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Solu-Cortef (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Pharmacia Limited
Διεύθυνση Ramsgate Road, Sandwich, Kent, CT13 9NJ
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Δωρεάν εγγραφή

Name of the medicinal product

Solu-Cortef 100 mg or Hydrocortisone sodium succinate for injection BP 100 mg.

Qualitative and quantitative composition

Each vial contains Hydrocortisone sodium succinate 133.7 mg equivalent to hydrocortisone 100.0 mg.

Pharmaceutical form

White, freeze dried powder for parenteral use.

Therapeutic indications

Anti-inflammatory agent. Solu-Cortef is indicated for any condition in which rapid and intense corticosteroid effect is required such as: 1. Endocrine disorders Primary or secondary adrenocortical insufficiency ...

Posology and method of administration

Solu-Cortef may be administered by intravenous injection, by intravenous infusion, or by intramuscular injection, the preferred method for initial emergency use being intravenous injection. Following the ...

Contraindications

Solu-Cortef is contra-indicated where there is known hypersensitivity to components and in systemic fungal infection unless specific anti-infective therapy is employed. Administration of live or live, ...

Special warnings and precautions for use

Warnings and Precautions 1. A Patient Information Leaflet is provided in the pack by the manufacturer. 2. Undesirable effects may be minimised by using the lowest effective dose for the minimum period. ...

Interaction with other medicinal products and other forms of interaction

Convulsions have been reported with concurrent use of corticosteroids and cyclosporin. Since concurrent administration of these agents results in a mutual inhibition of metabolism, it is possible that ...

Pregnancy and lactation

Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however, hydrocortisone readily crosses the placenta. Administration of corticosteroids to pregnant animals ...

Effects on ability to drive and use machines

The effect of corticosteroids on the ability to drive or use machinery has not been systematically evaluated. Undesirable effects, such as syncope, vertigo, and convulsions are possible after treatment ...

Undesirable effects

Since Solu-Cortef is normally employed on a short-term basis it is unlikely that side-effects will occur; however, the possibility of side-effects attributable to corticosteroid therapy should be recognised ...

Overdose

There is no clinical syndrome of acute overdosage with Solu-Cortef. Hydrocortisone is dialysable.

Pharmacodynamic properties

Hydrocortisone sodium succinate has the same metabolic and anti-inflammatory actions as hydrocortisone. It is a glucocorticosteroid. Used in pharmacological doses, its actions supress the clinical manifestations ...

Pharmacokinetic properties

Twelve normal subjects received 100, 200 or 400 mg Solu-Cortef intravenously. Radio-immunoassay results were as follows:- DOSE (mg) CMAX (mcg/100 ml) TMAX (hr) 12-HR AUC (mG/100 ml x hr) 100 132.3 0.35 ...

List of excipients

Sodium biphosphate Sodium phosphate

Incompatibilities

None stated.

Shelf life

Shelf-life of the medicinal product as packaged for sale: 60 months. After reconstitution with Sterile Water for Injections, use immediately, discard any remainder.

Special precautions for storage

Store below 25°C. Refer to Section 4.2 Dosage and Administration. No diluents other than those referred to are recommended. Parenteral drug products should be inspected visually for particulate matter ...

Nature and contents of container

Type I flint glass vials with a butyl rubber plug and metal seal. Each vial of Solu-Cortef 100 mg contains the equivalent of 100 mg hydrocortisone as the sodium succinate for reconstitution with 2 ml of ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Pharmacia Limited Ramsgate Road Sandwich Kent CT13 9NJ UK

Marketing authorization number(s)

PL 0032/5019

Date of first authorization / renewal of the authorization

Date of first authorisation (PL 0032/5019): 18 May 1990 Last renewal date: 15 March 2005

Date of revision of the text

Oct 2012
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