PREVAIL- flunixin meglumine solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

FLUNIXIN MEGLUMINE (UNII: 8Y3JK0JW3U) (FLUNIXIN - UNII:356IB1O400)

Dostupné s:

VetOne/MWI

INN (Mezinárodní Name):

FLUNIXIN MEGLUMINE

Složení:

FLUNIXIN MEGLUMINE 50 mg in 1 mL

Podání:

INTRAVENOUS

Druh předpisu:

PRESCRIPTION

Terapeutické indikace:

INDICATIONS Horse: Prevail™ (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: Prevail™ (flunixin meglumine injection) is indicated for the control of pyrexia associated with bovine respiratory disease, endotoxemia and acute bovine mastitis. Prevail™ is also indicated for the control of inflammation in endotoxemia. 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 inhibition of parturition. The use of flunixin can delay parturition and prolong labor which may increase the risk of stillbirth. Do not use Prevail™ (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.

Přehled produktů:

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

Stav Autorizace:

Abbreviated New Animal Drug Application

Charakteristika produktu

PREVAIL- FLUNIXIN MEGLUMINE SOLUTION
VETONE/MWI
----------
PREVAIL™
(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.
CAUTIONFederal law restricts this drug to use by or on the order of a
licensed
veterinarian.
DESCRIPTIONEach milliliter of Prevail™ (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.
PHARMACOLOGY:
Flunixin meglumine is a potent, non-narcotic nonsteroidal, analgesic
agent with anti-
inflammatory and antipyretic 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) which exhibits
a high degree of
plasma protein binding (approximately 99%) . However, free (unbound)
drug appears to
readily partition into body tissues (V
predictions range from 297 to 782 mL/kg
. Total
body water is approximately equal to 570 mL/kg) . In cattle,
elimination occurs primarily
through biliary excretion.
This may, at least in part, explain the presence of multiple
peaks in the blood concentration/time profile following IV
administration.
In healthy cattle, total body clearance has been reported to range
from 90 to 151
mL/kg/hr.
These studies also report a large discrepancy between the volume of
distribution at steady state (V
) and the volume of distribution associated with the
terminal elimination phase (V ). This discrepanc