ZOSTAVAX zoster virus vaccine live min 19400 PFU/0.65mL powder for injection vial with pre-filled diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

live varicella vaccine, Quantity: 19400 PFU

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

live varicella vaccine

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: monosodium glutamate monohydrate; sodium chloride; sucrose; hydrolysed gelatin; dibasic sodium phosphate; monobasic potassium phosphate; potassium chloride; urea

Administration route:

Subcutaneous

Units in package:

1 vial + 1 diluent syringe, 10 vials + 10 diluent syringes

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ZOSTAVAX is indicated for the prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is indicated for the prevention of postherpetic neuralgia (PHN) and for reduction of acute and chronic zoster-associated pain in individuals 60 years of age and older.

Product summary:

Visual Identification: White compact, crystalline pellet.; Container Type: Multiple containers; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2007-06-19

Patient Information leaflet

ZOSTAVAX
®
_Zoster Virus Vaccine Live, Refrigerator Stable._
CONSUMER MEDICINE INFORMATION
WARNINGS
ZOSTAVAX is a live vaccine and should not be used in people with a
weakened immune system, as it can cause serious
illness and death from infection with the vaccine virus.
Tell your doctor if you are taking medicines that may weaken your
immune system including high-dose corticosteroids or
cancer medicines, or other treatment.
If you become unwell after vaccination, you should seek medical
attention and tell your doctor that you have recently re-
ceived ZOSTAVAX.
Seek immediate medical attention if you:
-
develop a chickenpox-like rash within 2 to 4 weeks of vaccine
administration
-
feel unwell
-
develop a fever.
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 expected
benefits it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS VACCINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ZOSTAVAX IS
USED FOR
ZOSTAVAX is a vaccine used to
help prevent shingles (zoster). It can
be given to adults 50 years of age and
older.
ZOSTAVAX boosts your immune
system to help protect you from
shingles and its complications.
ZOSTAVAX cannot be used to treat
existing shingles or the pain
associated with existing shingles.
ZOSTAVAX can reduce the intensity
and length of time your pain from
shingles will last. If you are 70 years
of age or older and you get shingles
even though you have been
vaccinated, ZOSTAVAX can help
prevent the long-lasting nerve pain
that can follow shingles.
Symptoms of shingles include 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 fo

Summary of Product characteristics

S-WPC-V211-R-1-052018
1
AUSTRALIAN PRODUCT INFORMATION
ZOSTAVAX® ZOSTER VIRUS VACCINE LIVE REFRIGERATOR STABLE (LIVE
VARICELLA VACCINE)
WARNINGS
Rarely, disseminated varicella zoster virus (VZV) infection with
vaccine (Oka) strain can
occur in patients following administration of the live-attenuated
ZOSTAVAX vaccine.
There have been fatal reports of disseminated vaccine-related VZV
infection in Australia,
including in patients on low dose immunosuppressive medication. The
risk increases with
the degree of immunosuppression.
ZOSTAVAX is contraindicated in patients with current or recent severe
immunocompromising conditions from either a primary or acquired
medical condition or
medical treatment (See 4.3 CONTRAINDICATIONS).
Careful pre-screening and a risk-based assessment is required prior to
administration of
any dose of ZOSTAVAX. If appropriate, this assessment should include
medical specialist
consultation and potentially screening for pre-existing antibody to
VZV. In such cases,
vaccination should be deferred until such advice and/or results have
been obtained.
The Australian Immunisation Handbook contains specific guidance about
ZOSTAVAX
administration in patients who are immunocompromised or have medical
conditions that
place them at risk of immunocompromise. If uncertain about a
person’s level of
immunocompromise and whether vaccination is safe,
DO NOT VACCINATE
and seek further
specialist advice.
Any patient who experiences a disseminated vesicular (chickenpox-like)
rash 2 to 4 weeks
after vaccine administration, or who feels unwell or has a fever,
should seek medical
attention immediately and ensure that their treating health
professional is aware of their
recent vaccination history.
If inadvertent vaccination in an immunosuppressed patient has
occurred, the patient should
be advised regarding the potential for disseminated VZV infection and
the need to seek
medical advice should symptoms suggestive of this occur, so that they
can be considered
for pre-emptive antiviral therapy.
If a recent ZOSTAVAX re