extrose injection, and administered over a 4 hour period for 3 consecutive days.
Osteolytic Bone Metastases of Breast Cancer
The recommended dose of 90 mg should be diluted in 250 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 2 hour period every 3 to 4 weeks.
Osteolytic Bone Lesions of Multiple Myeloma
The recommended dose of 90 mg should be diluted in 500 mL of sterile 0.45% or 0.9% sodium chloride injection, or 5% dextrose injection, and administered over a 4 hour period on a monthly basis.
Pamidronate disodium must not be mixed with calcium-containing infusion solutions, such as Ringer’s solution, and should be given in a single intravenoussolution and line separate from all other drugs.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Pamidronate disodium for injection reconstituted with sterile water for injection may be stored under refrigeration at 2° to 8°C (36° to 46°F) for up to 24 hours.
HOW SUPPLIED
Pamidronate Disodium Injection is supplied as follows:
30 mg in 10 mL; single dose, flip-top vials as a clear-colorless solution containing pamidronate disodium 3 mg/mL. NDC 55390-604-01, individually boxed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Pamidronate Disodium for Injection is supplied as follows:
30 mg vials each contains 30 mg of sterile, lyophilized pamidronate disodium and 470 mg of mannitol. NDC 55390-157-01, individually boxed.
90 mg vials each contains 90 mg of sterile, lyophilized pamidronate disodium and 375 mg of mannitol. NDC 55390-159-01, individually boxed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured for: Bedford Laboratories™ Distributed by: Ben Venue Laboratories, Inc.
Bedford, OH 44146 Bedford, OH 44146
*Albumin-corrected serum calcium (CCa, mg/dL) = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL).
January 2009 &