FLU-NIX- flunixin meglumine injection, solution
Flu-Nix by
Drug Labeling and Warnings
Flu-Nix by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc, Huvepharma EOOD. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
- GENERAL PRECAUTIONS
- INDICATIONS & USAGE
-
ADVERSE REACTIONS
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 WARNING
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. - STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- GENERAL PRECAUTIONS
-
DESCRIPTION
Description
Each milliliter of Flu-Nix™ (flunixin meglumine
injection) contains flunixin meglumine equivalent
to 50 mg flunixin, 0.1 mg edetate disodium, 2.5
mg sodium formaldehyde sulfoxylate, 4.0 mg
diethanolamine, 207.2 mg propylene glycol, 5.0
mg phenol as preservative, hydrochloric acid,
water for injection q.s. -
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
Pharmacology
Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with
anti-inflammatory and anti-pyretic activity. It is significantly more potent than pentazocine,
meperidine and codeine as an analgesic in the rat yeast paw test.
Horse: Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as
measured by the reduction in lameness and swelling in the horse. 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.
Cattle: Flunixin meglumine is a weak acid (pKa=5.82)1 which exhibits a high degree of
plasma protein binding (approximately 99%).2 However, free (unbound) drug appears to readily
partition into body tissues (Vss predictions range from 297 to 782 mL/kg.2-5 Total body water is
approximately equal to 570 mL/kg).6 In cattle, elimination occurs primarily through biliary
excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood
concentration/time profile following IV administration.2
In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5
These studies also report a large discrepancy between the volume of distribution at a steady
state (Vss) and the volume of distribution associated with the terminal elimination phase
(Vß). This discrepancy appears to be attributable to extended drug elimination from a deep
compartment.8 The terminal half-life has been shown to vary from 3.14 to 8.12 hours.2-5
Flunixin persists in inflammatory tissues9 and is associated with anti-inflammatory properties
which extend well beyond the period associated with detectable plasma drug concentrations.4,9
These observations account for the counterclock-wise hysteresis associated with
flunixin's pharmacokinetic/pharmacodynamic relationships.10 Therefore, prediction of drug
concentrations based upon the estimated plasma terminal elimination half-life will likely
underestimate both the duration of drug action and the concentration of drug remaining at the
site of activity. -
INDICATIONS & USAGE
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. -
DOSAGE & ADMINISTRATION
Dose and Administration
Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1
mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular
injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak
response occurs between 12 and 16 hours. Peak response occurs between 12 and 16 hours and
duration of activity is 24-36 hours.
The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound
of body weight. Intravenous administration is recommended for prompt relief. Clinical studies
show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when
signs of colic recur. During clinical studies approximately 10% of the horses required one or
two additional treatments. The cause of colic should be determined and treated with
concomitant therapy.
Cattle: The recommended dose for control of pyrexia associated with bovine respiratory
disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg
(0.5 to 1 mg/lb;1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration
either once a day as a single dose or divided into two doses administered at 12-hour intervals for
up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight.
Avoid rapid intravenous administration of the drug.
The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body
weight given once by intravenous administration. -
CONTRAINDICATIONS
Contraindications
Horse: There are no known contraindications to this drug when used as directed. Intra-arterial
injection should be avoided. Horses inadvertently injected intra-arterially can show adverse
reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness.
Signs are transient and disappear without antidotal medication within a few minutes. Do
not use in horses showing hypersensitivity to flunixin meglumine.
Cattle: NSAIDS inhibit production of prostaglandins which are important in signaling
the initiation of parturition. The use of flunixin can delay parturition and prolong labor which
may increase the risk of stillbirth. Do not use Flu-Nix™ (flunixin meglumine injection) within 48
hours of expected parturition.
Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal
impairment or gastric ulceration are suspected -
RESIDUE WARNING
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. -
PRECAUTIONS
Precautions
As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal and renal
toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients
at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or
those with renal, cardiovascular, and/or hepatic dysfunction.
Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant
use of Flunixin Meglumine Injection with other anti-inflammatory drugs, such as other NSAIDs
and corticosteroids, should be avoided or closely monitored.
Horse: The effect of Flunixin Meglumine Injection on pregnancy has not been determined.
Studies to determine activity of Flunixin Meglumine Injection when administered
concomitantly with other drugs have not been conducted. Drug compatibility should be monitored
closely in patients requiring adjunctive therapy.
Cattle: Do not use in bulls intended for breeding, as reproductive effects of Flunixin
Meglumine Injection in these classes of cattle have not been investigated. NSAIDs are known to
have potential effects on both parturition (See Contraindications) and the estrous cycle. There
may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of
the estrous cycle. NSAIDS are known to have the potential to delay parturition through a tocolytic
effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine
involution and expulsion of fetal membranes. Cows should be monitored carefully for placental
retention and metritis if Flunixin Meglumine Injection is used within 24 hours after parturition. -
SUMMARY OF SAFETY AND EFFECTIVENESS
Safety
Horse: A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was
safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous
dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days
produced no changes in blood or urine parameters. No injection site irritation was
observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation
was observed following a 3-fold dose administered intramuscularly.
Cattle: No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X
(2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal
toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered
daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria
or fecal blood are observed. -
ADVERSE REACTIONS
Adverse Reactions
In horses, isolated reports of local reactions following intramuscular injection, particularly in
the neck, have been received. These include localized swelling, sweating, induration, and
stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections
have been reported in association with intramuscular use of Flunixin Meglumine
Injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have
been fatal, have been reported, primarily following intravenous use.
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. - HOW SUPPLIED
- STORAGE AND HANDLING
-
REFERENCES
REFERENCES
1. Johansson M, Anler EL. Gas chromatographic
analysis of flunixin in equine urine after
extractive methylation. J Chromatogr.
1988;427:55-66.
2. Oldensvik K, Johansson M. High-performance
liquid chromatography method for
determination of flunixin in bovine plasma and
pharmacokinetics after single and repeated
doses of the drug. Am J Vet Res.
1995;56:489-495.
3. Anderson KL, Neff-Davis CA, Davis LE, Bass VD.
Pharmacokinetics of flunixin meglumine in
lactating cattle after single and multiple
intramuscular and intravenous administrations.
Am J Vet Res. 1990;51:1464-1467.
4. Oldensvik K. Pharmacokinetics of flunixin and
its effect on prostaglandin F2a metabolite
concentrations after oral and intravenous
administration in heifers. J Vet Pharmacol Ther.
1995;18:254-259.
5. Hardee GE, Smith JA, Harris SJ.
Pharmacokinetics of flunixin meglumine in the
cow. Res Vet Sci. 1985;39:110-112.
6. Ruckebusch Y, Phaneuf LP, Dunlop R. Physiology
of Small and Large Animals. Chapter 2; "Body
Fluid Compartments," Philadelphia, Pa: B.C.
Decker; 1991:8-18.
7. Kopcha M, Ahi AS. Experimental use of flunixin
meglumine and phenylbutazone in
food-producing animals. J Am Vet
Med Assoc. 1989;194:45-49.
8. Wagner JG. Significance of ratios of different
volumes of distribution in pharmacokinetics.
Biopharm & Drug Dispos. 1983;4:263-270.
9. Lees P, Higgins AJ. Flunixin inhibits
prostaglandin E2 production in equine
inflammation. Res Vet Sci. 1984;37:347-349.
10. Landoni MF, Cunningham FM, Lees P.
Determination of pharmacokinetics and
pharmacodynamics of flunixin in calves by
use of pharmacokinetic/ pharmacodynamic
modeling. Am J Vet Res. 1995;56:786-794. -
INDICATIONS & USAGE
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.
Read accompanying directions for use.
Approved by FDA under ANADA # 200-061
®Registered trademark of Huvepharma, Inc.
Manufactured for
Huvepharma, Inc.
Peachtree City, GA 30269
Rev. 05-2022 F-2847-05 - SPL UNCLASSIFIED SECTION
- GENERAL PRECAUTIONS
- INDICATIONS & USAGE
-
ADVERSE REACTIONS
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.
Peachtree City, GA 30269Rev. 09-2021
F-2847-05 -
RESIDUE WARNING
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. - STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- INDICATIONS & USAGE
- PRECAUTIONS
-
DESCRIPTION
Description
Each milliliter of Flu-Nix™ (flunixin meglumine injection)
contains flunixin meglumine equivalent to 50 mg flunixin,
0.1 mg edetate disodium, 2.5 mg sodium formaldehyde
sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene
glycol, 5.0 mg phenol as preservative, hydrochloric acid,
water for injection q.s. -
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
Pharmacology
Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with
anti-inflammatory and anti-pyretic activity. It is significantly more potent than pentazocine,
meperidine and codeine as an analgesic in the rat yeast paw test.
Horse: Flunixin is four times as potent on a mg-per-mg basis as phenylbutazone as
measured by the reduction in lameness and swelling in the horse. 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.
Cattle: Flunixin meglumine is a weak acid (pKa=5.82)1 which exhibits a high degree of
plasma protein binding (approximately 99%).2 However, free (unbound) drug appears to readily
partition into body tissues (Vss predictions range from 297 to 782 mL/kg.2-5 Total body water is
approximately equal to 570 mL/kg).6 In cattle, elimination occurs primarily through biliary
excretion.7 This may, at least in part, explain the presence of multiple peaks in the blood
concentration/time profile following IV administration.2
In healthy cattle, total body clearance has been reported to range from 90 to 151 mL/kg/hr.2-5
These studies also report a large discrepancy between the volume of distribution at a steady
state (Vss) and the volume of distribution associated with the terminal elimination phase
(Vß). This discrepancy appears to be attributable to extended drug elimination from a deep
compartment.8 The terminal half-life has been shown to vary from 3.14 to 8.12 hours.2-5
Flunixin persists in inflammatory tissues9 and is associated with anti-inflammatory properties
which extend well beyond the period associated with detectable plasma drug concentrations.4,9
These observations account for the counterclock-wise hysteresis associated with
flunixin's pharmacokinetic/pharmacodynamic relationships.10 Therefore, prediction of drug
concentrations based upon the estimated plasma terminal elimination half-life will likely
underestimate both the duration of drug action and the concentration of drug remaining at the
site of activity. -
INDICATIONS & USAGE
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. -
DOSAGE & ADMINISTRATION
Dose and Administration
Horse: The recommended dose for musculoskeletal disorders is 0.5 mg per pound (1
mL/100 lbs) of body weight once daily. Treatment may be given by intravenous or intramuscular
injection and repeated for up to 5 days. Studies show onset of activity is within 2 hours. Peak
response occurs between 12 and 16 hours. Peak response occurs between 12 and 16 hours and
duration of activity is 24-36 hours.
The recommended dose for the alleviation of pain associated with equine colic is 0.5 mg per pound
of body weight. Intravenous administration is recommended for prompt relief. Clinical studies
show pain is alleviated in less than 15 minutes in many cases. Treatment may be repeated when
signs of colic recur. During clinical studies approximately 10% of the horses required one or
two additional treatments. The cause of colic should be determined and treated with
concomitant therapy.
Cattle: The recommended dose for control of pyrexia associated with bovine respiratory
disease and endotoxemia and control of inflammation in endotoxemia is 1.1 to 2.2 mg/kg
(0.5 to 1 mg/lb;1 to 2 mL per 100 lbs) of body weight given by slow intravenous administration
either once a day as a single dose or divided into two doses administered at 12-hour intervals for
up to 3 days. The total daily dose should not exceed 2.2 mg/kg (1.0 mg/lb) of body weight.
Avoid rapid intravenous administration of the drug.
The recommended dose for acute bovine mastitis is 2.2 mg/kg (1.0 mg/lb; 2 mL per 100 lbs) of body
weight given once by intravenous administration. -
CONTRAINDICATIONS
Contraindications
Horse: There are no known contraindications to this drug when used as directed. Intra-arterial
injection should be avoided. Horses inadvertently injected intra-arterially can show adverse
reactions. Signs can be ataxia, incoordination, hyperventilation, hysteria, and muscle weakness.
Signs are transient and disappear without antidotal medication within a few minutes. Do
not use in horses showing hypersensitivity to flunixin meglumine.
Cattle: NSAIDS inhibit production of prostaglandins which are important in signaling
the initiation of parturition. The use of flunixin can delay parturition and prolong labor which
may increase the risk of stillbirth. Do not use Flu-Nix™ (flunixin meglumine injection) within 48
hours of expected parturition.
Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal
impairment or gastric ulceration are suspected -
RESIDUE WARNING
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. -
PRECAUTIONS
Precautions
As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal and renal
toxicity. Sensitivity to drug-associated adverse effects varies with the individual patient. Patients
at greatest risk for renal toxicity are those that are dehydrated, on concomitant diuretic therapy, or
those with renal, cardiovascular, and/or hepatic dysfunction.
Since many NSAIDs possess the potential to induce gastrointestinal ulceration, concomitant
use of Flunixin Meglumine Injection with other anti-inflammatory drugs, such as other NSAIDs
and corticosteroids, should be avoided or closely monitored.
Horse: The effect of Flunixin Meglumine Injection on pregnancy has not been determined.
Studies to determine activity of Flunixin Meglumine Injection when administered
concomitantly with other drugs have not been conducted. Drug compatibility should be monitored
closely in patients requiring adjunctive therapy.
Cattle: Do not use in bulls intended for breeding, as reproductive effects of Flunixin
Meglumine Injection in these classes of cattle have not been investigated. NSAIDs are known to
have potential effects on both parturition (See Contraindications) and the estrous cycle. There
may be a delay in the onset of estrus if flunixin is administered during the prostaglandin phase of
the estrous cycle. NSAIDS are known to have the potential to delay parturition through a tocolytic
effect. The use of NSAIDs in the immediate post-partum period may interfere with uterine
involution and expulsion of fetal membranes. Cows should be monitored carefully for placental
retention and metritis if Flunixin Meglumine Injection is used within 24 hours after parturition. -
SUMMARY OF SAFETY AND EFFECTIVENESS
Safety
Horse: A 3-fold intramuscular dose of 1.5 mg/lb of body weight daily for 10 consecutive days was
safe. No changes were observed in hematology, serum chemistry, or urinalysis values. Intravenous
dosages of 0.5 mg/lb daily for 15 days; 1.5 mg/lb daily for 10 days; and 2.5 mg/lb daily for 5 days
produced no changes in blood or urine parameters. No injection site irritation was
observed following intramuscular injection of the 0.5 mg/lb recommended dose. Some irritation
was observed following a 3-fold dose administered intramuscularly.
Cattle: No flunixin-related changes (adverse reactions) were noted in cattle administered a 1X
(2.2 mg/kg; 1.0 mg/lb) dose for 9 days (three times the maximum clinical duration). Minimal
toxicity manifested itself at moderately elevated doses (3X and 5X) when flunixin was administered
daily for 9 days, with occasional findings of blood in the feces and/or urine. Discontinue use if hematuria
or fecal blood are observed. -
ADVERSE REACTIONS
Adverse Reactions
In horses, isolated reports of local reactions following intramuscular injection, particularly in
the neck, have been received. These include localized swelling, sweating, induration, and
stiffness. In rare instances in horses, fatal or nonfatal clostridial infections or other infections
have been reported in association with intramuscular use of Flunixin Meglumine
Injection. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have
been fatal, have been reported, primarily following intravenous use.
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. - HOW SUPPLIED
- STORAGE AND HANDLING
-
REFERENCES
REFERENCES
1. Johansson M, Anler EL. Gas chromatographic
analysis of flunixin in equine urine after
extractive methylation. J Chromatogr.
1988;427:55-66.
2. Oldensvik K, Johansson M. High-performance
liquid chromatography method for
determination of flunixin in bovine plasma and
pharmacokinetics after single and repeated
doses of the drug. Am J Vet Res.
1995;56:489-495.
3. Anderson KL, Neff-Davis CA, Davis LE, Bass VD.
Pharmacokinetics of flunixin meglumine in
lactating cattle after single and multiple
intramuscular and intravenous administrations.
Am J Vet Res. 1990;51:1464-1467.
4. Oldensvik K. Pharmacokinetics of flunixin and
its effect on prostaglandin F2a metabolite
concentrations after oral and intravenous
administration in heifers. J Vet Pharmacol Ther.
1995;18:254-259.
5. Hardee GE, Smith JA, Harris SJ.
Pharmacokinetics of flunixin meglumine in the
cow. Res Vet Sci. 1985;39:110-112.
6. Ruckebusch Y, Phaneuf LP, Dunlop R. Physiology
of Small and Large Animals. Chapter 2; "Body
Fluid Compartments," Philadelphia, Pa: B.C.
Decker; 1991:8-18.
7. Kopcha M, Ahi AS. Experimental use of flunixin
meglumine and phenylbutazone in
food-producing animals. J Am Vet
Med Assoc. 1989;194:45-49.
8. Wagner JG. Significance of ratios of different
volumes of distribution in pharmacokinetics.
Biopharm & Drug Dispos. 1983;4:263-270.
9. Lees P, Higgins AJ. Flunixin inhibits
prostaglandin E2 production in equine
inflammation. Res Vet Sci. 1984;37:347-349.
10. Landoni MF, Cunningham FM, Lees P.
Determination of pharmacokinetics and
pharmacodynamics of flunixin incalves by
use of pharmacokinetic/ pharmacodynamic
modeling. Am J Vet Res. 1995;56:786-794. -
INDICATIONS & USAGE
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.
Read accompanying directions for use.
Approved by FDA under ANADA # 200-061
®Registered trademark of Huvepharma, Inc.Manufactured for
Huvepharma, Inc.
Peachtree City, GA 30269Rev. 05-2022 F-2847-06
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FLU-NIX
flunixin meglumine injection, solutionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 23243-0120 Route of Administration INTRAVENOUS, INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400) FLUNIXIN 50 mg in 1 mL phenol (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) phenol 5 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 23243-0120-4 100 mL in 1 VIAL, MULTI-DOSE 2 NDC: 23243-0120-5 200 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200061 02/10/2015 Labeler - Huvepharma, Inc (619153559) Registrant - Huvepharma EOOD (552691651)
Trademark Results [Flu-Nix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLU-NIX 75146210 not registered Dead/Abandoned |
AGRI LABORATORIES, LTD. 1996-08-06 |
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