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    • 5. 发明申请
    • METHODS AND PACKAGES TO ENHANCE SAFETY WHEN USING IMIQUIMOD TO TREAT CHILDREN DIAGNOSED WITH SKIN DISORDERS
    • 使用IMIQUIMOD治疗患有皮肤疾病的儿童治疗儿童时的安全性的方法和包装
    • WO2008118762A9
    • 2011-01-06
    • PCT/US2008057758
    • 2008-03-20
    • GRACEWAY PHARMACEUTICALS LLCSLADE HERBERT BLEE JAMES H
    • SLADE HERBERT BLEE JAMES H
    • A01N43/42A61K31/44
    • A61K31/44
    • Pharmaceutical packages and methods for enhancing the safety of imiquimod when used to treat chiidren affected by skin disorders are disclosed. More particularly, the safety profile of imiquimod use is enhanced by providing information to the children, guardians of the children, including parents and health care professionals, that systemic absorption of imiquimod and other effects may be observed when imiquimod therapy is used to treat children of between about 2 and about 12 years of age. Examples of systemic absorption include a serum imiquimod concentrations of less than about 2 ng/mL, a decrease in median white blood cell count by about 1.4*109/L or a decrease in median absolute neutrophil count by about 1.42*109/L. Topical and/or transdermal delivery of imiquimod, including creams, ointments, gels, lotions, salves and pressure- sensitive adhesive compositions to treat dermatologica! disorders in children, namely, molluscum contagiosum, viral infections, such as Type I or Type Il Herpes simplex infections and condyloma acuminata, genital warts and perianal warts, actinic keratosis and superficial basal cell carcinoma, and to induce interferon biosynthesis, are disclosed.
    • 公开了用于增强咪喹莫特用于治疗受皮肤疾病影响的儿童的安全性的药物包装和方法。 更特别地,通过向儿童,儿童的监护人,包括父母和保健专业人员提供信息来增强咪喹莫特使用的安全性,当咪喹莫特治疗用于治疗儿童时,可观察到咪喹莫特的全身吸收和其他作用 约2至约12岁。 全身吸收的实例包括小于约2ng / mL的血清咪喹莫特浓度,白细胞计数中位数降低约1.4 * 109 / L或中位绝对嗜中性粒细胞计数降低约1.42 * 109 / L。 咪喹莫特的局部和/或透皮给药,包括霜剂,软膏,凝胶,洗剂,药膏和压敏胶粘剂组合物以治疗皮肤病! 公开了儿童疾病,即传染性软体动物,病毒感染,例如I型或II型单纯疱疹感染和尖锐湿疣,生殖器疣和肛周疣,光化性角化病和浅表性基底细胞癌,以及诱导干扰素生物合成。