50 mg\u00a0solution for injection\u00a0in a pre-filled\u00a0pen\u00a0
etanercept (etanerceptum)<\/p>\n\n\n\n
Erelzi is a drug made from two human proteins. It binds to another protein that causes inflammation and blocks its activity. This blockage reduces the inflammation associated with the disease.
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In adults (18 and older) can Erelzi used for moderate or severe rheumatoid arthritis, psoriatic arthritis,<\/strong> severe axial spondyloarthritis<\/strong> including ankylosing spondylitis,<\/strong> and moderate or severe psoriasis –<\/strong> most often used when other widely used treatments have not worked well enough or are not suitable for you. Erelzi is usually used in combination with methotrexate to treat rheumatoid arthritis<\/strong>, but it can also be used as the only medicine if treatment with methotrexate is unsuitable for you. Whether Erelzi is used alone or in combination with methotrexate, Erelzi can slow down the damage to your joints caused by rheumatoid arthritis and improve your ability to perform daily activities. For patients who have multiple joints affected by psoriatic arthritis<\/strong>, Erelzi may increase the ability to perform daily activities. For patients with multiple symmetrical aching or swollen joints (eg hands, ankles, and feet), Erelzi may delay the breakdown of the joint surfaces. Erelzi is also used to treat the following diseases in children and adolescents:<\/p>\n\n\n\n Talk to your doctor before using Erelzi.<\/p>\n\n\n\n Erelzi is not intended for use in children and adolescents weighing less than 62.5 kg.<\/p>\n\n\n\n Erelzi should not normally be used in children younger than 2 years or weighing less than 62.5 kg, with polyarthritis or enlarged oligoarthritis, or in children younger than 12 years, or weighing less than 62.5 kg, with enthesitis-related arthritis or psoriatic arthritis, or in children younger than 6 years, or weighing less than 62.5 kg, with psoriasis.<\/p>\n\n\n\n Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines (including anakinra, abatacept, and sulfasalazine), including over-the-counter medicines. Do not use Erelzi at the same time as medicines containing anakinra or abatacept as an active substance.<\/p>\n\n\n\n Erelzi should only be used during pregnancy if clearly needed. Contact your doctor if you become pregnant, think you may be pregnant, or are planning to have a baby. If you have had Erelzi during pregnancy, your baby may be at greater risk of getting an infection. In one study, more malformations were found when the mother had received etanercept during pregnancy, compared with mothers who had not received etanercept or other similar drugs ( TNF – antagonist), but no specific type of malformation was reported. Another study again found an increased risk of malformations when the mother had received etanercept during pregnancy. Your doctor will help you decide if the benefits of treatment outweigh the potential risk to your child. You must tell the infant’s doctor or another healthcare professional that Erelzi has been used during pregnancy before the infant receives any vaccination (for more information, see section 2, \u201cVaccinations\u201d). You should not breast-feed while using Erelzi as Erelzi will pass into breast milk.<\/p>\n\n\n\n The use of Erelzi is not expected to affect your ability to drive or use machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per 50 mg, ie essentially ‘sodium-free’.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. If you have the impression that the effect of Erelzi is too strong or too weak, talk to your doctor or pharmacist. You have been prescribed Erelzi in a strength of 50 mg. Erelzi is available in 25 mg strengths for doses of 25 mg. Use in adult patients (over 18 years of age)<\/strong> Rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis including ankylosing spondylitis<\/em> The recommended dose is 25 mg twice a week or 50 mg once a week as an injection under the skin. Your doctor may determine a different frequency for your injections. Plaque psoriasis<\/em> The recommended dose is 25 mg given twice a week or 50 mg given once a week. Alternatively, 50 mg can be given twice a week for up to 12 weeks followed by 25 mg twice a week or 50 mg once a week. Your doctor will decide how long you should use Erelzi and if the resumption of treatment is needed based on the treatment results. If Erelzi has not had any effect on your condition after 12 weeks, your doctor may ask you to stop treatment. Use for children and adolescents<\/strong><\/p>\n\n\n\n The appropriate dose and how often it should be given to your child or adolescent depends on body weight and illness. The doctor determines the correct dose for the child and prescribes etanercept with appropriate strength. Pediatric patients weighing 62.5 kg or more may be given 25 mg twice a week or 50 mg once a week with a fixed-dose in a pre-filled syringe or pre-filled pen. Other etanercept preparations with suitable dosage forms for children are available. For patients from 2 years of age weighing 62.5 kg or more, with polyarthritis or enlarged oligoarthritis, or for patients from 12 years of age weighing 62.5 kg or more, with enthesitis-related arthritis or psoriatic arthritis, the usual dose is one 25 mg twice a week or 50 mg once a week. For patients from 6 years of age with psoriasis weighing 62.5 kg or more, the usual dose is 50 mg once a week. If Erelzi does not show any effect after 12 weeks, your doctor may ask you to stop treatment with this medicine. Your doctor will provide you with detailed instructions for preparing and measuring the correct dose. Method and route of delivery<\/strong> Erelzi is injected under the skin (via subcutaneous injection ). Erelzi can be taken with or without food or drink. Detailed instructions on how to inject Erelzi can be found in section 7 \u201cInstructions for using the Erelzi SensoReady pen\u201d.<\/strong> Do not mix the Erelzi solution with any other medicine. To make it easier for you to remember, it can be helpful to write in a calendar which days of the week Erelzi should be taken.<\/p>\n\n\n\n If you have injected more Erelzi than your doctor prescribed (either by injecting too much at one time or taking one dose too much) you should contact your doctor or pharmacist immediately. Always carry the labeled outer packaging of the medicine, even if it is empty. If you miss a dose, you should inject one as soon as you remember, unless the next scheduled dose is to be taken the next day, then skip the missed dose. Then continue to inject the medicine on the usual scheduled day. If you do not remember a dose until the day of the usual injection, do not take a double dose (two doses on the same day) to make up for a forgotten dose. Your symptoms may return if treatment is stopped.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist. Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions<\/strong> If any of the following symptoms occur, do not inject more Erelzi without contacting your or your child’s doctor or the emergency department at the nearest hospital.<\/strong><\/p>\n\n\n\n Severe allergic reactions are rare, but one or more of the above symptoms may indicate an allergic reaction caused by Erelzi and medical attention should be sought immediately. Serious side effects are<\/strong> If you or your child observes any of the following symptoms, seek medical attention immediately.<\/p>\n\n\n\n These are rare or unusual side effects, but serious (some of them can be fatal). If these signs occur, contact your or your child’s physician or the emergency department of the nearest hospital immediately. Known side effects of Erelzi are as follows, divided into groups according to decreasing frequency:<\/p>\n\n\n\n Side effects and frequency of side effects in children and adolescents are the same as in adults, see the description above. 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 and label it on the pre-filled SensoReady pen after EXP. The expiration date is the last day of the specified month. Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Do not freeze. Store the pre-filled pens in the outer carton. Sensitive to light. After removing Erelzi from the refrigerator, wait approximately 15-30 minutes for the Erelzi solution in the pen to reach room temperature<\/strong>. Do not heat Erelzi in any other way. Thereafter, immediate use is recommended. Erelzi can be stored outside the refrigerator at temperatures up to a maximum of 25 \u00b0 C for a single period of up to four weeks, after which it should not be stored in the refrigerator again. Erelzi should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date that Erelzi is removed from the refrigerator and the date when Erelzi is to be discarded (no longer than 4 weeks after removal from the refrigerator). Inspect the solution in the pen through the clear window. The solution should be clear or slightly opalescent, colorless to slightly yellowish, and may contain small white or almost transparent particles of protein. This appearance is normal for Erelzi. Do not use the solution if it is discolored, cloudy or if particles other than those described above occur. If you have any further questions on the use of this solution, ask your pharmacist for help. 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 active substance is etanercept.<\/p>\n\n\n\n Each pre-filled pen contains 50 mg etanercept. The other ingredients are anhydrous citric acid, sodium citrate dihydrate, sodium chloride, sucrose, L-lysine hydrochloride, sodium hydroxide, hydrochloric acid, and water for injections.<\/p>\n\n\n\n Erelzi was delivered as an injection solution in a pre-filled pen (SensoReady). The SensoReady pen contains a clear or slightly opalescent, colorless to slightly yellowish solution for injection ( injection ). Each pack contains 1, 2, or 4 pens, multi-pack contains 12 (3 packs of 4) pre-filled pens. Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/p>\n\n\n\n Sandoz GmbH<\/p>\n\n\n\n Biochemistry. 10<\/p>\n\n\n\n A \u2011 6250 Kundl<\/p>\n\n\n\n Austria Manufacturer<\/strong><\/p>\n\n\n\n Sandoz GmbH Schaftenau<\/p>\n\n\n\n Biochemiestr. 10<\/p>\n\n\n\n A \u2011 6336 Langkampfen<\/p>\n\n\n\n Austria Erelzi is a drug made from two human proteins. It binds to another protein that causes inflammation and blocks its activity. This blockage reduces the inflammation associated with the disease.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2205,2200],"tags":[3944,3946,3941,3943,2215,2213,3945,3942],"class_list":["post-8289","post","type-post","status-publish","format-standard","hentry","category-e","category-medicines","tag-erelzi","tag-erelzi-side-effects","tag-etanercept","tag-etanercept-side-effects","tag-injection","tag-medicines","tag-what-is-erelzi","tag-what-is-etanercept"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8289","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=8289"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8289\/revisions"}],"predecessor-version":[{"id":10437,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/8289\/revisions\/10437"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=8289"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=8289"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=8289"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/p>\n\n\n\n2. What you need to know before using Erelzi<\/h2>\n\n\n\n
Do not use Erelzi<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Erelzi<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Erelzi contains sodium<\/h2>\n\n\n\n
3. How to use Erelzi<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you take more Erelzi than you should<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you forget to take Erelzi<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you stop using Erelzi<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/p>\n\n\n\nAdditional side effects in children and adolescents<\/h2>\n\n\n\n
<\/p>\n\n\n\n5. How to store Erelzi<\/h2>\n\n\n\n
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<\/p>\n\n\n\n6. Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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