Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A clear, yellow to amber spot-on solution.

Each ml contains 150 mg metaflumizone and 150 mg amitraz.

Each unit dose (pipette) of ProMeris Duo delivers:

	Volume(ml)	Metaflumizone(mg)	Amitraz(mg)
ProMeris Duo Spot-on for small dogs ( ≤5kg)	0.67	100.5	100.5
ProMeris Duo Spot-on for medium sized dogs (5.1-10.0kg)	1.33	199.5	199.5
ProMeris Duo Spot-on for medium/large sized dogs (10.1-25.0kg)	3.33	499.5	499.5
ProMeris Duo Spot-on for large dogs (25.1-40.0kg)	5.33	799.5	799.5
ProMeris Duo Spot-on for extra large dogs (40.1-50.0kg)	6.66	999	999

Uses

For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis) and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulatus and Dermacentor variabilis) in dogs over 8 weeks of age. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

Dosage and administration

Dosage

The recommended minimum dose is 20 mg/kg bodyweight for each of metaflumizone and amitraz, equivalent to 0.133ml/kg bodyweight. The following table defines the size of pipette to be used according to the weight of the dog

Weight Range of Dog (kg)	Pipette size to be used	Volume (ml)
≤5	ProMeris Duo for Small Dogs	0.67
5.1 – 10.0	ProMeris Duo Medium Sized Dogs	1.33
10.1 – 25.0	ProMeris Duo Spot-on for Medium/Large Sized Dogs	3.33
25.1 – 40.0	ProMeris Duo Spot-on for Large Dogs	5.33
40.1 – 50.0	ProMeris Duo Spot-on for Extra Large Dogs	6.66

For dogs more than 50 kg, use a combination of two pipettes that most closely matches the body weight.

Method of administration

For external use only. Spot-on use.

Remove the pipette from the package. Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line. The top of the tip will fold back against the pipette.

Part the hair and apply the content of the pipette to a single spot on the skin of the dog between the shoulder blades.

Place the tip of the pipette on the skin and squeeze the pipette to empty the entire contents.

Do not apply the medicine to the surface of the dog’s hair coat.

Treatment schedule

For optimal control of flea and/or tick infestation the veterinary medicinal product should be administered at monthly intervals throughout the flea and/or tick season, or the treatment schedule can be based on the local epidemiological situation.

The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.

Contra-indications, warnings, etc

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.

Pharmaceutical precautions

Keep out of the reach and sight of children.

Do not store above 25 °C.

Do not use after the expiry date stated on the carton after “EXP”.

Legal category

POM-V

Prescription Only Medicine – Veterinarian

To be supplied only on veterinary prescription

Packaging Quantities

Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.

Not all pack sizes may be marketed.

Further information

For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide. In addition it is recommended to treat the environment with a suitable insecticide.

Marketing authorisation number

EU/2/06/065/001 - 010

Significant Changes