Generic Name: flunixin meglumine injection
Dosage Form: FOR ANIMAL USE ONLY
ANADA# 200-489, Approved by FDA
Flunazine-S Injection
(flunixin meglumine)
Injectable Solution 50 mg/mL
Veterinary
For intramuscular use in swine.
Not for use in breeding swine.
CAUTION
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Each mL of Flunazine-S Injectable Solution contains flunixin meglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.2 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.
PHARMACOLOGY
Flunixin meglumine is a potent non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent that pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test.
Flunixin is known to persist in inflammatory tissues1 and is associated with detectable plasma drug concentrations2. Therefore, prediction of drug concentrations based upon 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.
The pharmacokinetic profiles were found to follow a 2-compartmental model, although a deep (third) compartment was observed in some animals. The mean terminal elimination half-life (B half-live) of flunixin after a single intramuscular injection of flunixin (2.2 mg/kg) to pigs was between 3 and 4 hours. The mean observed maximum plasma concentration was 2944 ng/mL, achieved at a mean time of approximately 0.4 hours. The mean AUC (0-L0Q) was 6431 ng*hr/mL. Following IM administration of flunixin, quantifiable drug concentration could be measured up to 18 hours post dose. The mean volume of distribution was 2003 mL/kg and the mean total clearance was 390 mL/hr/kg. The mean absolute bioavailability of flunixin following an intramuscular injection in the neck was 87%.
INDICATION
Flunazine-S Injectable Solution is indicated for the control of pyrexia associated with swine respiratory disease.
DOSAGE AND ADMINISTRATION
The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.
Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.
There are no known contraindications to this drug in swine when used as directed. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration is suspected.
Swine must not be slaughtered for human consumption within 12 days of the last treatment.
PRECAUTIONS
As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostoglandins that maintain normal homeostatic function. Such prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed. Since may NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of flunixin meglumine with other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided.
Not for use in breeding swine. The reproductive effects of Flunazine-S Injection Solution have not been investigated in this class of swine. Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. this may result in trim loss of edible tissue at slaughter.
SAFETY
Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days. Minimal toxicity manifested itself as statistically significant increased spleen weight at elevated doses (5X or higher daily for 9 days) with no changes in normal microscopic architecture.
Flunazine-S Injectable Solution, 50 mg/mL, is available in 100 mL multi-dose vial.
Store between 2degrees and 30degrees C (36degrees and 86degrees F).
REFERENCES
1. Lees P, Higgins AJ. Flunixin inhibits prostaglandin E2 production in equine inflammation. Res Vet Sci. 1984; 37:347-349.
2. Odensvik K. Pharmacokinetics of flunixin and its effect on prostaglandin F2a metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharacol Ther. 1995; 18:254-259
Multi-Dose Vial
Flunazine-S
(flunixin meglumine)
Injectable Solution
Sterile 50 mg/mL
Veterinary
For Animal Use Only
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA# 200-489, Approved by FDA
Net Contents: 100mL
| Flunazine-S flunixin meglumine injection, suspension | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANADA | ANADA200489 | 03/01/2010 | |
| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bimeda-MTC Animal Health | 043653216 | manufacture | |
No comments:
Post a Comment