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Tick Control n Dogs
For the control of tick (DDermacentor variabilis) infestations in dogs, REVOLUTION should be admin-
istered on a monthly basis.In heavy tick infestations,complete efficacy may not be achieved after the
first dose.In these cases,one additional dose may be administered 2 weeks after the previous dose,
with onthly osing continued thereafter.
Nematode Treatment n Cats
For the treatment and control of intestinal hookworm (AA. tubaeforme) and roundworm (TT cati)infections,
REVOLUTION should e applied once s a single opical ose.
SAFETY:
REVOLUTION has been tested safe in over 100 different pure and mixed breeds of healthy dogs and
over 15 different pure and mixed breeds of healthy cats,including pregnant and lactating females,
breeding males and females,puppies 6 weeks of age and older,kittens 8 weeks of age and older,
and avermectin-ssensitive collies.A kitten, estimated to be 5-6 weeks old (00.3 kg),, died 8 1 .2 hours
after receiving a single treatment of REVOLUTION at the recommended dosage.The kitten displayed
clinical signs which included muscle spasms,salivation and neurological signs.The kitten was a stray
with n unknown istory and was alnourished and underweight (ssee WARNINGS).
Dogs:In safety studies,REVOLUTION was administered at 1,3,5,and 10 times the recommended
dose to 6-week old puppies,and no adverse reactions were observed.The safety of REVOLUTION
administered orally also was tested in case of accidental oral ingestion.Oral administration of
REVOLUTION at the recommended topical dose in 5-to 8-month-old beagles did not cause any
adverse reactions.In a pre-clinical study selamectin was dosed orally to ivermectin-ssensitive collies.
Oral administration of 2.5,10,and 15 mg/kg in this dose-escalating study did not cause any adverse
reactions;however,8 hours after receiving 5 mg/kg orally,one avermectin-sensitive collie became
ataxic for several hours,but did not show any other adverse reactions after receiving subsequent
doses of 10 and 15 mg/kg orally.In a topical safety study conducted with avermectin-sensitive collies
at 1,3 and 5 times the recommended dose of REVOLUTION,salivation was observed in all treatment
groups, including the vehicle control. REVOLUTION also was administered at 3 times the recom-
mended ose to eartworm infected dogs, nd o adverse ffects ere observed.
Cats:In safety studies, REVOLUTION was applied at 1, 3, 5, and 10 times the recommended dose
to 6-week-old kittens.No adverse reactions were observed.The safety of REVOLUTION administered
orally also was tested in case of accidental oral ingestion.Oral administration of the recommended
topical dose of REVOLUTION to cats caused salivation and intermittent vomiting.REVOLUTION also
was applied at 4 times the recommended dose to patent heartworm infected cats,and no adverse
reactions were observed.
In well-controlled clinical studies,REVOLUTION was used safely in animals receiving other frequently
used veterinary products such as vaccines,anthelmintics,antiparasitics,antibiotics, steroids,collars,
shampoos nd ips.
STORAGE ONDITIONS: Store below 30 °C 86 °F)..
HOW SUPPLIED:Available in 7 separate dose strengths for dogs and cats of different weights (see
DOSAGE).REVOLUTION for puppies and kittens is available in cartons containing 3 single dose
tubes.EVOLUTION for ats and dogs s available n cartons ontaining 3 or ingle dose ubes.
For a copy of the Material Safety Data Sheet (MSDS)or to report adverse reactions call Pfizer Animal
Health t 1-800-366-5288.
NADA 141-152, pproved y FDA
July 2008
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