Miacalcin
PATIENT INFORMATION
Careful instructions on pump assembly, priming of the pump and nasal introduction of MiacalcinÒ Nasal Spray should be given to the patient. Although instructions for patients are supplied with individual bottles, procedures for use should be demonstrated to each patient. Patients should notify their physician if they develop significant nasal irritation.
Patients should be advised of the following:
· Store new, unassembled bottles in the refrigerator between 2°C-8°C (36°F-46°F).
· Protect the product from freezing.
· Before priming the pump and using a new bottle, allow it to reach room temperature.
· Store bottle in use at room temperature between 15°C-30°C (59°F-86°F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses.
· See DOSAGE AND ADMINISTRATION, Priming (Activation) of Pumpfor complete instructions on priming the pump and administering MiacalcinÒ Nasal Spray.
You should keep track of the number of doses used from the bottle.
After 30 doses, each spray may not deliver the correct amount of medication, even if the bottle is not completely empty.
Generic Name: Calcitonin-Salmon
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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