Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
VAQTA Paediatric is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA Paediatric is recommended for healthy individuals from 12 months of age to 17 years of age who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., hepatitis C with diagnosed liver disease).
The use of VAQTA Paediatric should be based on official recommendations.
For optimal antibody response, primary immunisation should be given at least 2, preferably 4, weeks prior to expected exposure to hepatitis A virus.
VAQTA Paediatric will not prevent hepatitis caused by infectious agents other than hepatitis A virus.
The vaccination series consists of one primary dose and one booster dose given according to the following schedule:
Primary dose:
Children and adolescents aged 12 months to 17 years of age should receive a single 0.5 mL (25 U) dose of vaccine at an elected date.
Safety and effectiveness in infants <12 months of age have not been established.
Booster dose:
Individuals who received a primary dose at 12 months to 17 years of age should receive a booster dose of 0.5 mL (25 U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 10 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years (see section 5.1).
A booster dose of VAQTA Paediatric may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines as shown by data for adults, 18 to 83 years of age; no such data are available for VAQTA (25 U/0.5 mL) presentation.
VAQTA Paediatric should be injected INTRAMUSCULARLY. The deltoid muscle is the preferred site for injection. The anterolateral thigh region may be used in infants if the deltoid muscle is not sufficiently developed. The vaccine should not be administered subcutaneously or intradermally since administration by these routes may result in a less than optimal antibody response.
For individuals with bleeding disorders who are at risk of haemorrhage following intramuscular injection (e.g., haemophiliacs) other measures can be taken such as intramuscular administration of the vaccine after anti-haemophilia or other similar therapy, or applying pressure. This vaccine may be administered subcutaneously to these subjects.
For instructions on preparation of the medicinal product before administration, see section 6.6.
There are no data with regard to overdose.
3 years.
Store in a refrigerator (2°C-8°C).
DO NOT FREEZE since freezing destroys potency.
0.5 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend or bromobutyl).
0.5 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend or bromobutyl), without needle, with a tip-cap (chlorobutyl isoprene blend or bromobutyl isoprene blend), with 0, 1 or 2 separate needles.
0.5 mL suspension in a vial (glass), grey rubber stopper (chlorobutyl isoprene blend).
Pack sizes: Pack of 1 syringe or 1 vial.
Not all pack sizes and presentations may be marketed.
The vaccine should be used as supplied; no reconstitution is necessary.
Parenteral drug products should be inspected visually for extraneous particulate matter and discolouration prior to administration. After thorough agitation, VAQTA Paediatric is a slightly opaque white suspension.
Shake well immediately before use. Thorough agitation is necessary to maintain suspension of the vaccine. For syringe without attached needle, hold the syringe barrel and attach the needle by twisting in clockwise direction until the needle fits securely on the syringe.
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infections from one person to another.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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