Synagis 50 mg/vial西那吉斯 凍晶注射劑

藥品中文

中文商品名 西那吉斯 凍晶注射劑
 
藥品英文商品名

Synagis 50 mg/vial

主成分及含量

Palivizumab 50 mg/vial
用  途

可作用於RSV 疾病高危險群之幼兒病患
 
用  法
注射藥
 
副作用

有些人可能會在注射部位有發熱疼痛感
 
警  語

只能以注射用水稀釋，靜置20分以上，直至澄清，切勿搖晃避免產生泡沫，限6小時內用畢
 
保存方式

冷藏
 
藥  廠
BOEHRINGER INGELHEIM PHARMA

 
SYNAGIS给药说明

50mg/vial SYNAGISPalivizumab，100mg/vial的IM注射PWD后重建;

液体soln的通用名称，不含防腐剂。

法律分类：RX

SYNAGISAntiviral单克隆抗体类药物（IgG1K）。

SYNAGISMedImmune，公司制造商
 
主治严重降低呼吸道高风险的RSV疾病（如支气管肺发育不良或出生≤35周胎龄的婴儿）在儿科患者呼吸道合胞病毒（RSV）引起的疾病，或先天性心脏疾病血流动力学显著的儿童SYNAGISPrevention ）。

成人剂量SYNAGISNot适用。

儿童的剂量为SYNAGISGive由IM注射到大腿前外侧。按15mg/kg RSV的赛季之前和期间，每月一次。体外循环：见文献。鸿沟剂量1ML到2 INJ网站。

注意事项SYNAGISHave肾上腺素（1:1000）注射可。

怀孕（Cat.C）。

SYNAGISAnaphylaxis的不良反应，hypesensitivity反应，上呼吸道感染/症状（如发烧，气喘），胃肠功能紊乱，中耳炎，皮疹，疝，SGOT上升。

如何SYNAGIS提供？

单用小瓶（PWD）-1
单用小瓶（soln）-1

Palivizumab is used for:

Preventing serious lower respiratory tract infection caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

Palivizumab is a monoclonal antibody. It works by preventing RSV from reproducing.

Do NOT use Palivizumab if:
you are allergic to any ingredient in Palivizumab
Contact your doctor or health care provider right away if any of these apply to you.

Before using Palivizumab :
Some medical conditions may interact with Palivizumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a bleeding or blood clotting disorder or low blood platelet levels
if you are having heart surgery (cardiopulmonary bypass)
if you are taking a blood thinner (eg, warfarin)
Some MEDICINES MAY INTERACT with Palivizumab . However, no specific interactions with Palivizumab are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Palivizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Palivizumab :
Use Palivizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Palivizumab . Talk to your pharmacist if you have questions about this information.
Palivizumab is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Palivizumab at home, a health care provider will teach you how to use it. Be sure you understand how to use Palivizumab . Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Palivizumab if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Continue to use Palivizumab even if you feel well. Do not miss any doses.
Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
If you miss a dose of Palivizumab , contact your doctor right away.
Ask your health care provider any questions you may have about how to use Palivizumab .

Important safety information:
Children, including those who develop RSV, should continue to receive monthly doses of Palivizumab throughout the RSV season (generally November through April in the Northern Hemisphere). The first dose should be given before the RSV season begins.
PREGNANCY and BREAST-FEEDING: Palivizumab is not for use in adults. It is not known if Palivizumab can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Palivizumab while you are pregnant. Palivizumab is not indicated for use in breast-feeding mothers. Do not breast-feed while taking Palivizumab .
Possible side effects of Palivizumab :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; mild fever; minor pain, redness, swelling, or warmth at the injection site; runny or stuffy nose; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness; muscle weakness or limpness); blue lips or skin (including under the fingernails); ear pain or discharge; fever; irregular heartbeat; stomach pain; unusual bruising or bleeding; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Palivizumab :
Palivizumab is usually handled and stored by a health care provider. If you are using Palivizumab at home, store Palivizumab as directed by your pharmacist or health care provider. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Palivizumab out of the reach of children and away from pets.

General information:
If you have any questions about Palivizumab , please talk with your doctor, pharmacist, or other health care provider.
Palivizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Palivizumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Synagis药品介绍

Synagis是一种人源化的单克隆抗体，于1998年获FDA批准用于防止呼吸道合胞病毒（RSV）感染高危婴幼儿因RSV而引起的严重下呼吸道疾病。Synagis是首个获准用于防止此类感染的单克隆抗体，也是该类药物中首个可以安全用于儿科患者的药物。
 
RSV感染是婴幼儿和儿童中最常见的呼吸道感染，其在美国每年导致125000例1岁以下婴幼儿住院。约有半数婴幼儿会在出生后的第一年中受到RSV感染，几乎所有婴幼儿会在2周岁之前至少感染1次。早产儿、慢性肺疾病患儿和先天性心脏病患儿是RSV感染的高危人群。
北半球的10月到次年5月是RSV感染的高发季节。Synagis被批准用于防止高危婴幼儿因RSV引起的严重下呼吸道感染，其用药方式为肌内注射，在RSV高发季节一月注射1次。

新型Synagis注射液的上市给医务工作者、患儿家长以及患儿都带来了方便。Synagis最初获准的剂型是注射用冻干剂，使用时需要先将其用无菌水溶解，此过程需要20分钟，而且配制成注射液后必须在6小时内使用。而新的Synagis注射液免去了以往使用冻干剂时所需的配制步骤，也减少了患儿等候的时间。
 
Synagis可降低呼吸道合胞病毒感染高危婴儿的住院率的原因:
按照推荐的每月注射时间用药是治疗成功的关键。对于某些高危患儿，为了预防RSV感染，治疗一个季节以上是有益的。在予Synagis预防的24例患儿中，仅有7例因RSV而入院。这与RSV影响试验所观察的住院率相吻合。

本研究7例住院患儿的4例，没以按上述推荐的方法治疗，在住院前至少有一次没有给药。另3例为在RSV感染的第一季节开始治疗的患儿，这3例患儿在RSV感染的第二季节未再接受Synagis治疗。这提示某些患儿在继之RSV感染的季节里，预防性应用Synagis是有益的。
Alber marchetli博士等的论文《非Palivizumab预防疗法RSV感染婴儿住院费用的观察》的研究结果表明：对因RSV感染入院并接受Synagis预防疗法的少数患儿，其住院费用明显少于非预防疗法患儿的费用。在这项对20例RSV感染住院的前瞻性研究中，有10例入院前Synagis预防疗法，另10例未予Synagis。

接受Synagis 治疗患儿平均住院费用8,492美元、住院期4.1天；而非其疗法的患儿住院费用为15,786美元、住院期6.8天。

其它研究结果亦显示，Synagis可有效的降低RSV高危患儿的住院率。本研究的结论表明：对于少数几例预防用药后仍病毒感染入院的患者，Synagis降低了RSV感染的严重程度，从而降低了医疗费用。
Robetter Hirsch Medimmune博士亦在论文中阐述，“临床实践表明，Synagis可降低高危患儿RSV感染所致的全身并发症”。

研究结果还显示,高危患儿预防性用药可大大降低医疗费用。相信这些研究能引起儿科医生对早产儿及其他高危婴儿治疗的高度重视。