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

Small elliptical tablets containing L-Thyroxine Sodium. To the right of the score line on the face of each tablet is the tablet strength in milligrams (e.g. 0.1, 0.2 etc). The tablets are uniformly coloured, each dosage strength being thus uniquely identified:

0.1 mg yellow

0.2 mg orange

0.3 mg green

0.5 mg white

0.8 mg blue

Uses

For the long term treatment of thyroid insufficiency in dogs. L-Thyroxine is a synthetic product chemically identical to the naturally occurring thyroid hormone `T4'. Its effect is slow in onset, but of long duration.

Dosage and administration

The dosage should be adjusted for the individual case based on the response of the patient and laboratory investigations, and should be administered daily. Pharmacokinetic trials demonstrate that once daily dosing gives higher blood levels than dividing the daily dose over the day.

The commonly prescribed dose is 22 µg/kg bodyweight/day. This is frequently too low, and doses of up to 44 µg/kg bodyweight/day may be required.

Appropriate laboratory tests should be conducted to confirm the diagnosis and ensure correct dosage. For oral administration.

Contra-indications, warnings, etc

Do not use in dogs with thyrotoxicosis or uncorrected adrenal insufficiency.

The effects of Thyroxine therapy are slow in being manifested.

Administer with caution to animals with clinically significant heart disease, hypertension or other complications for which a sharply increased metabolic rate might prove hazardous.

Chronic overdosage will eventually lead to thyrotoxicosis, manifested by: panting, nervousness, tachycardia, aggressive behaviour, polyuria, polydipsia, polyphagia and weight loss.

If you notice any serious effects or other effects not mentioned in the leaflet, please inform your veterinary surgeon.

Operator warnings: Wash hands after use.

In case of accidental ingestion, seek medical advice immediately and show the doctor the leaflet.

General precautions: For animal treatment only.

Pharmaceutical precautions

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

Disposal: Dispose of used packaging in the household refuse. Unused product should be returned to the veterinary surgeon.

Legal category

POM-V

Packaging Quantities

Hermetically sealed bottles of 250 tablets.

Further information

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and Ireland.

Marketing authorisation numbers

For each strength:

0.1 mg - Vm 10434/4011

0.2 mg - Vm 10434/4012

0.3 mg - Vm 10434/4013

0.5 mg - Vm 10434/4014

0.8 mg - Vm 10434/4015