HEXASOL- oxytetracycline, flunixin meglumine injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

oxytetracycline (UNII: X20I9EN955) (oxytetracycline - UNII:X20I9EN955), flunixin meglumine (UNII: 8Y3JK0JW3U) (flunixin - UNII:356IB1O400)

Available from:

Norbrook Laboratories Limited

INN (International Name):

oxytetracycline

Composition:

oxytetracycline 300 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle. Do not use in animals showing hypersensitivity to either flunixin meglumine or oxytetracycline.

Product summary:

Hexasol Injection is available in 100 mL, 250 mL and 500 mL vials containing 300 mg oxytetracycline and 20 mg flunixin as flunixin meglumine per mL.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

HEXASOL- OXYTETRACYCLINE, FLUNIXIN MEGLUMINE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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HEXAS OL INJECTION
(OXYTETRACYCLINE AND FLUNIXIN MEGLUMINE)
ANTIBIOTIC/NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)
EACH ML CONTAINS 300 MG OF OXYTETRACYCLINE BASE AS AMPHOTERIC
OXYTETRACYCLINE AND 20 MG OF
FLUNIXIN AS FLUNIXIN MEGLUMINE.
FOR INTRAMUSCULAR OR SUBCUTANEOUS USE IN BEEF AND NON-LACTATING DAIRY
CATTLE, CALVES AND
YEARLINGS .
NOT FOR USE IN FEMALE DAIRY CATTLE 20 MONTHS OF AGE OR OLDER, BULLS
INTENDED FOR BREEDING, AND
CALVES INTENDED TO BE PROCESSED FOR VEAL.
READ ENTIRE PACKAGE INSERT CAREFULLY BEFORE USING THIS PRODUCT.
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION:
Hexasol™ Injection is a sterile, pre-constituted solution of the
broad-spectrum antibiotic
oxytetracycline dihydrate and the non-steroidal anti-inflammatory drug
(NSAID) flunixin meglumine.
Each mL contains 300 mg of oxytetracycline base as amphoteric
oxytetracycline; 20 mg of flunixin base
as flunixin meglumine, 40% (v/v) glycerol formal, 10% (v/v)
polyethylene glycol 200, 2.7% (w/v)
magnesium oxide, 0.4% (w/v) sodium formaldehyde sulphoxylate (as a
preservative) and
monoethanolamine (as required to adjust pH).
INDICATIONS:
For the treatment of bacterial pneumonia associated with _Pasteurella_
spp. and for the control of
associated pyrexia in beef and non-lactating dairy cattle.
DOSAGE AND ADMINISTRATION:
Administer Hexasol Injection once as an intramuscular or subcutaneous
injection of 1 mL per 22 lb body
weight (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW). Do not
administer more than 10 mL per
injection site (1 to 2 mL per site in small calves). Hexasol Injection
is recommended where retreatment
of calves and yearlings is impractical due to husbandry conditions,
such as cattle on range, or where
their repeated restraint is inadvisable.
Animal weight (lb)
Number of mL or cc
100
4.5
200
9.0
300
13.6
400
18.1
500
22.6
600
27.2
700
31.7
800
36.3
900
40.8
TM
100