ProMeris Duo - Veterinary medicines - European Drugs Reference Encyclopedia

1.

NAME OF VETERINARY THE 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

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances

Each ml contains 150 mg metaflumizone and 150 mg amitraz.

Each unit dose (pipette) of ProMeris Duo delivers:

ProMeris Duo Spot-on for Dogs

Volume

(ml)

Metaflumizone

(mg)

Amitraz

(mg)

for Small Dogs ( 5 kg)

0.67

100.5

for Medium Sized Dogs - (5.1 – 10.0 kg)

1.33

199.5

for Medium/Large Sized Dogs (10.1 – 25.0 kg)

3.33

499.5

for Large Dogs (25.1 – 40.0 kg)

5.33

799.5

for Extra Large Dogs (40.1 – 50.0 kg)

6.66

999

Excipients

For a full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Spot-on solution

A clear, yellow to amber solution

4.

CLINICAL PARTICULARS

4.1 Target species

Dogs over 8 weeks of age

4.2 Indications for use, specifying the target species

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 ), 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).

4.3 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.

2

4.4 Special warnings

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

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.

4.5 Special precautions for use

Special precautions for use in animals

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.

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.

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

animals

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.

3

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.

4.6 Adverse reactions (frequency and seriousness)

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.

4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

Treatment with other products containing amitraz is not recommended whilst the dog is being treated

with ProMeris Duo Spot-On for Dogs.

4.9 Amounts to be administered and administration route

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 for Medium/Large Sized Dogs

3. 33

25.1 – 40.0

ProMeris Duo for Large Dogs

5.33

40.1 – 50.0

ProMeris Duo for Extra Large Dogs

6.66

4

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 contents 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 veterinary medicinal product to the surface of the dog’s hair coat.

Treatment schedule:

For optimal control of flea and/or tick infestation the 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. Kills most ticks within 48 hours. For treatment of biting lice a single dose

should be sufficient. 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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

5

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.

4.11 Withdrawalperiod(s)

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Vet Code QP 53AD51

Pharmacotherapeutic group:

Metaflumizone is an insecticide belonging to the semicarbazone group of compounds. Metaflumizone

is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.

Amitraz is a formamidine acaricide. It acts at octopamine receptor sites in ectoparasites giving rise to

increased nervous activity and death of insects.

Metaflumizone and amitraz are combined in the final formulation to provide a broad spectrum of

activity against both fleas and ticks, respectively, due to non-systemic exposure of the parasites on the

skin and hair. Maximum efficacy is achieved within 48 hours.

5.2 Pharmacokinetic particulars

After topical administration at a single site at the base of the skull, both metaflumizone and amitraz

were rapidly distributed throughout the surface of the skin. Maximum concentrations in the hair were

generally reached between 2 to 7 days post treatment and gradually declined through 56 days post

treatment. Both components were still measurable in the hair 56 days following treatment.

After topical administration at a single site at the base of the skull, both metaflumizone and amitraz

levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.

5.3 Environmental properties

See section 6.6

6.

PHARMACEUTICAL PARTICULARS

6.1 List of excipients

N, N-Diethyl-m-toluamide

1-Methoxy-2-propyl-acetate

Dimethyl sulfoxide

1, 8-Cineole

Gamma-hexalactone

6.2 Incompatibilities

None known.

6

6.3 Shelf life

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

6.4 Special precautions for storage

Do not store above 25 C

6.5 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.

Box of 1 or 2 blister card of 3 x 0.67 ml pipettes

Box of 1 or 2 blister card of 3 x 1.33 ml pipette

Box of 1 or 2 blister card of 3 x 3.33 ml pipettes

Box of 1 or 2 blister card of 3 x 5.33 ml pipettes

Box of 1 or 2 blister card of 3 x 6.66 ml pipettes

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste

materials derived from the use of such products

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.

7.

MARKETING AUTHORISATION HOLDER

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

8.

MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/001-010

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 December 2006

7

10 DATE OF REVISION OF THE TEXT

22/12/2010

Detailed information on this veterinary medicinal product is available on the website of the European

Medicines Agency http://www.ema.europa.eu

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable

8

ANNEX II

A.

MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR

BATCH RELEASE

B.

CONDITIONS OR RESTRICTIONS OF THE MARKETING

AUTHORISATION REGARDING SUPPLY OR USE

C.

CONDITIONS OR RESTRICTIONS OF THE MARKETING

AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE

D.

STATEMENT OF THE MRLs

9

A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH

RELEASE

Name and address of the manufacturer responsible for batch release

Wyeth Lederle Italia S.p.A.

18, Via Franco Gorgone

95121 Catania

Italy

B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION

REGARDING SUPPLY OR USE

To be supplied only on veterinary prescription.

The holder of this marketing authorisation must inform the European Commission about the marketing

plans for the medicinal product authorised by this decision.

C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH

REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT

Not applicable.

D. STATEMENT OF THE MRLs

Not applicable.

10

ANNEX III

LABELLING AND PACKAGE LEAFLET

11

A. LABELLING

12

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box for 1 blister card - Carton box for 2 blister cards

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo 100.5 mg + 100.5 mg Spot-on for small dogs {≤ to 5 kg}

2.

STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 0.67 ml pipette delivers:

Active substance: 100.5 mg metaflumizone and 100.5 mg amitraz

3.

PHARMACEUTICAL FORM

Spot-on solution

4.

PACKAGE SIZE

Box of 1 blister card of 3 x 0.67 ml pipettes

Box of 2 blister cards of 3 x 0.67 ml pipettes

5.

TARGET SPECIES

For dogs over 8 weeks of age.

6.

INDICATION(S)

For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and

lice.

7.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only.

Read the package leaflet before use.

8.

WITHDRAWAL PERIOD

Not applicable

13

9.

SPECIAL WARNING(S), IF NECESSARY

Do not administer to puppies under 8 weeks of age. Children should not have contact with the product

or with animals during treatment. For further information see package leaflet.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS , IF ANY

Dispose of waste material in accordance with local requirements. The veterinary medicinal product

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

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/001 – 1 blister card of 3 pipettes of 0.67ml

EU/2/06/065/002 – 2 blister cards of 3 pipettes of 0.67ml

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

14

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box for 1 blister card - Carton box for 2 blister cards

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo 199.5 mg + 199.5 mg Spot-on for medium sized dogs {5.1 – 10.0 kg}

2.

STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 1.33 ml pipette delivers:

Active substance: 199.5 mg metaflumizone and 199.5 mg amitraz

3.

PHARMACEUTICAL FORM

Spot-on solution

4.

PACKAGE SIZE

Box of 1 blister card of 3 x 1.33 ml pipettes

Box of 2 blister cards of 3 x 1.33 ml pipettes

5.

TARGET SPECIES

For dogs over 8 weeks of age.

6.

INDICATION(S)

For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and

lice.

7.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only.

Read the package leaflet before use.

8.

WITHDRAWAL PERIOD

Not applicable

9.

SPECIAL WARNING(S), IF NECESSARY

Do not administer to puppies under 8 weeks of age. Children should not have contact with the product

or with animals during treatment. For further information see package leaflet.

15

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS , IF ANY

Dispose of waste material in accordance with local requirements. The veterinary medicinal product

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

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/003 – 1 blister card of 3 pipettes of 1.33ml

EU/2/06/065/004 – 2 blister cards of 3 pipettes of 1.33ml

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

16

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box for 1 blister card - Carton box for 2 blister cards

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo 499.5 mg + 499.5 mg Spot-on for medium/large sized dogs {10.1 – 25.0 kg}

2.

STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 3.33 ml pipette delivers:

Active substance: 499.5 mg metaflumizone and 499.5 mg amitraz

3.

PHARMACEUTICAL FORM

Spot-on solution

4.

PACKAGE SIZE

Box of 1 blister card of 3 x 3.33 ml pipettes

Box of 2 blister cards of 3 x 3.33 ml pipettes

5.

TARGET SPECIES

For dogs over 8 weeks of age.

6.

INDICATION(S)

For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and

lice.

7.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only.

Read the package leaflet before use.

8.

WITHDRAWAL PERIOD

Not applicable

17

9.

SPECIAL WARNING(S), IF NECESSARY

Do not administer to puppies under 8 weeks of age. Children should not have contact with the product

or with animals during treatment. For further information see package leaflet.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS , IF ANY

Dispose of waste material in accordance with local requirements. The veterinary medicinal product

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

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/005 – 1 blister card of 3 pipettes of 3.33 ml

EU/2/06/065/006 – 2 blister cards of 3 pipettes of 3.33 ml

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

18

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box for 1 blister card - Carton box for 2 blister cards

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo 799.5 mg + 799.5 mg Spot-on for large dogs {25.1 – 40.0 kg}

2.

STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 5.33 ml pipette delivers:

Active substance: 799.5 mg metaflumizone and 799.5 mg amitraz

3.

PHARMACEUTICAL FORM

Spot-on solution

4.

PACKAGE SIZE

Box of 1 blister card of 3 x 5.33 ml pipettes

Box of 2 blister cards of 3 x 5.33 ml pipettes

5.

TARGET SPECIES

For dogs over 8 weeks of age.

6.

INDICATION(S)

For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and

lice.

7.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only.

Read the package leaflet before use.

8.

WITHDRAWAL PERIOD

Not applicable

19

9.

SPECIAL WARNING(S), IF NECESSARY

Do not administer to puppies under 8 weeks of age. Children should not have contact with the product

or with animals during treatment. For further information see package leaflet.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS , IF ANY

Dispose of waste material in accordance with local requirements. The veterinary medicinal product

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

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/007 – 1 blister card of 3 pipettes of 5.33 ml

EU/2/06/065/008 – 2 blister cards of 3 pipettes of 5.33 ml

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

20

PARTICULARS TO APPEAR ON THE OUTER PACKAGE

Carton box for 1 blister card - Carton box for 2 blister cards

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo 999 mg + 999 mg Spot-on for extra large dogs {40.1 – 50.0 kg}

2.

STATEMENT OF ACTIVE AND OTHER SUBSTANCES

Each 6.66 ml pipette delivers:

Active substance: 999 mg metaflumizone and 999 mg amitraz

3.

PHARMACEUTICAL FORM

Spot-on solution

4.

PACKAGE SIZE

Box of 1 blister card of 3 x 6.66 ml pipettes

Box of 2 blister cards of 3 x 6.66 ml pipettes

5.

TARGET SPECIES

For dogs over 8 weeks of age.

6.

INDICATION(S)

For the treatment and prevention of infestations by fleas and ticks, and treatment of demodicosis and

lice.

7.

METHOD AND ROUTE(S) OF ADMINISTRATION

For external use only.

Read the package leaflet before use.

8.

WITHDRAWAL PERIOD

Not applicable

21

9.

SPECIAL WARNING(S), IF NECESSARY

Do not administer to puppies under 8 weeks of age. Children should not have contact with the product

or with animals during treatment. For further information see package leaflet.

10. EXPIRY DATE

EXP {month/year}

11. SPECIAL STORAGE CONDITIONS

Do not store above 25C

12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS , IF ANY

Dispose of waste material in accordance with local requirements. The veterinary medicinal product

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

13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR

RESTRICTIONS REGARDING SUPPLY AND USE, if applicable

For animal treatment only - to be supplied only on veterinary prescription.

14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”

Keep out of the reach and sight of children.

15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Marketing authorisation holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent CT13 9NJ

United Kingdom

16. MARKETING AUTHORISATION NUMBER(S)

EU/2/06/065/009 – 1 blister card of 3 pipettes of 6.66 ml

EU/2/06/065/010 – 2 blister cards of 3 pipettes of 6.66 ml

17. MANUFACTURER’S BATCH NUMBER

Lot {number}

22

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

FOIL 0.67ml

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo S

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

EXPIRY DATE

EXP {month/year}

4.

BATCH NUMBER

Lot {number}

5.

THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

23

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

FOIL 1.33ml

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo M

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

EXPIRY DATE

EXP {month/year}

4.

BATCH NUMBER

Lot {number}

5.

THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

24

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

FOIL 3.33ml

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo M/L

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

EXPIRY DATE

EXP {month/year}

4.

BATCH NUMBER

Lot {number}

5.

THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

25

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

FOIL 5.33ml

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo L

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

EXPIRY DATE

EXP {month/year}

4.

BATCH NUMBER

Lot {number}

5.

THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

26

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

FOIL 6.66ml

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo XL

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

EXPIRY DATE

EXP {month/year}

4.

BATCH NUMBER

Lot {number}

5.

THE WORDS “FOR ANIMAL TREATMENT ONLY”

For animal treatment only.

27

MINIMUM PARTICULARS TO APPEAR ON PIPETTES

for small dogs

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo S

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

100.5 mg + 100.5 mg

4.

EXPIRY DATE

EXP {month/year}>

5.

BATCH NUMBER

LOT {number}

28

MINIMUM PARTICULARS TO APPEAR ON PIPETTES

for medium sized dogs

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

PrMeris Duo M

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

199.5 mg + 199.5 mg

4.

EXPIRY DATE

EXP {month/year}>

5.

BATCH NUMBER

LOT {number}

29

MINIMUM PARTICULARS TO APPEAR ON PIPETTES

for medium/large sized dogs

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo M/L

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

499.5 mg + 499.5 mg

4.

EXPIRY DATE

EXP {month/year}>

5.

BATCH NUMBER

LOT {number}

30

MINIMUM PARTICULARS TO APPEAR ON PIPETTES

for large dogs

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo L

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

799.5 mg + 799.5 mg

4.

EXPIRY DATE

EXP {month/year}>

5.

BATCH NUMBER

LOT {number}

31

MINIMUM PARTICULARS TO APPEAR ON PIPETTES

for extra large dogs

1.

NAME OF VETERINARY THE MEDICINAL PRODUCT

ProMeris Duo XL

2.

NAME OF THE MARKETING AUTHORISATION HOLDER

PFIZER

3.

CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES

999 mg + 999 mg

4.

EXPIRY DATE

EXP {month/year}>

5.

BATCH NUMBER

LOT {number}

32

B. PACKAGE LEAFLET

33

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

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

1. 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

95121 Catania

Italy

2.

NAME OF VETERINARY THE 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

3.

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

ProMeris Duo Spot-on for Medium Sized Dogs -

(5.1 – 10.0 kg)

1.33

199.5

ProMeris Duo Spot-on for Medium/Large Sized

Dogs (10.1 – 25.0 kg)

3.33

499.5

ProMeris Duo Spot-on for Large Dogs

(25.1 – 40.0 kg)

5.33

799.5

ProMeris Duo Spot-on for Extra Large Dogs

(40.1 – 50.0 kg)

6.66

999

34

4.

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).

5.

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.

6.

ADVERSE REACTION