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The first and only treatment for Morquio A syndrome (议员IVA).

Life-threatening allergic reactions, known as anaphylaxis, can occur during VIMIZIM® (elosulfase阿尔法)输注. 过敏反应的典型症状包括咳嗽, 皮疹, 喉咙闷, 荨麻疹, 冲洗, 皮肤颜色的变化, 低血压, 呼吸急促(气促), 胸部疼痛, 以及恶心等胃肠道症状, 腹部疼痛, 干呕, 和呕吐. 联系 your doctor or get medical help right away if these symptoms occur during or after VIMIZIM infusions. 如果你有呼吸道疾病, you may be at risk for a sudden worsening of your condition, 你可能需要额外的监控.

VIMIZIM® (elosulfase阿尔法) is the first approved enzyme replacement therapy designed to address the underlying cause of Morquio A syndrome, or mucopolysaccharidosis IVA (议员IVA) — a deficiency in the enzyme N-acetylgalactosamine-6 sulfatase (GALNS). VIMIZIM works at a cellular level to help with deficient enzyme activity.

Morquio A is a rare and progressive inherited disease that affects major organ systems in the body. People living with Morquio A are missing an enzyme essential in the breakdown and removal of the glycosaminoglycans (GAGs) called keratan sulfate (KS) and chondroitin-6-sulfate (C6S).


指示

VIMIZIM® (elosulfase阿尔法) is indicated for patients with Mucopolysaccharidosis type IVA (议员IVA; Morquio A syndrome).

重要安全资讯

Life-threatening allergic reactions, known as anaphylaxis, can occur during VIMIZIM® (elosulfase阿尔法)输注. 过敏反应的典型症状包括咳嗽, 皮疹, 喉咙闷, 荨麻疹, 冲洗, 皮肤颜色的变化, 低血压, 呼吸急促(气促), 胸部疼痛, 以及恶心等胃肠道症状, 腹部疼痛, 干呕, 和呕吐. 联系 your doctor or get medical help right away if these symptoms occur during or after VIMIZIM infusions. 如果你有呼吸道疾病, you may be at risk for a sudden worsening of your condition, 你可能需要额外的监控.

维咪嗪是一种处方药. Before treatment with VIMIZIM, it is important to discuss your medical history with your doctor. Tell your doctor if you are sick or taking any medication and if you are allergic to any medicines. Also tell your doctor if you are pregnant, planning to become pregnant, or are a nursing mother. 你的医生会决定viimizim是否适合你. If you have questions or would like more information about VIMIZIM, contact your doctor.

Anaphylaxis can occur during any VIMIZIM infusion and up to three hours after any infusion, and hypersensitivity reactions have been observed as early as 30 minutes from the start of infusion but as late as six days after infusion.

Serious and severe reactions can happen with VIMIZIM treatment, including life-threatening allergic reactions (anaphylaxis), 荨麻疹, 肿胀, 咳嗽, 呼吸急促(气促), 和冲洗. You should receive medication such as antihistamines before VIMIZIM infusions to reduce the risk of reactions. 如果发生反应, the infusion should be slowed or stopped and you may be given additional medication. 如果发生严重的反应, the infusion should be stopped immediately and you will receive appropriate medical treatment.

If you have acute febrile or respiratory illness at the time of VIMIZIM infusion, you may be at higher risk of life-threatening complications from hypersensitivity reactions. If you use supplemental oxygen or continuous positive airway pressure (CPAP), you should have it available during your infusion in the event of a sudden reaction, 或者抗组胺药引起的极度嗜睡.

Spinal cord damage may occur due to the natural 议员IVA disease process. 脊髓损伤的症状包括背部疼痛, 麻木和瘫痪, 膀胱和肠道失控. 联系 your doctor immediately if you develop any of these symptoms.

The most common side effects reported during VIMIZIM infusions included fever, 呕吐, 头疼, 恶心想吐, 腹部疼痛, 发冷, 和疲劳. These are not all of the possible side effects with VIMIZIM. Talk to your doctor if you have any symptoms that bother you or that do not go away.

打电话给你的医生咨询有关副作用的医疗建议. You may report side effects to 十大赌博平台排行榜 at 1-866-906-6100 and the 十大赌博靠谱网络平台 by visiting www.食品及药物管理局.gov /提交确证 或致电1-800-十大赌博靠谱网络平台-1088.

For more information, call 十大赌博平台排行榜 Rare连接ions™ at 1-866-906-6100.

请参阅全文 处方信息,包括重要警告.


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