美国食品药物管理局(FDA)的已经核准二价(基因重组)人类乳突病毒(HPV)的疫苗(Cervarix的,格兰素史克药厂)用于预防年龄介于10至25岁人乳头瘤病毒第16,18型病毒造成的子宫颈癌与癌前病变。 部分中文Cervarix处方资料(仅供参考) 制造商: 类药物: 活性成分(S): 指示(S): 药理: 临床试验: 在研究2中,受试者接种的Cervarix,不管其基线HPV DNA的状态,血清状况,或细胞学检查。疫苗接种前,宫颈样本被评定为致癌HPV DNA检测和血清状态的HPV - 16和HPV - 18抗体。疗效分析包括妇女无论基线DNA的地位和血清状况产生病变。 (天真和非幼稚的妇女),在这一人群中的Cervarix是有效预防与HPV - 16或HPV - 18相关的癌前病变或AIS的。妇女谁在基线HPV DNA阳性,无论对血清状况,没有表现出疗效,对癌前病变或与HPV - 16或HPV - 18相关的认可机构。在人口天真的致癌HPV的中的Cervarix减少,CIN1/2/3或AIS,CIN2 / 3或AIS,和CIN3或AIS无论在病变的HPV DNA类型的总发病率。在幼稚和天真的非疫苗对CIN1/2/3或AIS,CIN2 / 3或AIS,和CIN3或在所有妇女,不管在病变的HPV DNA类型的AIS被证明是有效的。 在10-14岁的女孩的Cervarix的疗效推断的基础上从研究3和第4获得免疫原性数据。研究3相比的Cervarix,以A型肝炎疫苗的免疫原性。所有最初的血清阴性科目的Cervarix的3剂量为他们的实验结果转换为HPV - 16和HPV - 18,以血清学阳性,。在研究4中,女孩10-14岁的Cervarix的免疫原性相比,在15-25岁的女性。测定1个月后剂量3,在年轻人群中的免疫反应,老年组的非劣。 法律分类: 成年人和儿童: 警告/注意事项: 相互作用(S): 不良反应(S): 如何提供: 最后更新: 卉妍康Cervarix疫苗—预防子宫颈癌新武器 卉妍康Cervarix疫苗被批准用于10岁至25岁之女性,以预防由HPV16/18型所引起的偶发性及持续性感染、与这两型病毒相关之子宫颈上皮内赘瘤及癌前病变,从而预防子宫颈癌。 4.卉妍康Cervarix疫苗预防接种期间之怀孕处置: CERVARIX Manufacturer:GlaxoSmithKline Pharmaceuticals Pharmacological Class:Vaccine (HPV) Active Ingredient(s):Bivalent human papillomavirus (HPV) vaccine types 16 and 18 vaccine; recombinant; aluminum adsorbed; suspension for IM injection; preservative-free. Indication(s):In females 10–25 years old, to prevent cervical cancer, cervical intraepithelial neoplasia (CIN) grade 1, grade 2 or worse and adenocarcinoma in situ, (AIS), caused by HPV types 16 and 18. Pharmacology:Cervarix is a non-infectious vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid (virus), of oncogenic HPV types 16 and 18. Clinical Trials:Two trials were conducted to assess the efficacy of Cervarix in preventing CIN2/3 or AIS in 19,778 females 15–25 years of age. The first study enrolled subjects who were negative for oncogenic HPV DNA (including types 16 and 18 and 12 other types) in cervical samples, seronegative for HPV-16 and HPV-18, and had normal cytology. A follow-up study for Study 1 was begun to assess the vaccine's long-term efficacy, safety, and immunogenicity. In both this study and the extension (with up to 6.4 years follow-up [mean 5.9 years]), efficacy against CIN2/3 or AIS associated with HPV-16 or HPV-18 was 100%. In Study 2, subjects were vaccinated with Cervarix regardless of their baseline HPV DNA status, serostatus, or cytology. Before vaccination, cervical samples were assessed for oncogenic HPV DNA and serostatus of HPV-16 and HPV-18 antibodies. Efficacy analyses included lesions arising among women regardless of baseline DNA status and serostatus. In this population (naive and non-naive women), Cervarix was effective in the prevention of precancerous lesions or AIS associated with HPV-16 or HPV-18. Among women who were HPV DNA positive regardless of serostatus at baseline, efficacy was not demonstrated against precancerous lesions or AIS associated with HPV-16 or HPV-18. In the population naive to oncogenic HPV, Cervarix reduced the overall incidence of CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS regardless of the HPV DNA type in the lesion. In the naive and non-naive group, the vaccine was shown to be effective against CIN1/2/3 or AIS, CIN2/3 or AIS, and CIN3 or AIS in all women regardless of HPV DNA type in the lesion. The efficacy of Cervarix in girls 10–14 years of age is inferred based on immunogenicity data obtained from Studies 3 and 4. Study 3 compared the immunogenicity of Cervarix to Hepatitis A vaccine. All initially seronegative subjects given the 3-dose course of Cervarix for whom assay results were available converted to seropositive for HPV-16 and HPV-18. In Study 4, the immunogenicity of Cervarix in girls 10–14 years old was compared to that in females 15–25 years old. Measured 1 month after dose 3, the immune responses in the younger group were non-inferior to those of the older group. Legal Classification:Rx Adults & Children:Give by IM inj in deltoid. Each dose is 0.5mL. <10 years: not recommended. Females 10–25 years: Give 1st dose at elected date, 2nd dose 1 month after 1st dose, 3rd dose 6 months after 1st dose. Monitor 15 minutes post-dose. Warnings/Precautions:Not a substitute for routine cervical screening. Immunosuppressed. Latex allergy (prefilled syringes). Pregnancy (Cat.B): not recommended. Nursing mothers. Interaction(s):Immunosuppressants: may get suboptimal response. Adverse Reaction(s):Injection site reactions, fatigue, headache, myalgia, GI upset, arthralgia, syncope (transient tonic-clonic movements, other seizure-like activity possible post-dose). How Supplied:Single-dose vial—10 |
卉妍康Cervarix疫苗-美国FDA核准用于子宫颈癌预防简介:
美国食品药物管理局(FDA)的已经核准二价(基因重组)人类乳突病毒(HPV)的疫苗(Cervarix的,格兰素史克药厂)用于预防年龄介于10至25岁人乳头瘤病毒第16,18型病毒造成的子宫颈癌与癌前病变。
部分 ... 关键字:Cervarix疫苗
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