\n\n40mg \/ 0.8 ml solution for injection
adalimumab\n\n<\/p>\n\n\n\n
Amsparity contains the active substance adalimumab, a medicine that affects the body’s immune system (immune system).
<\/p>\n\n\n\n
Amsparity is intended for the treatment of the following inflammatory diseases:<\/p>\n\n\n\n
The active substance in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.<\/p>\n\n\n\n
The target of adalimumab is a protein called tumor necrosis factor (TNF\u03b1), which is involved in the immune system and is found in elevated levels in the inflammatory diseases listed above. By binding to TNF\u03b1, Amsparity blocks its action and reduces inflammation in these diseases.<\/p>\n\n\n\n
Polyarticular juvenile idiopathic arthritis<\/em><\/p>\n\n\n\n Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that often first occurs in childhood. Amsparity is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents 2\u221217 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work enough, your child will be given Amsparity to treat polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.<\/p>\n\n\n\n Enthesitis-related arthritis in children and adolescents<\/em><\/p>\n\n\n\n Pediatric arthritis-related arthritis is an inflammatory disease of the joints and tendon attachments.<\/p>\n\n\n\n Amsparity is used to treat arthritis-related arthritis in children and adolescents 6\u221217 years of age. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat arthritis-related arthritis.<\/p>\n\n\n\n Plaque psoriasis in children and adolescents<\/em><\/p>\n\n\n\n Plaque psoriasis is a disease that causes red, flaky, and dry plaques on the skin covered by silvery scales. Plaque psoriasis can also involve the nails, which can then crumble, become thicker and lift from the nail bed, which can be painful. Psoriasis is thought to be caused by a disorder in the body’s immune system that leads to increased production of skin cells.<\/p>\n\n\n\n Amsparity is used to treat severe plaque psoriasis in children and adolescents 4\u221217 years of age where local treatment and light therapy have not worked or are not appropriate. Hidradenitis suppurativa in adolescents<\/em><\/p>\n\n\n\n Hidradenitis suppurativa (sometimes called acne inversa) is a long-lasting and often painful inflammatory skin disease. The symptoms can be sore nodules ( lumps ) and abscesses (boils) that can leak anywhere. The disease usually affects specific areas of the skin, e.g. under the breasts, armpits, inside of the thighs, groin, and buttocks. Scarring can also occur in the affected areas.<\/p>\n\n\n\n Amsparity is used to treat hidradenitis suppurativa in adolescents from 12 years of age. Amsparity can reduce the number of lumps and boils that your child has as well as the pain that is often associated with the disease. Your child may be given other medicines first. If these medicines do not have the desired effect, your child will receive Amsparity.<\/p>\n\n\n\n Crohn’s disease in children and adolescents<\/em><\/p>\n\n\n\n Crohn’s disease is an inflammatory bowel disease. Amsparity is used to treat Crohn’s disease in children and adolescents aged 6\u221217 years.<\/p>\n\n\n\n If your child has Crohn’s disease, they will first be given other medicines. If these drugs do not help enough, your child will be given Amsparity to reduce the signs and symptoms of Crohn’s disease.<\/p>\n\n\n\n Uveitis in children and adolescents<\/em><\/p>\n\n\n\n Non- infectious uveitis (non-infectious uveitis ) is an inflammatory disease that affects certain parts of the eye. Inflammation can lead to impaired vision and\/or the presence of floaters in the eye (black dots or striped lines moving across the field of vision ). Amsparity works by reducing this inflammation.<\/p>\n\n\n\n Amsparity is used to treat children and adolescents from the age of 2 with chronic non- infectious uveitis where inflammation affects the front of the eye.<\/p>\n\n\n\n Your child may be given other medicines first. If these drugs do not work enough, your child will be given Amsparity to reduce the signs and symptoms of the disease. Talk to your child’s doctor or pharmacist before using Amsparity. It is important that you and your child’s doctor document the name and batch number of your child’s medicine. Allergic reactions<\/em><\/p>\n\n\n\n Infection is<\/em><\/p>\n\n\n\n Tuberculosis<\/em><\/p>\n\n\n\n Infection during travel \/ recurrent infection<\/em><\/p>\n\n\n\n Hepatitis B<\/em><\/p>\n\n\n\n Operations and dental procedures<\/em><\/p>\n\n\n\n Demyelinating disease<\/em><\/p>\n\n\n\n Vaccination<\/em><\/p>\n\n\n\n Heart failure<\/em><\/p>\n\n\n\n Fever, bruising, bleeding, or pallor<\/em><\/p>\n\n\n\n Cancer<\/em><\/p>\n\n\n\n Autoimmune diseases<\/em><\/p>\n\n\n\n Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines. Amsparity can be taken with methotrexate or certain disease-modifying anti-rheumatic drugs (sulfasalazine, hydroxychloroquine, leflunomide, and gold preparations for injection ), steroids, or painkillers, including non-steroidal anti-inflammatory drugs ( NSAIDs ).<\/p>\n\n\n\n Your child should not use Amsparity with medicines containing the active substances anakinra or abatacept due to the increased risk of serious infections. Co-administration of adalimumab, or other TNF – antagonists, with anakinra or abatacept, is not recommended based on the potential increased risk of infection, including serious infections and other potential pharmacological interactions. If you have any further questions, ask your child’s doctor.<\/p>\n\n\n\n Your child should consider using adequate contraception to prevent becoming pregnant and continue to use it for at least 5 months after the last treatment with Amsparity.<\/p>\n\n\n\n If your child is pregnant, thinks she may be pregnant, or is planning to have a baby, talk to her doctor before using this medicine.<\/p>\n\n\n\n Amsparity should only be used during pregnancy if needed.<\/p>\n\n\n\n According to a pregnancy study, there was no increased risk of birth defects when the mother had received adalimumab during pregnancy compared to mothers with the same disease who had not used adalimumab.<\/p>\n\n\n\n Amsparity can be used during breastfeeding. If your baby gets Amsparity during her pregnancy, her newborn baby may be at increased risk of getting an infection. It is important that you tell your pediatrician and other healthcare professionals that she used Amsparity during her pregnancy before the newborn baby is vaccinated. For more information on vaccines, see the section “Warnings and precautions”.<\/p>\n\n\n\n Amsparity may have a small effect on your child’s ability to drive, cycle, or use machines. A feeling that the room is spinning (dizziness) and visual disturbances can occur when Amsparity is used.<\/p>\n\n\n\n This medicine contains less than 1 mmol sodium (23 mg) per 0,8 ml dose, it is essential ‘sodium-free’.<\/p>\n\n\n\n Always use this medicine exactly as your doctor, nurse or pharmacist has told you. If you are not sure, talk to your child’s doctor, nurse, or pharmacist. The child’s doctor may prescribe a different strength of Amsparity if the child needs a different dosage. Amsparity is injected under the skin ( subcutaneous use). Children and adolescents with polyarticular juvenile idiopathic arthritis<\/em><\/p>\n\n\n\n Children and adolescents from 2 years of age weighing from 10 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is 20 mg every two weeks. Children and adolescents from 2 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is 40 mg every two weeks. Children and adolescents with arthritis-related arthritis<\/em><\/p>\n\n\n\n Children and adolescents from 6 years of age weighing from 15 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is 20 mg every two weeks. Children and adolescents from 6 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is 40 mg every two weeks. Children and adolescents with psoriasis<\/em><\/p>\n\n\n\n Children and adolescents 4 <\/em>\u221217 years weighing from 15 kg up to 30 kg<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is a starting dose of 20 mg, followed by 20 mg a week later. Thereafter, the usual dose is 20 mg every two weeks. Children and adolescents 4 <\/em>\u221217 years weighing 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of Amsparity is a starting dose of 40 mg, followed by 40 mg one week later. Thereafter, the usual dose is 40 mg every two weeks. Adolescents with hidradenitis suppurativa 12\u221217 years who weigh 30 kg or more<\/em><\/p>\n\n\n\n The recommended dose of one of Amsparity is a starting dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg every other week starting one week<\/p>\n\n\n\n later. If this dose does not give the desired effect, your doctor may increase the dose to 40 mg every week or 80 mg every two weeks.<\/p>\n\n\n\n It is recommended that a bactericidal solution be used daily on the affected areas. Children and adolescents with Crohn’s disease <\/em><\/p>\n\n\n\n Children and adolescents 6 <\/em>\u221217 years weighing less than 40 kg<\/em><\/p>\n\n\n\n The usual dose is 40 mg initially followed by 20 mg two weeks later. If a faster response is required, your child’s doctor may prescribe an initial dose of 80 mg (as two 40 mg injections on the same day) followed by 40 mg two weeks later. Thereafter, the usual dose is 20 mg every two weeks. If this dose does not give the desired effect, your child’s doctor may increase the dose by one to 20 mg every week. Children and adolescents 6<\/em> – 17 years weighing 40 kg or more<\/em><\/p>\n\n\n\n The usual dose is 80 mg (as two 40 mg injections on the same day) initially followed by 40 mg two weeks later. If a faster response is required, your child’s doctor may prescribe a starting dose of 160 mg (as four 40 mg injections on the same day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections you on the same day) two weeks later. Thereafter, the usual dose is 40 mg every two weeks. If this dose does not give the desired effect, your child’s doctor may increase the dose one to 40 mg every week or 80 mg every two weeks. Children and adolescents from 2 years of age with chronic non-infectious uveitis<\/em><\/p>\n\n\n\n Children and adolescents from 2 years of age weighing less than 30 kg<\/em><\/p>\n\n\n\n The usual dose of Amsparity is 20 mg every two weeks with methotrexate. Your child’s doctor may also prescribe a starting dose of 40 mg given one week before starting the usual dose.<\/p>\n\n\n\n Children and adolescents from 2 years of age weighing 30 kg or more<\/em><\/p>\n\n\n\n The usual dose of Amsparity is 40 mg every two weeks with methotrexate.<\/p>\n\n\n\n Your child’s doctor may also prescribe an initial dose of 80 mg given one week before starting the usual dose.<\/p>\n\n\n\n Amsparity is given as an injection under the skin (via subcutaneous injection ). Detailed instructions for injecting Amsparity can be found in the “Instructions for Use” section.<\/strong> If you accidentally inject your child with a larger amount of Amsparity solution or if you inject Amsparity more often than your doctor has prescribed, call your doctor or pharmacist and tell them that your child has been given too much of the medicine. Always carry the outer carton or vial with you, even if it is empty. If you have given too little Amsparity<\/strong><\/p>\n\n\n\n If you accidentally inject your child with a small amount of Amsparity solution or if you inject your child with Amsparity less often than your doctor has prescribed, call your doctor or pharmacist and tell them that your child has been given too little of the medicine. Always carry the outer carton or vial with you, even if it is empty.<\/p>\n\n\n\n If you forget to give your child an injection of Amsparity, give the next dose of Amsparity as soon as you remember. Then give your child the next dose on the day you would have given it if you had not forgotten a dose.<\/p>\n\n\n\n The decision to stop using Amsparity should be discussed with your child’s doctor. Your child’s symptoms may return when treatment is stopped. If you have any further questions on the use of this product, ask your child’s doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects can occur up to at least 4 months after the last Amsparity injection.<\/p>\n\n\n\n Seek medical attention immediately<\/strong> if any of the following symptoms occur:<\/p>\n\n\n\n Tell your child’s doctor as soon as possible<\/strong> if you notice any of the following:<\/p>\n\n\n\n The signs and symptoms described above may represent the side effects described below, which have been observed with the use of adalimumab: Very common<\/strong> (may affect more than 1 user in 10)<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people)<\/p>\n\n\n\n Has been reported<\/strong> (occurs in an unknown number of users)<\/p>\n\n\n\n Some side effects observed with Amsparity may not cause symptoms but may only be detected by blood tests. These include: Very common<\/strong> (may affect more than 1 user in 10)<\/p>\n\n\n\n Common<\/strong> (may affect up to 1 in 10 people)<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 people)<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 people)<\/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 label\/carton after EXP.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C \u2212 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Store the bottles in the outer carton. Sensitive to light. Alternative storage:<\/em><\/p>\n\n\n\n If needed (for example when traveling), an Amsparity vial can be stored at room temperature (up to 30 \u00b0 C) for a maximum of 30 days – ensure that it is protected from light. When removed from the refrigerator for storage at room temperature, the vial must be used within 30 days or discarded<\/strong>, even if it is put back in the refrigerator. You must write down the date when the vial is taken out of the refrigerator for the first time, and the date when it will be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your child’s doctor or 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 adalimumab. The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.<\/p>\n\n\n\n Amsparity 40 mg solution for injection in a vial is provided as a sterile solution containing 40 mg adalimumab dissolved in 0.8 ml solution. Amsparity vial is a glass vial containing a clear, colorless to the very light brown solution of adalimumab. One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 bottle adapter, and 2 alcohol swabs. Amsparity may be available as a vial, pre-filled syringe and\/or as a pre-filled pen.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Pfizer Europe MA EEIG<\/p>\n\n\n\n Boulevard de la Plaine 17<\/p>\n\n\n\n 1050 Brussels<\/p>\n\n\n\n Belgium Manufacturer<\/strong><\/p>\n\n\n\n Pfizer Service Company BVBA<\/p>\n\n\n\n High Way 10<\/p>\n\n\n\n Zaventem 1930<\/p>\n\n\n\n Belgium Contact the representative of the marketing authorization holder to find out more about this medicine: Amsparity contains the active substance adalimumab, a medicine that affects the body’s immune system (immune system).<\/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":[2201,2200],"tags":[10492,10495,10497,10500,10496,10501,10494,10499,10493,10498],"class_list":["post-5408","post","type-post","status-publish","format-standard","hentry","category-a","category-medicines","tag-adalimumab","tag-adalimumab-injection","tag-amsparity","tag-amsparity-injection","tag-side-effects-of-adalimumab","tag-side-effects-of-amsparity","tag-what-adalimumab-is-used-for","tag-what-amsparityis-used-for","tag-what-is-adalimumab","tag-what-is-amsparity"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5408","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=5408"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5408\/revisions"}],"predecessor-version":[{"id":12671,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/5408\/revisions\/12671"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=5408"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=5408"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=5408"}],"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 your child uses Amsparity<\/h2>\n\n\n\n
Do not use Amsparity<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
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<\/p>\n\n\n\nOther medicines and Amsparity<\/h2>\n\n\n\n
<\/p>\n\n\n\nPregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
<\/p>\n\n\n\nDriving and using machines<\/h2>\n\n\n\n
Amsparity contains excipients<\/h2>\n\n\n\n
3. How your child uses Amsaprity<\/h2>\n\n\n\n
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<\/p>\n\n\n\nHow Amsparity is given<\/h2>\n\n\n\n
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<\/p>\n\n\n\nIf you take more Amsparity than you should<\/h2>\n\n\n\n
<\/p>\n\n\n\nIf you have forgotten to give your child Amsparity<\/h2>\n\n\n\n
If your child stops using Amsparity<\/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\n5. How to store Amsparity<\/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
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<\/p>\n\n\n\nMarketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
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<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Luxembourg \/ Luxemburg<\/strong>Pfizer NV \/ SATel: +32 (0) 2 554 62 11<\/td> \u038e\u03c0\u03c1\u03bf\u03c2<\/strong>PFIZER E\u039b\u039bA\u03a3 AE (CYPRUS BRANCH):\u0397\u03bb: +357 22 817690<\/td><\/tr> Czech Republic<\/strong>Pfizer, spol. s roTel: + 420-283-004-111<\/td> Hungary<\/strong>Pfizer Kft.Tel: +36 1 488 3700<\/td><\/tr> Denmark<\/strong>Pfizer ApSTel: +45 44 201 100<\/td> Malta<\/strong>Drugsales LtdTel: +356 21 419070\/1\/2<\/td><\/tr> Germany:<\/strong>Pfizer Pharma PFE GmbHTel: +49 (0) 800 8535555<\/td> The Netherlands<\/strong>Pfizer bvTel: +31 (0) 10 406 43 01<\/td><\/tr> Bulgaria<\/strong>The Pfizer of Luxembourg,Clone of BulgariaTel: +359 2 970 4333<\/td> Norway<\/strong>Pfizer ASTel: +47 67 52 61 00<\/td><\/tr> Eesti<\/strong>Pfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500<\/td> Austria<\/strong>Pfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0<\/td><\/tr> Greece<\/strong>PFIZER E\u039b\u039bA\u03a3 AE.:\u0397\u03bb .: +30 210 67 85 800<\/td> Poland<\/strong>Pfizer Polska Sp. z ooTel .: +48 22 335 61 00<\/td><\/tr> Spain<\/strong>Pfizer SLTel: +34 91 490 99 00<\/td> Portugal<\/strong>Pfizer Laboratories, Lda.Tel: +351 21 423 5500<\/td><\/tr> France<\/strong>PfizerTel: +33 (0) 1 58 07 34 40<\/td> Romania<\/strong>Pfizer Rom\u00e2nia SRLTel: +40 (0) 21 207 28 00<\/td><\/tr> Croatia<\/strong>Pfizer Croatia dooTel: +385 1 3908 777<\/td> Slovenia<\/strong>Pfizer Luxembourg SARL,<\/em> Pfizer, podru\u017enicafor cleaning and pharmaceutical pharmaceuticalsdejavnosti, LjubljanaTel: +386 (0) 1 52 11 400<\/td><\/tr> Ireland<\/strong>Pfizer Healthcare IrelandTel: +1800 633 363 (toll free)Tel: +44 (0) 1304 616161<\/td> Slovak Republic<\/strong>Pfizer Luxembourg SARL, organizerTel: +421 2 3355 5500<\/td><\/tr> Iceland<\/strong>Icepharma hf.Tel: +354 540 8000<\/td> Finland \/ Finland<\/strong>Pfizer PFE Finland OyPuh \/ Tel: +358 (0) 9 430 040<\/td><\/tr> Italy<\/strong>Pfizer Italia SrlTel: +39 06 33 18 21<\/td> <\/td><\/tr> Latvia<\/strong>Pfizer Luxembourg SARL subsidiary Latvij\u0101Tel. +371 67035775<\/td> United Kingdom<\/strong>Pfizer LimitedTel: +44 (0) 1304 616161<\/td><\/tr> Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel. +3705 2514000<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"