ADVERSE REACTIONS SECTION.

Adverse Reactions. The following adverse reactions have been reported with hydroxocobalamin injection and other parenteral vitamin B12 products:Hypersensitivity reactions including anaphylactic shock, urticaria, rash, pruritus, flushing, and edema Injection site pain, erythema, and injection site reactions Headache and dizziness Nausea and diarrhea Fever and chills Rare cases of hypokalemia during intensive treatment of severe megaloblastic anemia Serious hypersensitivity reactions, including anaphylaxis, may occur in sensitive patients.To report suspected adverse reactions, contact Xseer Pharmaceuticals at (888) 658-8005 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

COMPONENTS.

Components. Each mL contains Hydroxocobalamin mg as the active pharmaceutical ingredient. Hydroxocobalamin is naturally occurring form of vitamin B12 used for vitamin B12 replacement therapy and support of normal hematologic and neurologic function.Benzyl Alcohol 0.9% as preservativeSodium Chloride mg for isotonicity Sterile Water for Injection q.s. as solvent vehicle The pH is adjusted with Hydrochloric Acid and/or Sodium Hydroxide to pH range of 4.0 to 7.5.

CONTRAINDICATIONS SECTION.

Contraindications. Hydroxocobalamin Injection is contraindicated in patients with known hypersensitivity to hydroxocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation.Hypersensitivity reactions, including anaphylactic shock and serious allergic reactions, have been reported following parenteral administration of hydroxocobalamin and other vitamin B12 products.Administration to patients with hereditary optic nerve atrophy (Lebers disease) may result in severe and rapid optic nerve atrophy.

DESCRIPTION SECTION.

Desription. Hydroxocobalamin Injection is sterile, red-colored, preservative-containing injectable solution supplied as multi-dose vial for intramuscular administration. Hydroxocobalamin is naturally occurring form of vitamin B12 essential for normal hematopoiesis, neurologic function, and cellular metabolism.Each mL contains:Hydroxocobalamin .............................. mg Benzyl Alcohol .................................. 0.9% Sodium Chloride ................................ mg Sterile Water for Injection .............. q.s. The pH is adjusted with hydrochloric acid and/or sodium hydroxide to target pH range of 4.0 to 7.5.Hydroxocobalamin appears as dark red crystals or crystalline powder and is sparingly soluble in water. The solution should appear clear and red in color.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package Label Principal display Panel. Hydroxocobalamin Injection mg/mL For Intramuscular Administration30 mL Multi-Dose VialRx OnlySterile, Preservative-Containing SolutionEach mL contains: Hydroxocobalamin mg, Benzyl Alcohol 0.9%, Sodium Chloride mg, Sterile Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide. Store at USP Controlled Room Temperature 20C to 25C (68F to 77F). Protect from light and freezing.Compounded by: Xseer Pharmaceuticals 1990 Westwood Blvd., Suite 300 Los Angeles, CA 90025 Phone: (888) 658-8005 Lot Exp. Date: To report suspected adverse reactions, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Front label.

STORAGE AND HANDLING SECTION.

Storage and Handling. Store Hydroxocobalamin Injection at USP Controlled Room Temperature, 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F to 86F).Protect from light and freezing. Keep vial in carton until use.Inspect solution visually prior to administration. Do not use if the solution is cloudy, discolored, or contains particulate matter.Use aseptic technique when handling and withdrawing product from the multi-dose vial.

WARNINGS AND PRECAUTIONS SECTION.

Warnings and Precautions. Hypersensitivity reactions, including anaphylactic shock, rash, pruritus, urticaria, and edema, have been reported following parenteral administration of vitamin B12 products, including hydroxocobalamin. Patients with known sensitivity to hydroxocobalamin, cobalt, benzyl alcohol, or any component of the formulation may be at increased risk for serious allergic reactions.This product contains benzyl alcohol as preservative. Benzyl alcohol has been associated with serious and fatal adverse reactions, including gasping syndrome, in premature infants and neonates.Administer under appropriate medical supervision. Monitor patients for signs and symptoms of hypersensitivity during administration.Do not use if the solution is cloudy, discolored, or contains particulate matter. Use aseptic technique during handling and administration.Protect from light. Not for intravenous administration.