Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Powder (RSVPreF3 antigen)

Trehalose dihydrate
Potassium dihydrogen phosphate
Dipotassium phosphate
Polysorbate 80

Suspension (AS01E Adjuvant System)
Sodium chloride
Potassium dihydrogen phosphate
Dioleoyl phosphatidylcholine
Disodium phosphate anhydrous
Cholesterol
3-O-desacyl-4’-monophosphoryl lipid A (MPL)
Purified Quillaja Saponin (QS-21)
Water for injection

For adjuvant see also section 2

6.2   Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3   Shelf life

The expiry date of the product is indicated on the packaging materials.
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.

6.4    Special precautions for storage

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 
6.5    Nature and contents of container

Arexvy is presented as:
• Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a mustard green flip-off cap (antigen).
• Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber) and a brown flip- off cap (adjuvant).

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.

6.6    Special precautions for disposal and other handling
The powder and the suspension must be reconstituted prior to administration.
Antigen             Adjuvant
Powder             Suspension



1 dose (0.5 mL)

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.