Zostavax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Varicella-zoster virus, Oka/Merck strain, live, attenuated 19400 PFU;  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Varicella vaccine 19400 PFU

Dosage:

19400 PFU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Varicella-zoster virus, Oka/Merck strain, live, attenuated 19400 PFU   Excipient: Dibasic sodium phosphate monohydrate Gelatin Monobasic potassium phosphate Monosodium glutamate Potassium chloride Sodium chloride Sucrose Urea Water for injection

Units in package:

Combination pack, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

Zostavax is indicated for: · prevention of herpes zoster (shingles)

Product summary:

Package - Contents - Shelf Life: Combination pack, vial + diluent syringe - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, vial + diluent vial - 1 dose units - 18 months unopened stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, vial + diluent syringe - 10 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, diluent - 1 dose units - 36 months from date of manufacture stored at or below 25°C - Vial, glass, Active ingredient - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 30 minutes reconstituted stored at or below 25°C

Authorization date:

2005-07-11

Patient Information leaflet

ZOSTAVAX
®
_Zoster Vaccine Live (Oka/Merck) _
_Refrigerator stable_
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about ZOSTAVAX. It does not
contain all
the available information. It does not take the place of talking to
your doctor or
pharmacist.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the risks of
you being given ZOSTAVAX against the benefits they expect it will have
for you.
If you have any concerns about being given this vaccine, ask your
doctor.
Keep this leaflet with the medicine. You may need to read it again.
WHAT ZOSTAVAX IS USED FOR
Your doctor has recommended or administered ZOSTAVAX to prevent
shingles (also
known as zoster). ZOSTAVAX is an injectable live virus vaccine that is
used to prevent
shingles.
Shingles is a painful, blistering rash that may result in scarring.
The blisters can persist for
several weeks. They often break out in one part of the body. The nerve
pain that comes
from shingles can last for months or even years after the rash heals.
Shingles is caused by the same virus that causes chickenpox. After
your chickenpox
blisters heal, the virus that caused them stays in your body in nerve
cells. The virus may
be there for many years and not cause a problem. Sometimes, though, it
becomes active
again. If this happens, it can cause a blistering and painful rash.
If you do get shingles even though you have been vaccinated, ZOSTAVAX
can help
prevent the long-lasting nerve pain that can follow shingles. ZOSTAVAX
can also reduce
the intensity and length of time your pain from shingles will last.
ZOSTAVAX cannot be used to treat existing shingles or the pain
associated with existing
shingles.
ZOSTAVAX can be administered at the same time as inactivated influenza
vaccine.
ZOSTAVAX is used in adults 50 years of age or older.
ZOSTAVAX boosts your immune system to help protect you from shingles.
As with any vaccine, ZOSTAVAX may not protect all people who receive
the vaccine.
BEFORE YOU ARE GIVEN ZOSTAVAX
WHEN YOU SHOULD NOT BE GIVEN IT

Summary of Product characteristics

1
1 PRODUCT NAME
ZOSTAVAX ®
Zoster Vaccine Live (Oka/Merck)
Refrigerator stable
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution with accompanying vial or pre-filled syringe of
diluent, 1 dose (0.65 mL)
contains a minimum of 19,400 PFU (plaque forming units) of the
Oka/Merck strain of
varicella-zoster virus (VZV).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Injection with diluent
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZOSTAVAX is indicated for:
•
prevention of herpes zoster (shingles)
•
prevention of postherpetic neuralgia (PHN)
•
reduction of acute and chronic zoster-associated pain.
ZOSTAVAX is indicated for immunisation of individuals 50 years of age
or older.
4.2
DOSE AND METHOD OF ADMINISTRATION
For subcutaneous administration. Do not inject intravenously.
Individuals should receive a single dose.
ZOSTAVAX is not a treatment for zoster or PHN.
ZOSTAVAX can be administered concomitantly with inactivated influenza
vaccine using
separate syringes.
Reconstitute immediately upon removal from the refrigerator.
To reconstitute the vaccine, use only the diluent supplied, since it
is free of preservatives or
other antiviral substances which might inactivate the vaccine virus.
Vial of diluent:
To reconstitute the vaccine, first withdraw the entire contents of the
diluent vial into a
syringe. Inject all of the diluent in the syringe into the vial of
lyophilised vaccine and gently
agitate to mix thoroughly. Withdraw the entire contents into a syringe
and inject the total
2
volume of reconstituted vaccine subcutaneously, preferably into the
upper arm (preferably in
the deltoid region).
Prefilled syringe of diluent:
To reconstitute the vaccine, inject all the diluent in the syringe
into the vial of lyophilized
vaccine and gently agitate to mix thoroughly. Withdraw the entire
contents into a syringe and
inject the total volume of reconstituted vaccine subcutaneously,
preferably into the upper
arm (preferably in the deltoid region).
IT IS RECOMMENDED THAT THE VAC