SOLU-MEDRONE Powder for injection Ref.[7317] Active ingredients: Methylprednisolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Product name and form

Solu-Medrone 125 mg or methylprednisolone sodium succinate for injection.

Pharmaceutical Form

Powder for injection.

Qualitative and quantitative composition

Solu-Medrone 125 mg: Methylprednisolone sodium succinate 165.8 mg equivalent to 125 mg of methylprednisolone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Methylprednisolone

Methylprednisolone is a synthetic glucocorticoid and a methyl derivative of prednisolone. Methylprednisolone is a potent anti-inflammatory agent with the capacity to profoundly inhibit the immune system.

List of Excipients

Sodium biphosphate
Sodium phosphate

Pack sizes and marketing

Type I clear glass vial with butyl rubber plug and flip top seal.

Each vial of Solu-Medrone 125 mg contains the equivalent of 125 mg of methylprednisolone as the sodium succinate for reconstitution with 2 ml of Sterile Water for Injections.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Marketing authorization dates and numbers

PL 00057/1046

2nd February 2005

Drugs

Drug Countries
SOLU-MEDRONE Cyprus, Ireland, Malta, United Kingdom

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