Drugs List

Therapeutic Indications

Uses

Immunisation against hepatitis A and typhoid

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 in the deltoid region. The vaccine should not be administered in the gluteal region, nor by the subcutaneous or intradermal routes since administration by these routes may result in a less than optimal response.

In exceptional circumstances the vaccine may be given subcutaneously to patients with risk of haemorrhage or thrombocytopenia since bleeding may occur following intramuscular administration.

Contraindications

Severe febrile conditions.
Hepatyrix administration in children under 15 years of age.
ViATIM administration in children under 16 years of age.

Precautions and Warnings

Subcutaneous use only if risk of haemorrhage
Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
May contain trace amounts of neomycin
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
May not be effective in patients incubating hepatitis
Follow national immunisation guidelines
Pregnancy: Use only if high risk of hepatitis A and typhoid fever
Breastfeeding: Only use if high risk of hepatitis A and typhoid fever
Ability to drive or operate machinery may be affected by side effects

Children aged 15 to 16 years - not all available brands are licensed for this age group, see specific product literature.

These vaccines are not effective against other hepatitis-causing agents nor other serotypes of Salmonella enterica.

Syncope can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury.

Pregnancy and Lactation

Pregnancy

Hepatitis A with typhoid vaccine should be used with caution in pregnancy.
Limited human data of use during pregnancy and limited animal reproduction studies indicate no adverse effects on pregnancy or the foetus/neonate. As for any purified polysaccharide vaccine and inactivated vaccine, no risk to the foetus would be expected. However the manufacture recommend the vaccine should only be used during pregnancy after careful consideration.
The monovalent vaccine is recommended if the patient is at risk of only hepatitis A or typhoid fever.
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

Use hepatitis A with typhoid vaccine with caution in breastfeeding.
Adequate human data on use during breastfeeding is not available.
It is unknown if the hepatitis A and typhoid vaccine is excreted into human breast milk.

The vaccine should only be used in women who are breastfeeding after careful consideration.
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 Arthralgia Erythema at injection site Fever
Headache
Local pain (injection site) Malaise Myalgia Nausea Paraesthesia Pruritus Rash Swelling (injection site) Vomiting
Hepatyrix specific side effects

Convulsions Decreased appetite General aches Guillain-Barre syndrome Neuralgic amyotrophy Syncope Transverse myelitis

ViATIM specific side effects

Abdominal pain Aggravation of existing asthma
Asthenia Diarrhoea Dizziness Increases in serum transaminases (reversible) Induration (injection site) Nodules (injection site) Serum sickness Urticaria

Presentation

Combined vaccine containing Salmonella typhi (Ty 2 strain) and inactivated hepatitis A virus ( GBM strain cultured on MRC5 human diploid cells)
Combined vaccine containing Salmonella typhi (Ty 2 strain) and inactivated hepatitis A viral antigen ( HM175 hepatitis A virus strain propagated in MRC5 human diploid cells)

Drugs List

Therapeutic Indications

Uses

Immunisation against hepatitis A and typhoid

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

Adults

Elderly

Adolescents

Administration

For intramuscular injection in the deltoid region. The vaccine should not be administered in the gluteal region, nor by the subcutaneous or intradermal routes since administration by these routes may result in a less than optimal response.

In exceptional circumstances the vaccine may be given subcutaneously to patients with risk of haemorrhage or thrombocytopenia since bleeding may occur following intramuscular administration.

Contraindications

Severe febrile conditions.
Hepatyrix administration in children under 15 years of age.
ViATIM administration in children under 16 years of age.

Precautions and Warnings

Subcutaneous use only if risk of haemorrhage
Postpone immunisation if there is active or suspected infection
Impaired response possible in immunocompromised patients
Vaccine may not be effective in 100% of patients
May contain trace amounts of neomycin
Do not mix with other vaccines in the same syringe
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
May not be effective in patients incubating hepatitis
Follow national immunisation guidelines
Pregnancy: Use only if high risk of hepatitis A and typhoid fever
Breastfeeding: Only use if high risk of hepatitis A and typhoid fever
Ability to drive or operate machinery may be affected by side effects

Children aged 15 to 16 years - not all available brands are licensed for this age group, see specific product literature.

These vaccines are not effective against other hepatitis-causing agents nor other serotypes of Salmonella enterica.

Syncope can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury.

Pregnancy and Lactation

Pregnancy

Hepatitis A with typhoid vaccine should be used with caution in pregnancy.
Limited human data of use during pregnancy and limited animal reproduction studies indicate no adverse effects on pregnancy or the foetus/neonate. As for any purified polysaccharide vaccine and inactivated vaccine, no risk to the foetus would be expected. However the manufacture recommend the vaccine should only be used during pregnancy after careful consideration.
The monovalent vaccine is recommended if the patient is at risk of only hepatitis A or typhoid fever.
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

Use hepatitis A with typhoid vaccine with caution in breastfeeding.
Adequate human data on use during breastfeeding is not available.
It is unknown if the hepatitis A and typhoid vaccine is excreted into human breast milk.

The vaccine should only be used in women who are breastfeeding after careful consideration.
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

Counselling

Advise patients that the vaccine may cause dizziness. If affected do not drive or operate machinery.

Side Effects

Allergic reaction Anaphylactic reaction Anaphylactoid reaction Arthralgia Erythema at injection site Fever
Headache
Local pain (injection site) Malaise Myalgia Nausea Paraesthesia Pruritus Rash Swelling (injection site) Vomiting
Hepatyrix specific side effects

Convulsions Decreased appetite General aches Guillain-Barre syndrome Neuralgic amyotrophy Syncope Transverse myelitis

ViATIM specific side effects

Abdominal pain Aggravation of existing asthma
Asthenia Diarrhoea Dizziness Increases in serum transaminases (reversible) Induration (injection site) Nodules (injection site) Serum sickness Urticaria

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: September 2013

Reference Sources

British National Formulary, 66th Edition (September 2013-March 2014) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

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.

Handbook on Injectable Drugs, 15th Edition (2009), Trissel, L. American Society of Health-System Pharmacists.

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: September 11, 2013

Medications and Mother's Milk, 14th edition (2010) Hale, T.W. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Hepatyrix. GlaxoSmithKline UK. Revised January 2012.

Summary of Product Characteristics: ViATIM. Sanofi Pasteur MSD Ltd. Revised August 2012.