SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Dunlop’s 40CB Solution for Injection

2. Qualitative and quantitative composition

Active Substance:

40% w/v Calcium Borogluconate

Each 400ml contains:-

11.88g Calcium provided by Calcium Gluconate and Calcium Borogluconate.

Contains 6.5% w/v Boric Acid

Excipients:

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Solution for injection

A clear, pale yellow liquid

4. Clinical Particulars

4.1 Target species

Cattle

4.2 Indications for use, specifying the target species

For the treatment of hypocalcaemia

4.3 Contra-indications

None

4.4 Special Warnings for each target species

None

4.5 Special precautions for use

i. Special precautions for use in animals

The solution should be warmed to body temperature before administration. Intravenous injections should be given slowly. Observe aseptic precautions.

Massage gently sites of subcutaneous administration.

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

Care should be taken to avoid accidental self-injection: may cause irritation at site of injection.

4.6 Adverse reactions (frequency and seriousness)

Provided the recommendations are followed carefully, undesirable effects should not occur.

4.7 Use during pregnancy, lactation or lay

Dunlop’s 40CB can be safely administered to pregnant and lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

No known interactions.

4.9 Amounts to be administered and administration route

Administer by subcutaneous or slow intravenous injection at the following rate:

Cattle : 150 - 500 ml

Not applicable.

Meat: Zero days

Milk: Zero hours

5. pharmacological properties

Pharmacotherapeutic group: Mineral supplements, Calcium

ATC Vet Code: QA12AA

Milk fever which is characterised by hypocalcaemia is caused by an acute drop in the level of ionised calcium. Administration of calcium borogluconate by subcutaneous or slow intravenous injection replenishes plasma calcium levels and reverses the hypocalcaemia.

6. Pharmaceutical particulars

6.1 List of excipients

Boric Acid (for pH adjustment)

Sodium Bicarbonate (for pH adjustment)

Water for Injections

None known

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Do not store above 25^ºC. Protect from light.

This product does not contain an antimicrobial preservative.

The product is intended for single use only. Any product remaining in the bottle after withdrawal of the first dose should be discarded.

400 ml Amber Type III glass vials sealed with black rubber wads and aluminium screw caps, or 400 ml white polypropylene containers sealed with grey bromobutyl bungs and aluminium caps.

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

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm: 02000/4166

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation – 19^th March 1996

10. DATE OF REVISION OF THE TEXT

June 2010