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Solu-Cortef (2012)

Active ingredients: Cortisol

Product Name and Form

Solu-Cortef 100 mg or Hydrocortisone sodium succinate for injection BP 100 mg.

Pharmaceutical form

White, freeze dried powder for parenteral use.

Qualitative and Quantitative Composition

Each vial contains Hydrocortisone sodium succinate 133.7 mg equivalent to hydrocortisone 100.0 mg.

Chemical substance
Description
Cortisol

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction in the vascular component of the inflammatory response and reduction in the formation of inflammatory fluid and cellular exudates.

List of excipients

Sodium biphosphate
Sodium phosphate

Pack sizes and Marketing

Type I flint glass vials with a butyl rubber plug and metal seal. Each vial of Solu-Cortef 100 mg contains the equivalent of 100 mg hydrocortisone as the sodium succinate for reconstitution with 2 ml of Sterile Water for Injections.

Marketing authorization holder
Authorization dates

Pharmacia Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
UK

Date of first authorisation (PL 0032/5019): 18 May 1990

Last renewal date: 15 March 2005

Marketing authorization number:

PL 0032/5019