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Date: Sunday, May 22, 2022 1:56

Description: Logo Audevard
Release 2.70
Equioxx 57 mg chewable tablets for horses
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Oral: Horse NSAIDs
Active ingredient: Firocoxib
Product:EQUIOXX 57 mg chewable tablets for horses firocoxib
Product index: EQUIOXX 57 mg chewable tablets for horses firocoxib
Withdrawal notes: Meat & Offal: 26 days. Not authorised for use in animals producing milk for human consumption
Qualitative and quantitative composition
Each chewable tablet contains:
Active substance: Firocoxib 57 mg
Pharmaceutical form
Chewable tablets.
Brown, round, convex, scored tablets.
Clinical particulars
Target Species
Horses (450-600 kg)
Indications for use, specifying the target species
Alleviation of pain and inflammation associated with osteoarthiritis and reduction of associated lameness in horses.
Contrainidcations
Do not use in animals suffering from gastrointestinal disorders and haemorrhage, impaired hepatic, caridac or renal function and bleeding disorders.
Do not use in breeding, pregnant or lactating animals (see section 4.7).
Do not use concomitantly with corticosteroids or other non-steroidal anti-inflammatory drugs (NSAIDs) (see section 4.8).
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for us in animals
Do not exceed the recommended dosage.
For safe and effective use, this product should only be administered to horses in the weight range 450-600 kg. For horses weighing under 450 kg or over 600 kg, and where firocoxib is the treatment of choice, use of other firocoxib-containing formulations that allow for accurate dosing is advised.
Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity. Concurrent administration of potentially nephrotoxic veterinary medicinal products should be avoided. The recommended treatment dose and duration should not be exceeded.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
In case of accidental ingestion, seek medical advice immediately and who the package leaflet or the label to the physician.
Wash hands after use of the veterinary medicinal product.
Adverse reactions (frequency and seriousness)
Lesions (erosion/ulceration) of the oral mucosa and of the skin around the mouth were very commonly observed in treated animals during tolerance studies. These lesions were mild and resolved without treatment. Salivation and labial and tongue oedema have been uncommonly associated with the oral lesions in a field study.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animals in 10,000 animals, including isolated reports treated)
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product for us in breeding, pregnant or lactating horses has not been established. Laboratory studies in laboratory animals have shown evidence of embryofoetotoxicity, malformations, delayed parturition and decreased pup survival. Do not use in breeding, pregnant or lactating animals.
Interaction with other medicinal products and other forms of interaction
Other NSAIDs, diuretic and substances with high protein binding may compete for binding and lead to toxic effects. Do not use concomitantly with corticosteriods or other NSAIDs.
Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects and a treatment-free period with such medicinal products should therefore be observed. The treatment-free period should take into account the pharmacological properties of the medicinal products used previously.
Concomitant treatment with molecules displaying action on renal flow (e.g. diuretics) should be subject to clinical monitoring. Concurrent administration of potentially nephrotoxic medicinal products should be avoided as there might be an increased risk of renal toxicity.
Amounts to be administered and administration route
Oral use.
Administer one tablet once daily for horses weighing 450-600 kg bodyweight.
Duration of treatment will be dependent on the response observed, but should not exceed 14 days.
One tablet should be administered with a small amount of food in a bucket or direct by hand, presenting the tablet combined with a small amount of food or with a treat in the palm of the hand.
After administration, it is recommended to examine the buccal cavity to ensure that the tablet has been adequately swallowed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
At high dosages and prolonged treatement (3 times the recommended dose for 42 consecutive days and 2.5 times the recommended dose for 92 consecutive days administered once daily) mild to moderate renal lesions were observed. If clinical signs occur, treatment should be discontinued and symptomatic treatment initiated.
The incidence of oral/skin lesions increases with increasing dose.
Withdrawal period(s)
Meat and offal: 26 days
Not authorized for use in animals producing milk for human consumption.
Pharmacological particulars
Pharmacotherapeutic group: Anti-inflammatory and anti-rheumatic products, non-steriods. ATCvet code: QM01AH90.
Pharmacodynamic properties
Firocoxib is non-steroidal anti-inflammatory drug (NSAID) belonging to the Coxib group, which acts by selective inhibition of cyclooxygenase-2 (Cox-2)-medicated prostaglandin synthesis. Cyclooxygenase is responsible for generation of prostaglandins. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Coxibs therefore display analgesic, anti-inflammatory, and antipyretic properties. COX-2 is also thought to be involved in ovulation, implantation and closure of the ductus arteriosus, and central nervous system functions (fever induction, pain perception, and cognitive function). "In "in vitro" equine whole blood assays, firocoxib exhibits 222 to 643 fold selectivity for COX-2 over COX-1. The concentration of firocoxib required to inhibit 50% of the COX-2 enzyme (i.e. the IC50) is 0.0369 to 0.12 μM, whereas the IC50 for COX-1 is 20.14 to 33.1 μM.
Pharmacokinetic particulars
Following oral administration in horses at the recommended dose of 1 tablet per horses, firocoxib is rapidly absorbed, and the time to maximal concentration (Tmax) is 2.43 (+ 2.17) hours. The peak concentration (Cmax) is 0.075 (+ 0.021) μg/ml, area under the curve (AUCO-inf) is 3.48 (+1.15) μg x hr/ml. The elimination half-life (t½) after a single dose is 38.7 (+ 7.8) hours. Firocoxib is approximately 97% bound to plasma proteins. Following multiple oral administrations, the steady state is reached by approximately the eighth daily dose. Firocoxib is metabolised predominantly by dealkylation and glucuronidation in the liver. Elimination is principally in the excreta (primarily the urine), with some biliary excretion also observed.
Pharmaceutical particulars
List of excipients
Lactose monohydrate
Microcrystalline cellulose
Chartor hickory smoke flavour
Hydroxypropyl cellulose
Croscarmellose sodium
Magnesium stearate
Caramel (E150d)
Silica, colloidal anhydrous Yellow Iron Oxide (E172)
Red Iron Oxide (E172)
Major incompatibilities
Not applicable.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
Do not store above 30°C.
Store in the original package.
Nature and composition of immediate packaging
The chewable tablets are available in the following pack size:
- 1 cardboard box containing 10 tablets in transparent PVC/aluminium foil blisters.
- 1 cardboard box containing 30 tablets in transparent PVC/aluminium foil blisters.
- 1 cardboard box containing 180 tablets in transparent PVC/aluminium foil blisters.
- 1 cardboard box containing 60 tablets in a 30 ml high density polyethylene bottle.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Audevard
42-46 rue Mederic
92110, Clichy
France
Marketing Authorisation Number
UK(NI) : EU/2/08/083/006-009
UK(GB) : Vm 44684/5001
Significant changes
Date of the first authorisation or date of renewal
Date of first authorisation: 25/06/2008
Date of last renewal: 06/06/2013
Date of revision of the text
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Any other information
Nil.
Legal category
Legal category: POM-V
GTIN
GTIN description:EQUIOXX 57 mg chewable tablets for horses firocoxib
GTIN:03515650160167