Registered Tanzania · TMDA

Prevenar 13 Multidose Vaccine

Pneumococcal polysaccharide Serotype

TAN 21 HM 0311 suspension vaccine 2.2/4.4

What it does

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

Commonly used for: pneumonia (pneumococcal pneumonia), meningitis (pneumococcal meningitis), bloodstream infections (pneumococcal bacteremia)

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

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Registration & product details

Registration no.
TAN 21 HM 0311
Registration date
2021-08-20
Expiry date
2026-08-19
Status
Registered/Compliant
Active ingredient
Pneumococcal polysaccharide Serotype
Dosage form
suspension vaccine
Strength
2.2/4.4
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
Pfizer Laboratories Limited
Country of origin
-

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-07-13 03:13:52 · updated 2026-08-17 03:00:40

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

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.

About serotype

Serotype is a classification used to identify different strains of bacteria or viruses based on their surface proteins. It helps in understanding infections and guiding treatment.

What it treats

  • bacterial infections
  • viral infections

How it works

Serotypes help scientists and doctors distinguish between different strains of pathogens, which can affect how diseases spread and how they are treated.

Who it's for

This information is useful for healthcare professionals and researchers studying infections.

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

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.

Clinical monograph: serotype

Serotype refers to a distinct variation within a species of bacteria or virus, characterized by its unique surface antigens. Identifying serotypes is critical in microbiology for diagnosing infections, understanding epidemiology, and developing vaccines. The term is commonly used in the context of pathogens like Streptococcus pneumoniae, Salmonella spp., and various viral infections, including those caused by the influenza virus.

Indications

  • Identification of bacterial and viral infections
  • Epidemiological studies
  • Vaccination strategies
  • Clinical diagnostics

Dosage

Children: Refer to specific product guidelines or clinical protocols for dosing information as it varies based on the condition and serotype involved.

Adults: Refer to specific product guidelines or clinical protocols for dosing information as it varies based on the condition and serotype involved.

Mechanism of action

Serotyping involves the use of specific antibodies that bind to surface antigens of pathogens. This binding facilitates the identification and classification of serotypes based on their immunological properties. The immune response generated by these antigens can influence the severity of infections and the effectiveness of vaccines.

Pharmacodynamics

The pharmacodynamics of serotypes are not directly related to drug action but rather to the immune response they elicit. Different serotypes can cause varying degrees of virulence and influence host immune responses differently. The effectiveness of vaccines may also vary depending on the serotype, highlighting the importance of serotyping in vaccine development and epidemiology.

Pharmacokinetics

As serotypes are classifications based on antigenic properties rather than drugs, there are no pharmacokinetic profiles associated with them. However, understanding the pharmacokinetics of vaccines targeting specific serotypes is essential for assessing their efficacy and safety.

Pregnancy

Safety during pregnancy has not been established. Use only if potential benefits justify the risks.

Breast-feeding

Caution is advised. It is unknown whether this drug is excreted in human milk.

Storage

Store in a cool, dry place, protected from light. Follow specific manufacturer's instructions for storage conditions.

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.