Grisol V Granules 7.5%

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Griseofulvin

Available from:

Vetoquinol UK Ltd

ATC code:

QD01BA01

INN (International Name):

Griseofulvin

Authorization status:

Expired

Summary of Product characteristics

Revised: August 2014
AN: 00572/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Grisol V Granules 7.5%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains 75 mg Griseofulvin
FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1
3.
PHARMACEUTICAL FORM
Granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of ringworm in horses caused by _ Trichophyton _
spp. And
_Microsporum _spp_._
Other systemic fungal infections including those caused by _ Candida
albicans_
and _Aspergillus _spp. do not respond to griseofulvin therapy.
4.3
CONTRA-INDICATIONS
Not to be used for the treatment of pregnant mares.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in horses with severe hepatic impairment.
Revised: August 2014
AN: 00572/2014
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Buildings occupied by infected animals should be thoroughly cleaned
and disinfected; all equipment used during the treatment should also
be
cleaned
and
disinfected.
These
measures
will
minimise
risk
of
infection. Mix thoroughly with the total feed ration so that the
required
dose is contained in the amount each animal will consume at one feed.
Add to feed immediately prior to administration. Discard any remaining
medicated feed.
May be used for the treatment of groups of animals or for individuals.
For dosing, animals should be approximately equal in bodyweight.
Adequate trough space should be available and shy feeders should be
fed individually to ensure adequate dosage.
Prophylactic therapy is advised for in-contact animals only. The
normal
7-day course is recommended.
Keep horses away from infected cattle.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
When
handling
the
product
or
feed
containing
the
product,
wear
impervious
gloves
and
either
a
disposable
half-mask
respirator
conforming
to
European
Standard
EN
149
or