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

A clear, colourless, sterile, apyrogenic solution for intravenous infusion containing:

Sodium Chloride 0.18 % w/v

Glucose Monohydrate 4.4 % w/v

(equivalent to anhydrous Glucose 4.0 % w/v)

Water for injections to 100 % w/v

Approximate ionic content in millimoles per litre:

Sodium 30 mmol/L

Chloride 30 mmol/L

Each one litre provides approximately 150 kcal.

Uses

This product is administered by intravenous infusion for maintenance therapy of dehydration in cattle, calves, horses, dogs and cats. It should be used once the underlying fluid balance has been restored.

Dosage and administration

The solution should ideally be warmed to approximately 37°C prior to administration.

The volume and rate of infusion will depend upon the clinical condition, existing deficits of the animal, maintenance needs and continuing losses.

Generally, recommended dose for maintenance therapy: 50 ml per kg body weight per day.

The infusion rate should be decreased in the presence of cardiac and pulmonary disease.

The maximum recommended infusion rate is 12 ml/kg/hour.

DIRECTIONS FOR USE

VISUAL INSPECTION

1. Ensure that the solution is clear and free from particles, and that the container is undamaged (check for leaks). If you regard the integrity of the pack as suspect, discard solution.

2. Read all precautionary notes (label and package leaflet) and check the expiry date before use.

PACK PREPARATION

1. Warm the pack to approximately 37°C.

2. Remove the pack from the protective overwrap by tearing downwards from the serrated edge.

3. Carefully straighten hanger and ports if necessary.

4. Remove the port plug protecting the sterile giving port. Do this by twisting off the top section while holding the bottom section.

5. Insert the administration set fully to produce a leak-proof connection and suspend the bag from an infusion stand.

6. An air inlet is not required.

7. Prime and regulate the administration set in accordance with the manufacturer’s instructions. If the administration set becomes blocked, do not pump solution back into the pack, replace equipment.

AFTER USE

1. The solution does not contain an antimicrobial preservative and is intended for single use only. Discard any unused solution.

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

Contra-indications, warnings, etc

Sodium overload may occur in animals with cardiac or renal impairment. It should be noted that Sodium excretion may be impaired post-surgery/trauma.

Administration of this product to diabetic animals must be conducted with extreme caution.

The solution should be warmed to approximately 37°C prior to the administration of large volumes, or if the administration rate is high, in order to avoid hypothermia.

This product should not be used for prolonged periods of time unless there is continuing excessive loss of electrolytes, as it may provoke hyperkalaemia.

There is a risk of thrombosis with intravenous infusion.

Excessive infusion rates can cause restlessness, moist lung sounds, tachycardia, tachypnoea, nasal discharge, coughing, vomiting and diarrhoea.

The product should not be administered at a rate in excess of 12 ml/kg/hour, otherwise it is liable to cause glycosuria and osmotic diuresis.

Use under veterinary supervision during pregnancy and lactation or lay.

Overdose: Monitor fluid output and blood Glucose. The administration of a diuretic may be necessary.

Incompatabilities: Check compatability of additives prior to administration.

General precautions: For animal treatment only.

Withdrawal period: Cattle meat - zero days.

Cattle milk - zero days.

Horse meat - zero days.

Pharmaceutical precautions

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

Shelf life: Do not use unless the solution is clear, free from visible particles and the container is undamaged.

Unopened: 100 ml - 18 months; 250 ml, 500 ml, 1000 ml, 2000 ml, 3000 ml and 5000 ml - 2 years.

After opening: The product does not contain an antimicrobial preservative. It is intended for single use only and any unused contents should be discarded.

Disposal: Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM-V

Packaging Quantities

Presented in clear polyvinylchloride (PVC) infusion bags, overwrapped with polypropylene, in cartons of 50 x 100 ml, 20 x 250 ml, 20 x 500 ml, 10 x 1000 ml, 4 x 2000 ml, 4 x 3000 ml and 2 x 5000 ml.

Not all pack sizes may be marketed.

Each carton contains sufficient number of package leaflets so that individual units may be supplied.

Further information

ATC Vet Code: QB05BB02. Electrolytes with carbohydrates.

Pharmacodynamic properties: The solution is used as a source of water, Glucose and electrolytes for animals that cannot be given fluids orally.

Pharmacokinetic properties: Intravenous infusion ensures rapid distribution. The constituents of the infusion solution will be metabolised and excreted through the same pathways as those substances derived from normal dietary sources.

To be supplied only on veterinary prescription.

UK authorised veterinary medicinal product.

Marketing authorisation number

Vm 10434/4058.