VE2/UK/SPC/6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the Veterinary Medicinal Product
Equifulvin Granules 7.5% Premix
2.
Qualitative and Quantitative Composition
Granules containing 7.5% w/w Griseofulvin
For a full list of excipients, see section 6.1
3.
Pharmaceutical Form
Premix for medicated feed
4.
Clinical Particulars
4.1
Target Species
Horses
4.2
Indications for use, specifying the target species
Griseofulvin is an anti-fungal antibiotic, for use in horses for the treatment of
ringworm caused by Trichophyton spp. and Microsporum spp.
4.3
Contraindications
None
4.4
Special warnings
None
4.5
Special Precautions for Use
Add to feed immediately prior to administration. Discard any remaining
medicated feed.
(i) Special precautions for use in animals
Not recommended for use in horses with severe hepatic impairment.
Prophylatic medication is advised for in-contact animals only; the normal 7
day course is recommended.
Buildings occupied by infected animals should be thoroughly cleaned and
disinfected. These measures will minimise the risk of infection
VE2/UK/SPC/6
(ii) Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Impervious gloves and a dust mask must be worn when handling this product
or feed containing the product.
The product or feed containing the product must not be handled by women
with child bearing potential.
4.6
Undesirable Effects (frequency and seriousness)
Long term administration of high doses of griseofulvin with food has been
reported to be hepatotoxic in cats and induce hepatomas in mice and thyroid
tumours in rats but not hamsters. The clinical significance of these findings in
the target species is not known.
Griseofulvin may be teratogenic.
4.7
Use during Pregnancy and Lactation
Equifulvin Granules must not be used for the treatment of pregnant mares.
4.8
Interaction with other Medicaments and other forms of Interaction
None known
4.9
Amounts to be administered and administration route.
Equifulvin Granules should be administered orally, by direct addition into
feed. Equifulvin Granules should be added to the feed ration so that the
required dose is contained in the amount each animal will consume at one
feed.
The recommended dose is 10 mg griseofulvin per kg body weight daily for 7
consecutive days. This is achieved by administering 10 g Equifulvin
Granules per 75 kg body weight daily.
To aid dosing, a five gram measuring scoop is included in the pack
Add to feed immediately before administration.
4.10
Overdose (Symptoms, Emergency Procedures, Antidotes)
Not applicable.
4.11
Withdrawal Periods
In accordance with the Horse Passport legislation (Commission Decision
2000/68/EC as implemented in national legislation) a 6 month withdrawal
period applies to the use of this product.
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5
Pharmacological Properties
Griseofulvin is an anti-fungal antibiotic, deposited in Keratin precursor cells
and concentrated in the stratum corneum of the of skin, hair and nails, thus
preventing fungal invasion
6.0
Pharmaceutical Particulars.
6.1
List of excipients
Povidone K30
Sodium Starch Glycollate
Lactose monohydrate
6.2
Incompatibilities
None known
6.3
Shelf Life
Shelf life of the veterinary medicinal product, as packaged for sale : 2 years
6.4
Special Precautions for Storage
Do not store above 25°C. Protect from light.
6.5
Nature and composition of immediate packaging
500 g and 1 kg packs. Polyethylene bag inside a polypropylene container.
Not all pack sizes may be marketed.
6.6
Special precautions for the disposal of unused veterinary medicinal
products or waste materials derived from the use of such products.
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance with
local requirements.
7.0
Marketing Authorisation Holder
Boehringer Ingelheim Limited
Ellesfield Avenue
Bracknell
Berkshire
RG12 8YS, UK
8.
Marketing authorisation number
Vm 00015/4025
VE2/UK/SPC/6
9.
Date of first authorisation/renewal of the authorisation
Date of first authorisation : 28 January 1998
Date of last renewal : 28 January 2003
10
Date of revision of text
August 2007, post approval AN 02175/06