PREDNISOLONE Suppositories Ref.[7048] Active ingredients: Prednisolone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: RPH Pharmaceuticals AB, Lagervรคgen 7, 136 50 Jordbro, Sweden

Product name and form

Prednisolone 5mg Suppositories.

Pharmaceutical Form

Suppository.

Cream coloured, oval shaped waxy suppositories.

Qualitative and quantitative composition

One suppository contains 5mg prednisolone as the sodium phosphate ester.

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

Witepsol H15

Pack sizes and marketing

Fin sealed plastic cavities moulded from 100 micron non-toxic PVC. Each cartoned plastic mould contains 10 suppositories (2 strips of 5 suppositories).

Marketing authorization holder

RPH Pharmaceuticals AB, Lagervรคgen 7, 136 50 Jordbro, Sweden

Marketing authorization dates and numbers

PL 36301/0055

23/02/1993 / 19/05/2003

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