Drugs List

Therapeutic Indications

Uses

Vaccination against pneumococcal diseases

Active immunisation against invasive disease (including bacteraemia, sepsis, meningitis, bacteraemic pneumonia and acute otitis media ) caused by Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 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:
Patients aged 65 years and over
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 systemic 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 kidney disease at stage 4 and 5, those on kidney dialysis, and renal transplantation.
Chronic hepatic disease
Including cirrhosis, biliary atresia, and chronic hepatitis.
Diabetes
Diabetes requiring insulin or oral hypoglycaemic drugs. Not including diabetes that is diet controlled.
Immunosuppression
Due to disease or treatment, including asplenia or splenic dysfunction, bone marrow transplant, multiple myeloma or genetic disorder affecting the immune system, HIV infection at all stages and patients undergoing immunosuppressive chemotherapy leading to immunosuppression. 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/kg or greater 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. Conditions related to CSF leaks include all CSF shunts.
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/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Administration

By intramuscular or subcutaneous injection only.

Contraindications

Acute infection
Children under 2 years
Severe febrile conditions

Precautions and Warnings

Immunosuppression
Breastfeeding
Immunodeficiency syndromes
Pregnancy

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
Resuscitation facilities must be immediately available
Severe, sudden fever may require early antimicrobial use - advise patients
Follow national immunisation guidelines

Vaccination of patients with multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma, especially during treatment, and in chronic alcoholics, may be relatively ineffective.

Advise patients at increased risk of severe pneumococcal infection (e.g. asplenic, immunocompromised etc.) to contact a physician immediately if sudden severe febrile illness occurs as they may require early antimicrobial treatment.

Patients with idiopathic thrombocytopenic purpura may develop thrombocytopenia following vaccination.

Patients with haematological disorders may develop haemolytic anaemia following vaccination.

There is limited clinical data available regarding the administration of more than two doses. Healthy adults and children should not receive routine revaccination.

Pneumococcal polysaccharide vaccine may not protect against infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid.

Individuals with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Pregnancy and Lactation

Pregnancy

Use pneumococcal vaccine with caution during pregnancy.

The risk to foetus from pneumococcal polysaccharide vaccine during first trimester is unknown (Briggs, 2015).

There have been no reports of adverse consequences in newborns whose mothers were inadvertently vaccinated during pregnancy. Pneumococcal-containing vaccines may be given to pregnant women when the need for protection is clearly necessary and required without delay.

Schaefer (2015) concludes that vaccination does not seem to be harmful for the foetus, and does not require any intervention.

Lactation

Use pneumococcal vaccine with caution during breastfeeding.

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

Lactmed (2018) states that immunisation of the mother during the 3rd trimester of pregnancy markedly increases the amount of pneumococcal antibodies in breast milk.

Side Effects

Anaphylactoid reaction
Angioneurotic oedema
Arthralgia
Arthritis
Asthenia
Cellulitis (injection site)
Chills
Decreased limb mobility
Erythema at injection site
Febrile convulsions
Fever
Guillain-Barre syndrome
Haemolytic anaemia
Headache
Heat and redness (injection site)
Induration (injection site)
Injection site reactions
Leucocytosis
Lymphadenitis
Lymphadenopathy
Malaise
Myalgia
Nausea
Pain / soreness (injection site)
Paraesthesia
Peripheral oedema
Radiculopathy
Raised C-reactive protein
Rash
Serum sickness
Swelling (injection site)
Thrombocytopenia
Urticaria
Vomiting

Presentation

Vaccine containing polysaccharide from 23 capsular types of pneumococcus.

Drugs List

Therapeutic Indications

Uses

Vaccination against pneumococcal diseases

Active immunisation against invasive disease (including bacteraemia, sepsis, meningitis, bacteraemic pneumonia and acute otitis media ) caused by Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 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:
Patients aged 65 years and over
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 systemic 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 kidney disease at stage 4 and 5, those on kidney dialysis, and renal transplantation.
Chronic hepatic disease
Including cirrhosis, biliary atresia, and chronic hepatitis.
Diabetes
Diabetes requiring insulin or oral hypoglycaemic drugs. Not including diabetes that is diet controlled.
Immunosuppression
Due to disease or treatment, including asplenia or splenic dysfunction, bone marrow transplant, multiple myeloma or genetic disorder affecting the immune system, HIV infection at all stages and patients undergoing immunosuppressive chemotherapy leading to immunosuppression. 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/kg or greater 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. Conditions related to CSF leaks include all CSF shunts.
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/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book

Dosage

Adults

Children

Additional Dosage Information

Administration

By intramuscular or subcutaneous injection only.

Contraindications

Acute infection
Children under 2 years
Severe febrile conditions

Precautions and Warnings

Immunosuppression
Breastfeeding
Immunodeficiency syndromes
Pregnancy

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
Resuscitation facilities must be immediately available
Severe, sudden fever may require early antimicrobial use - advise patients
Follow national immunisation guidelines

Vaccination of patients with multiple myeloma, Hodgkin's and non-Hodgkin's lymphoma, especially during treatment, and in chronic alcoholics, may be relatively ineffective.

Advise patients at increased risk of severe pneumococcal infection (e.g. asplenic, immunocompromised etc.) to contact a physician immediately if sudden severe febrile illness occurs as they may require early antimicrobial treatment.

Patients with idiopathic thrombocytopenic purpura may develop thrombocytopenia following vaccination.

Patients with haematological disorders may develop haemolytic anaemia following vaccination.

There is limited clinical data available regarding the administration of more than two doses. Healthy adults and children should not receive routine revaccination.

Pneumococcal polysaccharide vaccine may not protect against infection resulting from basilar skull fracture or from external communication with cerebrospinal fluid.

Individuals with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Pregnancy and Lactation

Pregnancy

Use pneumococcal vaccine with caution during pregnancy.

The risk to foetus from pneumococcal polysaccharide vaccine during first trimester is unknown (Briggs, 2015).

There have been no reports of adverse consequences in newborns whose mothers were inadvertently vaccinated during pregnancy. Pneumococcal-containing vaccines may be given to pregnant women when the need for protection is clearly necessary and required without delay.

Schaefer (2015) concludes that vaccination does not seem to be harmful for the foetus, and does not require any intervention.

Lactation

Use pneumococcal vaccine with caution during breastfeeding.

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

Lactmed (2018) states that immunisation of the mother during the 3rd trimester of pregnancy markedly increases the amount of pneumococcal antibodies in breast milk.

Side Effects

Anaphylactoid reaction
Angioneurotic oedema
Arthralgia
Arthritis
Asthenia
Cellulitis (injection site)
Chills
Decreased limb mobility
Erythema at injection site
Febrile convulsions
Fever
Guillain-Barre syndrome
Haemolytic anaemia
Headache
Heat and redness (injection site)
Induration (injection site)
Injection site reactions
Leucocytosis
Lymphadenitis
Lymphadenopathy
Malaise
Myalgia
Nausea
Pain / soreness (injection site)
Paraesthesia
Peripheral oedema
Radiculopathy
Raised C-reactive protein
Rash
Serum sickness
Swelling (injection site)
Thrombocytopenia
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: January 2019

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Immunisation Against Infectious Disease. The Green Book.
Available at: https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book
Last accessed: 09 January 2019.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Pneumococcal vaccines Last revised: 31 October 2018
Last accessed: 09 January 2019

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 January 2019.

Summary of Product Characteristics: Pneumococcal Polysaccharide Vaccine. Merck Sharp and Dohme Limited. Revised April 2018.

Summary of Product Characteristics: Pneumovax 23 solution for injection in pre-filled syringe. Merck Sharp and Dohme Limited. Revised August 2018.