Revised: November 2010
AN: 00611/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Copprite 4 g hard capsule
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient g/capsule
Copper oxide 4.0*
* equivalent to 3.4 g metallic copper
Other ingredients
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Revised: November 2010
AN: 00611/2010
Quinoline yellow (E 104)
Indigo carmine (E 132)
Titanium dioxide (E 171)
g/100g
0.160
0.270
1.200
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Revised: November 2010
AN: 00611/2010
3. PHARMACEUTICAL FORM
Capsule, hard.
An opaque green, hard, gelatine capsule containing copper oxide rods.
4. CLINICAL PARTICULARS
4.1 Target species
Sheep and calves.
4.2 Indications for use, specifying the target species
For the prevention and treatment of copper deficiency in sheep and calves. For the prevention of swayback in lambs by treatment of ewes.
4.3 Contraindications
Do not use unless copper deficiency is known to exist or known to be a risk.
4.4 Special warnings for each target species
Following administration of Copprite to sheep or cattle, other forms of copper supplementation are unnecessary and must not be given.
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.
Caution is advised and veterinary advice should be sought before treating housed sheep and those breeds known to be susceptible to copper toxicity (e.g. North Ronaldsay).
Administration should be avoided in animals with known hepatic impairment.
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 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
Can be used during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
No known interactions with other medicaments, however copper interacts with other elements including molybdenum, sulphur, iron and zinc.
4.9 Amounts to be administered and administration route
Administer the capsules by the oral route.
Ewes: 1 capsule. For the prevention of congenital swayback the dose should be given at tupping or during the first half of pregnancy. On farms where copper deficiency is known to be particularly severe it is advisable to administer the dose during the second or third month of pregnancy rather than at tupping.
Calves: Young calves (under 100kg) can be satisfactorily dosed with 2 x 4g capsules.
Dosing instructions:
Dosing should be carried out using a Copprite doser or similar dosing device. For optimum results the following precautions should be noted:
The animal to be treated should be held securely and the doser used gently to avoid injury or choking.
The end of the doser should be passed over the back of the tongue before ejecting the capsule.
Each animal should be carefully checked (before being released) to ensure that it has swallowed the capsule.
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.
4.11 Withdrawal period(s)
Cattle: Meat - Zero days
Milk - Zero hours
Sheep: Meat - Zero days
Milk - Zero hours
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Mineral supplements, other.
ATC Vet Code: QA12CX
A proportion of the administered copper oxide lodges in the abomasum of the treated animal. This provides a sustained-release source of copper for absorption from the gut. This steady supplementation ensures adequate copper status but avoids the sharp rises in copper levels which can be associated with copper toxicity.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Gelatin
Ferric Oxide Yellow (E 172)
Brilliant Blue FCF (E 133)
Titanium dioxide (E 171)
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
Store in a dry place.
Store in tightly closed original container.
Protect from direct sunlight.
Protect from heat.
6.5 Nature and composition of immediate packaging
Pack size: 50 capsules.
Container: White opaque polypropylene tub.
Closure: White opaque polyethylene cap (push fit).
Dosing device: Copprite capsule dosing gun.
Contents: Large, green, hard, gelatin capsules containing copper oxide rods.
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
Pfizer Ltd.
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8. MARKETING AUTHORISATION NUMBER
Vm 00057/4142
9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation 24th September 1993
10. DATE OF REVISION OF THE TEXT
November 2010
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