Introduction

Company name: Animalcare Limited

Address: Common Road

Dunnington

York YO19 5RU

Telephone: 01904 487687

Fax: 01904 487611

Email: animalcare@animalcare.co.uk

Presentation

A strong sterile solution for injection, which must be diluted prior to use, with active ingredient:

Sodium Calciumedetate 250mg/ml.

Uses

In the treatment of lead poisoning, for use in cattle and dogs.

Dosage and administration

Dilute immediately before use with sufficient Sodium Chloride Intravenous Infusion or Glucose Intravenous Infusion to give a 50mg/ml solution of Sodium Calciumedetate, e.g. 1ml Sodium Calciumedetate Injection + 4ml diluent.

Cattle: 75mg/kg body weight – see also Withdrawal Periods.

Dogs: 75mg/kg body weight – total daily dose for dogs, not more than 2000mg.

Give by slow intravenous (i.v.) injection or infusion. Administer in 4 equally divided doses per day, i.e. every 6 hours, for 2–5 days. Repeat the treatment course after two or three days, as necessary, if signs of lead poisoning are still present.

Ensure that the animal has unrestricted access to non-contaminated drinking water.

Contra-indications, warnings, etc

Do not administer more than 2000mg per day to dogs.

Withdrawal Periods

Cattle (meat): Cattle should not be slaughtered for human consumption until 3 months have elapsed from the the removal of the source of poisoning and the clinical recovery of the animal is achieved.

Cattle (milk): milk should be discarded until after milk lead levels on 2 successive days have been determined and found to be below 0.02ppm (i.e. below 20ug/l). Bulk milk lead levels may be determined in outbreaks of lead poisoning in herds.

The use of Sodium Calciumedetate in the treatment of any other species should be at the discretion of the veterinary surgeon. If used in the treatment of any food producing species other than cattle, such animals MUST NOT enter the food chain.

Operator Warning

If accidentally injected in humans obtain medical help promptly and show the doctor this warning.

Advice to the doctor: As excretion is predominantly renal, 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.

General Precautions

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.

Other antidotes may be employed, and supportive measures may be required.

The source of lead causing the poisoning should be identified and removed from the animal's environment.

Pharmaceutical precautions

Do not store above 25°C.

For animal treatment only. Keep out of the reach of children.

Use a dry, sterile needle and syringe. This product does not contain antimicrobial preservative. Dilute immediately before use. Any unused product should be discarded. Any solution remaining in the vial following withdrawal of the required dose should be discarded.

Keep container in outer carton.

Legal category

POM-V

Packaging Quantities

100ml glass vial.

Further information

Sodium Calciumedetate acts as a chelating substance enabling lead to be mobilised and excreted, mainly through the kidneys. It may be effective for some other heavy metals such as cadmium, but is unsuitable for the treatment of arsenic, mercury, or thallium poisoning.

Disposal advice

Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Marketing authorisation number

VM 10347/4011.