Valid Ghana · FDA Ghana

PNEUMOSIL 0.5ML-1 DOSE & 2.5ML-5 DOSE PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED) (10 VALENT)

PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE

FDA/HVC/245-08015 PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE 0.5ML/1 DOSE & 2.5ML/5DOSE

What it does

Conjugate is a type of medicine that may be used for various health conditions.

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/245-08015
Registration date
2024-08-12
Expiry date
2029-05-01
Status
Valid
Active ingredient
PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE
Strength
0.5ML/1 DOSE & 2.5ML/5DOSE
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Serum Institute Of India
Country of origin
-
Manufacturer location
Serum Institute Of India, 212/2, off Soli Poonawalla Road, Parijat Colony, Sadhana Society, Hadapsar, Pune, Maharashtra 411028, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:44 · updated 2026-10-20 04:00:05

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

About conjugate

Conjugate is a type of medicine that may be used for various health conditions.

How it works

The exact way conjugate works may depend on the specific condition it is being used for.

Who it's for

Conjugate may be suitable for individuals with certain health issues 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 pneumococcal

Pneumococcal vaccines help protect against infections caused by the pneumococcus bacteria, which can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections.

What it treats

  • pneumonia (pneumococcal pneumonia)
  • meningitis (pneumococcal meningitis)
  • bloodstream infections (pneumococcal bacteremia)

How it works

The vaccine works by training your immune system to recognize and fight the pneumococcus bacteria, helping to prevent infections.

Who it's for

It is recommended for infants, young children, older adults, and people with certain health conditions that increase their risk of pneumococcal infections.

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

About polysaccharide

Polysaccharide is a type of carbohydrate that can be found in various forms and is used in different treatments.

What it treats

  • nutritional support
  • wound healing
  • gastrointestinal issues

How it works

Polysaccharides provide energy and support bodily functions, and some types may help in healing and digestion.

Who it's for

Polysaccharides may be used by people needing extra nutrition or support for healing.

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

Clinical monograph: conjugate

Conjugates are a class of compounds formed by the chemical linkage of two or more substances, often used in pharmacology to enhance the properties of a drug, such as its solubility, stability, and targeted delivery. Conjugation can occur with various molecules, including proteins, carbohydrates, and nucleic acids, leading to conjugate drugs that can improve therapeutic efficacy and reduce side effects.

Indications

  • Cancer therapy
  • Autoimmune diseases
  • Infectious diseases
  • Targeted drug delivery systems
  • Vaccination strategies

Dosage

Children: Refer to specific product guidelines for dosing information, as it varies widely based on the conjugate and indication.

Adults: Refer to specific product guidelines for dosing information, as it varies widely based on the conjugate and indication.

Mechanism of action

The mechanism of action of conjugate drugs varies widely depending on the specific substances involved in the conjugation. Generally, conjugation can facilitate drug uptake into cells, enhance bioavailability, and alter the pharmacokinetics of the active drug. Some conjugates are designed to target specific receptors or tissues, thereby improving the specificity and efficacy of the therapeutic effect.

Pharmacodynamics

Pharmacodynamics of conjugate drugs is largely dependent on the nature of the conjugated entities. They may exhibit altered binding affinities, modified distribution profiles, and varying degrees of activity compared to their non-conjugated counterparts. The therapeutic effect could be amplified or diminished based on the conjugation strategy employed, with implications for potency and duration of action.

Pharmacokinetics

Pharmacokinetics of conjugate drugs is influenced by the characteristics of both the parent drug and the conjugated moiety. Factors such as absorption, distribution, metabolism, and excretion (ADME) can be significantly altered. Conjugates may exhibit improved solubility and permeability, leading to enhanced absorption and bioavailability. Metabolic pathways may also be modified, potentially altering the half-life and clearance rates of the drug.

Pregnancy

The safety of conjugate vaccines during pregnancy has not been fully established. Use during pregnancy should be based on the benefit-to-risk assessment.

Breast-feeding

Conjugate vaccines are generally considered safe during breastfeeding. Vaccination can be beneficial for the infant when the mother is immunized.

Storage

Conjugate vaccines should be stored in a refrigerator at 2-8 degrees Celsius and 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: pneumococcal

Pneumococcal vaccines are designed to protect against infections caused by Streptococcus pneumoniae, a bacterium responsible for various diseases, including pneumonia, meningitis, and otitis media. These vaccines stimulate the immune system to produce antibodies against the polysaccharide capsules that encapsulate the bacteria, thereby preventing invasive disease.

Indications

  • Prevention of pneumococcal pneumonia
  • Prevention of invasive pneumococcal disease
  • Prevention of meningitis caused by Streptococcus pneumoniae
  • Prevention of otitis media in children

Dosage

Children: Refer to specific vaccine guidelines; typically administered as a series of doses during infancy and early childhood.

Adults: Refer to specific vaccine guidelines; typically administered as a single dose for adults, with possible revaccination based on risk factors and vaccine type.

Mechanism of action

Pneumococcal vaccines work primarily by inducing an immune response that leads to the production of specific antibodies against the polysaccharide capsule of Streptococcus pneumoniae. Upon vaccination, B cells are activated, and memory cells are formed, providing long-term immunity against future infections.

Pharmacodynamics

The efficacy of pneumococcal vaccines is related to their ability to generate an immune response. Vaccination leads to the production of immunoglobulin G (IgG) antibodies, which help opsonize the bacteria, enhancing phagocytosis by immune cells. The vaccines are effective in preventing invasive pneumococcal disease and reducing the incidence of pneumonia caused by the serotypes included in the vaccine formulation.

Pharmacokinetics

Pneumococcal vaccines do not have a pharmacokinetic profile in the traditional sense since they are biological products that induce an immune response rather than being absorbed, distributed, metabolized, and excreted like conventional drugs. The onset of immunity typically occurs within 2 to 3 weeks following vaccination.

Adverse effects

  • Local reactions at the injection site
  • Fever
  • Fatigue
  • Malaise
  • Headache
  • Nausea

Precautions

  • Use with caution in individuals with a history of severe allergic reactions to any component of the vaccine
  • Monitor for anaphylaxis in patients with known allergies

Pregnancy

The pneumococcal vaccine is generally considered safe during pregnancy, but vaccination should be discussed with a healthcare provider.

Breast-feeding

The pneumococcal vaccine is safe for breastfeeding mothers.

Storage

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

Formulations

  • Pneumococcal polysaccharide vaccine (PPSV23)
  • Pneumococcal conjugate vaccine (PCV13)

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: polysaccharide

Polysaccharides are large carbohydrate molecules composed of long chains of monosaccharide units bound together by glycosidic linkages. They serve various biological functions, including energy storage and structural support in living organisms. Depending on their structure, polysaccharides can be classified into storage polysaccharides, such as starch and glycogen, and structural polysaccharides, such as cellulose and chitin. In clinical settings, polysaccharides include a variety of natural and synthetic compounds that are utilized for their therapeutic and physiological properties, including as immunomodulators, anticoagulants, and in the preparation of vaccines.

Mechanism of action

Polysaccharides exert their effects through various mechanisms, often involving the modulation of immune responses. For example, certain polysaccharides can act as pathogen-associated molecular patterns (PAMPs) that are recognized by pattern recognition receptors on immune cells, leading to the activation of innate immunity. Additionally, some polysaccharides can enhance the proliferation and activation of lymphocytes, such as T-cells and B-cells, thereby influencing adaptive immune responses. Some polysaccharides also play a role in anticoagulation by inhibiting thrombin and other factors in the coagulation cascade.

Pharmacodynamics

The pharmacodynamics of polysaccharides vary widely depending on their structure and the specific biological pathways they influence. For instance, polysaccharides that act as immunomodulators can increase cytokine production, enhance phagocytosis by macrophages, and promote the differentiation of immune cells, leading to a more robust immune response. Furthermore, polysaccharides can exhibit anti-inflammatory properties by modulating the release of pro-inflammatory cytokines and chemokines. In the case of anticoagulant polysaccharides, their action may involve the binding and inhibition of specific clotting factors, thus preventing thrombus formation.

Pharmacokinetics

The pharmacokinetics of polysaccharides depend on their molecular weight, structure, and route of administration. Generally, polysaccharides are poorly absorbed in the gastrointestinal tract when taken orally due to their large size and complexity. However, certain polysaccharides are designed for parenteral administration, where they can be directly introduced into the bloodstream. Following administration, they may be metabolized by specific enzymes or by gut microbiota. The elimination half-life can vary significantly, influenced by factors such as the degree of sulfation or acetylation, which can affect their

Pregnancy

Polysaccharides are generally considered safe during pregnancy, but specific formulations should be evaluated on a case-by-case basis. Always consult a healthcare provider.

Breast-feeding

Polysaccharides are typically considered safe during breastfeeding, although individual formulations may vary. Consultation with a healthcare provider is recommended.

Storage

Polysaccharides should be stored in a cool, dry place, away from direct sunlight and moisture. Specific storage conditions may vary depending 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.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.