** Naso-Cyanocobalamin [Cyanocobalamin 500 mcg/dose (0.1ml)] 2.3 ml Nasal Spray + Nasal spray pump. One bottle will deliver 8 doses.

** Composition: Each unit dose (0.1 ml) contains: Cyanocobalamin 500 mcg

** Indications: Naso-cyanocobalamin Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement. Naso-cyanocobalamin Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including: I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare). II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn’s disease, tropical sprue, and nontropical sprue (idiopathic teatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency. III. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc. IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind 1oop syndrome may produce deficiency of vitamin B12 or folate. V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia. It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption, use of a gluten free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of vitamin B12. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation. Naso-cyanocobalamin Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).

** Dosage & administration: The recommended initial dose of Naso-cyanocobalamin Nasal Spray is one spray (500 mcg) administered in ONE nostril once weekly. Naso-cyanocobalamin Nasal Spray should be administered at least one hour before or one hour after ingestion of hot foods or liquids. Periodic monitoring of serum B12 levels should be obtained to establish adequacy of therapy. Before the first dose and administration, the pump must be primed. Remove the clear plastic cover and the plastic safety clip from the pump. To prime the pump, place nozzle between the first and second finger. With the thumb on the bottom of the bottle, pump the unit firmly and quickly until the first appearance of spray. Then prime the pump an additional 2 times. Now the nasal spray is ready for use. The unit must be re-primed before each dose. Prime the pump once immediately before each administration of doses 2 through 8.

** Store at a temperature not exceeding 30 degrees C. Keep out of reach of children.

** Manufactured by: Global Napi Pharmaceuticals For: Pharmapack Pharmaceuticals