Cepfenicol 5 mg/ml Eye Drops, Solution for Dogs and Cats

Excipients:
Qualitative composition of excipients
and other constituents
Quantitative composition if that
information is essentialfor proper
administration of the veterinary
medicinal product
Benzalkonium chloride0.040 mgBoric acidBoraxPolysorbate 80Water for injections
Clear, colourless to slightly yellowish solution.
3. CLINICAL INFORMATION
3.1 Target species
Dog and cat
3.2 Indications for use for each target species
Treatment of bacterial eye infections such as conjunctivitis, keratitis, dacryocystitis
and blepharitis.
3.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the
excipients.
3.4 Special warnings
Before starting treatment, it should be ensured that there are no mechanical or
physical causes for the eye inflammation e.g. ectopic cilium, entropion, foreign body,
deficiency in tear secretion.
Cross-resistance has been shown between chloramphenicol and others phenicols.
Use of the product should be carefully considered when susceptibility testing has
shown resistance to phenicols because its effectiveness may be reduced.
3.5 Special precautions for use
Special precautions for safe use in the target species:
Use of the product should be based on identification and susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based on
epidemiological information and knowledge of susceptibility of the target pathogens
at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional
antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG
category) should be used for first line treatment where susceptibility testing suggests
the likely efficacy of this approach.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
Chloramphenicol and benzalkonium chloride can cause allergic reactions. People
with known hypersensitivity to chloramphenicol and/or benzalkonium chloride should
only administer the veterinary medicinal product with disposable gloves.
In humans, there is evidence that exposure to chloramphenicol may increase the risk
of severe aplastic anaemia.
It is therefore essential to avoid skin and eye contact and wash hands after
administration of the veterinary medicinal product. In case of accidental skin or eye
contact, flush with plenty of water. In the event of hypersensitivity reactions, seek
medical advice and show the package leaflet or the label to the physician.
Chloramphenicol may cause serious harm to the unborn child and children who are
breastfed. The veterinary medicinal product should therefore not be administered by
pregnant and breastfeeding women.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dog and cat:
Rare
(1 to 10 animals / 10,000
animals treated):
Allergic reaction
Corneal opacity
1
superficial, temporary
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product during pregnancy and lactation has not
been established.
Chloramphenicol can cross the placenta and pass into milk. Effects on fetuses or
suckling puppies and kittens are unlikely, but the veterinary medicinal product should
only be used according to the benefit-risk assessment by the responsible
veterinarian.
3.8 Interaction with other medicinal products and other forms of interaction
No data available.
3.9 Administration routes and dosage
Ocular use.
Put one drop (one drop contains 0.15 mg chloramphenicol) in the conjunctival sac of
the affected eye, if necessary in both eyes; initially 6-8 times a day, then 4-6 times a
day. Severe eye disease may require more frequent dosing (one drop every 1-2
hours) for the first 24-48 hours. Treatment should be continued for 2 days after
symptoms have subsided.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
With local application an overdose is very unlikely.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.