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:

Eli Lilly and Company Limited

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: June 2012
AN: 00227/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Surolan Ear Drops and Cutaneous Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
MG/ML
ACTIVE SUBSTANCES:
Miconazole Nitrate
23
Prednisolone Acetate
5
Polymyxin B Sulfate
0.5293
For a 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.
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.
Page 1 of 5
Revised: June 2012
AN: 00227/2012
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
For external use only.
Due to likely variability (time, geographical) in the occurrence of
resistance of bacteria for Polymyxin B, bacteriological sampling and
susceptibility testing are recommended.
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