Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Merck Sharp & Dohme (UK) Limited, 120 Moorgate, London, EC2M 6UR, UK
VAQTA Adult is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA Adult is recommended for healthy adults 18 years of age and older who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., those with Human Immunodeficiency Virus [HIV] or hepatitis C with diagnosed liver disease).
The use of VAQTA Adult 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 Adult 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:
Adults 18 years of age and older should receive a single 1.0 mL (50U) dose of vaccine at an elected date.
Booster dose:
Adults 18 years of age and older who received a primary dose should receive a booster dose of 1.0 mL (50U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 6 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 may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines (See section 5.1).
HIV-infected adults should receive a single dose of 1.0mL (50U) of VAQTA Adult at an elected date followed by a booster dose of 1.0mL (50U) 6 months later.
There is a paediatric formulation available for children and adolescents. For details please refer to the Summary of Product Characteristics for VAQTA Paediatric.
VAQTA Adult should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered intradermally since administration by this route may result in a less than optimal response.
For individuals with bleeding disorders who are at risk of haemorrhage following intramuscular injection (e.g. haemophiliacs), this vaccine may be administered subcutaneously (see section 5.1).
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.
1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend).
1 mL suspension in a pre-filled syringe (type I glass) with plunger-stopper (chlorobutyl isoprene blend), without needle, with a tip-cap (chlorobutyl isoprene blend), with 0, 1 or 2 separate needles.
1 mL suspension in a vial (type I glass), grey rubber stopper (chlorobutyl isoprene blend).
Pack sizes: Pack of 1 syringe or 1 vial.
Not all pack sizes or 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 discoloration prior to administration. After thorough agitation, VAQTA Adult 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.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
