OXYTETRACYCLINE 200- 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 200 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Oxytetracycline Injection 200 is intended for use in the treatment of the following diseases in beef cattle; dairy cattle; calves, including preruminating (veal) calves; and swine when due to oxytetracycline-susceptible organisms: Cattle: Oxytetracycline Injection 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; 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 staphylococci and streptococci organisms sensitive to oxytetracycline. Swine: Oxytetracycline Injection 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli ; pneumonia caused by Pasteurella multocida; and leptosp

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

OXYTETRACYCLINE 200 - OXYTETRACYCLINE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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OXYTETRACYCLINE INJECTION 200
(OXYTETRACYCLINE INJECTION)
200 MG/ML
ANTIBIOTIC
EACH ML CONTAINS 200 MG OF OXYTETRACYCLINE
FOR THE TREATMENT OF DISEASE IN BEEF CATTLE; DAIRY CATTLE; CALVES,
INCLUDING
PRERUMINATING (VEAL) CALVES; AND SWINE.
CAUTION: FEDERAL LAW RESTRICTS THIS DRUG TO USE BY OR ON THE ORDER OF
A
LICENSED VETERINARIAN.
FOR ANIMAL USE ONLY.
READ ENTIRE PACKAGE INSERT CAREFULLY BEFORE USING THIS PRODUCT.
Oxytetracycline Injection 200 (oxytetracycline injection) is a
sterile, ready-to-use solution
for the administration of the broad-spectrum antibiotic
oxytetracycline by injection.
Oxytetracycline Injection 200 does not require refrigeration; however,
it is
recommended that it be stored at controlled room temperature 20-25°C
(68-77°F);
excursions permitted 15-30°C (59-86°F). The antibiotic activity of
oxytetracycline is not
appreciably diminished in the presence of body fluids, serum, or
exudates.
CAUTION: When administered to cattle, muscle discoloration may
necessitate trimming
of the injection site(s) and surrounding tissues during the dressing
procedure.
WARNINGS:
Discontinue treatment at least 28 days prior to slaughter of cattle
and swine. Milk taken
from animals during treatment and for 96 hours after the last
treatment must not be
used for food. Rapid intravenous administration may result in animal
collapse.
Oxytetracycline should be administered intravenously slowly over a
period of at least 5
minutes.
PRECAUTIONS:
Exceeding the highest recommended dosage level of drug per lb of body
weight per
day, administering more than the recommended number of treatments,
and/or
exceeding 10 mL intramuscularly or subcutaneously per injection site
in adult beef and
dairy cattle, and 5 mL intramuscularly per injection site in adult
swine, may result in
antibiotic residues beyond the withdrawal period.
At the first sign of any adverse reaction, discontinue use of the
product and seek the
advice of your veter