Hexaxim

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU; Haemophilus influenzae type b polysaccharide 12 µg ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)); Hepatitis B virus surface antigen 10 µg; Pertussis filamentous haemagglutinin 25 µg (adsorbed); Pertussis toxoid, adsorbed 25 µg; Polio virus type 1 40 DAgU (Mahoney); Polio virus type 2 8 DAgU (MEF-1); Polio virus type 3 32 DAgU (Saukett); Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU
Available from:
sanofi-aventis new zealand limited
INN (International Name):
Diphtheria toxoid, adsorbed 30 Lf U (equivalent to not less than 20 IU)
Pharmaceutical form:
Suspension for injection
Composition:
Active: Diphtheria toxoid, adsorbed 30 Lf U equivalent to not less than 20 IU Haemophilus influenzae type b polysaccharide 12 µg ((polyribosylribitol phosphate) conjugated to tetanus protein (22-36 mcg)) Hepatitis B virus surface antigen 10 µg Pertussis filamentous haemagglutinin 25 µg (adsorbed) Pertussis toxoid, adsorbed 25 µg Polio virus type 1 40 DAgU (Mahoney) Polio virus type 2 8 DAgU (MEF-1) Polio virus type 3 32 DAgU (Saukett) Tetanus toxoid, adsorbed 10 Lf U equivalent to not less than 40 IU Excipient: Aluminium hydroxide Amino acids Dibasic sodium phosphate Monobasic potassium phosphate Sucrose Trometamol Water for injection
Prescription type:
Prescription
Manufactured by:
Sanofi Pasteur SA
Therapeutic 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.
Product summary:
Package - Contents - Shelf Life: Syringe, glass, tip cap closure. Two needles provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. One needle provided separately. - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Twenty needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration. - Syringe, glass, tip cap closure. Ten needles provided separately. - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 72 hours not refrigerated stored at or below 25°C protect from light. At the end of this period, Hexaxim should be used or discarded. Do not return to refrigeration.
Authorization number:
TT50-9354
Authorization date:
2013-07-24

Read the complete document

HEXAXIM

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-

Barré 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.

HEXAXIM

swelling of one or both feet and

lower limbs which may occur

along with bluish discolouration

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 D

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

Read the complete document

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Page 1

NEW ZEALAND DATA SHEET

1

HEXAXIM (SUSPENSION FOR INJECTION)

Hexaxim 0.5 mL, suspension for injection

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

(inactivated) and

Haemophilus influenzae

type b conjugate vaccine (adsorbed).

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Hexaxim is a preservative free liquid formulation for intramuscular administration which combines:

Diphtheria and Tetanus toxoids, Acellular Pertussis (2-component), Recombinant Hepatitis B surface

antigen, Inactivated Poliomyelitis virus and Haemophilus influenzae type b polysaccharide conjugated to

tetanus protein

Each 0.5 mL, adsorbed to aluminium hydroxide hydrate (0.6 mg Al

), contains:

Table 1 - Hexaxim Composition

Active substance

Quantity (per 0.5 mL dose)

Diphtheria Toxoid

≥ 20 IU

Tetanus Toxoid

≥ 40 IU

Bordetella Pertussis

Pertussis Toxoid

Pertussis Filamentous Haemagglutinin

25 microgram

25 microgram

Hepatitis B surface antigen

10 microgram

Poliovirus (Inactivated)

Type 1 (Mahoney)

Type 2 (MEF-1)

Type 3 (Saukett)

40 D antigen

Units

8 D antigen

Units

32 D antigen

Units

Haemophilus influenzae type B polysaccharide conjugated to Tetanus protein

12 microgram

22 – 36 microgram

1 As lower confidence limit (p= 0.95) and not less than 30 I.U as mean value

2 As lower confidence limit (p= 0.95)

3 Surface antigen of hepatitis B virus produced from recombinant strain of the yeast Hansenula polymorpha

4 Produced on vero cells

5 Quantity of antigen in the final bulk product, according to WHO (TRS 673, 1992)

6 Or equivalent antigenic quantity determined by a suitable immunochemical method

hexa-ccdsv7-dsv5-14jun21

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The vaccine may contain traces of glutaral, formaldehyde, neomycin, streptomycin and

polymyxin B.

Contains phenylalanine. For the full list of excipients, see section 6.1 List of excipients.

3

PHARMACEUTICAL FORM

Hexaxim is a whitish cloudy suspension for injection.

4

CLINICAL PARTICULARS

4.1

THERAPEUTIC 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.

4.2

DOSE AND METHOD OF ADMINISTRATION

Hexaxim is for intramuscular injection according to the dosing schedule below.

Table 2 - Dosing Schedule

Dose

Vaccination

Dosing Schedule

General Considerations

3 Dose

Primary*

Three doses of 0.5 mL (such as: 6, 10,

14 weeks; 2, 3, 4 months; 3, 4, 5

months; 2, 4, 6 months)

There should be an interval of at least 4

weeks between primary doses in

accordance with the national

recommendation as per the current

Immunisation Handbook.

Booster

A booster dose may be given

The booster dose should be given at least

6 months after the last priming dose and in

accordance with the national

recommendation as per the current

Immunisation Handbook.

In case where a booster dose is not

administrated, a dose of Hib vaccine

should be given.

hexa-ccdsv7-dsv5-14jun21

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Dose

Vaccination

Dosing Schedule

General Considerations

2 Dose

Primary*

Two doses of 0.5 mL (such as 2,4

months; 3, 5 months)

There should be an interval of at least 8

weeks between primary doses and in

accordance with the national

recommendation as per the current

Immunisation Handbook.

Booster

A booster dose must be given

The booster dose should be given at least

6 months after the last priming dose in

accordance with the national

recommendation as per the current

Immunisation Handbook.

In case where a booster dose is not

administrated, a dose of Hib vaccine must

be given.

*Where a dose of hepatitis B vaccine is given at birth, Hexaxim can be used for supplementary

doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is

required before this age, monovalent hepatitis B vaccine should be used.

For further information, refer to the current Immunisation Handbook.

Administration

Before use, the vaccine should be shaken in order to obtain a homogeneous whitish cloudy

suspension.

Hexaxim should be administered intramuscularly. The recommended injection sites are generally

the antero-lateral aspect of the upper thigh in infants and toddlers and the deltoid muscle in older

children.

Do not administer via intravascular route: ensure that the needle does not penetrate a blood vessel.

Do not administer by intradermal or subcutaneous injection.

Separate syringes, separate injection sites and preferably separate limbs must be used in case of

concomitant administration with other vaccines.

Hexaxim is for single use only and must not be used in more than one individual. Discard any

remaining unused contents.

4.3

CONTRAINDICATIONS

Hexaxim should not be administered to anyone with a history of severe allergic reaction to any

component of the vaccine or to any pertussis vaccine, after previous administration of the vaccine

or a vaccine containing the same components or constituents.

hexa-ccdsv7-dsv5-14jun21

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Vaccination with Hexaxim is contraindicated if the individual has experienced an encephalopathy

of unknown aetiology within 7 days of administration of a previous dose of any vaccine

containing pertussis antigens (whole cell or acellular pertussis vaccines). In these circumstances

pertussis vaccination should be discontinued and the vaccination course should be continued with

diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.

Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy. Pertussis

vaccine should not be administered to individuals with these common conditions until the

treatment regimen has been established, the condition has stabilised and the benefit clearly

outweighs the risk.

Generally vaccination must be postponed in cases of moderate or severe febrile and/or acute

disease and low-grade fever does not constitute a contraindication.

4.4

SPECIAL WARNINGS AND PRECAUTIONS FOR USE

Do not administer intravenously, intradermally or subcutaneously.

Prior to vaccination

Anaphylaxis

As with all injectable vaccines, appropriate medical treatment and supervision should always be

readily available in case of a rare anaphylactic event following administration of the vaccine.

Hypersensitivity

As each dose may contain undetectable traces of glutaraldehyde, formaldehyde, neomycin,

streptomycin and polymyxin B, caution should be exercised when the vaccine is administered to

individuals with hypersensitivity to these substances.

Bleeding disorder

As with all injectable vaccines, the vaccine must be administered with caution to individuals with

thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular

administration.

Previous pertussis vaccination

If any of the following events are known to have occurred in temporal relation to receipt of

pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccine

should be carefully considered:

Temperature of ≥ 40°C within 48 hours not due to another identifiable cause.

Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of

vaccination.

Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours of vaccination.

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Convulsions with or without fever, occurring within 3 days of vaccination.

Family and individual history

A history of febrile convulsions, a family history of convulsions or Sudden Infant Death

Syndrome (SIDS) do not constitute a contraindication for the use of Hexaxim. Individuals with a

history of febrile convulsions should be closely followed up as such adverse events may occur

within 2 to 3 days post vaccination.

Protection

Hexaxim will not prevent disease caused by pathogens other than Corynebacterium diphtheriae,

Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or

Haemophilus influenzae

type b. However, it can be expected that hepatitis D will be prevented by immunisation as

hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

Hexaxim will not protect against hepatitis infection caused by other agents such as hepatitis A,

hepatitis C and hepatitis E or by other liver pathogens.

Because of the long incubation period of hepatitis B, 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.

Hexaxim does not protect against infectious diseases caused by other types of

Haemophilus

influenzae

or against meningitis of other origins.

As with any vaccine, vaccination with Hexaxim may not protect 100% of susceptible individuals.

Special patient groups

Premature and low birth weight infants

No data are available for premature infants and infants of low birth weight < 2.5 kg. Lower

immune response may be observed in this population in relation with immaturity of the immune

system. However, according to several national recommendations, vaccination should not be

delayed.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 hours should be

considered when administering the primary immunisation series to very premature infants (born

≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory

immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not

be withheld or delayed.

Immunocompromised individuals

The immunogenicity of the vaccine may be reduced by immunosuppressive treatment or

immunodeficiency. It is recommended to postpone vaccination until the end of such treatment or

hexa-ccdsv7-dsv5-14jun21

Page 6

disease. Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV

infection is recommended even if the antibody response may be limited.

Neurological disorder

If Guillain Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine

containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be

based on careful consideration of the potential benefits and possible risks, such as whether or not

the primary immunisation schedule has been completed. Vaccination is usually justified for

infants whose primary immunisation schedules are incomplete (i.e. fewer than three doses have

been received).

Some case reports of multiple sclerosis have been reported after administration of hepatitis B

vaccine. To date a causal relationship has not been demonstrated with hepatitis B vaccine.

Chronic renal failure

In individuals with chronic renal failure, an impaired hepatitis B response is observed and

administration of additional doses of hepatitis B vaccine should be considered according to the

antibody level against hepatitis B virus surface antigen (anti-HBsAg).

Genetic polymorphism

Immune responses to the vaccine have not been studied in the context of genetic polymorphism.

Paediatric Population

The safety and efficacy of Hexaxim in children over 24 months of age have not been established.

Use in the elderly

Not applicable.

Genotoxicity

Hexaxim has not been evaluated for genotoxic potential.

Carcinogenicity

Hexaxim has not been evaluated for carcinogenic potential.

Effect on Laboratory Tests

Interference of Hexaxim with laboratory and/or diagnostic tests has not been studied.

However, Antigenuria (PRP antigen) has been detected in some instances following receipt of

Haemophilus influenzae

type b conjugate vaccine. Therefore, urine antigen detection may not

hexa-ccdsv7-dsv5-14jun21

Page 7

have definite diagnostic value in suspected

Haemophilus influenzae

type b disease within two

weeks of immunisation.

4.5

INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION

Hexaxim must not be mixed with other vaccines or other parenterally administered drugs.

Separate injection sites must be used in case of concomitant administration.

Data

concomitant

administration

Hexaxim

with

7-valent

13-valent

pneumococcal

polysaccharide conjugate vaccines have shown no clinically relevant interference in the antibody

response to each of the individual antigens.

Data on concomitant administration of Hexaxim with measles-mumps-rubella vaccine and with

varicella vaccine have shown no clinically relevant interference in the antibody response to each

of the antigens when given as a booster vaccination.

Data on concomitant administration of rotavirus vaccines have shown no clinically relevant

interference in the antibody response to each of the antigens.

Data on concomitant administration of Hexaxim with a meningococcal serogroup C-tetanus

toxoid conjugate vaccine or a meningococcal serogroups A, C, W-135, Y-tetanus toxoid

conjugate

vaccine have shown no clinically relevant interference in the antibody response to each of the

antigens.

Except in the case of immunosuppressive therapy (see section 4.4 Special warnings and

precautions for use), no significant clinical interaction with other treatments or biological products

has been reported.

4.6

FERTILITY, PREGNANCY AND LACTATION

Effects on Fertility

Animal studies have not been conducted to determine the effects of Hexaxim on fertility.

Use in Pregnancy (Category B2)

Hexaxim is not indicated for use during pregnancy and has not been evaluated for potential

harmful effects during pregnancy in animals or humans.

Use in Lactation

Hexaxim is not indicated for use in lactating women and it is not known whether Hexaxim

components are excreted in human milk.

hexa-ccdsv7-dsv5-14jun21

Page 8

4.7

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Not applicable

4.8

UNDESIRABLE EFFECTS

The adverse events are ranked under headings of frequency per dose, using the following

convention:

Very common

≥ 1/10 (≥ 10%)

Common

≥ 1/100 to < 1/10 (≥ 1% and < 10%)

Uncommon

≥ 1/1,000 to < 1/100 (≥ 0.1% and < 1%)

Rare

≥ 1/10,000 to < 1/1000 (≥ 0.01% and < 0.1%)

Very rare

< 1/10,000 (< 0.01%)

Not known

Cannot be estimated from available data

Clinical Trials Experience

In clinical studies in individuals who received Hexaxim, the most frequently reported reactions

(expressed per dose) include injection site pain, irritability, crying and injection site erythema.

Slightly higher solicited reactogenicity was observed after the first dose compared to subsequent

doses.

Immune system disorders

Uncommon: Hypersensitivity reaction

Metabolism and nutrition disorders

Very common: Anorexia

Nervous system disorders

Very common: Crying, somnolence

Common: Abnormal crying (prolonged crying)

Very rare: Hypotonic reactions or hypotonic-hyporesponsive episodes (HHE)

Gastrointestinal disorders

Very common: Vomiting

Common: Diarrhoea

hexa-ccdsv7-dsv5-14jun21

Page 9

Skin and subcutaneous tissue disorders

Rare: Rash

General disorders and administration site conditions

Very common: Injection site pain, injection site erythema, injection site swelling, irritability,

pyrexia (body temperature ≥ 38.0°C)

Common: Injection site induration

Uncommon: Injection site nodule, pyrexia (body temperature ≥ 39.6°C)

Rare: Extensive limb swelling

Large injection site reactions (> 50 mm), including extensive limb swelling from the injection site

beyond one or both joints, have been reported in children. These reactions start within 24-72

hours after vaccination, may be associated with erythema, warmth, tenderness or pain at the

injection site and resolve spontaneously within 3-5 days. The risk appears to be dependent on the

number of prior doses of acellular pertussis containing vaccine, with a greater risk following the

4th and 5th doses.

Adverse Reactions from Post-Marketing Surveillance

Immune system disorders

Very rare: Anaphylactic reactions

Nervous system disorders

Very rare: Convulsions with or without fever

Potential adverse events

(i.e. adverse events which have been reported with other vaccines containing one or more of the

components or constituents of Hexaxim and not directly with Hexaxim).

Brachial neuritis and Guillain Barré Syndrome have been reported after administration of a

tetanus toxoid containing vaccine.

Oedematous reaction affecting one or both lower limbs may occur following vaccination

with

Haemophilus Influenzae

type b containing vaccines. If this reaction occurs, it is

mainly after primary injections and within the first few hours following vaccination.

Associated symptoms may include cyanosis, redness, transient purpura and severe crying.

All events resolve spontaneously without sequel within 24 hours.

Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central

nervous system demyelination (multiple sclerosis) have been reported after administration

of an hepatitis B antigen containing vaccine.

Encephalopathy/encephalitis

hexa-ccdsv7-dsv5-14jun21

Page 10

Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4 Special

warnings and precautions for use)

Reporting suspected adverse reactions after registration of the medicinal product is important.

allows

continued

monitoring

benefit-risk

balance

medicinal

product.

Healthcare

professionals

asked

report

suspected

adverse

reactions

www.tga.gov.au/reporting-problems (Australia) or https://nzphvc.otago.ac.nz/reporting/ (New

Zealand).

4.9

OVERDOSE

Not documented.

For general advice on overdose management, contact the Poisons Information Centre, telephone

number 13 11 26 (Australia) or the National Poisons Centre, 0800 POISON or 0800 764 766

(New Zealand).

5

PHARMACOLOGICAL PROPERTIES

5.1

PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Vaccines, Bacterial and viral vaccines combined, ATC

code: J07CA09

Mechanism of action

Hexaxim induces the production of antibodies against diphtheria, tetanus, pertussis, hepatitis B,

poliomyelitis and invasive infections caused by

Haemophilus influenzae

type b.

Clinical trials

The primary vaccination schedules that have been used are: 3, 5 months without hepatitis B

vaccination at birth; 6, 10, 14 weeks with and without hepatitis B vaccination at birth; 2, 3, 4

months without hepatitis B vaccination at birth; 2, 4, 6 months with and without hepatitis B

vaccination at birth.

Results obtained in the clinical studies for each of the components are summarised in the tables

below:

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