ZOSTAVAX (ZOSTER VACCINE LIVE)

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LIVE ATTENUATED OKA/MERCK STRAIN OF VARICELLA-ZOSTER VIRUS

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

J07BK02

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

LIVE ATTENUATED OKA/MERCK STRAIN OF VARICELLA-ZOSTER VIRUS 19400 PFU / 0.65 ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME LLC, USA

Therapeutic group:

ZOSTER, LIVE ATTENUATED

Therapeutic area:

ZOSTER, LIVE ATTENUATED

Therapeutic indications:

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.

Authorization date:

2017-09-30

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS
(PREPARATIONS) 1986
This medicine is to be marketed upon physician’s prescription only
ZOSTAVAX
®
(ZOSTER VACCINE LIVE)
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
After reconstitution, one dose (0.65 mL) contains:
Varicella-zoster virus
1
, Oka/Merck strain, (live, attenuated) not less than 19,400 PFU
(plaque-forming units).
1
Produced in human diploid (MRC-5) cells
For a list of inactive ingredients see section 6 “FURTHER
INFORMATION” and section 2.6 “Important
information about some of the ingredients of ZOSTAVAX”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU ARE VACCINATED WITH
ZOSTAVAX.
•
This leaflet contains concise information about ZOSTAVAX. If you have
any further questions, refer to
the doctor or the pharmacist.
•
This vaccine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their
medical condition seems similar.
1. WHAT ZOSTAVAX IS INTENDED FOR?
ZOSTAVAX is a live attenuated vaccine indicated for prevention of
herpes zoster (shingles) in individuals
50 years of age and older.
THERAPEUTIC GROUP: Vaccines, Viral vaccine.
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.
2. BEFORE USING ZOSTAVAX
2.1
DO NOT USE ZOSTAVAX IF:
−
you are allergic (hypersensitive) to any of the components of this
vaccine (including neomycin
(which may be present as trace residue) or any of the other
ingredients listed in section 6). For a list
of inactive ingredients, see section 6 “FURTHER INFORMATION”.
−
you have a blood d

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
ZOSTAVAX
®
(ZOSTER VACCINE LIVE)
shingles (herpes zoster) vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one 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 in a pre-filled
syringe.
The powder is a white to off-white compact crystalline plug.
The solvent is a clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ZOSTAVAX is a live attenuated virus vaccine indicated for prevention
of herpes zoster (shingles) in
individuals 50 years of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals should receive a single dose (0.65 mL) administered
subcutaneously.
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).
2
Method of administration
The vaccine is to be injected subcutaneously (SC), preferably in the
deltoid region (see sections 4.8 and
5.1).
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.
_ _
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, to any of the excipients
listed in section 6.1 or neomycin
(which may be present as trace residues, see sections 2 and 4.4).
•
Primary and acquired immunodeficiency states due to conditions such
as: acute and chronic
leuka