FLUNIXIN-S- flunixin meglumine injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

flunixin meglumine (UNII: 8Y3JK0JW3U) (flunixin - UNII:356IB1O400)

Sẵn có từ:

Norbrook Laboratories Limited

INN (Tên quốc tế):

flunixin meglumine

Thành phần:

flunixin 50 mg in 1 mL

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

Flunixin Injection -S (flunixin meglumine injection), 50 mg/mL, is available in 100 mL and 250 mL multi-dose vials. Store between 2° and 30°C (36° and 86°F).

Tình trạng ủy quyền:

Abbreviated New Animal Drug Application

Đặc tính sản phẩm

FLUNIXIN-S- FLUNIXIN MEGLUMINE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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FLUNIXIN INJECTION -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 Flunixin Injection -S (flunixin meglumine
injection) contains 50 mg flunixin
(equivalent to 83 mg flunixin meglumine), 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.
CLINICAL 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.
Flunixin is known to
persist in inflammatory tissues¹ and is associated with
anti-inflammatory properties
which extend well beyond the period 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 (ß half-life) of flunixin after a single intramuscular
injection of flunixin 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(0-LOQ) 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 bioava