VetaMeg: Product Information (Page 2 of 2)

SAFETY

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. In horses and cattle, rare instances of anaphylactic-like reactions, some of which have been fatal, have been reported, primarily following intravenous use.

How Supplied

HOW SUPPLIED

VetamegTM Injectable Solution, 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials.

Storage

Store between 2°C and 30°C (36°F and 86°F). PROTECT FROM FREEZING.

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. Odensvik 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. Odensvik 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, Pheneuf 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, Ahl AS. Experimental uses 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.

Package Label Principle Display Panel

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VETAMEG
flunixin meglumine injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46066-102
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flunixin meglumine (FLUNIXIN) FLUNIXIN 50 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46066-102-03 100 mL in 1 VIAL, MULTI-DOSE None
2 NDC:46066-102-04 250 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200387 03/02/2006
Labeler — Aspen Veterinary Resources (627265361)
Registrant — Bimeda, Inc., Division of Cross Vetpharm Group (060492923)
Establishment
Name Address ID/FEI Operations
Bimeda-MTC Animal Health, Division of Cross Vetpharm Group 256232216 manufacture
Establishment
Name Address ID/FEI Operations
Zhejiang Hisoar Pharmaceutical Co., Ltd. 530736917 api manufacture
Establishment
Name Address ID/FEI Operations
Excella, GmBH 329809800 api manufacture

Revised: 01/2020 Aspen Veterinary Resources

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