Source: FDA, National Drug Code (US) Revision Year: 2018
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.
Miacalcin (calcitonin salmon, USP) Injection, Synthetic 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 sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin salmon, 200 USP Units.
Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP.
The activity of Miacalcin injection 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 for Biological Standards and Control, Holly Hill, London.
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Miacalcin injection is available as a clear, colorless, sterile solution of synthetic calcitonin salmon, USP in individual 2 mL multi-dose vials containing 200 USP Units per mL. |
| How Supplied |
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Miacalcin (calcitonin salmon, USP) Injection, Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 USP Units per mL. NDC 67457-675-02 – carton containing 1 × 2 mL multi-dose vial Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A. Manufactured by: Alcami Corporation, Charleston, SC 29405 U.S.A. |
| Drug | Countries | |
|---|---|---|
| MIACALCIN | United States |
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