Trifexis
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
08-10-2018
Valmisteyhteenveto
(SPC)
08-10-2018
Julkisesta arviointikertomuksesta
(PAR)
08-10-2018
Aktiivinen ainesosa:
spinosad, milbemycin oxime
Saatavilla:
Eli Lilly and Company Limited
ATC-koodi:
QP54AB51
INN (Kansainvälinen yleisnimi):
spinosad, milbemycin oxime
Terapeuttinen ryhmä:
Dogs
Terapeuttinen alue:
Antiparasitic products, insecticides and repellents, Endectocides
Käyttöaiheet:
For the treatment and prevention of flea (Ctenocephalides felis) infestations in dogs where one or more of the following indications are required concurrently: prevention of heartworm disease (L3, L4 Dirofilaria immitis);prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) Angiostrongylus vasorum;treatment of gastrointestinal nematode infections caused by hookworm (L4, immature adult, L5) and adult Ancylostoma caninum), roundworms (immature adult L5, and adult Toxocara canis and adult Toxascaris leonina) and whipworm (adult Trichuris vulpis).
Tuoteyhteenveto:
Revision: 4
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2013-09-19
Pakkausseloste
Medicinal product no longer authorised
19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET FOR:
TRIFEXIS 270 MG/4.5 MG CHEWABLE TABLETS FOR DOGS
TRIFEXIS 425 MG/7.1 MG CHEWABLE TABLETS FOR DOGS
TRIFEXIS 665 MG/11.1 MG CHEWABLE TABLETS FOR DOGS
TRIFEXIS 1040 MG/17.4 MG CHEWABLE TABLETS FOR DOGS
TRIFEXIS 1620 MG/27 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:
Eli Lilly and Company Ltd
Elanco Animal Health
Priestley Road
Basingstoke
Hampshire
RG24 9NL
UNITED KINGDOM
Manufacturer responsible for batch release:
Eli Lilly and Company Ltd
Speke Operations
Fleming Road
Liverpool
L24 9LN
UNITED KINGDOM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg)
Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 – 9.4 kg)
Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 – 14.7 kg)
Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 – 23.1 kg)
Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 – 36.0 kg)
spinosad / milbemycin oxime
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
ACTIVE SUBSTANCES:
Each tablet contains:
Trifexis 270 mg/4.5 mg
spinosad 270 mg/milbemycin oxime 4.5 mg
Trifexis 425 mg/7.1 mg
spinosad 425 mg/milbemycin oxime 7.1 mg
Trifexis 665 mg/11.1 mg
spinosad 665 mg/milbemycin oxime 11.1 mg
Trifexis 1040 mg/17.4 mg
spinosad 1040 mg/milbemycin oxime 17.4 mg
Trifexis 1620 mg/27 mg
spinosad 1620 mg/milbemycin oxime 27.0 mg
The tablets are a mottled tan to brown colour, and are round and
chewable. The following list shows
the code and the number of dimples marked on each strength of tablet:
Trifexis 270 mg/4.5 mg tablets:
4333 and 2 dimples
Trifexis 425 mg/7.1 mg tablets:
4346 and 3 dimples
Trifexis 665 mg/11.1 mg tablets:
4347 and no dimples
Medicinal product no longer authorised
21
Trifexis 1040 mg/17.4 mg tablets:
4349 and 4 dimpl
Lue koko asiakirja
Valmisteyhteenveto
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trifexis 270 mg/4.5 mg chewable tablets for dogs (3.9 – 6.0 kg)
Trifexis 425 mg/7.1 mg chewable tablets for dogs (6.1 – 9.4 kg)
Trifexis 665 mg/11.1 mg chewable tablets for dogs (9.5 – 14.7 kg)
Trifexis 1040 mg/17.4 mg chewable tablets for dogs (14.8 – 23.1 kg)
Trifexis 1620 mg/27 mg chewable tablets for dogs (23.2 – 36.0 kg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each tablet contains:
Spinosad
Milbemycin oxime
Trifexis 270 mg/4.5 mg
270 mg
4.5 mg
Trifexis 425 mg/7.1 mg
425 mg
7.1 mg
Trifexis 665 mg/11.1 mg
665 mg
11.1 mg
Trifexis 1040 mg/17.4 mg
1040 mg
17.4 mg
Trifexis 1620 mg/27 mg
1620 mg
27.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablets.
Mottled tan to brown, round, biconvex tablets with a debossed code on
one side and dimples on the
other side.
The following list shows the code and the number of dimples marked on
each strength of tablet:
Trifexis 270 mg/4.5 mg tablets:
4333 and 2 dimples
Trifexis 425 mg/7.1 mg tablets:
4346 and 3 dimples
Trifexis 665 mg/11.1 mg tablets:
4347 and no dimples
Trifexis 1040 mg/17.4 mg tablets:
4349 and 4 dimples
Trifexis 1620 mg/27 mg tablets:
4336 and 5 dimples
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and prevention of flea (
_Ctenocephalides felis_
) infestations in dogs where one or
more of the following indications are required concurrently:
-
prevention of heartworm disease (L3, L4
_Dirofilaria immitis_
),
-
prevention of angiostrongylosis by reducing the level of infection
with immature adult (L5)
_Angiostrongylus vasorum,_
-
treatment of gastrointestinal nematode infections caused by hookworm
(L4, immature adult (L5)
and adult
_Ancylostoma caninum_
), roundworms (immature adult L5, and adult
_Toxocara canis _
and
adult
_Toxascaris leonina_
) and
Lue koko asiakirja
