Diphtheria, tetanus, pertussis (5 component), hepatitis b, poliomyelitis and
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing diphtheria, tetanus, pertussis (5 component), hepatitis b, poliomyelitis and haemophilus influenzae b.
Drugs List
Therapeutic Indications
Uses
Diphtheria - prophylaxis
Immunisation against haemophilus influenzae type B invasive disease
Pertussis - prophylaxis
Poliomyelitis - prophylaxis
Prophylaxis of hepatitis B
Tetanus - prophylaxis
Dosage
Children
Children aged 6 weeks and above
Primary vaccination
Two or three doses, with an interval of at least 1 month between doses.
Booster vaccination
A booster dose should be administered at least 6 months after the last priming dose.
Booster dose should be given in accordance with the official recommendations. As a minimum, a dose of Hib vaccine must be administered.
Additional Dosage Information
Where a hepatitis B vaccine is given at birth, this vaccine can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used. This vaccine can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule.
Administration
For intramuscular injection only.
Contraindications
Children under 6 weeks
Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
History of anaphylaxis
Severe febrile conditions
Uncontrolled epileptic disorder
Uncontrolled neurological disorder
Precautions and Warnings
History of febrile convulsions
History of post vaccination pyrexia above 40 degrees C within 48 hours
Immunosuppression
Premature infants
Previous post vaccination convulsions within 3 days
Previous post vaccination crying for over 3 hours within 48 hours
Previous post vaccination shock like state within 48 hours
Coagulopathy
Guillain Barre syndrome within 6 weeks of previous tetanus toxoid vaccine
Immunodeficiency syndromes
Thrombocytopenia
No protection against other strains of haemophilus influenzae or meningitis
Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Pre-treatment medical history and clinical examination
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
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Monitor patient for 2-3 days if history of febrile convulsions
Risk of apnoea in premature infants - monitor respiration for 72 hours
May affect results of some laboratory tests
Follow national immunisation guidelines
This vaccine should not be administered if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances, pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, polio and H. influenza type B vaccines.
Note that the rate of fever is higher when this vaccine is co-administered with a pneumococcal conjugate vaccine (PCV13) following the booster dose in the second year of life, compared to the primary series. These reactions were mild or moderate (less than 39.5°C) and transient.
Pregnancy and Lactation
Pregnancy
Not indicated in patients of child bearing age, relevant data is not available.
Lactation
Not indicated in patients of child bearing age, relevant data is not available.
Side Effects
Abdominal pain
Anaphylactic reaction
Angioedema
Apnoea
Bruising at injection site
Convulsions
Cough
Crying
Decreased appetite
Diarrhoea
Dyspnoea
Erythema
Erythema multiforme
Facial oedema
Fatigue
Febrile convulsions
Hyperhidrosis
Hypersensitivity reactions
Hypotonia
Hypotonic hyporesponsive episode
Increased appetite
Induration (injection site)
Injection site reactions
Insomnia
Irritability
Limb swelling
Lymphadenopathy
Nodules (injection site)
Oedema
Pain
Pallor
Pyrexia
Rash
Restlessness
Rhinitis
Sensation of warmth
Shock
Sleep disorders
Somnolence
Swelling (injection site)
Urticaria
Vomiting
Effects on Laboratory Tests
False positive urine tests can be observed for at least 30 days following vaccination due to Hib capsular polysaccharide antigen being excreted in urine. Other tests should be performed in order to confirm Hib infection during this period.
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: June 2021
Reference Sources
Summary of Product Characteristics: Vaxelis suspension for injection in pre-filled syringe. Sanofi Pasteur. Revised January 2021.
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: 17 June 2021
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