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

Administration

For intramuscular injection.

Contraindications

Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions

Precautions and Warnings

History of post vaccination pyrexia above 40 degrees C within 48 hours
Immunosuppression
Patients over 3 years
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
History of neurological disorder
Immunodeficiency syndromes
Neurological disorder
Thrombocytopenia

No protection against other strains of haemophilus influenzae or meningitis
Postpone immunisation if there is active or suspected infection
Prophylactic antipyretic recommended if history of seizure
Impaired response possible in immunocompromised patients
Pre-treatment medical history and clinical examination
Prophylactic antipyretic recommended if history of febrile reactions
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
Inject other vaccines at different sites
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 interfere with diagnostic antigen tests for 2 weeks post vaccination
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 febrile reactions is higher when this vaccine is co-administered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measles-mumps-rubella-varicella vaccine, compared to that occurring following the administration of this vaccine alone. These reactions were mostly moderate (less than or equal to 39°C) and transient.

Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode were observed with concomitant administration of this vaccine with pneumococcal 13 valent vaccines.

Pregnancy and Lactation

Pregnancy

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 3 years of age or older.

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

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 3 years of age or older.

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

Allergic reaction
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Apnoea
Bronchitis
Collapse
Convulsions
Cough
Crying
Decreased appetite
Dermatitis
Diarrhoea
Fatigue
Fever
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Limb swelling
Lymphadenopathy
Nervousness
Pain
Pruritus
Rash
Restlessness
Shock-like state
Somnolence
Swelling (injection site)
Thrombocytopenia
Upper respiratory tract infection
Urticaria
Vesicles
Vomiting

Presentation

Injection containing diphtheria, tetanus, pertussis (acellular, component), hepatitis B, poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed).

These products have been produced by recombinant technology using Saccharomyces cerevisiae.

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

Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type B vaccine should be administered in accordance with official recommendations and/or local practice.

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

Children

Administration

For intramuscular injection.

Contraindications

Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions

Precautions and Warnings

History of post vaccination pyrexia above 40 degrees C within 48 hours
Immunosuppression
Patients over 3 years
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
History of neurological disorder
Immunodeficiency syndromes
Neurological disorder
Thrombocytopenia

No protection against other strains of haemophilus influenzae or meningitis
Postpone immunisation if there is active or suspected infection
Prophylactic antipyretic recommended if history of seizure
Impaired response possible in immunocompromised patients
Pre-treatment medical history and clinical examination
Prophylactic antipyretic recommended if history of febrile reactions
Vaccine may not be effective in 100% of patients
May contain trace amounts of formaldehyde
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
Inject other vaccines at different sites
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 interfere with diagnostic antigen tests for 2 weeks post vaccination
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 febrile reactions is higher when this vaccine is co-administered with a pneumococcal conjugate vaccine (PCV7, PCV10, PCV13), or with a measles-mumps-rubella-varicella vaccine, compared to that occurring following the administration of this vaccine alone. These reactions were mostly moderate (less than or equal to 39°C) and transient.

Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode were observed with concomitant administration of this vaccine with pneumococcal 13 valent vaccines.

Pregnancy and Lactation

Pregnancy

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 3 years of age or older.

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

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 3 years of age or older.

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

Allergic reaction
Anaphylactic reaction
Anaphylactoid reaction
Angioedema
Apnoea
Bronchitis
Collapse
Convulsions
Cough
Crying
Decreased appetite
Dermatitis
Diarrhoea
Fatigue
Fever
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Limb swelling
Lymphadenopathy
Nervousness
Pain
Pruritus
Rash
Restlessness
Shock-like state
Somnolence
Swelling (injection site)
Thrombocytopenia
Upper respiratory tract infection
Urticaria
Vesicles
Vomiting

Effects on Laboratory Tests

The Haemophilus influenzae type b capsular polysaccharide antigen is excreted in the urine, and so a positive urine test can be observed within one to two weeks following vaccination. Consequently, to confirm Haemophilus influenzae type b infection during this period, alternative tests should be performed.

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: August 2017

Reference Sources

Summary of Product Characteristics: Infanrix hexa, Powder and suspension for suspension for injection. GlaxoSmithKline UK. Revised July 2017.

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 August 2017