Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Janssen Animal Health
A division of Janssen-Cilag Ltd
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4EG
Telephone: 01494 567555
Fax: 01494 567556
Email: ahealth@its.jnj.com
Presentation
White, non-aqueous ear drops and cutaneous suspension containing the following active ingredients per ml: miconazole nitrate 23 mg, prednisolone acetate 5 mg, polymyxin B sulfate 0.5293 mg
Uses
Target species: Dogs and Cats.
For the topical treatment of otitis externa and skin infections caused by Gram-positive bacteria e.g. Staphylococcus aureus and Streptococcus spp. and Gram-negative bacteria Escherichia coli and Pseudomonas aeruginosa.
For the topical treatment of otitis externa and skin infections caused by fungi and yeasts: Trichophyton spp., Microsporum spp., Malassezia pachydermatis, Candida spp.
For the topical treatment of otitis externa caused by the ear mite Otodectes cynotis.
The product also has anti-inflammatory and anti-pruritic activity.
Dosage and administration
This product is for topical administration. Shake the bottle well before use. At the beginning of treatment, hair surrounding or covering the lesions must be clipped; this should be repeated during treatment if necessary.
Ears
Clean the auditory canal and place a few drops of the product into the ear twice daily. For infections caused by Otodectes cynotis, instill five drops twice daily for 14 days. Massage the ear and the auditory canal gently but thoroughly to obtain optimum distribution.
Skin
Having ensured the area to be treated is clean, apply a few drops of the product (depending on lesion size) twice a day and rub well.
Treatment should be continued until a few days after complete disappearance of the clinical symptoms. In some obstinate cases, 2 to 3 weeks treatment may be necessary.
Where ear mite infestation is present, consideration should be given to treating both ears even if infestation is only apparent in one ear.
Contra-indications, warnings, etc
Do not use in animals with perforated ear drums since Polymyxin B is known to be a potential ototoxic agent.
Long term use of topical steroids may cause skin thinning and delay wound healing. Corticosteroids are not recommended for use in pregnant animals.
As Surolan is a prescription only medicine, treatment should be closely supervised by a veterinary practitioner. Due to likely variability (time, geographical) in the occurrence of resistance of bacteria for Polymyxin B, bacteriological sampling and susceptibility testing are recommended.
For external use only.
Overdose
No toxic side effects have been observed after accidental intake by licking.
Operator warnings
Do not handle the product if you are allergic to the ingredients in the product. Accidental spillage on the skin should be washed off immediately with soap and water. Wash hands after use. Corticosteroids may produce irreversible effects in the skin. They can be absorbed and may have harmful effects, especially with frequent and extensive contact or when used in pregnancy. Always wear single use disposable gloves when applying the product to animals.
Disposal
Any unused product or waste materials should be disposed of in accordance with national requirements.
For animal treatment only. Keep out of the reach and sight of children.
Pharmaceutical precautions
Do not store above 25 °C.
Legal category
POM-V
Packaging Quantities
15 ml and 30 ml plastic dropper bottle.
Further information
Nil.
Marketing authorisation number
Vm 00242/4012.
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