SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Norcal 40 Solution for Injection

2. Qualitative and Quantitative composition

Each 400ml vial contains:

Active Substance:

11.88g Calcium provided by Calcium Gluconate and Calcium Borogluconate. Also contains 6.5% w/v Boric Acid.

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Solution for injection.

A clear pale, yellow liquid.

4. Clinical Particulars

Cattle

4.2 Indications for use, specifying the target species

For the treatment of hypocalcaemia.

4.3 Contraindications

None.

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.

See also warning under 6.4

(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 and lactation

Norcal 40 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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal period(s)

Meat – Zero days

Milk – Zero hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Mineral Supplement

ATC Vet Code:QA12AX

5.1 Pharmacodynamic properties

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

Boric acid or

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 solution does not contain an antimicrobial preservative.

The product is intended for single use only.

Any product remaining in the bottle after withdrawal of the required dose should be discarded.

6.5 Nature and composition of immediate packaging

400 ml amber glass Type III bottle with black rubber natural wad with aluminium overcap (screw fit).

400 ml white polypropylene container with grey rubber bromobutyl bung with an aluminium overseal.

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

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4167

9. DATE OF FIRST AUTHORISATION

19^th March 1996

10. DATE OF REVISION OF THE TEXT

May 2009