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PNEUMOC 13-VAL CONJ-DIP CRM/PF（商品名：PREVNAR 13）肺炎球菌13-价组合疫苗[白喉CRM197蛋白],美国产品，平价供应(二)
烧（> 5％），发冷（> 5％）和皮疹（> 5％）。
要报告疑似不良反应，请致电1-800-438-1985联系惠氏制药公司，或致电1-800-822-7967联系惠勒，或访问http://vaers.hhs.gov。
用于特定人群
儿科用途：Prevnar 13在6周龄以下儿童中的安全性和有效性尚未确定。
包装提供/存储和处理
预填充注射器，1剂量（每包10个）- NDC 0005-1971-02。
预填充注射器，1剂量（每包1个）- NDC 0005-1971-05。
发货后，Prevnar 13可能会在2°C至25°C（36°F至77°F）的温度下到达。
收到后，储存在2°C至8°C（36°F至46°F）的冷藏。
不要冻结。 如果疫苗已经冷冻则丢弃。
Prevnar 13在高达25°C（77°F）的温度下稳定4天。 这些数据不是运输或存储的建议，但可以指导在临时温度偏移的情况下使用的决策。
预装注射器的尖端帽和橡胶柱塞不是用天然橡胶胶乳制成的。
IMPORTANT SAFETY INFORMATION AND INDICATION FOR PREVNAR 13®
MINIMIZE
IMPORTANT SAFETY INFORMATION
Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13® or any diphtheria toxoid-containing vaccine is a contraindication
Immunocompromised individuals or individuals with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant's medical status, and the potential benefits and risks
In infants and toddlers, the most commonly reported serious adverse events were bronchiolitis (0.9%), gastroenteritis (0.9%), and pneumonia (0.9%)
In children 6 weeks through 17 years, the most commonly reported solicited adverse reactions were injection site tenderness, redness, or swelling, irritability, decreased appetite, decreased or increased sleep, and fever
In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
Patients should always ask their doctors for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
INDICATION
Prevnar 13® is a vaccine indicated in children 6 weeks through 17 years (prior to the 18th birthday) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and for children 6 weeks through 5 years of age (prior to the 6th birthday) for the prevention of otitis media caused by 7 of the 13 serotypes only (4, 6B, 9V, 14, 18C, 19F, and 23F)
In adults 18 years of age and older, Prevnar 13® is indicated for active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
Limitations of Use and Effectiveness
Prevnar 13® does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine |
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