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MIACALCIN 50 IU/ml and 100 IU/ml Ampoules (2012)

Active ingredients: Calcitonin

Product Name and Form

Miacalcic 50 IU/ml solution for injection and infusion.

Miacalcic 100 IU/ml solution for injection and infusion.

Pharmaceutical form

Solution for injection and infusion.

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

Miacalcic 100 IU/ml is a clear, colourless aqueous solution.

Qualitative and Quantitative Composition

Each 1ml injection delivers 50 IU or 100 IU of calcitonin as calcitonin (salmon, synthetic) where one IU corresponds to 0.167 micrograms of the drug substance.

Miacalcic is essentially sodium-free, see section 4.4.

For the full list of excipients, see section 6.1.

Chemical substance
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. Miacalcic ampoules 50 IU/ml or 100 IU/ml are supplied as packs containing 5, 10, 50 and 100 ampoules. Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Novartis Pharmaceuticals UK Limited, Trading as Sandoz Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR

7 May 2007

Marketing authorization number:

50IU/ml solution for injection and infusion – PL 0101/0202

100IU/ml solution for injection and infusion – PL 0101/0095R