Do not administer to puppies under 8 weeks of age.

Do not administer to cats.

Do not administer to sick or debilitated dogs or dogs suffering from heat stress.

Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.

For use only under the supervision of a veterinary surgeon.

This veterinary medicinal product is for spot-on application only. Do not administer orally or via any other route.

The veterinary medicinal product remains effective if the animal becomes wet. However, prolonged, intense exposure to water should be avoided. Dogs should be prevented from accessing streams and rivers for the 24-hour period following treatment. In cases of frequent water exposure the duration of activity may be reduced. In these cases do not treat more frequently than once a fortnight. If the dog requires shampooing, it is better to do so before applying the veterinary medicinal product.

Known side-effects of amitraz and metabolites, such as sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing may be observed in a small number of animals. Most of these signs are due to alpha-2-adreno-receptor agonist effects. Signs are usually transitory and generally resolved without treatment within 24 hours. If symptoms are severe or persist the alpha-2-adreno-receptor antagonist atipamezole hydrochloride may be used at a dose of 0.2 mg/kg bodyweight by intramuscular injection to reverse these side-effects.

Hypersalivation may occur if the animal licks the application site immediately after treatment. This is not a sign of intoxication and disappears within minutes without treatment. Correct application will minimise licking of the application site.

It is important to apply the dose to an area where the animal cannot lick it off and to make sure that animals do not lick each other following treatment.

Do not allow puppies to lick the application site of their mothers when it is still wet.

Care should be taken to ensure that the contents of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.

Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.

The application of the veterinary medicinal product may produce a local, temporary oily appearance and clumping or spiking of the hair at the application site. A dry residue may also be observed. This is normal and will generally resolve within a few days after administration, though may persist longer on rare occasions. These changes do not affect the safety or efficacy of the veterinary medicinal product.

Withdrawal period: Not applicable

Operator warnings:

Keep out of reach and sight of children. Stored pipettes must be kept in the intact foil package. This product should not be administered by children.

This product contains amitraz, which can lead to adverse neurological effects in humans and especially in children. Children should not have access to used pipettes. Used pipettes should be disposed of immediately.

Amitraz is a monoamine oxidase inhibitor (MOAI); therefore, people taking MOAI-containing medication should take particular care when handling this product.

Avoid direct contact with treated animals until the application site is dry. Children should not be allowed to have contact with treated animals until the application site is dry. It is therefore strongly recommended to treat the animals during the evening and that recently treated animals are not allowed to sleep with owners, especially children.

This product may cause skin sensitisation and allergic reactions in humans. Dermal exposure to the product should therefore be avoided. The use of protective gloves while handling the product is recommended.

If ill effects are noted following exposure to the product, seek immediate medical assistance, and show the product packaging to the physician.

Wash hands thoroughly after use. In case of accidental spillage onto skin, wash off immediately with soap and water.

This product may cause mild eye irritation. If the product accidentally gets into eyes, they should be thoroughly flushed with water.

Do not smoke, drink or eat while handling the product.

Disposal:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

The veterinary medicinal product should not enter watercourses, as this may be dangerous for fish and other aquatic organisms.

Carefully dispose of used pipettes immediately after use.