STRONGHOLD PLUS VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SAROLANER; SELAMECTIN

Available from:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Pharmaceutical form:

SOLUTION

Composition:

SAROLANER 10 MG / 1 ML; SELAMECTIN 60 MG / 1 ML

Administration route:

TOPICAL

Prescription type:

Required

Manufactured by:

ZOETIS LLC (SUBSIDIARY OF ZOETIS INC), USA

Therapeutic indications:

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). Ticks must attach to the host and commence feeding in order to be exposed to sarolaner. Nematodes: • Treatment of adult roundworms (Toxocara cati) and adult intestinal hookworms (Ancylostoma tubaeforme). • Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration.

Authorization date:

2021-01-06

Patient Information leaflet

VETERINARY MEDICINE PACKAGE LEAFLET
This medicine is dispensed with a veterinarian’s prescription only
For use in animals only
1.
NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE
Stronghold Plus Veterinary
Spot-on solution for cat skin
2.
ACTIVE INGREDIENTS
Each millilitre contains:
selamectin
60.00mg
sarolaner
10.00mg
For a list of the inactive ingredients and allergens in this medicine
see section 13.
3.
WHAT IS THIS MEDICINE INTENDED FOR?
This product is intended for cats with, or at risk from, mixed
parasitic infestations
by ticks, fleas, lice, mites, gastrointestinal nematodes or heartworm
(dirofilariasis).
This veterinary medicinal product is exclusively indicated in cases of
infestation
with ticks together with one or more of the other target parasites 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 aids in the control of environmental flea infestations in the
area in which
the animal is located.
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 mite killing activity for 5 weeks against _Ixodes
ricinus_ and _Ixodes _
_hexagonus_, and for 4 weeks against _Dermacentor reticulatus_ and
_Rhipicephalus _
_sanguineus_.
Treatment of ear mites (_Otodectes cynotis_).
Treatment of biting lice infestations (_Felicola subrostratus_).
Ticks must attach to the host’s body and commence feeding on it, in
order to be
exposed to sarolaner.
Nematodes (roundworms):
Treatment of adult roundworms (_Toxocara cati_) and adult intestinal
hookworms
(_Ancylostoma tubaeforme_).
Prevention of a disease caused by heartworm (_Dirofilaria immitis_)
with monthly
administration.

Summary of Product characteristics

Stronghold Plus Veterinary LPD CC
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stronghold Plus Veterinary
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 butylated hydroxytoluene.
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_).
Stronghold Plus Veterinary LPD CC
-
Treatment of biting lice infestations _(Felicola subrostratus_).
Ticks must attach to the host and commence feeding in order to be
exposed to sarolaner.
NEMATODES:
-
Treatment of adult roundworms (_Toxocara cati