药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201111320034332.PDF,201111320033934.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文CytoGam处方资料(仅供参考)
CytoGam 一种免疫球蛋白,用于预防巨细胞病毒(CMV)感染,这也是一种肾移植患者发生的机会致病原感染的疾病 Cytogam是唯一得到FDA批准的可预防性用于移植受者的免疫球蛋白制剂。不能防止CMV感染,而只能减轻疾病的严重程度。花费高,仅推荐用于严重的CMV疾病。 巨细胞病毒(CMV)免疫球蛋白(CytoGam)已在美国批准拓展它的适应证。过去此种球蛋白仅用于预防肾移植接受者, 现在把适应证范围扩展到肺、肝、胰和心脏的接受移植者。
产品名称:Cyto Gam(巨细胞病毒免疫球蛋白IV)
适应症(用途): ①防治肾移植病人的巨细胞病毒(CMV); ②防治与肾、肺、肝、胰腺和心脏移植病人有关的CMV病毒
批准日期: ①第一适应症批准于1990年4月; ②第二适应症批准于1998年12月。
CytoGam Pronunciation: sye-toe-MEG-a-loe-vye-rus Generic Name: Cytomegalovirus Immune Globulin Brand Name: CytoGam
CytoGam is used for: Reducing the risk of cytomegalovirus (CMV) disease associated with kidney, lung, liver, pancreas, and heart transplants. It may also be used for other conditions as determined by your doctor.
CytoGam is an intravenous immune globulin (IGIV) enriched in antibodies against CMV. It works by temporarily increasing the antibody concentration in the body.
Do NOT use CytoGam if: •you are allergic to any ingredient in CytoGam •you have selective immunoglobulin A (IgA) deficiency
Contact your doctor or health care provider right away if any of these apply to you.
Before using CytoGam: Some medical conditions may interact with CytoGam. 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 kidney problems, diabetes, a blood infection, or low blood volume
Some MEDICINES MAY INTERACT with CytoGam. Tell your health care provider if you are taking any other medicines, especially any of the following: •Live vaccines (eg, measles, mumps, rubella) because the effectiveness of the vaccine may be decreased
This may not be a complete list of all interactions that may occur. Ask your health care provider if CytoGam 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 CytoGam: Use CytoGam as directed by your doctor. Check the label on the medicine for exact dosing instructions. •CytoGam is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using CytoGam at home, carefully follow the injection procedures taught to you by your health care provider. •If CytoGam contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it. Ask your health care provider any questions you may have about the proper use of CytoGam. •The infusion should begin within 6 hours after entering the vial and should be complete within 12 hours of entering the vial. This product does not contain a preservative. •Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal. •If you miss a dose of CytoGam, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use CytoGam.
Important safety information: •Because CytoGam is obtained from human plasma, there is a risk that viruses can be passed on to patients who use CytoGam. •Administration of live virus vaccines (eg, measles, mumps, rubella) should be delayed until approximately 3 months after receiving CytoGam. •Contact your health care provider at once if any of the following occur: severe headache, stiff neck, drowsiness, fever, sensitivity to light, painful eye movements, nausea, vomiting. •Local reactions to the injection site may occur (eg, tenderness, pain, hives, swelling). Apply a warm compress. If the symptoms persist, contact your health care provider. •LAB TESTS, including liver and kidney function and immune globulin levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments. •Use CytoGam with caution in the ELDERLY because they may be more sensitive to its effects, such as kidney problems. •PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using CytoGam during pregnancy. It is unknown if CytoGam is excreted in breast milk. If you are or will be breast-feeding while you are using CytoGam, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects of CytoGam: 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: Chills; fever; flushing; joint or back pain; muscle pain; nausea; pain, redness, or swelling at injection site; vomiting; wheezing.
Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased urine output; drowsiness; eye pain; hoarseness; lightheadedness, especially upon standing; sensitivity to light; severe headache; shortness of breath; stiff neck; sudden weight gain.
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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected: Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of CytoGam: Store CytoGam in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. The product does not contain a preservative. The infusion should begin within 6 hours after entering the vial. Keep CytoGam out of the reach of children and away from pets.
General information: •If you have any questions about CytoGam, please talk with your doctor, pharmacist, or other health care provider. •CytoGam 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. •Check with your pharmacist about how to dispose of unused medicine.
This information is a summary only. It does not contain all information about CytoGam. 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.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201111320034332.PDF,201111320033934.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |