Gallimycin - 100 description, usages, side effects, indications, overdosage, supplying and lots more!

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Gallimycin - 100

Bimeda Inc., Division of Cross Vetpharm Group
Bimeda Inc., Division of Cross Vetpharm Group




FULL PRESCRIBING INFORMATION

Gallimycin®-100

Erythromycin Injection 
100 mg per ml


Antibacterial for Cattle                                                          Sterile

For Intramuscular Injection

FOR ANIMAL USE ONLY

KEEP OUT OF REACH OF CHILDREN

Restricted Drug (California); Use only as directed.

NADA 012-123, APPROVED BY FDA

Net Contents:

100 ml (3.4 Fl Oz)

DESCRIPTION: Gallimycin®-100 Injection is an erythromycin preparation formulated in a sterile solution for intramuscular administration only.

Each mL Contains:

Erythromycin base........................... 100 mg

In a non-aqueous, buffered, alcohol base sterile solution.

Uses

INDICATIONS AND USAGE: Gallimycin® - 100 Injection is indicated for the treatment of bovine respiratory disease (shipping fever complex and bacterial pneumonia) associated with Pasturella multiocida organisms susceptible to erythromycin.

WARNING: Treated animals should not be slaughtered for food within 6 days of the last injection. Temporary tissue irritation follows injection. To avoid excessive trim do not slaughter cattle within 21 days of the last injection. Do not use in female dairy cattle greater than 20 months of age.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

PRECAUTIONS:

In animals weighing over 200 lbs., the neck region is the preferred site for the deep intramuscular injection. Since there may be transient swelling or soreness at the site of injection, it is advisable, when more than one treatment is required, to vary the site of the injection. This is achieved by alternating sides of the neck if necessary, alternating between the leg and the neck muscles. No more than 10 ml should be injected at any one site (in small calves under 200 lbs. no more than 4 mL should be injected per site and then only in the heavy muscles of the leg).

Swelling or soreness encountered at the site of the injection is usually mild, transient and disappears in 2 to 4 days. Deep intramuscular injection will minimize the incidence of local soreness and swelling.

DOSAGE AND ADMINISTRATION:

Deep intramuscular injection into the heavy neck muscles, or if necessary for alternating injection sites, into the heavy muscular portion of the leg muscle (round). In calces under 200 lbs., deep intramuscular injection into the heavy muscles of the leg only. Administer 4mL/100 lbs. body weight (4mg/lb body weight) once daily for up to 5 days as needed. Use a 1-inch to 2-inch, 16 or 18 gauge needle depending on the animal's size.

STORAGE:

STORE AT ROOM TEMPERATURE, 15 - 30ºC (59 - 86ºF).

HOW SUPPLIED:

Galimycin is supplied in sterile 100 mL multiple-dose, rubber-stoppered vials.

Gallimycin - 100 Gallimycin - 100

Gallimycin - 100

Erythromycin INJECTION

Product Information

Product Type Otc animal drug label Item Code (Source) NDC:61133-5252
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ERYTHROMYCIN ERYTHROMYCIN 100 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61133-5252-2 100 in 1 VIAL

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA012123 2007-11-15


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