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.
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.
Glacial acetic acid
Sodium acetate trihydrate
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.
Novartis Pharmaceuticals UK Limited, Trading as Sandoz Pharmaceuticals, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR
7 May 2007
50IU/ml solution for injection and infusion – PL 0101/0202
100IU/ml solution for injection and infusion – PL 0101/0095R