Surolan Ear Drops and Cutaneous Suspension

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Verfügbar ab:

Elanco Europe Ltd

ATC-Code:

QS02CA01

INN (Internationale Bezeichnung):

Miconazole Nitrate, Polymyxin B Sulphate, Prednisolone Acetate

Darreichungsform:

Ear drops, suspension

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats, Dogs

Therapiebereich:

Antimicrobial; Anti Inflammatory; Antimycotic

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

1985-09-05

Fachinformation

Revised: July 2023
AN: 02511/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Surolan Ear Drops and Cutaneous Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES: MG/ML
Miconazole Nitrate
23
Prednisolone Acetate
5
Polymyxin B Sulfate
0.5293
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Ear drops suspension and cutaneous suspension.
White suspension
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
4.3 CONTRAINDICATIONS
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: July 2023
AN: 02511/2022
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As the product is a prescription only medicine, treatment should be
closely
supervised by a veterinary practitioner.
4.5 SPECIAL PRECAUTIONS FOR USE
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) Speci