FLU-NIX- flunixin meglumine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400), phenol (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)

Available from:

Huvepharma, Inc

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular use in Horses. Before using this drug, read package outsert for complete product information. Only for Intravenous Use in Beef and Dairy Cattle. Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous and Intramuscular Use in Horses. Indications    Horse: Flu-Nix™ (flunixin meglumine injection) is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.    Cattle: Flu-Nix™ (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Flu-Nix™ (flunixin meglumine injection) is also indicated for the control of inflammation in endotoxemia. Contraindications    Horse: There are no known contraindications t

Product summary:

How Supplied Flu-Nix™ (flunixin meglumine injection), 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials. How Supplied Flu-Nix™ (flunixin meglumine injection), 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

FLU-NIX- FLUNIXIN MEGLUMINE INJECTION, SOLUTION
HUVEPHARMA, INC
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STERILE NDC 23243-0120-4
FLU-NIX™
(FLUNIXIN MEGLUMINE INJECTION)
50 MG/ML
CAUTION: FEDERAL LAW RESTRICTS THIS
DRUG TO USE BY OR ON THE ORDER OF A
LICENSED VETERINARIAN.
APPROVED BY FDA UNDER ANADA # 200-061
NET CONTENTS: 100 ML
Only for Intravenous Use in Beef and Dairy Cattle.
Not for Use in Dry Dairy Cows and Veal Calves. For Intravenous
and Intramuscular use in Horses.
Before using this drug, read package outsert for complete
product information.
To report suspected adverse drug events, for technical
assistance or to obtain a copy of the Safety Data Sheet (SDS),
contact Huvepharma, Inc. at 1-877-994-4883 or
www.huvepharma.us. For additional information about adverse
drug experience reporting for animal drugs, contact FDA at
1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
®Registered trademark of Huvepharma, Inc.
Manufactured for
Huvepharma, Inc. Rev. 09-2021
Peachtree City, GA 30269 F-2847-04
RESIDUE WARNINGS:
Cattle must not be slaughtered for human consumption within 4 days of
the last treatment. Milk that has been taken during treatment and for
36
hours after the last treatment must not be used for food. Not for use
in
dry dairy cows. A withdrawal period has not been established for this
product in preruminating calves. Do not use in calves to be processed
for
veal. Do not use in horses intended for food. Approved only for
intravenous
administration in cattle. Intramuscular administration has resulted in
violative residues in the edible tissues of cattle sent to slaughter.
STORE AT CONTROLLED
ROOM TEMPERATURE,
20º TO 25º C (68º TO
77º F) [SEE USP].
Lot No.: Exp. Date:
FLU-NIX™
(FLUNIXIN MEGLUMINE INJECTION)
50 MG/ML
ONLY FOR INTRAVENOUS USE IN BEEF AND DAIRY CATTLE.
NOT FOR USE IN DRY DAIRY COWS AND VEAL CALVES.
FOR INTRAVENOUS AND INTRAMUSCULAR USE IN HORSES.
CAUTION
Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
DESCRIPTION
Each milliliter of Flu-Nix™ (flunixin meglumine
inject