Norofulvin 33.3% W/W Equine Oral Paste
Revised: December 2014
AN: 00770/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Norofulvin 33.3% w/w Equine Oral Paste.
2. Qualitative and quantitative composition
Active Substance:
Norofulvin Equine Paste contains Griseofulvin 33.3% w/w
Excipients:
Methyl Parahydroxybenzoate 0.15% w/w
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
- Oral Paste.
- A white, viscous paste for oral administration
4. Clinical Particulars
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.
Contraindications
Other systemic fungal infections including Candida albicans and Aspergillus spp. do not respond to Griseofulvin therapy.
Do not use on pregnant mares.
4.4 Special Warnings for each target species
No special warnings.
4.5 Special precautions for use
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the veterinary product to animals
The product must not be handled by women of child-bearing potential.
Protective gloves should be worn when using this product.
Take care to avoid skin contact. In the case of skin contact wash affected area thoroughly. If irritation occurs/persists seek medical advice.
Take care to avoid accidental eye contact. In case of accidental eye contact flush thoroughly with clean water and seek medical advice.
Ingestion: If accidentally swallowed, seek medical attention and show product label and/or pack leaflet to the doctor.
Wash hands thoroughly after using this product.
Long-term administration of high doses of griseofulvin with foods has been reported to induce hepatomas in mice and thyroid tumours in rats, but not hamsters. The clinical significance of those findings for man is not known.
4.6 Adverse reactions (frequency and seriousness)
None.
4.7 Use during pregnancy, lactation or lay
Not for use in pregnant mares
4.8 Interaction with other medicinal products and other forms of interaction
Substances such as phenylbutazone and sedatives which induce drug metabolising enzymes may result in impaired efficacy.
4.9 Amounts to be administered and administration route
There are 15 x 150kg doses marked on the syringe
For oral administration, using a dial-a-dose syringe, at a dose rate of 10 mg Griseofulvin/kg daily for seven consecutive days. Each complete turn of the dial delivers 4.61 g of product (1.5g Griseofulvin). The following is the dosage regimen recommended for each of the seven days dosing period.
-
Liveweight
Dose (grams of Griseofulvin)
No. of Dial Turns
150kg
1.5
1
300kg
3.0
2
450kg
4.5
3
600kg
6.0
4
Where animal’s weight is other than the above weights, ¼, ½ and ¾ turns of the dial may be given as appropriate.
Prophylactic administration of the medication is advised for in-contact animals only.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal period
Not authorised for use in horses intended for human consumption.
5. pharmacological properties
Pharmacotherapeutic group: Antifungals for dermatological use, Antifungals for systematic use.
ATC Vet Code: QD01BA01
Pharmacodynamic properties
Griseofulvin is a fungistatic antibiotic which is absorbed over a prolonged period from the gastrointestinal tract and is deposited in the keratin precursor cells. It concentrates in the stratum corneum of the skin, in the nail and in hair thus preventing fungal invasion of newly forming cells.
6. Pharmaceutical particulars
List of excipients
Methyl Parahydroxybenzoate
Sorbitan Monolaurate
Polysorbate 20
Propylene Glycol
Glycerol
6.2 Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and composition of immediate packaging
Marketed in a 70g multidose dial a dose oral syringe comprising of a white opaquue high density polyethylene barrel and white opaque low density polyethylene plunger closed with white opaque low density polyethylene push fit cap.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused product or waste material should be disposed of in accordance with national requirements.
7. MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co. Down
BT35 6JP
Northern Ireland
8. MARKETING AUTHORISATION NUMBER
Vm 02000/4055
9. DATE OF FIRST AUTHORISATION
Date: 10 May 1985
10. DATE OF REVISION OF THE TEXT
Date: December 2014
APPROVED 
10/12/14
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