ProMeris
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
13-07-2015
Vara einkenni
(SPC)
13-07-2015
Opinber matsskýrsla
(PAR)
14-07-2015
Virkt innihaldsefni:
metaflumizone
Fáanlegur frá:
Pfizer Limited
ATC númer:
QP53AX25
INN (Alþjóðlegt nafn):
metaflumizone
Meðferðarhópur:
Cats
Lækningarsvæði:
Ectoparasiticides for topical use, incl. insecticides
Ábendingar:
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).
Vörulýsing:
Revision: 8
Leyfisstaða:
Withdrawn
Leyfisdagur:
2006-12-19
Upplýsingar fylgiseðill
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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Vara einkenni
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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