Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about IPOL vaccine.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of you or your child being given IPOL against the benefits they expect it will have.

If you have any concerns about being given this vaccine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What IPOL is used for

IPOL is a vaccine used to prevent poliomyelitis ('polio').

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 all 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.

Before you or your child is given IPOL

When you or your child must not be given it

Do not have IPOL if you or your child has an allergy 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

Do not have IPOL after the expiry date printed on the pack.

Do not have IPOL if the packaging is torn or shows signs of tampering.

Talk to your doctor or pharmacist if you are not sure whether you or your child should have IPOL.

Before you or your child is given it

Tell your doctor if you or your child has ever had a life-threatening allergic reaction to a vaccine.

Tell your doctor if you or your child 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.

Tell your doctor if you or your child has, or has had, any medical conditions, especially the following:

• Weakened immunity due to disease such as cancer or AIDS
• Weakened immunity due to treatment with medicines such as corticosteroids, cyclosporin or other medicines used to treat cancer, including radiation

Your body's response to IPOL may be reduced. If you think this may apply to you, speak to your doctor.

Tell your doctor if you or your child has allergies to:

• polymyxin B, streptomycin or neomycin (antibiotics)
• Any other medicines
• Any other substances such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant. The risk to the foetus is not well known. Your doctor will discuss the risks and benefits of using it if you are pregnant.

Tell your doctor if you are breast-feeding or planning to breast-feed. Your doctor will discuss the possible risks and benefits of vaccination.

Taking Other Medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription.

Having Other vaccines

IPOL can be given at the same time as other vaccines.

How IPOL is given

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.

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

Side effects

Do not be alarmed by this list of possible side effects. You or your child may not experience any of them.

Tell your doctor or pharmacist as soon as possible if you or your child does not feel well after having IPOL.

All medicines (including vaccines) may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. Your doctor has weighed the risks of using this vaccine against the benefits they expect it will have for you or your child.

Tell your doctor if you notice any of the following and they worry you:

• Local reactions around the injection site such as redness, swelling, pain or discomfort, rash or the formation of hard lumps
• Mild fever
• Agitation, sleepiness, irritability
• Headaches
• Muscle or joint pain
• Diarrhoea
• Vomiting

These are generally mild, and short-lived.

Tell your doctor immediately if you notice any of the following:

• Swelling of the glands in the neck, armpit or groin
• Tingling or numbness of the hands or feet

These may be serious side effects. You or your child may need urgent medical attention. Serious side effects are very rare.

If any of the following happens tell your doctor immediately or go to the Accident and Emergency at your nearest hospital:

• Sudden skin reactions such as rash, itching or hives
• Swelling of the head or neck, including face, lips, tongue or other parts of the body
• Shortness of breath, wheezing or difficulty breathing
• A seizure or convulsion
• Nerve pain, weakness or paralysis in the limbs, often moving to chest and face

These are very serious side effects. You or your child may need urgent medical attention or hospitalisation.

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 that is making you or your child feel unwell.

After using IPOL

Storage

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

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

Product description

What it looks like and contents of the pack

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

What IPOL vaccine contains

Each 0.5 mL dose of IPOL contains the following ingredients:

Active ingredients:

• Poliovirus antigen Type 1, 40 D antigen units
• Poliovirus antigen Type 2, 8 D antigen units
• Poliovirus antigen Type 3, 32 D antigen units

Other ingredients:

• 2-phenoxyethanol
• Formaldehyde,
• Medium 199 Hanks supplemented with polysorbate 80, and pH adjusted with hydrochloric acid or sodium hydroxide

IPOL may also contain traces of the following:

• Polymyxin B
• Streptomycin
• Neomycin
• Bovine serum albumin

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.

Name and Address of the Sponsor:

Australia:
sanofi-aventis australia pty ltd
12 - 24 Talavera Road
Macquarie Park NSW 2113
Australia
Tel: 1800 829 468

New Zealand:
sanofi-aventis new zealand limited
Level 8, James & Wells Tower
56 Cawley St
Ellerslie
Auckland
New Zealand
Tel: 0800 727 838

Aust R number
Aust R 47217

Date of preparation
16 January 2013

Published by MIMS December 2013

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