Χώρα: Ευρωπαϊκή Ένωση
Γλώσσα: Αγγλικά
Πηγή: EMA (European Medicines Agency)
selamectin
Zoetis Belgium SA
QP54AA05
selamectin
Dogs; Cats
Antiparasitic products, insecticides and repellents, Endectocides, Macrocyclic lactones,
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).
Revision: 23
Authorised
1999-11-25
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 Διαβάστε το πλήρες έγγραφο
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 Διαβάστε το πλήρες έγγραφο