HEXAXIM

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  • Available in:
  • HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 215536
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

215536

HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

11/09/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe

Product Type

Single Medicine Product

Effective date

21/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Hexaxim is indicated for vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive

infections caused by Haemophilus influenzae type b. Use of this vaccine should be in accordance with the national recommendation as per the current

Immunisation Handbook.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

36 Months

Store at 2 to 8

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

10 single dose pre-filled syringes with 1 or 2 separate needles per each

syringe

(S4) Prescription Only Medicine

1 single dose pre-filled syringe with 1 or 2 separate needles

(S4) Prescription Only Medicine

Components

1. HEXAXIM DTPa-hepB-IPV-Hib Suspension for injection in pre-filled syringe

Dosage Form

Injection, suspension

Route of Administration

Intramuscular

Visual Identification

Hexaxim is a whitish, cloudy suspension.

Active Ingredients

Diphtheria toxoid

20 IU

Haemophilus type B polysaccharide

12 microgram

hepatitis B surface antigen

10 microgram

Pertussis filamentous haemagglutinin

25 microgram

Pertussis toxoid

25 microgram

Poliovirus

32 DAgU

Poliovirus

8 DAgU

Poliovirus

40 DAgU

Tetanus protein

22 microgram

Tetanus toxoid

40 IU

Public Summary

Page 1 of

Produced at 22.11.2017 at 11:42:53 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 2 of

Produced at 22.11.2017 at 11:42:53 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

HEXAXIM

®

DTPa-hepB-IPV-Hib

Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and

Haemophilus influenzae type b conjugate vaccine (adsorbed)

Consumer Medicine Information

What is in this leaflet

Read all of this leaflet carefully

before your child is vaccinated.

Keep this leaflet. You may need

to read it again.

If you have any further questions,

ask your doctor or pharmacist.

This vaccine has been prescribed

for your child. Do not pass it on

to others.

If any of the side effects gets

serious, or if you notice any side

effects not listed in this leaflet,

please tell your doctor or

pharmacist.

In this leaflet:

What Hexaxim is and what it is

used for

Before your child is given

Hexaxim

How Hexaxim is given

Possible side effects

Storing Hexaxim

Further information

What Hexaxim is and

what it is used for

Hexaxim (DTPa-hepB-IPV-Hib) is a

vaccine used to protect against

infectious diseases.

Hexaxim helps to protect against

diphtheria, tetanus, pertussis,

hepatitis B, poliomyelitis and serious

diseases caused by Haemophilus

influenzae type b. Hexaxim can be

given to children from six weeks of

age.

The vaccine works by causing the

body to produce its own protection

(antibodies) against the bacteria and

viruses that cause these different

infections:

Diphtheria is an infectious

disease that usually first affects

the throat. In the throat, the

infection causes pain and

swelling which can lead to

suffocation. The bacteria that

cause the disease also make a

toxin (poison) that can damage

the heart, kidneys and nerves.

Tetanus (often called lock jaw) is

usually caused by the tetanus

bacteria entering a deep wound.

The bacteria make a toxin

(poison) that causes spasms of the

muscles, leading to inability to

breathe and the possibility of

suffocation.

Pertussis (often called whooping

cough) is a highly infectious

illness that affects the airways. It

causes severe coughing that may

lead to problems with breathing.

The coughing often has a

"whooping" sound. The cough

may last for one to two months or

longer. Whooping cough can also

cause ear infections, chest

infections (bronchitis) which may

last a long time, lung infections

(pneumonia), fits, brain damage

and even death.

Hepatitis B is caused by the

hepatitis B virus. It causes the

liver to become swollen

(inflamed). In some people, the

virus can stay in the body for a

long time, and can eventually

lead to serious liver problems,

including liver cancer.

Poliomyelitis (often just called

polio) is caused by viruses that

affect the nerves. It can lead to

paralysis or muscle weakness

most commonly of the legs.

Paralysis of the muscles that

control breathing and swallowing

can be fatal.

Haemophilus influenzae type b

infections (often just called Hib)

are serious bacterial infections

and can cause meningitis

(inflammation of the outer

covering of the brain), which can

lead to brain damage, deafness,

epilepsy, or partial blindness.

Infection can also cause

inflammation and swelling of the

throat, leading to difficulties in

swallowing and breathing, and

infection can affect other parts of

the body such as the blood, lungs,

skin, bones, and joints.

Important information about

the protection provided

Hexaxim will only help to prevent

these diseases if they are caused by

the bacteria or viruses targeted by the

vaccine. Your child could get

diseases with similar symptoms if

they are caused by other bacteria or

viruses.

The vaccine does not contain any live

bacteria or viruses and it cannot

cause any of the infectious diseases

against which it protects.

HEXAXIM

This vaccine does not protect against

infections caused by other types of

Haemophilus influenzae nor against

meningitis due to other micro-

organisms.

Hexaxim will not protect against

hepatitis infection caused by other

agents such as hepatitis A, hepatitis

C and hepatitis E.

Because symptoms of hepatitis B

take a long time to develop, it is

possible for unrecognised hepatitis B

infection to be present at the time of

vaccination. The vaccine may not

prevent hepatitis B infection in such

cases.

Remember that no vaccine can

provide complete, lifelong protection

in all people who are vaccinated.

Before your child is

given Hexaxim

When your child must not be

given it

Do not have Hexaxim if your child:

has had respiratory disorder or

swelling of the face (anaphylactic

reaction) after administration of

Hexaxim.

has had an allergic reaction

to any of the ingredients listed

in FURTHER

INFORMATION

after previous administration

of Hexaxim or any other

diphtheria, tetanus, pertussis,

poliomyelitis, hepatitis B or

Hib containing vaccines.

suffered from a severe reaction

affecting the brain

(encephalopathy) within 7 days of

a prior dose of a pertussis vaccine

(acellular or whole cell pertussis).

has an uncontrolled condition or

severe illness affecting the brain

and nervous system (uncontrolled

neurologic disorder) or

uncontrolled epilepsy.

Take special care with

Hexaxim

Tell your doctor if your child:

has a moderate or high

temperature or an acute illness

(e.g. fever, sore throat, cough,

cold or flu). Vaccination with

Hexaxim may need to be delayed

until your child is better.

has had any of the following

events after receiving a pertussis

vaccine, as the decision to give

further doses of pertussis

containing vaccine will need to be

carefully considered:

fever of 40°C or above within

48 hours not due to another

identifiable cause.

collapse or shock-like state

with hypotonic-

hyporesponsive episode (drop

in energy) within 48 hours of

vaccination.

persistent, inconsolable crying

lasting 3 hours or more,

occurring within 48 hours of

vaccination.

fits (convulsions) with or

without fever, occurring

within 3 days of vaccination.

previously had Guillain-Barre

syndrome (temporary

inflammation of nerves causing

pain, paralysis and sensitivity

disorders) or brachial neuritis

(severe pain and decreased

mobility of arm and shoulder)

after being given a vaccine

containing tetanus toxoid (an

inactivated form of tetanus toxin).

In this case, the decision to give

any further vaccine containing

tetanus toxoid should be

evaluated by your doctor.

is having a treatment that

suppresses her/his immune

system (the body's natural

defences) or has any disease that

causes the weakness of the

immune system. In these cases

the immune response to the

vaccine may be decreased. It is

normally recommended to wait

until the end of the treatment or

disease before vaccinating.

However children with long

standing problems with their

immune system such as HIV

infection (AIDS) may still be

given Hexaxim but the protection

may not be as good as in children

whose immune system is healthy.

is born prematurely. Lower

responses to the vaccine may be

observed in relation with

immaturity of the immune

system. However, according to

national recommendations,

vaccination should not be

delayed. In addition, longer gaps

than normal between breaths may

occur for 2 -3 days after

vaccination.

suffers from an acute or chronic

illness including chronic renal

insufficiency or failure (inability

of the kidneys to work properly).

suffers from any undiagnosed

illness of the brain or epilepsy

which is not controlled. Your

doctor will assess the potential

benefit offered by vaccination.

has any problems with the blood

that cause easy bruising or

bleeding for a long time after

minor cuts. Your doctor will

advise you whether your child

should have Hexaxim.

Taking other medicines

Please tell your doctor if your child is

taking or has recently taken any other

medicines, including medicines

obtained without prescription.

Having other vaccines

Your doctor will advise you if

Hexaxim is to be given with another

vaccine.

How Hexaxim is given

Hexaxim is administered to your

child by your doctor or your nurse.

HEXAXIM

Hexaxim is injected into the muscle

in the upper part of your child's leg or

upper arm.

First course of vaccination

(primary vaccination)

Your child will receive three

injections given at an interval of one

to two months (at least four weeks

apart). This vaccine should be used

according to the local vaccination

programme.

Additional injections (booster)

After the first course of injections,

your child may require a booster

dose, in accordance with local

recommendations. Your doctor will

advise you if your child requires a

booster dose.

If you forget one dose of

Hexaxim

If your child misses a scheduled

injection, it is important that you

discuss with your doctor or nurse

who will decide when to give the

missed dose.

It is important to follow the

instructions from the doctor or nurse

so that your child completes the

course of injections. If not, your child

may not be fully protected against the

diseases.

If you have any further questions on

the use of this vaccine, ask your

doctor, pharmacist or nurse.

Possible side effects

Like all medicines, Hexaxim can

cause side effects, although not

everybody gets them.

Serious allergic reactions

If any of these symptoms occur after

leaving the place where your child

received his/her injection, you must

consult a doctor IMMEDIATELY:

difficulty in breathing

blueness of the tongue or lips

a rash

swelling of the face or throat

low blood pressure causing

dizziness or collapse.

When these signs or symptoms occur

they usually develop quickly after the

injection is given and while the child

is still in the clinic or doctor's

surgery.

Serious allergic reactions are a very

rare possibility (may affect up to 1 in

10,000 people) after receiving any

vaccine.

Other side effects:

If your child experiences any of the

following side effects, please tell

your doctor, nurse or pharmacist.

Very common (may affect more than

1 in 10 people):

pain, redness or swelling at the

injection site

loss of appetite

crying

sleepiness

vomiting

irritability

fever (temperature 38°C or

higher)

Common (may affect up to 1 in 10

people):

abnormal crying (prolonged

crying)

diarrhoea

injection site hardness

Uncommon (may affect up to 1 in

100 people):

allergic reaction

lump at the injection site

high fever (temperature 39.6°C or

higher)

Rare (may affect up to 1 in 1000

people):

rash

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 24-72 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.

Very rare (may affect up to 1 in

10,000 people):

episodes when your child goes

into a shock-like state or is pale,

floppy and unresponsive for a

period of time (hypotonic

reactions or hypotonic

hyporesponsive episodes HHE).

serious allergic reaction

(anaphylactic reaction)

fits (convulsions) with or without

fever

Other side effects not listed above

have been reported occasionally with

other diphtheria, tetanus, pertussis,

poliomyelitis, hepatitis B or Hib

containing vaccines and not directly

with Hexaxim:

temporary inflammation of nerves

causing pain, paralysis and

sensitivity disorders (Guillain-

Barre syndrome) and severe pain

and decreased mobility of arm

and shoulder (brachial neuritis)

have been reported after

administration of a tetanus

containing vaccine.

inflammation of several nerves

causing sensory disorders or

weakness of limbs

(polyradiculoneuritis), facial

paralysis, visual disturbances,

sudden dimming or loss of vision

(optic neuritis), inflammatory

disease of brain and spinal cord

(central nervous system

demyelination, multiple sclerosis)

have been reported after

administration of a hepatitis B

antigen containing vaccine.

swelling or inflammation of the

brain (encephalopathy/

encephalitis).

in babies born very prematurely

(at or before 28 weeks of

gestation) longer gaps than

normal between breaths may

occur for 2 -3 days after

vaccination.

swelling of one or both feet and

lower limbs which may occur

along with bluish discolouration

HEXAXIM

of the skin, redness, small areas

of bleeding under the skin and

severe crying following

vaccination with Haemophilus

influenzae type b containing

vaccines. If this reaction occurs, it

is mainly after first injections and

within the first few hours

following vaccination. All

symptoms should disappear

completely within 24 hours

without need for treatment.

If your child gets any side effects,

talk to your doctor, pharmacist or

nurse. This includes any possible side

effects not listed in this leaflet.

Storing Hexaxim

Hexaxim is usually stored in the

doctor's surgery or clinic, or at the

pharmacy. However, if you need to

store Hexaxim

Keep out of reach and sight of

children.

Keep Hexaxim in the original

pack until it is time for it to be

given.

Keep it in the refrigerator, store at

2°C to 8°C. Do not freeze Hexaxim.

Do not use Hexaxim after the expiry

date which is stated on the carton

after EXP.

Do not have Hexaxim if the

packaging is torn or shows signs of

tampering.

Medicines should not be disposed of

via wastewater or household waste.

Ask your pharmacist how to dispose

of medicines no longer required.

These measures will help to protect

the environment.

Further Information

What Hexaxim contains

Each 0.5 ml dose of Hexaxim

contains:

At least 20 IU of diphtheria

toxoid

At least 40 IU of tetanus toxoid

25 microgram of pertussis toxoid

and 25 microgram of pertussis

filamentous haemagglutinin

10 microgram of hepatitis B

surface antigen

40 D antigen Units of poliovirus

Type 1, 8 D antigen Units of

poliovirus Type 2, 32 D antigen

Units of poliovirus Type 3

12 microgram of Haemophilus

type B polysaccharide conjugated

to 22 - 36 microgram of tetanus

protein

The other ingredients include sodium

phosphate-dibasic, potassium

phosphate-monobasic, trometamol,

sucrose, essential amino acids

(cystine, tyrosine, arginine

hydrochloride, histidine, isoleucine,

leucine, lysine hydrochloride,

methionine, phenylalanine,

threonine, tryptophan and valine) and

water for injections.

The vaccine may contain traces of

glutaraldehyde, formaldehyde,

neomycin, streptomycin and

polymyxin B.

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.

What Hexaxim looks like and

contents of the pack

Hexaxim is provided as a suspension

for injection in pre-filled syringe (0.5

mL).

Hexaxim is available in pack

containing 1 pre-filled syringe with 1

or 2 needles.

Hexaxim is available in pack

containing 10 pre-filled syringes with

10 or 20 needles.

Not all pack sizes may be marketed.

After shaking, the normal appearance

of the vaccine is a whitish cloudy

suspension.

Name and Address of

Australian Sponsor

sanofi-aventis australia pty ltd

Talavera Corporate Centre - Building

12-24 Talavera Road

Macquarie Park NSW 2113

Australia

Tel: 1800 829 468 (1800 Vaxin8)

Name and Address of New

Zealand Sponsor

sanofi-aventis new zealand pty ltd

Level 8, James & Wells Tower

56 Cawley St

Ellerslie

Auckland

New Zealand

Tel: 0800 727 838

AUST R number

AUST R 215536

Date of preparation

2 March 2015

hexa-ccdsv5-cmiv1-1-2mar15

HEXAXIM