Stronghold
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
15-01-2019
Karatteristiċi tal-prodott
(SPC)
15-01-2019
Rapport ta 'Valutazzjoni Pubblika
(PAR)
07-04-2015
Ingredjent attiv:
selamectin
Disponibbli minn:
Zoetis Belgium SA
Kodiċi ATC:
QP54AA05
INN (Isem Internazzjonali):
selamectin
Grupp terapewtiku:
Dogs; Cats
Żona terapewtika:
Antiparasitic products, insecticides and repellents, Endectocides, Macrocyclic lactones,
Indikazzjonijiet terapewtiċi:
Cats and dogs: Treatment and prevention of flea infestations caused by Ctenocephalides spp. for one month following a single administration. This is as a result of the adulticidal, larvicidal and ovicidal properties of the product. The product is ovicidal for 3 weeks after administration. Through a reduction in the flea population, monthly treatment of pregnant and lactating animals will also aid in the prevention of flea infestations in the litter up to seven weeks of age. The product can be used as part of a treatment strategy for flea allergy dermatitis and through its ovicidal and larvicidal action may aid in the control of existing environmental flea infestations in areas to which the animal has access.Prevention of heartworm disease caused by Dirofilaria immitis with monthly administration. Stronghold may be safely administered to animals infected with adult heartworms, however, it is recommended, in accordance with good veterinary practice, that all animals 6 months of age or more living in countries where a vector exists should be tested for existing adult heartworm infections before beginning medication with Stronghold. It is also recommended that dogs should be tested periodically for adult heartworm infections, as an integral part of a heartworm prevention strategy, even when Stronghold has been administered monthly. This product is not effective against adult D. immitis.Treatment of ear mites (Otodectes cynotis). Cats:Treatment of biting lice infestations (Felicola subrostratusTreatment of adult roundworms (Toxocara cati)Treatment of adult intestinal hookworms (Ancylostoma tubaeforme). Dogs:Treatment of biting lice infestations (Trichodectes canis)Treatment of sarcoptic mange (caused by Sarcoptes scabiei)Treatment of adult intestinal roundworms (Toxocara canis).
Sommarju tal-prodott:
Revision: 23
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
1999-11-25
Fuljett ta 'informazzjoni
24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET:
STRONGHOLD SPOT-ON SOLUTION
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 15 mg spot-on solution for cats and dogs ≤ 2.5 kg
Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg
Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg
Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg
Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg
Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg
Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg
Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg
selamectin
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each single-dose (pipette) delivers:
Stronghold 15 mg for cats and dogs
6% w/v solution
selamectin
15 mg
Stronghold 30 mg for dogs
12% w/v solution
selamectin
30 mg
Stronghold 45 mg for cats
6% w/v solution
selamectin
45 mg
Stronghold 60 mg for cats
6% w/v solution
selamectin
60 mg
Stronghold 60 mg for dogs
12% w/v solution
selamectin
60 mg
Stronghold 120 mg for dogs
12% w/v solution
selamectin
120 mg
Stronghold 240 mg for dogs
12% w/v solution
selamectin
240 mg
Stronghold 360 mg for dogs
12% w/v solution
selamectin
360 mg
EXCIPIENTS:
Butylated hydroxytoluene
0.08%.
Colourless to yellow solution.
4.
INDICATION(S)
CATS AND DOGS:
TREATMENT AND PREVENTION OF FLEA INFESTATIONS
caused by
_Ctenocephalides_
spp. for one month
following a single administration. This is as a result of the
adulticidal, larvicidal and ovicidal
properties of the veterinary medicinal product. The veterinary
medicinal product is ovicidal for 3
weeks after administration. Through a reduction in the flea
population, monthly treatment of
pregnant and lactating animals will also aid in the prevention of flea
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stronghold 15 mg spot-on solution for cats and dogs ≤ 2.5 kg
Stronghold 30 mg spot-on solution for dogs 2.6–5.0 kg
Stronghold 45 mg spot-on solution for cats 2.6–7.5 kg
Stronghold 60 mg spot-on solution for cats 7.6–10.0 kg
Stronghold 60 mg spot-on solution for dogs 5.1–10.0 kg
Stronghold 120 mg spot-on solution for dogs 10.1–20.0 kg
Stronghold 240 mg spot-on solution for dogs 20.1–40.0 kg
Stronghold 360 mg spot-on solution for dogs 40.1–60.0 kg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose (pipette) delivers:
ACTIVE SUBSTANCE:
Stronghold 15 mg for cats and dogs
6% w/v solution
selamectin
15 mg
Stronghold 30 mg for dogs
12% w/v solution
selamectin
30 mg
Stronghold 45 mg for cats
6% w/v solution
selamectin
45 mg
Stronghold 60 mg for cats
6% w/v solution
selamectin
60 mg
Stronghold 60 mg for dogs
12% w/v solution
selamectin
60 mg
Stronghold 120 mg for dogs
12% w/v solution
selamectin
120 mg
Stronghold 240 mg for dogs
12% w/v solution
selamectin
240 mg
Stronghold 360 mg for dogs
12% w/v solution
selamectin
360 mg
EXCIPIENTS:
Butylated hydroxytoluene
0.08%.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spot-on solution.
Colourless to yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATS AND DOGS:
•
TREATMENT AND PREVENTION OF FLEA INFESTATIONS
caused by
_Ctenocephalides_
spp. for one month
following a single administration. This is as a result of the
adulticidal, larvicidal and ovicidal
properties of the product. The product is ovicidal for 3 weeks after
administration. Through a
reduction in the flea population, monthly treatment of pregnant and
lactating animals will also
aid in the prevention of flea infestations in the litter up to seven
weeks of age. The product can be
used as part of a treatment strategy for flea allergy dermatitis and
through its ovicidal and
3
larvicidal action may
Aqra d-dokument sħiħ
