SYNOPLEX (poly- acetyl, arginyl glucosamine powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

POLY(N-ACETYL, N-ARGINYL)GLUCOSAMINE (50000-80000 MW) (UNII: UA7MY2JY0E) (POLY(N-ACETYL, N-ARGINYL)GLUCOSAMINE (50000-80000 MW) - UNII:UA7MY2JY0E)

Available from:

Synedgen, Inc.

INN (International Name):

POLYGLUCOSAMINE GLUCOSAMINE - UNII:UA7MY2JY0E)

Composition:

POLY(N-ACETYL, N-ARGINYL)GLUCOSAMINE (50000-80000 MW) 1 g in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Derived from chitin obtained from Arctic shrimp shells, Synoplex® has an approximate molecular weight of 20 to 100 kDa. Each gram of Synoplex® contains 1 gram of poly (acetyl, arginyl) glucosamine. Synoplex® is supplied as a dry soluble powder, that is rehydrated with sterile water prior to use. Synoplex® acts on the bacterial membrane causing aggregation of bacteria and pore formation leading to reduction of viable bacteria and prevention of biofilm formation.

Product summary:

Synoplex® is supplied as a dry soluble powder in amber glass bottles containing 1-gram of poly (acetyl, arginyl) glucosamine. Synoplex® is packaged in cartons containing either one (1) bottle or five (5) bottles of 1-gram of poly (acetyl, arginyl) glucosamine.

Authorization status:

Legally Marketed Unapproved New Animal Drugs for Minor Species

Summary of Product characteristics

SYNOPLEX- POLY (ACETYL, ARGINYL) GLUCOSAMINE POWDER, FOR SOLUTION
SYNEDGEN, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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SYNOPLEX® (POLY(ACETYL, ARGINYL) GLUCOSAMINE) WOUND RINSE, 1G
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
For topical use on animals in the family Elephantidae and
Rhinocerotidae only. Not intended for oral,
parenteral, or ocular administration.
NOT APPROVED BY FDA - Legally marketed as an FDA Indexed Product under
MIF 900-012. Extra-
label use is prohibited.
Note---In order to be legally marketed, an animal drug product
intended for a minor species must be
Approved, Conditionally Approved, or Indexed by the FDA. THIS PRODUCT
IS INDEXED.
It is a violation of Federal law to use this product in a manner other
than as directed in the labeling.
NET CONTENTS: 1 g poly(acetyl, arginyl) glucosamine/amber glass bottle
DESCRIPTION
Derived from chitin obtained from Arctic shrimp shells, Synoplex® has
an approximate molecular
weight of 20 to 100 kDa. Each gram of Synoplex® contains 1 gram of
poly (acetyl, arginyl)
glucosamine. Synoplex® is supplied as a dry soluble powder, that is
rehydrated with sterile water prior
to use. Synoplex® acts on the bacterial membrane causing aggregation
of bacteria and pore formation
leading to reduction of viable bacteria and prevention of biofilm
formation.
Synoplex Bottle Label
INDICATION
For topical application on animals in the family Elephantidae and
Rhinocerotidae for treatment of foot
and dermal lesions infected with aerobic or facultative anaerobic
Gram-positive and/or Gram-negative
bacteria; and for treatment of sterile chronic foot and dermal
lesions.
FOR USE IN ANIMALS IN THE FAMILY ELEPHANTIDAE AND RHINOCEROTIDAE
ONLY; THIS PRODUCT IS NOT TO BE USED IN ANIMALS INTENDED FOR USE AS
FOOD FOR HUMANS OR OTHER ANIMALS.
WARNING
NOT FOR USE IN HUMANS. KEEP OUT O