ProMeris Duo
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
13-07-2015
Charakterystyka produktu
(SPC)
13-07-2015
Sprawozdanie z oceny publicznego
(PAR)
14-07-2015
Składnik aktywny:
metaflumizone, amitraz
Dostępny od:
Pfizer Limited
Kod ATC:
QP53AD51
INN (International Nazwa):
metaflumizone, amitraz
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Ectoparasiticides for topical use, incl. insecticides
Wskazania:
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).
Podsumowanie produktu:
Revision: 7
Status autoryzacji:
Withdrawn
Data autoryzacji:
2006-12-19
Ulotka dla pacjenta
Medicinal product no longer authorised
B. PACKAGE LEAFLET
33
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
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 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
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
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
34
Medicinal product no longer authorised
*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.
4.
INDICATION(S)
For the treat
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Charakterystyka produktu
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 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
100.5
for Medium Sized Dogs - (5.1 – 10.0 kg)
1.33
199.5
199.5
for Medium/Large Sized Dogs (10.1 – 25.0 kg)
3.33
499.5
499.5
for Large Dogs (25.1 – 40.0 kg)
5.33
799.5
799.5
for Extra Large Dogs (40.1 – 50.0 kg)
6.66
999
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
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS
Avoid contact with the eyes of the dog and avoid oral ingestion by the
dog.
The veterinary medicinal product remain
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