Baxter国际公司宣布，美国食品和药物管理局（FDA）已批准10％GAMMAGARD LIQUID皮下给药用于原发性免疫缺陷（PI）患者。这一新的给药途径的批准，将会使医生和PI患者一起工作，以确定哪种GAMMAGARD LIQUID的给药途径是最合适的。GAMMAGARD LIQUID的皮下给药使患者可每周在家自我给药。

    Baxter的丙种球蛋白试验的医疗主任、医学博士、药学博士Richard Schiff说：“FDA批准GAMMAGARD LIQUID的一个皮下给药途径向PI患者提供了GAMMAGARD LIQUID给药途径的选择权，即根据他们的个体需求去选择静脉给药或皮下给药。在多年的强大的GAMMAGARD LIQUID的临床数据的基础上，我们的PI患者的皮下临床试验表明，疗效与其他免疫球蛋白静脉和皮下给药的临床研究一致。”（最常报道的不良反应是局部反应，发生率为2.7％。）

    Baxter通过聚焦于病人护理的项目和继续有权使用治疗如GARDian支持倡导机构和治疗中心，GARDian是一个提供教育资源、保险支持和治疗连续指导的项目。GARDian方案也有一些新的特征以支持病人选择皮下使用GAMMAGARD LIQUID。

    GAMMAGARD LIQUID可作为原发性体液免疫缺陷的成人及两岁或以上的儿童患者的替代疗法。它为治疗PI患者的临床医生提供了灵活性，因为现在有两条给药途径可用，总计5个剂量，并且不添加糖、钠或防腐剂。它是由一个专门的、三步病毒灭活/去除工艺进行处理的。

GAMMAGARD LIQUID [Immune Globulin Intravenous (Human)] 10% is the most widely used 10% IVIG.1*

• Tolerability

  GAMMAGARD LIQUID is formulated to help address a wide range of patient needs with no added sugars, no added sodium, no added preservatives, and no latex in the packaging.

• Efficacy

  For consistent treatment from infusion to infusion, consider GAMMAGARD LIQUID. A pivotal open label study has demonstrated the efficacy of GAMMAGARD LIQUID with zero validated acute serious bacterial infections and median IgG trough levels maintained at 960 to 1,120 mg/dL.2,3

• Convenience

  GAMMAGARD LIQUID provides efficiency and ease of use. Learn about the convenience features that distinguish GAMMAGARD LIQUID, including 5 color-coded sizes, 12-month storage at room temperature (25°C, 77°F),2** and peel-off labels.

  ** Within 24 months of manufacture. After storage at room temperature, the product must not be returned to the refrigerator.

• Viral Safety

  With GAMMAGARD LIQUID, you can give your patients confidence in their therapy. GAMMAGARD LIQUID is sourced and processed exclusively from plasma collected at FDA-registered donor sites, then treated with a dedicated 3-step viral inactivation/removal process.2

* Based on the number of grams distributed in the U.S. Jan-Dec 2009.

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10%

Indications

GAMMAGARD LIQUID is a ready-to-use, liquid medicine that contains immunoglobulin G (IgG) antibodies, which protect the body against infection.

GAMMAGARD LIQUID is used to treat patients with primary immunodeficiency diseases (PI). There are many forms of PI. The most common types of PI result in an inability to make a very important type of protein called antibodies, which help the body fight off infections from bacteria or viruses. GAMMAGARD LIQUID is made from human plasma that is donated by healthy people. GAMMAGARD LIQUID contains antibodies collected from these healthy people that replace the missing antibodies in PI patients.

Detailed Important Risk Information for Patients

Tell your healthcare provider about any side effect that bothers you or that does not go away.

GAMMAGARD LIQUID can cause the following serious reactions:

• Severe allergic reactions causing difficulty in breathing or skin rashes
• Decreased kidney function or kidney failure
• Blood clots in the heart, brain, lungs or elsewhere in the body
• Severe headache, drowsiness, fever, painful eye movements, or nausea and vomiting
• Dark colored urine, swelling, fatigue, or difficulty breathing

If you have a history of poor kidney function or kidney failure, GAMMAGARD LIQUID should be infused at the slowest infusion rate as determined by your healthcare provider.

You should drink plenty of fluids before beginning an infusion of GAMMAGARD LIQUID. If your kidney function worsens, your doctor may consider not using this product.

Do not use GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to immune globulin or other blood products. If you have such a history, discuss this with your doctor to determine if GAMMAGARD LIQUID can be given to you. Tell your doctor if you have a condition called selective (or severe) immunoglobulin A (IgA) deficiency.

If any of the following problems occur after starting treatment with GAMMAGARD LIQUID, stop the infusion immediately and contact your healthcare provider or call emergency services. These could be signs of a serious problem.

• Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
• Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation of the lining around your brain.
• Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
• Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
• Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver problem or a blood problem.
• Chest pain or trouble breathing, blue lips or extremities. These could be signs of a serious heart or lung problem.
• Fever over 100°F. This could be a sign of an infection.

These are not all of the possible side effects with GAMMAGARD LIQUID. You can ask your healthcare provider for physician’s information leaflet.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting viruses.

The following one or more possible reactions may occur at the site of infusion. These generally go away within a few hours, and are less likely after the first few infusions.

During the infusion of GAMMAGARD LIQUID, look out for the first signs of the following common side effects:

Whenever giving yourself treatments at home, you should have another responsible person present to help treat side effects or get help should a serious adverse reaction occur. Ask your healthcare provider whether you should have rescue medications, such as antihistamines or epinephrine.