Stronghold Plus

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

selamectin, sarolaner

Saatavilla:

Zoetis Belgium SA

ATC-koodi:

QP54AA55

INN (Kansainvälinen yleisnimi):

selamectin, sarolaner

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

Antiparasitic products, insecticides and repellents, Macrocyclic lactones, , combinations

Käyttöaiheet:

For cats with, or at risk from, mixed parasitic infestations by ticks and fleas, lice, mites, gastrointestinal nematodes or heartworm.The veterinary medicinal product is exclusively indicated when use against ticks and one or more of the other target parasites is indicated at the same time.

Tuoteyhteenveto:

Revision: 4

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-02-08

Pakkausseloste

19
B. PACKAGE LEAFLET
20
PACKAGE LEAFLET
STRONGHOLD PLUS 15 MG/2.5 MG SPOT-ON SOLUTION FOR CATS ≤2.5 KG
STRONGHOLD PLUS 30 MG/5 MG SPOT-ON SOLUTION FOR CATS >2.5–5 KG
STRONGHOLD PLUS 60 MG/10 MG SPOT-ON SOLUTION FOR CATS >5–10 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 and manufacturer responsible for batch
release:
Zoetis Belgium SA
Rue Laid Burniat 1
1348 Louvain-la-Neuve
BELGIUM
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg
Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5–5 kg
Stronghold Plus 60 mg/10 mg spot-on solution for cats >5–10 kg
selamectin/sarolaner
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each unit dose (pipette) delivers:
ACTIVE SUBSTANCES:
Stronghold Plus
spot-on solution
Total volume of
unit dose (ml)
selamectin (mg)
sarolaner (mg)
Cats ≤2.5 kg
0.25
15
2.5
Cats >2.5–5 kg
0.5
30
5
Cats >5–10 kg
1
60
10
EXCIPIENTS:
0.2 mg/ml butylhydroxytoluene.
Spot-on solution.
Clear, colourless to yellow solution.
4.
INDICATION(S)
For cats with, or at risk from, mixed parasitic infestations by ticks
and fleas, lice, mites,
gastrointestinal nematodes or heartworm. The veterinary medicinal
product is exclusively indicated
when use against ticks and one or more of the other target parasites
is indicated at the same time.
ECTOPARASITES:
-
For the treatment and prevention of flea infestations (
_Ctenocephalides_
spp.). The veterinary
medicinal product has immediate and persistent flea killing activity
against new infestations for
5 weeks. The product kills adult fleas before they lay eggs for 5
weeks. Through its ovicidal and
larvicidal action, the veterinary medicinal product may aid in the
control of existing
environmental flea infestations in areas to which the animal has
access.
-
The product can be used as part of a treatment strategy for flea
allergy dermatitis (FAD

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stronghold Plus 15 mg/2.5 mg spot-on solution for cats ≤2.5 kg
Stronghold Plus 30 mg/5 mg spot-on solution for cats >2.5–5 kg
Stronghold Plus 60 mg/10 mg spot-on solution for cats >5–10 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each unit dose (pipette) delivers:
ACTIVE SUBSTANCES:
Stronghold Plus
spot-on solution
Pipette content
(ml)
selamectin (mg)
sarolaner (mg)
Cats ≤2.5 kg
0.25
15
2.5
Cats >2.5–5 kg
0.5
30
5
Cats >5–10 kg
1
60
10
EXCIPIENTS:
0.2 mg/ml butylhydroxytoluene.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Clear, colourless to yellow 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 parasitic infestations by ticks
and fleas, lice, mites,
gastrointestinal nematodes or heartworm. The veterinary medicinal
product is exclusively indicated
when use against ticks and one or more of the other target parasites
is indicated at the same time.
ECTOPARASITES:
-
For the treatment and prevention of flea infestations (
_Ctenocephalides_
spp.). The veterinary
medicinal product has immediate and persistent flea killing activity
against new infestations for
5 weeks. The product kills adult fleas before they lay eggs for 5
weeks. Through its ovicidal and
larvicidal action, the veterinary medicinal product may aid in the
control of existing
environmental flea infestations in areas to which the animal has
access.
-
The product can be used as part of a treatment strategy for flea
allergy dermatitis (FAD).
-
Treatment of tick infestations. The veterinary medicinal product has
immediate and persistent
acaricidal effect for 5 weeks against
_Ixodes ricinus _
and
_Ixodes hexagonus_
, and 4 weeks against
_Dermacentor reticulatus _
and
_ Rhipicephalus sanguineus_
.
-
Treatment of ear mites (
_Otodectes cynotis_
).
-
Treatment of biting lice infestations
_(Felicola subrostratus