MEDOPRED Solution for injection / infusion Ref.[28364] Active ingredients: Prednisolone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Product name and form

Medopred 30mg/1ml solution for injection/infusion.

Pharmaceutical Form

Solution for injection or infusion.

Clear and colourless or yellowish solution.

Qualitative and quantitative composition

Each ampoule contains the equivalent of 30 mg of prednisolone phosphate as prednisolone sodium phosphate E.P.

Excipient with known effect: sodium metabisulphite.

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

Nicotinamide
Edetate disodium
Sodium metabisulphite
Phenol
Sodium hydroxide
Water for injection

Pack sizes and marketing

Glass type I, brown ampoules, containing 1ml of the solution, labelled and packed in a card cartons of 10 or 100 ampoules.

Not all pack sizes may be marketed.

Marketing authorization holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Marketing authorization dates and numbers

21839

Date of first authorisation: 19/07/2013 / 15/11/2019

Drugs

Drug Countries
MEDOPRED Cyprus

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