近日,美国食品和药物管理局(FDA)批准6价疫苗Vaxelis,这是一种全液体、即用型的6联疫苗,用于6周龄的婴儿至4岁的儿童(5岁生日之前)。 Vaxelis是一种主动免疫疫苗,适用于6周龄至4岁婴幼儿,预防白喉、破伤风、百日咳、脊髓灰质炎、乙型肝炎以及由B型流感嗜血杆菌引起的侵袭性疾病。Vaxelis采用3针免疫程序,分别在2、4、6个月龄时进行肌肉注射,剂量为0.5mL。 批准日期:2018年12月28日 公司:赛诺菲和默沙东 VAXELIS(白喉、破伤风类毒素、脱细胞百日咳、灭活脊髓灰质炎病毒、嗜血杆菌b结合物[脑膜炎球菌蛋白结合物]和乙肝[重组]疫苗([Diphtheria and Tetanus Toxoids and Acellular PertussisAdsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate]and Hepatitis B[Recombinant]Vaccine])悬液,肌内注射用 美国初步批准:2018年 作用机制 白喉 白喉是由C.白喉的产毒菌株引起的一种急性毒性介导的疾病。预防疾病是由于对白喉毒素的中和抗体的发展。血清白喉抗毒素水平为0.01IU/mL为最低水平,具有一定的保护作用。抗毒素含量≥0.1国际单位/毫升通常被视为保护。的水平1.0IU/mL与长期保护有关。 破伤风 破伤风是一种急性疾病,由破伤风杆菌产生的一种非常强的神经毒素引起。 预防疾病是由于破伤风毒素中和抗体的发展。 破伤风抗毒素血清水平≥0.01国际单位/毫升,以中和试验是consideredthe最低保护水平。破伤风antitoxoid水平≥0.1国际单位/毫升以theELISA VAXELIS被认为是保护用于临床研究。 百日咳 百日咳是由百日咳杆菌引起的一种呼吸道疾病。这种革兰氏阴性杆菌产生多种生物活性成分,但其在百日咳发病机制或百日咳免疫中的作用尚未明确。 小儿麻痹症 脊髓灰质炎病毒有三种血清型(1型、2型和3型),它们是肠病毒。脊髓灰质炎病毒类型特异性中和抗体的存在与预防脊髓灰质炎有关。 乙型肝炎 乙型肝炎病毒是引起全身感染的几种肝炎病毒之一,其主要病理在肝脏。抗体的浓度≥10个人/毫升对HBsAg关联withprotection对乙肝病毒感染。 b型流感嗜血杆菌侵袭性疾病 H.流感b型可导致侵袭性疾病,如脑膜炎和败血症。抗prp抗体已被证明与预防由b型流感嗜血杆菌引起的侵入性疾病有关。 基于数据从被动与流感嗜血杆菌抗体研究和一个功效研究类型bpolysaccharide疫苗在芬兰,接种后anti-PRP水平≥0.15微克/毫升被列为一个最小的保护水平。数据有效性研究与流感嗜血杆菌类型bpolysaccharide疫苗在芬兰表明一个anti-PRP水平≥1.0微克/毫升3周aftervaccination预测保护通过随后的1年时间。这些水平用于评价流感嗜血杆菌b型结合疫苗的有效性,包括VAXELIS的prp-ompc组分。 适应症和用法 VAXELIS是一种用于积极预防白喉、破伤风、百日咳、脊髓灰质炎、乙肝和B型流感嗜血杆菌引起的侵袭性疾病的疫苗。VAXELIS被批准作为3剂系列疫苗用于6周至4岁(5岁生日之前)的儿童身上。 剂量和管理 3剂免疫系列包括0.5mL肌肉注射,分别在2、4和6个月大时接种。 剂型及强度 注射用悬浮液(0.5mL剂量),单剂量瓶。 禁忌症 对以前剂量的VAXELIS、任何成分的VAXELIS或任何其他白喉类毒素、破伤风类毒素、含百日咳疫苗、灭活脊髓灰质炎疫苗、乙型肝炎疫苗或B型流感嗜血杆菌疫苗的严重过敏反应(如过敏反应)。 没有其他可确认的原因的先前百日咳含疫苗者的7天内发生脑病。进展性神经紊乱,直到确定了治疗方案,病情稳定下来。 警告和预防措施 有以下病史的VAXELIS topersons给药前应仔细考虑利与弊: -发烧≥40.5°C(≥105°F),hypotonic-hyporesponsive集(7)orpersistent,极为伤心的哭泣持续≥3小时后48小时内aprevious pertussis-containing疫苗。 -前一次注射含百日咳疫苗后3天内癫痫发作。如果格林-巴利综合征发生在接种含有破伤风类毒素的疫苗后6周内,那么VAXELIS治疗后格林-巴利综合征的风险可能会增加。 一些早产婴儿在肌肉注射疫苗后出现呼吸暂停。决定何时给早产儿注射肌肉内疫苗,包括VAXELIS,应考虑到个体婴儿的健康状况,以及接种疫苗的潜在好处和可能风险。尿抗原检测对接种vaxelis疫苗后疑似流感嗜血杆菌b型疾病可能没有明确的诊断价值。 不良反应 请求任何剂量后不良反应是易怒(≥55%),哭(≥45%),注射部位疼痛(≥44%),嗜睡(≥40%),注射部位,红斑(≥25%),食欲下降(≥23%),发烧≥38.0°C(≥19%),注射部位肿胀(≥18%)和呕吐(≥9%)。 包装提供/储存和处理 提供 VAXELIS是一个单剂量小瓶(NDC 63361-245-58)包装10瓶(NDC 63361-245-10)。 小瓶塞不是由天然橡胶制成的。 储存和处理 VAXELIS应该存储在2°C到8°C(36°F 46°F)。不冻结。接触过冷冻的产品不能使用。不要在标签上显示的过期日期后使用。 完整说明资料附件:https://www.merck.com/product/usa/pi_circulars/v/vaxelis/vaxelis_pi.pdf Sanofi: FDA Approves VAXELIS(TM), Sanofi and MSD's Pediatric Hexavalent Combination Vaccine U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th birthday). VAXELIS was developed as part of a joint-partnership between Sanofi and MSD (MRK), known as Merck inside the United States and Canada. Sanofi and MSD are working to maximize production of VAXELIS to allow for a sustainable supply to meet anticipated U.S. demand. Commercial supply will not be available in the U.S. prior to 2020. Indication for VAXELIS in the US VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). Select Safety Information for VAXELIS VAXELIS is contraindicated in children with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine, hepatitis B vaccine, or H. influenzae type b vaccine. Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), within 7 days of a pertussis-containing vaccine, that is not attributable to another identifiable cause. Do not administer VAXELIS to anyone with a history of progressive neurologic disorder until a treatment regimen has been established and the condition has stabilized. Vaccination with VAXELIS may not protect all individuals. Carefully consider benefits and risks before administering VAXELIS to persons with a history of: fever of greater than or equal to 40.5°C (greater than or equal to 105°F), hypotonic-hyporesponsive episode (HHE) or persistent, inconsolable crying lasting greater than or equal to 3 hours within 48 hours after a previous pertussis-containing vaccine. seizures within 3 days after a previous pertussis-containing vaccine. If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following VAXELIS. Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including VAXELIS, to an infant born prematurely should be based on considerations of the individual infant`s medical status and the potential benefits and possible risks of vaccination. Urine antigen detection may not have definitive diagnostic value in suspected H. influenza type b disease following vaccination with VAXELIS. The solicited adverse reactions following any dose were irritability (greater than or equal to 55%), crying (greater than or equal to 45%), injection site pain (greater than or equal to 44%), somnolence (greater than or equal to 40%), injection site erythema (greater than or equal to 25%), decreased appetite (greater than or equal to 23%), fever greater than or equal to 38.0°C (greater than or equal to 19%), injection site swelling (greater than or equal to 18%), and vomiting (greater than or equal to 9%). |
Vaxelis Suspension for Injection(多种免疫疫苗注射悬浮液)简介:近日,美国食品和药物管理局(FDA)批准6价疫苗Vaxelis,这是一种全液体、即用型的6联疫苗,用于6周龄的婴儿至4岁的儿童(5岁生日之前)。Vaxelis是一种主动免疫疫苗,适用于6周龄至4岁婴幼儿,预防白喉、 ... 责任编辑:p53 |
最新文章更多推荐文章更多热点文章更多
|