Adacel

Main information

  • Trade name:
  • Adacel 0.5 mL Suspension for injection
  • Dosage:
  • 0.5 mL
  • Pharmaceutical form:
  • Suspension for injection
  • Units in package:
  • Vial, glass, single dose, 1 x 0.5 mL, 0.5 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Sanofi Pasteur Limited

Documents

Localization

  • Available in:
  • Adacel 0.5 mL Suspension for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ADACEL is indicated for active immunisation against tetanus, diphtheria and pertussis in persons aged 10 years and over as a booster following primary immunisation.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12359
  • Authorization date:
  • 31-01-2006
  • Last update:
  • 27-09-2017

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ADACEL

ADACEL

®

Pertussis Vaccine - Acellular Combined with Diphtheria and Tetanus Toxoids (Adsorbed)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ADACEL

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 you having

ADACEL

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 ADACEL

®

is

used for

ADACEL

is a vaccine used to help

prevent whooping cough (pertussis),

tetanus and diphtheria.

This vaccine is for use as a booster in

persons from the age of 10 years who

have previously received childhood

immunisation.

ADACEL

is not intended for

childhood immunisation.

The use of ADACEL

should be

determined on the basis of official

recommendations and by your

doctor.

Whooping cough, tetanus and

diphtheria cause significant sickness

and sometimes death in unvaccinated

infants, children, and adults.

How it works

ADACEL

works by causing the

body to produce its own protection

against whooping cough, tetanus, and

diphtheria. 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.

A course of whooping cough, tetanus

and diphtheria vaccine is usually

given during early childhood at 2, 4

and 6 months of age, followed by a

booster at 4 years of age. In case of

whooping cough, tetanus and

diphtheria, a second booster is

required at the age of 15-17 years.

Most people will produce enough

antibodies against these diseases.

However, as with all vaccines, 100%

protection cannot be guaranteed.

The vaccine will not give you any of

these diseases.

The chance of a severe reaction from

ADACEL

is very small, but the

risks from not being vaccinated

against these diseases may be very

serious.

Before you are given

ADACEL

®

When you must not be given

it

Do not have ADACEL

®

if you have

an allergy to:

ADACEL

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 pertussis, tetanus and

diphtheria

had serious encephalopathy

(disease of brain) without an

apparent cause within 7 days of a

previous pertussis, tetanus or

diphtheria vaccination

any vaccines

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

ADACEL

is not recommended for

use in children under 10 years.

If you are not sure whether you

should have ADACEL

, talk to your

doctor or pharmacist.

ADACEL

Before you are given it

Tell your doctor if you have

reacted to previous vaccination

with any of the following:

life-threatening allergic reaction

fainting or collapse

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

severe skin reaction at the

injection site, including severe

bruising

Tell your doctor if you have not

previously received the complete

course of tetanus and diphtheria

vaccination.

Tell your doctor if you have 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 you have, or

have 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

severe allergic reactions

a low blood platelet count

Tell your doctor if you have

allergies to:

any vaccines

any other medicines

any other substances, such as

foods, preservatives or dyes

Tell your doctor if you are

pregnant or intend to become

pregnant.

Your doctor will discuss the possible

risk and benefits of having

ADACEL

during pregnancy.

Tell your doctor if you are breast-

feeding.

Your doctor will discuss the possible

risks and benefits of having

ADACEL

during breast-feeding.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that you

buy without a prescription from

your pharmacy, supermarket or

health food shop.

Having other vaccines

Your doctor will advise you if

ADACEL

is to be given with

another vaccine.

How ADACEL

®

is

given

ADACEL

is given as an injection,

usually into your upper arm muscle

by a doctor or nurse.

For some people with bleeding

problems, ADACEL

may need to be

given under the skin.

ADACEL

should not be injected

directly into the veins.

How much is given

The dose of ADACEL

is a single

dose of 0.5mL.

When it is given

ADACEL

is generally given

whenever a booster dose of

whooping cough, tetanus and

diphtheria vaccine is required.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well after having ADACEL

®

.

ADACEL

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.

You 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, pain or

discomfort, swelling or the

formation of hard lumps

headaches

tiredness, weakness or fatigue

fever

chills

soreness, aching muscles, muscle

tenderness or weakness (not

caused by exercise)

joint pain or joint swelling

nausea and vomiting

diarrhoea

loss of appetite

Mostly these are mild and short-

lived. If however, these symptoms

persist, then you should tell your

doctor.

If any of the following happen, tell

your doctor immediately or go to

Accident and Emergency

department at your nearest

hospital:

ADACEL

sudden severe allergic reactions

(anaphylactic reaction), for which

symptoms may include rash,

itching or hives on the skin

(urticaria, pruritus), low blood

pressure (hypotension), swelling

of the face, lips, tongue or other

parts of the body (angioedema,

oedema), shortness of breath,

wheezing or trouble breathing

neurological disorders that may

results in confusion, numbness or

tingling, pain and weakness of the

limbs, loss of balance, loss of

reflexes, paralysis of parts or all

the body (Guillain-Barre

syndrome, brachial neuritis,

myelitis)

decreased feeling or sensitivity,

especially in the skin

(hypoesthesia)

weakness, and pain in muscles

(myositis)

fainting

convulsion

drooping eyelid and sagging

muscles on one side of the face

(facial palsy)

tingling or numbness of the hands

or feet (paraesthesia)

These are very serious side effects.

You may need urgent medical

attention or hospitalisation.

All of these side effects are very rare.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything that is making you

feel unwell.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using ADACEL

®

Storage

ADACEL

is usually stored in the

doctor's surgery or clinic, or at the

pharmacy. However, if you need to

store ADACEL

Keep it where children cannot

reach it.

Keep ADACEL

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 ADACEL

. Freezing

destroys the vaccine.

Do not use ADACEL

®

after the

expiry date printed on the pack.

Do not use ADACEL

®

if the

packaging is torn or shows signs of

tampering

Product description

What it looks like

ADACEL

is a sterile, uniform,

cloudy, white suspension for

injection.

Ingredients

Active ingredients:

2.5 mcg pertussis toxoid

5 mcg pertussis filamentous

haemagglutinin

5 mcg pertussis fimbriae types 2

and 3

3 mcg pertussis pertactin

2 or more IU diphtheria toxoid

20 or more IU tetanus toxoid

Other ingredients:

aluminium phosphate

phenoxyethanol

formaldehyde

glutaraldehyde

water for injections

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.

Name and address of the

sponsor

Australia:

sanofi-aventis australia pty ltd

Talavera Corporate Centre - Building

12 - 24 Talavera Road

Macquarie Park NSW 2113

Australia

Tel: 1800 829 468

New Zealand:

sanofi-aventis new zealand limited

Level 8, James & Wells Tower

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 727 838

AUST R number

AUST R 106554

Date of preparation

05 January 2017

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