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Cayston(Aztreonam for Inhalation Solution)
2015-03-01 22:01:51 来源: 作者: 【 】 浏览:331次 评论:0

Generic Name and Formulations:
Aztreonam 75mg/vial; pwd for inhalation via nebulization after reconstitution; preservative-free.

Company:
Gilead Sciences, Inc.
Indications for CAYSTON:
To improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa.

Adults and Children:
<7yrs: not established. Use a short-acting bronchodilator 15 minutes to 4 hours before each dose; or a long-acting bronchodilator 30 minutes to 12 hours before starting therapy. >7yrs: 75mg (1 vial) by nebulization three times daily (at least 4 hours apart) for 28 days. Use Altera Nebulizer only.

Pharmacological Class:
Monobactam.

Warnings/Precautions:
Monobactam or beta-lactam allergy. FEV<25% or >75% predicted, patients colonized with Burkholderia cepacia: safety/effectiveness not established. Pregnancy (Cat.B).

Interactions:
Do not mix with other drugs in nebulizer.

Adverse Reactions:
Cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, vomiting, rash; chest tightness, bronchospasm, allergic reactions (discontinue if occurs).

Note:
To support and assist patients with cystic fibrosis contact the Cayston Access Program at (877) 7CAYSTON. Should be administered immediately after reconstitution. Do not reconstitute until ready to administer a dose.

Generic Availability:
NO

How Supplied:
Vials—84 (w. diluent)






2010年2月24日,Gilead制药公司的产品Cayston(氨曲南吸入溶液)日前已通过美国食品药品管理局(FDA)的批准,用于治疗由绿脓杆菌感染导致的囊肿性纤维化(CF),以缓解患者呼吸症状。
Cayston每次使用剂量75毫克,每天用药3次,疗程28天,通过Altera Nebulizer系统给药(属便携式给药装置,采用了Pari 制药公司的eFlow技术)。
为了使该药符合Altera Nebulizer给药系统的使用特点,Pari公司也参与了药物的配方研发工作。该药将于近日进入美国市场销售。
据悉,Cayston已获准在欧盟地区、加拿大和澳大利亚销售,它在瑞士和土耳其的销售申请也在审批过程中。 

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