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Date: Thursday, December 2, 2021 15:52

Release 2.47
Ophtocycline® 10 mg/g Eye Ointment for Dogs, Cats and Horses
 
Species: Cats, Dogs, Horses and other equidae
Therapeutic indication: Pharmaceuticals: Antimicrobials: Topical preparations: Ear/eye/nose
Active ingredient: Chlortetracycline Hydrochloride
Product:Ophtocycline® 10 mg/g Eye Ointment for Dogs, Cats and Horses
Product index: Ophtocycline 10 mg/g Eye Ointment for Dogs, Cats and Horses
Withdrawal notes: Meat and offal: 1 day. Not authorised for use in horses producing milk intended for human consumption.
Qualitative and quantitative composition
1 gram contains: Active substance:
Chlortetracycline hydrochloride 10.0 mg
(equivalent to 9.3 mg chlortetracycline)
Pharmaceutical form
Eye ointment. Yellowish to yellow homogenous ointment.
Clinical particulars
Target species
Dogs, cats and horses.
Indications for use
Treatment of keratitis, conjunctivitis and blepharitis caused by Staphylococcus spp., Streptococcus spp., Proteus spp. and/or Pseudomonas spp. sensitive to chlortetracycline.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special precautions for use in animals
Due to the likely variability (time, geographical) in the occurrence of tetracycline resistant bacteria, bacteriological sampling and susceptibility testing are recommended.
Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.
Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to chlortetracycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Due to possible sensitisation and/or hypersensitivity reactions direct skin contact should be avoided during administration. Wear impermeable gloves when handling the product.
In case of contact with the skin, wash exposed skin with water and soap. If you develop symptoms following exposure such as a skin rash, seek medical advice immediately and show the package leaflet or label to the physician.
Use during pregnancy and lactation
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Amounts to be administered and administration route
For ocular use only.
Horses: Apply 2-3 cm of ointment (depending on the size of the animal) in the conjunctival sac 4 times a day for 5 days. If after 3 days of treatment no clinical improvement has occurred, alternative therapy should be considered.
Dogs and cats: Apply 0.5-2 cm of ointment (depending on the size of the animal) in the conjunctival sac 4 times a day for 5 days. If after 3 days of treatment no clinical improvement has occurred, alternative therapy should be considered.
Withdrawal periods
Meat and offal: 1 day
Not authorised for use in horses producing milk intended for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: ophthalmologicals: antibiotics
ATCvet code: QS01AA02
Pharmacodynamic properties
Chlortetracycline hydrochloride is a first-generation tetracycline. It is a predominantly bacteriostatic antibiotic that inhibits bacterial protein synthesis by binding to the 30S subunit of the bacterial ribosome. Chlortetracycline has time-dependent as well as concentration-dependent effects with AUC/MIC being the main PK/PD parameter. Chlortetracycline has a broad spectrum including both aerobic and anaerobic Gram-positive and Gram-negative bacteria. Resistance may be mediated by efflux, ribosomal protection and ribosomal modification. Cross-resistance among tetracyclines is common.
Pharmacokinetic properties
Chlortetracycline is a non-lipophilic molecule. After topical administration in the eye, systemic absorption is expected to be minimal.
Pharmaceutical particulars
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.
Shelf-life after first opening the tube: 14 days
Special precautions for storage
Do not store above 25ºC.
Immediate packaging
Epoxy resin lacquered aluminium tube with a content of 5 g, with a HDPE cannula and screw cap. One tube in a cardboard box.
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)
Le Vet Beheer BV, Wilgenweg 7, 3421 TV Oudewater, The Netherlands.
Marketing Authorisation Number
Vm 41821/4043
Significant changes
Date of the first authorisation or date of renewal
9 August 2017
Date of revision of the text
June 2018
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:Ophtocycline 10 mg/g Eye Ointment for Dogs, Cats and Horses
GTIN:08717973569411