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Date: Thursday, April 25, 2024 11:45

Release 2.76
Cyclo Spray®, Chlortetracycline HCL 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle
 
Species: Cattle, Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Skin
Active ingredient: Chlortetracycline Hydrochloride
Product:Cyclo Spray®, Chlortetracycline HCL 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle
Product index: Cyclo Spray, Chlortetracycline HCL 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle
Cattle - milk: Zero hours
Cattle - meat: Zero days
Sheep - meat: Zero days
Pig - meat: Zero days
Withdrawal notes: Do not use on the udder of lactating animals if milk is intended for human consumption. Stained part of the pigskin must be removed prior to the rest of the animal being used for human consumption.
Incorporating:
Qualitative and quantitative composition
Active substance: Chlortetracycline HCl. The active ingredient content is 2.45 % w/w
Excipients:
Patent Blue V, colouring agent 0.15 % w/w
Butane 100 68.77 % w/w
Pharmaceutical form
Cutaneous Spray, suspension. Blue coloured.
Clinical particulars
Target species
Cattle, sheep and pigs.
Indications for use
Prevention of infections of superficial traumatic or surgical wounds caused by micro-organisms sensitive to chlortetracycline.
The product can be used as part of a treatment for superficial claw/hoof infections, in particular interdigital dermatitis (foot rot) in sheep and digital dermatitis in cattle.
Contraindications
Do not use in case of hypersensitivity to tetracyclines.
Special precautions for use in animals
Protect the eyes when spraying in the vicinity of the head. Clean the affected area thoroughly before spraying. Treatment of foot conditions should always be preceded by appropriate paring of the hoof, as this is critical for achieving an adequate response. After spraying the feet, the animal should be kept on dry ground for at least one hour.
The animal should be discouraged from licking the treated area, or treated areas on other animals.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions to chlortetracycline.
Wear appropriate impermeable gloves whilst handling the product.
Because of risk of eye irritation, contact with the eyes should be avoided. Protect the eyes and face.
Do not spray on an open flame or other ignition source. Do not pierce or burn, even after use.
Avoid inhaling vapours. Apply the product in open air or in sufficiently ventilated area.
Wash hands after use.
Do not eat or smoke whilst administering the product.
In case of accidental ingestion or in case of contact with eyes, seek medical advice immediately and show the label to the physician.
Adverse reactions
Hypersensitivity reactions may occur rarely.
Use during pregnancy and lactation
Following cutaneous administration of CYCLO SPRAY, absorption of chlortetracycline is negligible and it is not detectable in the milk.
Interactions
After cutaneous administration of chlortetracycline spray, absorption of chlortetracycline is negligible. No data on interactions with other local treatments are available.
Amounts to be administered and administration route
CYCLO Spray is indicated for cutaneous administration. Shake the container thoroughly before spraying. The container should be held at a distance of 15-20 cm from the area to be sprayed; spray for approximately 3 seconds (equivalent to approximately 3.9 g of product or 0.10 g chlortetracycline) until the treatment-area is evenly coloured. In case of claw/hoof infections this treatment should be repeated after 30 seconds.
- For prevention of infections after superficial traumatic or surgical wounds a single administration is recommended.
- For treatment of Dermatitis Digitalis, a double administration (with a 30 second interval) is recommended daily for three consecutive days.
- For treatment of other hoof infections (foot rot), a double administration (with a 30 second interval) is recommended. Dependent on the seriousness of the injury and the rate of improvement treatment should be repeated within 1 to 3 days
Withdrawal periods
Meat : zero days
Milk : zero hours
Do not use on the udder of lactating animals if milk is intended for human consumption.
Stained part of the pigskin must be removed prior to the rest of the animal being used for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Tetracycline antibiotics.
ATCvet code: QD06AA02
Pharmacodynamic properties
In vitro, chlortetracycline is primarily bacteriostatic. Chlortetracycline exerts its action by inhibiting the protein synthesis of the bacterial cell. Especially cell-division and the formation of the cell wall are impaired. Chlortetracycline binds to receptors on the 30S-subunit of the bacterial ribosome where they interfere with the binding of the aminoacyl-transfer RNA to the acceptor site on the messenger RNA ribosome complex.
Pharmacokinetic properties
Following cutaneous administration of chlortetracycline spray, chlortetracycline absorption is negligible. Therefore CYCLO SPRAY will only have a local effect, no systemic effects are to be anticipated.
Pharmaceutical particulars
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 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
A 270 ml pressurised container of coated tin plate with a plastic valve mechanism and spraying nozzle containing 130.76 g of product.
A 520 ml pressurised container of coated tin plate with a plastic valve mechanism and spraying nozzle containing 261.52 g of product.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products 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 16849/4002
Significant changes
Date of the first authorisation or date of renewal
14 August 2006
Date of revision of the text
January 2023
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:Cyclo Spray, Chlortetracycline HCL 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle 200 ml:
GTIN:08714225165933
GTIN description:Cyclo Spray, Chlortetracycline HCL 2.45% w/w, Cutaneous Spray, Suspension for Pigs, Sheep and Cattle 400 ml:
GTIN:08714225165940