\n\n250 micrograms \/ ml, powder and solvent for solution for injection
interferon beta-1b<\/p>\n\n\n\n
What Betaferon is<\/strong> Betaferon is a type of medicine called interferon, which is used to treat multiple sclerosis. Interferons are proteins produced in the body that help fight attacks on the immune system, e.g. viral infections. How Betaferon works<\/strong> 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.<\/p>\n\n\n\n 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<\/em> ). It can cause temporary disabilities, such as difficulty walking. The symptoms may disappear completely or partially.<\/p>\n\n\n\n Interferon beta-1b has been shown to alter the immune system’s response and help reduce disease activity. How Betaferon helps you fight the disease:<\/strong> Isolated clinical events indicating a high risk of developing multiple sclerosis<\/strong>: Betaferon 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. Betaferon 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. Betaferon can reduce the number of attacks and the severity of the attacks, as well as delay the progression of the disability. What Betaferon is used for<\/strong> Betaferon is intended for use in patients<\/strong><\/p>\n\n\n\n Talk to your doctor before using Betaferon: Your doctor also needs to know the following while you are taking Betaferon:<\/strong> Other things to consider when using Betaferon:<\/strong> Injection site reactions<\/strong> During treatment with Betaferon, you are likely to experience reactions at the injection site<\/strong>. Symptoms include redness, swelling, discoloration, inflammation, pain, and hypersensitivity. Degradation of 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<\/em> ), and in rare cases, a skin transplant is required. Healing can take up to 6 months. To reduce the risk of injection site reactions, you should<\/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, which may be associated with swelling or fluid leaking from the injection site:<\/strong> 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. However, there are some data available from the treatment of children and adolescents between 12 and 16 years of age. These data suggest that the safety profile for this age group is similar to the safety profile for adults when Betaferon is given 8.0 million IU under the skin every other day. There is no information on the use of Betaferon in children under 12 years of age. Betaferon should therefore not be used in 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, including medicines obtained without a prescription. No formal interaction studies have been performed to investigate whether Betaferon affects or is affected by other medicines. Using Betaferon with other medicines that affect the immune system is not recommended, except anti-inflammatory medicines called corticosteroids you<\/em> or adrenocorticotropic hormone (ACTH).<\/em> Betaferon should be used with caution along with:<\/p>\n\n\n\n Betaferon is injected under the skin. Therefore, it is not believed that food and drink have any effect on Betaferon.<\/p>\n\n\n\n If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. No harmful effects on the breast-fed infant\/infant are expected. Betaferon can be used during breast-feeding.<\/p>\n\n\n\n Betaferon may 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 The excipients in Betaferon include<\/p>\n\n\n\n If you are allergic ( hypersensitive<\/em> ) to any of the excipients or if you become one during treatment, do not take Betaferon. Betaferon 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. If you are not sure, talk to your doctor, pharmacist, or nurse. The recommended dose is:<\/em><\/strong> Every other day<\/strong> (once every other day), 1.0 ml of the reconstituted Betaferon solution for injection under the skin ( subcutaneously<\/em> ) (see appendix \u201cProcedure for self-injection\u201d in the latter part of this leaflet). 1.0 ml is equivalent to a dose of 250 micrograms (8.0 million IU) of interferon beta-1b. When starting treatment with Betaferon, it is best tolerated by gradually increasing the dose , ie starting with only 0.25 ml of the medicine and then increasing after every third injection to 0.5 ml, 0.75 ml and finally to the full Betaferon dose (1 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. To easily increase the dosage one during the first 12 injections , you can be offered a titration pack<\/strong> containing four different-colored packages with specially marked syringes and with detailed instructions in a separate package leaflet for the introduction of the titration package. Preparation for injection<\/strong> Prior to injection , a ready-to-use Betaferon solution must be prepared<\/strong> from a vial of Betaferon 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. For instructions on how to prepare Betaferon solution for injection, see Appendix “Procedure for self-injection”, Part I. Detailed instructions on how to inject Betaferon yourself under the skin<\/strong> can be found in Part IE of the \u201cSelf-Injection Procedure\u201d appendix. Change the injection site at regular intervals<\/strong>. See section 2 \u201cWarnings and Precautions\u201d and follow the instructions in Part II \u201cSwitching the Injection Site\u201d and Part III \u201cBetaferon Treatment Calendar\u201d in the Annex \u201cProcedure for Self-Injection\u201d. Treatment time<\/strong> It is not known how long Betaferon treatment 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. 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 a forgotten dose.<\/p>\n\n\n\n Discuss with your doctor if you stop or want to stop treatment. Betaferon is not known to cause acute withdrawal symptoms at the end of treatment. Like all medicines, this medicine can cause side effects, although not everybody gets them. Betaferon 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. Side effects are common at the beginning of a treatment, but in general they become less common during treatment. The most common side effects are<\/p>\n\n\n\n To reduce the side effects at the beginning of treatment, your doctor should start giving you a low dose of Betaferon and increase it gradually (see section 3 \u201cHow to use Betaferon\u201d). The following list of adverse reactions is based on reports from clinical trials with Betaferon (list 1) and from reported side effects of the marketed medicinal product (list 2).<\/strong> List 1:<\/em><\/strong> Very common side effects that have occurred in clinical trials with Betaferon (at least 10% of cases) and that were more common than those who received placebo. The table also includes adverse reactions that occurred in less than 10% of cases but was significantly associated with treatment.<\/p>\n\n\n\n In addition, the following side effects have been identified after the launch of the drug. List 2:<\/strong><\/em> Adverse reaction reports for the launched product (spontaneous reports, frequencies are based – if known – on clinical trials ).<\/p>\n\n\n\n
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<\/li>What you need to know before using Betaferon<\/h2>\n\n\n\n
Do not use Betaferon<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/li>Children and young people<\/h2>\n\n\n\n
Other medicines and Betaferon<\/h2>\n\n\n\n
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Pregnancy and breastfeeding<\/h2>\n\n\n\n
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Betaferon contains mannitol, human albumin, and sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Betaferon<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you use more Betaferon than you should<\/h2>\n\n\n\n
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<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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