Certifect
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-07-2018
Charakterystyka produktu
(SPC)
27-07-2018
Sprawozdanie z oceny publicznego
(PAR)
27-07-2018
Składnik aktywny:
fipronil, amitraz, (S)-methoprene
Dostępny od:
Merial
Kod ATC:
QP53AX65
INN (International Nazwa):
fipronil / amitraz / (S)-methoprene
Grupa terapeutyczna:
Dogs
Dziedzina terapeutyczna:
Ectoparasiticides for topical use, incl. insecticides
Wskazania:
Treatment and prevention of infestations in dogs by ticks (Ixodes ricinus, Dermacentor reticulatus, Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis, Haemaphysalis elliptica, Haemaphysalis longicornis, Amblyomma americanum and Amblyomma maculatum) and fleas (Ctenocephalides felis and Ctenocephalides canis). Treatment of infestations by chewing lice (Trichodectes canis). Prevention of environmental flea contamination by inhibiting the development of all flea immature stages. The product can be used as part of a treatment strategy for the control of flea-allergy dermatitis. Elimination of fleas and ticks within 24 hours. One treatment prevents further infestations for five weeks by ticks and for up to five weeks by fleas.The treatment indirectly reduces the risk of transmission of tick-borne diseases (canine babesiosis, monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis) from infected ticks for four weeks.
Podsumowanie produktu:
Revision: 5
Status autoryzacji:
Withdrawn
Data autoryzacji:
2011-05-06
Ulotka dla pacjenta
Medicinal product no longer authorised
B. PACKAGE LEAFLET
21
Medicinal product no longer authorised
PACKAGE LEAFLET FOR
(Box of 3 pipettes)
CERTIFECT 67 MG/ 60.3 MG/ 80 MG SPOT-ON SOLUTION FOR DOGS 2-10 KG
CERTIFECT 134 MG/ 120.6 MG/ 160 MG SPOT-ON SOLUTION FOR DOGS 10-20 KG
CERTIFECT 268
MG/ 241.2 MG/ 320
MG SPOT-ON SOLUTION FOR DOGS 20-40 KG
CERTIFECT 402 MG/ 361.8 MG/ 480 MG SPOT-ON SOLUTION FOR DOGS 40-60 KG
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
MERIAL
29, avenue Tony Garnier
FR-69007 Lyon
France.
Manufacturer responsible for the batch release:
MERIAL
4, Chemin du Calquet
FR-31000 Toulouse Cedex
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg
CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg
CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
3.
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Spot-on solution.
Clear amber to yellowish solution.
Each unit dose (dual cavity pipette) delivers:
CERTIFECT spot-on solution
Volume of unit
dose (ml)
Fipronil
(mg)
(S)-methoprene
(mg)
Amitraz
(mg)
dogs 2-10 kg
1.07
67.0
60.3
80.0
dogs 10-20 kg
2.14
134.0
120.6
160.0
dogs 20-40 kg
4.28
268.0
241.2
320.0
dogs 40-60 kg
6.42
402.0
361.8
480.0
Excipients essential for proper administration: butylhydroxyanisole
(0.02 %) and butylhydroxytoluene
(0.01 %).
22
Medicinal product no longer authorised
4.
INDICATIONS
Treatment and prevention of infestations in dogs by ticks (
_Ixodes ricinus, Dermacentor reticulatus, _
_Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis,
Haemaphysalis elliptica, _
_Haemaphysalis longicornis, Amblyomma americanum _
and
_Amblyomma maculatum) _
and fleas
_(Ctenocephalides felis _
and
_Ctenocephalides canis)._
Treatment of infestations by chewing lice (
_Trichodect
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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
CERTIFECT 67 mg/ 60.3 mg/ 80 mg spot-on solution for dogs 2-10 kg
CERTIFECT 134 mg/ 120.6 mg/ 160 mg spot-on solution for dogs 10-20 kg
CERTIFECT 268 mg/ 241.2 mg/ 320 mg spot-on solution for dogs 20-40 kg
CERTIFECT 402 mg/ 361.8 mg/ 480 mg spot-on solution for dogs 40-60 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Each unit dose delivers:
CERTIFECT spot-on solution
Volume of unit
dose (ml)
Fipronil
(mg)
(S)-Methoprene
(mg)
Amitraz
(mg)
dogs 2-10 kg
1.07
67
60.3
80
dogs 10-20 kg
2.14
134
120.6
160
dogs 20-40 kg
4.28
268
241.2
320
dogs 40-60 kg
6.42
402
361.8
480
Excipients:
Butylhydroxyanisole (0.02 %)
Butylhydroxytoluene (0.01 %)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear amber to yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of infestations in dogs by ticks (
_Ixodes ricinus, Dermacentor reticulatus, _
_Rhipicephalus sanguineus, Ixodes scapularis, Dermacentor variabilis,
Haemaphysalis elliptica, _
_Haemaphysalis longicornis, Amblyomma americanum _
and
_Amblyomma maculatum) _
and fleas
_(Ctenocephalides felis _
and
_Ctenocephalides canis)._
Treatment of infestations by chewing lice (
_Trichodectes canis_
).
Prevention of environmental flea contamination by inhibiting the
development of all flea immature
stages. The product can be used as part of a treatment strategy for
the control of Flea Allergy
Dermatitis (FAD). Elimination of fleas and ticks within 24 hours. One
treatment prevents further
infestations for 5 weeks by ticks and for up to 5 weeks by fleas.
2
Medicinal product no longer authorised
The treatment indirectly reduces the risk of transmission of
tick-borne diseases (canine babesiosis,
monocytic ehrlichiosis, granulocytic anaplasmosis and borreliosis)
from infect
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