Adacel Polio

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Diphtheria toxoid, adsorbed 2 [iU] (NLT, equiv to 2 Lf per dose); Pertactin 3ug; Pertussis filamentous haemagglutinin 5ug; Pertussis fimbriae 2+3 5ug; Pertussis toxoid, adsorbed 2.5ug; Polio virus type 1 29 DAgU (Mahoney, by parallel line method (equiv to 40 DAgU by sigmoid method)); Polio virus type 2 7 DAgU (MEF 1, by parallel line method (equiv to 8 DAgU by sigmoid method)); Polio virus type 3 26 DAgU (Saukett, by parallel line method (equiv to 32 DAgU by sigmoid method)); Tetanus toxoid 20 [iU] (NLT, equiv to 5 Lf per dose)

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Diphtheria toxoid, adsorbed 2 IU (NLT, equiv to 2 Lf per dose)

Dosage:

0.5 mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Diphtheria toxoid, adsorbed 2 [iU] (NLT, equiv to 2 Lf per dose) Pertactin 3ug Pertussis filamentous haemagglutinin 5ug Pertussis fimbriae 2+3 5ug Pertussis toxoid, adsorbed 2.5ug Polio virus type 1 29 DAgU (Mahoney, by parallel line method (equiv to 40 DAgU by sigmoid method)) Polio virus type 2 7 DAgU (MEF 1, by parallel line method (equiv to 8 DAgU by sigmoid method)) Polio virus type 3 26 DAgU (Saukett, by parallel line method (equiv to 32 DAgU by sigmoid method)) Tetanus toxoid 20 [iU] (NLT, equiv to 5 Lf per dose) Excipient: Aluminium phosphate Ethanol Phenoxyethanol Polysorbate 80 Water for injection

Units in package:

Syringe, glass, 0.5mL with up to 2 detached needles, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Pasteur Limited

Therapeutic indications:

ADACEL® POLIO is indicated for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis in adults, adolescents and children aged 4 years and older as a booster following primary immunisation. Children 4-6 years of age should have already received four doses of DTPa and IPV or OPV. ADACEL® POLIO is not intended for primary immunisation. ADACEL® POLIO may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus. The use of ADACEL® POLIO should be determined on the basis of official recommendations.

Product summary:

Package - Contents - Shelf Life: Syringe, glass, 0.5mL with up to 2 detached needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5mL with no needle - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5mL with attached needle - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5mL with no needle - 5 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, 0.5mL with attached needle - 5 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2006-01-31

Patient Information leaflet

Adacel®Polio
1
ADACEL® POLIO
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 AM I USING ADACEL POLIO?
Adacel Polio contains the active ingredients diphtheria toxoid,
tetanus toxoid, pertussis toxoid, pertussis filamentous
haemagglutinin, pertussis fimbriae 2+3, pertactin and poliovirus types
1,2 and 3 (Vero). Adacel Polio is used to help to protect
you or your child against whooping cough (pertussis), tetanus,
diphtheria and polio.
For more information, see Section 1. Why am I using Adacel Polio? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADACEL POLIO?
Do not use if you or your child has ever had an allergic reaction to
Adacel Polio or any of the ingredients listed at the end of the
CMI, or if you or your child ever had a disease of brain without an
apparent cause within 7 days of a previous pertussis, tetanus or
diphtheria vaccination. Talk to your doctor if you have any other
medical conditions, take any other medicines, or are pregnant or
plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Adacel Polio? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Adacel Polio and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ADACEL POLIO?
Adacel Polio is given by your doctor, nurse or pharmacist. More
instructions can be found in Section 4. How do I use Adacel Polio?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADACEL POLIO?
THINGS YOU SHOULD DO
Tell your doctor, nurse or pharmacist before you receive the vaccine
if you or your child
•
is allergic to the active ingredients or any of the other ingredients
in this vaccine.
•
is suffering from an illness
•
has a bleeding problem or bruise easily.
•
ever fainted from an injection
•
has not previously received the complete course

Summary of Product characteristics

ada-pol-ccdsv12-dsv5-14jun23
Page 1 of 15
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
ADACEL
®
POLIO 0.5 mL suspension for injection
Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with
Inactivated Poliovirus Type 1, 2 and 3 (Vero cell)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Adacel Polio is a sterile, uniform cloudy, white suspension for
injection in prefilled syringes or vials.
Each 0.5 mL dose of Adacel Polio contains:
Diphtheria toxoid

2 IU (2 Lf)
Tetanus toxoid

20 IU (5 Lf
1
)
Pertussis toxoid
2.5 micrograms
Pertussis filamentous haemagglutinin
5 micrograms
Pertactin
3 micrograms
Pertussis fimbriae 2 + 3
5 micrograms
Poliovirus inactivated type 1, Vero (Mahoney)
40 D antigen Units
Poliovirus inactivated type 2, Vero (MEF1)
8 D antigen Units
Poliovirus inactivated type 3, Vero (Saukett)
32 D antigen Units
Adsorbed on aluminium phosphate
1.5 mg (0.33mg aluminium)
a
The formulated content of 5LfU per 0.5 mL of tetanus toxoid is the
same as in the related product Tripacel
®
.
This vaccine may contain traces of formaldehyde, glutaral,
streptomycin sulfate, neomycin, polymyxin
B
sulfate
and
bovine
serum
albumin,
and
Medium
199
Hanks
without
phenol
red
(including
phenylalanine), which are used during the manufacturing process.
For the full list of excipients, see Section 6.1 List of excipients.
The vaccine is prepared from: purified formaldehyde detoxified and
adsorbed diphtheria and tetanus
toxins; purified and glutaral-detoxified and adsorbed pertussis toxin
(pertussis toxoid or PT); purified
formaldehyde treated and adsorbed filamentous haemagglutinin (FHA);
adsorbed purified pertactin
(PRN) and co-purified and adsorbed fimbriae types 2 and 3 (FIM); and
poliomyelitis viruses type 1, 2
and 3 cultivated on Vero cells, purified and then inactivated by
formaldehyde.
Adacel Polio is a diphtheria-tetanus-acellular pertussis combination
vaccine (dTpa) combined with
inactivated poliovirus vaccine with a reduced content of pertussis
toxoid, filamentous haemagglutinin
and diph