Animal NDC 0061-8134-01 Orbenin-dc
Cloxacillin Benzathine
Animal Product Information
Orbenin-dc Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
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CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
SUSCEPTIBILITY TEST: The Kirby-Bauer
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.
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:
| Resistant | Intermediate | Susceptible |
|---|---|---|
| ≤ 10 mm | 11-12 mm | ≥ 13 mm |
Orbenin-DC™ is a trademark used by Intervet Inc.
Approved by FDA under NADA # 055-069
| TAKE TIME | OBSERVE LABEL DIRECTIONS |
Manufactured by: G.C. Hanford Mfg. Co.
Syracuse, NY 13201
© 2015-2021 Intervet Inc., a subsidiary of Merck & Co., Inc., Madison, NJ 07940, US
All rights reserved.
Rev. 08/2021
359106 R3
PAL16270 01
MERCK
Animal Health
Description
DESCRIPTION: Orbenin-DC (cloxacillin benzathine intramammary infusion) is a stable, nonirritating suspension of cloxacillin benzathine containing the equivalent of 500 mg of cloxacillin per disposable syringe. Orbenin-DC is manufactured by a nonsterilizing process.
Cloxacillin benzathine is a semisynthetic penicillin derived from the penicillin nucleus, 6-amino-penicillanic acid. Cloxacillin benzathine 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.
Mechanism Of Action
ACTION: Cloxacillin benzathine 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.
Veterinary Indications
INDICATIONS: Orbenin-DC is indicated in the treatment and prophylaxis of bovine mastitis in nonlactating cows due to Staphylococcus aureus and Streptococcus agalactiae.
Contraindications
CONTRAINDICATIONS: Because cloxacillin benzathine 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
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.
Precautions
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 & Administration
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 pail 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 pail contains 144 alcohol wipes to facilitate proper cleaning and disinfecting of the teat orifice.
How Supplied
HOW SUPPLIED: Orbenin-DC is supplied in pails of 144 single dose syringes with 144 alcohol wipes. Each disposable syringe contains 500 mg of cloxacillin as the benzathine salt in 7.5 g of suitable base.
Storage And Handling
Do Not Store Above 24°C (75°F)
Principal Display Panel - 7.5 G Syringe Label
Orbenin-DC™
(cloxacillin benzathine intramammary infusion)
7.5 g
DRY COW
Long Acting Formula
Caution: Federal law restricts this drug to use by or on the order of a
licensed veterinarian. Approved by FDA under NADA # 055-069.
Principal Display Panel - 7.5 G Syringe Carton
Orbenin-DC™
(cloxacillin benzathine
intramammary infusion)
DRY COW
Intramammary Infusion
short tip
LONG-ACTING FORMULA
Caution: Federal law restricts this drug to use by
or on the order of a licensed veterinarian.
12 single-dose (7.5 g),
disposable syringes
Approved by FDA under NADA # 055-069
MERCK
Animal Health
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.