Consumer Medicine Information (CMI) summary
The
full CMI on the later pages has more details. If you are worried about having your child receive
this vaccine, speak to your child’s doctor or nurse.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why is my child receiving Vaxelis?
Vaxelis is a vaccine given to help protect your child against diphtheria, tetanus
(lockjaw), pertussis (whooping cough), hepatitis B, polio and Hib (Haemophilus influenzae type b).
2. What should I know before my child receives Vaxelis?
Do not use if your child has had shortness of breath or swelling of the face after
a previous dose of Vaxelis, has ever had an allergic reaction to Vaxelis or any of
the ingredients listed at the end of the CMI, has suffered from a severe reaction
affecting the brain (encephalopathy) within 7 days of a prior dose of a pertussis
vaccine or has an uncontrolled condition or severe illness affecting the brain and
nervous system (uncontrolled neurologic disorder) or uncontrolled epilepsy.
Talk to your doctor if your child has or has had any other medical conditions or is
taking any other medicines.
3. What if my child is taking other medicines?
Some medicines may interfere with Vaxelis and affect how it works.
4. How will my child receive Vaxelis?
Vaxelis is given by your child’s doctor or nurse as an injection into the muscle.
5. What should I do after my child receives Vaxelis?
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Things you should do
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Tell your child’s doctor or nurse immediately after your child receives the vaccine
and if your child has
difficulty in breathing.
blueness of the tongue or lips.
swelling of the face or throat.
low blood pressure causing dizziness or collapse.
a rash associated with any of the above symptoms
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6. Are there any side effects?
Very common side effects include decreased appetite, irritability, crying more than
usual, vomiting, sleepiness or drowsiness, fever (temperature 38°C or higher), pain,
redness, swelling at the injection site. Serious side effects can include signs of
allergy such as: difficulty in breathing, blueness of the tongue or lips, swelling
of the face or throat, low blood pressure causing dizziness or collapse, a rash associated
with any of the other signs of allergy.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information.
You can help by reporting any side effects you may get. You can report side effects
to your doctor, or directly at www.tga.gov.au/reporting-problems
Active ingredient(s): diphtheria, tetanus, pertussis, hepatitis B, poliovirus and Hib (Haemophilus influenzae type b)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Vaxelis. You should also speak to your doctor or nurse if you would like further information
or if you have any concerns or questions about using Vaxelis.
Where to find information in this leaflet:
1. Why is my child receiving Vaxelis?
Vaxelis is a vaccine, that helps to protect your child against diphtheria, tetanus
(lockjaw), pertussis (whooping cough), hepatitis B, polio and Hib (Haemophilus influenzae type b). Vaxelis may be given to children from the age of six weeks.
The vaccine works by causing the body to produce its own protection (antibodies) against
the bacteria and viruses that cause the following diseases:
Diphtheria: a bacterial infection that usually first affects the throat, causing pain
and swelling which can lead to suffocation. The bacteria also make a toxin (poison)
that can damage the heart, kidneys and nerves.
Tetanus (often called lock jaw): 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): 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: 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): 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 infections): serious bacterial infections
causing 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
Vaxelis will only help to prevent these diseases caused by the bacteria and viruses
targeted by the vaccine. Vaxelis does not protect your child against diseases caused
by other bacteria and viruses that may cause similar symptoms.
The vaccine does not contain any live bacteria or viruses and it cannot cause any
of the infectious diseases against which it protects.
As with any vaccine, Vaxelis may not protect 100% of children who receive the vaccine.
2. What should I know before my child receives Vaxelis?
Warnings
Do not allow your child to receive Vaxelis if your child:
has had shortness of breath or swelling of the face (anaphylactic reaction) after
administration of a previous dose of Vaxelis.
is allergic to Vaxelis vaccine or any diphtheria, tetanus, pertussis, poliomyelitis,
hepatitis B or Hib containing vaccines, or any of the ingredients listed at the end
of this leaflet.
has 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.
Always check the ingredients to make sure your child can be given this vaccine.
Check with your doctor if your child:
has a moderate to severe acute disease, with or without fever (e.g. sore throat, cough,
cold or flu). Vaccination with Vaxelis may need to be delayed until your child is
better.
has had any of the following events after receiving a vaccine against pertussis (whooping
cough), 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.
became floppy, unresponsive or unconscious after the previous vaccination, within
48 hours of vaccination.
cried continuously and could not be comforted for more than 3 hours within 48 hours
of vaccination.
had a fit (convulsions) with or without fever, within 3 days of vaccination.
previously had Guillain-Barré syndrome (temporary loss of feeling and movement) after
being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
Your doctor will decide whether to give Vaxelis to your child.
is receiving a treatment (such as steroids, chemotherapy or radiotherapy) or has a
disease that suppresses or weakens the body’s ability to fight infections. It is normally
recommended to postpone vaccination until the end of such treatment or disease. However,
children with long standing problems with their immune system such as HIV infection
(AIDS) may still be given Vaxelis but the protection may not be as good as in children
with a healthy immune system.
suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Your doctor or nurse will assess the potential benefit offered by vaccination once
the condition is stabilized.
suffers from fits during a fever, or there is family history of fits occurring during
a fever.
has any problems with bleeding for a long time after minor cuts, or bruises easily.
Your doctor will advise you whether your child should receive Vaxelis.
was born very prematurely (at or before 28 weeks of pregnancy). In these infants,
longer gaps than normal between breaths may occur for 2 to 3 days after vaccination.
After vaccination, your child may be at risk of developing certain side effects. It
is important you understand these risks and how to monitor for them. See additional
information under Section
6. Are there any side effects?
3. What if my child is taking other medicines?
Tell your doctor or nurse if your child is taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Vaxelis can be given at the same time as other vaccines such as pneumococcal vaccines,
measles-mumps-rubella-varicella (MMRV) vaccines, rotavirus vaccines or meningococcal
C vaccines.
Your doctor or nurse will give these injections at different sites and will use different
syringes and needles for each injection.
Check with your doctor or nurse if you are not sure about what medicines, vitamins
or supplements your child is taking and if these affect Vaxelis.
4. How will my child receive Vaxelis ?
How much is given
Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines
and who are equipped to deal with any uncommon severe allergic reaction to the injection
(see section 4 Possible side effects).
Your doctor or nurse will inject Vaxelis into your child’s thigh (in infants from
the age of 6 weeks) or arm (in children older than one year).
The recommended dose is as follows:
First course of vaccination (primary vaccination)
Your child will receive two or three injections given at least one month apart. Your
doctor or nurse will tell you when your child should come back for their next injection
as per the local vaccination program.
Additional injection (booster)
After the first course of injections, if an additional injection (booster) is necessary,
the doctor or nurse will tell you when this dose should be given.
If your child misses a dose of Vaxelis
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 or nurse.
5. What should I do after my child receives Vaxelis?
Call your doctor straight away if your child has:
difficulty in breathing
blueness of the tongue or lips
swelling of the face or throat
low blood pressure causing dizziness or collapse.
a rash associated with any of the above symptoms
Driving or using machines
It is expected that Vaxelis would have no or negligible influence on the ability to
use bicycles and other such machines.
Looking after your child’s vaccine:
Vaxelis is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However,
if you need to store Vaxelis:
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vaccine in the outer
carton in order to protect from light.
Keep it where young children cannot reach it.
Getting rid of any unwanted vaccine
Medicines including vaccines should not be disposed of via wastewater or household
waste. If your child no longer needs this vaccine or it is out of date, take it to
any pharmacy for safe disposal. These measures will help to protect the environment.
Do not use this vaccine after its expiry date that is on the carton after EXP.
6. Are there any side effects?
All medicines including vaccines can have side effects. If your child experiences
any side effects, most of them are minor and temporary. However, some side effects
may need medical attention.
See the information below and, if you need to, ask your child’s doctor or nurse if
you have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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decreased appetite
irritability
crying
vomiting
sleepiness or drowsiness
fever (temperature 38°C or higher)
pain, redness, swelling at the injection site
diarrhoea
hard mass, lump (nodule) at the injection site
bruising at the injection site
rash
warmth, rash at the injection site
increased appetite
stomach pain
excessive sweating
cough
nasal congestion and runny nose
paleness
sleep disorders including inability to get adequate sleep
restlessness
swollen glands in the neck, armpit or groin
feeling tired
floppiness
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Speak to your doctor if your child has any of these side effects and they worry you.
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Serious side effects
Tell your doctor or nurse if you notice anything else that may be making you feel
unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects your child experienced,
you can report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this vaccine.
7. Product details
This vaccine is only available with a doctor's prescription.
What Vaxelis contains
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Active ingredient
(main ingredient)
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Diphtheria Toxoid1 not less than
20 IU6
Tetanus Toxoid1
not less than 40 IU6
Bordetella
pertussis antigens 1
Pertussis Toxoid (PT) 20 micrograms
Filamentous Haemagglutinin (FHA) 20 micrograms
Pertactin (PRN)
3 micrograms
Fimbriae Types 2 and 3 (FIM) 5 micrograms
Hepatitis B surface antigen2,3 10 micrograms
Poliovirus (Inactivated) 4
Type 1 (Mahoney)
40 D antigen units5
Type 2 (MEF-1)
8 D antigen units5
Type 3 (Saukett)
32 D antigen units5
Haemophilus influenzae type b polysaccharide
(Polyribosylribitol Phosphate)
3 micrograms
Conjugated to meningococcal protein2 50 micrograms
1 adsorbed on aluminium phosphate (0.17 mg Al3+)
2 adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al3+)
3 produced in yeast (Saccharomyces cerevisiae) by recombinant DNA technology
4 produced in Vero cells
5 or equivalent antigenic quantity determined by a suitable immunochemical method
6 or equivalent activity determined by an immunogenicity evaluation.
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Other ingredients
(inactive ingredients)
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Dibasic sodium phosphate and monobasic sodium phosphate, water for injections
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Potential allergens
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Glutaraldehyde, formaldehyde, neomycin, streptomycin, polymyxin B, and bovine serum
albumin
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Do not allow your child to receive this vaccine if he/she is allergic to any of these
ingredients.
What Vaxelis looks like
Vaxelis is a uniform, cloudy, white to off-white suspension, which may settle down
during storage.
Vaxelis is provided as a suspension for injection in pre-filled syringe (AUST R 363251)
or vial (AUST R 364413).
Pack size of 1 or 10 pre-filled syringes, without attached needles.
Pack size of 10 vials.
Not all pack sizes may be marketed.
Who distributes Vaxelis
Sanofi-Aventis Australia pty ltd
12 - 24 Talavera Road
Macquarie Park
NSW 2113 Australia
Tel: 1800 818 806
This leaflet was prepared in February 2023.