Animedazon Spray, 2.45 % w/w cutaneous spray suspension for cattle, sheep and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlortetracycline hydrochloride

Available from:

aniMedica GmbH

ATC code:

QD06AA02

INN (International Name):

Chlortetracycline hydrochloride

Dosage:

3.21 gram/spray container

Pharmaceutical form:

Cutaneous spray, suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

chlortetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-10-24

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)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT_ _
Patent Blue V 85 % (E 131)
0.23 g
Isobutane (Propellant)
92.2 g
Isopropyl alcohol
Sorbitan trioleate
Silica colloidal anhydrous
Evenly blue coloured spray
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, sheep, pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of superficial traumatic or surgical wounds contaminated
with chlortetracycline-sensitive
agents. The veterinary medicinal product can be used as part of a
treatment for superficial skin and claw
infections, in particular interdigital dermatitis (foot rot, foul in
the foot) and dermatitis digitalis
(Mortellaro disease), caused by micro-organisms sensitive to
chlortetracycline.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients. Do not use in
cases of known resistance to tetracyclines.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Protect the eyes of the animal when spraying in the vicinity of the
head. Clean the affected area
thoroughly before spraying. Use of the veterinary medicinal product
should be based on identification
and susceptibility testing of the target pathogen(s). If this is not
possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the
target pathogen(s) at farm level, or
at local/regional level. Use of the veterinary medicinal product
should be in accordance with official,
national and regional antimicrobial policies. The animal should