Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Powder (gE antigen):
Sucrose
Sodium dihydrogen phosphate dihydrate
Dipotassium phosphate
Polysorbate 80

Suspension (AS01B Adjuvant System):
Sodium chloride
Dioleoyl phosphatidylcholine
Potassium dihydrogen phosphate
Cholesterol
Disodium phosphate anhydrous
3-O-desacyl-4’-monophosphoryl lipid A (MPL)
Purified Quillaja Saponin (QS-21)
Water for injections


6.2   Incompatibilities
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 24 hours at 30°C.

From a microbiological point of view, the vaccine should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at 2°C to 8°C.

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

• Powder for 1 dose in a vial (type I glass) with a stopper (butyl rubber)
• Suspension for 1 dose in a vial (type I glass) with a stopper (butyl rubber).

Shingrix is available in a pack size of 1 vial of powder and 1 vial of suspension or in a pack size of 10 vials of powder and 10 vials of suspension.

Not all pack sizes may be marketed

6.6   Special precautions for disposal and other handling
Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).
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 Shingrix:

Shingrix must be reconstituted prior to administration.

1. Withdraw the entire contents of the vial containing the suspension into the syringe.
2. Add the entire contents of the syringe into the vial containing the powder.
3. Shake gently 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.

After reconstitution, the vaccine should be used promptly; if this is not possible, the vaccine should be stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded.

Before administration:

1. Withdraw the entire contents of the vial containing the reconstituted vaccine into the syringe.
2. Change the needle so that you are using a new needle to administer the vaccine.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.