Solution for infusion for cattle, horses, dogs and cats

PACKAGE LEAFLET FOR:

Marketing authorisation holder:

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom

Manufacturer responsible for batch release:

Terumo BCT Limited, Old Belfast Road, Millbrook, Larne, Co. Antrim, BT40 2SH, Northern Ireland

Name of the veterinary medicinal product:

Vetivex 11 solution for infusion for cattle, horses, dogs and cats

Statement of the active substances and other ingredients:

1 ml contains:

Sodium: 131 mmol/litre, Potassium: 5 mmol/litre, Calcium: 2 mmol/litre, Bicarbonate (as lactate): 29 mmol/litre, Chloride: 111 mmol/litre. Solution for infusion. Clear, colourless solution.

Indications:

For the treatment of dehydration and metabolic acidosis in cattle, horses, dogs and cats.

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.

Adverse reactions:

Excessive infusion rates can cause restlessness, moist lung sounds, tachycardia, tachypnoea, nasal discharge, coughing, vomiting and diarrhoea. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Target species:

Cattle, horses, dogs and cats.

Dosage for each species, route and method of administration:

Intravenous use.

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.

Advice on correct administration:

Withdrawal period:

Cattle and horses: Meat and offal/milk – zero days/hours.

Special storage precautions:

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not freeze.

Special warnings:

Special precautions for the disposal of unused product or waste materials:

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

Date on which the package leaflet was last approved:

24-04-2013

Other information:

For animal treatment only. To be supplied only on veterinary prescription. Polyvinylchloride infusion bag overwrapped with polypropylene.

Pack sizes: 250 ml, 500 ml, 1000 ml, 3000 ml, 5000 ml and 5000 ml Combi. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

Dechra Veterinary Products Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire, SY4 4AS, United Kingdom

LEAF/V11/7

PRINCIPAL DISPLAY PANEL - 5000 mL Container Label

5000 ml
Code V11E

VETIVEX™ 11
Solution for infusion for
cattle, horses, dogs
and cats

1 ml contains:
Active substances:
Sodium lactate 3.17 mg
Sodium chloride 6.00 mg
Potassium chloride 0.40 mg
Calcium chloride dihydrate 0.27 mg

Read the package leaflet before use.
For animal treatment only. To be supplied
only on veterinary prescription.
Keep out of the sight and reach
of children.

UK: Vm 10434/4080 POM-V

IE: VPA 10799/025/001 POM

V11E/3

Dechra

Lot:
EXP: