Broadline
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-04-2020
Charakterystyka produktu
(SPC)
08-04-2020
Sprawozdanie z oceny publicznego
(PAR)
17-10-2019
Składnik aktywny:
eprinomectin, fipronil, praziquantel, (S)-methoprene
Dostępny od:
Boehringer Ingelheim Vetmedica GmbH
Kod ATC:
QP54AA54
INN (International Nazwa):
eprinomectin, fipronil, praziquantel, (S)-methoprene
Grupa terapeutyczna:
Cats
Dziedzina terapeutyczna:
Antiparasitic products, insecticides and repellents, Avermectins, Eprinomectin, combinations,
Wskazania:
For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites. The veterinary medicinal product is exclusively indicated when all three groups are targeted at the same time.EctoparasitesTreatment and prevention of infestations by fleas (Ctenocephalides felis). Elimination of fleas within 24 hours. One treatment prevents further infestations for at least one month.Prevention of environmental flea contamination by inhibiting the development of flea immature stages (eggs, larvae and pupae) for over a month.The product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).Treatment and prevention of infestations by ticks (Ixodes ricinus). Elimination of ticks within 48 hours. One treatment prevents further infestations for up to 3 weeks.Treatment of notoedric mange (Notoedres cati).CestodesTreatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).NematodesTreatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina, L4 larvae and adults of Ancylostoma tubaeforme and Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior).Treatment of infestations with vesical worms (Capillaria plica).Prevention of heartworm disease (Dirofilaria immitis larvae) for one month.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Authorised
Data autoryzacji:
2013-12-04
Ulotka dla pacjenta
19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET
:
BROADLINE SPOT-ON SOLUTION FOR CATS < 2.5 KG
BROADLINE SPOT-ON SOLUTION FOR CATS 2.5–7.5 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:
Boehringer Ingelheim Vetmedica GmbH
55216 Ingelheim/Rhein
GERMANY
Manufacturer responsible for batch release:
Boehringer Ingelheim Animal Health France SCS
4 Chemin du Calquet,
31000 Toulouse
FRANCE
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats 2.5–7.5 kg
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose (applicator) delivers:
Volume of
unit dose (ml)
Fipronil
(mg)
(S)-methoprene
(mg)
Eprinomectin
(mg)
Praziquantel
(mg)
Cats <2.5 kg
0.3
24.9
30.0
1.20
24.9
Cats 2.5-7.5 kg
0.9
74.7
90.0
3.60
74.7
Excipient: Butylhydroxytoluene (E321) 1 mg/ml.
Spot-on solution.
4.
INDICATIONS
For cats with, or at risk from mixed infestations by cestodes,
nematodes and ectoparasites. The
veterinary medicinal product is exclusively indicated when all three
groups are targeted at the same
time.
Ectoparasites
-
Treatment and prevention of infestations by fleas (
_Ctenocephalides felis)_
. Elimination of fleas
within 24 hours. One treatment prevents further infestations for at
least one month.
-
Prevention of environmental flea contamination by inhibiting the
development of flea immature
stages (eggs, larvae and pupae) for over a month.
-
The product can be used as part of a treatment strategy for the
control of flea allergy dermatitis
(FAD).
-
Treatment and prevention of infestations by ticks (
_Ixodes ricinus)_
. Elimination of ticks within
48 hours. One treatment prevents further infestations for up to 3
weeks.
-
Treatment of notoedric mange (
_Notoedres cati_
).
21
Cestodes
-
Treatment of infestations with tapeworms (
_Dipylidium caninum_
,
_Taenia taeniaeformis_
,
_Echinococcus multilocularis_
,
_Joyeuxiella pasq
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BROADLINE spot-on solution for cats < 2.5 kg
BROADLINE spot-on solution for cats 2.5-7.5 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Each unit dose applicator delivers:
Volume of
unit dose (ml)
Fipronil
(mg)
(S)-methoprene
(mg)
Eprinomectin
(mg)
Praziquantel
(mg)
Cats <2.5 kg
0.3
24.9
30.0
1.20
24.9
Cats 2.5–7.5 kg
0.9
74.7
90.0
3.60
74.7
EXCIPIENTS:
Butylhydroxytoluene (E321) 1 mg/ml.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear colourless to yellow to red/brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For cats with, or at risk from mixed infestations by cestodes,
nematodes and ectoparasites. The
veterinary medicinal product is exclusively indicated when all three
groups are targeted at the same
time.
Ectoparasites
-
Treatment and prevention of infestations by fleas (
_Ctenocephalides felis)_
. Elimination of fleas
within 24 hours. One treatment prevents further infestations for at
least one month.
-
Prevention of environmental flea contamination by inhibiting the
development of flea immature
stages (eggs, larvae and pupae) for over a month.
-
The product can be used as part of a treatment strategy for the
control of flea allergy dermatitis
(FAD).
-
Treatment and prevention of infestations by ticks (
_Ixodes ricinus)_
. Elimination of ticks within
48 hours. One treatment prevents further infestations for up to 3
weeks.
-
Treatment of notoedric mange (
_Notoedres cati_
).
Cestodes
-
Treatment of infestations with tapeworms (
_Dipylidium caninum_
,
_Taenia taeniaeformis_
,
_Echinococcus multilocularis_
_, Joyeuxiella pasqualei _
(adult), and
_ Joyeuxiella fuhrmanni (_
adult
_))_
.
3
Nematodes
-
Treatment of infestations with gastrointestinal nematodes (L3, L4
larvae and adults of
_Toxocara _
_cati_
, adults of
_Toxascaris leonina,_
L4 larvae and adults of
_Ancylostoma tubaeforme
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