NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC- neomycin sulfate, polymyxin b sulfate and bacitracin zinc ointment

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Αγόρασέ το τώρα

Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
03-11-2022

Δραστική ουσία:

Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297), Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K), Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)

Διαθέσιμο από:

Akorn

INN (Διεθνής Όνομα):

Neomycin Sulfate

Σύνθεση:

Neomycin 3.5 mg in 1 g

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION

Θεραπευτικές ενδείξεις:

This product is indicated for the treatment of superficial bacterial infections of the eyelid and conjunctiva of dogs and cats when due to organisms susceptible to one or more of the antibiotics contained in the ointment. Laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment.

Περίληψη προϊόντος:

NDC 59399-135-35 Tube of 3.5 g (1/8 oz) with ophthalmic tip.

Καθεστώς αδειοδότησης:

Abbreviated New Animal Drug Application

Αρχείο Π.Χ.Π.

                                NEOMYCIN AND POLYMYXIN B SULFATES, AND BACITRACIN ZINC- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC OINTMENT
AKORN
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NEOMYCIN AND POLYMYXIN B SULFATES AND
BACITRACIN ZINC OPHTHALMIC OINTMENT (STERILE)
– VETERINARY
ANADA 200-553, Approved by FDA
DESCRIPTION:
Each gram contains: polymyxin B sulfate 10,000 units, bacitracin zinc
400 units,
neomycin sulfate 5 mg (equivalent to 3.5 mg neomycin base) in a white
petrolatum base,
q.s.
ACTIONS:
Polymyxin B is one of a group of closely related substances produced
by various strains
of _Bacillus polymyxa_. The activity of polymyxin B is sharply
restricted to gram-negative
bacteria. Neomycin, isolated from _Streptomyces fradiae_, has
antibacterial activity _in vitro_
against a wide range of gram-negative and gram-positive organisms.
Bacitracin, an
antibiotic substance derived from cultures of _Bacillus subtilis_
(Tracy), exerts antibacterial
action _in vitro_ against a variety of gram-positive and a few
gram-negative organisms.
INDICATIONS:
This product is indicated for the treatment of superficial bacterial
infections of the eyelid
and conjunctiva of dogs and cats when due to organisms susceptible to
one or more of
the antibiotics contained in the ointment.
Laboratory tests should be conducted including _in vitro_ culturing
and susceptibility tests
on samples collected prior to treatment.
PRECAUTIONS:
If irritation develops discontinue treatment with this drug. If there
is no response to
treatment in 2 to 3 days, discontinue treatment and re-evaluate
diagnosis. Prolonged
use may result in overgrowth of nonsusceptible organisms, including
fungi.
Care should be taken not to contaminate the applicator tip during
administration of the
preparation.
ADVERSE REACTIONS:
Adverse reactions, such as itching, burning, or inflammation may occur
in animals
sensitive to this product.
DOSAGE AND ADMINISTRATION:
Properly cleanse area to be treated. Foreign bodies, crusted exudates
and debris should
be carefully removed. Express a small quantity of ointment into the

                                
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