普泽欣 注射液
PedvaxHIB
制造商
默沙东
性状
本疫苗是一种供肌肉注射的轻微混浊的白色无菌溶液。每针0.5 mL的疫苗所含活性成分为7.5 ug的b型流感PRP和125 ug脑膜炎球菌外膜蛋白的偶联结合物。
药理作用
本疫苗是一种多糖- 蛋白偶联疫苗，能诱导机体产生抗b型流感嗜血杆菌荚膜多糖抗体。
适应症
本疫苗适用于2-71月龄婴幼儿常规免疫接种，预防由b型流感嗜血杆菌引起的侵袭性疾病。
用法用量
供肌肉注射使用，勿静脉注射。经肌肉注射0.5 mL，首选接种部位为大腿前外侧或上臂外侧。
2-14月龄2-14月龄的婴儿最好在2月龄时接种第一针（0.5 mL）疫苗，间隔2个月后（或此后尽早）接种第二针（0.5 mL）疫苗。若在12月龄之前已完成两针基础免疫接种，还须加强免疫接种一针。
15月龄或更大月龄幼儿只须接种一针本疫苗。
加强免疫接种 在12月龄前已完成两针基础免疫接种的婴幼儿，应在12-15月龄期间再加强免疫接种一针（0.5 mL），加强免疫与基础免疫第二针之间的间隔不得少于2个月。
各月龄组婴幼儿免疫接种程序如下 ：
不良反应
上市后发现以下不良反应 ：淋巴结病、血管神经性水肿（极少）、癫痢（包括发热性癫痢）。在一项比较普泽欣和冻干PedvaxHIB两种不同剂型疫苗免疫接种效果的多中心临床研究（接种人数n=903中，678名2-6月龄健康的普通美国婴儿接种了1699针普泽欣。其中大多数接种对象还同时接种了DPT（白百破三联疫苗）和OPV（口服脊髓灰质炎疫苗）。接种对象对两种不同剂型的PedvaxHIB疫苗耐受性良好，未发现与疫苗相关的严重不良反应。这些婴幼儿在接种本疫苗初免后3天内，最常出现的不良反应（发生率>1%）（不考虑是何原因所引起）除了表中所列以外，还有（根据发生率高低依次递减排列） ：烦躁、嗜睡、接种部位疼痛/溃疡、接种部位红斑（直径≤ (smaller than or equal to) 2.5 cm，见表）、接种部位肿块/硬结（直径≤ (smaller than or equal to) 2.5 cm，见表），异常高声哭闹、哭闹时间过长（>4小时）、腹泻、呕吐、哭闹、疼痛、中耳炎、皮疹和上呼吸道感染。下表为婴幼儿接种本疫苗初免后，家长观察48小时以上所报告的一些经过选择的客观观察指标的结果总结。加强免疫接种后3天内，所观察到的不良反应类型和发生率与初免接种后相类似。
禁忌症
对疫苗任何成分或稀释剂过敏者。
注意事项
恶性肿瘤患者，正在接受免疫抑制治疗的患者或存在其它免疫功能缺陷者，若接种本疫苗，可能无法获得应有的免疫保护效果。接种本疫苗后若出现过敏反应，应迅速采取有效的治疗措施，包括使用肾上腺素。与其它疫苗一样，接种本疫苗后不可能立即诱导机体产生达到保护作用水平的抗体，并不是100%的接种对象都能产生具有保护性的抗体反应。与b型流感嗜血杆菌多糖疫苗及另一种b型流感嗜血杆菌所报道的情况类似，接种本疫苗一周内，在诱导机体产生针对细菌的保护性效应前，仍可能出现b型流感嗜血杆菌致病。尚无充分证据表明自然接触b型流感嗜血杆菌后迅速接种本疫苗是否能阻止发病。任何急性感染或发热性疾病期间，应暂缓接种本疫苗，除非医师认为不接种疫苗会导致更严重的危险。接种液体b型流感嗜血杆菌偶联疫苗后，会产生针对载体蛋白（脑膜炎球菌）的免疫原发性应答，但此反应的临床意义尚不清楚。
孕妇及哺乳期妇女用药
本疫苗尚未进行动物生殖毒性试验。
儿童用药
尚未在不足2月龄婴儿和6岁及6岁以上儿童中进行本疫苗的安全性和有效性试验。建议6岁及6岁以上个体不要接种本疫苗。
药物相互作用
正在接受免疫抑制治疗的患者接种本疫苗后，可能无法获得应有的免疫反应。临床研究证明 ：普泽欣与初次免疫和/或加强免疫的DPT（白百破三联疫苗）和OPV（口服脊髓灰质炎疫苗）同时接种 ；或与M-M-R II同时接种（采用不同注射部位及不同注射器），对所测试的各单一抗原产生的免疫反应不会产生影响和损害。在这些疫苗同时使用的研究中，所观察到的不良反应类型，发生率及反应轻重程度与上述疫苗单独使用相类似。
用药须知
非口服（肠道外用）制剂在使用前应肉眼检查有无异物颗粒和变色，接种时要特别小心，务必不要将本疫苗注射到血管里。每个接种对象应分别使用不同的无菌注射器和针头，以防止接种对象之间互相传染乙型肝炎或其它传染性疾病。本疫苗即开即用，不需要溶解或稀释。疫苗在使用前应充分摇匀，以维持疫苗的混悬状态。
贮藏/有效期
本疫苗在运输过程中及储存时应保存在2-8°C，以确保疫苗的效力不受损失。勿冰冻。
Important note
HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Monograph title
HAEMOPHILUS INFLUENZAE B VACCINE - INJECTION
Phonetic pronunciation
(hee-MAW-fih-liss in-flew-EN-zuh B)
Common brand name(s)
Acthib, Hibtiter
Uses
This vaccine helps protect young children from Haemophilus influenzae type b (Hib) infection. Hib is a bacterial infection that can cause serious illness, including brain infection (meningitis). Children younger than age 5 are at highest risk for infection. Vaccination is the best way to protect against this life-threatening disease. Vaccines work by causing the body to produce its own protection (antibodies).This vaccine is not usually used in children over the age of 5 or in adults.
How to use
Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.This medication is given by injection into a muscle by a health care professional. It is usually given in the upper thigh, or in the upper arm in older children.A series of injections is needed to provide the best protection. It is very important that your child receive all the injections ordered by the doctor, or the vaccine may not work as well. Keep all scheduled medical appointments.Hib vaccine can be given at the same time as the other usual childhood vaccinations (e.g., diphtheria/tetanus/pertussis, hepatitis, polio) either in the same injection or using a separate needle and injection site, depending on the types of vaccine being given.
Missed dose
It is important to receive each vaccination as scheduled. Be sure to make a note of when the vaccination was last given for your child's medical record.
Precautions
Before receiving this vaccination, tell your doctor or pharmacist if your child is allergic to it or to any other vaccines; or if your child has any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if your child has certain medical conditions. Before using this medicine, consult the doctor or pharmacist if your child has: high fever, moderate/severe acute illness.Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: bleeding disorders, history of Guillain-Barre syndrome, a weakened immune system (e.g., due to cancer, HIV, leukemia, lymphoma, radiation treatment), vaccination history including previous reactions to any vaccines.Patients with Hodgkin's disease should receive the vaccine at least 10-14 days before beginning treatment or wait at least 3 months after chemotherapy is stopped.This vaccine is not recommended for use during pregnancy and is not usually used in adults.It is not known whether this drug passes into breast milk. This vaccine is not usually used in adults. Consult your doctor before breast-feeding.
Side effects
Pain, swelling, and redness at the injection site may occur. Drowsiness, irritability/crying, loss of appetite, diarrhea, fever, or vomiting may also occur. If any of these effects persist or worsen, notify the doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.Seek immediate medical attention if any of these rare but very serious side effects occur: seizures, unresponsiveness.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.
Drug interactions
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring your child for it. Do not start, stop or change the dosage of any medicine before checking with them first.Before your child receives this vaccine, tell the doctor or pharmacist of all prescription and nonprescription/herbal products the child may use, especially of: "blood thinners" (e.g., warfarin, heparins), corticosteroids (e.g., hydrocortisone, prednisone), cancer chemotherapy, drugs that lower the immune system (e.g., cyclosporine, tacrolimus).This medication may interfere with certain laboratory tests. Make sure laboratory personnel and the doctor know if your child has recently been vaccinated.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.
Notes
Consult the doctor or pharmacist about the temporary use of acetaminophen to treat pain and fever due to this vaccine.There are various combinations of vaccines available. Based on your child's age, vaccination history, and previous reaction to vaccines, your health care professional will determine the most appropriate vaccines. Discuss the risks and benefits of vaccination with your health care provider.History of infection with Hib does not always protect against future infections with Hib bacteria. Your child should still receive this vaccine if your doctor orders it.
Storage
Not applicable. This vaccine is given in a doctor's office and will not be stored at home.
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