SUMMARY CMI

Ipol^®

Consumer Medicine Information (CMI) summary

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

1. Why do I need Ipol?

Ipol is a vaccine. It is used to prevent poliomyelitis ('polio') in infants, children and adults.

For more information, see Section 1. Why do I or my child need Ipol? in the full CMI.

2. What should I know before I am given Ipol?

Do not use if you or your child ever had an allergic reaction to Ipol or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you or your child has any other medical conditions, or take any other medicines.

Talk to your doctor if you are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I am given Ipol? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ipol 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 is Ipol given?

Ipol is given by a doctor or nurse as an injection into the tissue below the skin of the upper arm, or into the thigh in infants and small children, although your doctor may choose to inject it elsewhere.

More instructions can be found in Section 4. How is Ipol given? in the full CMI.

5. What should I know after I am given Ipol?

For more information, see Section 5. What should I know after I am given Ipol? in the full CMI.

6. Are there any side effects?

Common side effects include local reactions around the injection site (such as redness, swelling, pain or discomfort, rash or the formation of hard lumps), fever, agitation, sleepiness, irritability, headaches, muscle or joint pain, diarrhoea, vomiting. Serious side effects include swelling of the glands in the neck, armpit or groin, tingling or numbness of the hands or feet, sudden skin reactions such as rash, itching or hives, a seizure or convulsion or sudden-life threatening allergic reaction.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Ipol^®

Active ingredient(s): Poliovirus (inactivated)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ipol. 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 Ipol.

Where to find information in this leaflet:

1. Why do I need Ipol?
2. What should I know before I am given Ipol?
3. What if I am taking other medicines?
4. How is Ipol given?
5. What should I know after I am given Ipol?
6. Are there any side effects?
7. Product details

1. Why do I need Ipol?

Ipol contains the active ingredient poliovirus (inactivated). Ipol is a vaccine used to prevent poliomyelitis ('polio') in infant, children, and adults.

How it works

Ipol works by helping the body to make its own protection against polio. After receiving the primary course (3 doses) of Ipol, the body will make antibodies. These antibodies help the body to recognise the poliovirus and prevent infection. To be protected, you or your child must be given all doses of Ipol as recommended.

Most people will produce antibodies against polio. However, as with many vaccines, 100% protection cannot be guaranteed.

The vaccine will not give you, or your child, polio.

The chance of a severe reaction to Ipol is very small, but the risks of not being vaccinated against polio may be very serious.

2. What should I know before I am given Ipol?

Warnings

Do not use Ipol if you or your child:

• Is allergic to Ipol, or any of the ingredients listed at the end of the leaflet. Symptoms of an allergic reaction may include:
  - Shortness of breath, wheezing or difficulty breathing
  - Swelling of the face, lips, tongue or other parts of the body
  - Skin rash, itching or hives
• has an illness with a high temperature or any acute illness. Your doctor may decide to delay vaccination until the illness has passed. A mild illness, such as a cold, is not usually a reason to delay vaccination.

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

Check with your doctor if you or your child:

• has weakened immunity due to disease (such as cancer or AIDS) or due to treatment with medicines such as corticosteroids or other medicines used to treat cancer, including radiation.
• has allergies to polymyxin B sulfate, streptomycin sulfate or neomycin (antibiotics), or any other medicines, foods, preservatives or dyes
• has a bleeding disorder

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

Check with your doctor if you are pregnant or intend to become pregnant. The risk to the foetus is not well known.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor will discuss the possible risks and benefits of vaccination.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you or 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. Ipol must not be mixed with other vaccines or medicinal products. Ipol can be given at the same time as other vaccines.

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

4. How is Ipol given?

How much to use

Ipol is given as an injection into the tissue below the skin of the upper arm, or into the thigh in infants and small children, although your doctor may choose to inject it elsewhere.

When to use Ipol

Children

Primary immunisation:

• Three doses of Ipol are given 2 months apart.
• In infants, Ipol can be given at the same time as their DTPa (Diphtheria-Tetanus-Pertussis) vaccine.

Booster doses:

• All children who have received the first three doses of Ipol in infancy should be given another dose (a booster dose) of vaccine around 4 years of age.

Adults

Primary Immunisation:

• If you have not been immunised against polio, then you should receive the complete primary immunisation course of 3 doses.
• If you have received only part of your primary immunisation course for polio, you must receive the remaining doses. It does not matter how long ago you received your last dose.

Booster doses:

• A single booster dose is necessary if you are in an 'at risk' group (please see below).
• If you are at ongoing risk of infection, then you need to have a single booster dose every 10 years. This applies to all adults who are at ongoing risk.

'At Risk' Adults

Some adults are at greater risk of coming into contact with a live polio virus and should be vaccinated. These are adults who belong to one of the following groups:

• Travellers to areas or countries where polio disease is present and is a serious health problem
• Laboratory workers who handle specimens which may contain the polioviruses
• Health care workers in close contact with patients who may be excreting polioviruses

If you or your child missed a dose of Ipol

If you or your child missed a dose of Ipol, talk to your doctor and arrange another visit as soon as possible.

If you or your child received too much Ipol

Overdose is most unlikely because your doctor or nurse gives the injections. If you have any concerns, ask your doctor.

5. What should I know after I am given Ipol?

Things you should do

• Keep an updated record of vaccinations.
• Keep follow-up appointments with your doctor or clinic. It is important you and your child has follow-up doses of Ipol at the appropriate times to make sure the vaccine has the best chance of providing protection polio.

Call your doctor straight away if you or your child:

• does not feel well after having Ipol.

Remind any doctor you visit that you or your child had Ipol.

Looking after your vaccine

Ipol is usually stored in the doctor's surgery or clinic, or at the pharmacy. However, if you need to store Ipol:

• Keep Ipol where children cannot reach.
• Keep Ipol in the original pack until it is time for it to be given.
• Keep Ipol in the refrigerator between 2°C and 8°C. Do not freeze. Freezing destroys the vaccine.

If you or your child no longer needs to use this vaccine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this vaccine after the expiry date.

6. Are there any side effects?

All medicines including vaccines can have side effects. If you or your child does 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

All of these side effects are very rare. Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything else that may be making you or your child 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 or your child experiences, you can report side effects as follows:

Australia: 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.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines or stop giving any medicines to your child.

7. Product details

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

What Ipol contains

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

The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case of vCJD (considered to be the human form of encephalopathy) has resulted from the administration of any vaccine product.

Do not take this vaccine if you or your child are allergic to any of these ingredients.

What Ipol looks like

Ipol is 0.5 mL of liquid vaccine in a single dose syringe.

Aust R 47217

Who distributes Ipol

Australia:
sanofi-aventis australia pty ltd
12 - 24 Talavera Road,
Macquarie Park, NSW 2113
Australia
Tel: 1800 818 806

This leaflet was prepared in December 2023.

ipol-ccdsv6-cmiv4-07dec23

Published by MIMS February 2024

1 Name of Medicine

Poliovirus (inactivated).

2 Qualitative and Quantitative Composition

Ipol is a clear, colourless sterile suspension of three strains of poliovirus: type 1 (Mahoney), type 2 (MEF-1) and type 3 (Saukett). The viruses are grown in cultures of Vero cells, a continuous line of monkey kidney cells, by the microcarrier technique. The viruses are concentrated, purified and made non infectious by inactivation with formaldehyde.
Each sterile 0.5 mL immunising dose of trivalent vaccine is formulated to contain:
Poliovirus inactivated type 1 (Mahoney)¹: 29 D antigen units²;
Poliovirus inactivated type 2 (MEF-1)¹: 7 D antigen units²;
Poliovirus inactivated type 3 (Saukett)¹: 26 D-antigen units².
¹ Cultivated on Vero cells.
² These 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.
Traces of neomycin, streptomycin sulfate and polymyxin B sulfate used in vaccine production may be present.
Contains phenylalanine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. Recommendations for the use of live and inactivated poliovirus vaccines are described in the national immunisation guidelines.
1. General recommendations. It is recommended that all infants, unimmunised children and adolescents not previously immunised be vaccinated routinely against paralytic poliomyelitis. Ipol should be offered to patients who have refused OPV, or in whom OPV is contraindicated.
2. Ipol is also indicated for:
The primary vaccination of immunocompromised individuals of all ages (see Section 4.4 Special Warnings and Precautions for Use), and household contacts of such individuals (when vaccination is indicated);
Unvaccinated or inadequately vaccinated (*) adults, particularly if at increased risk of exposure to live poliovirus, including:
Travellers to areas or countries where poliomyelitis is epidemic or endemic;
Laboratory workers handling specimens which may contain polioviruses;
Healthcare workers in close contact with patients who may be excreting polioviruses.
(*) Such as those who had not completed a primary series of vaccination or not received a booster dose since infancy.

4.2 Dose and Method of Administration

Dose.

Primary immunisation.

Booster doses.

Adults.

Method of administration.

4.3 Contraindications

Known systemic hypersensitivity to any component of Ipol or serious reaction after previous administration of the vaccine or vaccine containing the same substances.
Vaccination should be postponed in cases of febrile or acute disease.

4.4 Special Warnings and Precautions for Use

As each dose may contain undetectable traces of neomycin, streptomycin sulfate and polymyxin B sulfate which are used during vaccine production, caution should be exercised when the vaccine is administered to individuals with hypersensitivity to these antibiotics (and other antibiotics of the same classes).
As each dose contains phenoxyethanol, formaldehyde and polysorbate 80, caution should be exercised when the vaccine is administered to individuals with hypersensitivity to these products.
As with other injectable vaccines, appropriate medical treatment and supervision should always be available in case of anaphylactic reactions. Adrenaline (epinephrine) (1:1000) and other appropriate agents should be available for immediate use in case of an anaphylactic or sudden sensitivity reaction.
The immunogenicity of Ipol could be reduced by immunosuppressive treatment or immunodeficiency. In such cases it is recommended to postpone the vaccination until the end of the treatment or disease. Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response might be limited.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h 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.
Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.
As with any injectable vaccine, Ipol must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these individuals.
Syncope can occur following, or even before, any vaccination as a psychogenic response to the needle injection. Procedures should be in place to prevent falling and injury and to manage syncope.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

There are no known interactions of Ipol with drugs or foods. Simultaneous administration of other parenteral vaccines is not contraindicated.
Different syringes and separate injection sites must be used in case of concomitant administration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Adverse events presented in this section are listed using MedDRA terminology (system organ classes and terms). Within each system organ class, the adverse events are ranked under headings of frequency (most frequent reactions first), using the following convention:
Very common: ≥ 10%;
Common: ≥ 1% and < 10%;
Uncommon: ≥ 0.1% and < 1%;
Rare: ≥ 0.01% and < 0.1%;
Very rare: < 0.01%;
Not known: cannot be estimated from the available data.

Clinical trial experience.

Post-marketing reports.

Blood and lymphatic system disorders.

General disorders and administration site conditions.

Immune system disorders.

Musculoskeletal and connective tissue disorders.

Nervous system disorders.

Psychiatric disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

No case of overdose has been reported.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

Pharmacotherapeutic group: Viral vaccines, ATC code: J07BF03.

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

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

Phenoxyethanol¹, Formaldehyde, Medium 199 Hanks².
¹ Phenoxyethanol contained in a solution of phenoxyethanol at 50% in ethanol.
² Medium 199 Hanks (without phenol red) is a complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (including glucose), supplemented with polysorbate 80, diluted in water for injections. Hydrochloric acid or sodium hydroxide is added for pH adjustment.
Traces of neomycin, streptomycin sulfate and polymyxin B sulfate used in vaccine production may be present. Trace amounts of bovine serum albumin may also be present.
The manufacture of this product includes exposure to bovine derived 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.

6.2 Incompatibilities

This vaccine must not be mixed with other vaccine or medicinal products.

6.3 Shelf Life

36 months (when stored at 2°C to 8°C).

6.4 Special Precautions for Storage

Store at 2°C to 8°C. Refrigerate. Do not freeze.

6.5 Nature and Contents of Container

Ipol is available in a single dose pack containing one 0.5 mL 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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes