Advertisement
Advertisement

Tripacel

Pertussis Vaccine-Acellular, Combined with Diphtheria and Tetanus Toxoids (Adsorbed)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Tripacel. It does not contain all the information that is known about Tripacel. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What TRIPACEL is used for

TRIPACEL is a combination vaccine used to help prevent three diseases, diphtheria, tetanus and whooping cough (pertussis), in infants and children. These three diseases can each cause severe or life threatening illness in young children.
The full course (of five injections) of TRIPACEL usually begins at 2 months of age and finishes by the child's eighth birthday.

How TRIPACEL works

TRIPACEL works by causing the body to produce its own protection against the bacteria (germs) which cause diphtheria, tetanus and whooping cough. The body makes substances (antibodies) which circulate in the blood and fight diphtheria, tetanus and pertussis germs.
It usually takes several weeks after the full course of vaccination to develop acceptable levels of protection against diphtheria, tetanus and pertussis.
Full protection requires a primary course providing 3 injections at recommended intervals. A fourth and fifth dose (follow-up, or booster doses) are also required.
Most children who receive all five doses will produce enough antibodies to protect against the diseases diphtheria, tetanus and pertussis. However, as with all vaccines, 100% protection cannot be guaranteed.
TRIPACEL cannot give your child the illnesses diphtheria, tetanus or whooping cough (pertussis).

Before you are given TRIPACEL

When your child must not be given TRIPACEL

Do not give TRIPACEL to a child who has an allergy to:
TRIPACEL.
any of the ingredients listed at the end of this leaflet,
any other diphtheria, tetanus and pertussis vaccine.
Do not give TRIPACEL to a child who has, or has had, any of the following medical conditions:
an immediate severe allergic reaction to a previous dose of TRIPACEL or any other diphtheria, tetanus and pertussis vaccine.
an otherwise unidentifiable brain disorder within 7 days of a previous dose of TRIPACEL or any other diphtheria, tetanus and pertussis vaccine. Symptoms of severe, acute brain disorder include: prolonged seizure, fit or convulsion, prolonged unconsciousness, or an abnormality of the nervous system.
Do not use TRIPACEL after the expiry date printed on the pack.
Do not use TRIPACEL if the packaging is torn or shows signs of tampering.
Do not mix TRIPACEL with any other vaccines in the same syringe.
If you are not sure whether your child should have TRIPACEL, talk to your doctor or pharmacist.

Before your child is given TRIPACEL

TRIPACEL should not be given to children after their eighth birthday.
Defer TRIPACEL immunisation during polio outbreaks.
Tell your doctor if your child has reacted to TRIPACEL or any other vaccine with any of the following:
severe allergic reaction.
fits or convulsions within three days.
within 2 days, shock-like state or unresponsiveness for a long period of time. Symptoms include shallow breathing, breathing which stops temporarily, skin pale when compared to normal healthy skin colour.
within 2 days, high temperature (greater than 40.5°C), without any other identifiable cause.
within 2 days, crying or screaming lasting for more than 3 hours.
Tell your doctor if your child has or has had any medical conditions, especially the following:
serious illness, including high fever.
lowered immunity due to diseases such as HIV/AIDS or cancer.
lowered immunity due to treatment with medicines such as corticosteroids, antimetabolites, alkylating agents, cytotoxic drugs, or other cancer treatment (including radiation therapy).
fits or convulsions, particularly in the past 3 weeks.
a family history of fits or convulsions.
current disorder of the nervous system.
blood or bleeding problems.
Tell your doctor if your child has allergies to:
any other medicines.
any other substances, such as foods, preservatives or dyes.

Taking other medicines

Tell your doctor or pharmacist if your child is taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and TRIPACEL may interfere with each other. These include:
medicines which lower the immune system, such as corticosteroids, antimetabolites, alkylating agents, cytotoxic drugs, or other cancer treatments (including radiation therapy).
These medicines may be affected by TRIPACEL, or may affect how well it works. (Your child may need different amounts of these medicines, or you may need to take different medicines). Your doctor or pharmacist will advise you and help decide whether or not to give the vaccine.

Having other vaccines

Tell your doctor if your child has had any vaccines in the previous 4 weeks.
Your doctor will advise you if TRIPACEL is to be given at the same visit as another vaccine.

How TRIPACEL is given

TRIPACEL is given by a doctor or nurse as an injection into muscle. For infants under the age of 12 months, it is given as an injection into the upper thigh. In older children who have started walking, the vaccine is usually injected into the upper arm.
TRIPACEL must not be:
injected into a vein or blood vessel, or
given just under the skin.

How much TRIPACEL is given

One dose (injection of 0.5 mL) of TRIPACEL is usually given at each of 2, 4 and 6 months of age. (These three injections form the primary course.)
A booster dose (injection of 0.5 mL) is usually given at 18 months of age. Another booster dose should be given when children are between 4 and 6 years of age (about the time of school entry).

When TRIPACEL is given

The injections are given as part of the Australian Standard Childhood Vaccination Schedule.
A primary course of 3 injections and 2 booster injections of TRIPACEL should be given to children before they are 8 years old.
Medical supervision and treatment should be available, as for other vaccines, in case of a severe allergic reaction. An appropriate antipyretic may be given at the time of vaccination, in the dosage recommended in its prescribing information, to reduce some of the side effects of the vaccine. Further doses may be given for 24 hours following immunisation. This is particularly recommended for children with a family history of convulsions.
Ask your doctor or pharmacist to answer any questions you may have.

If your child misses a dose

If your child misses a dose, talk to your doctor and arrange another visit as soon as possible.

Overdose

Overdose is unlikely as your doctor is giving your child the injection.
If you have any concerns, ask your doctor.

After having TRIPACEL

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 all follow-up doses of TRIPACEL at the appropriate times to make sure the vaccine has the best chance of providing protection against diphtheria, tetanus and whooping cough (pertussis).

Side effects

Tell your doctor or pharmacist as soon as possible if your child does not feel well after having TRIPACEL.
TRIPACEL 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 he/she gets some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.

Allergic reaction

As with all vaccines given by injection, there is a very small risk of a severe allergic reaction.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
sudden onset of signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, difficulty breathing or collapse.
These are very serious side effects. If your child has them, your child may have had a severe allergic reaction to TRIPACEL. Your child needs urgent medical attention or hospitalisation. Mostly this type of side effect occurs within the first few hours of vaccination.
The following are the more common side effects of TRIPACEL. Mostly they are mild and short-lived.
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, swelling, whole thigh or upper arm swelling.
drowsiness.
lethargy.
generally feeling unwell.
irritability, fussiness.
eating and drinking less than usual.
crying more than usual.
vomiting.
fever greater than 37°C.
skin pale, compared to normal healthy skin colour.
Tell your doctor immediately if you notice any of the following:
constant inconsolable crying lasting 3 or more hours.
fits or convulsions.
a blue tinge to skin colour.
rash.
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:
shock-like state or prolonged unresponsiveness.
shallow breathing or breathing which stops temporarily.
a convulsion which may be accompanied by a very high temperature.
a blue tinge to skin colour.
All of these side effects are very rare.
Other side effects not listed above may occur in some children.
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 TRIPACEL

TRIPACEL is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store TRIPACEL:
keep TRIPACEL where children cannot reach it.
keep TRIPACEL in the original pack until it is time for it to be given.
keep TRIPACEL in the refrigerator, at 2°C to 8°C. DO NOT FREEZE TRIPACEL.
Freezing destroys the vaccine.

Product description

TRIPACEL is contained in a single-dose 0.5 mL glass container (vial).

What TRIPACEL looks like

TRIPACEL is a cloudy liquid.

Ingredients

Active ingredients:
10 mcg pertussis toxoid
5 mcg pertussis filamentous haemagglutinin
5 mcg pertussis fimbriae 2 + 3
3 mcg pertussis 69kDa outer membrane protein
30IU (15 Lf) diphtheria toxoid
40IU (5 Lf) tetanus toxoid
Other ingredients:
aluminium phosphate
phenoxyethanol
water for injections
The manufacture of this product includes exposure to bovine derive 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.

Distributor

Australia:
Sanofi Pasteur Pty Ltd
Talavera Corporate Centre - Building D
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 829 468
New Zealand:
sanofi-aventis new zealand limited
Level 8
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 727 838

AUST R Number

AUST R 63120

Date of Preparation

24 December 2015
tripacel-ccdsv4-cmiv2-24dec15
TRIPACEL is a registered trademark of Sanofi Pasteur Limited