Animedazon Spray
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-09-2013
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Active ingredient:
chlortetracycline 3.21 g
Available from:
aniMedica GmbH
ATC code:
QD06AA02
Pharmaceutical form:
Cutaneous spray
Therapeutic group:
chlortetracycline
Therapeutic area:
Cattle, Pigs, Sheep
Authorization date:
2010-02-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Animedazon Spray, 2.45 % w/w cutaneous spray suspension for cattle, sheep and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray container contains:
ACTIVE SUBSTANCE :
Chlortetracycline hydrochloride 3.210 g (equivalent to 2.45 % w/w)
(equivalent to chlortetracycline 2.983 g)
EXCIPIENT(S):
Patent Blue V 85 % (E 131):
0.23 g
Isobutane
92.2 g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous Spray, Suspension
Evenly blue coloured spray
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of superficial traumatic or surgical wounds contaminated with chlortetracycline-sensitive
agents. The product can be used as part of a treatment for superficial skin and claw infections, in
particular interdigital dermatitis (foot rot and foul in the foot) and digital dermatitis caused by micro-
organisms sensitive to chlortetracycline.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to tetracyclines. Do not use on the udder of lactating animals if
milk is intended for human consumption.
4.4
SPECIAL WARNINGS
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Protect the eyes of the animal when spraying in the vicinity of the head. Clean the affected area
thoroughly before spraying. Use of the product should be based on susceptibility testing and take into
account official and local antimicrobial policies. The animal should be
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