Copasure 24 g Capsule, Hard

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Copper Oxide

Available from:

Animax Ltd

ATC code:

QA12CX

INN (International Name):

Copper Oxide

Pharmaceutical form:

Capsule, hard

Prescription type:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Therapeutic group:

Cattle

Therapeutic area:

Mineral

Authorization status:

Authorized

Authorization date:

2002-05-24

Summary of Product characteristics

Revised: July 2023
AN: 00342/2023
Page 1 of 5
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
24.00 g
(equivalent to elemental copper
20.88 g)
EXCIPIENTS
Capsule
Sunset Yellow (E110)
0.0016 g
Erythrosine (E127)
0.0080 g
Titanium dioxide (E171)
0.0066 g
Iron oxide (E172)
0.0042 g
Methyl Parahydroxybenzoate
0.0068 g
Propyl Parahydroxybenzoate
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.
Revised: July 2023
AN: 00342/2023
Page 2 of 5
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 interact