75 mg\u00a0solution for injection\u00a0in a pre-filled\u00a0syringe
omalizumab<\/p>\n\n\n\n
Xolair contains the active substance omalizumab, an artificial\u00a0protein\u00a0that is similar to the natural\u00a0proteins\u00a0produced in the body.\u00a0Omalizumab belongs to a group of medicines called monoclonal\u00a0antibodies.<\/p>\n\n\n\n
Xolair is used to treat:<\/p>\n\n\n\n
Allergic asthma<\/p>\n\n\n\n
This medicine is used to prevent the worsening of\u00a0asthma\u00a0by controlling the symptoms of severe allergic\u00a0asthma\u00a0in adults, adolescents, and children (aged 6 and over) who are already taking other asthma medicines, but whose asthma symptoms are not well controlled despite medicines such as high-\u00a0dose\u00a0inhaled steroids\u00a0and beta stimulators for inhalation.<\/p>\n\n\n\n
Chronic inflammation of the nose and sinuses with nasal polyps<\/p>\n\n\n\n
This medicine is used to treat\u00a0chronic\u00a0inflammation\u00a0of the nose and sinuses with nasal polyps in adults (from the age of 18) who are already using a corticosteroid that is taken into the nose (cortisone nasal spray), but whose symptoms are not well-controlled.\u00a0Nasal polyps are small growths on the\u00a0mucous membrane\u00a0of the nose.\u00a0Xolair helps reduce the size of the\u00a0polyps\u00a0and improves symptoms such as nasal congestion, impaired sense of smell, mucus in the back of the throat, and runny nose.<\/p>\n\n\n\n
Xolair works by blocking a substance called IgE (short for immunoglobulin E), which is produced in the body. IgE contributes to a type of inflammation that plays a key role in causing allergic asthma and chronic inflammation of the nose and sinuses with nasal polyps. If you think you may be allergic to any of the ingredients, tell your doctor, as you should not use Xolair.<\/a><\/p>\n\n\n\n Talk to your doctor before using Xolair:<\/p>\n\n\n\n Xolair should not be used to treat acute asthma symptoms, eg a sudden asthma attack.<\/p>\n\n\n\n Xolair is not intended to prevent or treat other allergic conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder),\u00a0aspergillosis\u00a0(a lung disease caused by mold), food allergy,\u00a0eczema, or hay fever because Xolair has not been studied in these conditions.<\/p>\n\n\n\n Be alert for signs of allergic reactions and other serious side effects<\/strong><\/p>\n\n\n\n Xolair can cause serious\u00a0side effects.\u00a0You need to look out for signs of these when using Xolair.\u00a0Seek immediate medical attention if you notice any signs of a severe\u00a0allergic reaction\u00a0or another serious side effect.\u00a0Such signs are listed under “Serious side effects” in section 4.<\/p>\n\n\n\n Before you or a family member injects Xolair, you must be trained in how to recognize the early symptoms of serious allergic reactions and how to deal with them if they occur (see section 3 “How to use Xolair”).\u00a0The majority of serious allergic reactions occur with the first 3 doses of Xolair.<\/p>\n\n\n\n Children and young people<\/strong><\/p>\n\n\n\n Allergic asthma<\/p>\n\n\n\n Xolair is not recommended for children under 6 years of age. Use in children under 6 years has not been studied.<\/p>\n\n\n\n Chronic inflammation of the nose and sinuses with nasal polyps<\/p>\n\n\n\n Xolair is not recommended for children and adolescents under 18 years of age. Use in patients under 18 has not been studied.<\/a><\/p>\n\n\n\n Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n This is especially important if you are taking:<\/p>\n\n\n\n If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.\u00a0The doctor will discuss the benefits and possible risks of using this medicine during pregnancy with you.<\/p>\n\n\n\n If you become pregnant while being treated with Xolair, tell your doctor immediately.<\/p>\n\n\n\n Xolair can pass into breast milk.\u00a0If you are breastfeeding or plan to breastfeed, consult your doctor before using this medicine.<\/p>\n\n\n\n Xolair is unlikely to affect your ability to drive or use machines. Always use this medicine as directed by your doctor.\u00a0Consult a doctor, nurse, or pharmacist if you are unsure.<\/p>\n\n\n\n How Xolair is given<\/strong><\/p>\n\n\n\n Xolair should be given as an injection under the skin (so-called subcutaneous injection ).<\/p>\n\n\n\n Injection of Xolair<\/p>\n\n\n\n For detailed instructions on how to inject Xolair, see “Instructions for using the Xolair pre-filled syringe” at the end of this leaflet.<\/p>\n\n\n\n Education to recognize severe allergic reactions<\/p>\n\n\n\n You mustn’t inject Xolair yourself until you have been trained by your doctor or nurse to:<\/p>\n\n\n\n For more information on the early signs and symptoms of serious allergic reactions, see section 4.<\/p>\n\n\n\n What dose to use<\/strong><\/p>\n\n\n\n Your doctor will decide how much Xolair you need and how often you will be treated. It is based on your body weight and the amount of IgE in your blood. A blood sample to measure the amount of IgE is taken before treatment begins.<\/p>\n\n\n\n You will need 1 to 4 injections each time, either every two or four weeks.<\/p>\n\n\n\n Continue to take your usual asthma medication and\/or nasal polyp medication during treatment with Xolair. Do not stop taking any of your asthma and\/or nasal polyp medications without talking to your doctor.<\/p>\n\n\n\n You may not see any improvement immediately after starting treatment with Xolair. In patients with nasal polyps, an effect has been seen 4 weeks after starting treatment. In asthma patients, it generally takes 12 to 16 weeks for the treatment to be fully effective.<\/p>\n\n\n\n Use for children and adolescents<\/strong><\/p>\n\n\n\n Allergic asthma<\/p>\n\n\n\n Xolair can be used by children and adolescents who are 6 years of age and older and who are already taking other asthma medications, but whose asthma symptoms are not well controlled despite medications such as high-dose\u00a0inhaled steroids\u00a0and inhaled beta-stimulators.\u00a0The doctor calculates how much Xolair the child needs and how often it needs to be given.\u00a0This is calculated based on the child’s body weight and the results of the blood samples taken before the start of treatment to measure the amount of\u00a0IgE\u00a0in the blood.<\/p>\n\n\n\n Children (6 to 11 years) are not expected to self-administer Xolair.\u00a0If the doctor considers it appropriate, for example, a guardian can\u00a0administer\u00a0Xolair after training.<\/p>\n\n\n\n Chronic inflammation of the nose and sinuses with nasal polyps<\/p>\n\n\n\n Xolair should not be given to children and adolescents under the age of 18.<\/a><\/p>\n\n\n\n If you have missed an appointment for a Xolair injection, contact the doctor or hospital as soon as possible to make a new appointment.<\/p>\n\n\n\n If you forget to use a\u00a0dose\u00a0of Xolair yourself, inject\u00a0dose\u00a0one as soon as you remember.\u00a0Then talk to your doctor about when to take the next\u00a0dose.<\/p>\n\n\n\n Do not stop Xolair treatment unless your doctor tells you to. After stopping or stopping treatment with Xolair, your symptoms may return.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.\u00a0The side effects\u00a0caused by Xolair are generally mild to moderate but can be serious in some cases.<\/p>\n\n\n\n Serious side effects:<\/p>\n\n\n\n Seek immediate medical attention if you notice any signs of the following side effects:<\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n No known frequency (frequency cannot be calculated from available data)<\/p>\n\n\n\n Other side effects are:<\/p>\n\n\n\n Very common (may affect more than 1 in 10 people)<\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n No known frequency (frequency cannot be calculated from available data)<\/p>\n\n\n\n <\/a><\/p>\n\n\n\n Xolair\u00a0solution for injection\u00a0is supplied as a clear to slightly opalescent, colorless to slightly brown-yellow solution in a pre-filled\u00a0syringe.<\/p>\n\n\n\n Xolair 75 mg solution for injection is supplied in packs containing 1 pre-filled syringe and in multipacks containing 4 (4 x 1) or 10 (10 x 1) pre-filled syringes.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/a><\/p>\n\n\n\n Novartis Europharm Limited<\/p>\n\n\n\n Vista Building<\/p>\n\n\n\n Elm Park, Merrion Road<\/p>\n\n\n\n Dublin 4<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you use Xolair<\/h2>\n\n\n\n
Do not use Xolair<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Xolair<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow to use Xolair<\/h2>\n\n\n\n
If you forget a dose of Xolair<\/h2>\n\n\n\n
If you stop using Xolair<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Xolair<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n