Zostavax vaccine powder and solvent for suspension for injection 0.65ml pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Varicella-Zoster virus live attenuated (Oka/Merck strain)

Available from:

Merck Sharp & Dohme Ltd

INN (International Name):

Varicella-Zoster virus live attenuated (Oka/Merck strain)

Pharmaceutical form:

Powder and solvent for suspension for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 14040000; GTIN: 5015973743019

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOSTAVAX®
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN A PRE-FILLED
SYRINGE
shingles (herpes zoster) vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED BECAUSE
IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This vaccine has been prescribed for you only. Do not pass it on to
others.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ZOSTAVAX is and what it is used for
2.
What you need to know before you receive ZOSTAVAX
3.
How to use ZOSTAVAX
4.
Possible side effects
5.
How to store ZOSTAVAX
6.
Contents of the pack and other information
1.
WHAT ZOSTAVAX IS AND WHAT IT IS USED FOR
ZOSTAVAX is a vaccine used to prevent shingles (zoster) and
zoster-related post-herpetic neuralgia
(PHN), the long-lasting nerve pain that follows shingles.
ZOSTAVAX is used to vaccinate individuals 50 years of age or older.
ZOSTAVAX cannot be used to treat existing shingles or the pain
associated with existing shingles.
DISEASE INFORMATION ON SHINGLES:
What is shingles?
Shingles is a painful, blistering rash. It usually occurs in one part
of the body and can last for several
weeks. It may lead to severe and long-lasting pain and scarring. Less
commonly, bacterial skin
infections, weakness, muscle paralysis, loss of hearing or vision can
occur. Shingles is caused by the
same virus that causes chickenpox. After you have had chickenpox, the
virus that caused it stays in
your body in nerve cells. Sometimes, after many years, the virus
becomes active again and causes
shingles.
What is PHN?
After the shingles blisters heal, pain can last for months or years
and may be severe. This long-lasting
nerve pain is called post-herpetic neuralgia or PHN.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE ZOSTAVAX
DO NOT RECEIVE ZOSTAVA

Summary of Product characteristics

OBJECT 1
ZOSTAVAX
Summary of Product Characteristics Updated 15-Jan-2018 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
ZOSTAVAX® powder and solvent for suspension for injection
ZOSTAVAX® powder and solvent for suspension for injection in a
pre-filled syringe
shingles (herpes zoster) vaccine (live)
2. Qualitative and quantitative composition
After reconstitution, 1 dose (0.65 mL) contains:
Varicella-zoster virus
1
, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU
2
1
produced in human diploid (MRC-5) cells
2
PFU = Plaque-forming units
This vaccine may contain traces of neomycin. See sections 4.3 and 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for suspension for injection.
The powder is a white to off-white compact crystalline plug.
The solvent is a clear, colourless fluid.
4. Clinical particulars
4.1 Therapeutic indications
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.
4.2 Posology and method of administration
Posology
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.
_Paediatric population_
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).
Method of administration
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 ins