ST LOUIS (MD Consult) - On August 24, 2009, Sanofi-aventis announced that the US Food and Drug Administration (FDA) has approved Xyzal (levocetirizine dihydrochloride) for the treatment of symptoms of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (chronic hives) in children aged 6 months and older. This new approval also allows for use of the product in children aged 2 years and older with symptoms of seasonal allergic rhinitis (outdoor allergies). Xyzal was previously approved to treat patients aged 6 years and older with symptoms of perenniel and seasonal allergic rhinitis or with chronic idiopathic urticaria.

Xyzal is a once-daily prescription antihistamine in both tablet and liquid formulations.

In patients aged 12 years and older, adverse effects may include somnolence, fatigue, sore throat, and dry mouth. In children aged 6 to 12 years, untoward effects may include fever, cough, somnolence, and epistaxis. In children aged 1 to 5 years, adverse effects may include fever, diarrhea, vomiting, and ear infections. In infants aged 6 to 11 months, undesirable effects may include diarrhea and constipation.

 

圣路易斯（MD Consult）——2009年8月17日，CSL Bering公司宣布美国食品药品管理局（FDA）已批准Helixate FS作为常规预防药物用于16岁以下、无关节损伤史的甲型血友病儿童。应用Helixate FS旨在减少出血发作次数及关节损伤风险。Helixate FS是基因重组第VIII凝血因子，还适用于控制或预防甲型血友病成人患者出血发作。

在大多数Helixate FS检验规格中，2.5 ml 稀释液可购得。该药的配方或纯化过程中未使用白蛋白，生产制作过程包括有机溶剂法/清洁剂法病毒灭活步骤，可在室温（达25°C, 77°F）下储存3个月。

Helixate FS关联的最为严重的不良反应是全身超敏反应和产生高滴度抑制因子水平，因而不得不转为抗血友病因子替代治疗方案。临床试验中观察到的最常见不良反应为在无既往治疗史或极少接受治疗的患者中抑制因子的形成、皮肤相关的超敏反应、输注部位反应，以及采用中心静脉输液装置的患者发生的导管相关血流感染。

 

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