通用名称：α-1蛋白酶抑制剂人
剂型：注射剂

适应症及用法
ARALAST NP表示为A1-PI具有先天的不足，临床上明显的肺气肿患者治疗的慢性增强。ARALAST NP表示为治疗肺部疾病的患者，其中先天性A1-PI缺乏尚未建立。

重要的风险信息
ARALAST NP是禁忌的个人与选择性IgA缺乏症（IgA水平低于15毫克/分升）谁知道对IgA的抗体，因为他们可能会遇到严重的反应，包括过敏性休克。

ARALAST NP是来自从汇集的人血浆的，它可能携带传染性病原体的传播的风险，例如，病毒和理论上，Creutzfeldt-Jakob病（CJD）的代理。

管理（≤0.08mL/kg/min）的推荐率应密切跟踪和连续监测生命体征。如果发生过敏或严重过敏性反应，应立即停止输液。

ARALAST NP应在三（3）小时内，在室温下施用配制后，应单独给药，不与其他药物混合或稀释的解决方案的情况下。

NP ARALAST的安全性进行了评估，ARALAST在交叉临床PK可比性研究。视为相关的ARALAST NP包括头痛和肌肉骨骼不适的最常见的不良事件，无严重不良反应或死亡的报道在研究。在的ARALAST的关键研究最常见的不良反应为头痛和嗜睡。
Aralast NP
[Alpha1-Proteinase Inhibitor (Human)]Solvent Detergent Treated
Nanofiltered
Aralast NP Description

What is Aralast NP (alpha 1-proteinase inhibitor)?
Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important for preventing the breakdown of tissues in the lungs.
In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs).
Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema.
Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase inhibitor will not cure this condition.
Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this medication guide.
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What is the most important information I should know about Aralast NP (alpha 1-proteinase inhibitor)?
You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.
Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.
Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease.
Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
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What should I discuss with my health care provider before using Aralast NP (alpha 1-proteinase inhibitor)?
You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA. Before you receive alpha 1-proteinase inhibitor, tell your doctor about all of your medication conditions.
FDA pregnancy category C. Alpha 1-proteinase inhibitor may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alpha 1-proteinase inhibitor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.
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How should I use Aralast NP (alpha 1-proteinase inhibitor)?
Alpha 1-proteinase inhibitor is usually given once per week.
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.
Follow the directions on your prescription label.
Alpha 1-proteinase inhibitor is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.
You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.
You will need to mix alpha 1-proteinase inhibitor with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. After mixing alpha 1-proteinase inhibitor with a diluent, you must use the medicine within 3 hours. It is best not to mix your alpha 1-proteinase inhibitor dose until you are ready to give the injection.
The mixture should look clear or slightly yellow-green and may have a few small particles in it.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. You may gently swirl the medication while mixing.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Store the Aralast brand of this medication in the refrigerator. Do not freeze.StoreProlastin or Zemaira at cool room temperature (no warmer than 77 degrees F), away from moisture and heat. Aralast may also be stored at room temperature but you must use it within 30 days after removing it from the refrigerator.
Do not use this medication after the expiration date on the medicine label has passed.
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What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of alpha 1-proteinase inhibitor.
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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
An overdose of alpha 1-proteinase inhibitor is not expected to produce life-threatening symptoms.
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What should I avoid while taking Aralast NP (alpha 1-proteinase inhibitor)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using alpha 1-proteinase inhibitor.
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Aralast NP (alpha 1-proteinase inhibitor) side effectsGet emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as: chest pain, severe headache, buzzing in your ears, uneven heartbeats;fast heart rate; problems with vision; or fever, chills, runny nose, skin rash, and joint pain.
Less serious side effects may include:drowsiness, dizziness, weakness; cough, sore throat, stuffy nose; pain or bleeding where the medication was injected; warmth, redness, or tingly feeling under your skin; nausea, diarrhea, stomach pain; headache; or mild itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
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What other drugs will affect Aralast NP (alpha 1-proteinase inhibitor）There may be other drugs that can interact with alpha 1-proteinase inhibitor. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
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Where can I get more Your pharmacist can provide more information about alpha 1-proteinase inhibitor.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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Stogage
ARALAST NP should be stored at temperatures not to exceed 25°C
(77°F). Do not freeze. Donot use after the expiration date printed on the label.

附件：

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注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
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产地国家: 美国
原产地英文商品名:
ARALAST NP 0.5G/25ML/VIAL
原产地英文药品名:
ALPHA-1-PROTEINASE INHIBITOR
中文参考商品译名:
ARALAST NP 0.5克/25毫升/瓶
中文参考药品译名:
α1-蛋白酶抑制剂
生产厂家中文参考译名:
美国百特
生产厂家英文名:
Baxter Healthcare Corporation
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产地国家: 美国
原产地英文商品名:
ARALAST NP 1G/50ML/VIAL
原产地英文药品名:
ALPHA-1-PROTEINASE INHIBITOR
中文参考商品译名:
ARALAST NP 1克/50毫升/瓶
中文参考药品译名:
α1-蛋白酶抑制剂
生产厂家中文参考译名:
美国百特
生产厂家英文名:
Baxter Healthcare Corporation