SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

VETIVEX 1 (9 mg/ml) solution for infusion for cattle, horses, dogs and cats [UK, IE]

VETIVEX 9 mg/ml solution for infusion for cattle, horses, dogs and cats [BE, FR, NL]

AQUALEC 9 mg/ml solution for infusion for cattle, horses, dogs and cats [DE, DK, SE]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Sodium Chloride 9 mg

Sodium: 150 mmol/litre

Chloride: 150 mmol/litre

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for infusion.

Clear, colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle, horses, dogs and cats.

4.2 Indications for use, specifying the target species

This product is administered by intravenous infusion for the treatment of dehydration in cattle, horses, dogs and cats. It may be used to correct hypovolaemia resulting from shock or gastrointestinal disease (especially where metabolic alkalosis is present, e.g. in cases of sustained vomiting or abomasal disorders in cattle). It may be administered to meet normal fluid and electrolyte requirements when fluids cannot be given orally.

4.3 Contraindications

None

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals:

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

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

A risk of thrombosis with intravenous infusion should be considered.

The 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.

This product should not be used for longer than is necessary to correct and sustain circulating volume. Inappropriate/excessive use may worsen or create a metabolic acidosis.

Maintain aseptic precautions.

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

None.

4.6 Adverse reactions (frequency and seriousness)

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

4.7 Use during pregnancy, lactation or lay

Use under veterinary supervision.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

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 urine output is restored. The maximum infusion rate should be decreased in the presence of cardiac, renal and pulmonary disease.

4.10 Overdose (symptoms, emergency procedures, antidotes)

Monitor fluid output. The administration of a diuretic may be necessary.

4.11 Withdrawal period

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

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Electrolytes, ATCvet code: QB05BB01

5.1 Pharmacodynamic properties

The intravenous infusion is used to replace depleted water and electrolytes when fluids cannot be given orally. It will restore extracellular volume (including plasma volume) and, where metabolic alkalosis is present, it will help to correct it.

5.2 Pharmacokinetic particulars

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.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Water for injections.

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:

100 ml: 18 months

500 ml, 1000 ml and 2000 ml: 2 years

The product should be used immediately and not stored after opening.

6.4. Special precautions for storage

Do not store above 25C.

Do not freeze.

6.5 Nature and composition of immediate packaging

Polyvinylchloride infusion bag overwrapped with polypropylene.

Pack sizes: Individual fluid bags of 100 ml, 500 ml, 1000 ml and 2000 ml, each supplied with a package leaflet, or boxes containing 50 x 100 ml, 20 x 500 ml, 10 x 1000 ml, 4 x 2000 ml.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Dechra Limited
Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire

BD23 2RW

8. MARKETING AUTHORISATION NUMBER

Vm 10434/4079

9. DATE OF FIRST AUTHORISATION

20 June 2013

10. DATE OF REVISION OF THE TEXT

January 2016

Approved: 05 January 2016