RESFLOR GOLD- florfenicol and flunixin meglumine injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Florfenicol (UNII: 9J97307Y1H) (Florfenicol - UNII:9J97307Y1H), Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400)

Available from:

Merck Sharp & Dohme Corp.

INN (International Name):

Florfenicol

Composition:

Florfenicol 300 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Do not use in animals that have shown hypersensitivity to florfenicol or flunixin.

Product summary:

RESFLOR GOLD® is available in 100, 250, and 500 mL sterile, multiple-dose, glass vials.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

RESFLOR GOLD- FLORFENICOL AND FLUNIXIN MEGLUMINE INJECTION
MERCK SHARP & DOHME CORP.
----------
RESFLOR
GOLD
(Florfenicol and Flunixin Meglumine)
Antimicrobial/Non-Steroidal Anti-Inflammatory Drug
FOR SUBCUTANEOUS USE IN BEEF AND NON-LACTATING DAIRY CATTLE ONLY.
NOT FOR USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER OR IN
CALVES TO
BE PROCESSED FOR VEAL.
PRODUCT INFORMATION
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
RESFLOR GOLD is an injectable solution of the synthetic antibiotic
florfenicol and the
non-steroidal anti-inflammatory drug (NSAID) flunixin. Each milliliter
of sterile RESFLOR
GOLD contains 300 mg florfenicol, 16.5 mg flunixin as flunixin
meglumine, 300 mg 2-
pyrrolidone, 35 mg malic acid, and triacetin qs.
INDICATION
RESFLOR GOLD is indicated for treatment of bovine respiratory disease
(BRD)
associated with _Mannheimia haemolytica, Pasteurella multocida_, and
_Histophilus somni_,
and _Mycoplasma bovis_, and control of BRD-associated pyrexia in beef
and non-lactating
dairy cattle.
DOSAGE AND ADMINISTRATION
RESFLOR GOLD should be administered once by subcutaneous injection at
a dose rate
of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight
(6 mL/100 lb).
Do not administer more than 10 mL at each site. The injection should
be given only in the
neck. Injection sites other than the neck have not been evaluated. For
the 500 mL vial,
do not puncture the stopper more than 20 times.
RESFLOR GOLD DOSAGE GUIDE
ANIMAL WEIGHT
(LB)
DOSAGE
(ML)
100
6.0
Recommended
Injection
Location
200
12.0
300
18.0
®
®
®
®
®
®
*
*
300
18.0
400
24.0
500
30.0
600
36.0
700
42.0
800
48.0
900
54.0
1000
60.0
CONTRAINDICATIONS
Do not use in animals that have shown hypersensitivity to florfenicol
or flunixin.
WARNINGS
NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. This product
contains
material that can be irritating to skin and eyes. Avoid direct contact
with skin, eyes, and
clothing. In case of accidental eye exposure, flush with water for