Drugs List

Therapeutic Indications

Uses

Diphtheria - prophylaxis
Pertussis - prophylaxis
Poliomyelitis - prophylaxis
Tetanus - prophylaxis

Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis from 3 years of age as a booster following primary vaccination.

The Department of Health has stated that this vaccine is not intended for primary vaccination as the low dose of the diphtheria component means it is unsuitable for this purpose. It should not be given to children of 10 years of age or older as pertussis vaccine is not currently recommended for this age group.

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

For intramuscular injection, preferably into the deltoid region. The vaccine should not be administered into the gluteal area.

May be administered by deep subcutaneous injection under certain conditions (i.e. clotting disorders), but other routes are contraindicated.

Contraindications

Children under 3 years
Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions
Uncontrolled epileptic disorder
Uncontrolled neurological disorder

Precautions and Warnings

Immunosuppression
Coagulopathy
Immunodeficiency syndromes
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
May contain trace amounts of glutaral
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
May contain trace amounts of streptomycin
Aspirate prior to injection to avoid intravascular administration
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Pertussis vaccination not routinely recommended in patients over 10 years
Resuscitation facilities must be immediately available
Establish full medical history and health status prior to vaccine
Follow national immunisation guidelines

Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). Administration of the vaccine should be carefully considered in patients who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components.

If Guillain-Barre syndrome or neuralgic amyotrophy has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary immunisation schedule has been completed.

Pregnancy and Lactation

Pregnancy

Use diphtheria, tetanus, pertussis (5 component) and poliomyelitis vaccine with caution in pregnancy.

Diphtheria, tetanus, pertussis and poliomyelitis vaccine is not generally recommended during pregnancy, however the Department of Health has introduced a temporary programme since October 2012 to vaccinate pregnant women against pertussis. See national guidelines.

At the time of writing, available data suggest that exposure to this vaccine during pregnancy does not have any adverse foetal or maternal effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Diphtheria, tetanus, pertussis and poliomyelitis vaccine may be given during breastfeeding.

Limited data on the use of this vaccine during breastfeeding is available. The vaccine contains toxoids and inactivated antigens, however no risk to the breastfed infant should be expected. The benefits versus the risk of administration to breastfeeding women should be evaluated by the health-care providers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anaphylactic reaction
Arthralgia
Asthenia
Bruising at injection site
Chills
Convulsions
Dermatitis
Diarrhoea
Dizziness
Dyspnoea
Erythema at injection site
Facial oedema
Facial palsy
Fatigue
Fever
Guillain-Barre syndrome
Headache
Hypoesthesia
Induration (injection site)
Irritability
Joint swelling
Limb swelling
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Myelitis
Nausea
Neuralgic amyotrophy
Pain in vaccinated limb
Pallor
Paraesthesia
Pruritus
Rash
Swelling (injection site)
Syncope
Urticaria
Vasovagal syncope
Vomiting

Presentation

Vaccine containing diphtheria and tetanus with pertussis and poliomyelitis

Drugs List

Therapeutic Indications

Uses

Diphtheria - prophylaxis
Pertussis - prophylaxis
Poliomyelitis - prophylaxis
Tetanus - prophylaxis

Active immunisation against diphtheria, tetanus, pertussis and poliomyelitis from 3 years of age as a booster following primary vaccination.

The Department of Health has stated that this vaccine is not intended for primary vaccination as the low dose of the diphtheria component means it is unsuitable for this purpose. It should not be given to children of 10 years of age or older as pertussis vaccine is not currently recommended for this age group.

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

For intramuscular injection, preferably into the deltoid region. The vaccine should not be administered into the gluteal area.

May be administered by deep subcutaneous injection under certain conditions (i.e. clotting disorders), but other routes are contraindicated.

Contraindications

Children under 3 years
Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions
Uncontrolled epileptic disorder
Uncontrolled neurological disorder

Precautions and Warnings

Immunosuppression
Coagulopathy
Immunodeficiency syndromes
Thrombocytopenia

Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
May contain trace amounts of glutaral
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
May contain trace amounts of streptomycin
Aspirate prior to injection to avoid intravascular administration
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Pertussis vaccination not routinely recommended in patients over 10 years
Resuscitation facilities must be immediately available
Establish full medical history and health status prior to vaccine
Follow national immunisation guidelines

Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). Administration of the vaccine should be carefully considered in patients who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components.

If Guillain-Barre syndrome or neuralgic amyotrophy has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary immunisation schedule has been completed.

Pregnancy and Lactation

Pregnancy

Use diphtheria, tetanus, pertussis (5 component) and poliomyelitis vaccine with caution in pregnancy.

Diphtheria, tetanus, pertussis and poliomyelitis vaccine is not generally recommended during pregnancy, however the Department of Health has introduced a temporary programme since October 2012 to vaccinate pregnant women against pertussis. See national guidelines.

At the time of writing, available data suggest that exposure to this vaccine during pregnancy does not have any adverse foetal or maternal effects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Diphtheria, tetanus, pertussis and poliomyelitis vaccine may be given during breastfeeding.

Limited data on the use of this vaccine during breastfeeding is available. The vaccine contains toxoids and inactivated antigens, however no risk to the breastfed infant should be expected. The benefits versus the risk of administration to breastfeeding women should be evaluated by the health-care providers.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anaphylactic reaction
Arthralgia
Asthenia
Bruising at injection site
Chills
Convulsions
Dermatitis
Diarrhoea
Dizziness
Dyspnoea
Erythema at injection site
Facial oedema
Facial palsy
Fatigue
Fever
Guillain-Barre syndrome
Headache
Hypoesthesia
Induration (injection site)
Irritability
Joint swelling
Limb swelling
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Myelitis
Nausea
Neuralgic amyotrophy
Pain in vaccinated limb
Pallor
Paraesthesia
Pruritus
Rash
Swelling (injection site)
Syncope
Urticaria
Vasovagal syncope
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: September 2016

Reference Sources

Summary of Product Characteristics: Repevax. Sanofi Pasteur MSD Ltd. Revised July 2016.

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: September 6, 2016

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 28 June 2017