Duphacycline Aerosol 3.6% w/w Cutaneous Spray Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline Hydrochloride

Available from:

Norbrook Laboratories Limited

ATC code:

QD06AA03

INN (International Name):

Oxytetracycline Hydrochloride

Authorization status:

Expired

Summary of Product characteristics

Revised: November 2011
AN: 01298/2011
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphacycline Aerosol 3.6 % w/w Cutaneous Spray Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Each 140g aerosol
Oxytetracycline Hydrochloride 3.6% w/w,
5g
Excipients:
Patent Blue V (E 131) 0.33%w/w as a marker dye
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cutaneous spray solution
A blue opaque solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, sheep and pigs
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For the treatment of foot rot in sheep and topical infections caused
by
organisms sensitive to oxytetracycline in cattle, sheep and pigs
4.3
CONTRAINDICATIONS
For external use only
4.4
SPECIAL WARNINGS
For the treatment of superficial infections only
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None
Revised: November 2011
AN: 01298/2011
Page 2 of 4
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Keep away from eyes.
Avoid contact with skin.
Avoid inhaling vapours.
Wash hands after use.
Do not spray on a naked flame or any incandescent material.
Highly flammable.
Must be used in a well ventilated area.
Do not smoke when using this product.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The product can be safely administered to pregnant and lactating
animals.
4.8
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For the treatment of foot rot, the hooves should be cleaned and pared
prior
to administration. Wounds should be cleaned prior to administration.
Shake
the can before use. Spray for a few seconds or until the lesion is
adequately
covered.
Treated sheep should be allowed to stand on dry ground for one hour
before
returning to pasture.
4.10
OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTI