300 PRO LA- oxytetracycline injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

oxytetracycline (UNII: X20I9EN955) (oxytetracycline anhydrous - UNII:SLF0D9077S)

Available from:

Norbrook Laboratories Limited

INN (International Name):

oxytetracycline

Composition:

oxytetracycline 300 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

300 PRO LA is intended for use in treatment for the following diseases when due to oxytetracycline - susceptible organisms: Beef cattle, non-lactating dairy cattle, calves, including pre-ruminating (veal) calves: 300 PRO LA is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. 300 PRO LA is indicated for the treatment of infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis, foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, it is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica. Swine: 300 PRO LA is indicated in the trea

Authorization status:

New Animal Drug Application

Summary of Product characteristics

300 PRO LA - OXYTETRACYCLINE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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Approved by FDA under NADA # 141-143
300 PRO LA
(OXYTETRACYCLINE INJECTION)
ANTIBIOTIC
Each mL contains 300 mg of oxytetracycline base (equivalent to 323.5
mg of
oxytetracycline dihydrate).
FOR USE IN BEEF CATTLE, NON-LACTATING DAIRY CATTLE, CALVES, INCLUDING
PRE-
RUMINATING (VEAL) CALVES AND SWINE.
READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
INTRODUCTION:
300 PRO LA (oxytetracycline injection) is a sterile, ready to use
solution of the broad-
spectrum antibiotic oxytetracycline dihydrate. Oxytetracycline is an
antimicrobial agent
that is effective in treatment of a wide range of diseases caused by
susceptible gram-
positive and gram-negative bacteria. The antibiotic activity of
oxytetracyline is not
appreciably diminished in the presence of body fluids, serum or
exudates.
INGREDIENTS:
300 PRO LA (oxytetracycline injection) is a sterile, pre-constituted
solution of the broad-
spectrum antibiotic oxytetracycline dihydrate. Each mL contains 300 mg
of
oxytetracycline base (equivalent to 323.5 mg of oxytetracycline
dihydrate), 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:
300 PRO LA is intended for use in treatment for the following diseases
when due to
oxytetracycline - susceptible organisms:
_Beef cattle, non-lactating dairy cattle, calves, including
pre-ruminating (veal) calves:_ 300
PRO LA is indicated in the treatment of pneumonia and shipping fever
complex
associated with _Pasteurella_ spp., and _Histophilus_ spp. 300 PRO LA
is indicated for the
treatment of infectious bovine keratoconjunctivitis (pink eye) caused
by _Moraxella bovis,_
foot-rot and diphtheria caused by _Fusobacterium necrophorum;_
bacterial enteritis
(scours) caused by _Escherichia