Package leaflet: Information for the user. Poliomyelitis Vaccine (Inactivated) suspension for injection in pre-filled syringe

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Roland Hood
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1 Package leaflet: Information for the user Poliomyelitis Vaccine (Inactivated) suspension for injection in pre-filled syringe Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor, pharmacist or nurse. - This vaccine has been prescribed for you or for your child only. Do not pass it on to others. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Poliomyelitis Vaccine (Inactivated) is and what it is used for 2. What you need to know before you use Poliomyelitis Vaccine (Inactivated) 3. How to use Poliomyelitis Vaccine (Inactivated) 4. Possible side effects 5. How to store Poliomyelitis Vaccine (Inactivated) 6. Contents of the pack and other information 1. What Poliomyelitis Vaccine (Inactivated) is and what it is used for Poliomyelitis Vaccine (Inactivated) is a vaccine. Vaccines are used to protect you against infectious diseases. This vaccine helps to protect against polio. When an injection of Poliomyelitis Vaccine (Inactivated) is given, the body's natural defences will produce protection against polio infection. Poliomyelitis Vaccine (Inactivated) can be given to infants from 2 months of age, children and adults. Polio is an infectious disease that is usually caught by swallowing polio viruses in food or drink. It can also be caught by eating with unwashed hands if there is virus on them. The viruses spread to the nervous system and can cause permanent paralysis. The viruses in the vaccine have been killed so that they cannot cause polio but they can cause your body to make antibodies to protect against future infections. 2. What you need to know before you receive Poliomyelitis Vaccine (Inactivated) Do not receive Poliomyelitis Vaccine (Inactivated): - if you or your child are allergic (hypersensitive) to the active substance, to any of the excipients or any residual component carried over from manufacture (streptomycin, neomycin or polymixin B) which may be present in trace amounts (listed in the section 6) - if you or your child are currently suffering from any acute illness, including febrile illness with high temperature. Vaccination with Poliomyelitis Vaccine (Inactivated) may need to

2 be delayed until after recovery from infection. A minor illness without fever such as mild upper respiratory infection is not usually a reason to defer immunization. - Warnings and precautions Talk to your doctor, pharmacist or nurse before vaccination: if you or your child have ever had an allergic reaction to a vaccine that contained inactivated poliomyelitis vaccine along with other active ingredients. Your doctor or nurse will advise you if Poliomyelitis Vaccine (Inactivated) can still be given. if you or your child have problems with the immune system due to any reason (including HIV infection) so that your immune system is poor. You/your child may still be given Poliomyelitis Vaccine (Inactivated) but the protection against infections after having the vaccine may not be as good as in people with normal immune systems. Your doctor or nurse may advise you to have a blood test some time after vaccination to see if you have responded well or not. if you or your child have any problems with the blood that cause easy bruising or bleeding for a long time after minor cuts. Your doctor or nurse may still advise that you/your child should have Poliomyelitis Vaccine (Inactivated) but extra care is needed because of the risk of bleeding at the injection site. Sometimes your doctor or nurse may give Poliomyelitis Vaccine (Inactivated) as an injection deep into the skin instead of into muscle (See section 3) to try to reduce the risk of bleeding. Like all vaccines, Poliomyelitis Vaccine (Inactivated) cannot completely prevent the infection that it is meant to protect against and protection may not be lifelong. Other medicines or vaccines and Poliomyelitis Vaccine (Inactivated) Poliomyelitis Vaccine (Inactivated) can generally be given at the same time as other vaccines. If this is necessary, the different vaccines will be injected separately into different injection sites. In case of medical treatment affecting the body's natural defences please refer to the section "Warnings and precautions" above. Tell your doctor or nurse if you or your child is taking, has recently taken or might take any other medicines. Pregnancy, breast-feeding and fertility Tell your doctor or nurse if you or your child is pregnant or breast-feeding, think you or your child might be pregnant or planning to have a baby. Poliomyelitis Vaccine (Inactivated) should be given to pregnant women only if clearly needed. Your doctor or nurse can advise you whether or not vaccination should be delayed. The effect of vaccination while breastfeeding has not been assessed. Driving and using machines Some of the possible side effects mentioned in section 4 of this leaflet (such as dizziness) might affect your ability to drive or use machines.

3 Poliomyelitis Vaccine (Inactivated) contains ethanol Poliomyelitis Vaccine (Inactivated) contains small amounts of ethanol (alcohol), less than 100 mg per dose. 3. How to receive Poliomyelitis Vaccine (Inactivated) The vaccination should be given by medical or healthcare professionals who are trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection. Poliomyelitis Vaccine (Inactivated) is usually given as an injection into a muscle in the upper part of the arm or, in infants and very young children, into the upper part of the leg. For persons who are at risk of severe bleeding after an injection deep into muscle, the vaccine can be injected deep under the skin. Your doctor or nurse will avoid giving the injection into a blood vessel. First course of vaccination If you or your child has never been vaccinated against polio before, three injections of 0.5 millilitre Poliomyelitis Vaccine (Inactivated) are needed. The vaccine can be given from the age of 2 months onwards. A gap of at least one month should occur between the three doses. Your doctor or nurse will tell you when to attend for the second and third doses. Booster Vaccination Booster doses of Poliomyelitis Vaccine (Inactivated) are needed to make sure that protection continues. Your doctor or nurse will advise you when booster doses need to be given. Poliomyelitis Vaccine (Inactivated) can be given to you or your child as a booster injection if you previously received doses of poliomyelitis vaccine by mouth. 4. Possible side effects Like all medicines and vaccines, Poliomyelitis Vaccine (Inactivated) can cause side effects although not everybody gets them. Serious allergic reactions are a very rare possibility after receiving any vaccine. These reactions occur in less than one in ten thousand persons. Symptoms may include difficulty in breathing, blueness of the tongue or lips, a rash, swelling of the face or throat and low blood pressure. When these signs or symptoms occur they usually develop very quickly after the injection is given and while you/your child is still in the clinic or doctor s surgery. If any of these symptoms occur after leaving the place where the injection was given, you must consult a doctor IMMEDIATELY. Other side effects Very common side effects (may affect more than one in 10 people): Pain at the injection site. Fever (high temperature). Common side effects (may affect up to one in 10 people): Redness at the injection site. Dizziness. Nausea, vomiting, diarrhoea.

4 Joint and muscle pain. Headache, sleepiness. Irritability and crying. Inability to sleep. Vertigo. Uncommon side effects (may affect up to one in 100 people): Lump at the injection site Side effects that have been reported during marketed use include (frequency cannot be estimated from the available data): Swollen glands. Swelling or rash at the injection site lasting 1-2 days. Rashes on other parts of the body that can be lumpy or itchy. Flu like symptoms, usually just on the day of vaccination. Fits with or without a fever. Pins and needles within 2 weeks of vaccination that will clear up without treatment. Restlessness or sleepiness. 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. Reporting of side effects If you get any side effect, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. In Ireland You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. In the UK You can also report side effects directly via the Yellow Card Scheme at By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Poliomyelitis Vaccine (Inactivated) Keep this vaccine out of the sight and reach of children. Do not use this vaccine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C - 8 C). Do not freeze. The vaccine should not be used if it has been frozen. Keep the vaccine in the outer carton in order to protect from light.

5 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 protect the environment. 6. Contents of the pack and other information What Poliomyelitis Vaccine (Inactivated) contains The active substances in each 0.5 millilitre dose of vaccine are: Inactivated type 1 polio virus (Mahoney) D-antigen 2 units 3 Inactivated type 2 polio virus (MEF-1) D-antigen 2 units 3 Inactivated type 3 polio virus (Saukett) D-antigen 2 units 3 1 Cultivated on Vero cells 2 Quantity of antigen in the Final Bulk Product, according to WHO (TRS 673, 1982) 3 Or equivalent nominal amount of poliovirus of each type expressed in European Pharmacopoeia Units of D-antigen (parallel line method) The other ingredients are: 2-phenoxyethanol, ethanol, formaldehyde, medium 199 without phenol red (complex mixture of amino acids (including phenylalanine), mineral salts, vitamins and other components (including glucose), supplemented with polysorbate 80 and diluted in water for injections). What Poliomyelitis Vaccine (Inactivated) looks like and contents of the pack Poliomyelitis Vaccine (Inactivated) is a suspension for injection in a pre-filled syringe. It comes in a 0.5 millilitre prefilled syringe (enough for one dose). It is supplied in packs of 1, 10 or 20 prefilled syringes (doses). Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The company licensed to sell Poliomyelitis Vaccine (Inactivated) in the UK and Ireland is Sanofi Pasteur MSD Limited. Their address is Mallards Reach, Bridge Avenue, Maidenhead, Berkshire, SL6 1QP in the UK and Block A, Second Floor, Cookstown Court, Old Belgard Road, Tallaght, Dublin 24 in Ireland. Poliomyelitis Vaccine (Inactivated) is made by Sanofi Pasteur SA, Campus Mérieux, 1541 avenue Marcel Mérieux, F Marcy L Etoile, France. This medicinal product is authorised in the Member States of the EEA under the following names: Ireland, United Kingdom, Germany Poliomyelitis Vaccine (Inactivated) IPV Mérieux This leaflet was last revised in September 2015

6 The following information is intended for medical or healthcare professionals only: The vaccine should be brought to room temperature before use. The vaccine should not be used if it is cloudy, contains particles or if it has been frozen. Shake before use. See also section 3. How to use Poliomyelitis Vaccine (Inactivated)

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