Solu-Cortef (2012)
Βιβλιογραφική αναφορά
Στοιχεία εκδότη
Εκδότης | Pharmacia Limited |
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Διεύθυνση | Ramsgate Road, Sandwich, Kent, CT13 9NJ |
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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