Recombinant medicines are made using DNA technology. They can help treat various conditions by providing the body with proteins it may be lacking.

What it treats

  • certain genetic disorders
  • some types of cancer
  • hormonal imbalances

How it works

Recombinant medicines work by introducing specific proteins into the body, which help in treating or managing certain health conditions.

Who it's for

These medicines are typically prescribed for patients with specific genetic conditions or those needing hormone replacement.

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

About respiratory

Respiratory medications help manage conditions affecting the lungs and breathing.

What it treats

  • asthma
  • chronic obstructive pulmonary disease (COPD)
  • allergic reactions
  • cough and cold symptoms

How it works

These medications work by opening the airways, reducing inflammation, or thinning mucus to make breathing easier.

Who it's for

They are for individuals with breathing difficulties, such as those with asthma or COPD.

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

About syncytial

Syncytial is a medication that is used to treat certain viral infections.

What it treats

  • respiratory syncytial virus infection (RSV)

How it works

Syncytial works by targeting the virus to help reduce its effects on the body.

Who it's for

This medication is typically for people with viral infections like RSV, especially in infants and young children.

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: recombinant

Recombinant drugs are biologically engineered medications produced using recombinant DNA technology. These drugs are designed to replace or supplement proteins or hormones that are deficient or absent in patients. They are crucial in the treatment of various conditions, including genetic disorders, certain cancers, and autoimmune diseases. Common examples include recombinant insulin for diabetes management and erythropoietin for anemia associated with chronic kidney disease.

Indications

  • Diabetes mellitus
  • Chronic kidney disease-related anemia
  • Hemophilia
  • Cancer (as targeted therapy)
  • Autoimmune diseases (e.g., rheumatoid arthritis)

Dosage

Children: Refer to specific product guidelines for dosing information.

Adults: Refer to specific product guidelines for dosing information.

Mechanism of action

Recombinant drugs function by mimicking the action of naturally occurring proteins in the body. For instance, recombinant insulin binds to insulin receptors on target tissues, facilitating glucose uptake and metabolism. Erythropoietin stimulates erythropoiesis by binding to erythropoietin receptors in the bone marrow, promoting the production of red blood cells.

Pharmacodynamics

The pharmacodynamics of recombinant drugs vary depending on the specific protein or hormone being replaced or supplemented. Generally, they exert their effects at the cellular level by interacting with specific receptors, leading to a cascade of biological responses. The therapeutic effects are usually dose-dependent and can vary based on the patient's biological response and the presence of antibodies against the recombinant product.

Pharmacokinetics

Pharmacokinetics of recombinant drugs include absorption, distribution, metabolism, and excretion (ADME) characteristics that can differ significantly based on the specific drug. Many recombinant proteins have a short half-life and require parenteral administration. They are typically distributed throughout the body via the bloodstream, metabolized by the liver and other tissues, and excreted primarily through the kidneys. The pharmacokinetics may be influenced by the patient's age, weight, and overall health.

Pregnancy

Recombinant proteins should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when administering recombinant proteins during breastfeeding, as the effects on the infant are not well established.

Storage

Store in a refrigerator at 2-8 degrees Celsius. Do not freeze, and protect from light.

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: respiratory

Respiratory medications encompass a broad category of drugs used to treat various conditions affecting the respiratory system, including asthma, chronic obstructive pulmonary disease (COPD), and other pulmonary disorders. These medications may include bronchodilators, corticosteroids, anticholinergics, mucolytics, and antibiotics, each serving distinct roles in managing respiratory conditions by alleviating symptoms and improving lung function.

Indications

  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Bronchitis
  • Pulmonary fibrosis
  • Cystic fibrosis
  • Respiratory distress syndrome

Dosage

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

Adults: Refer to specific product guidelines and BNF for appropriate dosing guidelines.

Mechanism of action

The mechanism of action varies among different respiratory medications. Bronchodilators, such as beta-2 agonists, work by stimulating beta-2 adrenergic receptors in the airways, leading to relaxation of bronchial smooth muscle and dilation of the air passages. Corticosteroids reduce inflammation by inhibiting the production of inflammatory mediators and suppressing immune responses. Anticholinergics block the action of acetylcholine at muscarinic receptors, leading to reduced bronchoconstriction. Mucolytics help in thinning and loosening mucus, making it easier to expel.

Pharmacodynamics

The pharmacodynamic effects of respiratory medications are primarily observed in their ability to improve airflow, reduce respiratory distress, and enhance gas exchange. Bronchodilators provide rapid relief from acute bronchospasm, while corticosteroids exert a longer-term effect by decreasing airway hyperresponsiveness and inflammation. The efficacy of these medications is often assessed through improvements in lung function tests, symptom relief, and reduction in exacerbation frequency.

Pharmacokinetics

Pharmacokinetics may differ significantly among respiratory drugs. Generally, bronchodilators are rapidly absorbed and can have onset of action within minutes, with varying half-lives depending on the specific agent. Corticosteroids can have delayed onset of action, with systemic absorption dependent on the formulation (inhaled vs systemic). The metabolism of these medications often involves hepatic pathways, and elimination is typically renal. The bioavailability of inhaled medications is also an important factor affecting their therapeutic effectiveness.

Pregnancy

The safety of respiratory medications during pregnancy depends on the specific drug. Some may be used, while others are contraindicated. Always consult a healthcare professional.

Breast-feeding

Many respiratory medications can be used during breastfeeding, but it is essential to check specific drug safety profiles.

Storage

Store at room temperature, away from moisture and heat. 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: syncytial

Syncytial refers to a type of viral infection, most commonly associated with respiratory syncytial virus (RSV). RSV is a significant cause of respiratory illness in infants and young children, leading to bronchiolitis and pneumonia. The virus spreads easily through respiratory droplets and can survive on surfaces for several hours, making it highly contagious. It primarily affects the respiratory tract and is a leading cause of hospitalization in children under the age of one.

Indications

  • Respiratory syncytial virus infection
  • Bronchiolitis caused by RSV
  • Pneumonia caused by RSV

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines in paediatric patients, particularly for infants and young children, as RSV infections often require tailored treatment approaches.

Adults: Refer to the BNF for specific dosing guidelines in adult patients, as dosing can vary based on the severity of the infection and individual patient factors.

Mechanism of action

RSV infects epithelial cells of the upper and lower respiratory tract. The virus enters cells through the fusion of its envelope with the host cell membrane, facilitated by the F protein of the virus. Once inside, the viral RNA is released and begins to hijack the host's cellular machinery to replicate and produce more viral particles. This results in cell death and significant inflammation, contributing to the clinical symptoms observed in infected patients.

Pharmacodynamics

The pathophysiology of RSV infection involves the destruction of respiratory epithelial cells and an intense inflammatory response. The immune response to the infection can lead to the release of pro-inflammatory cytokines, further exacerbating airway obstruction and respiratory distress. The severity of the disease can vary based on the patient's age, underlying health conditions, and the presence of other respiratory infections.

Pharmacokinetics

RSV does not have a specific pharmacokinetic profile, as it is a virus rather than a drug. However, antiviral treatments for RSV, such as ribavirin, are administered via aerosolized routes for direct respiratory delivery, allowing for localized effects while minimizing systemic exposure. The pharmacokinetics of antiviral agents can vary widely based on the formulation, route of administration, and individual patient factors.

Pregnancy

The effects of syncytial drugs during pregnancy are not well-studied; caution is advised when prescribing.

Breast-feeding

Lactation safety data are limited; consult relevant guidelines before use while breastfeeding.

Storage

Store at room temperature, 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: 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.