Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: GlaxoSmithKline Biologicals SA, Rue de lInstitut 89, 1330 Rixensart, Belgium
Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
Arexvy is administered as a single dose of 0.5 mL.
The need for revaccination with a subsequent dose has not been established.
The safety and efficacy of Arexvy in children have not been established.
No data are available.
For intramuscular injection only, preferably in the deltoid muscle.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
No case of overdose has been reported in the clinical studies.
2 years.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C–8°C or at room temperature up to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Store in the original package in order to protect from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Arexvy is presented as:
Arexvy is available in a pack size of 1 vial of powder plus 1 vial of suspension or in a pack size of 10 vials of powder plus 10 vials of suspension.
Not all pack sizes may be marketed.
The powder and the suspension must be reconstituted prior to administration.
The powder and suspension should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not reconstitute the vaccine.
How to prepare Arexvy:
Arexvy must be reconstituted prior to administration.
1. Withdraw the entire contents of the vial containing the suspension into a syringe.
2. Add the entire contents of the syringe into the vial containing the powder.
3. Gently swirl until the powder is completely dissolved.
The reconstituted vaccine is an opalescent, colourless to pale brownish liquid.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of appearance. If either is observed, do not administer the vaccine.
Chemical and physical in-use stability has been demonstrated for 4 hours at 2°C–8°C or at room temperature up to 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 4 hours.
Before administration:
1. Withdraw 0.5 mL of the reconstituted vaccine into the syringe.
2. Change the needle so that you are using a new needle.
Administer the vaccine intramuscularly.
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.
