Drugs List

Therapeutic Indications

Uses

Vaccination against pneumococcal diseases

Active immunisation against invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F.

Vaccination should be based on official recommendations and the variability of serotype epidemiology in different geographical areas. The impact of invasive disease at different age groups should be considered.

Individuals at an increased risk from pneumococcal infection:

Asplenia or splenic dysfunction (including homozygous sickle cell disease and coeliac disease which could lead to splenic dysfunction).

Chronic respiratory disease (including chronic obstructive pulmonary disease, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia, children with respiratory conditions caused by aspiration, or neurological disease (e.g. cerebral palsy) with risk of aspiration, asthma that requires the use of oral steroids at a dose sufficient to act as a significant immunosuppressant).

Chronic heart disease (including those requiring medication/follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure).

Chronic renal disease (including nephrotic syndrome, chronic renal failure, and renal transplantation).

Chronic hepatic disease (including cirrhosis, biliary atresia, and chronic hepatitis).

Diabetes (requiring insulin or oral hypoglycaemic drugs).

Immunosuppression (due to disease or treatment. Including asplenia or splenic dysfunction, HIV infection at all stages, patients undergoing immunosuppressive chemotherapy. Individuals on or likely to be on systemic steroids for more than one month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day).

Individuals with cochlear implants (immunisation should not delay cochlear implantation).

Individuals with cerebrospinal fluid leaks (includes leakage following trauma or major skull surgery).

Children under 5 years with a history of invasive pneumococcal disease.

Individuals at occupational risk.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Dosage

Primary vaccination
One single dose of 0.5ml.

Administration

The vaccine should be given by intramuscular injection preferably in the deltoid muscle.

The vaccine may be given subcutaneously to patients with thrombocytopenia or coagulation disorder if the potential benefit outweighs the risks.

Contraindications

Children under 18 years
Severe febrile conditions

Precautions and Warnings

Immunosuppression
Breastfeeding
Coagulopathy
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Prophylactic antibiotic therapy should continue after immunisation
Vaccine may not be effective in 100% of patients
Delay treatment if acute febrile illness
Do not mix with other vaccines in the same syringe
Have adrenaline injection ready for use in case of anaphylaxis
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Severe, sudden fever may require early antimicrobial use - advise patients
Follow national immunisation guidelines

Pregnancy and Lactation

Pregnancy

Use pneumococcal 20-valent polysaccharide conjugated vaccine with caution during pregnancy.

The manufacturer states that caution should be exercised when pneumococcal 20-valent polysaccharide conjugated vaccine is administered during pregnancy when the potential benefits outweigh the potential risk to the mother and foetus.

At the time of writing there is limited published information regarding the use of pneumococcal 20-valent polysaccharide conjugated vaccine during pregnancy. Potential risks are unknown.

Lactation

Use pneumococcal 20-valent polysaccharide conjugated vaccine with caution during breastfeeding.

The manufacturer states that caution should be exercised when pneumococcal 20-valent polysaccharide conjugated vaccine is administered during breastfeeding and it is unknown whether the vaccine is excreted in breast milk.

Side Effects

Angioedema
Bronchospasm
Chills
Decreased appetite
Decreased limb mobility
Diarrhoea
Dyspnoea
Erythema at injection site
Facial oedema
Fatigue
Fever
Headache
Hypersensitivity reactions
Induration (injection site)
Joint pain
Local pain (injection site)
Lymphadenopathy
Muscle pain
Nausea
Pruritus
Pyrexia
Rash
Swelling (injection site)
Tenderness (injection site)
Urticaria
Vomiting

Presentation

Vaccine containing polysaccharide from 20 capsular types of pneumococcus.

Drugs List

Therapeutic Indications

Uses

Vaccination against pneumococcal diseases

Active immunisation against invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F and 33F.

Vaccination should be based on official recommendations and the variability of serotype epidemiology in different geographical areas. The impact of invasive disease at different age groups should be considered.

Individuals at an increased risk from pneumococcal infection:

Asplenia or splenic dysfunction (including homozygous sickle cell disease and coeliac disease which could lead to splenic dysfunction).

Chronic respiratory disease (including chronic obstructive pulmonary disease, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia, children with respiratory conditions caused by aspiration, or neurological disease (e.g. cerebral palsy) with risk of aspiration, asthma that requires the use of oral steroids at a dose sufficient to act as a significant immunosuppressant).

Chronic heart disease (including those requiring medication/follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure).

Chronic renal disease (including nephrotic syndrome, chronic renal failure, and renal transplantation).

Chronic hepatic disease (including cirrhosis, biliary atresia, and chronic hepatitis).

Diabetes (requiring insulin or oral hypoglycaemic drugs).

Immunosuppression (due to disease or treatment. Including asplenia or splenic dysfunction, HIV infection at all stages, patients undergoing immunosuppressive chemotherapy. Individuals on or likely to be on systemic steroids for more than one month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day).

Individuals with cochlear implants (immunisation should not delay cochlear implantation).

Individuals with cerebrospinal fluid leaks (includes leakage following trauma or major skull surgery).

Children under 5 years with a history of invasive pneumococcal disease.

Individuals at occupational risk.

For comprehensive information or advice on this product or the immunisation programme in the UK, the following website should be accessed.
https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book

Dosage

Primary vaccination
One single dose of 0.5ml.

Administration

The vaccine should be given by intramuscular injection preferably in the deltoid muscle.

The vaccine may be given subcutaneously to patients with thrombocytopenia or coagulation disorder if the potential benefit outweighs the risks.

Contraindications

Children under 18 years
Severe febrile conditions

Precautions and Warnings

Immunosuppression
Breastfeeding
Coagulopathy
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Prophylactic antibiotic therapy should continue after immunisation
Vaccine may not be effective in 100% of patients
Delay treatment if acute febrile illness
Do not mix with other vaccines in the same syringe
Have adrenaline injection ready for use in case of anaphylaxis
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Severe, sudden fever may require early antimicrobial use - advise patients
Follow national immunisation guidelines

Pregnancy and Lactation

Pregnancy

Use pneumococcal 20-valent polysaccharide conjugated vaccine with caution during pregnancy.

The manufacturer states that caution should be exercised when pneumococcal 20-valent polysaccharide conjugated vaccine is administered during pregnancy when the potential benefits outweigh the potential risk to the mother and foetus.

At the time of writing there is limited published information regarding the use of pneumococcal 20-valent polysaccharide conjugated vaccine during pregnancy. Potential risks are unknown.

Lactation

Use pneumococcal 20-valent polysaccharide conjugated vaccine with caution during breastfeeding.

The manufacturer states that caution should be exercised when pneumococcal 20-valent polysaccharide conjugated vaccine is administered during breastfeeding and it is unknown whether the vaccine is excreted in breast milk.

Side Effects

Angioedema
Bronchospasm
Chills
Decreased appetite
Decreased limb mobility
Diarrhoea
Dyspnoea
Erythema at injection site
Facial oedema
Fatigue
Fever
Headache
Hypersensitivity reactions
Induration (injection site)
Joint pain
Local pain (injection site)
Lymphadenopathy
Muscle pain
Nausea
Pruritus
Pyrexia
Rash
Swelling (injection site)
Tenderness (injection site)
Urticaria
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2022

Reference Sources

Immunisation against infectious disease (The Green Book).
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last revised: 15 June 2022
Last accessed: 15 September 2022

Summary of Product Characteristics: Apexxnar suspension for injection in pre-filled syringe. Pfizer Limited. Revised August 2022.