QUADRACEL®
Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with Inactivated Poliovirus Types 1, 2 and 3 (MRC-5 Cell)
What is in this leaflet
This leaflet answers some common questions about QUADRACEL.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines, including vaccines, have risks and benefits. Your doctor has
weighed the risks of your child having QUADRACEL against the benefits they
expect it will have.
If you have any concerns about this vaccine, ask your doctor, nurse or
pharmacist.
Keep this leaflet. You may need to read it again.
What QUADRACEL is used for
QUADRACEL is a vaccine used to help prevent whooping cough, tetanus,
diphtheria and polio.
This vaccine is for use in children up to 6 years of age, and is used in
infants from the age of 2 months who are at the greatest risk from these
diseases.
Polio, whooping cough, tetanus and diphtheria cause significant sickness and
sometimes death in unvaccinated infants, children, and adults.
How it works
QUADRACEL works by causing the body to produce its own protection against
whooping cough, tetanus, diphtheria, and polio. It does this by making
substances called antibodies in the blood, which fight the bacteria and toxins
that cause these diseases. If a vaccinated person comes into contact with
these bacteria and toxins, the body is usually ready to destroy them.
It usually takes several weeks after vaccination to develop protection
against these diseases.
Protection requires 3 doses of this vaccine or this vaccine used alternately
with other vaccines protecting against the same diseases. A booster dose may
be required between 15 months of age and six years.
Most children will produce enough antibodies against these diseases.
However, as with all vaccines, 100% protection cannot be guaranteed.
The vaccine will not give your child any of these diseases.
The chance of a severe reaction from QUADRACEL is very small, but the risks
from not being vaccinated against these diseases may be very serious.
Before you are given QUADRACEL
When your child must not be given it
Do not give QUADRACEL to a child who has:
- an allergy to QUADRACEL or any of the ingredients listed at
the end of this leaflet. - had an anaphylactic or other allergic reaction to a previous dose of
this vaccine or another vaccine designed to protect against whooping cough,
tetanus, diphtheria, polio, or Haemophilus influenzae type b. - had serious encephalopathy without an apparent cause within 7 days of a
previous diphtheria, tetanus or whooping cough vaccination.
Symptoms of an allergic reaction may include:
- shortness of breath, wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- skin rash, itching or hives
Do not use QUADRACEL after the expiry date printed on the pack.
Do not use QUADRACEL if the packaging is torn or shows signs of
tampering.
If you are not sure whether your child should have QUADRACEL, talk to
your doctor or pharmacist.
Before your child is given it
Tell your doctor if your child has reacted to previous vaccination with
any of the following:
- life-threatening allergic reaction
- shock-like state or being unresponsive for a long period of time
- fits or convulsions
- high temperature (greater than 40°C)
- crying or screaming lasting for more than 3 hours
Tell your doctor if your child has an infection or high temperature.
Your doctor may decide to delay vaccination until the illness has passed.
A mild illness, such as a cold, is not usually a reason to delay vaccination.
Tell your doctor if your child has or has had any medical conditions,
especially the following:
- lowered immunity due to diseases such as some blood disorders, malaria,
kidney disease requiring dialysis, HIV/AIDS or cancer - lowered immunity due to treatment with medicines such as
corticosteroids, cyclosporin or other medicines used to treat cancer
(including radiation therapy) - leukaemia or any other cancers of the blood, bone marrow or lymph system
- brain disease
- epilepsy
- fits or convulsions
- allergies or allergic reactions, including: runny, blocked or itchy
nose; itchy rash or hives; swelling of the face, lips, mouth or tongue - a low blood platelet count
Tell your doctor if your child has allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
Taking other medicine / Having other vaccines
Tell your doctor if you have had any vaccines in the last 4 weeks.
Your doctor will advise you if QUADRACEL is to be given with another vaccine.
Your doctor and pharmacist may have more information on medicines and vaccines
to be careful with or avoid during vaccination with QUADRACEL.
How QUADRACEL is given
For infants under the age of 12 months, QUADRACEL is given as an injection
into the upper thigh muscle. In older children who have started walking, the
vaccine is usually injected into the upper arm muscle.
QUADRACEL should not be injected directly into the veins.
How much is given and when it is given
Primary immunisation is three 0.5mL doses given in the first year of life
according to the New Zealand Immunisation Schedule. A booster dose may be
given at 15 months to 6 years of age.
If your child misses a dose
If your child misses a dose, talk to your doctor and arrange another visit
as soon as possible.
After having QUADRACEL
Things you must do
Keep an updated record of your child's vaccinations.
Keep follow-up appointments with your doctor or clinic.
It is important your child has follow-up doses of QUADRACEL at the appropriate
times to make sure the vaccine has the best chance of providing protection
against whooping cough, tetanus, diphtheria, and polio.
Side effects
Tell your doctor or pharmacist as soon as possible if your child does
not feel well after having QUADRACEL.
QUADRACEL may have unwanted side effects in a few people. All medicines,
including vaccines, can have side effects. Sometimes they are serious, most of
the time they are not. Your child may need medical treatment if you get some
of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they
worry you:
- local reaction around the injection site such as redness, tenderness,
pain or discomfort, or swelling - flushing or redness of the skin
- fussiness
- decreased activity
- decreased eating
- crying
- fever
- vomiting
- diarrhoea
- sleepiness
These are the more common side effects of QUADRACEL. Mostly these are mild
and short-lived.
Tell your doctor immediately if you notice any of the following:
- abscess at the injection site
- high fever (>40.5°C)
- unusual high-pitched or inconsolable crying
- fits or convulsions which may be accompanied by a very high temperature
- unusual stiffness causing loss of movement
These may be serious side effects. Your child may need urgent medical
attention. Serious side effects are rare.
If any of the following happen, tell your doctor immediately or go to
Accident and Emergency at your nearest hospital:
- sudden signs of allergy such as rash, itching or hives on the skin,
swelling of the face, lips, tongue or other parts of the body, - pinkish, itchy swellings on the skin, also called hives or nettle rash
- shortness of breath, wheezing or trouble breathing
- headache and high temperature associated with hallucinations, confusion,
paralysis of part or all of the body, disturbances of behaviour, speech and
eye movements, stiff neck and sensitivity to light - swelling of the legs with bluing or rash.
- tingling of the hands or feet, or sudden numbness or weakness in the
legs or arms.
These are very serious side effects. Your child may need urgent medical
attention or hospitalisation.
All of these side effects are very rare.
Very rarely children may experience swelling of the whole arm after the
booster (4th) dose. This reaction occurs very rarely in association
with all vaccines with similar active ingredients to QUADRACEL. It is a
short-lived reaction, which resolves spontaneously without any permanent
damage.
Other side effects not listed above may occur in some patients. Tell
your doctor or pharmacist if you notice anything that is making your child
feel unwell.
Do not be alarmed by this list of possible side effects.
Your child may not experience any of them.
Storing QUADRACEL
QUADRACEL is usually stored in the doctor's surgery or clinic, or at the
pharmacy. However, if you need to store QUADRACEL:
- Keep it where children cannot reach it.
- Keep QUADRACEL in the original pack until it is time for it to be given.
- Keep it in the refrigerator, between 2°C and 8°C. Do not freeze
QUADRACEL.
Freezing destroys the vaccine.
Product description
What it looks like
QUADRACEL is a sterile, cloudy, uniform suspension for injection.
Ingredients
Active ingredients:
- 20µg pertussis toxoid
- 20µg pertussis filamentous haemagglutinin
- 5µg pertussis fimbriae 2+3
- 3µg pertussis 69kDa outer membrane protein
- ≥30 IU diphtheria toxoid
- ≥40 IU tetanus toxoid
- 40 DAgU Poliovirus inactivated type 1
- 8 DAgU Poliovirus inactivated type 2
- 32 DAgU Poliovirus inactivated type 3
Other ingredients:
- aluminium phosphate
- phenoxyethanol
- polysorbate 80
- albumin - bovine serum
- polymyxin B sulfate
- neomycin
- formaldehyde
- glutaraldehyde
- water for injections
QUADRACEL does not contain thiomersal, lactose, sucrose, gluten, tartrazine
or any other azo dyes.
The manufacture of this product includes exposure to bovine 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