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INFLUENZA VACCINE SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

suspension for injection in pre-filled syringe Influenza Vaccine (Surface Antigen, Inactivated)

INFLUENZA VACCINE,
Read all of this leaflet carefully before you or your child is vaccinated. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This vaccine has been prescribed for you or your child. Do not pass it on to others. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet 1. WHAT INFLUENZA VACCINE IS AND WHAT IT IS USED FOR 2. BEFORE YOU OR YOUR CHILD USE INFLUENZA VACCINE 3. HOW TO USE INFLUENZA VACCINE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE INFLUENZA VACCINE 6. FURTHER INFORMATION 1. WHAT Influenza Vaccine IS AND WHAT IT IS USED FOR Influenza Vaccine is a vaccine. This vaccine helps to protect you or your child against influenza (flu), particularly in subjects who run a high risk of associated complications. The use of Influenza Vaccine should be based on official recommendations. When a person is given the vaccine Influenza Vaccine, the immune system (the bodys natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching flu is during the cold months between October and March. If you or your child was not vaccinated in the autumn, it is still sensible to be vaccinated up until the spring since you or your child runs the risk of catching flu until then. Your doctor will be able to recommend the best time to be vaccinated. Influenza Vaccine will protect you or your child against the three strains of virus contained in the vaccine from about 2 to 3 weeks after the injection. The incubation period for flu is a few days, so if you are exposed to flu immediately before or after your vaccination, you could still develop the illness. The vaccine will not protect you against the common cold, even though some of the symptoms are similar to flu. 2. BEFORE YOU OR YOUR CHILD USE Influenza Vaccine To make sure that Influenza Vaccine is suitable for you or your child, it is important to tell your doctor or pharmacist if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or pharmacist to explain. Do not use Influenza Vaccine - If you or your child is allergic (hypersensitive) to the active substances, to any of the excipients of Influenza Vaccine, to Influenza Vaccine specific residues: e.g. eggs, chicken proteins, such ovalbumin (For other ingredients of Influenza Vaccine, see section 6 "Further information"). - If you or your child has an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child has recovered. Take special care with Influenza Vaccine You should tell your doctor before vaccination if you or your child has a poor immune response (immunodeficiency or taking medicines affecting the immune system). Thiomersal is present (in trace amounts) in this product, and it is possible that you/your child may experience an allergic reaction. Tell your doctor if you/your child have/has experience any known allergies. Tell your doctor if you/your child have/has experience any health problems after previous administration of a vaccine. Your doctor will decide if you or your child should receive the vaccine. If, for any reason, you or your child has a blood test within a few days following a flu vaccination, please tell your doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated. As with all vaccines, Influenza Vaccine may not fully protect all persons who are vaccinated. Using other medicines - Please tell your doctor or pharmacist if you or your child is taking or has recently taken other vaccines or any other medicines, including medicines obtained without a prescription. - Influenza Vaccine can be given at the same time as other vaccines by using separate limbs. It should be noted that the side effects may be stronger. - The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy. Pregnancy and breast-feeding Tell your doctor or pharmacist if you are pregnant or think you may be pregnant. Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from the flu, administration of the vaccine is recommended, irrespective of their stage of pregnancy. Influenza Vaccine may be used during breast-feeding.

Your doctor/pharmacist will be able to decide if you should receive Influenza Vaccine. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines The vaccine is unlikely to affect your ability to drive or use machines. Important information about some of the ingredients of Influenza Vaccine One dose of Influenza Vaccine (0.5 ml) contains less than 1mmol (39 mg) potassium and less than 1mmol (23 mg) sodium. This means that Influenza Vaccine is essentially free from potassium and sodium. 3. HOW TO USE Influenza Vaccine Dosage Adults and children aged from 48 months receive one 0.5 ml dose. If your child has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks. Method and/or route(s) of administration Your doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Influenza Vaccine can cause side effects, although not everybody gets them. During clinical trials, the following side effects have been observed. Their frequencies have been estimated as Common: affects 1 to 10 users in 100. headache sweating muscular pain (myalgia), joint pain (arthralgia) fever, generally feeling unwell (malaise), shivering, fatigue local reactions: redness, swelling, pain, bruising (ecchymosis), hardness (induration) around the area where the vaccine is injected. These reactions usually disappear within 1-2 days without treatment. Next to the above common side effects, the following side effects occurred after the vaccine came on the market: allergic reactions: - leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock) in rare cases, - swelling most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema) in very rare cases. skin reactions that may spread throughout the body including itchiness of the skin (pruritus, urticaria), rash blood vessel inflammation which may result in skin rashes (vasculitis) and in very rare cases in temporary kidney problems. pain situated on the nerve route (neuralgia), anomalies in the perception of touch, pain, heat and cold (paraesthesia), fits (convulsions) associated with fever, neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis, Guillain-Barr Syndrom)

temporary reduction in the number of certain types of particles in the blood called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia); temporary swelling of the glands in the neck, armpit or groin (transient lymphadenopathy) Thiomersal is present (in trace amounts) in this product and it is possible that you/your child may experience an allergic reaction. Tell your doctor if you/your child have any known allergies. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE Influenza Vaccine Keep out of the reach and sight of children. Do not use Influenza Vaccine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Store at +2C to +8C (in a refrigerator). Do not freeze. Keep container in the original carton. 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 to protect the environment. 6. FURTHER INFORMATION Influenza virus surface antigens (haemagglutinin and neuraminidase), of the following strains*: A/California/7/2009 (H1N1) derived strain used NYMC X-181 15 micrograms HA** A/Perth/16/2009 (H3N2) like strain used NYMC X-187 derived from A/Victoria/210/2009 15 micrograms HA** B/Brisbane/60/2008 15 micrograms HA** Per 0.5 ml dose *propagated in fertilized hens eggs from healthy chicken flocks ** haemagglutinin This vaccine complies with the WHO (World Health Organisation) recommendations (Northern hemisphere) and EU decision for the 2010/2011 season. The other ingredients are: Potassium dihydrogen phosphate Disodium hydrogen phosphate Sodium chloride Water for injection What Influenza Vaccine looks like and contents of the pack The vaccine is a suspension for injection presented in a pre-filled syringe of 0.5 ml in a box of 1 or 10. Not all the pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Novartis Vaccines and Diagnostics Limited Gaskill Road, Speke Liverpool, L24 9GR United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Not applicable This leaflet was last approved in 06/2009.

The following information is intended for medical or healthcare professional only: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. The vaccine should be allowed to reach room temperature before use. Shake before use. The vaccine appears as a clear liquid. It must not be mixed with other medicinal products. The vaccine should under no circumstances be administered intravascularly.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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