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

Method of administration

The solution can be administered by intravenous, subcutaneous, intramuscular, intra-articular or periarticular injection, or given after dilution by enema.

Intravenous injections of high doses should be given slowly over a period of 3-5 minutes.

Intra-articular and periarticular injections should be given under strict aseptic conditions, as glucocorticoids decrease the resistance to infections.

Posology

Subcutaneous or intramuscular injection

In general, glucocorticoid dosage depends on the severity of the condition and the response of the patient. Under certain circumstances, for instance in stress and changed clinical picture, dose adjustments may be necessary. As an initial dosage, a daily injection of 25 mg is usually sufficient (corresponding to 0.85ml of Medopred). This dosage is maintained or increased if needed until a satisfactory reaction is obtained. If no favourable response is obtained within a few days, continuation of therapy is undesirable. As soon as symptoms diminish, gradual dosage reduction should be attempted, while maintaining the therapeutic result, and if possible switching to an oral glucocorticoid therapy, preferably one administration in the morning or one administration per 48 hours (alternate therapy). A continuous attempt should be made to further reduce the dosage or taper it off completely. After prolonged treatment, discontinuation of the therapy should be very gradual. This reduces the probability of relapse, restricts complications and allows recovery of the suppressed hypothalamic-pituitary-adrenal system (therefore less risk of adrenal insufficiency).

Intravenous injection

For acute, life-threatening situations (e.g. strong anaphylactic reactions, acute severe asthma) higher dosages up to 125 mg may be needed (corresponding to 4.2ml of Medopred).

Intra-articular or periarticular injection

Dosage depends on the size of the joint or periarticular space and on the severity of symptoms. In general, one injection of 25 mg is sufficient (corresponding to 0.85ml of Medopred). If necessary, the injection may be repeated. Sometimes, one or more injections of 10-15mg can be effective (corresponding to 0.3ml-0.5ml of Medopred).

Through an enema in patients with ulcerative colitis

25 mg diluted in 120 ml normal saline (corresponding to 0.85ml of Medopred).

There is no clinical picture of acute overdose with a glucocorticoid.

Glucocorticoids are dialysable.

24 months.

Store below 25°C, in the original package. Do not refrigerate or freeze.

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.

For parenteral administration.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.