Sodium Calciumedetate 250 mg/ml Concentrate for Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Sodium Calciumedetate

Available from:

Animalcare Ltd

ATC code:

QV03AB03

INN (International Name):

Sodium Calciumedetate

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Dogs

Therapeutic area:

Mineral anti-toxic

Authorization status:

Expired

Authorization date:

1995-01-13

Summary of Product characteristics

Revised: June 2013
AN: 00242/2013
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sodium Calciumedetate 250mg/ml Concentrate for Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE(S)
Sodium Calciumedetate
EXCIPIENTS
For a full list of excipients, see section 6.1
250 mg/ml
3.
PHARMACEUTICAL FORM
Concentrate for solution for injection.
A clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In the treatment of lead poisoning for cattle and dogs.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Dogs: Do not administer more than 2000mg per day.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Ensure the animal has unrestricted access to non-contaminated drinking
water.
Other antidotes may be employed and supportive measures may be
required.
The source of lead poisoning should be identified and removed from the
animal’s
environment.
Revised: June 2013
AN: 00242/2013
Page 2 of 4
ii.
Special precautions for the person administering the veterinary
medicinal product
to animals
If accidentally injected to humans, obtain medical help promptly and
show the
doctor this warning.
Advice to doctor
As excretion is predominantly renal, an adequate urinary flow must be
established
and maintained. Monitoring of proteinuria and haematuria, and of renal
function is
advisable. Monitoring of zinc levels may also be required as Sodium
Calciumedetate can chelate with several endogenous metals.
Wash hands after use.
iii.
Other precautions
None
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The kidneys of animals with high lead burdens may become overloaded
when Sodium
Calciumedetate is given, especially if the chelator is administered
too rapidly, with
resulting adverse kidney reactions or occasional deaths. Overdosage
may result in
temporary nephroses.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
None
4.8
INTERACTION WITH OTHE