Copinox Cattle 24 g Capsule, Hard

Summary of Product characteristics

                                Revised: 22 July 2010
AN: 00218/2010
Page 1 of 5
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Copinox Cattle 24g capsule, hard.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains
ACTIVE SUBSTANCE
Copper Oxide
(equivalent to metallic copper
EXCIPIENTS
Capsule shell
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.
Revised: 22 July 2010
AN: 00218/2010
Page 2 of 5
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 in
                                
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