Oridermyl ear gel

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neomycin sulphate; Nystatin; Triamcinolone acetonide; Permethrin (25:75) technical

Available from:

Vetoquinol Ireland Limited

ATC code:

QS02CA04

INN (International Name):

Neomycin sulphate; Nystatin; Triamcinolone acetonide; Permethrin (25:75) technical

Dosage:

.

Pharmaceutical form:

Gel

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

triamcinolone and antiinfectives

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-06-13

Summary of Product characteristics

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oridermyl ear gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Permethrin technical cis/trans ratio 25:75
10
mg
Neomycin (as neomycin sulfate)
3500
IU
Nystatin
100 000
IU
Triamcinolone acetonide
1
mg
Excipients to
1
g
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ear gel.
Pale yellow gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
For the treatment of mixed ear infections (otitis externa) due to
bacteria sensitive to neomycin, yeasts sensitive to nystatin and
ear mites (_Otodectes cynotis_) sensitive to permethrin.
4.3 CONTRAINDICATIONS
Do not use in animals with perforated tympanic membrane, as this may
lead to ototoxicity and deafness.
Do not use in case of hypersensitivity to the active substances.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
See section 4.5.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Accidental ingestion may lead to absorption of the active substances
triamcinolone and permethrin. Do not allow any surplus
ointment to remain on the coat in order to avoid accidental ingestion
by licking or grooming.
Prior to use, the integrity of the ear drum should be confirmed.
During administration, press the tube while slowly withdrawing
the cannula in order to avoid tympanic pressure.
Cats are particularly sensitive to the effects of permethrin if
ingested. Accidental ingestion may lead to adverse effects
including salivation, agitation and vomiting in cats.
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 3
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Wash your hands with water and soap after administering the product.
In case of contact with eyes or skin, rinse immediately with plenty of
water.
In case of accidental ingestion, seek medical