Japanese encephalitis inactivated adsorbed vaccine
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Vaccine containing japanese encephalitis virus strain SA14-14-2 (inactivated) adsorbed on aluminium hydroxide.
Drugs List
Therapeutic Indications
Uses
Active immunisation against Japanese encephalitis
Dosage
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
Adults
Primary vaccination series
One dose of 0.5ml on day 0 and then repeated on day 28.
Rapid vaccination series
One dose of 0.5ml on day 0 and then repeated on day 7.
Primary immunisation to be completed at least one week prior to exposure.
Booster dose
One dose of 0.5ml (a third dose) should be given 1 to 2 years after completing the primary immunisation course. Persons at continuous risk for acquiring Japanese encephalitis should receive a booster dose at month 12 after the primary immunisation course. Longterm seroprotection data following a first booster dose at 1 to 2 years after primary immunisation suggests that a second booster should be given 10 years after the first booster dose, prior to exposure.
Elderly
Primary vaccination series
One dose of 0.5ml on day 0 and then repeated on day 28.
Rapid vaccination series (unlicensed)
The Green Book advises that although not licensed, the rapid vaccination schedule of one dose of 0.5ml on day 0 and then repeated on day 7, may be used in circumstances where there is genuinely insufficient time to complete the standard schedule prior to travel.
Primary immunisation to be completed at least one week prior to exposure.
Booster dose
The immune response in the elderly is lower than in younger adults. Duration of protection is uncertain in elderly patients, therefore a booster dose (third dose) should be considered before any further exposure. Longterm seroprotection following a booster dose is not known.
Children
Children aged 3 to 18 years
Primary vaccination series
One dose of 0.5ml on day 0 and then repeated on day 28.
Primary immunisation to be completed at least one week prior to exposure.
Rapid vaccination series(unlicensed)
The Green Book advises that although not licensed, the rapid vaccination schedule of one dose of 0.5ml on day 0 and then repeated on day 7, may be used in circumstances where there is genuinely insufficient time to complete the standard schedule prior to travel.
Booster dose
A booster dose 0.5ml (third dose) should be given within the second year (i.e. 1 to 2 years) after the primary immunisation, prior to exposure. Children and adolescents at continuous risk should receive a booster dose at 12 months after primary immunisation.
Children aged 2 months to 3 years
Primary vaccination series
One dose of 0.25ml on day 0 and then repeated on day 28.
Primary immunisation to be completed at least one week prior to exposure.
Rapid vaccination series (unlicensed)
The Green Book advises that although not licensed, the rapid vaccination schedule of one dose of 0.25ml on day 0 and then repeated on day 7, may be used in circumstances where there is genuinely insufficient time to complete the standard schedule prior to travel.
Booster dose
For children aged 14 months to 3 years a booster dose 0.25ml (third dose) should be given within the second year (i.e. 1 to 2 years) after the primary immunisation, prior to exposure. Children and adolescents at continuous risk should receive a booster dose at 12 months after primary immunisation.
Additional Dosage Information
In situations where the primary course plus initial booster has been interrupted, the schedule should be resumed and not restarted.
Administration
The vaccine should be administered by intramuscular injection into the deltoid muscle. In infants the anterolateral aspect of the thigh may be used.
In exceptional circumstances, the vaccine may be administered subcutaneously in patients with thrombocytopenia or bleeding disorders. However, there are no clinical efficacy data to support administration via this route. Subcutaneous administration could lead to a suboptimal response to the vaccine.
Contraindications
Children under 2 months
Severe febrile conditions
Precautions and Warnings
Immunosuppression
Patients over 65 years
Breastfeeding
Coagulopathy
Immunodeficiency syndromes
Pregnancy
Thrombocytopenia
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 formaldehyde
May contain trace amounts of protamine
May contain trace amounts of sodium metabisulfite
Different brands may not be interchangeable
Do not mix with other drugs or substances
Do not use if any signs of precipitate or particulate matter apparent
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Follow national immunisation guidelines
Pregnancy and Lactation
Pregnancy
Use japanese encephalitis vaccine with caution in pregnancy.
There is limited data on the use of japanese encephalitis vaccine in pregnant women and the manufacturer recommends avoiding use. Miscarriage has been associated with japanese encephalitis virus infection acquired during the first 2 trimesters of pregnancy. The vaccine should only be used in pregnancy if the benefit outweighs any potential risk. Reproduction studies in rats have revealed no evidence of impaired fertility or harm to the foetus.
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 japanese encephalitis vaccine with caution in breastfeeding.
There is limited data on the use of japanese encephalitis vaccine during breastfeeding. The manufacturer recommends avoiding use.
The Centre for Disease Control and Prevention state that in general vaccines given to a nursing mother do not affect the safety of breastfeeding for mothers or infants. Therefore, breastfeeding is not a contraindication to japanese encephalitis vaccine in mothers who require it.
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
Arthralgia
Asthenia
Chills
Cough
Decreased appetite
Diarrhoea
Dizziness
Dysgeusia
Dyspnoea
Erythema
Erythema at injection site
Eyelid oedema
Fatigue
Headache
Hyperhidrosis
Increases in hepatic enzymes
Influenza-like symptoms
Irritability
Itching (injection site)
Local pain (injection site)
Lymphadenopathy
Malaise
Migraine
Myalgia
Nausea
Neuritis
Painful extremities
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Pyrexia
Rash
Stiffness
Swelling (injection site)
Tachycardia
Tenderness (injection site)
Thrombocytopenia
Urticaria
Vertigo
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: July 2018
Reference Sources
Summary of Product Characteristics: Ixiaro suspension for injection. Novartis Vaccines. Revised May 2016
Immunisation against infectious disease - The Green Book.
Available at: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Last accessed: 17 July 2018
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 26 April 2019
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
Japanese Encephalitis Vaccine Last revised: 02 June 2016
Last accessed: 17 July 2018
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