Varivax

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Varicella vaccine 1350 PFU (Oka/Merck);  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Varicella vaccine 1350 PFU (Oka/Merck)

Dosage:

1350 PFU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Varicella vaccine 1350 PFU (Oka/Merck)   Excipient: Dibasic sodium phosphate dodecahydrate Gelatin Monobasic potassium phosphate Monosodium glutamate Potassium chloride Sodium chloride Sucrose Urea Water for injection

Units in package:

Combination pack, Vaccine + diluent, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

VARIVAX is indicated for vaccination against varicella in individuals 12 months of age and older.

Product summary:

Package - Contents - Shelf Life: Combination pack, Vaccine + diluent - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored between 20-25°C - Combination pack, 10 x vaccine + diluent - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored between 20-25°C - Vial, glass, single dose, Diluent - 0.7 mL - 24 months from date of manufacture stored at or below 25°C. (may be refrigerated but do not freeze) - Vial, glass, single dose, vaccine - 1350 PFU - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

1997-07-14

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
VARIVAX
®
_Varicella Virus Vaccine Live (Oka/Merck) _
Single dose vial
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about VARIVAX. It does not
contain all the
available information. It does not take the place of talking to your
doctor.
All medicines and vaccines have risks and benefits. Your doctor has
weighed the risks of
you being given VARIVAX against the benefits your doctor expects it
will have for you.
If you have any concerns about being given this vaccine, ask your
doctor.
Keep this leaflet. You may need to read it again.
WHAT VARIVAX IS USED FOR
VARIVAX is a vaccine used to help prevent chickenpox. It can be given
to children 12
months of age and above, teenagers and adults.
Chickenpox is easily passed from one person to another and occurs in
millions of people
worldwide each year, most often in children 5 to 9 years of age. It is
primarily spread from
person to person through the air by sneezing or coughing. Once a
person has been
infected, it usually takes about 2 to 3 weeks before symptoms start.
Symptoms of chickenpox include mild headache, moderate fever, and
general discomfort.
These are followed by a rash of itchy, little red spots which usually
start on the chest,
stomach or back, but can appear anywhere on the body. There may be
only a few spots
or clusters of spots, or even hundreds of spots that develop over the
next 3 to 5 days. The
spots will change into clear blisters filled with fluid which then
become cloudy, break open,
dry, scab, and heal, usually within 5 to 20 days.
Although chickenpox is generally a fairly harmless disease, it may be
associated with
serious complications and/or rarely death. In children, the most
common complications
are bacterial skin infections. Less frequent but very serious
complications include
pneumonia, inflammation of the brain (encephalitis), Reye syndrome,
and death. Severe
disease and serious complications are more likely to occur in
adolescents and adults.
BEFORE YOU ARE GIVEN VARIVAX
WHEN Y

Summary of Product characteristics

Page 1 of 13
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
VARIVAX
®
Varicella Virus Vaccine Live (Oka/Merck)
0.5 mL single dose vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VARIVAX is live, attenuated virus vaccine (a lyophilised preparation
of the Oka/Merck strain
of varicella).
Each 0.5 mL dose of VARIVAX contains: a minimum of 1350 PFU (plaque
forming units) of
Oka/Merck varicella virus when reconstituted as directed and stored at
room temperature for
150 minutes.
The product also contains residual components of MRC-5 cells and trace
quantities of
neomycin and bovine calf serum from MRC-5 culture media. The product
contains no
preservative.
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VARIVAX is indicated for vaccination against varicella in individuals
12 months of age and
older.
4.2
DOSE AND METHOD OF ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION
Do not inject intravenously.
Children 12 months to 12 years of age should receive a 0.5 mL dose
administered
subcutaneously. A second dose of VARIVAX administered at least 3
months later is
recommended to ensure optimal protection against varicella (see
Section 5
PHARMACOLOGICAL PROPERTIES).
Adolescents and adults 13 years of age and older should receive a 0.5
mL dose
administered subcutaneously at elected date and a second 0.5 mL dose 4
to 8 weeks later.
The outer aspect of the upper arm (deltoid region) is the preferred
site of injection.
For instructions on reconstitution of VARIVAX before administration,
see section 6.6.
Page 2 of 13
4.3
CONTRAINDICATIONS
History of hypersensitivity to any component of the vaccine, including
gelatin.
History of anaphylactoid reaction to neomycin (each dose of
reconstituted vaccine contains
trace quantities of neomycin).
Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant
neoplasms
affecting the bone marrow or lymphatic systems.
Immunosuppressive therapy (including high-dose corticosteroids