Source: FDA, National Drug Code (US) Revision Year: 2022
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Calcitonin Salmon Nasal Solution is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:
It is provided in a 3.7 mL fill glass bottle as a solution for nasal administration. This is sufficient medication for at least 30 doses.?renderMultiMedia?
Active Ingredient: calcitonin-salmon, 2200 International Units per mL (corresponding to 200 International Units per 0.09 mL actuation).
Inactive Ingredients: sodium chloride, chlorobutanol (possesses a characteristic odor), hydrochloric acid (added as necessary to adjust pH), purified water and nitrogen.
The activity of Calcitonin Salmon Nasal Solution is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute of Biologic Standards and Control, Holly Hill, London.
| Dosage Forms and Strengths |
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Calcitonin Salmon Nasal Solution consists of one glass bottle and one screw on pump. The bottle contains 3.7 mL of calcitonin-salmon clear solution at a concentration of 2200 International Units per mL. A primed pump delivers 0.09 mL (200 International Units) calcitonin-salmon per actuation. |
| How Supplied |
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Available as a metered dose clear solution in a 3.7 mL fill clear glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL/spray). A screw-on pump is provided. The pump, following priming, will deliver 0.09 mL of solution. Calcitonin Salmon Nasal Solution contains 2200 International Units/mL calcitonin-salmon and is provided in an individual box containing one glass bottle and one screw-on pump (NDC 49884-161-11). |
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