Product Name: MEGLUVET

Type: NSAID (Anti-inflammatory Injection)

COMPOSITION

Each ml contains:

• Flunixin Meglumine ...... 50 mg (equivalent to 50 mg flunixin)
• Phenol ...... 5.0 mg (as preservative)
• Propylene Glycol ...... 207.2 mg (as vehicle/solvent)
• Edetate Disodium ...... 0.1 mg
• Sodium Formaldehyde Sulfoxylate ...... 2.5 mg
• Diethanolamine ...... 4.0 mg
• Water for Injection ...... q.s. to 1 ml

DESCRIPTION

MEGLUVET is a potent, non-narcotic, non-steroidal anti-inflammatory drug (NSAID) with significant analgesic (pain-relieving) and antipyretic (fever-reducing) activity

Mechanism of Action: Flunixin Meglumine acts as a potent cyclooxygenase (COX) inhibitor, blocking the production of prostaglandins—key mediators of pain, inflammation, and fever in the body . Prostaglandins are synthesized from arachidonic acid via the COX enzyme pathway; by inhibiting this enzyme, flunixin reduces the formation of these inflammatory mediators at the site of tissue injury .

Pharmacokinetics: Flunixin meglumine is a weak acid (pKa=5.82) that exhibits a high degree of plasma protein binding (approximately 99%)

Cattle: In cattle, elimination occurs primarily through biliary excretion . The terminal half-life ranges from 3.14 to 8.12 hours . Flunixin persists in inflamed tissues, and its anti-inflammatory properties extend well beyond the period associated with detectable plasma drug concentrations . This persistence accounts for the extended duration of action despite relatively short plasma half-life.

Horses: Plasma half-life in horse serum is 1.6 hours following a single dose of 1.1 mg/kg. Measurable amounts are detectable in horse plasma at 8 hours post-injection . Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as measured by reduction in lameness and swelling in the horse

Swine: Following intramuscular administration (2.2 mg/kg), plasma elimination half-life is 3-4 hours, with peak concentration of 2.94 μg/mL reached at 0.4 hours. The bioavailability after single neck injection is 87%

Onset and Duration of Activity: Studies show onset of activity is within 2 hours in horses, with peak response occurring between 12 and 16 hours and duration of activity lasting 24-36 hours . For equine colic, pain is alleviated in less than 15 minutes in many cases when administered intravenously .

INDICATIONS
MEGLUVET is indicated for the following conditions in target species:

Cattle (Bovine):

• Control of pyrexia (fever) associated with Bovine Respiratory Disease (BRD)
• Control of inflammation in endotoxemia and septic shock
• Adjunctive therapy in the treatment of acute bovine mastitis
• Alleviation of acute inflammation and pain associated with musculoskeletal disorders
• Reduction of post-operative pain following dehorning in calves less than 9 weeks old

Horses (Equine):

• Alleviation of inflammation and pain associated with musculoskeletal disorders
• Alleviation of visceral pain associated with colic
• Treatment of endotoxemia or septic shock associated with gastric torsion and other conditions compromising gastrointestinal blood circulation

Swine (Pigs):

• Control of pyrexia associated with Swine Respiratory Disease
• Supportive treatment of Mastitis-Metritis-Agalactia (MMA) syndrome in sows
• Relief of acute inflammation and pain associated with musculoskeletal disorders
• Reduction of post-operative pain following castration and tail docking in suckling piglets

DOSAGE & ADMINISTRATION

For intravenous (IV) or intramuscular (IM) use depending on species. Allow the solution to reach room temperature before administration and inject slowly . Use aseptic technique when drawing doses from the vial. Use a calibrated syringe for accurate dosing.

Recommended Dosage:

Important Administration Notes:

• Cattle: Approved only for intravenous administration. Intramuscular administration has resulted in violative residues in edible tissues
• Horses: Avoid intra-arterial injection, which can cause ataxia, incoordination, hyperventilation, hysteria, and muscle weakness (signs are transient and disappear without antidotal medication within a few minutes)
• Swine: Limit injection volume to a maximum of 5 ml per injection site
• The stopper should not be punctured more than 50 times. A draw-off needle should be used to avoid excessive puncturing of the stopper

WITHDRAWAL PERIODS

PRECAUTIONS & CONTRAINDICATIONS

Contraindications:

• Cattle: Do not use within 48 hours of expected parturition, as NSAIDs inhibit prostaglandin production important for signaling parturition—use can delay labor and increase stillbirth risk
• Do not use in bulls intended for breeding (reproductive effects not investigated)
• Do not use in calves to be processed for veal
• Do not use in dry dairy cows
• Horses: Do not use in horses showing hypersensitivity to flunixin meglumine. Avoid intra-arterial injection
• Swine: Not for use in breeding swine
• All Species: Do not use in animals with gastrointestinal ulceration, bleeding disorders, or hypersensitivity to flunixin meglumine
• Use judiciously when renal impairment or gastric ulceration is suspected

Drug Interactions:

• Do not use concurrently with other NSAIDs or corticosteroids, as this may increase the risk of gastrointestinal ulceration and bleeding
• Because of high plasma protein binding (approximately 99%), flunixin may displace other protein-bound drugs, potentially enhancing their effects or toxicity
• Use with caution in patients on diuretic therapy or with renal, cardiovascular, or hepatic dysfunction

Adverse Reactions:

• In Horses: Local reactions following intramuscular injection (swelling, sweating, induration, stiffness). Rare cases of fatal or nonfatal clostridial infections have been reported
• In Cattle & Horses: Rare instances of anaphylactic-like reactions, some fatal, primarily following intravenous use
• In All Species: Long-term or high-dose use may cause gastric ulceration, renal toxicity, and blood in feces or urine. Discontinue use if hematuria or fecal blood are observed
• In swine, intramuscular injection may cause local tissue irritation and damage

Reproductive Considerations:

• There may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of the estrous cycle
• Use in the immediate post-partum period may interfere with uterine involution and expulsion of fetal membranes. Monitor cows carefully for placental retention and metritis if used within 24 hours after parturition
• The effect on pregnancy has not been determined in horses

Operator Safety:

• For veterinary use only. Avoid self-injection. In case of accidental self-injection, seek medical advice immediately
• Wash hands thoroughly after handling
• Dispose of empty containers responsibly according to local regulations

Storage:

• Store between 2°C and 30°C (36°F and 86°F)
• Protect from light and freezing
• Use within 60 days of first puncture
• When using a draw-off spike or needle with a bore diameter larger than 16-gauge, discard any product remaining in the vial immediately after use
• Keep out of reach of children.

Target Species: Cattle (Beef and Dairy), Horses, Swine

Pack Sizes: 100 ml Vial

PRODUCT SUMMARY
MEGLUVET NSAID (Anti-inflammatory Injection) Solution for Injection Flunixin Meglumin….... 50mg Phenol…................ 4 mg Livestock 100ml Vial

FOR VETERINARY USE ONLY