ProMeris

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2015
Public Assessment Report Public Assessment Report (PAR)
14-07-2015

Active ingredient:

metaflumizone

Available from:

Pfizer Limited 

ATC code:

QP53AX25

INN (International Name):

metaflumizone

Therapeutic group:

Cats

Therapeutic area:

Ectoparasiticides for topical use, incl. insecticides

Therapeutic indications:

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).

Product summary:

Revision: 8

Authorization status:

Withdrawn

Authorization date:

2006-12-19

Patient Information leaflet

                                Medicinal product no longer authorised
B. PACKAGE LEAFLET
19
Medicinal product no longer authorised
PACKAGE LEAFLET
PROMERIS SPOT-ON FOR CATS
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 THE VETERINARY MEDICINAL PRODUCT
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
*DUE TO LIMITED SPACE ON THE PACKAGING, THE ABBREVIATIONS "S" AND "L",
WHICH REPRESENT
"SMALL" AND "LARGE", RESPECTIVELY, ARE USED ON THE BLISTER FOIL AND
APPLICATOR PIPETTES.
4.
INDICATION(S)
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.
CONTRAINDICATIONS
Do not use in kittens under 8 weeks of age.
In sick or debilitated animals use only according to the benefit/risk
assessment.
20
Medicinal product no longer authorised
6.
ADVERSE REACTIONS*
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 ch
                                
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Summary of Product characteristics

                                Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ProMeris 160 mg Spot-on solution for small cats
ProMeris 320 mg Spot-on solution for large cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
PHARMACEUTICAL FORM
Spot-on solution
A clear, yellow to amber solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats over 8 weeks of age.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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).
4.3
CONTRAINDICATIONS
Do not administer to kittens under 8 weeks of age.
4.4
SPECIAL WARNINGS
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
Medicinal product no longer authorised
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In sick or debilitated animals, use only according to the benefit/risk
assessment by the responsible
veterinarian.
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 ot
                                
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Active ingredient metaflumizone

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ATC code QP53AX25

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Marketed by Pfizer Limited 

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INN (International Name) metaflumizone

metaflumizone

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Patient Information leaflet Patient Information leaflet Bulgarian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2015
Public Assessment Report Public Assessment Report Bulgarian 14-07-2015
Patient Information leaflet Patient Information leaflet Spanish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2015
Public Assessment Report Public Assessment Report Spanish 14-07-2015
Patient Information leaflet Patient Information leaflet Czech 13-07-2015
Summary of Product characteristics Summary of Product characteristics Czech 13-07-2015
Public Assessment Report Public Assessment Report Czech 14-07-2015
Patient Information leaflet Patient Information leaflet Danish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Danish 13-07-2015
Public Assessment Report Public Assessment Report Danish 14-07-2015
Patient Information leaflet Patient Information leaflet German 13-07-2015
Summary of Product characteristics Summary of Product characteristics German 13-07-2015
Public Assessment Report Public Assessment Report German 14-07-2015
Patient Information leaflet Patient Information leaflet Estonian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Estonian 13-07-2015
Public Assessment Report Public Assessment Report Estonian 14-07-2015
Patient Information leaflet Patient Information leaflet Greek 13-07-2015
Summary of Product characteristics Summary of Product characteristics Greek 13-07-2015
Public Assessment Report Public Assessment Report Greek 14-07-2015
Patient Information leaflet Patient Information leaflet French 13-07-2015
Summary of Product characteristics Summary of Product characteristics French 13-07-2015
Public Assessment Report Public Assessment Report French 14-07-2015
Patient Information leaflet Patient Information leaflet Italian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Italian 13-07-2015
Public Assessment Report Public Assessment Report Italian 14-07-2015
Patient Information leaflet Patient Information leaflet Latvian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Latvian 13-07-2015
Public Assessment Report Public Assessment Report Latvian 14-07-2015
Patient Information leaflet Patient Information leaflet Lithuanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-07-2015
Public Assessment Report Public Assessment Report Lithuanian 14-07-2015
Patient Information leaflet Patient Information leaflet Hungarian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Hungarian 13-07-2015
Public Assessment Report Public Assessment Report Hungarian 14-07-2015
Patient Information leaflet Patient Information leaflet Maltese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Maltese 13-07-2015
Public Assessment Report Public Assessment Report Maltese 14-07-2015
Patient Information leaflet Patient Information leaflet Dutch 13-07-2015
Summary of Product characteristics Summary of Product characteristics Dutch 13-07-2015
Public Assessment Report Public Assessment Report Dutch 14-07-2015
Patient Information leaflet Patient Information leaflet Polish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Polish 13-07-2015
Public Assessment Report Public Assessment Report Polish 14-07-2015
Patient Information leaflet Patient Information leaflet Portuguese 13-07-2015
Summary of Product characteristics Summary of Product characteristics Portuguese 13-07-2015
Public Assessment Report Public Assessment Report Portuguese 14-07-2015
Patient Information leaflet Patient Information leaflet Romanian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Romanian 13-07-2015
Public Assessment Report Public Assessment Report Romanian 14-07-2015
Patient Information leaflet Patient Information leaflet Slovak 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovak 13-07-2015
Public Assessment Report Public Assessment Report Slovak 14-07-2015
Patient Information leaflet Patient Information leaflet Slovenian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 13-07-2015
Public Assessment Report Public Assessment Report Slovenian 14-07-2015
Patient Information leaflet Patient Information leaflet Finnish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Finnish 13-07-2015
Public Assessment Report Public Assessment Report Finnish 14-07-2015
Patient Information leaflet Patient Information leaflet Swedish 13-07-2015
Summary of Product characteristics Summary of Product characteristics Swedish 13-07-2015
Public Assessment Report Public Assessment Report Swedish 14-07-2015
Patient Information leaflet Patient Information leaflet Norwegian 13-07-2015
Summary of Product characteristics Summary of Product characteristics Norwegian 13-07-2015
Patient Information leaflet Patient Information leaflet Icelandic 13-07-2015
Summary of Product characteristics Summary of Product characteristics Icelandic 13-07-2015

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