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Published Online: Monday, October 1, 2007   [ Request Print ]

Cefotetan Disodium for Injection

Abraxis Pharmaceutical Products (Schaumburg, Ill) recently received FDA approval to market Cefotetan Disodium for Injection. The product is the generic equivalent of AstraZeneca's Cefotan. Cefotetan Disodium for Injection has the longest half-life of any first- or second-generation cephalosporin. The product is administered prior to surgery to help prevent surgical prophylaxis and secondary infections following certain abdominal and gynecologic procedures such as colorectal surgery, vaginal or abdominal hysterectomies, and cesarean sections. Cefotetan Disodium for Injection also is indicated to treat and prevent infections elsewhere in the body that are proven or strongly suspected to be caused by bacteria, including urinary tract infections, lower respiratory tract infections, intra-abdominal infections, and bone and joint infections. Available in 1- and 2-g vials, the product is AP-rated, is preservative-free, and includes a bar code and a latex-free vial stopper. For more information, visit www.appdrugs.com, or call 800-551-7176.

Zingo (lidocaine hydrochloride monohydrate)

Anesiva Inc (South San Francisco, Calif) recently received FDA approval for Zingo. The product is an amide local anesthetic indicated for use on intact skin to provide local analgesia prior to venipuncture or peripheral intravenous (IV) cannulation in children aged 3 to 18 years. Zingo is an easy-to-administer, single- use, needle-free system containing 0.5 mg of sterile lidocaine powder. The product provides a rapid onset of action, allowing IV line placement or venipuncture to begin 1 to 3 minutes after administration. The procedure should be performed within 10 minutes after Zingo administration. In addition to the hospital setting, Zingo may be used in physicians' offices and clinical laboratories. For more information, visit www.anesiva.com.

Reclast (zoledronic acid)

Novartis' (East Hanover, NJ) Reclast recently received FDA approval as the first and only once-yearly medicine for postmenopausal osteoporosis. The product also is indicated for the treatment of Paget's disease of bone in men and women. The recommended dose for the treatment of postmenopausal osteoporosis is a single 5-mg infusion once a year given intravenously over no less than 15 minutes. The recommended dose for the treatment of Paget's disease of bone is a single 5-mg infusion given intravenously over no less than 15 minutes. Patients with Paget's disease should receive 1500 mg of elemental calcium and 800 international units of vitamin D daily, particularly during the 2 weeks after dosing. For more information, visit www.reclast.com.

Evicel Fibrin Sealant (Human)

OMRIX Biopharmaceuticals Inc (New York, NY) recently received FDA approval for its supplemental Biologics License Application to market its liquid fibrin sealant, Evicel, in vascular surgery. The product is indicated as an adjunct to hemostasis for use in patients undergoing liver or vascular surgery, when control of bleeding by standard surgical techniques, including suture, ligature, and cautery, is ineffective or impractical. Evicel Fibrin Sealant is not indicated for the treatment of massive and brisk arterial bleeding. The product is a single-use kit consisting of 2 packages: one containing 1 vial each of frozen sterile solutions of Biological Active Component 2 and Thrombin and the other containing a sterile spray application device. The 2 components are mixed and applied topically. Evicel Fibrin Sealant should be sprayed or dripped onto the tissue in short bursts to produce a thin, even layer. If the hemostatic effect is not complete, a second layer should be applied. The amount of the product required depends on the area of tissue to be treated and the method of application. For more information, visit www.omrix.com, or call 877-384-4266.

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