FDA Approves Extended Expiration Date for Clevor® (ropinirole ophthalmic solution)
The U.S. Food & Drug Administration recently approved a three-year expiration date for Clevor® (ropinirole ophthalmic solution) when stored in its original packaging. The extension increases its previous expiration date by 12 months to 36 months from the date of manufacture.
Clevor is the first and only FDA-approved product for emesis induction in dogs. Its unique ocular administration makes the process easy and injection-free — all of which add up to a quicker, less stressful process for veterinarians, staff, dogs, and their owners.
The extension was granted after extensive product stability testing. There has been no change to the formulation. Clinics in possession of Clevor with the lot number EM099 now have an additional 12 months of expiration.
Clevor can be stored at room temperature and is available in ready-to-use droppers. After opening a dropper, Clevor should be used within 30 minutes.
CLEVOR is indicated for the induction of vomiting in dogs.
IMPORTANT SAFETY INFORMATION: Do not use in dogs with central nervous system depression or seizures. Do not use in cases of ingestion of sharp foreign objects, corrosive agents (acids or alkalis), volatile substances or organic solvents. CLEVOR should not be administered in cases with corneal ulceration, ocular irritation, or ocular injury. Do not use when there is a known sensitivity to ropinirole or the inactive ingredients. ADVERSE REACTIONS MAY INCLUDE: Transient mild or moderate hyperemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm, transient mild lethargy and increased heart rate. Not recommended for use in breeding, pregnant or lactating dogs. CLEVOR has not been evaluated in dogs with heart or liver impairments or dogs younger than 4.5 months or less than 4 pounds. Dopamine antagonists, neuroleptics and other medicines with antiemetic properties may reduce the effectiveness of ropinirole. CLEVOR should be administered by a veterinary professional. Gloves and protective eyewear should be worn when administering. Not for use in humans. Keep out of reach of children. For full prescribing information, visit www.vetoquinolusa.com/clevor-info.
About Vetoquinol USA
Headquartered in Fort Worth, Texas, Vetoquinol USA is owned by Vetoquinol S.A., an independent, family-owned French pharmaceutical company founded in 1933. Dedicated exclusively to animal health, Vetoquinol USA is focused on the development, production, and marketing of AAFCO, NASC, EPA, and FDA-regulated pharmaceutical, nutritional, and dermatological products for small and large animals.
Source: www.vetoquinolusa.com
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