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Fortical Nasal Spray (Upsher-Smith)
DESCRIPTION
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.
The active ingredient in FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin-salmon produced by chemical synthesis.
This is shown by the following graphic formula:
It is provided in a 3.7 mL fill glass bottle as a solution for intranasal administration with sufficient medication for at least 30 doses. Each spray delivers 200 International Units calcitonin-salmon in a volume of 0.09 mL.
Active Ingredient: Calcitonin-salmon 2200 International Units/mL, corresponding to 200 International Units per actuation (0.09 mL).
Inactive Ingredients: Sodium Chloride USP, Citric Acid USP, Phenylethyl Alcohol USP, Benzyl Alcohol NF, Polysorbate 80 NF, Hydrochloric Acid NF or Sodium Hydroxide NF (added as necessary to adjust pH) and Purified Water USP.
HOW SUPPLIED
FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray is presented as a metered dose solution in a 3.7 mL fill amber glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL). A screw-on pump is provided. Following priming, the pump will deliver solution containing 200 International Units of calcitonin-salmon per activation. FORTICAL® calcitonin-salmon (rDNA origin) Nasal Spray contains 2200 International Units/mL calcitonin-salmon and is provided in individual boxes containing one glass bottle with screw cap and one screw-on pump (NDC# 0245-0008-35).
Store and Dispense
Store unopened bottle in refrigerator between 36-46°F (2-8°C). Protect from freezing. After opening, store bottle in use in an upright position for up to 30 days at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Discard 30 days after first use.
Distributed by
Upsher-Smith LABORATORIES, INC.
Minneapolis, MN USA 55447-4709
US Patent 6,440,392
US Patent 6,103,495
US Patent 6,210,925
US Patent 6,627,438
US Patent 6,737,250
US Patent 5,789,234
FCPI01 Revised 0805
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