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ProMeris Duo Spot on for Dogs

ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs

ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs

ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs

ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs

ProMeris Duo 999 mg + 999mg Spot-on for extra large dogs

Description

ProMeris Duo is a clear, yellow to amber spot-on solution for dogs based on a unique combination of metaflumizone and amitraz for the treatment and prevention of infestations by fleas, ticks and lice.

Active substances
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 (<5 kg) 0.67 100.5 100.5
ProMeris Duo Spot-on for Medium Sized Dogs - (5.1 - 10.0 kg) 1.33 199.5 199.5
ProMeris Duo Spot-on for Medium/Large Sized Dogs (10.1 - 25.0 kg) 3.33 499.5 499.5
ProMeris Duo Spot-on for Large Dogs (25.1 - 40.0 kg) 5.33 799.5 799.5
ProMeris Duo Spot-on for Extra Large Dogs (40.1 - 50.0 kg) 6.66 999 999

INDICATIONS

For the treatment and prevention of infestations by fleas (Ctenocephalides canis and C. felis) and ticks (Ixodes ricinus, Ixodes hexagonus, Rhipicephalus sanguineus, Dermacentor reticulates and Dermacentor variabilis), and treatment of demodicosis (caused by Demodex spp.) and lice (Trichodectes canis) in dogs. The veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis (FAD).

CONTRAINDICATIONS

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.

ADVERSE REACTIONS

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.
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. In rare cases, transient irritation may occur at the site of product application. In very rare cases temporary local hair loss may occur.

TARGET SPECIES

For dogs over 8 weeks of age.

DOSAGE, ROUTE AND METHOD OF 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.
Apply the content of the pipette to a single spot on the skin of the dog at the base of the skull.
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.
application
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. For treatment of biting lice a single dose should be sufficient. Kills most ticks within 48 hours. Most lice are killed within 7 days.
For treatment of demodicosis, the product should be administered at monthly intervals until clinical signs resolve. Where possible, treatment should not be discontinued until skin scrapings are negative on at least two monthly occasions. As demodicosis is a multi- factorial disease, where possible, it is advisable to also treat any underlying disease appropriately.
The veterinary medicinal product will prevent flea infestation for up to 6 weeks and tick infestation for 4 weeks following a single administration.

ADVICE ON CORRECT ADMINISTRATION

For use only under the supervision of a veterinary supervision.
This veterinary medicinal product is for spot-on application only. Do not administer orally or via any other route.
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 content of the pipette or the applied dose does not come into contact with the eyes or mouth of the recipient and/or other animals.
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.
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.

WITHDRAWAL PERIOD

Not applicable.

SHELF LIFE

Shelf life of the veterinary medicinal product as package for sale: 24 months.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C

SPECIAL 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. Recently treated animals should not be allowed to sleep with the owners, especially children. ProMeris Duo contains components that , on very rare occasions, can cause respiratory irritation in certain people. To minimise the potential for inhalation, it is recommended that the product is applied in open air or in well ventilated rooms.
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.
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.

OTHER INFORMATION

ATC Vet Code QP 53AD51
Nature and composition of immediate packaging
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes over packed in an aluminium foil package. It is supplied in units of 3 pipettes per cardboard card and one or two cards per cardboard box.
All blisters in a box are the same size.
Each strength of the veterinary medicinal product is available in boxes with 1 and in boxes with 2 blister cards of 3 pipettes.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) www.emea.eu.int

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