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POM-V Prescription Required Companion Animal

Surolan Ear Drops and Cutaneous Suspension

Active ingredients: Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Form

Drops

Species

Cats Dogs

Manufacturer

Elanco GmbH

VMD MA No.

52127/5083

What it's used for

For the topical treatment of otitis externa and skin infections caused by Gram- positive bacteria e.g. Staphylococcus aureus and Streptococcus . and Gram-...

Full indications, dosage and side effects ↓
View official SPC (PDF)

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Prescription required

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Clinical information

Surolan Ear Drops and Cutaneous Suspension — SPC Details

Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.

For the topical treatment of otitis externa and skin infections caused by Gram-
positive bacteria e.g. Staphylococcus aureus and Streptococcus . and Gram-
negative bacteria Escherichia coli and
For the topical treatment of otitis externa and skin infections caused by fungi and
yeasts: TrichophytonMicrosporum 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.
Do not use in animals with perforated ear drums since Polymyxin B is known to be
a potential ototoxic agent.
Do not use in cases of known hypersensitivity to the active substances or to any
of the excipients.

Revised: April 2025
AN: 04322/2024
Dogs and cats:
Very rare
(< 1 animal / 10,000 animals treated,
including isolated reports):
Deafness
Impaired hearing
Mainly in elderly dogs. If this occurs, treatment should be stopped. Decreased
hearing or deafness is generally temporary in nature.
Prolonged use of topical steroids can cause skin discoloration and delay wound
healing.

Revised: April 2025
AN: 04322/2024
The conventional adverse effects of corticosteroids can occur (disturbance of
biochemical parameters, such as increased cortisol and hepatic enzyme
levels).
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 the national
competent authority via the national reporting system. See also the last
section of the package leaflet for contact details.
As the product is a prescription only medicine, treatment should be closely
supervised by a veterinary practitioner.

i) Special precautions for use in animals
For external use only.
Due to the likely variability (temporal, geographical) in the emergence of bacterial
resistance to polymyxin B, bacteriological sampling and sensitivity testing
(antibiogram) is recommended.
If there is overgrowth of resistance bacteria and/or fungi, treatment with this
product should be discontinued and treatment with an appropriate alternative
should be initiated.
ii) Special precautions to be taken by the person administering the veterinary
medicinal product to animals
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 in pregnancy. Always wear single use
disposable gloves when applying the product to animals
Special precautions for the protection of the environment:
Not applicable.
iii) Other precautions
Not applicable
Do not use concomitantly with medicines that induce ototoxicity.
Store below 25 °C
Not applicable

Revised: April 2025
AN: 04322/2024
5.

This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.

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