HYDROCORTISONE Solution for injection Ref.[7549] Active ingredients: Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Efcortesol Injection.

Hydrocortisone 100mg/ml solution for injection.

Hydrocortisone 500mg/5ml solution for injection.

Pharmaceutical Form

Solution for injection.

Qualitative and quantitative composition

Hydrocortisone Sodium Phosphate 13.39% w/v.

Active Ingredient Description

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

Disodium edetate
Disodium hydrogen phosphate, anhydrous
Sodium acid phosphate
Sodium formaldehyde bisulphite monohydrate
Phosphoric acid (10% solution)
Water for injections

Pack sizes and marketing

1ml and 5ml neutral glass ampoules.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 20072/0229


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