Millophyline-V 140 mg/ml Solution for Injection

Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

Millophyline-V 140 mg/ml Solution for Injection is a clear colourless solution for injection containing Etamiphylline Camsilate 140 mg per ml with Chlorocresol 1 mg per ml (as a preservative).

Uses

Cardiac and respiratory stimulant.

As an aid in the management of coughing in horses, dogs and cats.

May be used in conjunction with an antibiotic to ease respiratory infection.

Dosage and administration

By intramuscular or subcutaneous injection. May be repeated no more frequently than every 8 hours. Duration depends on clinical response.

Horses: 10 ml

Dogs and Cats:

 3–5 kg

0.5 ml

 6–10 kg

1.0 ml

11–20 kg

2.0 ml

21–30 kg

3.0 ml

31–40 kg

5.0 ml

The product should only be diluted immediately prior to IV use and the remaining diluted injection be discarded.

The injection is recommended for the initial treatment of acute cases. May be administered by slow intravenous injection in acute cases (after 1:1 dilution in water for injections), subsequent dosing being given with oral presentations.

Contra-indications, warnings, etc

No data is available on use during pregnancy.

Do not use in animals less than 3 kg body weight.

Incompatible with alkaline products.

Side effects: Occasional CNS stimulation, which is readily countered, if necessary, by the use of a suitable hypnotic drug.

Overdosage: Treat hypokalaemia with intravenous infusions of Potassium Chloride. Administer Diazepam intravenously to control convulsions.

Operator warnings: If accidental injection occurs, or if signs of adverse reaction are seen, seek immediate medical advice showing the product label to a doctor. If splashed in the eye, wash with running water for at least 10 minutes.

Wash hands after use.

General precautions: For animal treatment only.

Withdrawal period: Horse meat: Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.

Pharmaceutical precautions

Do not store above 25°C. Store in a dry place. Keep out of the reach and sight of children.

Following withdrawal of the first dose use the product within 28 days. Discard unused material.

When the container is broached (opened) for the first time, using the in-use shelf-life which is specified above, the date on which any product remaining in the container should be discarded should be calculated. The discard date should be written in the space provided on the label.

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

Legal category

POM-V

Packaging Quantities

Multi-dose bottles of 50 ml.

Further information

Etamiphylline Camsilate possesses most of the properties of Theophylline, but is soluble and relatively non-irritant to tissues when injected.

The diuretic properties are low. The concurrent use of a suitable diuretic may be recommended.

Some racing authorities (including The British Jockey Club) regard Etamiphylline Camsilate as a prohibited substance under the rules of racing. The use of the product should be discontinued 7 days prior to racing. Under these circumstances all but the most exceptional case will be catered for.

To be supplied only on veterinary prescription.

UK authorised veterinary medicinal product.

Marketing authorisation number

Vm 10434/4023.