Mircera 50 mcg/0.3 ml Solution for Injection

Mircera 50 micrograms/0.3 mL solution for injection in pre-filled syringe. One pre-filled syringe contains 50 micrograms of Methoxy polyethylene glycol-epoetin beta* at a concentration of 167 micrograms/mL. The strength indicates the quantity of the protein moiety of the methoxy polyethylene glycol-epoetin beta molecule without consideration of the glycosylation. *Protein produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells and covalently conjugated to a linear methoxy-polyethylene glycol (PEG). The potency of methoxy polyethene glycol-epoetin beta should not be compared to the potency of another pegylated or non-pegylated protein of the same therapeutic class Excipients: L- Methionine 0.447 mg/0.3 mL, Sodium sulphate anhydrous1.704 mg/0.3 mL, Sodium dihydrogen phosphate monohydrate 0.414 mg/0.3 mL, Mannitol 9.000 mg/0.3 mL, Poloxamer 188 0.030 mg/0.3 mL, Hydrochloric acid diluted q.s (pH 6.2), Sodium hydroxide diluted solution q.s (Ph 6.2), Water for injection q.s ad total weight