Aludex 50 g/a concentrate for cutaneous solution Data Sheet
Presentation
A clear emulsifiable concentrate for dilution and topical application containing 5% w/v amitraz as Amitraz technical. On dilution with water, the liquid forms an emulsion.
Uses
For the treatment of local and generalised demodectic mange and sarcoptic mange in dogs.
Dosage and administration
Shake the container/bottle before use. For external use only.
Demodectic mange:
Use 50ml Aludex per 5 litres of water for small dogs or 100ml Aludex per 10 litres of water for larger dogs. Whatever the quantity of wash required, it is essential that the initial concentration is not varied from 1 part Aludex to 100 parts water (0.05% amitraz).
Repeat treatment at intervals of 5 to 7 days until neither live mites nor viable eggs can be identified microscopically in skin scrapings. In the absence of facilities to determine the degree of control by skin scrapings, continue treatment for at least 3 weeks after all overt clinical symptoms have subsided.
Sarcoptic mange:
Use 25ml Aludex per 5 litres of water for small dogs, or 50ml Aludex per 10 litres of water for larger dogs.
Do not vary the concentration from 1 part Aludex to 200 parts water (0.025% amitraz).
Repeat treatment at weekly intervals for 2 to 6 weeks.
Application:
If necessary, shampoo the dog to remove dirt and grease. Long-haired animals can be clipped prior to treatment if required.
Prepare the dog wash outdoors or in a very well ventilated area by adding the appropriate amount of Aludex to the required volume of clean warm water, stirring to ensure complete mixing. Prepare only the required amount of wash for the individual treatment. Fouled wash becomes unstable after 6 hours and must be safely discarded.
Sufficient wash should be prepared to allow complete immersion of the dog’s paws and to enable complete wetting of the animal. 5 litres of the wash is normally a minimum requirement and up to 10 litres may be required for larger dogs.
In the well-ventilated area, stand the dog in a bath or sink and pour the wash over the animal, gently working into the skin and hair with a soft brush or sponge to ensure the dog is thoroughly wetted to the skin in all areas.
Avoid excessive contact with mucosal membrane.
Do NOT rinse the dog but remove it from the bath and allow it to dry naturally in a warm, draught-free place. Alternatively, it can be a good idea to take the dog for a short walk after treatment to allow it to start to dry. This also helps to disperse the solvent fumes and stops the dog licking itself and ingesting the wash. Using an Elizabethan collar to prevent licking can also be helpful on some dogs. Do not use a hair dryer.
Avoid handling the dog after treatment until the coat is dry.
Contra-indications, warnings, etc.
For external use only.
For use on dogs only. Do not use on Chihuahuas.
Do not use on dogs suffering from heat stress.
Do not use on pregnant or lactating bitches or puppies less than 3 months old.
This product is not recommended for use on cats.
Amitraz is toxic for horses.
Do not use simultaneously with other ectoparasiticidal preparations.
Operator warnings
Wear waterproof gloves, apron and face shield when handling the product and wash all protective clothing thoroughly after use, including the inside of gloves.
Avoid any contact of the product with the skin or eyes. In case of contamination, wash thoroughly with soap and water.
Do not eat, drink or smoke whilst using the product. When treatment is completed, wash hands thoroughly before eating, drinking or smoking.
Prepare and use the dilution of the product in a well-ventilated area.
May cause sensitization by skin contact.
Do not handle treated animals without use of protective clothing until the coat has dried thoroughly.
If you feel unwell, seek medical advice taking the product label with you.
Guide to doctor
Amitraz is NOT an organophosphorus compound. If poisoning is suspected, treatment should be symptomatic and supportive, paying particular attention to monitoring of respiratory and cardiac function. However recovery is normally spontaneous. Do NOT use Atropine as an antidote. Do NOT induce vomiting.
Environmental warnings:
Aludex is harmful to fish and other aquatic life. Do not contaminate ponds, waterways or ditches with the product or empty container. Wash out container thoroughly. Do not re-use the containers.
Empty containers should be disposed of in the domestic refuse disposal in accordance with any guidance from an appropriate waste regulation authority.
After treatment dogs should not be allowed to enter water until the coat is dry. Dispose of diluted product immediately after use via the waste water disposal system.
Hazard warnings:
Flammable.
General warnings:
For the treatment of demodectic mange, use at half normal rate (0.025% or 25ml per 5 litres/50ml per 10 litres) on severely debilitated dogs.
Only for use under the supervision of a veterinary surgeon.
FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Pharmaceutical warnings
Do not store above 25°C. Store in tightly closed original container in safe place. Store away from food, drink and animal feeding stuffs. Store in a dry place.
Shake container before use.
Make up wash immediately before use. Any remaining diluted product must be discarded.
Legal category
POM-V To be supplied only on veterinary prescription.
Package quantities
6 x 50ml glass bottles.
Further information
This product can be used with other dermatological preparations (except those that are water repellant) and with anthelmintics. Concurrent use with other alpha-2-adreno-receptor agonists is not recommended.
Aludex treatment can lead to side-effects such as sedation, lethargy, CNS depression, bradycardia and slow, shallow breathing in a small number of dogs. Symptoms usually subside after 24 hours or less. Most of these signs are due to alpha-2 adreno-receptor agonistic effects. If symptoms persist, the dog should be washed in soapy water (not washing-up detergent), dried and warmed. The alpha-2 adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2mg/kg bodyweight by intramuscular injection to reverse these side-effects.
Aludex has been used for the treatment of ectoparasitic infestations such as mange mites in other small animal species (rabbits, guinea pigs, rats and hamsters etc.). A more dilute concentration of Aludex is required. For further information, please contact the Veterinary Adviser of the company.
Marketing Authorisation number
Vm 01708/4408
