ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
ProMeris 160 mg Spot-on solution for small cats
ProMeris 320 mg Spot-on solution for large cats
2.
Active substances
Each ml contains 200 mg metaflumizone.
Each unit dose (pipette) of ProMeris delivers:
Volume (ml)
Metaflumizone (mg)
ProMeris for Small Cats (≤ 4 kg)
0.80 ml
160 mg
ProMeris for Large Cats (> 4 kg)
1.60 ml
320 mg
Excipients
For a full list of excipients, see section 6.1.
3.
Spot-on solution
A clear, yellow to amber solution
4.
Cats over 8 weeks of age.
Treatment and prevention of flea infestations (
Ctenocephalides
canis and C.
felis
) in cats. The
veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis
(FAD).
Do not administer to kittens under 8 weeks of age.
Avoid contact with the eyes of the cat and avoid oral ingestion by the animal.
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.
2
In sick or debilitated animals, use only according to the benefit/risk assessment.
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. Do not allow animals to
groom each other following treatment.
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
Avoid direct contact with skin, eyes or mouth. Wash hands thoroughly after use. In case of accidental
spillage onto skin, wash off immediately with soap and water. If the veterinary medicinal product
accidentally gets into eyes, they should be thoroughly flushed with water.
Do not smoke, drink or eat while handling the veterinary medicinal product.
Avoid direct contact with treated animals until the application site is dry.
Children should not be allowed to play with treated animals until the application site is dry. It is
therefore recommended to treat the animals during the evening and that recently treated animals are
not allowed to sleep with owners, especially children.
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 fur at the application site. A dry residue may also be observed. This is
normal and will generally resolve within 1 – 4 days after administration. 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 the product application. In very rare cases temporary local hair loss may occur.
Can be used during pregnancy and lactation.
None known.
3
Dosage:
The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg
bodyweight. The following table defines the size of pipette to be used according to the weight of the
cat
Weight Of Cat (kg)
Pipette size to be used
Volume (ml)
≤ 4
ProMeris for Small Cats
0.80
> 4
ProMeris for Large Cats
1.60
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 cat’s neck at the base of the skull.
Part the fur on the cat's neck at the base of the skull until the skin is visible. 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 cat’s hair coat.
Treatment schedule:
For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6
week intervals throughout the flea 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 following a single
administration depending on the level of environmental rechallenge.
4
No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals
with 3-5 times the recommended dose.
Not applicable.
5.
5.1
Pharmacodynamic properties
Pharmacotherapeutic group: ATC Vet Code QP 53AX25
Metaflumizone is an ectoparasiticide belonging to the semicarbazone group of compounds.
Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and
death of insects. Metaflumizone is active against fleas 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 on the cat’s neck at the base of the skull, metaflumizone is
rapidly distributed throughout the surface of the skin. Maximum concentrations in the hair were
generally reached between 1 to 2 days post-treatment and gradually declined through 56 days post-
treatment. Metaflumizone was still measurable in the hair 56 days following treatment. These results
are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
After topical administration at a single site on the cat’s neck at the base of the skull, metaflumizone
levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
5.3 Environmental properties
See section 6.6
6.
6.1 List of excipients
Synperonic NCA 830
Dimethyl sulfoxide
Gamma-hexalactone
6.2 Incompatibilities
None known.
6.3 Shelf life
Shelf life of the veterinary medicinal product as package for sale: 36 months
6.4. Special precautions for storage
Do not store above 25°C
5
6.5 Nature and composition of immediate packaging
The veterinary medicinal product is packaged in individual-dose transparent plastic pipettes
overpacked 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 0.80 ml pipettes
Box of 1 or 2 blister card of 3 x 1.60 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.
7.
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
8.
EU/2/06/064/001-004
9.
19 December 2006
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
6
ANNEX II
A. MANUFACTURING AUTHORISATION HOLDER 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
7
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 SAFE AND EFFECTIVE USE
Not applicable
D. STATEMENT OF THE MRLs
Not applicable.
8
ANNEX III
LABELLING AND PACKAGE LEAFLET
9
A. LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box for 1 blister card -Carton box for 2 blister cards
1.
ProMeris 160 mg Spot-on for small cats {
<
4 kg}
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 0.80 ml pipette delivers:
Active substance: 160 mg metaflumizone
3.
Spot-on solution
4.
PACKAGE SIZE
Box of 1 blister card of 3 x 0.80 ml pipettes
Box of 2 blister cards of 3 x 0.80 ml pipettes
5.
For cats over 8 weeks of age.
6.
For the treatment and prevention of infestations by fleas.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Do not administer to kittens under 8 weeks of age. Consult your veterinarian before using the
veterinary medicinal product on sick or debilitated cats.
11
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Dispose of waste material in accordance with local requirements.
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.
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/06/064/001 – 1 blister card of 3 pipettes of 0.80 ml
EU/2/06/064/002 – 2 blister cards of 3 pipettes of 0.80 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
12
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Carton box for 1 blister card
Carton box for 2 blister cards
1.
ProMeris 320 mg Spot-on for large cats {> 4 kg}
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Each 1.60 ml pipette delivers:
Active substance: 320 mg metaflumizone
3.
Spot-on solution
4.
PACKAGE SIZE
Box of 1 blister card of 3 x 1.60 ml pipettes
Box of 2 blister cards of 3 x 1.60 ml pipettes
5.
For cats over 8 weeks of age.
6.
For the treatment and prevention of infestations by fleas.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
For external use only.
Read the package leaflet before use.
8.
Not applicable
9.
SPECIAL WARNING(S), IF NECESSARY
Do not administer to kittens under 8 weeks of age. Consult your veterinarian before using the
veterinary medicinal product on sick or debilitated cats.
13
10. EXPIRY DATE
EXP {month/year}
11. SPECIAL STORAGE CONDITIONS
Do not store above 25C
12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS , IF ANY
Dispose of waste material in accordance with local requirements.
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.
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
EU/2/06/064/003 – 1 blister card of 3 pipettes of 1.60 ml
EU/2/06/064/004 – 2 blister cards of 3 pipettes of 1.60 ml
17. MANUFACTURER’S BATCH NUMBER
Lot {number}
14
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
FOIL 0.80ml for small cats
1.
ProMeris S
2.
PFIZER
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
15
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
FOIL 1.60 ml for large cats
1.
ProMeris L
2.
PFIZER
3.
EXPIRY DATE
EXP {month/year}
4.
BATCH NUMBER
Lot {number}
5.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
For animal treatment only.
16
MINIMUM PARTICULARS TO APPEAR ON PIPETTES
for small cats
1.
ProMeris S
2.
PFIZER
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
160 mg
4.
EXPIRY DATE
EXP {month/year}>
5.
BATCH NUMBER
LOT {number}
17
MINIMUM PARTICULARS TO APPEAR ON PIPETTES
for large cats
1.
ProMeris L
2.
PFIZER
3.
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
320 mg
4.
EXPIRY DATE
EXP {month/year}>
5.
BATCH NUMBER
LOT {number}
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET
ProMeris Spot-on for cats
1.
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.
ProMeris 160 mg Spot-on for small cats
ProMeris 320 mg Spot-on for large cats
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active Substance
Each ml contains 200 mg metaflumizone
Each unit dose (pipette) of ProMeris delivers:
Volume (ml)
Metaflumizone (mg)
ProMeris for Small Cats (≤ 4 kg)
0.80
160
ProMeris for Large Cats (> 4 kg)
1.60
320
4.
Treatment and prevention of flea infestations (
Ctenocephalides canis
and
C.
felis
) in cats. The
veterinary medicinal product can be used as part of a treatment strategy for flea allergy dermatitis
(FAD).
5.
Do not use in kittens under 8 weeks of age.
In sick or debilitated animals use only according to the benefit/risk assessment.
20
6.
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 fur at the application site. A dry residue may also be observed. This is
normal and will generally resolve within 1 – 4 days after administration. 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 the product application. In very rare cases temporary local hair loss may occur.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your
veterinary surgeon.
7.
Cats above 8 weeks of age.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Dosage:
The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg
bodyweight. The following table defines the size of pipette to be used according to the weight of the
cat.
Weight Of Cat (kg)
Pipette size to be used
Volume (ml)
4
ProMeris for Small Cats
0.80
> 4
ProMeris for Large Cats
1.60
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 cat’s neck at the base of the skull.
Part the fur on the cat’s neck at the base of the skull until the skin is visible. 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 cat’s hair coat.
21
Treatment schedule:
For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6
week intervals throughout the flea 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 following a single
administration depending on the level of environmental rechallenge.
9.
ADVICE ON CORRECT ADMINISTRATION
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. Do not allow animals to
groom each other following treatment.
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.
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.
10. WITHDRAWAL PERIOD
Not applicable
11. 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”.
22
12. SPECIAL WARNING(S)
Avoid direct contact with skin, eyes or mouth. Wash hands thoroughly after use. In case of accidental
spillage onto skin, wash off immediately with soap and water. If the veterinary medicinal product
accidentally gets into eyes, flush the eyes thoroughly with water.
Do not smoke, drink or eat while handling the product.
Avoid direct contact with treated animals until the application site is dry.
Children should not be allowed to play with treated animals until the application site is dry. It is
therefore recommended to treat the animals during the evening and that recently treated animals are
not allowed to sleep with owners, especially children.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal
products should be disposed of in accordance with local requirements. Carefully dispose of used
pipettes immediately after use.
14. DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED
22/12/2010
Detailed information on this product is available on the website of the European Medicines Agency
15. 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.
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.: +32 (0)2 554 62 11
Luxembourg
Pfizer Animal Health s.a.,
Tél.: + 32 (0)2 554 62 11
Република България
Pfizer Luxembourg SARL
Tel: + 359 2 970 43 21
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
23
WASTE MATERIALS, IF ANY
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 5 269 17 96
Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 52 11 57 20
Ελλάδα
Pfizer Hellas A.E.
Τηλ.: +30 210 6785800
Polska
Pfizer Trading Polska Sp. z.o.o.
Tel: +48 22 335 61 00
España
Pfizer S.A.
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 93
Ireland
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
Tel: +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
Pfizer Oy Animal Health
Tel: +358 (0)9 4300 40
Latvija
Pfizer Animal Health
Tel: +370 5 269 17 96
United Kingdom
Pfizer Ltd
Tel: +44 (0) 1304 616161
Lietuva
Pfizer Animal Health
Tel: +370 5 269 17 96
24
Source: European Medicines Agency
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