ORBENIN-DC- cloxacillin benzathine suspension

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Vedd Meg Most

Letöltés Termékjellemzők (SPC)
14-03-2023

Aktív összetevők:

cloxacillin benzathine (UNII: AC79L7PV2G) (cloxacillin - UNII:O6X5QGC2VB)

Beszerezhető a:

Merck Sharp & Dohme Corp.

INN (nemzetközi neve):

cloxacillin benzathine

Összetétel:

cloxacillin 500 mg in 7.5 mL

Az alkalmazás módja:

INTRAMAMMARY

Recept típusa:

PRESCRIPTION

Terápiás javallatok:

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 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.

Termék összefoglaló:

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. Do Not Store Above 24°C (75°F)

Engedélyezési státusz:

New Animal Drug Application

Termékjellemzők

                                ORBENIN-DC- CLOXACILLIN BENZATHINE SUSPENSION
MERCK SHARP & DOHME CORP.
----------
ORBENIN-DC™
(CLOXACILLIN BENZATHINE
INTRAMAMMARY INFUSION)
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
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.
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.
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:
RESISTANT
INTERMEDIATE
SUSCEPTIBLE
≤ 10 mm
11-12 mm
≥ 13 mm
1
INDICATIONS: Orbenin-DC is indicated in the treatment and prophylaxis
of bovine
mastitis in nonl
                                
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