SUMMARY CMI

Adacel^® Polio

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Adacel Polio?

Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and poliovirus types 1,2 and 3 (Vero). Adacel Polio is used to help to protect you or your child against whooping cough (pertussis), tetanus, diphtheria and polio. For more information, see Section 1. Why am I using Adacel Polio? in the full CMI.

2. What should I know before I use Adacel Polio?

Do not use if you or your child has ever had an allergic reaction to Adacel Polio or any of the ingredients listed at the end of the CMI, or if you or your child ever had a disease of brain without an apparent cause within 7 days of a previous pertussis, tetanus or diphtheria vaccination. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Adacel Polio? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Adacel Polio and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Adacel Polio?

Adacel Polio is given by your doctor, nurse or pharmacist. More instructions can be found in Section 4. How do I use Adacel Polio? in the full CMI.

5. What should I know while using Adacel Polio?

For more information, see Section 5. What should I know while using Adacel Polio? in the full CMI.

6. Are there any side effects?

Common side effects include a 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 swelling, irritability, nausea and vomiting, diarrhoea. Serious side effects can include 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, tingling or numbness of the hands or decreased feeling or sensitivity of the vaccinated arm, a paralysed nerve in the face, dizziness, generally feeling unwell, pale skin, stomach pain. See your doctor immediately if you notice this. For more information, including what to do if you or your child have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Adacel^® Polio

Active ingredient(s): Pertussis Vaccine - Acellular and Diphtheria and Tetanus Toxoids (Adsorbed) Combined with Inactivated Poliovirus Type 1, 2 and 3 (Vero cell)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Adacel Polio. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Adacel Polio.

Where to find information in this leaflet:

1. Why am I using Adacel Polio?
2. What should I know before I use Adacel Polio?
3. What if I am taking other medicines?
4. How do I use Adacel Polio?
5. What should I know while using Adacel Polio?
6. Are there any side effects?
7. Product details

1. Why am I using Adacel Polio?

Adacel Polio contains the active ingredients diphtheria toxoid, tetanus toxoid, pertussis toxoid, pertussis filamentous haemagglutinin, pertussis fimbriae 2+3, pertactin and poliovirus types 1,2 and 3 (Vero).

Adacel Polio is a vaccine used to help to protect you or your child against whooping cough (pertussis), tetanus, diphtheria and polio.

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.

Use of Adacel Polio during pregnancy allows antibodies to be passed to the baby in the womb from the pregnant woman to protect the baby from whooping cough during the first few months of life.

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. Polio, whooping cough, tetanus and diphtheria cause significant sickness and sometimes death in unvaccinated infants, children, and adults.

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.

2. What should I know before I use Adacel Polio?

Warnings

Do not use Adacel Polio if you or your child:

• 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.
• Always check the ingredients to make sure you or your child can receive this vaccine.

Adacel Polio is not recommended for use in children under 4 years.

Check with your doctor if you or your child:

• Has or ever had any other medical conditions, such as:
  - a poor or reduced immune system due to medication (e.g. steroid or medicines used to treat cancer (including radiation therapy) diseases such as some blood disorders, malaria, kidney disease requiring dialysis, HIV/AIDS or cancer
  - a progressive illness affecting the brain/nerves or uncontrolled fits

After vaccination, you or 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?

Pregnancy and breastfeeding

Tell your doctor or nurse if you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby. Your doctor will help you decide if you should receive Adacel Polio during pregnancy.

Adacel Polio may be administered during pregnancy for prevention of pertussis in young infants.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Adacel Polio.

4. How do I use Adacel Polio?

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 to receive Adacel Polio

• 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.

5. What should I know while using Adacel Polio?

Things you should do

Keep an updated record of your vaccinations.

Call your doctor straight away if you or your child:

• does not feel well after having Adacel Polio
• has any signs of allergic reaction which may include difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, cold, clammy skin, palpitations, dizziness, weakness, fainting, rash or itching.

Driving or using machines

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.

Looking after your medicine

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 Adacel Polio 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 Adacel Polio.

Do not use Adacel Polio after the expiry date which is stated on the carton after EXP.

Do not use Adacel Polio if the packaging is torn or shows signs of tampering.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

6. Are there any side effects?

All medicines can have side effects. If you do experience 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 doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist 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 you experience, 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 medicine.

7. Product details

This medicine is only available with a doctor's prescription.

What Adacel Polio contains

*These quantities are the same as those previously expressed when measured by a suitable method.

Do not take this medicine if you are allergic to any of these ingredients.

What Adacel Polio looks like

Adacel Polio is a sterile, uniform cloudy, white suspension for injection.

Aust R 106576 - Syringe

Who distributes Adacel Polio

Australia:

sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park
NSW 2113, Australia
Tel: 1800 816 806

This leaflet was prepared in November 2023.

ada-pol-ccdsv15-cmiv5-21nov23

Published by MIMS January 2024

1 Name of Medicine

Pertussis vaccine - acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus type 1, 2 and 3 (Vero cell).

2 Qualitative and Quantitative Composition

Adacel Polio is a sterile, uniform cloudy, white suspension for injection in prefilled syringes.
Diphtheria toxoid ≥ 2 IU² (2 Lf);
Tetanus toxoid ≥ 20 IU² (5 Lf¹);
Pertussis toxoid 2.5 microgram;
Pertussis filamentous haemagglutinin 5 microgram;
Pertactin 3 microgram;
Pertussis fimbriae 2 + 3 5 microgram;
Poliovirus inactivated type 1, Vero (Mahoney)³ 29 D antigen units⁴;
Poliovirus inactivated type 2, Vero (MEF1)³ 7 D antigen units⁴;
Poliovirus inactivated type 3, Vero (Saukett)³ 26 D antigen units⁴;
Adsorbed on aluminium phosphate 1.5 mg (0.33 mg aluminium).
¹ The formulated content of 5 Lf of tetanus toxoid per 0.5 mL is the same as in the related product Tripacel.
²As lower confidence limit (p equals 0.95) of activity measured according to the assay described in the European Pharmacopoeia.
³Cultivated on vero cells.
⁴These antigen quantities are strictly the same as those previously expressed as 40-8-32 D-antigen units, for virus type 1, 2 and 3 respectively, when measured by another suitable immunochemical method.
This vaccine may contain traces of formaldehyde, glutaral, streptomycin sulfate, neomycin, polymyxin B sulfate and bovine serum albumin, and Medium 199 Hanks without phenol red (including phenylalanine), which are used during the manufacturing process.
For the full list of excipients, see Section 6.1 List of Excipients.
The vaccine is prepared from: purified formaldehyde detoxified and adsorbed diphtheria and tetanus toxins; purified and glutaral detoxified and adsorbed pertussis toxin (pertussis toxoid or PT); purified formaldehyde treated and adsorbed filamentous haemagglutinin (FHA); purified and adsorbed pertactin (PRN) and co-purified and adsorbed fimbriae types 2 and 3 (FIM); and poliomyelitis viruses type 1, 2 and 3 cultivated on Vero cells, purified and then inactivated by formaldehyde.
Adacel Polio is a diphtheria-tetanus-acellular pertussis combination vaccine (dTpa) combined with inactivated poliovirus vaccine with a reduced content of pertussis toxoid, filamentous haemagglutinin and diphtheria toxoid compared to paediatric diphtheria-tetanus-acellular pertussis (DTPa) formulations.
Adacel Polio should not be used as part of a primary course of immunisation for diphtheria, tetanus, pertussis or poliomyelitis.
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.

3 Pharmaceutical Form

Adacel Polio is supplied in a prefilled syringe for single dose (0.5 mL) use.

4 Clinical Particulars

4.1 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.
Adacel Polio may be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.
The use of Adacel Polio should be determined on the basis of official recommendations. For further information, refer to the current Immunisation Handbook.

4.2 Dose and Method of Administration

Adacel Polio should be administered as a single injection of one dose (0.5 mL) by the intramuscular route. The same dose applies to all age groups. Adacel Polio may be administered from the age of four years onwards.
Adacel Polio can be used for repeat vaccination, after a previous dose of Adacel Polio or Adacel, to boost immunity to diphtheria, tetanus and pertussis at 5- to 10-year intervals. Repeat vaccination should be performed taking into account national recommendations.
If Adacel Polio is administered to a pregnant woman, it should be done according to official national recommendations for pertussis vaccination of a pregnant woman.
For further information, refer to the current Immunisation Handbook.

Method of administration.

4.3 Contraindications

Hypersensitivity.

Acute neurological disorders.

Febrile or acute disease.

4.4 Special Warnings and Precautions for Use

General.

Hypersensitivity.

Neurological adverse events.

Serious and severe adverse events related precautions.

Administration route related precautions.

Syncope.

Altered immune status.

Protection.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

A clinical study has shown that Adacel Polio can be safely administered concomitantly with hepatitis B vaccine, using a separate limb for the site of injection. Adacel Polio has safely been given concomitantly with measles-mumps-rubella vaccine (MMR II). Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. However, in accordance with commonly accepted immunisation guidelines, since Adacel Polio is an inactivated product, there is no theoretical reason why it should not be administered concomitantly with other vaccines or immunoglobulins at separate sites.
Separate injection sites and separate syringes must be used in case of concomitant administration.
Immunosuppressive treatment may interfere with the development of the expected immune response to Adacel Polio, see Section 4.4 Special Warnings and Precautions for Use.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

(Category A)

Human data.

Multiple studies involving numerous pregnant women and their offspring have generated considerable safety, immunogenicity and effectiveness data on the use of Adacel Polio and Adacel, which contains the same tetanus, diphtheria and acellular pertussis components as Adacel Polio, primarily during the second and third trimesters of pregnancy.
Safety data are available from 4 randomised controlled trials (310 pregnancy outcomes), 6 observational studies (84,371 pregnancy outcomes) and from passive surveillance:
Adacel Polio and Adacel led to no more than the expected (generally mild or moderate, and usually self-limited) adverse events for pregnant women who receive it. Safety outcomes for pregnant women were very similar to those seen when these vaccines were given to non-pregnant women of childbearing age.
Adacel Polio and Adacel have not been shown to cause harm to the fetus or newborn.
Immunogenicity data from 13 studies and effective data from 3 studies have shown:
Pertussis antibody responses following vaccination with Adacel are robust in most pregnant women, are amplified when measured in newborn cord blood, persist for 2 to 4 months in the infant, but appear to blunt (reduce) the infant's antibody responses to her or his own pertussis vaccinations later in infancy. There is no evidence to suggest that this blunting is clinically relevant in protection against pertussis.
Adacel Polio and Adacel are > 90% effective when given to women during pregnancy in preventing pertussis disease and hospitalisation in their infants younger than 3 months of age as detailed in Table 1.
The decision to administer Adacel Polio to a pregnant woman should be made according to the official national recommendations for pertussis vaccination of a pregnant woman.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

4.8 Adverse Effects (Undesirable Effects)

The reactions are listed within body systems and categorised by frequency according to the following definitions: very common (≥ 1/10); common (< 1/10 and ≥ 1/100); uncommon (< 1/100 and ≥ 1/1,000).

Clinical trial experience.

Safety following repeat vaccination with Adacel.

Postmarketing experience.

Blood and lymphatic disorders.

Immune system disorders.

Nervous system disorders.

Musculoskeletal and connective tissue disorders.

Gastrointestinal disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: vaccine against diphtheria, tetanus, pertussis and poliomyelitis.
ATC code: J07CA02.

Clinical trials.

Antibody persistence.

Immunogenicity following repeat vaccination.

5.2 Pharmacokinetic Properties

No pharmacokinetic studies have been performed.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Aluminium phosphate, ethanol, phenoxyethanol, polysorbate 80, water for injections.
Manufacturing process residuals per dose include ≤ 5 microgram formaldehyde, ≤ 0.02 mg glutaral, ≤ 0.2 microgram streptomycin sulfate, ≤ 0.02 microgram neomycin, ≤ 0.025 microgram polymyxin B sulfate, Medium 199 Hanks (without phenol red) and bovine serum albumin.

6.2 Incompatibilities

The vaccine must not be mixed with other vaccines or medicinal products.

6.3 Shelf Life

48 months at 2° to 8°C.

6.4 Special Precautions for Storage

Store at 2° to 8°C. Refrigerate. Do not freeze. Do not use after expiry date.
In the absence of photostability studies, store the vaccine container in its original packaging.

6.5 Nature and Contents of Container

0.5 mL of suspension in pre-filled syringe.

6.6 Special Precautions for Disposal

After use, any remaining vaccine and container must be disposed of safely according to locally agreed procedures.

6.7 Physicochemical Properties

Not applicable to vaccines.

References

1. Galazka AM. Module 2: Diphtheria. In: The immunological basis for immunization series. WHO/EPI/GEN/93.12 Geneva: World Health Organization; 1993.
2. Galazka AM. Module 3: Tetanus. In: The immunological basis for immunization series. WHO/EPI/GEN/93.13 Geneva: World Health Organization; 1993.
3. Storsaeter J. et al, Levels of anti-pertussis antibodies related to protection after household exposure to Bordetella pertussis. Vaccine 1998;16(20):1907-16.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription medicine.

Summary Table of Changes