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The following product inserts are from http://www.luitpold.com
ADEQUAN=AE i.m. Brand of Polysulfated Glycosaminoglycan (PSGAG)
Solution 500mg/5mL. For Intramuscular (I.M.) Use in Horses=20
Caution: Federal law restricts this drug to use by or on the order of a=20
licensed veterinarian.=20
Description: Each 5 milliliters of Adequan=AE i.m. contains 5OO mg=20
Polysulfated Glycosaminoglycan and Water for injection q.s. Sodium=20
Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH.=20
Sodium Chloride may be added to adjust tonicity.=20
Pharmacology: Polysulfated Glycosaminoglycan is chemically similar to=20
the mucopolysaccharides of cartilaginous tissue. It is a potent=20
proteolytic enzyme inhibitor and diminishes or reverses the processes=20
which result in the loss of cartilaginous mucopolysaccharides. PSGAG=20
improves joint function by stimulating synovial membrane activity,=20
reducing synovial protein levels and increasing synovial fluid viscosity=20
in traumatized equine carpal and hock joints.=20
Toxicity: Toxicity studies were conducted in horses. Doses as high as=20
2,500 mg were administered intramuscularly to 6 horses twice a week for=20
12 weeks. This dosage is 5 times the recommended dosage and 3 times the=20
recommended therapeutic regimen. Clinical observations revealed no=20
soreness or swelling at the injection site or in the affected joint. No=20
animal had any clinical illness during the trials and none showed any=20
clinical or laboratory evidence of toxicity.=20
Indications: Adequan=AE i.m. is recommended for the intramuscular=20
treatment of non-infectious degenerative and/or traumatic joint=20
dysfunction and associated lameness of the carpal and hock joint in=20
horses.=20
Contraindications: There are no known contraindications to the use of=20
intramuscular Polysulfated Glycosaminoglycan.=20
Warning: Not for use in horses intended for food.=20
Dosage and Administration: The recommended dose of Adequan i.m. in=20
horses is 5OO mg every 4 days for 28 days intramuscularly. The injection=20
site must be thoroughly cleansed prior to injection. Do not mix Adequan=20
i.m. with other drugs or solvents.=20
Reproductive Safety: Studies have not been conducted to establish safety=20
in breeding horses.=20
Warning: Keep this and all medications out of the reach of children.=20
How Supplied: Adequan=AE i.m. solution, 500 mg/5 mL, is available in 5mL=20
glass ampules or vials, packaged in boxes of 4.=20
Storage Conditions: Store in a cool place 8=B0 - 15=B0 C (46=B0 - 59=B0 F).=
=20
Discard unused portion.=20
Made in U.S.A.
IN 995Ol
Rev. 04/92
NADA# 140-901, Approved by FDA
------------------------------------------------------------------------
ADEQUAN=AE I.A. (Polysulfated Glycosaminoglycan) (PSGAG)
Solution 250mg/mL. For Intra-articular (I.A.) use in horses=20
Description: Each milliliter of Adequan=AE contains 250 mg of Polysulfated=
=20
Glycosaminoglycan and Water for injection q.s. Sodium Hydroxide and/or=20
Hydrochloric Acid added when necessary to adjust pH.=20
Pharmacology: Polysulfated Glycosaminoglycan is chemically similar to=20
the mucopolysaccharides of cartilagenous tissue. It is a potent=20
proteolytic enzyme inhibitor and diminishes or reverses the processes=20
which result in the loss of cartilagenous mucopolysaccharides. PSGAG=20
improves joint function by stimulating synovial membrane activity,=20
reducing synovial protein levels and increasing synovial fluid viscosity=20
in traumatized equine carpal joints.=20
Toxicity: Toxicity studies were conducted in horses. Doses as high as=20
1,250 mg were administered intracarpally to 6 horses once a week for 18=20
weeks. This dosage is 5 times the recommended dosage and 3.6 times the=20
recommended therapeutic regimen. Clinical observations revealed a=20
soreness and swelling in 1.8% (2 of 109 animals) at the injection site=20
which was mild, self limiting and lasted less than one day. There was a=20
dose related elevation on partial thromboplastin time, creatinine and=20
glucose. No animal had any clinical illness during the trial and none=20
showed clinical evidence of toxicity except for transient swelling at=20
the injection site, possibly due to mechanical invasion of the joint.=20
Indication: Adequan=AE is recommended for the treatment of non-infectious=20
degenerative and/or traumatic joint dysfunction and associated lameness=20
of the carpal joint in horses.=20
Contradiction: Do not use in horses showing hypersensitivity to=20
Polysulfated Glycosaminoglycan. Do not administer Adequan=AE in the face=20
of joint sepsis.=20
Warning: Not for use in horses intended for food.=20
Dosage and Administration: The recommended dose of Adequan in horses is=20
250mg (1 vial) once a week for five weeks, intra-articularly. The joint=20
area must be shaved, cleansed and sterilized as in a surgical procedure=20
prior to injection. Do not mix Adequan with other drugs or solvents.=20
Adverse Reactions: Two major categories of adverse reactions have been=20
reported following the intra-articular administration of Adequan=AE:=20
1.Inflammatory joint reactions consisting of joint pain, effusion, and=20
swelling with associated lameness. 2.Septic arthritis.=20
Less frequently, nonseptic arthritis, hemarthrosis, and cellulitis at=20
the injection site and surrounding tissues have been reported.=20
Precautions: Adequan is indicated for use only in the carpal joint of=20
horses. Do not mix Adequan with other drugs or solvents.=20
Reactions in the joint may occasionally occur within 48 hours after=20
intra-articular treatment. If the reaction involves excessive=20
inflammation, cease therapy with Adequan=AE.=20
Post-injection inflammation may result from possible sensitivity to=20
Adequan=AE; traumatic injection technique; exceeding the recommended dose,=
=20
frequency of administration or number of Adequan=AE injections; and from=20
combining Adequan=AE with other drugs. Excessive joint inflammation may be=
=20
manifested by rapid onset tenderness, swelling and warmth over the=20
injected carpus. Inflammatory joint reactions may successfully be=20
treated by systemic anti-inflammatory drugs, cold hydrotherapy, and=20
rest. Serious reactions of this type may indicate the presence of joint=20
sepsis.=20
Joint sepsis is a rare but potentially life-threatening complication of=20
intra-articular injection. It usually results from the deposition of=20
skin organisms into the joint space by the needle tip. Gustafson et al.,=20
(1989) have demonstrated that Adequan=AE may potentiate a subinfective=20
dose of contaminant bacteria. (2, 3). Hence, strict aseptic injection=20
technique is of utmost importance.=20
Successful resolution of joint sepsis depends on prompt recognition and=20
rigorous antimicrobial treatment. (1, 4, 5, 6). Early diagnosis of=20
septic arthritis may be complicated by the similar appearance of joint=20
inflammation. Excessive inflammation accompanied by lameness, swelling,=20
and edema extending beyond the joint limits should alert the=20
practitioner to the possibility of sepsis. Synovial fluid analysis with=20
cytology and bacterial culture of the fluid or a section of synovial=20
membrane are valuable diagnostic aids. Upon suspicion of joint sepsis,=20
broad spectrum antibiotic therapy should be instituted without delay and=20
joint lavage considered. It is recommended that samples used for=20
bacterial culture be taken prior to initiating antibiotic therapy.=20
The concomitant use of Adequan=AE with steroidal or non-steroidal=20
anti-inflammatory agents may mask the symptoms of joint sepsis, thereby=20
delaying the diagnosis and reducing the likelihood of a satisfactory=20
resolution.=20
Intra-articular injections should not be performed when the overlying=20
skin is scurfed or blistered, as this precludes adherence to aseptic=20
injection technique.=20
Veterinarians are directed to the Reference Section below for additional=20
information concerning septic arthritis and its treatment.=20
Impairment of Fertility: Fertility impairment studies in mares and=20
stallions have not been conducted. Do not use in horses intended for=20
breeding.=20
Caution: Federal law restricts this drug to use by or on the order of a=20
licensed veterinarian.=20
How Supplied: Adequan=AE solution. 250mg/mL is available as:=20
=95NDC 10797-991-72 1mL Single Dose Vials Packaged in boxes of 6=20
Storage Conditions: Store in a cool place. 8=B0 - 15=B0/C (46=B0 - 59=B0F).=
=20
Discard unused portion. References:=20
1.Bertone, A; McIlwraith, CW et al: Comparison of various treatments for=20
experimentally induced equine infectious arthritis. Am J. Vet Res. (48):=20
519, 1987. 2.Gustafson, SB: McIlwraith, CW: Jones, RL: Comparison of the=20
effect of polysulfated glycosaminoglycan, corticosteroids and sodium=20
hyaluronate in the potentiation of a subinfective dose of Staphylococcus=20
aureus in the midcarpal joint of horses. Am. J. Vet Res. (50):=20
2014-2017, 1989. 3.Gustafson, SB: McIlwraith, CW:Jones, RL: Dixon-White,=20
HE: Further investigations into the potentiation of infection by=20
intra-articular injection of polysulfated glycosaminoglycan and the=20
effect of filtration and intra-articular injection of amikacin in=20
horses. Am J. Vet Res. (50): 2018-2022, 1989. 4.Koch, DB: Management of=20
infectious arthritis in the horse. Comp. Cont. Educ. (1): 546, 1979. 5.
McIlwraith, CW: Treatment of infectious arthritis. Vet. Clin. N. Am.,=20
Lg. Anim. Pract. (5): 363, 1983. 6.Morris, PG: The clinical management=20
of septic arthritis in the horse. Comp. Cont. Educ. (2): 5207. 1980. 7.
Von Essen, R. and Holtta, A: Improved method of isolating bacteria from=20
joint fluids by the use of blood culture bottles. Ann. Rheum. Dis. (45):=20
454, 1966.=20
Made in USA
IN 99171
Rev. 04/92
NADA #136-383, Approved by FDA=20
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