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Date: Tuesday, May 7, 2024 22:21

Release 2.56
TAF Spray® 28.5 mg/g Cutaneous Spray, Solution
 
Species: Cattle, Goats, Horses and other equidae, Mink, Pigs, Rabbits, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Skin
Active ingredient: Thiamphenicol
Product:TAF Spray® 28.5 mg/g Cutaneous Spray, Solution
Product index: TAF Spray 28.5 mg/g Cutaneous Spray, Solution
Cattle - milk: Zero hours
Cattle - meat: Zero days
Sheep - meat: Zero days
Pig - meat: 14 days
Withdrawal notes: Do not use on the udder of lactating animals if their milk is intended for human consumption. Withdrawal period - Goat meat: Zero days. Withdrawal period - Rabbit meat: Zero days.
Incorporating:
Qualitative and quantitative composition
Each g contains: Active substance: Thiamphenicol 28.5 mg
Excipients: Curcumine (E100) 0.5 mg
Pharmaceutical form
Cutaneous spray, solution. Clear yellow solution.
Clinical particulars
Target species
Horses, cattle, goats, sheep, pigs, mink, rabbits.
Indications for use
In all target species:
Treatment of superficial wound infections caused by micro-organisms susceptible to thiamphenicol.
In cattle, goats and sheep:
Treatment of infections of the claw and hoof such as foot rot, interdigital dermatitis, digital dermatitis caused by micro-organisms susceptible to thiamphenicol.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients. See also Withdrawal periods.
Special warnings for each target species
Clean the affected area thoroughly before spraying. After administration of the product the animal should be kept on dry ground for at least one hour.
Special precautions for use in animals
Protect the eyes when spraying in the vicinity of the head. The animal should be prevented from licking the treated area, or treated areas on other animals.
Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacterial resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In cases of accidental eye contact, this product may cause irritation. The use of eye protection (such as safety glasses) is recommended. Do not spray towards a person. If irritation occurs, seek medical advice and show the label or package leaflet to the physician.
Asthma and rhinitis may occur following inhalation. Do not inhale vapours. Apply the product in the open air, or in a sufficiently ventilated area.
This product can be toxic when ingested.
Contact with the treated area should be avoided and children should not be allowed to play with treated pet animals until the application site is dry.
Do not eat, drink or smoke during administration.
Hypersensitivity (allergy) to thiamphenicol may occur rarely. People with known hypersensitivity to thiamphenicol should avoid contact with the veterinary medicinal product. Should symptoms occur such as swelling of the face, lips or eyes or difficulty breathing, seek urgent medical attention.
Wash hands after use.
Do not spray on an open flame or other ignition source.
Do not pierce or burn, even after use.
Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Only use in accordance with the benefit/risk assessment by the responsible veterinarian.
Amounts to be administered and administration route
Cutaneous use. Shake the container thoroughly before spraying. Spray the solution on the affected area for 3 seconds (equivalent to approximately 45 mg thiamphenicol) once a day. Treatment can be repeated depending on the healing process, up to 3 consecutive days.
The container should be held at a distance of approximately 15-20 cm from the area to be sprayed. For optimal use, wounds should be cleaned before application. The spray container is suitable to be used in upright and inverted positions.
Withdrawal periods
Meat and offal:
Horses, cattle, goats, sheep, rabbits: zero days.
Pigs: 14 days.
Milk: zero hours.
Do not use on the udder of lactating animals if their milk is intended for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Antibiotic for dermatological use, other antibiotic.
ATCvet code: QD06AX
Pharmacodynamic properties
Thiamphenicol is a broad-spectrum antimicrobial agent, structurally similar to chloramphenicol. It is bacteriostatic for both Gram-positive and Gram-negative bacteria and acts by blocking the protein synthesis.
The most common mechanism of resistance to thiamphenicol is acquired by micro-organisms via a plasmid-encoded acetyltransferase that inactivates the drug. Cross-resistance of thiamphenicol with chloramphenicol is complete in bacteria which possess chloramphenicol acetyltransferases (CATs). Acetylation of the hydroxyl groups by CATs prevents drug binding to the 50S ribosomal subunit. There are also other mechanisms of resistance, such as efflux systems, inactivation by phosphotransferases, and mutation of the target site or permeability barriers. The CAT genes are commonly found on plasmids and most of these plasmids carry one or more additional resistance genes.
Pharmacokinetic properties
The absorption of thiamphenicol following dermal administration is negligible.
Pharmaceutical particulars
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Special precautions for storage
Extremely flammable aerosol. Pressurised container: May burst if heated. Protect from sunlight. Do not expose to temperatures exceeding 50°C. Keep away from heat/hot surfaces/sparks/open flames and other ignition sources. No smoking.
Immediate packaging
Aluminium pressurised containers with epoxy phenolic pigment lacquer of 50, 150, 200, 300 and 400 ml:
- Polyamide/polyethylene valve mechanism integrated in aluminium container top.
- Polypropylene spray nozzle with polyoxymethylene nebuliser.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Eurovet Animal Health BV, Handelsweg 25, 5531 AE Bladel, The Netherlands.
Marketing Authorisation Number
Vm 16849/4051
Significant changes
Date of the first authorisation or date of renewal
13 January 2015
Date of revision of the text
October 2019
Any other information
For animal treatment only. To be supplied only on veterinary prescription. Keep out of the sight and reach of children.
Legal category
Legal category: POM-V
GTIN
GTIN description:TAF Spray 28.5 mg/g Cutaneous Spray, Solution 150 ml:
GTIN:08714225156863