4.5

Special precautions for use

i.

Special precautions for use in animals

Animals should only be dosed if copper deficiency is known to exist or known to be a risk.

No other form of copper supplementation should be given immediately prior to or 6 months after administration of the capsules.

Do not exceed the recommended dose.

Care must be taken when dosing animals to avoid causing injury to the mouth and pharynx.

ii.

Special precautions for the person administering the veterinary medicinal product to animals

None.

iii.

Other precautions

None

4.6

Adverse reactions (frequency and seriousness)

Not to be expected provided the recommended dosage regimes are followed.

4.7

Use during pregnancy, lactation or lay

No adverse effects known

4.8

Interaction with other medicinal products and other forms of interaction

Copper reacts with many elements, the most important of which is molybdenum. This interaction may lead to the formation of insoluble copper molybdates which may reduce absorption of copper from the gut

4.9

Amount(s) to be administered and administration route

For oral administration only.

Adult sheep (50kg) receive one 4g (ivory) capsule (equivalent to 80 mg CuO/kg for a 50 kg sheep).

Calves (ruminant calves 75-100kg and over 2 months of age) receive two 4g (ivory) capsules (equivalent to 80 mg CuO/kg for a 100 kg calf).

Adult sheep and calves may be dosed with standard drench guns fitted with the special adapters provided. The 4g capsule is inserted at one end and the other is attached to the drench gun. The capsule is ejected by expulsion with water. Conventional balling guns may also be employed. Always check the animal has swallowed the capsule.

To be used at intervals of not less than 6 months.

In ewes, for the prevention of congenital swayback, the dose should be given at tupping or during the first half of pregnancy. It may be advisable to administer the dose during the second or third month of gestation rather than at tupping on farms where copper deficiency is particularly severe.

4.10

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

Copper toxicity may lead to the following clinical signs; thirst, apathy, haemolytic anaemia, jaundice, hepatic necrosis and death.

No specific antidote is available for use in food producing animals.

4.11

Withdrawal period(s)

Meat – zero days

Milk – zero hours

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Mineral supplements, other.

ATC Vet Code: QA12CX

5.1

Pharmacodynamic properties

The effect is to provide a supplementary source of a single nutrient, copper, over a prolonged period of time. Copper oxide rods are released in the reticulo-rumen, passing slowly through the ruminant stomachs for a period of 2 to 3 months. Exposure to abomasal acidity causes slow particle solution, enabling partial absorption to take place.

5.2

Pharmacokinetic properties

The copper stored in the liver then acts as a depot from which copper is slowly released to maintain normal concentrations in the blood during periods when the animal may be receiving an inadequate copper intake.

The recommended dosage should maintain adequate copper levels for the whole grazing season unless more frequent dosing is required on veterinary advice.

5.3

Environmental properties

Not applicable

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Gelatin

Capsule colourants

E171 titanium dioxide

E172 yellow iron oxide

6.2

Incompatibilities

None known.

6.3

Shelf life

Shelf life of the veterinary medicinal product as packaged: 4 years

6.4

Special precautions for storage

Do not store above 25°C.

Protect from light.

Protect from frost.

Protect from moisture

Store in a dry place.

Partly used containers should be closed

6.5

Nature and composition of immediate packaging

50, 100 or 250 capsules contained within a white opaque polypropylene tub with a paper/foam spacer or foam spacer sealed with a white paque polypropylene screw fit lid.

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, if appropriate

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

Animax Ltd

Shepherds Grove West

Stanton

Bury St Edmunds

Suffolk

IP31 2AR

U.K.

8.

MARKETING AUTHORISATION NUMBER(S)

Vm 14016/4001

9.

DATE OF FIRST AUTHORISATION

Date: 23 December 1999

10.

DATE OF REVISION OF THE TEXT

Date: December 2012

Approved by: 05/12/12