ProQuad

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose)); Mumps virus, Jeryl-Lynn strain 19952 TCID50 (B Level (4.3 log per dose)); Rubella virus, Wistar RA27/3 strain 1000 TCID50 ((3 log per dose) ); Varicella vaccine 9772 PFU (Oka/Merck strain (3.99 log per dose));  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose))

Dosage:

0.5 mL

Pharmaceutical form:

Injection with diluent

Composition:

Active: Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose)) Mumps virus, Jeryl-Lynn strain 19952 TCID50 (B Level (4.3 log per dose)) Rubella virus, Wistar RA27/3 strain 1000 TCID50 ((3 log per dose) ) Varicella vaccine 9772 PFU (Oka/Merck strain (3.99 log per dose))   Excipient: Dibasic potassium phosphate Dibasic sodium phosphate Gelatin Minimum Essential Medium Eagle Medium 199 Monosodium glutamate Phenolsulfonphthalein Potassium chloride Sodium bicarbonate Sodium chloride Sorbitol Sucrose Urea Water for injection

Units in package:

Combination pack, active plus diluent in separate vials, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck Sharp & Dohme Corp

Therapeutic indications:

ProQuad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.

Product summary:

Package - Contents - Shelf Life: Combination pack, active plus diluent in separate vials - 1 dose units - 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, active plus diluent in separate vials - 10 dose units - 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, diluent only - 0.5 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, active (vaccine) only - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2004-11-17

Patient Information leaflet

PROQUAD
®

_Measles, Mumps, Rubella and Varicella Virus Vaccine Live _
Single dose vial 
WHAT IS IN THIS LEAFLET 
This leaflet answers some common questions about ProQuad.  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 or your child being given ProQuad 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 PROQUAD IS USED FOR 
ProQuad is a vaccine used to help protect people from getting
measles, mumps, rubella 
(German measles) and varicella (chickenpox).  It should be given to
children 12 months 
through 12 years of age. 

Protection against these infections is important as they can cause
serious problems in 
some people. 

Measles is a serious disease that is very easily passed from one
person to another.  It 
causes a high fever (temperature), cough and a rash and lasts for 1 to
2 weeks.  One out 
of every 10 children who catch measles will also have an ear infection
or pneumonia.  On 
rare occasions, measles can also cause an infection of the brain that
could lead to 
seizures, hearing loss, mental retardation, and even death.  Babies
and adults who catch 
measles are often much sicker for a longer time or are more likely to
die than school 
children and teenagers who catch measles. 

Mumps is easily passed from one person to another and causes fever,
headache, and 
swollen, painful glands under the jaw (salivary glands).  Mumps can
sometimes be a very 
serious disease and usually lasts for several days.  Mumps can cause
a mild inflammation 
of the coverings of the brain and spinal cord (meningitis) in about
one person in every 10 
who catch it.  About one out of every 4 teenage or adult males with
mumps will have a 
pa

Summary of Product characteristics

NAME OF MEDICINE 
PROQUAD
®

_Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine
Live _
Subcutaneous injection 
PRESENTATION 
The vaccine is supplied in vials as a sterile lyophilised preparation
together with vials of 
diluent containing sterile water.  Before reconstitution, the
lyophilised vaccine is a white to 
pale yellow compact crystalline plug.  ProQuad, when reconstituted,
is a clear pale yellow to 
light pink liquid. 

THERAPEUTIC CLASS 
ProQuad is a combined attenuated live virus vaccine containing
measles, mumps, rubella, 
and varicella viruses.  ProQuad is a sterile lyophilised preparation
of (1) the components of 
M-M-R
®
 II (Measles, Mumps and Rubella Virus Vaccine Live): Measles Virus
Vaccine Live, 
a more attenuated line of measles virus, derived from Enders'
attenuated Edmonston strain 
and propagated in chick embryo cell culture; Mumps Virus Vaccine
Live, the Jeryl Lynn™ 
(B level) strain of mumps virus propagated in chick embryo cell
culture; Rubella Virus 
Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella
virus propagated in WI-38 
human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live
(Oka/Merck), the 
Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells
(hereafter referred to 
as VARIVAX
®
). 

INDICATIONS 
ProQuad is indicated for vaccination against measles, mumps, rubella,
and varicella in 
individuals 12 months through 12 years of age. 

DOSAGE AND ADMINISTRATION 
DOSAGE 
Individuals 12 months through 12 years of age should receive a single
dose of ProQuad 
administered subcutaneously. 

If a second dose of measles-containing vaccine is to be administered
according to 
applicable official recommendations, then ProQuad may be used for this
dose. 

If the first dose of a measles-containing vaccine is given between 6
months of age and less 
than 12 months of age (in an at-risk situation such as measles
outbreak, or due to official 
recommendations) the response to t