COPPER 20MG/ML SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-12-2015
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Active ingredient:
COPPER METHIONATE
Available from:
Ballinskelligs Vet. Products Ltd
ATC code:
QA12CX
INN (International Name):
COPPER METHIONATE
Dosage:
20 Mg/Ml
Pharmaceutical form:
Suspension for Injection
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine, Ovine
Therapeutic area:
Other mineral products
Therapeutic indications:
Vitamins & Minerals
Authorization status:
Authorised
Authorization date:
1991-10-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Copper 20mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
A sterile blue suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention and treatment of copper deficiency in cattle and sheep.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient.
Not for intravenous administration.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The copper status of animals should be checked pre-treatment. This is particularly important in sheep where overdose can
lead to haemolytic crisis.
ACTIVE SUBSTANCE:
Copper (as copper methionate) 20 mg
EXCIPIENT:
Chlorocresol (as preservative)
1 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 24/11/2015_
_CRN 7021889_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Shake the vial vigorously to re-suspend the solid prior to use.
Inject into a clean site only in the neck area by deep intramuscular injection.
Avoid injection into the rump muscles.
It is generally advised to avoid injection on wet days as this can increase the likelihood of contamination.
The product should not be administered with any other injections.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS
To the user:
Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger. If
you are accidentally injected with this product, seek prompt
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