Water

INDICATIONS AND USAGE Sterile Water for Injection, USP in the Pharmacy Bulk Package is indicated for use with automated compounding devices for preparing intravenous admixtures in the pharmacy.

DOSAGE AND ADMINISTRATION Sterile Water for Injection, USP in the 2000 mL flexible Pharmacy Bulk Package is designed for use with automated compounding devices for preparing intravenous admixtures. Dosages will be in accordance with the recommendation of the prescribing physician. Sterile Water for Injection, USP is not intended for direct infusion. Admixtures should be made by or under the direction of a pharmacist using strict aseptic technique under a laminar flow hood. Compounded admixtures may be stored under refrigeration for up to 24 hours. Administration of admixtures should be completed within 24 hours after removal from refrigeration. Drug Interactions The Pharmacy Bulk Package is intended only for use in the preparation of sterile, intravenous admixtures using automated compounding devices. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique 1. During use, container must be stored, and all manipulations performed, in an appropriate laminar flow hood. 2. Remove cover from outlet port at bottom of container. 3. Insert piercing pin of transfer set and suspend unit in a laminar flow hood. Insertion of a piercing pin into the outlet port should be performed only once in a Pharmacy Bulk Package solution. Once the outlet site has been entered, the withdrawal of container contents should be completed promptly in one continuous operation. Should this not be possible, a maximum time of 4 hours from transfer set pin or implement insertion is permitted to complete fluid transfer operations; i.e., discard container no later than 4 hours after initial closure puncture. 4. Sequentially dispense aliquots of Sterile Water for Injection, USP into I.V. containers using appropriate transfer set. During fluid transfer operations, the Pharmacy Bulk Package should be maintained under the storage conditions recommended in the labeling.

ADVERSE REACTIONS Accidental contamination from careless technique may transmit infection. Should any adverse reaction occur, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination, if deemed necessary.