1. What this product is and what it is used for Influvac 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 Influvac should be based on official recommendations. When a person is given the vaccine Influvac, the immune system (the body’s 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 or your child 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 were 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. Influvac 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 or your child are exposed to flu immediately before or after your vaccination, you or your child could still develop the illness. The vaccine will not protect you or your child against the common cold, even though some of its symptoms are similar to flu. 2. What you need to know before you use this product To make sure that Influvac 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 Influvac - If you or your child are allergic (hypersensitive) to: • the active substances, or • any of the other ingredients of Influvac (see section 6), or • any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80 or gentamicin (an antibiotic that is used to treat bacterial infections). - If you or your child have an illness with a high temperature or acute infection, the vaccination shall be postponed until after you or your child have recovered. Warnings and precautions You should tell your doctor before vaccination if you or your child have a poor immune response (immunodeficiency or taking medicines affecting the immune system). Fainting, feeling faint or other stress related reactions can occur following, or even before, any needle injection. Therefore tell your doctor or nurse if you or your child have experienced this kind of reaction with a previous injection. Your doctor will decide if you or your child should receive the vaccine. If, for any reason, you or your child have 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, Influvac may not fully protect all persons who are vaccinated. Other medicines and Influvac • Please tell your doctor or pharmacist if you or your child are taking or have recently taken other vaccines or any other medicines, including medicines obtained without a prescription. • Influvac 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, think you may be pregnant or are currently breast-feeding. Flu vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of flu vaccines do not indicate that the vaccine would have harmful effects on the pregnancy or the baby. Influvac may be used during breast-feeding. Your doctor/pharmacist will be able to decide if you should receive Influvac. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Influvac has no or negligible influence on the ability to drive or use machines. 3. How to use this product. Dosage Adults receive one 0.5 ml dose. Use in children Children from 36 months and older receive one 0.5 ml dose. Children from 6 months to 35 months may receive either one 0.25 ml dose or one 0.5 ml dose, in accordance with existing national recommendations. 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, Influvac 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: - in rare cases leading to medical emergency with a failure of the circulatory system to maintain adequate blood flow to the different organs (shock), - in very rare cases: swelling, most apparent in the head and neck, including the face, lips, tongue, throat or any other part of the body (angioedema). • 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-Barré 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). Reporting of side effects If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. To report any side effect(s): -National Pharmacovigilance Center (NPC) o Fax: +966-11-205-7662 o SFDA Call Center: 19999 o E-mail: [email protected] o Website: https://ade.sfda.gov.sa 5. How to store this product • Keep out of the sight and reach of children. • Do not use Influvac after the expiry date which is stated on the carton after EXP. A month and a year are mentioned. The expiry date refers to the last day of that month. • Store Influvac in a refrigerator (+ 2 °C to + 8 °C). Do not freeze. • Store the product in the original package in order to protect from light. • 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.