Medine.co.uk

Copasure 24 G Capsule, Hard

Revised: 22 July 2010

AN: 00221/2010

SUMMARY OF PRODUCTS CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT


Copasure 24g capsule, hard.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION


Each capsule contains


Active Substance

Copper Oxide

(equivalent to elemental copper


Excipients

Capsule

Sunset Yellow (E110)

Erythrosine (E127)

Titanium dioxide (E171)

Iron oxide (E172)

Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate




24.00 g

20.88 g)



0.0016 g

0.0080 g

0.0066 g

0.0042 g

0.0068 g

0.0017 g


For a full list of excipients see Section 6.1.

3.

PHARMACEUTICAL FORM


Capsule, hard.

Maroon capsule of approximately 48mm length and 20mm diameter, (Size 11L).

4.

CLINICAL PARTICULARS

4.1

Target species


Cattle.

4.2

Indications for use, specifying the target species


For the prevention and treatment of hypocuprosis in cattle.

4.3

Contraindications


Do not use unless copper deficiency is known to exist or known to be a risk.

Do not administer to pre-ruminant animals.



4.4



Special warnings for each target species


Do not administer to calves under 100kg or pre-ruminant calves.

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 required.

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.
Young stock (100-300kg bw) receive one 24g (maroon) capsule, (equivalent to 80 mg copper oxide/kg for a 300 kg animal).



Cattle (over 300kg bw) receive one or two 24g (maroon) capsules, depending on the severity of the copper deficiency (one capsule is equivalent to 60 mg copper oxide//kg for a 400 kg animal, two capsules are equivalent to 120 mg copper

oxide//kg for a 400 kg animal).


The capsules should be administered orally over the back of the tongue. Cattle are dosed using conventional balling guns, follow the instructions supplied with the balling gun. Always check the animal has swallowed the capsule.


To be used at intervals of not less than 6 months. The recommended dosage should maintain adequate copper levels for the whole grazing season unless more frequent dosing is recommended on veterinary advice.

4.10

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


Copper toxicity may lead to the following clinical signs; thirst, apathy, haemolytic crises, 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.


ATCVet 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 releasedto 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


Capsule

E110 - Sunset Yellow

E127 - Erythrosine

E171 - Titanium Dioxide

E172 - Iron Oxide

Methyl parahydroxybenzoate

Propyl parahydroxybenzoate

Sodium lauryl sulfate

Porcine gelatine

6.2

Incompatibilities


None known.

6.3

Shelf life


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

6.4

Special precautions for storage


Do not store above 25°C.

Protect from light.

Protect from freezing.

Protect from moisture. Store in a dry place.

Partly used containers should be tightly closed.

6.5

Nature and composition of immediate packaging


24 capsules contained in a shrink wrapped polyethylene coated cardboard tray with perforated supports sealed with a polyethylene coated cardboard lid.

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 4016/4003.

9.

DATE OF FIRST AUTHORISATION


Date: 24th May 2002.

10.

DATE OF REVISION OF THE TEXT


Date: July 2010



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