health-systems PRODUCT news
Baxa Repeater Pump Baxa Corp's (Englewood, Colo) Baxa Repeater Pump automates routine filling procedures, increases efficiency, and ensures accuracy. The product can be used for intravenous admixture and batch filling of Luer syringes, elastomeric infusers, and oral liquid vials and oral dispensers. Combining delivery speed with accuracy and motor strength, the pump increases labor efficiency for batch production, reduces the chance for touch contamination, and eliminates the potential for medication errors. For more information, visit www.baxa.com, or call 800-567-BAXA (800-567-2292).
Clindamycin Injection Abraxis Pharmaceutical Products (Schaumburg, Ill) recently received 2 FDA approvals for its Abbreviated New Drug Applications for Clindamycin Injection, 300 mg, 600 mg, 900 mg, and 9 g, USP. The product is latex-free, AP-rated, and the generic equivalent of Cleocin Phosphate Injection (Pfizer Inc). The product is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin Injection also is indicated for the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, for the judgment of the physician, penicillin is inappropriate. Because of the risk of colitis, as described in the WARNING box, before selecting the product the physician should consider the nature of the infection and the suitability of less toxic alternatives. Clindamycin Injection will be marketed in a 9-g pharmacy bulk pack and 300-, 600-, and 900-mg single-dose bar-coded vials. For more information, visit www.appdrugs.com, or call 800-551-7176.
Humate-P ZLB Behring (King of Prussia, Pa) recently received FDA approval for Humate-P (Antihemophilic Factor/von Willebrand Factor Complex [Human], Dried, Pasteurized), to prevent excessive bleeding during and after surgery, in adult and pediatric patients with severe von Willebrand disease (VWD) and mild-tomoderate VWD where the use of desmopressin is known or suspected to be inadequate. The product also is indicated in adult patients for the treatment and prevention of bleeding in hemophilia A and in adult and pediatric patients with VWD for the treatment of spontaneous and trauma-induced bleeding episodes. Physicians should strongly consider administration of hepatitis A and hepatitis B vaccines to individuals receiving plasma derivatives. The potential risks and benefits of vaccination should be carefully weighed by the physician and discussed with the patient. Administered intravenously, each vial of Humate-P contains the labeled amount of Factor VIII activity in international units (IU) for the treatment of hemophilia A. Each vial of the product also contains von Willebrand Factor: Ristocetin Cofactor activity for the treatment of VWD. For more information, visit www.humatep.com.
SmartPak Samson Medical Technologies LLC (Cherry Hill, NJ) and its partner ACS Dobfar SpA (Milan, Italy) recently received FDA approval for Cefazolin for Injection, USP, in their proprietary SmartPak system developed for compounding. This approval represents the first product in the SmartPak Pharmacy Bulk Package to carry full product labeling. Developed to assist pharmacists in compounding a large number of individual doses, each SmartPak bag contains up to 300 g of sterile antibiotic powder. Intended for intravenous use, SmartPak is a pharmacy bulk package composed of an inner polymer bag that has contact with the drug. There is a sealed double port on the bottom of the bag to allow for the introduction of a diluent, if the drug is in powder form, and for subsequent withdrawal of the bag contents into syringes. An outer foil bag protects the inner bag (and the drug) from light, moisture, and oxidation. SmartPak provides aseptic control, since product constitution takes place within a closed system design, and disposable components are used. Reduced handling of the product, with 1 bag equivalent to 10 to 30 vials of a typical pharmacy bulk package, is intended to further ensure that sterility of the product is maintained during constitution, if necessary, and filling into syringes. This bag system configuration is particularly well-adapted for use in the hospital or compounding pharmacy. For more information, call 877-418-3600, or visit www.samsonmt.com