Sebolyse Shampoo for Dogs and Cats

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Chlorhexidine Gluconate, Miconazole Nitrate

Available from:

Dechra Veterinary Products A/S

ATC code:

QD11AC30

INN (International Name):

Chlorhexidine Gluconate, Miconazole Nitrate

Authorization status:

Expired

Summary of Product characteristics

Revised: July 2010
(ATC vet code amended)
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sebolyse shampoo for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Chlorhexidine gluconate 2% w/v
Miconazole nitrate 2% w/v
PRESERVATIVES:
Methylchloroisothiazolinone 0.00075% w/v and
Methylisothiazolinone 0.00025% w/v
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Shampoo
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dog: for the treatment and control of seborrhoeic dermatitis
associated with
_Malassezia pachydermatis_ and _Staphylococcus intermedius_.
Cat: as an aid in the control and treatment of ringworm due to
_Microsporum_
_canis_ in conjunction with griseofulvin.
4.3
CONTRAINDICATIONS
Sebolyse shampoo in conjunction with griseofulvin should not be used
in
pregnant cats as griseofulvin is contra-indicated in pregnancy.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cat:
Sebolyse shampoo should only be used in conjunction with griseofulvin
when
treating for ringworm.
Shampooing cats may initially increase the recovery of _M. canis _by
brush
culture techniques.
Page 1 of 6
Revised: 21 January 2009
AN: 02123/2008
Puppies and kittens should not come into contact with nursing females
respectively, after treatment until the coat has dried.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
For external use only.
In case of accidental contact with eyes, rinse with plenty of water.
Do not allow the animal to lick itself during shampooing and rinsing,
or
before it is dried. Take care to avoid the animal inhaling the product
or
getting it into the nose or mouth during shampooing.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals

If known hypersensitivity to chlorhexidine exists, handle product with
care.

This product can cause eye irritation. Avoid contact with the eyes. In
case
of