Abraxane From Abraxis Bioscience With Paclitaxel 100mg/vial Information
The Ingredients: Paclitaxel
Dosage Form and Administration: For Suspension; Iv (infusion)
Drug Trade Name: Abraxane
Firm: Abraxis Bioscience
Strength: 100MG/VIAL
New Drug Application Type: N
The Drug Application Number:21660
Medicine Product Number: 1
Approval Date: 1/7/2005
Reference Listed Drug: Yes
Type: RX
Applicant Full Name: Abraxis Bioscience Llc
Medical Device Registration
Medical device registration offers a single place for patients to learn about registered devices and provides information about recalls. Medical devices include a wide range of products that vary in complexity and application. The Food and Drug Administration recognizes three classes of medical devices based on the level of control necessary in order to assure the safety and effectiveness of the device. An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure or enhance an existing biological structure. Medical implants are manufactured devices. The surface of implants that come in contact with body might be made of a biomedical material such as titanium, silicone or apatite, depending on what is the most functional. In some cases, implants contain electronics e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Among the most common types of medical implants are pins, rods, screws and plates used to anchor fractured bones as they heal. There have been many examples of implant failures, including rupture of silicone breast implants, faulty hip replacement joints and breakable artificial heart valves. The consequences of implant failure depend on the critical nature of the implant and its position in the body. Thus, heart valve failure is likely to threaten the life of the individual, while breast implant or hip joint failure is less likely to be life threatening. The process of implantation of medical devices is subject to the same complications as any other invasive medical procedure, including infection, inflammation and pain. Patients also run the risk of implant rejection if the immune system of the host reacts poorly.
Coronary Heart Disease and Stroke and Weight
Coronary heart disease means that the heart and circulation blood flow are not functioning normally. Often, the arteries have become hardened and narrowed. If a person has coronary heart disease, he or she may suffer from a heart attack, congestive heart failure, sudden cardiac death, angina chest pain or abnormal heart rhythm. In a heart attack, a disruption in the flow of blood and oxygen to the heart damages portions of the heart muscle. During a stroke, blood and oxygen do not flow normally to the brain, possibly causing paralysis or death. Coronary heart disease is the leading cause of death in the United States and stroke is the third leading cause.
Overweight people are more likely to develop high blood pressure, high levels of triglycerides blood fats and LDL cholesterol, which is a fat-like substance often called bad cholesterol, and low levels of HDL cholesterol, also known as good cholesterol. High blood pressure and cholesterol are risk factors for heart disease and stroke. In addition, excess body fat may produce substances that cause inflammation. Inflammation in blood vessels and throughout the body may raise heart disease risk.
When a person loses 5 to 10 percent of his or her weight, he or she has a lower chance for developing coronary heart disease or having a stroke. If a person weighs 200 pounds, this means losing as little as 10 pounds. Weight loss may improve blood pressure, triglyceride and cholesterol levels; improve heart function and blood flow; and decrease inflammation throughout the body.
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