Adacel

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Diphtheria toxoid, adsorbed 2 [iU] ((2 LfU)); Pertactin 3ug; Pertussis filamentous haemagglutinin 5ug; Pertussis fimbriae 2+3 5ug; Pertussis toxoid, adsorbed 2.5ug; Tetanus toxoid 20 [iU] ((5 LfU))

Tilgjengelig fra:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Diphtheria toxoid, adsorbed 2 IU ((2 LfU))

Dosering :

0.5 mL

Legemiddelform:

Suspension for injection

Sammensetning:

Active: Diphtheria toxoid, adsorbed 2 [iU] ((2 LfU)) Pertactin 3ug Pertussis filamentous haemagglutinin 5ug Pertussis fimbriae 2+3 5ug Pertussis toxoid, adsorbed 2.5ug Tetanus toxoid 20 [iU] ((5 LfU)) Excipient: Aluminium phosphate Phenoxyethanol Water for injection

Enheter i pakken:

Vial, glass, single dose, 1 x 0.5 mL, 0.5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Sanofi Pasteur Limited

Indikasjoner:

ADACEL is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation. Adacel may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

Produkt oppsummering:

Package - Contents - Shelf Life: Syringe, glass, 1 x 0.5 mL, with 0, 1 or 2 needles - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 10 x 0.5 mL, with 0, 10 or 20 needles - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 1 x 0.5 mL - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, 5 x 0.5 mL - 5 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Autorisasjon dato:

2006-01-31

Informasjon til brukeren

Adacel
®
1
ADACEL®
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?
Adacel is a vaccine. It is used to help prevent whooping cough
(pertussis), tetanus and diphtheria in persons aged 10 years and
over as a booster following primary immunisation. Use of Adacel during
pregnancy allows antibodies to be passed to the baby in
the womb from the pregnant woman to protect the baby from whooping
cough during the first few months of life.
For more information, see Section 1. Why am I using Adacel? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ADACEL?
Do not use if you have ever had an allergic reaction to Adacel or any
of the ingredients listed at the end of the CMI.
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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Adacel 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?
Adacel is given as an injection, usually into your upper arm muscle by
a doctor or nurse.
More instructions can be found in Section 4. How do I use Adacel? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ADACEL?
THINGS YOU
SHOULD DO
Tell your doctor or nurse before you receive this vaccine if you:
•
are allergic to the active substances or any of the other ingredients
in this vaccine
•
are currently suffering from an illness
•
had serious encephalopathy (disease of brain) without an apparent
cause within 7 days of a
previous pertussis, tetanus or diphtheria vaccination
THINGS YOU
SHOULD NOT DO
•
Do not have Adacel if you have a history of severe allergic reactions
to any of the ingredients listed,
previous dose of this vaccine o

Preparatomtale

adacel-ccdsv22-dsv9-25mar24 PAGE 1 OF 16
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Adacel
®
Pertussis Vaccine-Acellular Combined with Diphtheria and Tetanus
Toxoids (Adsorbed).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of Adacel contains:
Diphtheria toxoid

2 IU (2 Lf)
Tetanus toxoid

20 IU (5 Lf)*
Pertussis toxoid
2.5 micrograms
Pertussis filamentous haemagglutinin
5 micrograms
Pertactin
3 micrograms
Pertussis fimbriae 2+3
5 micrograms
Adsorbed on aluminium phosphate
1.5 mg (equivalent to 0.33mg)
aluminium)
*The formulated content of 5Lf of tetanus toxoid per 0.5mL dose is the
same as the related product Tripacel
®
.
This vaccine may contain traces of formaldehyde and glutaral 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, glutaral-detoxified and adsorbed pertussis
toxin (pertussis toxoid or PT);
purified, formaldehyde-treated and adsorbed filamentous haemagglutinin
(FHA); purified and
adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2
and 3 (FIM).
Adacel is an adult/adolescent formulation diphtheria-tetanus-acellular
pertussis (dTpa)
combination vaccine with reduced content of pertussis toxoid,
filamentous haemagglutinin and
diphtheria toxoid compared to paediatric diphtheria-tetanus-acellular
pertussis (DTPa)
formulations.
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.
adacel-ccdsv22-dsv9-25mar24 PAGE 2 OF 16
3
PHARMACEUTICAL FORM
Sterile suspension for injection. Adacel appears as a sterile,
uniform, cloudy, white suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adacel is indicated for active immunisation against tetanus,
diphtheria and pertussis in persons
aged 10 years and o