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

Qualitative and quantitative composition

Sodium Lactate Sodium Chloride Potassium Chloride Calcium Chloride Dihydrate

0.317 % w/v 0.600 % w/v 0.040 % w/v 0.027 % w/v

Approximate ionic content in millimoles per litre:

Sodium Potassium Calcium Bicarbonate (as Lactate) Chloride

131 mmol/l 5 mmol/l 2 mmol/l 29 mmol/l 111 mmol/l

For a full list of excipients see section 6.1.

Pharmaceutical form

Solution for infusion.

Clear, colourless solution for infusion.

Clinical particulars

Target species

Cattle, calves, horses, dogs and cats.

Indications for use

This product is administered by intravenous infusion for the treatment of dehydration and metabolic acidosis in cattle, calves, horses, dogs and cats. It may be used to correct volume depletion (hypovolaemia) resulting from gastrointestinal disease or shock.

Contraindications

Lactate-containing solutions will not be utilised effectively in animals with hepatic impairment and it is undesirable to use this product in animals with metabolic alkalosis.

Special warnings for each target species

None.

Special precautions for use in animals

A risk of thrombosis with intravenous infusion should be considered.

Maintain aseptic precautions.

This product 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.

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

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

This product should be used with caution in animals with cardiac or renal impairment as sodium overload may occur.

For animal treatment only.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

No special precautions required.

Adverse reactions

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

Use during pregnancy, lactation or lay

Use under veterinary supervision.

Interactions

See 6.2.

Amounts to be administered and administration route

For intravenous administration.

The infusion 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 aim to correct hypovolaemia by 50 % initially (ideally over 6 hours but faster if necessary) and reassess by clinical examination.

Deficits are generally in the range of 50 ml/kg (mild) to 150 ml/kg (severe). An infusion rate of 15 ml/kg/hour is recommended in the absence of shock (range 5-75 ml/kg/hour).

In shock, high initial infusion rates, up to 90 ml/kg/hour, are needed. High infusion rates should not be continued for longer than 1 hour unless renal function and urine output are restored. The maximum infusion rate should be decreased in the presence of cardiac, renal and pulmonary disease.

Overdose

Monitor fluid output.

Withdrawal periods

Cattle: meat - zero days.

Cattle: milk - zero days.

Horses: meat - zero days.

Pharmacological particulars

ATC Vet Code QB05BB01 Electrolytes.

Pharmacodynamic properties

This product replaces depleted water and electrolytes when administered via the intravenous route, to correct water imbalance in dehydration, and restore electrolyte and acid-base balance. It will restore plasma volume and correct metabolic acidosis as the hepatic metabolism of Lactate yields Bicarbonate slowly enough to prevent a counter-imbalance of alkalosis.

Pharmacokinetic properties

-

Pharmaceutical particulars

Excipients

Water for Injection; Hydrochloric acid, dilute.

Incompatibilities

This product is incompatible with Methylprednisolone, and Sodium Lactate or Sodium Bicarbonate intravenous infusions.

Shelf life of the veterinary medicinal product as packaged for sale

100 ml packs: 18 months.

250 ml, 500 ml, 1000 ml, 2000 ml, 3000 ml and 5000 ml packs: 2 years.

Shelf life after first opening the immediate packaging

Use immediately. For single use only. Discard unused contents.

Special precautions for storage

Do not store above 25°C. Do not freeze. Keep the container in the outer carton. Use Immediately.This product does not contain an antimicrobial preservative. For single use only. Discard unused contents. Keep out of the reach and sight of children.

Nature and composition of immediate packaging

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

Not all pack sizes may be marketed.

All pack sizes have two ports. In place of the additive port on the 5000 ml Vetivex 11 combi pack is a combi port. This enables two such bags to be connected in sequence and volumes greater than 5000 ml to be administered during one infusion.

Disposal

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Marketing authorisation number

Vm 10434/4048.

Date of the first authorisation or date of renewal

6th February 2007

Date of revision of the text

November 2008

Any other information

Also known as Hartmann's Solution.

To be supplied only on veterinary prescription.

Veterinary medicinal product authorised for use in UK and IE.

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.

USE OF THE COMBI PORT

The Combi port permits two Vetivex 11 Combi bags to be connected in sequence so volumes greater than 5 litres may be administered during a single transfusion. Each Combi port is protected by a snap off cover. This should be removed from each of two combi bags. One spike from each end of a double spike connector unit should be pushed firmly through the Combi port rubber septum of each of the bags. Suspend the bags (one higher than the other) from an infusion stand. To insert the administration set into the giving port of the lower bag, continue as from point 4 above.

Legal category

POM-V

Significant Changes