PROQUAD measles, mumps, rubella, varicella live virus vaccine injection vial with prefilled diluent syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Measles virus, Quantity: 3 TCID50; Mumps virus, Quantity: 4.3 TCID50; Rubella virus, Quantity: 3 TCID50; live varicella vaccine, Quantity: 3.99 PFU

Available from:

Merck Sharp & Dohme (Australia) Pty Ltd

INN (International Name):

live varicella vaccine,Measles virus,Mumps virus,Rubella virus

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: potassium chloride; hydrolysed gelatin; urea; neomycin; sodium bicarbonate; Albumin; sodium chloride; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; phenolsulfonphthalein; monosodium glutamate monohydrate; monobasic potassium phosphate; dibasic potassium phosphate; sorbitol; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Administration route:

Subcutaneous, Intramuscular

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to faint yellow, compact crystalline powder; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2007-02-08

Patient Information leaflet

PROQUAD
®
_Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live,
Refrigerator-stable formulation_
CONSUMER MEDICINE INFORMATION
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 your child being
given ProQuad against the benefits
they expect it will have for your
child.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS VACCINE, ASK YOUR
DOCTOR OR PHARMACIST.
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 chicken pox. It can be given to
children aged 12 months to 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
causes a high fever (temperature),
runny nose, cough, conjunctivitis and
a rash. It usually lasts for about 1 to 2
weeks. It is very easily passed from
one person to another in the tiny
droplets of moisture which are
expelled during coughing or
sneezing. 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 causes fever, headache, and
swollen, painful glands under the jaw
(salivary glands) and usually lasts
several days. It is easily passed from
one person to another by the tiny
droplets of moisture expelled during
coughing or sneezing. Mumps can
sometimes be a very serious disease,
causing a mild inflammation of the
coverings of the brain and spinal cord
(meningiti

Summary of Product characteristics

S-WPC-V221-I-ref-122019
1
AUSTRALIAN PRODUCT INFORMATION –
PROQUAD® MEASLES, MUMPS, RUBELLA AND VARICELLA VIRUS VACCINE
LIVE (REFRIGERATOR STABLE FORMULATION)
1
NAME OF THE MEDICINE
Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live
2
QUALITATIVE AND QUANTITATIVE COMPOSITION AND
3
PHARMACEUTICAL FORM
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).
ProQuad, when reconstituted as directed, is a sterile preparation for
intramuscular (IM) or
subcutaneous (SC) administration. Each 0.5 mL dose contains not less
than 3.00 log
10
TCID
50
(50% tissue culture infectious dose) of measles virus; 4.30 log
10
TCID
50
of mumps virus; 3.00
log
10
TCID
50
of rubella virus; and a minimum of 3.99 log10 PFU (plaque-forming
units) of
Oka/Merck varicella virus.
Powder for injection.
Before reconstitution, the lyophilised vaccine is a white to pale
yellow compact crystalline
powder. ProQuad, when reconstituted, is a clear pale yellow to light
pink liquid.
Excipients with known effect: The vaccine contains 16 mg of sorbitol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
This product also contains residual components of MRC-5 cells
including DNA and protein,
recombinant human albumin, bovine serum albumin and other buffer and
media ingredients.
This product contains no preservative.
The cells, virus pools, bovine serum, and recombinant human albumin