LEDCLAIR STERILE SODIUM CALCIUM EDETATE 20 %w/v Concentrate for Soln for Inj
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
SODIUM CALCIUM EDETATE
Available from:
Sinclair Pharmaceuticals Limited
INN (International Name):
SODIUM CALCIUM EDETATE
Dosage:
20 %w/v
Pharmaceutical form:
Concentrate for Soln for Inj
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2009-11-30
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ledclair Sterile Sodium Calcium Edetate Concentrate
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml ampoule contains 1 g sodium calcium edetate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion or concentrate for solution for intramuscular injection.
A clear, colourless concentrate for solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of lead and other heavy metal poisoning. It may also be used in the diagnosis of early and mild cases of
lead poisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Routes of Administration for Adults and Children
The diluted solution may be given either as an intravenous infusion or an intramuscular injection. See ‘Intravenous
Therapy’ and ‘Intramuscular Therapy’.
Intravenous Therapy
The contents of a 5 ml (1g) ampoule should be diluted with 250 to 500 ml of Injection of Sodium Chloride B.P. or
Injection of Dextrose B.P. 5% and the dilute solution given over a period of at least one hour. The concentration of
LEDCLAIR should not exceed 3% in the infusate (one ampoule diluted with at least 33 ml fluid).
The dose is 60-80 mg/kg per day given in two equal divided doses with 8-12 hours between each treatment. This
therapy is continued for up to 5 days followed, at least 48 hours later, by a further course of up to 80 mg/kg/day for a
maximum of 5 days.
It is important not to exceed the maximum daily dose of 80 mg/kg or to give more than a total of 800 mg/kg in the two
5 day treatment periods. If the patient’s condition necessitates further treatment with LECLAIR after the two five day
courses have been completed, there must be an interval of at least 7 days before recom
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