Comfortis

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

spinosad

MAH:

Elanco GmbH

ATC_code:

QP53BX03

INN:

spinosad

therapeutic_group:

Dogs; Cats

therapeutic_area:

Other ectoparasiticides for systemic use

therapeutic_indication:

Treatment and prevention of flea infestations (Ctenocephalides felis).The preventive effect against re-infestations is a result of the adulticidal activity and the reduction in egg production and persists for up to 4 weeks after a single administration of the product.The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).

leaflet_short:

Revision: 12

authorization_status:

Withdrawn

authorization_date:

2011-02-11

PIL

18
B. PACKAGE LEAFLET
Medicinal product no longer authorised
19
PACKAGE LEAFLET
COMFORTIS 140 MG CHEWABLE TABLETS FOR DOGS AND CATS
COMFORTIS 180 MG CHEWABLE TABLETS FOR DOGS AND CATS
COMFORTIS 270 MG CHEWABLE TABLETS FOR DOGS AND CATS
COMFORTIS 425 MG CHEWABLE TABLETS FOR DOGS AND CATS
COMFORTIS 665 MG CHEWABLE TABLETS FOR DOGS
COMFORTIS 1040 MG CHEWABLE TABLETS FOR DOGS
COMFORTIS 1620 MG CHEWABLE TABLETS FOR 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:
Elanco GmbH
Heinz-Lohmann-Str. 4
27472 Cuxhaven
Germany
Manufacturer responsible for batch release:
Elanco France S.A.S.
26 rue de la Chapelle
68330 Huningue
France
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Comfortis 140 mg chewable tablets for dogs and cats
Comfortis 180 mg chewable tablets for dogs and cats
Comfortis 270 mg chewable tablets for dogs and cats
Comfortis 425 mg chewable tablets for dogs and cats
Comfortis 665 mg chewable tablets for dogs
Comfortis 1040 mg chewable tablets for dogs
Comfortis 1620 mg chewable tablets for dogs
Spinosad
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each tablet contains:
ACTIVE SUBSTANCE:
Comfortis 140 mg
140 mg spinosad
Comfortis 180 mg
180 mg spinosad
Comfortis 270 mg
270 mg spinosad
Comfortis 425 mg
425 mg spinosad
Comfortis 665 mg
665 mg spinosad
Comfortis 1040 mg
1040 mg spinosad
Comfortis 1620 mg
1620 mg spinosad
Chewable tablets.
Medicinal product no longer authorised
20
Tan to brown, or speckled with embedded darker particles, round, flat,
bevelled edge tablets, plain on
one side and debossed with a letter on the other side:
140 mg: C
180 mg: L
270 mg: J
425 mg: C
665 mg: J
1040 mg: L
1620 mg: J
4.
INDICATION(S)
Treatment and prevention of flea infestations (
_Ctenocephalides felis_
).
The preventive effect against re-infestations is a result of the
activity against adult fleas and the
reduction in their production of eggs. This activity persists for up

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Comfortis 140 mg chewable tablets for dogs and cats
Comfortis 180 mg chewable tablets for dogs and cats
Comfortis 270 mg chewable tablets for dogs and cats
Comfortis 425 mg chewable tablets for dogs and cats
Comfortis 665 mg chewable tablets for dogs
Comfortis 1040 mg chewable tablets for dogs
Comfortis 1620 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Comfortis 140 mg
spinosad 140 mg
Comfortis 180 mg
spinosad 180 mg
Comfortis 270 mg
spinosad 270 mg
Comfortis 425 mg
spinosad 425 mg
Comfortis 665 mg
spinosad 665 mg
Comfortis 1040 mg
spinosad 1040 mg
Comfortis 1620 mg
spinosad 1620 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Tan to brown, or speckled with embedded darker particles, round, flat,
bevelled edge tablets plain on
one side and debossed with a letter and a line above on the other
side:
140 mg: C
180 mg: L
270 mg: J
425 mg: C
665 mg: J
1040 mg: L
1620 mg: J
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of flea infestations (
_Ctenocephalides felis_
).
The preventive effect against re-infestations is a result of the
adulticidal activity and the reduction in
egg production and persists for up to 4 weeks after a single
administration of the product.
Medicinal product no longer authorised
3
The veterinary medicinal product can be used as part of a treatment
strategy for the control of flea
allergy dermatitis (FAD).
4.3
CONTRAINDICATIONS
Do not use in dogs or cats under 14 weeks of age.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The veterinary medicinal product should be administered with food or
immediately after feeding. The
duration of efficacy may be reduced if the dose is a