Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands
ZOSTAVAX is indicated for prevention of herpes zoster (“zoster” or shingles) and herpes zoster-related post-herpetic neuralgia (PHN).
ZOSTAVAX is indicated for immunization of individuals 50 years of age or older.
Individuals should receive a single dose (0.65 mL).
The need for a booster dose is not known. See sections 4.8 and 5.1.
The safety and efficacy of ZOSTAVAX in children and adolescents have not been established. No data are available.
There is no relevant use of ZOSTAVAX in children and adolescents for prevention of primary varicella infection (chickenpox).
The vaccine can be injected subcutaneously (SC) or intramuscularly (IM), preferably in the deltoid region (see sections 4.8 and 5.1).
The vaccine should be administered subcutaneously in patients with severe thrombocytopenia or any coagulation disorder (see section 4.4).
The vaccine should under no circumstances be injected intravascularly.
For precautions to be taken before handling or administering the medicinal product see section 6.6.
For instructions on reconstitution of the medicinal product before administration see section 6.6.
Administration of a higher than recommended dose of ZOSTAVAX was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of ZOSTAVAX.
18 months.
After reconstitution, the vaccine should be used immediately. However, in-use stability has been demonstrated for 30 minutes when stored at 20°C–25°C.
Store and transport refrigerated (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.
ZOSTAVAX with solvent for reconstitution supplied in a vial: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
ZOSTAVAX with solvent for reconstitution supplied in a pre-filled syringe: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1, 10 or 20.
Not all pack sizes may be marketed.
Before mixing with the solvent, the powder vaccine is a white to off-white compact crystalline plug. The solvent is a clear colourless liquid. When reconstituted, ZOSTAVAX is a semi-hazy to translucent, off-white to pale yellow liquid.
Avoid contact with disinfectants as they may inactivate the vaccine virus.
To reconstitute the vaccine, use the solvent provided.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
One needle should be used for reconstitution and a separate, new needle for injection.
ZOSTAVAX with solvent for reconstitution supplied in a vial:
Withdraw the entire content of the solvent vial into a syringe. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event ofeither being observed, discard the vaccine.
It is recommended that the vaccine be administered immediately after reconstitution, to minimise loss of potency. Discard reconstituted vaccine if it is not used within 30 minutes.
Do not freeze the reconstituted vaccine.
Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the needle and inject the entire volume by subcutaneous or intramuscular route.
ZOSTAVAX with solvent for reconstitution supplied in a pre-filled syringe:
To attach the needle, it should be firmly placed on the tip of the syringe and secured by rotating a quarter of a turn (90).
Inject the entire content of the solvent syringe into the vial containing the powder. Gently agitate to dissolve completely.
The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vaccine.
It is recommended that the vaccine be administered immediately after reconstitution, to minimise loss of potency. Discard reconstituted vaccine if it is not used within 30 minutes.
Do not freeze the reconstituted vaccine.
Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the needle, and inject the entire volume by subcutaneous or intramuscular route.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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