Diphtheria, tetanus and poliomyelitis vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing diphtheria with tetanus and poliomyelitis
This product has been produced using Vero cells.
Drugs List
Therapeutic Indications
Uses
Diphtheria - prophylaxis
Poliomyelitis - prophylaxis
Tetanus - prophylaxis
Active immunisation against diphtheria, tetanus and poliomyelitis in children from 6 years of age, adolescents and adults as a booster following primary vaccination.
The advice from Public Health England states that this vaccine may be used for primary immunisation in children aged 10 years or more and adults. It is not suitable as a primary vaccination for children less than 10 years of age as children of this age should receive vaccination against pertussis.
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
Diphtheria, tetanus and poliomyelitis vaccine should be administered in accordance with official recommendations and/or local practice regarding the use of vaccines that contain an adult (low) dose of diphtheria toxoid plus tetanus toxoid and inactivated polio viruses.
Adults
Primary immunisation
0.5 ml (1 dose) every month for 3 doses.
Booster doses
0.5 ml (first booster dose) to be given 3 years after the primary course. When primary vaccination has been delayed, this first booster dose may be given at the scheduled visit - provided it is one year since the third primary dose.
0.5 ml (second booster dose) should be given 10 years after the first booster dose. Where the previous doses have been delayed, the second booster dose should be given at a scheduled appointment - provided a minimum of five years have elapsed between the first and second booster doses.
The second booster dose may also be used as a first booster dose in those who have received only 3 previous doses of a diphtheria-containing vaccine.
Elderly
(See Dosage; Adult)
Children
Children aged 10 years and over
Primary immunisation
0.5 ml (1 dose) every month for 3 doses.
Booster doses
0.5 ml (first booster dose) to be given 3 years after the primary course. When primary vaccination has been delayed, this first booster dose may be given at the scheduled visit - provided it is one year since the third primary dose.
0.5 ml (second booster dose) should be given 10 years after the first booster dose. Where the previous doses have been delayed, the second booster dose should be given at a scheduled appointment - provided a minimum of five years have elapsed between the first and second booster doses.
The second booster dose may also be used as a first booster dose in those who have received only 3 previous doses of a diphtheria-containing vaccine.
Children aged 6 to 10 years
The advice from Public Health England states that this vaccine is not suitable as a primary vaccination for children less than 10 years of age as children of this age should receive vaccination against pertussis.
Booster doses
0.5 ml (first booster dose) to be given 3 years after the primary course. When primary vaccination has been delayed, this first booster dose may be given at the scheduled visit - provided it is one year since the third primary dose.
0.5 ml (second booster dose) should be given 10 years after the first booster dose. Where the previous doses have been delayed, the second booster dose should be given at a scheduled appointment - provided a minimum of five years have elapsed between the first and second booster doses.
The second booster dose may also be used as a first booster dose in those who have received only 3 previous doses of a diphtheria-containing vaccine.
Additional Dosage Information
If a patient has a history of receiving a vaccine following a tetanus-prone injury, attempts should be made to identify which vaccine was given. If the vaccine given at the time was the same as that due for the booster dose and given at an appropriate interval, then the routine booster dose is not required. Otherwise, the dose given at the time of injury should be discounted as it may not provide long-term protection, and the scheduled immunisation should be given.
Children who have not completed the primary course should have the outstanding doses at monthly intervals. Children may receive the first booster dose as early as one year after the third primary dose. The second booster should be given at the time of leaving school to ensure long-term protection. A minimum of 5 years should be left between the first and second boosters.
For children with no reliable history of previous immunisation, it should be assumed that they are unimmunised and the full UK recommendations should be followed.
Administration
For intramuscular injection, preferably into the deltoid region.
May be administered by deep subcutaneous injection under certain conditions (e.g. bleeding disorders).
Contraindications
Children under 6 years
Febrile disorder
Neurological complications following diphtheria vaccination
Neurological complications following tetanus vaccination
Phenylketonuria
Precautions and Warnings
Diphtheria or tetanus vaccination within the last 5 years
Immunosuppression
Coagulopathy
Immunodeficiency syndromes
Positive HIV status
Pregnancy
Thrombocytopenia
Advise patient that vertigo may affect ability to drive/operate machinery
Impaired response possible in immunocompromised patients
Substitute for vaccine including pertussis in children under 10
Contains phenylalanine
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
May contain trace amounts of streptomycin
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Follow national immunisation guidelines
If Guillain-Barre syndrome or brachial neuritis has occurred following receipt of a 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.
Pregnancy and Lactation
Pregnancy
Diphtheria, tetanus and poliomyelitis vaccine should be used with caution in pregnancy.
The effect on embryo-foetal development has not been assessed in animals. No teratogenic effect has been observed following use in pregnant women.
Schaefer (2007) states that to protect against maternal illness and neonatal tetanus, sufficient immune protection should be guaranteed during the pregnancy. Basic immunisation is given in childhood; afterwards, a booster immunisation is recommended every 10 years. If the booster has been neglected, it can be made up in the second or third trimester. The mother may also be immunised in the first trimester if this is indicated.
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
No adverse effects have been reported using this drug during breastfeeding.
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
Allergic reaction
Anaphylactoid reaction
Arthralgia
Asthenia
Brachial plexopathy
Chills
Convulsions
Crying
Diarrhoea
Erythema at injection site
Facial oedema
Guillain-Barre syndrome
Headache
Hypoesthesia
Induration (injection site)
Influenza-like symptoms
Limb swelling
Local pain (injection site)
Lymphadenopathy
Malaise
Myalgia
Nausea
Nodules (injection site)
Oedema (injection site)
Pain in vaccinated limb
Pallor
Paraesthesia
Pyrexia
Rash
Restlessness
Shock
Sleep disturbances
Urticaria
Vasovagal attacks
Vertigo
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 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, 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: 7 January 2016
Joint Formulary Committee. British National Formulary. 70th ed. London: BMJ Group and Pharmaceutical Press; 2015.
Paediatric Formulary Committee. BNF for Children 2014-2015. London: BMJ Group, Pharmaceutical Press, and RCPCH Publications; 2014.
Summary of Product Characteristics: Revaxis. Sanofi Pasteur MSD Limited. Revised July 2020.
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