SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

ENERGAID powder for oral solution for calves.

2. Qualitative and quantitative composition

Active Substance:

Each 165 g sachet contains:

Sodium citrate dihydrate 9.73 g

Sodium acetate anhydrous 5.41 g

Sodium propionate anhydrous 1.91 g

Sodium chloride 4.65 g

Potassium chloride 2.96 g

Glucose anhydrous 135.3 g

On reconstitution in 2 litres of water the available ion concentrations are as follows:

Sodium 133 mmol/l

Potassium 20 mmol/l

Chloride 60 mmol/l

Propionate 10 mmol/l

Acetate 33 mmol/l

Citrate 16.54 mmol/l

Dextrose 375 mmol/l

The propionate, acetate and citrate ions together yield 93 mmol/l bicarbonate.

Excipients:

Sunset Yellow Dye (E110) 0.1 g

Silica, colloidal anhydrous 4.97 g

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Powder for oral solution.

A pink powder

4. Clinical Particulars

4.1 Target species

Calves

4.2 Indications for use, specifying the target species

The veterinary medicinal product is a calorific oral rehydration product indicated for the reversal of the processes of dehydration, electrolyte loss, metabolic acidosis and weight loss associated with scour in calves. Efficacy has been demonstrated in E. coli infected calves.

4.3 Contraindications

None.

4.4 Special Warnings for each target species

Milk or milk replacer may continue to be administered at the onset of the veterinary medicinal product administration if deemed appropriate by a veterinary surgeon.

In severe cases some calves may require additional intravenous therapy. In such cases consult a veterinary surgeon.

If signs of disease persist or appear the veterinary surgeon or veterinary practitioner should re-evaluate the situation.

A nipple bottle or tube feeder may be used if considered appropriate. On reconstitution the silicon dioxide does not go into solution but remains as a fine powder in the mixing vessel.

4.5 Special precautions for use

Special precautions for use in animals

None.

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

None

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction

Not investigated.

4.9 Amounts to be administered and administration route

Dosage: A solution for oral administration, is prepared as follows: dissolve the contents of one sachet in 2 litres of clean, warm water. Keep feeding utensils clean.

Administration: Two litres of the solution, freshly prepared as directed, is offered twice daily for 2 days. For the next two days, 1 litre of solution and 1 litre of milk or milk replacer (either mixed together or fed separately) are administered morning and evening. Thereafter normal diet is resumed. If symptoms are severe, the solution may be fed 3 or 4 times daily. The solution may be given for a maximum of 4 days only, when administered on its own. Normal feeding should be resumed after the course of treatment.

The product has been demonstrated to be well tolerated in the target species. Given the osmotic character of the product, overdose may lead in some cases to softening of the faeces. Therefore, care should be taken in the correct preparation of the resulting oral rehydration solution.

Zero days

5. pharmacological properties

Pharmacotherapeutic group: Oral electrolytes and carbohydrates

ATC Vet Code: QA07CQ02

5.1 Pharmacodynamic properties

The product provides an adequate source of nutrients and electrolytes to correct the symptoms associated with diarrhoea. In particular, it provides potassium to counteract decreasing intracellular potassium levels.

The intestinal absorption of water is dependant largely on sodium absorption. The concentration of sodium at a level of 133 mmol/l optimises the basic rehydrating ability of the product. Certain compounds including glucose and the bicarbonate precursors, citrate, propionate and acetate are able to assist enteric sodium uptake.

Absorption and metabolism of the bicarbonate precursors provides a potential 93 mmol/l of bicarbonate which has an important role to play in correcting acidosis, and terminally are an additional source of energy for the weakened calf. The final reconstituted solution also provides 375 mmol/l of glucose providing a high calorific content. Glucose, citrate and propionate all enter the Tricarboxylic Acid (Krebs) Cycle leading to the formation of energy, whilst acetate although utilised by a different route still yields energy.

5.2 Pharmacokinetic properties

-

6. Pharmaceutical particulars

6.1 List of excipients

Sunset Yellow Dye (E110)

Silica, colloidal anhydrous

6.2 Incompatibilities

None.

Unopened sachets: 24 months

Reconstituted solution: 24 hours.

Do not store above 25ºC.

Store in a dry place.

Each sachet contains 165 g and is composed of paper/low density polyethylene/aluminium. 24 sachets are contained in each carton.

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

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Camlough Road

NEWRY

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4127

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

18th September 2002

10. DATE OF REVISION OF THE TEXT

July 2007

PROHIBITION OF SALE, SUPPLY AND/OR USE