NOROMYCIN 300 LA- oxytetracycline injection, solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Norbrook Laboratories Limited

INN (Διεθνής Όνομα):

oxytetracycline

Σύνθεση:

oxytetracycline 300 mg in 1 mL

Οδός χορήγησης:

INTRAMUSCULAR

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

Noromycin 300 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: Noromycin 300 LA is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp., and Histophilus spp. Noromycin 300 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. Noromycin 300 LA is indicat

Καθεστώς αδειοδότησης:

New Animal Drug Application

Αρχείο Π.Χ.Π.

NOROMYCIN 300 LA- OXYTETRACYCLINE INJECTION, SOLUTION
NORBROOK LABORATORIES LIMITED
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Approved by FDA under NADA # 141-143
_NOROMYCIN_
_300 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:
Noromycin 300 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:
Noromycin 300 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:
Noromycin 300 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:_
Noromycin 300 LA is indicated in the treatment of pneumonia and
shipping fever
complex associated with _Pasteurella_ spp., and _Histophilus_ spp.
Noromycin 300 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 en