Rx
Intervet/Schering-Plough Animal Health
(benzathine cloxacillin)
DRY COW
Intramammary Infusion
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Orbenin-DC (benzathine
cloxacillin) is a stable, nonirritating suspension of benzathine
cloxacillin containing the equivalent of 500 mg of cloxacillin per
disposable syringe. Orbenin-DC is manufactured by a nonsterilizing
process.
Benzathine cloxacillin is a semisynthetic penicillin
derived from the penicillin nucleus, 6-amino-penicillanic acid.
Benzathine cloxacillin is the benzathine salt of
6-[3-(2-chlorophenyl)-5-methylisoxazolyl-4-carboxamido] penicillanic
acid.
The low solubility of Orbenin-DC results in an extended
period of activity. Therefore, directions for use should be followed
explicitly.
ACTION: Benzathine cloxacillin is
bactericidal in action against susceptible organisms during the stage of
active multiplication. It acts through the inhibition of biosynthesis
of cell wall mucopeptide. It is active against gram-positive organisms
associated with mastitis such as Staphylococcus aureus and Streptococcus agalactiae and, because of its resistance to penicillinase, penicillin G-resistant staphylococci which may be the cause of mastitis.
Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on pretreatment milk samples collected aseptically.
SUSCEPTIBILITY TEST: The
Kirby-Bauer* procedure, utilizing antibiotic susceptibility disks, is a
quantitative method that may be adapted to determining the sensitivity
of bacteria in milk to Orbenin-DC.
For testing the effectiveness of Orbenin-DC in milk,
follow the Kirby-Bauer procedure using the 1 mcg oxacillin
susceptibility disk. Zone diameters for interpreting susceptibility are:
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Resistant
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Intermediate
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Susceptible
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≤ 10 mm
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11-12 mm
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≥ 13 mm
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* Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic testing by a standardized single disk method, Am J Clin Path 45:493, 1966. Standardized Disk Susceptibility Test, Federal Register 37:20527-29, 1972.
INDICATIONS: Orbenin-DC is indicated in the treatment and prophylaxis of bovine mastitis in nonlactating cows due to Staphylococcus aureus and Streptococcus agalactiae.
CONTRAINDICATIONS: Because
benzathine cloxacillin is relatively insoluble, Orbenin-DC’s activity
will be prolonged. Therefore, Orbenin-DC should not be used for the
occasional cow which may have a dry period of less than 4 weeks. This
precaution will avoid residues in the milk following removal of the
colostrum.
|
WARNINGS: For use in dry cows only.
Do not use within 4 weeks (28 days) of calving. Treated animals must not
be slaughtered for food purposes within 4 weeks (28 days) of treatment.
|
|
PRECAUTION: Because it is a
derivative of 6-amino-penicillanic acid, Orbenin-DC has the potential
for producing allergic reactions. Such reactions are rare; however,
should they occur, the subject should be treated with the usual agents
(antihistamines, pressor amines).
DOSAGE AND ADMINISTRATION: At the
last milking of lactation, milk the cow out normally. Clean and
disinfect the teats with alcohol swabs provided in the carton, and
infuse 1 syringe of Orbenin-DC, which has been warmed to room
temperature, into each quarter. Do not milk out. The cow may be milked
as usual when she calves.
The extent of subclinical and latent mastitis in a herd
is frequently greater than suspected. In untreated herds a significant
buildup of subclinical mastitis may occur during the dry period, which
results in clinical severity after a few lactations. The adverse
influence of subclinical mastitis on milk yield, the risk of
cross-infection, and the chance of clinical mastitis flare-up make it
necessary to treat the matter as a herd problem. Clinical studies have
proven the value of treating all the cows in heavily infected herds as
they are dried off. When the herd infection has been reduced, it may be
desirable to be more selective in treating infected quarters.
Each carton contains 12 alcohol swabs to facilitate proper cleaning and disinfecting of the teat orifice.
HOW SUPPLIED: Orbenin-DC is supplied
in cartons of 12 single-dose syringes with 12 alcohol swabs. Each
disposable syringe contains 500 mg of cloxacillin as the benzathine salt
in 7.5 g of suitable base.
Precaution: Administration of this product in any manner other than described under Dosage and Administration may result in drug residues.
Veterinary Use Only-Not for Human Use
Keep Out of Reach of Children
Discard Empty Container-Do Not Reuse
Do Not Store Above 24°C (75°F)
Orbenin-DC® is a trademark owned by and used under license from SmithKline Beecham.
NADA #55-069, Approved by FDA
Manufactured by: G.C. Hanford Mfg. Co., Syracuse, NY 13201
Copyright ©2003, Schering-Plough Animal Health Corp., Union, NJ 07083. All rights reserved.
Made in the USA
10/03
F-27865909, B-27865909
INS15480 01, CTN15481 01
NAC No.: 10472351
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