CALCITONIN Solution for injection / infusion Ref.[49935] Active ingredients: Calcitonin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Essential Pharma Ltd., 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Product name and form

Calcitonin 50 IU/ml solution for injection and infusion.

Pharmaceutical Form

Solution for injection and infusion.

Calcitonin 50 IU/ml is a clear, colourless aqueous solution.

Qualitative and quantitative composition

Each 1ml injection delivers 50 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance.

Calcitonin is essentially sodium-free, see section 4.4.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Calcitonin

Calcitonin is a calciotropic hormone, which inhibits bone resorption by a direct action on osteoclasts. By inhibiting osteoclast activity via its specific receptors, salmon calcitonin decreases bone resorption.

List of Excipients

Glacial acetic acid
Sodium acetate trihydrate
Sodium chloride
Water for injection

Pack sizes and marketing

Type I, clear glass ampoule containing 1ml of solution. Calcitonin ampoules 50 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder

Essential Pharma Ltd., 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8RB, United Kingdom

Marketing authorization dates and numbers

PL 41871/0008

7 May 2007

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