Drugs List

Therapeutic Indications

Uses

Diphtheria - prophylaxis
Immunisation against haemophilus influenzae type B invasive disease
Pertussis - prophylaxis
Poliomyelitis - prophylaxis
Tetanus - prophylaxis

Active primary and booster immunisation against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by haemophilus influenzae type B in infants and children from the age of 2 months.

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.

The recommended injection site is the anterolateral aspect of the thigh.

Contraindications

Children under 6 weeks
Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions
Uncontrolled epileptic disorder
Uncontrolled neurological disorder

Precautions and Warnings

Children aged 6 weeks to 2 months
History of post vaccination pyrexia above 40 degrees C within 48 hours
Immunosuppression
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
Impaired response possible in immunocompromised patients
Not all available brands are licensed for all age groups
Vaccine may not be effective in 100% of patients
May contain polysorbate
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
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
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

Children with progressive, evolving or unstable neurological conditions (including seizures) should not be vaccinated until their condition is stabilised or corrected. The risk-benefit of immunising with this vaccine or deferring this vaccination should be weighed carefully in an infant or child suffering from a new onset or progression of a severe neurological disorder.

A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome do not constitute a contraindication for the use of this vaccine. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.

Pregnancy and Lactation

Pregnancy

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 10 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 10 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

Anaphylactic reaction
Anaphylactoid reaction
Angioneurotic oedema
Apnoea
Bronchitis
Convulsions
Cough
Crying
Decreased appetite
Dermatitis
Diarrhoea
Erythema at injection site
Fatigue
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Limb swelling
Local pain (injection site)
Lymphadenopathy
Pruritus
Pyrexia
Rash
Restlessness
Rhinorrhoea
Somnolence
Swelling (injection site)
Upper respiratory tract infection
Urticaria
Vesiculation (injection site)
Vomiting

Presentation

Vaccine containing diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

Drugs List

Therapeutic Indications

Uses

Diphtheria - prophylaxis
Immunisation against haemophilus influenzae type B invasive disease
Pertussis - prophylaxis
Poliomyelitis - prophylaxis
Tetanus - prophylaxis

Active primary and booster immunisation against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by haemophilus influenzae type B in infants and children from the age of 2 months.

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

Diphtheria, tetanus, pertussis, poliomyelitis and haemophilus influenzae type B vaccine should be administered in accordance with official recommendations and/or local practice, especially vaccinations given after the second year of life.

Children

Administration

For intramuscular injection.

The recommended injection site is the anterolateral aspect of the thigh.

Contraindications

Children under 6 weeks
Encephalopathy of unknown aetiology within 7 days previous pertussis vacc.
Severe febrile conditions
Uncontrolled epileptic disorder
Uncontrolled neurological disorder

Precautions and Warnings

Children aged 6 weeks to 2 months
History of post vaccination pyrexia above 40 degrees C within 48 hours
Immunosuppression
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
Impaired response possible in immunocompromised patients
Not all available brands are licensed for all age groups
Vaccine may not be effective in 100% of patients
May contain polysorbate
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
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
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

Children with progressive, evolving or unstable neurological conditions (including seizures) should not be vaccinated until their condition is stabilised or corrected. The risk-benefit of immunising with this vaccine or deferring this vaccination should be weighed carefully in an infant or child suffering from a new onset or progression of a severe neurological disorder.

A history of febrile convulsions, a family history of convulsions or Sudden Infant Death Syndrome do not constitute a contraindication for the use of this vaccine. Vaccinees with a history of febrile convulsions should be closely followed up as such adverse events may occur within 2 to 3 days post vaccination.

Pregnancy and Lactation

Pregnancy

In the current vaccination schedule in the UK, this vaccination is not indicated for use in any patient of 10 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 10 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

Anaphylactic reaction
Anaphylactoid reaction
Angioneurotic oedema
Apnoea
Bronchitis
Convulsions
Cough
Crying
Decreased appetite
Dermatitis
Diarrhoea
Erythema at injection site
Fatigue
Hypotonic hyporesponsive episode
Induration (injection site)
Irritability
Limb swelling
Local pain (injection site)
Lymphadenopathy
Pruritus
Pyrexia
Rash
Restlessness
Rhinorrhoea
Somnolence
Swelling (injection site)
Upper respiratory tract infection
Urticaria
Vesiculation (injection site)
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: June 2014

Reference Sources

Summary of Product Characteristics: Infanrix-IPV+Hib powder and suspension for suspension for injection. GlaxoSmithKline UK Ltd. Revised October 2013.

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 24 June, 2014.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 June 2017

Use of Infanrix-IPV+Hib in the infant immunisation schedule
Available at: https://www.gov.uk/government/publications/use-of-infanrix-ipvhib-in-the-infant-immunisation-schedule
Last accessed: 24 June, 2014.