Medicinal product no longer authorised

PACKAGE LEAFLET

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

authorised

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

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder Pfizer Limited
Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom

Manufacturer for the batch release Wyeth Lederle Italia S.p.A.
18, Via Franco Gorgone
no
95121 Catania Italy
NAME OF THE VETERINARY MEDICINAL PRODUCT

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

Medicinal

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

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

*Due to limited space on the packaging, the abbreviations "S", "M", "M/L", "L" and "XL", which represent "small", “medium”,” medium/large”, “large” and “extra large”, respectively, are used on the blister foil and applicator pipettes.

authorised

INDICATION(S)

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 REACTION*

no
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. In very rare cases, pemphigus foliaceous-like cutaneous signs have been reported. If pemphigus-like signs occur, further use of the product should be avoided. These signs are transient and reversible if prompt and appropriate treatment is administered.
Medicinal
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

*- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)
- Common (more than 1 but less than 10 animals in 100 animals)
- Uncommon (more than 1 but less than 10 animals in 1,000 animals )
- Rare (more than 1 but less than 10 animals in 10,000 animals)
- Very rare (less than 1 animal in 10,000 animals, including isolated reports).
TARGET SPECIES

For dogs over 8 weeks of age.

DOSAGE FOR EACH SPECIES, ROUTE(S) 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

authorised

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

Method of administration:

For cutaneous 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.

product

edicinal

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.

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.

authorised

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.

no
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.

Medicinal
WITHDRAWAL PERIOD

Not applicable
SPECIAL STORAGE 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”.
SPECIAL WARNING(S)
Avoid contact with the eyes of the dog and avoid oral ingestion by the dog.

Can be used during pregnancy and lactation.

Treatment with other products containing amitraz is not recommended whilst the dog is being treated with ProMeris Duo Spot-On for Dogs.
authorised
No adverse effects were observed in healthy dogs and puppies aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose. The risk of experiencing adverse effects may however increase when overdosing, so animals should always be treated with the correct pipette size according to body weight.

Known side-effects of amitraz and metabolites are sedation, lethargy, CNS depression, hyperglycaemia, bradycardia and slow, shallow breathing. 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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

no
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.

The solvent in ProMeris Duo may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

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.

Medicinal
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.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

authorised
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.
DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED

Detailed information on this product is available on the website of the European Medicines Agency
OTHER INFORMATION

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.

Medicinal

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien Pfizer Animal Health s.a., Tél/Tel.: +32 (0)2 554 62 11

Luxembourg

Pfizer Animal Health s.a.,

Tél/Tel.: + 32 (0)2 554 62 11

Република България Pfizer Luxembourg SARL Teл: + 359 2 970 41 71

authorised

Magyarország

Pfizer Kft.

Tel: +361 488 3695

Česká republika Pfizer Animal Health Tel: +420 283 004 111

Malta

Agrimed Limited Tel: +356 21 465 797

Danmark

Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40

Nederland

Pfizer Animal Health B.V., Tel: +31 (0)10 4064 600

Deutschland

Pfizer GmbH

Tel: +49 30-5500 5501

Norge

Pfizer Oy Animal Health Tlf: +358 (0)9 4300 40

Eesti

Pfizer Animal Health Tel: +370 525 14000

Ελλάδα

Pfizer Hellas A.E.

Τηλ.: +30 210 6785800

Österreich

Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 52 11 57 20

Polska

Pfizer Trading Polska Sp. z o.o.

Tel: +48 22 335 61 00

España

Pfizer S.L.

Tel: +34 91 4909900

Portugal

Laboratórios Pfizer, Lda. Tel: +351 21 423 55 00

France

Pfizer

Tél: +33 (0)1 58 07 46 00

Romania

Pfizer Romania SRL

Tel: + 0040 21 207 28 00

Ireland

Medicinal

Pfizer Healthcare Ireland, trading as: Pfizer Animal Health

Tel: +353 (0) 1 467 6500

Slovenija

Pfizer Luxembourg SARL Tel: +386 (0) 1 52 11 670

Ìsland

Pfizer Oy Animal Health Sími: +358 (0)9 4300 40

Slovenská republika

Pfizer Luxembourg SARL o.z. Tel: + 421 2 3355 5500

Italia

Pfizer Italia S.r.l.,

Tel: +39 06 3318 2933

Suomi/Finland

Pfizer Oy Animal Health,

Puh/Tel: +358 (0)9 4300 40

Kύπρος

Pfizer Hellas A.E.

Τηλ.: +30 210 6785800

Sverige

Orion Pharma Animal Health Tlf: +46 (0)8 623 64 40

Latvija

Pfizer Animal Health Tel: +370 525 14000

United Kingdom

Pfizer Ltd

Tel: +44 (0) 1304 616161

Lietuva

Medicinal

authorised

Pfizer Animal Health Tel: +370 525 14000

PACKAGE LEAFLET

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

NAME OF THE VETERINARY MEDICINAL PRODUCT

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS

Active substances

*Due to limited space on the packaging, the abbreviations "S", "M", "M/L", "L" and "XL", which represent "small", “medium”,” medium/large”, “large” and “extra large”, respectively, are used on the blister foil and applicator pipettes.

INDICATION(S)

CONTRAINDICATIONS

ADVERSE REACTION*

TARGET SPECIES

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dosage:

Method of administration:

ADVICE ON CORRECT ADMINISTRATION

WITHDRAWAL PERIOD

SPECIAL STORAGE PRECAUTIONS

SPECIAL WARNING(S)

Special precautions to be taken by the person administering the veterinary medicinal product to animals

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED

OTHER INFORMATION

België/Belgique/Belgien Pfizer Animal Health s.a., Tél/Tel.: +32 (0)2 554 62 11

Luxembourg

Република България Pfizer Luxembourg SARL Teл: + 359 2 970 41 71

Magyarország

Česká republika Pfizer Animal Health Tel: +420 283 004 111

Malta

Danmark

Nederland

Deutschland

Norge

Eesti

Ελλάδα

Österreich

Polska

España

Portugal

France

Romania

Ireland

Slovenija

Ìsland

Slovenská republika

Italia

Suomi/Finland

Kύπρος

Sverige

Latvija

United Kingdom

Lietuva