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

Dalophylline Gel is a colourless transparent gel for oral administration, containing 140 mg Etamiphylline Camsylate per unit dose of 2.7 g.

The gel is preserved with Sodium Methylparahydroxybenzoate and Sodium Propylparahydroxybenzoate.

Uses

Etamiphylline Camsylate is a smooth muscle relaxant and cardiac and respiratory stimulant.

It is indicated in the treatment of cardiac and respiratory failure and distress, and it may be used in pneumonia and upper respiratory tract infections.

Dalophylline Gel is indicated in the treatment of neonatal weakness in lambs and calves, associated with cardiac and respiratory distress particularly following dystocia or caesarean section.

Dosage and administration

For oral administration.

Each unit dose (one complete turn of the ring) is equivalent to 140 mg Etamiphylline Camsylate. Turn the ring to the required dose, remove the cap and express the dose as near to the back of the tongue as possible. Replace the cap after use.

Each marked division is equivalent to 2 unit doses.

Lambs: For neonatal weakness: 1 unit dose. A second unit dose may be given 3–4 hours later if required. Larger lambs (over 2.5 kg) may require 2 unit doses.

Calves: For neonatal weakness: 5 unit doses. A further 5 units may be given 3–4 hours later if required.

Contra-indications, warnings, etc

Operator warnings: Wash hands after use.

General precautions: For animal treatment only.

Withdrawal periods: Cattle meat - 7 days.

Sheep meat - 7 days.

Pharmaceutical precautions

Do not store above 25°C. Keep out of the reach and sight of children.

Disposal: Dispose of any used or part-used syringes in the farm refuse.

Legal category

POM-VPS

Packaging Quantities

Dalophylline Gel is available in dial-a-dose syringes. Each syringe contains 10 unit doses of 140 mg Etamiphylline Camsylate.

Further information

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and Ireland.

Manufacturer: Dales Pharmaceuticals, Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire, BD23 2RW, UK.

Marketing authorisation number

Vm 10434/4017.