Non-proprietary Name Injection
FDA Label NDC 85551-120

Cyanocobalamin 2mg/mL Injection is a sterile, red-colored, preservative-containing injectable solution supplied as a multi-dose vial for intramuscular or subcutaneous administration. Cyanocobalamin is a synthetic form of vitamin B12 essential for normal hematopoietic function, neurologic function, DNA synthesis, and red blood cell maturation.

Each mL contains:

Cyanocobalamin .................................. 2 mg
Benzyl Alcohol .................................. 0.9%
Sodium Chloride ................................ 9 mg
Sterile Water for Injection .............. q.s.

The pH is adjusted with hydrochloric acid and/or sodium hydroxide to a target pH range of 4.0 to 7.5.

Cyanocobalamin appears as dark red crystals or crystalline powder and is hygroscopic in the anhydrous form. It is sparingly soluble in water and stable under normal storage conditions when protected from light.

Each mL contains:

Cyanocobalami 2 mg

Benzyl alcohol 0.9%

Sodium chloride 9 mg

Sterile water for injection qs

pH is ajusted to 4.0-7.5 with Hydrochloric acid and/or Sodium Hydroxide

Cyanocobalamin Injection is a sterile injectable solution containing cyanocobalamin 2 mg/mL supplied in a 30 mL multi-dose vial for intramuscular or subcutaneous administration.

Dosage and frequency of administration should be individualized by the prescribing healthcare provider based on the severity of deficiency, patient condition, laboratory monitoring, and therapeutic response.

Administer by intramuscular or subcutaneous injection only. Administration should be performed by a licensed healthcare professional under appropriate medical supervision. This product is not intended for self-administration by the patient.

Inspect the solution visually prior to administration. Do not use if the solution is cloudy, discolored, or contains particulate matter, or if the container closure is damaged.

Use aseptic technique during withdrawal and administration. Follow applicable facility procedures for handling, storage, beyond-use dating after puncture, and disposal of multi-dose vials.

Cyanocobalamin Injection is contraindicated in patients with known hypersensitivity to cyanocobalamin, vitamin B12 preparations, cobalt, benzyl alcohol, or any component of the formulation.

Hypersensitivity reactions, including anaphylactic shock and death, have been reported following parenteral administration of cyanocobalamin.

Administration to patients with hereditary optic nerve atrophy (Leber’s disease) may result in severe and rapid optic nerve atrophy.

Store Cyanocobalamin Injection at USP Controlled Room Temperature, 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).

Protect from light and freezing.

Inspect solution visually prior to administration. Do not use if solution is cloudy, discolored, or contains particulate matter.

Use aseptic technique when handling and withdrawing product from the multi-dose vial.

Front Label (Cyanocobalami 2mg mL 30ml Vial Labe Jpg)

For Intramuscular or Subcutaneous Use

30 mL Multi-Dose Vial

Rx Only

Sterile, Preservative-Containing Solution

Each mL contains:
Cyanocobalamin 2 mg, Benzyl Alcohol 0.9%, Sodium Chloride 9 mg, Sterile Water for Injection q.s. pH adjusted with Hydrochloric Acid and/or Sodium Hydroxide.

Store at USP Controlled Room Temperature 20°C to 25°C (68°F to 77°F). 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.