ADRENACAINE SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-03-2015
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Active ingredient:
PROCAINE HYDROCHLORIDE, EPINEPHRINE
Available from:
Norbrook Laboratories Limited
ATC code:
QN01BA52
INN (International Name):
PROCAINE HYDROCHLORIDE, EPINEPHRINE
Dosage:
Unknown
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Procaine, combinations
Therapeutic indications:
Neurological Preparations
Authorization status:
Authorised
Authorization date:
2009-07-17
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adrenacaine Solution for Injection for Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for use in minor surgical procedures particularly dehorning and disbudding in cattle.
4.3 CONTRAINDICATIONS
Do not administer by intravenous, intra-articular or epidural injection.
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
ACTIVE SUBSTANCE:
Procaine Hydrochloride
50 mg/ml
Adrenaline (Epinephrine) (as Adrenaline Tartrate) 0.02 mg/ml
EXCIPIENTS:
Chlorocresol (as preservative)
1.0 mg/ml
Sodium Metabisulphite E223 (as antioxidant)
1.0 mg/ml
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 10/03/2015_
_CRN 7020142_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
I SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Care should be taken not to inject the product intravascularly.
II SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or label to the
physician. Immediately wash off any splashes to the eyes or skin with copious amounts of water.
Seek medical attention if irritation occurs.
Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNA
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