PREDNISOLONE Suspension for injection Ref.[7046] Active ingredients: Prednisolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom

Product name and form

Deltastab 25 mg/ml Suspension for Injection.

Prednisolone acetate 25mg/ml Suspension for Injection.

Pharmaceutical Form

Suspension for Injection.

A white or almost white suspension.

Qualitative and quantitative composition

Each ampoule contains 25 mg Prednisolone Acetate.

Excipient(s) with known effect:

Sodium chloride (9 mg/ml)
Sodium carboxymethylcellulose (Blanose 7 M8SF) (5 mg/ml)
Sodium hydroxide (q.s.)
Benzyl alcohol (10 mg/ml)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Prednisolone

Prednisolone is a glucocorticoid which has anti-inflammatory activity. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

List of Excipients

Water for injections
Sodium chloride for injections
Benzyl alcohol
Sodium carboxymethylcellulose (Blanose 7M8SF)
Polysorbate 80 (Tween 80)
With sodium hydroxide and/or sterile sodium hydroxide and/or hydrochloric acid as pH adjusters

Pack sizes and marketing

1ml flint neutral glass ampoules.

10 ampoules are packed in a polystyrene pack within a cardboard sleeve.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 20072/0222

01/04/1993

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