Opticlox Eye Ointment 16.7% w/w
Cloxacillin
Last verified
Veterinary medicinal product: eye ointment. Distribution category: POM-V (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Cloxacillin.1
In short: questions and answers
- Does Opticlox Eye Ointment 16.7% w/w need a prescription?
- Prescription only. As stated in the registration decision.1
- Which animals is Opticlox Eye Ointment 16.7% w/w for?
- Cats, Cattle, Dogs, Horses, Sheep.1
- What is the active substance in Opticlox Eye Ointment 16.7% w/w?
- Cloxacillin. ATCvet code: QS01AA90.13
- What is the withdrawal period of Opticlox Eye Ointment 16.7% w/w according to the leaflet?
- Cattle, milk: 0 days; Sheep, milk: 0 days; Cattle, meat: 0 days; Sheep, meat: 0 days; Horses, meat: 0 days.3
- Dispensing
- Prescription only1
POM-V: Prescription Only Medicine - Veterinarian. Supplied only on a prescription written by a veterinary surgeon who has assessed the animal.12
Supplied only on a veterinarian's prescription. As stated in the registration decision.
- Active substance
- Cloxacillin
- ATCvet code
- QS01AA903
- Manufacturer
- Marketing authorisation holder: Norbrook Laboratories Limited
Withdrawal period
Summary of product characteristics
Composition
Active Substance:
Each 5 g syringe contains 16.7% w/w Cloxacillin (as cloxacillin benzathine 21.3% w/w) equivalent to 835 mg cloxacillin.
Excipients:
For a full list of excipients, see section 6.1
6.1 List of excipients
Aluminium Stearate
Liquid Paraffin
Pharmaceutical form
Eye ointment.
A smooth sterile cream for ophthalmic use.
Pharmacological properties
Pharmacotherapeutic group: Antibiotics
ATC Vet Code: QS01AA90
5.1 Pharmacodynamic properties
Cloxacillin is active against Penicillin G resistant staphylococci. It binds to membrane bound proteins known as Penicillin-binding proteins (PBP's).
Target species
Horses
Cattle
Sheep
Dogs
Cats
Indications
Opticlox Eye Ointment is indicated for the treatment of eye infections in cattle, sheep, horses, dogs and cats caused by Staphylococcus spp and Bacillus spp.
Dosage
For topical administration only.
Evert the lower eyelid and instill a steady flow of ointment into the lower conjunctival sac. Normally a single application only is required, but treatment may be repeated after 48 - 72 hours if necessary.
Dosage guide:
| Cattle and Horses: | approximately 5 - 10 cm of ointment per eye. |
|---|---|
| Sheep: | approximately 5 cm of ointment per eye. |
| Dogs and Cats: | approximately 2 cm of ointment per eye. |
For animals with only a single infected eye it is recommended, to prevent cross infection, that both eyes be treated, treating the uninfected eye first to avoid transferring the infection. Each syringe to be used once only.
Contraindications
None, according to available data.
Adverse reactions
None, according to available data.
Warnings
Special precautions for use in animals
For external use only.
Wherever possible, Opticlox Eye Ointment should only be used based on susceptibility testing.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Operator warning - penicillin/cephalosporin sensitivity:
Penicillins and cephalosporins may cause hypersensitivity (allergy) following, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa.
Allergic reactions to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure such as skin rash you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes are more serious symptoms and require urgent medical attention.
Wash hands after use.
Use during pregnancy, lactation or lay
Opticlox Eye Ointment can be safely administered to pregnant and lactating animals.
Interactions
None known.
Overdose
No treatment specified.
Special warnings
No special warnings.
Withdrawal period
Cattle and Sheep (Milk): Zero hours.
Cattle, Sheep and Horses (Meat): Zero days.
Incompatibilities
None known.
Immediate packaging
A white low-density polyethylene syringe with a snap on cap containing 5g of a smooth sterile cream.
Storage
Do not store above 25ºC.
Each syringe should be used on one occasion only.
Unused ointment should be discarded after treatment.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Disposal of unused product
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Additional information
Vm 02000/4075
9 DATE OF FIRST AUTHORISATION
17th December 1986.
10 DATE OF REVISION OF THE TEXT
19th November 2008.
Registration holder
Norbrook Laboratories Limited
Station Works
Newry
Co. Down, BT35 6JP
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32