250 micrograms\/ml powder and solvent for injection, solution
interferon beta-1b<\/p>\n\n\n\n
What Extavia is<\/strong><\/p>\n\n\n\n Extavia is a type of medicine called interferon Interferons are proteins produced in the body that help fight attacks on the immune system, e.g. viral infections. How Extavia works<\/strong><\/p>\n\n\n\n Multiple sclerosis (MS)<\/strong> is a long-term condition that affects the central nervous system ( CNS ), especially the function of the brain and spinal cord. In MS, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS and prevents the nerves from functioning properly. This is called demyelination. The exact cause of MS is unknown. It is believed that an abnormal reaction in the body’s immune system plays an important role in the CNS- damaging process. CNS damage<\/strong> can occur in an MS attack ( relapse ). It can cause temporary disabilities, such as difficulty walking. The symptoms may disappear completely or partially. Interferon beta-1b has been shown to alter the immune system’s response and help reduce disease activity. How Extavia helps you fight the disease:<\/strong><\/p>\n\n\n\n Isolated clinical events indicating a high risk of developing multiple sclerosis<\/strong>: Extavia has been shown to delay the development of definitive multiple sclerosis. Relapsing multiple sclerosis<\/strong>: People with relapsing-remitting MS have sporadic attacks or relapses during which the symptoms become noticeably worse. Extavia has been shown to reduce the number of attacks and make them less serious. It reduces the number of hospital stays due to the disease and prolongs the time without relapse. Secondary progressive multiple sclerosis<\/strong>: In some cases, people with relapsing-remitting MS notice that their symptoms worsen and that they develop another form of MS called secondary progressive MS. With this, they notice that they are getting worse, regardless of whether they get a relapse or not. Extavia can reduce the number of attacks and the severity of the attacks, as well as delay the progression of the disability. What Extavia is used for<\/strong><\/p>\n\n\n\n Extavia is for use in patients<\/strong><\/p>\n\n\n\n Talk to your doctor before using Extavia:<\/p>\n\n\n\n Your doctor also needs to know the following while you are using Extavia <\/strong>:<\/strong><\/p>\n\n\n\n Other things to consider when using Extavia:<\/strong><\/p>\n\n\n\n Injection site reactions<\/strong><\/p>\n\n\n\n During treatment with Extavia, you are likely to experience reactions at the injection site. <\/strong>Symptoms include redness, swelling, discoloration, inflammation, pain, and hypersensitivity. Skin and tissue damage ( necrosis ) around the injection site is not as common. Over time, the reactions at the injection site tend to become less common. Skin and tissue degradation at the injection site may cause scarring. If this is severe, a doctor may need to remove foreign matter and dead tissue (debridement), and in rare cases, skin grafts are required. Healing can take up to 6 months. To reduce the risk of injection site reactions, you should <\/strong>:<\/strong><\/p>\n\n\n\n The use of an auto-injector may reduce the frequency of injection site reactions. Your doctor or nurse can tell you more about this. If you get stretch marks in the skin, associated with swelling or fluid leaking from the injection site <\/strong>:<\/strong><\/p>\n\n\n\n Your doctor will regularly check your injection technique,<\/strong> especially if you get reactions at the injection site.<\/p>\n\n\n\n No formal clinical trials have been performed in children or adolescents.<\/p>\n\n\n\n However, there are data from the treatment of adolescents between 12 and 17 years of age, which indicate that the safety of Extavia for this group is similar to that for adults. Extavia should not be used in children under 12 years of age, as no information is available for this age group.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. No formal interaction studies have been performed to investigate whether Extavia affects or is affected by other medicines. The use of Extavia in combination with other medicines that affect the immune system is not recommended, except for anti-inflammatory medicines called corticosteroids or adrenocorticotropic hormone (ACTH). Extavia should be used with caution along with:<\/p>\n\n\n\n Extavia is injected under the skin. Therefore, it is not believed that food and drink have any effect on Extavia.<\/p>\n\n\n\n If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. No adverse effects on the breastfed newborn\/infant are expected. Extavia can be used during breast-feeding.<\/p>\n\n\n\n Extavia can cause side effects in the central nervous system (see section 4 \u201cPossible side effects\u201d). If you are particularly sensitive, this may affect your ability to drive or use machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per ml, ie essentially ‘sodium-free’. Extavia treatment should always be started under the supervision of a doctor who has experience in the treatment of multiple sclerosis. Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The recommended dose is to<\/strong> inject 1.0 ml of the reconstituted Extavia solution for injection under the skin ( subcutaneously ) every other day<\/strong> (once every other day) (see appendix \u201cSelf-injection procedure\u201d in the second part of this leaflet). 1.0 ml is equivalent to a dose of 250 micrograms (8.0 million IU) of interferon beta-1b. Generally, treatment should be started with a low dose of 0.25 <\/strong>ml<\/strong> (62.5 micrograms). Dose one will then be gradually increased to a full dose of 1.0 ml (250 micrograms).<\/p>\n\n\n\n Dose one should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml). Your doctor may decide with you to change the time intervals for dose escalation depending on the side effects you may experience at the beginning of treatment. Your doctor will decide this in consultation with you. Preparation for injection<\/strong><\/p>\n\n\n\n Before injection, a ready-to-use Extavia solution must be prepared<\/strong> from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled syringe of diluent. Either your doctor or nurse does it or you do it yourself after you have first received careful instructions and practiced. Detailed instructions on how to inject Extavia under the skin<\/strong> can be found in the appendix at the end of this leaflet. These instructions also tell you how to prepare the Extavia solution for injection. Change the injection site at regular intervals<\/strong>. See section 2 \u201cWarnings and Precautions\u201d and follow the instructions under \u201cSwitching the Injection Site\u201d in the appendix at the end of this leaflet. Length of treatment<\/strong><\/p>\n\n\n\n It is not known how long treatment with Extavia should last. Your doctor will decide with you how long the treatment should last.<\/strong><\/p>\n\n\n\n No life-threatening symptoms occurred even when a dose was given that was many times higher than that recommended for the treatment of MS.<\/p>\n\n\n\n If you forget to give yourself an injection at the right time, do so as soon as you can. The next injection should be taken 48 hours later. Do not inject a double dose to make up for the forgotten dose.<\/p>\n\n\n\n Discuss with your doctor if you stop or want to stop treatment. Extavia is not known to cause acute withdrawal symptoms at the end of treatment.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Extavia can cause serious side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Side effects are common at the beginning of treatment, but generally, they decrease during the course of treatment. The most common side effects are:<\/p>\n\n\n\n To reduce the risk of side effects at the beginning of treatment, your doctor should start giving you a low dose of Extavia and increase it gradually (see section 3, \u201cHow to use Extavia\u201d). The following list of adverse reactions is based on reports from clinical trials with Extavia (List 1) and reported side effects of the marketed medicine (List 2).<\/strong> List 1:<\/strong> Very common side effects that have occurred in clinical trials with Extavia (may affect more than 1 in 10 people) and that were more common than those who received placebo. The list also includes side effects that have occurred as usual (may affect up to 1 in 10 people) but that was significantly related to treatment.<\/p>\n\n\n\n Also, the following side effects have been identified during post-authorization use. List 2: <\/strong>Adverse reactions reported for the marketed medicinal product (frequencies (if known) based on clinical trials ):<\/p>\n\n\n\n Side effects that occur only during the sales period <\/strong>:<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month. Do not store above 25 \u00b0 C. Do not freeze. You should use the solution immediately after reconstitution. If you can not do it, it is useful for 3 hours if stored in a refrigerator 2 \u00b0 C – 8 \u00b0 C. Do not use this medicine if it contains particles or is discolored. 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.<\/p>\n\n\n\n The cover on top of the pre-filled syringe contains a derivative of natural rubber latex. Therefore, the protection may contain natural rubber latex.<\/p>\n\n\n\n Extavia consists of a powder and diluent for solution for injection. The powder is white to off-white in color.<\/p>\n\n\n\n The Extavia powder is supplied in a 3-milliliter vial.<\/p>\n\n\n\n The diluent is a clear\/colorless solution.<\/p>\n\n\n\n The diluent for Extavia is supplied in a 2.25 ml pre-filled syringe and contains 1.2 ml of sodium chloride 5.4 mg \/ ml (0.54% w \/ v solution for solution). Extavia is available in pack sizes:<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/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 Ireland Manufacturer<\/strong><\/p>\n\n\n\n Novartis Pharma GmbH<\/p>\n\n\n\n Roonstrasse 25<\/p>\n\n\n\n D-90429 Nuremberg<\/p>\n\n\n\n Germany Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before using Extavia<\/h2>\n\n\n\n
Do not use Extavia<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
<\/li>
If you have ever had a seizure or if you are taking medicines to treat epilepsy <\/strong>( antiepileptic drugs ). Your doctor will then monitor your treatment closely (see also section \u201cOther medicines and Extavia\u201d and section 4 \u201cPossible side effects\u201d).
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/li>
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/li>
<\/strong><\/li>Children and young people<\/h2>\n\n\n\n
Other medicines and Extavia<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nExtavia with food and drink<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Extavia contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Extavia<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nIf you use more Extavia than you should<\/h2>\n\n\n\n
If you forget to use Extavia<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you stop using Extavia<\/h2>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/strong><\/li><\/ul>\n\n\n\n
<\/strong>
<\/p>\n\n\n\n
<\/li>
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n5. How to store Extavia<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorisation Holder<\/h2>\n\n\n\n
<\/p>\n\n\n\n
<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td> Lithuania<\/strong>SIA Novartis Baltics Lithuanian branchesTel: +370 5 269 16 50<\/td><\/tr> Bulgaria<\/strong>Novartis Bulgaria EOODTel .: +359 2 489 98 28<\/td> Luxembourg \/ Luxemburg<\/strong>Novartis Pharma NVTel: +32 2 246 16 11<\/td><\/tr> Czech Republic<\/strong>Novartis sroTel: +420 225 775 111<\/td> Hungary<\/strong>Novartis Hungary Kft.Tel .: +36 1 457 65 00<\/td><\/tr> Denmark<\/strong>Novartis Healthcare A \/ STel: +45 39 16 84 00<\/td> Malta<\/strong>Novartis Pharma Services Inc.Tel: +356 2122 2872<\/td><\/tr> Germany<\/strong>Novartis Pharma GmbHTel: +49 911 273 0<\/td> The Netherlands<\/strong>Novartis Pharma BVTel: +31 88 04 52 111<\/td><\/tr> Eesti<\/strong>SIA Novartis Baltics Eesti subsidiaryTel: +372 66 30 810<\/td> Norway<\/strong>Novartis Norge ASTel: +47 23 05 20 00<\/td><\/tr> Greece<\/strong>Novartis (Hellas) AEBE:\u0397\u03bb: +30 210 281 17 12<\/td> Austria<\/strong>Novartis Pharma GmbHTel: +43 1 86 6570<\/td><\/tr> Spain<\/strong>Novartis Pharmac\u00e9utica, SATel: +34 93 306 42 00<\/td> Poland<\/strong>Novartis Poland Sp. z ooTel .: +48 22 375 4888<\/td><\/tr> France<\/strong>Novartis Pharma SASTel: +33 1 55 47 66 00<\/td> Portugal<\/strong>Novartis Farma – Pharmaceutical Products, SATel: +351 21 000 8600<\/td><\/tr>