Introduction

Dechra

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 7.2 % w/v

Water for injections to 100 % w/v

Approximate ionic content in millimoles per litre:

Sodium 1232 mmol/L

Chloride 1232 mmol/L

Uses

This product is administered by intravenous infusion as adjunctive therapy in the treatment of circulatory shock (hypovolaemic or endotoxaemic) in cattle, calves, horses, dogs and cats.

Dosage and administration

Recommended doses are in the range 4-8 ml/kg, and an infusion rate of 60 ml/kg/hour should not be exceeded.

Hypertonic saline (7.2 % w/v) should be used in conjunction with conventional fluid therapy. The administration of hypertonic saline is usually followed by the intravenous administration of an isotonic intravenous fluid (e.g. an intravenous 0.9 % Sodium Chloride solution).

Adequate access to drinking water should also be provided.

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

The product should not be administered to hypernatraemic animals.

Maintain aseptic precautions.

Adequate access to drinking water should be provided when using the product.

Care should be taken to avoid the use of excessive doses (> 8 ml/kg) and excessive dose rates (> 60 ml/kg/hour).

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

Sodium overload may occur particularly in animals with cardiac or renal impairment, and it should be noted that Sodium excretion may be impaired post-surgery/trauma. It should also be noted that hypernatraemia may occur in animals that are dehydrated.

A risk of thrombosis with intravenous infusion should be considered.

Use under veterinary supervision during pregnancy and lactation or lay.

Overdose: Excessive doses and/or dose rates can cause hypernatraemia, hypotension, bradycardia, bronchoconstriction and hyperventilation.

Incompatabilities: It is generally recommended that no agents should be added to the solution.

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: 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 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: QB05BB01. Electrolytes.

Pharmacodynamic properties: The solution is used as adjunctive therapy in the treatment of circulatory shock. It is intended to provide an interim boost to cardiovascular function, pending restoration of the circulatory volume by conventional isotonic intravenous rehydration solutions. It is intended to improve cardiac output and cause a favourable redistribution of blood flow, to the renal and visceral circulation in particular.

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.