Drugs List

Therapeutic Indications

Uses

Influenza - prophylaxis

Prophylaxis of influenza, especially in those who are at an increased risk of associated complications.

Influenza vaccine will not control epidemics. Immunisation is recommended for individuals over 6 months of age with the following conditions:
Chronic respiratory disease, including asthma.
Chronic cardiac disease.
Chronic renal disease.
Chronic neurological disease.
Diabetes mellitus.
Immunosuppression due to disease or treatment.
Chronic liver disease.
HIV infection (regardless of immune status).
Asplenia or dysfunction of the spleen.
Morbid obesity (Class III obesity).
Pregnancy, all trimesters.
Individuals aged over 65 years.

Patients in nursing homes, residential homes, and other long-stay facilities should also be immunised, as well as carers where an elderly or disabled person may be at risk if the carer is ill.

Immunisation should be considered for household contacts of immunocompromised individuals, as well as healthcare and social care workers who are directly involved in patient care.

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

Administration

By deep subcutaneous or by intramuscular injection depending on brand used, see product literature for details. The subcutaneous route should be used for children with bleeding disorders.

Contraindications

Acute infection
Children under 6 months
Febrile disorder
History of severe allergic reaction to influenza vaccination

Precautions and Warnings

Children aged 6 months to 18 years
Immunosuppression
Predisposition to bleeding complications
Breastfeeding
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

Egg allergy: Use products containing less than 120 nanograms/ml ovalbumin
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 betapropiolactone
May contain trace amounts of cetyltrimethylammonium bromide
May contain trace amounts of formaldehyde
May contain trace amounts of gentamicin
May contain trace amounts of hydrocortisone
May contain trace amounts of kanamycin
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
Some brands may contain thiomersal
Do not mix with other vaccines in the same syringe
Do not use if any signs of precipitate or particulate matter apparent
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Warm to room temperature prior to use
Monitor children for fever for 2 - 3 days following vaccination
May give transient false +ve results in serology using the ELISA method
Follow national immunisation guidelines

Individuals who have egg allergy may be at increased risk of reaction to some influenza vaccines. Patients with either confirmed anaphylaxis to egg or egg allergy with uncontrolled asthma (BTS SIGN step 4 or above) can be immunised with an egg-free influenza vaccine if available. If no egg-free vaccine is available, patients should be referred to specialists for vaccination in hospital using an inactivated influenza vaccine with an ovalbumin content less than 120 nanograms/ml (equivalent to 60 nanograms for 0.5 ml dose). A split dose schedule may be required at the discretion of the supervising physician. Vaccines with ovalbumin content more than 120 nanograms/ml (equivalent to 60 nanograms for 0.5 ml dose) or where the content is not stated should not be used in egg-allergic individuals.

Children and pregnant women should receive a thiomersal-free influenza vaccine. If a thiomersal-free vaccine is not available then a thiomersal-containing vaccine should be given. The benefits of vaccination outweigh the risks, if any, of exposure to thiomersal-containing vaccines.

Trace amounts of betapropiolactone, cetrimonium bromide, formaldehyde, gentamicin, kanamycin, neomycin, octoxinol, polymyxin, polysorbate 80, sodium deoxycholate, hydrocortisone and thiomersal are in some brands, see specific product literature for details.

Pregnancy and Lactation

Pregnancy

Refer to current national guidelines and product literature as not all are licensed for pregnant women.

Seasonal influenza vaccine should be offered to pregnant women. A review of safety studies concluded that inactivated seasonal influenza vaccine can be safely and effectively administered during any trimester of pregnancy and that no study to date has demonstrated an increased risk of either maternal complications or adverse foetal outcomes associated with inactivated influenza vaccine.

Pregnant women should receive a thiomersal-free influenza vaccine. If a thiomersal-free vaccine is not available then a thiomersal-containing vaccine should be given.

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

Some vaccines may be used during breastfeeding, see product literature.

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
Anaphylactic reaction
Angioedema
Arthralgia
Asthenia
Cellulitis (injection site)
Chills
Convulsions
Decreased appetite
Diarrhoea
Ecchymosis (injection site)
Encephalomyelitis
Erythema at injection site
Erythema multiforme
False positive results in serology tests using the ELISA method
Fatigue
Febrile convulsions
Fever
Guillain-Barre syndrome
Headache
Hyperventilation
Induration (injection site)
Influenza-like symptoms
Irritability
Limb swelling
Local pain (injection site)
Local reaction at injection site
Lymphadenopathy
Malaise
Muscle weakness
Myalgia
Nausea
Neuralgia
Neuritis
Neurological disorders
Painful extremities
Paraesthesia
Presyncope
Pruritus
Rash
Shivering
Shock
Skin reactions
Sweating
Swelling (injection site)
Syncope
Thrombocytopenia (transient)
Tonic-clonic spasms
Urticaria
Vasculitis
Vasovagal syncope
Visual disturbances
Vomiting

Presentation

Vaccine containing inactivated influenza surface antigen.

Drugs List

Therapeutic Indications

Uses

Influenza - prophylaxis

Prophylaxis of influenza, especially in those who are at an increased risk of associated complications.

Influenza vaccine will not control epidemics. Immunisation is recommended for individuals over 6 months of age with the following conditions:
Chronic respiratory disease, including asthma.
Chronic cardiac disease.
Chronic renal disease.
Chronic neurological disease.
Diabetes mellitus.
Immunosuppression due to disease or treatment.
Chronic liver disease.
HIV infection (regardless of immune status).
Asplenia or dysfunction of the spleen.
Morbid obesity (Class III obesity).
Pregnancy, all trimesters.
Individuals aged over 65 years.

Patients in nursing homes, residential homes, and other long-stay facilities should also be immunised, as well as carers where an elderly or disabled person may be at risk if the carer is ill.

Immunisation should be considered for household contacts of immunocompromised individuals, as well as healthcare and social care workers who are directly involved in patient care.

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

Adults

Children

Administration

By deep subcutaneous or by intramuscular injection depending on brand used, see product literature for details. The subcutaneous route should be used for children with bleeding disorders.

Contraindications

Acute infection
Children under 6 months
Febrile disorder
History of severe allergic reaction to influenza vaccination

Precautions and Warnings

Children aged 6 months to 18 years
Immunosuppression
Predisposition to bleeding complications
Breastfeeding
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia

Egg allergy: Use products containing less than 120 nanograms/ml ovalbumin
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 betapropiolactone
May contain trace amounts of cetyltrimethylammonium bromide
May contain trace amounts of formaldehyde
May contain trace amounts of gentamicin
May contain trace amounts of hydrocortisone
May contain trace amounts of kanamycin
May contain trace amounts of neomycin
May contain trace amounts of polymyxin
Some brands may contain thiomersal
Do not mix with other vaccines in the same syringe
Do not use if any signs of precipitate or particulate matter apparent
Inject other vaccines at different sites
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Warm to room temperature prior to use
Monitor children for fever for 2 - 3 days following vaccination
May give transient false +ve results in serology using the ELISA method
Follow national immunisation guidelines

Individuals who have egg allergy may be at increased risk of reaction to some influenza vaccines. Patients with either confirmed anaphylaxis to egg or egg allergy with uncontrolled asthma (BTS SIGN step 4 or above) can be immunised with an egg-free influenza vaccine if available. If no egg-free vaccine is available, patients should be referred to specialists for vaccination in hospital using an inactivated influenza vaccine with an ovalbumin content less than 120 nanograms/ml (equivalent to 60 nanograms for 0.5 ml dose). A split dose schedule may be required at the discretion of the supervising physician. Vaccines with ovalbumin content more than 120 nanograms/ml (equivalent to 60 nanograms for 0.5 ml dose) or where the content is not stated should not be used in egg-allergic individuals.

Children and pregnant women should receive a thiomersal-free influenza vaccine. If a thiomersal-free vaccine is not available then a thiomersal-containing vaccine should be given. The benefits of vaccination outweigh the risks, if any, of exposure to thiomersal-containing vaccines.

Trace amounts of betapropiolactone, cetrimonium bromide, formaldehyde, gentamicin, kanamycin, neomycin, octoxinol, polymyxin, polysorbate 80, sodium deoxycholate, hydrocortisone and thiomersal are in some brands, see specific product literature for details.

Pregnancy and Lactation

Pregnancy

Refer to current national guidelines and product literature as not all are licensed for pregnant women.

Seasonal influenza vaccine should be offered to pregnant women. A review of safety studies concluded that inactivated seasonal influenza vaccine can be safely and effectively administered during any trimester of pregnancy and that no study to date has demonstrated an increased risk of either maternal complications or adverse foetal outcomes associated with inactivated influenza vaccine.

Pregnant women should receive a thiomersal-free influenza vaccine. If a thiomersal-free vaccine is not available then a thiomersal-containing vaccine should be given.

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

Some vaccines may be used during breastfeeding, see product literature.

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
Anaphylactic reaction
Angioedema
Arthralgia
Asthenia
Cellulitis (injection site)
Chills
Convulsions
Decreased appetite
Diarrhoea
Ecchymosis (injection site)
Encephalomyelitis
Erythema at injection site
Erythema multiforme
False positive results in serology tests using the ELISA method
Fatigue
Febrile convulsions
Fever
Guillain-Barre syndrome
Headache
Hyperventilation
Induration (injection site)
Influenza-like symptoms
Irritability
Limb swelling
Local pain (injection site)
Local reaction at injection site
Lymphadenopathy
Malaise
Muscle weakness
Myalgia
Nausea
Neuralgia
Neuritis
Neurological disorders
Painful extremities
Paraesthesia
Presyncope
Pruritus
Rash
Shivering
Shock
Skin reactions
Sweating
Swelling (injection site)
Syncope
Thrombocytopenia (transient)
Tonic-clonic spasms
Urticaria
Vasculitis
Vasovagal syncope
Visual disturbances
Vomiting

Effects on Laboratory Tests

False positive results in serology tests using the ELISA method to detect antibodies against HIV1, hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the result. The transient false positive reactions could be due to the IgM response induced by the vaccine.

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: July 2014

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.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Agrippal. Novartis Vaccines. Revised May 2012
Summary of Product Characteristics: Adjuvanted trivalent influenza vaccine (surface antigen, inactivated) suspension for injection in pre-filled syringe. Seqirus UK Ltd. Revised June 2020.
Summary of Product Characteristics: Adjuvanted quadrivalent influenza vaccine (surface antigen, inactivated) suspension for injection in pre-filled syringe influenza vaccine, adjuvanted with MF59C.1. Seqirus UK Ltd. Revised September 2021.
Summary of Product Characteristics: Fluad, suspension for injection in pre-filled syringe. Seqirus Vaccines Ltd. Revised July 2018
Summary of Product Characteristics: Fluad Tetra suspension for injection in pre-filled syringe. Seqirus UK Ltd. Revised May 2020.
Summary of Product Characteristics: Fluvirin. Novartis Vaccines. Revised September 2012
Summary of Product Characteristics: Imuvac 2013/2014. Solvay Healthcare Ltd. Revised August 2013
Summary of Product Characteristics: Influenza vaccine tetra MYL. Mylan products Ltd. Revised October 2018.
Summary of Product Characteristics: Influenza vaccine 2018/2019. Mylan products Ltd. Revised April 2018.
Summary of Product Characteristics: Influvac Desu. Abbott Healthcare Products Ltd. Revised August 2013
Summary of Product Characteristics: Influvac sub-unit 2012/2013. Abbott Healthcare Products Ltd. Revised August 2012
Summary of Product Characteristics: Influvac sub-unit tetra. Mylan products LTD. Revised May 2021.
Summary of Product Characteristics: Viroflu. Sanofi Pasteur MSD Ltd. Revised October 2012

Immunisation against infectious disease (The Green Book).
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last revised: 27 November 2020
Last accessed: 27 October 2021

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 July 2020.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Influenza vaccine. Last revised: September 3, 2013.
Last accessed: October 17, 2013.