TRIPACEL pertussis vaccine

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pertussis filamentous haemagglutinin, Quantity: 10 microgram/mL; Pertussis fimbriae 2 + 3, Quantity: 10 microgram/mL; Tetanus toxoid, Quantity: 80 IU/mL; Pertussis toxoid, Quantity: 20 microgram/mL; Diphtheria toxoid, Quantity: 60 IU/mL; Pertactin, Quantity: 6 microgram/mL

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: aluminium phosphate; water for injections; phenoxyethanol

Administration route:

Intramuscular

Units in package:

5 X 0.5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Tripacel is indciated for primary immunisation against diphtheria, tetanus and pertussis when commenced between 2 months and 12 months of age. Tripacel is also indicated for the fourth and fifth dose for children from 15 months of age up to their eighth birthday who have been immunised previously with three or four doses of diphtheria, tetanus and pertussis (whole cell or acellular) vaccines.

Product summary:

Visual Identification: Uniform,cloudy, white to off-white suspension.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

1998-04-23

Patient Information leaflet

TRIPACEL
®
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY DOES MY CHILD NEED TRIPACEL?
Tripacel is a vaccine. It is used to prevent three diseases,
diphtheria, tetanus and whooping cough (pertussis), in infants and
children.
For more information, see Section 1. Why does my child need Tripacel?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN TRIPACEL?
Do not use if your child ever had an allergic reaction to Tripacel or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAS HAD ANY OTHER MEDICAL
CONDITIONS OR IS TAKING ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child is given Tripacel? in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with Tripacel and affect how it works.
A list of these medicines is in Section 3. What if my child is taking
other medicines? in the full CMI.
4.
HOW TRIPACEL IS GIVEN?
Tripacel is given by a doctor or nurse as an injection into muscle.
More instructions can be found in Section 4. How is Tripacel given? in
the full CMI.
5.
WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN TRIPACEL?
THINGS YOU
SHOULD DO
•
KEEP AN UPDATED RECORD OF YOUR CHILD’S VACCINATIONS.
•
KEEP FOLLOW-UP APPOINTMENTS WITH YOUR DOCTOR OR CLINIC.
LOOKING AFTER
YOUR CHILD’S
MEDICINE
Tripacel is usually stored in the doctor’s surgery or clinic.
However, if you need to store Tripacel:
•
keep in the fridge between 2-8°C. Do not freeze.
For more information, see Section 5. What should I know after my child
is given Tripacel? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
•
Common side effects include local reaction around the injection site,
drowsiness, decreased activity, irritability, eating and
drinking less than usual, crying more than usual, screaming, nausea,
vomiting, diarrhoea, fever greater than 37°C, itching

Summary of Product characteristics

tripacel-ccdsv5-piv3-23mar20
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – TRIPACEL
®
(ACELLULAR PERTUSSIS VACCINE, COMBINED WITH
DIPHTHERIA AND TETANUS TOXOIDS (ADSORBED))
1
NAME OF THE MEDICINE
Pertussis Vaccine-Acellular, Combined With Diphtheria and Tetanus
Toxoids (Adsorbed).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tripacel is a sterile, isotonic suspension of purified acellular
pertussis antigens and diphtheria
and tetanus toxoids adsorbed on aluminium phosphate.
Each 0.5 mL dose is formulated to contain:
Diphtheria toxoid (
_Corynebacterium diphtheriae_
)
≥ 30 IU (15 Lf)
Tetanus toxoid (
_Clostridium tetani_
)
≥ 40 IU (5 Lf)
Pertussis toxoid (PT)
10 micrograms
Pertussis Filamentous Haemagglutinin (FHA)
5 micrograms
Pertussis Fimbriae 2 + 3 (FIM)
5 micrograms
Pertactin (PRN)
3 micrograms
Adsorbed on aluminium phosphate
1.5 milligrams
(0.33 milligrams aluminium)
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.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for injection.
After shaking, Tripacel is a white to off-white cloudy suspension for
intramuscular
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tripacel is indicated for primary immunisation against diphtheria,
tetanus and pertussis when
commenced between 2 months and 12 months of age.
tripacel-ccdsv5-piv3-23mar20
Page 2 of 13
Tripacel is also indicated for the fourth and fifth dose for children
from 15 months of age up
to their eighth birthday who have been immunised previously with three
or four doses of
diphtheria, tetanus and pertussis (whole-cell or acellular) vaccines.
4.2
DOSE AND METHOD OF ADMINISTRATION
For primary immunisation of infants, the following routine Tripacel
immunisation schedule is
recommended: one 0.5 mL dose administered at 2, 4 and 6 months of age.