"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection)
For administration by intravenous infusion.
Voluven® (6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment.
Each 100 mL of the solution contains:
|Hydroxyethyl Starch 130/0.4||6 g|
|Sodium Chloride USPin Water for Injection USP||900 mg|
|pH adjusted with Sodium Hydroxide USPor Hydrochloric Acid USP|
Electrolytes (mEq/L): Sodium 154, Chloride 154. pH 4 to 5.5. Calculated osmolarity 308 mOsmol/L.
The hydroxyethyl starch contained in Voluven® (hydroxyethyl starch in sodium chloride injection) is a synthetic colloid for use in plasma volume replacement. The chemical name of hydroxyethyl starch is poly(O-2-hydroxyethyl) starch. The structural formula of hydroxyethyl starch is
R = -H,-CH2CH2OH
R1 = -H,-CH2CH2OH or glucose units
Voluven® (hydroxyethyl starch in sodium chloride injection) is packaged in 500 mL flexible plastic containers (freeflex®). Freeflex® is a flexible container made from coextruded polyolefin and is free of PVC, plasticizers, adhesives or latex (Non-DEHP, Latex-free). The freeflex® container offers an air-closed system and can be used with non-vented IV sets which prevent external air contamination. Freeflex® is collapsible and can be used in emergency cases for pressure infusion.
Last reviewed on RxList: 2/1/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Voluven Information
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