Introduction

Company name: Genitrix Ltd

Address: Genitrix House

Daux Road

Billingshurst

West Sussex

RH14 9SJ

Telephone: 01403 786345

Fax: 01403 786346

Email: mail@genitrix.co.uk

Website: www.genitrix.co.uk

Qualitative and quantitative composition

Miconazole nitrate 10mg/ml

Pharmaceutical form

Topical Spray

Pharmacological properties

Mycozole is designed as a topical spray for use on rabbits, guinea pigs, rodents, birds and reptiles. The active ingredient Miconazole nitrate is effective against fungal and some bacterial infections of the skin.

Clinical particulars

Target species

Rabbits, guinea pigs, rodents, birds and reptiles.

Indications for use

Prevents and treats common fungal infections of the skin such as Candida spp, Malassezia pachydermatis and Dermatophytosis (ringworm) caused by, Microsporum spp., or Trichophyton spp. Mycozole will also treat bacterial infections of the skin caused by Streptococcus spp., Pseudomonas spp. and others susceptible to imidazole type drugs.

Contra-indications

For external use only. May irritate the eye. Do not apply to or around the eyes.

Special precautions for use

If you are uncertain about the condition of your pet, consult a veterinary surgeon. If symptoms persist, consult a veterinary surgeon.

Use during pregnancy and lactation

No data available. Do not use in pregnant or lactating animals.

Interactions

None known. Do not use in conjunction with any other medicine.

Amounts to be administered and administration route

Weigh animal carefully before administration to accurately assess the appropriate dose. Remove drinking water before use and replace with fresh water after application. Treat all animals in a group concurrently. Spray twice daily at a distance of 5 to 10 cm from the animal, ensuring that the product reaches the skin. In mammals and birds this will require lifting the fur or feathers to expose the skin surface. Do not use in animals less than 100g bodyweight. Continue application at this rate until the skin condition improves, but not longer than 7 days. If signs of disease persist beyond 7 days or reappear, then advice must be sought from a veterinary surgeon.

SPECIES	BODYWEIGHT	AMOUNT TO USE	FREQUENCY OF USE
All target species	100-200 g	0.2ml (1 pump)	Twice daily
	200-400g	0.4ml (2 pumps)
	400-600g	0.6ml (3 pumps)
	600-800g	0.8ml (4 pumps)
	800g-1kg	1ml (5 pumps)
	Over 1kg	0.2ml (1 pump) per 200g

Special warnings for each target species

As with many topically applied products, local irritation may occur. Should such a reaction occur discontinue use and consult a veterinary surgeon.

Withdrawal periods

Not applicable. Do not use in animals intended for human consumption.

Special precautions to be taken by the person administering the product

Ringworm is infectious to humans so it is advisable to wear gloves while handling and treating animals in which ringworm has been diagnosed or is suspected. Do not drink or smoke while applying this product. Wash hands with soap and water after application.

Pharmaceutical particulars

Major incompatibilities

None known.

Special precautions for storage

Do not store above 25°C. Do not freeze. Keep out of direct sunlight.

Keep out of reach of children.

Nature and contents of container

High density polypropylene (HDPE) container containing 50ml with pump aerosol.

Special precautions for the disposal of unused medicinal product or waste materials, if any

After use dispose of empty container with domestic refuse.

Marketing authorisation number

WL19886.

Any other information

-

Legal category

SAES

Significant Changes