Adaxio Shampoo for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlorhexidine digluconate; Miconazole nitrate

Available from:

Ceva Santé Animale

ATC code:

QD08AC52

INN (International Name):

Chlorhexidine digluconate; Miconazole nitrate

Dosage:

20, 20 milligram(s)/millilitre

Pharmaceutical form:

Shampoo

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

chlorhexidine, combinations

Therapeutic indications:

Antifungal

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

Health Products Regulatory Authority
14 August 2019
CRN008SGF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Adaxio Shampoo for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Chlorhexidine digluconate 20 mg (equivalent to chlorhexidine 11.26 mg)
Miconazole nitrate 20 mg (equivalent to miconazole 17.37 mg)
EXCIPIENTS:
Methylchloroisothiazolinone 0.0075 mg
Methylisothiazolinone 0.0025 mg
Benzoic acid (E210) 1.35 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Shampoo.
A clear light yellow to yellow liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of seborrhoeic dermatitis associated
with _Malassezia pachydermatis_ and/or _Staphylococcus _
_pseudintermedius_.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
In order to prevent recurrence of the infection, appropriate control
methods should be employed in the animal's environment
(e.g. cleaning and disinfection of kennel, beds).
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account when the product is used.
Take care to avoid the animal inhaling the product or getting it into
eyes, auditory canal, nose or mouth during shampooing.
In case of accidental contact with eyes, rinse with plenty of water.
If eye irritation persists, consult a veterinarian.
Do not allow the animal to lick itself during shampooing and rinsing,
or before it is dried. Puppies should not come into
contact with nursing females after treatment until the coat has dried.
Use of the product deviating from the SPC's recommendations may induce
a resistance in the population of skin bacteria.
Health Products Regulatory Authority
14 August 2019
CRN008SGF
Page 2 of 5
ii. Special precautions to be ta