\n\n50 mg solution for injection in pre-filled pen
etanercept<\/p>\n\n\n\n
Benepali contains the active substance etanercept.
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Benepali 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 years and older) Benepali can be used for:<\/p>\n\n\n\n
Benepali is most often used when other commonly used treatments have not worked well enough or are unsuitable for you.
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Benepali 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 Benepali is used as a single drug or in combination with methotrexate, Benepali 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, Benepali can increase the ability to perform daily activities. For patients with multiple symmetrical aching or swollen joints<\/strong> (eg hands, ankles, and feet), Benepali may delay the breakdown of joint surfaces. Benepali is also used to treat the following diseases in children and adolescents: Talk to your doctor before using Benepali. Benepali is not intended for children and adolescents weighing less than 62.5 kg. Benepali should not normally be used in children under 2 years of age or weighing less than 62.5 kg with polyarthritis or extended oligoarthritis, or in children under 12 years of age or weighing less than 62.5 kg with enthesitis-related arthritis or psoriatic arthritis, or for children under 6 years of age 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 sulfasalazine). You or your child should not use<\/strong> Benepali with other medicines that contain the active substances anakinra or abatacept.<\/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. Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during treatment with Benepali and for three weeks after stopping treatment. Benepali should only be used during pregnancy if absolutely necessary. If you have had Benepali during pregnancy, your baby may be at greater risk of getting an infection. One study also found more malformations when the mother had received etanercept during pregnancy, compared with mothers who had not received etanercept or other similar drugs ( TNF – antagonistic), but no specific type of malformation was reported. Another study did not show an increased risk of malformations when the mother received etanercept during pregnancy. Your doctor will help you determine if the benefits of the treatment outweigh the potential risk to your child. It is important that you tell your baby’s doctor or another healthcare professional if Benepali has been used during pregnancy before vaccinating your baby (for more information, see section 2, \u201cVaccinations\u201d). You should not breast-feed while using Benepali as Benepali passes into breast milk.<\/p>\n\n\n\n There is no information that the use of Benepali affects the ability to drive or use machines.<\/p>\n\n\n\n Benepali contains less than 1 mmol sodium (23 mg), ie essentially ‘sodium-free’. 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 Benepali is too strong or too weak, talk to your doctor or pharmacist. Use in adult patients (over 18 years of age)<\/strong><\/p>\n\n\n\n Rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis including ankylosing spondylitis<\/em><\/strong><\/p>\n\n\n\n The recommended dose is 50 mg once a week in the form of an injection under the skin.<\/p>\n\n\n\n Your doctor may decide on a different frequency for injecting Benepali. Plaque psoriasis<\/em><\/strong><\/p>\n\n\n\n The recommended dose is 50 mg given once a week. Alternatively, 50 mg can be given twice a week for up to 12 weeks followed by 50 mg once a week. Your doctor will decide how long you should use Benepali and if resuming treatment is needed based on the treatment results. If Benepali 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 Dose one and how often it should be given to the 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 pre-filled syringe or pre-filled pen at a set dose. There are other medicines with etanercept in suitable dosage form available for children. For patients from 2 years of age and weighing 62.5 kg or more with polyarthritis or extended oligoarthritis, or for patients from 12 years of age and weighing 62.5 kg or more with encephalitis-related arthritis or psoriatic arthritis, the usual dose is 25 mg twice a week or 50 mg once a week. For patients from 6 years of age who weigh 62.5 kg or more with psoriasis, the usual dose is 50 mg given once a week. If Benepali 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 the preparation and measurement of the correct dose. Method and route of delivery<\/strong><\/p>\n\n\n\n Benepali is injected under the skin ( subcutaneous use). Detailed instructions on how to inject Benepali can be found in section 7 “Instructions for use”. <\/strong>Do not mix the Benepali 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 Benepali should be taken. If you have injected more Benepali than your doctor has prescribed (either by injecting too much at one time or taking one dose too much) you should contact either your doctor or pharmacist immediately<\/strong>. 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. If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions<\/strong><\/p>\n\n\n\n If any of the following symptoms occur, do not inject Benepali anymore<\/b>, but contact your doctor immediately or the emergency department at the nearest hospital<\/strong>. Severe allergic reactions are rare, but one or more of the above symptoms may indicate an allergic reaction caused by Benepali and medical attention should be sought immediately. Serious side effects are<\/strong><\/p>\n\n\n\n If you or your child observes any of the following symptoms, seek medical attention immediately. These are rare or uncommon side effects, but serious (some of them can be fatal). If any of the above occur, contact your doctor or emergency department immediately at the nearest hospital. Other side effects ar<\/em><\/p>\n\n\n\n Known side effects of Benepali are as follows, divided into groups according to decreasing frequency: The side effects and their frequencies in children and adolescents are the same as in adults, see the description above.<\/p>\n\n\n\n <\/p>\n\n\n\n Reporting of side effects<\/em><\/p>\n\n\n\n If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. <\/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 and label on the pre-filled pen after EXP. The expiration date is the last day of the specified month. Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C). Do not freeze. Store the pre-filled pens in the outer carton. Sensitive to light. After removing Benepali from the refrigerator, wait approximately 30 minutes for the Benepali solution in the pen to reach room temperature<\/strong>.<\/p>\n\n\n\n Do not heat Benepali in any other way. Thereafter, immediate use is recommended. Benepali 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. Benepali should be discarded if not used within four weeks of removal from the refrigerator. It is recommended that you note the date Benepali is removed from the refrigerator and the date Benepali is to be discarded (no longer than 4 weeks after removal from the refrigerator). Inspect the solution in the pen by looking through the transparent inspection window. It should be clear or slightly opalescent, colorless or pale yellow, and may contain small white or almost transparent particles of protein. This appearance is normal for Benepali. Do not use this medicine if you notice that the solution 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 Benepali is supplied in a pre-filled pen. The pen contains a clear to slightly opalescent, colorless, or pale yellow solution for injection ( injection ). Benepali is available in packs containing 4 pre-filled pens and in multipacks containing 3 cartons, each containing 4 pre-filled pens. Not all pack sizes may be marketed.<\/p>\n\n\n\n Samsung Bioepis NL BV<\/p>\n\n\n\n Olof Palmestraat 10<\/p>\n\n\n\n 2616 LR Delft<\/p>\n\n\n\n The Netherlands Manufacturer<\/strong><\/p>\n\n\n\n Biogen (Denmark) Manufacturing ApS<\/p>\n\n\n\n Biogen All\u00e9 1<\/p>\n\n\n\n 3400 Hiller\u00f8d<\/p>\n\n\n\n Denmark Samsung Bioepis NL BV<\/p>\n\n\n\n Olof Palmestraat 10<\/p>\n\n\n\n 2616 LR Delft<\/p>\n\n\n\n Netherlands Contact the representative of the marketing authorization holder to find out more about this medicine: Benepali 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":[2202,2200],"tags":[9120,9124,9122,3941,4256,9119,9123,9118,9121,3942],"class_list":["post-5962","post","type-post","status-publish","format-standard","hentry","category-b","category-medicines","tag-benepali","tag-benepali-injection","tag-benepali-side-effects","tag-etanercept","tag-etanercept-injection","tag-side-effects-of-etanercept","tag-what-benepali-is-used-for","tag-what-etanercept-is-used-for","tag-what-is-benepali","tag-what-is-etanercept"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5962","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=5962"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5962\/revisions"}],"predecessor-version":[{"id":12104,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5962\/revisions\/12104"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5962"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5962"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5962"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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<\/li>2. What you need to know before using Benepali<\/h2>\n\n\n\n
Do not use Benepali<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Benepali contains sodium<\/h2>\n\n\n\n
<\/p>\n\n\n\n3. How to use Benepali<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you have used too much Benepali<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you forget to use Benepali<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you stop using Benepali<\/h2>\n\n\n\n
<\/p>\n\n\n\n4. Possible side effects<\/h2>\n\n\n\n
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<\/li>Side effects in children and adolescents<\/h2>\n\n\n\n
5. How to store Benepali<\/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
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
<\/p>\n\n\n\nMarketing Authorisation Holder<\/h2>\n\n\n\n
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