Adacel Polio

Main information

  • Trade name:
  • Adacel Polio 0.5 mL Suspension for injection
  • Dosage:
  • 0.5 mL
  • Pharmaceutical form:
  • Suspension for injection
  • Units in package:
  • Syringe, glass, 0.5mL with up to 2 detached needles, 1 dose unit
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Sanofi Pasteur Limited

Documents

Localization

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

Therapeutic information

  • 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. The use of ADACEL® POLIO should be determined on the basis of official recommendations.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 12417
  • Authorization date:
  • 31-01-2006
  • Last update:
  • 27-09-2017

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

ADACEL

POLIO

ADACEL

®

POLIO

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

Poliovirus Type 1, 2 and 3 (Vero cell)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ADACEL POLIO.

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 or your

child having ADACEL POLIO

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 POLIO

is used for

ADACEL POLIO is a vaccine used

to help prevent whooping cough

(pertussis), tetanus, diphtheria and

polio.

This vaccine is for use as a booster in

adults, adolescents and children aged

four years and older who have

previously received childhood

immunisation.

Children from four to six years of

age should have already received

four doses of whooping cough,

tetanus, diphtheria and polio vaccine.

ADACEL POLIO is not intended for

primary immunisation.

The use of ADACEL POLIO should

be determined on the basis of official

recommendations and by your

doctor.

Polio, whooping cough, tetanus and

diphtheria cause significant sickness

and sometimes death in unvaccinated

infants, children, and adults.

How it works

ADACEL POLIO works by causing

the body to produce its own

protection against whooping cough,

tetanus, diphtheria, and polio. 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.

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 or your

child any of these diseases.

The chance of a severe reaction from

ADACEL POLIO is very small, but

the risks from not being vaccinated

against these diseases may be very

serious.

Before you or your

child is given ADACEL

POLIO

When you or your child

must not be given it

Do not have ADACEL POLIO if

you or your child has:

had an allergic reaction to

ADACEL

POLIO or any of the

ingredients listed at the end of

this leaflet.

had an allergic reaction to

another vaccine designed to

protect against pertussis, tetanus,

diphtheria or polio.

had serious encephalopathy

(disease of brain) without an

apparent cause within 7 days of a

previous pertussis, tetanus or

diphtheria vaccination.

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 POLIO is not

recommended for use in children

under 4 years.

Do not use ADACEL POLIO after

the expiry date printed on the

pack.

Do not use ADACEL POLIO if the

packaging is torn or shows signs of

tampering.

ADACEL

POLIO

If you are not sure whether you or

your child should have ADACEL

POLIO, talk to your doctor or

pharmacist.

Before you or your child is

given it

Tell your doctor if you or your

child has 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 or your

child has not previously received

the complete course of tetanus and

diphtheria vaccination.

Tell your doctor if you or your

child has 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 or your

child has, or has 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 or your

child has 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

POLIO during pregnancy.

Tell your doctor if you are breast-

feeding.

Your doctor will discuss the possible

risks and benefits of having

ADACEL POLIO during breast-

feeding.

Taking other medicines

Tell your doctor or pharmacist if

you or your child is taking any

other medicines, including any that

you buy without a prescription

from your pharmacy, supermarket

or health food shop.

Having other vaccines

Tell your doctor if you or your

child has had any vaccines in the

last 4 weeks.

Your doctor will advise you if

ADACEL POLIO is to be given with

another vaccine.

Your doctor and pharmacist may

have more information on medicines

and vaccines to be careful with or

avoid during vaccination with

ADACEL POLIO.

How ADACEL POLIO

is given

ADACEL POLIO is given as an

injection, usually into your upper arm

muscle by a doctor or nurse.

How much is given

The dose of ADACEL POLIO is a

single dose of 0.5mL.

When it is given

ADACEL POLIO is generally given

whenever a booster dose of tetanus

and diphtheria is required and where

a booster dose of whooping cough

and polio is considered necessary.

After having ADACEL

POLIO

Things you or your child

must do

Keep an updated record of your

vaccinations.

Things to be careful of

Be careful driving or operating

machinery until you know how

ADACEL POLIO affects you.

ADACEL POLIO should not

normally interfere with your ability

to drive or operate machinery.

However, it may cause light-

headedness, tiredness, drowsiness in

some people.

Side effects

Tell your doctor or pharmacist as

soon as possible if you or your

child does not feel well after having

ADACEL POLIO.

ADACEL POLIO 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 or your

ADACEL

POLIO

child 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 bruising, redness,

itchiness, tenderness, pain or

discomfort, warmth, burning or

stinging, swelling or the

formation of hard lumps or scars

rash

headaches

tiredness, weakness or fatigue

fever

rigors

soreness, aching muscles, muscle

tenderness or weakness (not

caused by exercise)

joint pain or joint swelling

irritability

nausea and vomiting

diarrhoea

These are the more common side

effects of ADACEL POLIO. Mostly

these are mild and short-lived. If

however, these symptoms persist for

more than 1 week, then you should

tell your doctor.

Tell your doctor immediately if

you notice any of the following:

dizziness

generally feeling unwell

pale skin

stomach pain

pain in the vaccinated arm

swollen glands in the neck,

armpit or groin

large reactions at the injection site

(larger than 5 cm), including

extensive limb swelling from the

injection site beyond one or both

joints. These reactions start

within 48 hours after vaccination,

may be associated with redness,

warmth, tenderness or pain at the

injection site, and get better

within 3-5 days without the need

for treatment.

These may be serious side effects.

You or 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:

sudden signs of allergy such as

red, itchy rash or hives, , swelling

of the face, lips, tongue or other

parts of the body, shortness of

breath, wheezing or trouble

breathing

a temporary inflammation of the

nerves, causing pain, weakness,

and paralysis in the extremities

and often progressing to the chest

and face

severe pain and decreased

mobility of arm and shoulder

fits or convulsion

fainting

inflammation of spinal column

tingling or numbness of the hands

or decreased feeling or sensitivity

of the vaccinated arm

a paralysed nerve in the face

These are very serious side effects.

You or your child may need urgent

medical attention or hospitalisation.

All of these side effects are 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

or your child feel unwell.

Do not be alarmed by this list of

possible side effects.

You or your child may not

experience any of them.

After using ADACEL

POLIO

Storage

ADACEL POLIO is usually stored in

the doctor's surgery or clinic, or at

the pharmacy. However, if you need

to store ADACEL POLIO:

Keep it where children cannot

reach it.

Keep ADACEL POLIO 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 POLIO.

Freezing destroys the vaccine.

Product description

What it looks like

ADACEL POLIO 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

40 DAgU Poliovirus inactivated

type 1

8 DAgU Poliovirus inactivated

type 2

32 DAgU Poliovirus inactivated

type 3

Other ingredients

aluminium phosphate

phenoxyethanol

polymyxin B sulfate

neomycin

ADACEL

POLIO

streptomycin

formaldehyde

glutaraldehyde

polysorbate 80

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

sponsor

Australia:

sanofi-aventis australia 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, James & Wells Tower

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 727 838

Aust R number

Aust R 106565 - Vial (not marketed)

Aust R 106576 - Syringe

Date of preparation:

19 October 2016

31-7-2018

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