FLUNAZINE-S- flunixin meglumine injection, suspension

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400)

Fáanlegur frá:

Bimeda, Inc.

INN (Alþjóðlegt nafn):

Flunixin Meglumine

Samsetning:

Flunixin Meglumine 50 mg in 100 mL

Stjórnsýsluleið:

INTRAMUSCULAR

Gerð lyfseðils:

PRESCRIPTION

Ábendingar:

INDICATION Flunazine-S (flunixin meglumine injection) is indicated for the control of pyrexia associated with swine respiratory disease. CONTRAINDICATIONS 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.

Vörulýsing:

HOW SUPPLIED Flunazine-S (flunixin meglumine injection), 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials.

Leyfisstaða:

Abbreviated New Animal Drug Application

Vara einkenni

FLUNAZINE-S- FLUNIXIN MEGLUMINE INJECTION, SUSPENSION
BIMEDA, INC.
----------
FLUNAZINE -S
(FLUNIXIN MEGLUMINE INJECTION)
50 MG/ML
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.
DESCRIPTION
Each milliliter of Flunazine-S (flunixin meglumine injection) contains
50 mg flunixin
(equivalent to 83 mg flunixin meglumine), 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.
CLINICAL PHARMACOLOGY
Flunixin meglumine is a potent non-narcotic, nonsteroidal, 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 tissues and is associated
with anti-
inflammatory properties which extend well beyond the period associated
with detectable
plasma drug concentrations . 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 (β half-life) of flunixin after a single intramuscular
injection of flunixin meglumine
injection (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
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