Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this vaccine, speak
to your doctor, nurse or pharmacist.
1. Why is my child being given ProQuad?
ProQuad is a vaccine given to help prevent infection against measles, mumps, rubella
and varicella in children aged 12 months to 12 years of age.
2. What should I know before my child is given ProQuad?
Do not give ProQuad to your child if they have ever had an allergic reaction to ProQuad,
the antibiotic neomycin or any of the ingredients listed at the end of the CMI.
Talk to your doctor if your child has any medical conditions, takes any other medicines,
or is pregnant or is breastfeeding.
3. What if my child is taking other medicines?
Some medicines may interfere with ProQuad and affect how it works. Tell your doctor,
nurse or pharmacist if your child is taking, has recently taken or might take any
other vaccines or medicines, including medicines obtained without a prescription.
4. How is my child given ProQuad?
A doctor or nurse will give your child this vaccine as an injection just under the
skin or into the muscle (subcutaneously or intramuscularly) of the upper arm or the
upper thigh.
5. What should I know after my child is given ProQuad?
|
Things you should do
|
Keep a record of your child's vaccinations and update this after each injection.
Keep your child's follow-up appointment with your doctor or clinic.
Tell your doctor if your child is about to be injected with any immune globulin (including
varicella zoster) and your child has been injected with ProQuad within the past 2
months.
|
|
Things you should not do
|
Do not give aspirin or other salicylate medicines to your child for 6 weeks after
being given ProQuad.
A serious condition called Reye Syndrome has been reported following the use of aspirin
or other salicylate medicines during a natural chickenpox infection.
|
|
Looking after your vaccine
|
It is unlikely that you would be asked to store ProQuad. If you are, keep it in the
refrigerator where the temperature is between 2°C and 8°C, but not in the door compartment,
until ready to use.
The vaccine should not be frozen.
|
6. Are there any side effects?
Common side effects include: pain, tenderness or soreness at the injection site; local
reaction around the injection site such as soreness, redness, swelling or bruising;
fever, vomiting and diarrhea; rash including measles or varicella like rash, viral
skin rash and injection site rash
Serious side effects can include signs of allergic reaction such as: cough, wheezing
or shortness of breath; swelling of the face, lips, mouth, throat or neck which may
cause difficulty in swallowing or breathing; swelling of the hands, feet, or ankles;
pinkish, itchy swellings on the skin; and skin rash, itchiness
For a complete list of side effects and more information, including what to do if
you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live, Refrigerator-stable
formulation
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ProQuad. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using ProQuad.
Where to find information in this leaflet:
1. Why is my child being given ProQuad?
ProQuad is a vaccine used to help protect people from getting measles, mumps, rubella
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.
What is measles?
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.
What is mumps?
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 (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 painful
swelling of the testicles for several days. This does not usually affect their ability
to father children, but can cause sterility in rare cases. Teenagers and adults,
especially males, who catch mumps are often much sicker and more likely to suffer
longer than children do.
What is rubella?
Rubella is usually a mild disease that causes a mild fever, swollen glands in the
neck, pain and swelling in the joints, and a rash that lasts for 2 or 3 days. Rubella
is very dangerous if a pregnant woman catches it. Pregnant women who catch rubella
can have babies who are stillborn, or have heart disease, blindness, deafness, or
problems with learning. Rubella is also spread to others in the tiny droplets of
moisture expelled during coughing or sneezing.
What is chickenpox?
Chickenpox (Varicella) is an infectious disease caused by the varicella-zoster virus,
or otherwise known as varicella virus. It occurs in millions of people around the
world each year, most often in children 5 to 9 years of age. Chickenpox is easily
passed from one person to another. It is commonly spread from person to person through
the air by sneezing or coughing. Once a person is infected, it usually takes about
2 to 3 weeks before symptoms of the infection 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 groups 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 infection, 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 (which causes brain
and liver damage), and death. Severe disease and serious complications are more likely
to occur in teenagers and adults.
How it works
ProQuad contains weakened strains of living measles, mumps, rubella and varicella
viruses. These strains of live viruses cause either mild or no symptoms of infection.
When injected the vaccine causes the body to produce its own protection by making
disease-fighting substances (antibodies) against these infections.
If a vaccinated child comes into contact with measles, mumps, rubella or varicella
virus, the body is usually ready, and produces antibodies to destroy the virus. However,
as with all vaccines, 100% protection against measles, mumps, rubella and chickenpox
cannot be guaranteed. Also it may take up to 4-6 weeks for maximum protection to
develop, so occasionally infections may occur during this time.
It is not known whether ProQuad will prevent measles, mumps, rubella or chickenpox
if it is given after you have been exposed to the natural measles, mumps, rubella
or varicella virus. Therefore, vaccination before exposure is the best way to help
protect against infection and possible serious complications.
The chance of a severe reaction from ProQuad is very small, but the risks from not
being vaccinated are very serious
2. What should I know before my child is given ProQuad?
Warnings
Do not give your child ProQuad if:
Your child is allergic to ProQuad, or any of the ingredients listed at the end of
this leaflet including gelatin.
Your child has a serious allergy to the antibiotic neomycin.
Symptoms of a serious allergic reaction include swelling of the face, lips, tongue,
throat, difficulty in breathing, or hives.
Always check the ingredients to make sure your child can get this vaccine.
Your child has an infection with fever (high temperature)
Your child has active untreated tuberculosis (TB)
Your child is taking medicines which decrease the body's immune defence system (e.g.,
corticosteroids, cyclosporin, cancer medicines)
This does not include taking corticosteroids (e.g., cortisone, prednisone) as replacement
therapy for Addison's disease.
Your child has diseases which decrease the body's immune defence system, such as blood
disorders, cancers of the blood cells or lymph system (e.g., leukaemia, lymphoma)
and HIV/AIDS
Your child has a family history of immune deficiency
Your child is pregnant
If you are not sure whether your child should have ProQuad, talk to your doctor.
Check with your doctor if your child:
has the following medical conditions or a family history of them:
febrile convulsions (fits or seizures due to a high temperature)
brain damage
epilepsy
low blood platelet count
seizures
has a history of serious allergy to eggs.
The strains of measles and mumps viruses used to make ProQuad are grown in egg-derived
cultures.
has received blood or plasma transfusions or immune globulins within the past three
months.
Your doctor may decide to delay the injection of ProQuad.
is about to have a tuberculin test
This should be given either before or at the same time as the injection of ProQuad.
has any allergies to any other medicines especially to neomycin or vaccines, or any
other substances, such as foods, preservatives or dyes.
your child has a blood-clotting disorder or bleeds or bruises more easily.
In this case, your doctor will give your child the vaccine under the skin (subcutaneously).
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Pregnancy should be avoided for 3 months following vaccination.
The vaccine should not be given if the recipient is breast-feeding or intends to breast-feed.
In these situations, talk to your doctor.
Use in children under 12 months of age
The safety and effectiveness of ProQuad in children below the age of 12 months have
not been established.
3. What if my child is taking other medicines?
Tell your doctor, nurse or pharmacist if your child has been given any other vaccines
or is taking any other medicines, including any medicines, vitamins or supplements
that you buy without a prescription from your pharmacy, supermarket or health food
shop.
ProQuad should not be given to children who are using the following:
Medicines that decrease the immune system, such as corticosteroids (e.g. prednisone),
cyclosporine, or cancer medicines
Aspirin or other salicylate medicines
Your doctor will advise you whether your child is receiving any of these medicines.
Some medicines should not be used for 6 to 8 weeks after receiving ProQuad. These
include:
Aspirin or other salicylates. A serious condition called Reye Syndrome has been reported
following the use of aspirin or other salicylate medicines during a natural chickenpox
infection. Therefore, aspirin or other salicylates should be avoided for 6 weeks
following vaccination with ProQuad.
Immune globulins. Your doctor will discuss with you the possible risks and benefits
of having immune globulin injections in the 2 months following vaccination with ProQuad.
Use with other vaccines
ProQuad can be given at the same time as haemophilus b conjugate, hepatitis B, pneumococcal
7-valent conjugate, and hepatitis A (inactivated) vaccines. The injections should
be given at different places on the body and using separate syringes. At least one
month should elapse between a dose of ProQuad and all other vaccines. If a second
dose of a varicella-containing vaccine is given, there should be a minimum of 1 month
between doses. Your doctor will decide if ProQuad should be given with other vaccines.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements your child is taking and if these affect ProQuad.
4. How is my child given ProQuad?
How much is given
The entire contents of the vial.
ProQuad is usually injected just under the skin or into the muscle (subcutaneously
or intramuscularly) of the upper arm or the upper thigh by a doctor or trained nurse.
If your child has a blood-clotting disorder or bleeds or bruises more easily, the
vaccine should be given under the skin because bleeding may occur following administration
into the muscle.
The vaccine should not be injected directly into veins (intravenously).
When is it given
ProQuad is given by injection to persons aged 12 months through 12 years of age.
The appropriate time and number of injections will be determined by your doctor.
5. What should I know after my child is given ProQuad?
Things you should do
Keep a record of your child's vaccinations and update this after each injection.
Keep your child's follow-up appointment with your doctor or clinic.
If your child is about to be injected with any immune globulin (including varicella
zoster) and your child has been injected with ProQuad within the past 2 months, tell
your doctor.
If your child has been given ProQuad, avoid them coming into contact, for 6 weeks,
with a person who falls into one of the following categories:
People with a weakened immune system
Pregnant women who have never had chickenpox
Newborn babies whose mothers have never had chickenpox
These people may be at risk of catching chickenpox from your child.
Remind any doctor, nurse or pharmacist you visit that your child has been given ProQuad.
Things you should not do
Do not give aspirin or other salicylate medicines to your child for 6 weeks after
being given ProQuad.
A serious condition called Reye Syndrome has been reported following the use of aspirin
or other salicylate medicines during a natural chickenpox infection.
Looking after your vaccine
It is unlikely that you will be asked to store ProQuad. However, if you need to store
ProQuad:
Keep it where children cannot reach it.
Keep it in the refrigerator where the temperature is between 2°C and 8°C, but not
in the door compartment, until ready to use. ProQuad is stable for up to 18 months
when stored in the refrigerator.
The Vaccine should not be frozen.
Protect the injection from light by keeping it in the original pack until it is time
for it to be given.
6. Are there any side effects?
All medicines, including vaccines, can have side effects. If your child experiences
any side effects, most of them are minor and temporary. However, some side effects
may need medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Less serious side effects
Serious side effects
|
Serious side effects
|
What to do
|
|
A seizure or convulsion, which may or may not be accompanied by a very high fever
Headache and fever, progressing to hallucinations, confusion, stiff neck and sensitivity
to light
Pain, numbness, or tingling of the hands, arms, legs or feet
Fainting
Severe blisters with bleeding in the lips, eyes, mouth, nose or genitals
Unsteadiness walking
As with all vaccines given by injection, there is a very small risk of a serious allergic
reaction. Symptoms of an allergic reaction include:
Cough, wheezing or shortness of breath
Swelling of the face, lips, mouth, throat or neck which may cause difficulty in swallowing
or breathing
Swelling of the hands, feet, or ankles
Pinkish, itchy swellings on the skin, also called hives
Skin rash, itchiness
If your child has these, your child may have had a serious allergic reaction to ProQuad.
Your child may need urgent medical attention or hospitalisation. Most of these side
effects occur within 15-30 minutes of vaccination, before your child leaves the doctor's
surgery or clinic.
Other adverse events have been reported with at least one of the following: ProQuad,
M-M-R II, the monovalent components of M-M-R II or VARIVAX. These adverse events
include:
Bruising more easily than normal
Red or purple, flat, pinhead spots under the skin
Severe paleness
Unusual bleeding or bruising under the skin
Swelling of the testicles
Tingling of the skin
Shingles (herpes zoster) †
Inflammation swelling or infection of the brain (encephalitis)†
Inflammation of the coverings of the brain and spinal cord (meningitis)†
Severe skin disorders
Skin infection
Chickenpox (varicella)
Stroke
Seizures with or without a fever
Joint pain and/or swelling (which could be transient or chronic)
Inflammation of the lung (pneumonia/pneumonitis)
†Can be from naturally occurring chickenpox or the vaccine in healthy individuals
or individuals with lowered immunity in those given VARIVAX.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if your child gets any of these serious side effects.
Your child may need urgent medical attention. Serious side effects are rare.
|
Tell your child's doctor, nurse or pharmacist if you notice anything else that may
be making your child feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this vaccine.
7. Product details
This vaccine is only available with a doctor's prescription.
What ProQuad contains
|
Active ingredient
(main ingredient)
|
Weakened strains of measles, mumps, rubella and varicella viruses.
|
|
Other ingredients
(inactive ingredients)
|
Sucrose
Hydrolysed gelatin (porcine)
Urea
Sodium chloride
Sorbitol
Monosodium glutamate monohydrate
Monobasic sodium phosphate
Dibasic sodium phosphate
Sodium bicarbonate
Monobasic potassium phosphate
Potassium chloride
Dibasic potassium phosphate
Neomycin
Phenolsulfonphthalein
|
|
Potential allergens
|
Neomycin
|
This product also contains residual components of recombinant human albumin, bovine
serum albumin and other buffer and media ingredients.
The manufacture of this product includes exposure to bovine derived materials. No
evidence exists that any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted from the administration of any vaccine product.
Do not take this vaccine if you are allergic to any of these ingredients.
What ProQuad looks like
ProQuad comes as white to pale yellow powder in glass vials. It is reconstituted
with a special diluent to make a solution suitable for injection.
ProQuad vial (AUST R 126153)
ProQuad vial and sterile diluent syringe (AUST R 126157)
ProQuad vial and sterile diluent vial (AUST R 337388)
Not all presentations and pack sizes may be marketed.
Who distributes ProQuad
ProQuad is supplied in Australia by:
Seqirus (Australia) Pty Ltd
63 Poplar Road
PARKVILLE VIC 3052
This leaflet was prepared in September 2024
RCN:000026930-AU; 000025846-AU
WPPI-V205C-I-032024; WPPI-V205C-I-042023
Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA, and its affiliates. All rights
reserved.