ZACTRAN- gamithromycin injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

gamithromycin (UNII: ZE856183S0) (gamithromycin - UNII:ZE856183S0)

Հասանելի է:

Merial, Inc.

INN (Միջազգային անվանումը):

gamithromycin

Կազմը:

gamithromycin 150 mg in 1 mL

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION

Թերապեւտիկ ցուցումներ:

ZACTRAN is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle. ZACTRAN is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica and Pasteurella multocida . As with all drugs, the use of ZACTRAN is contraindicated in animals previously found to be hypersensitive to this drug.

Ապրանքի ամփոփագիր:

ZACTRAN is available in three ready-to-use bottle sizes. The 100, 250 and 500 mL bottles contain sufficient solution that will treat 10, 25 and 50 head of 550 lb (250 kg) cattle respectively.

Լիազորման կարգավիճակը:

New Animal Drug Application

Ապրանքի հատկությունները

ZACTRAN- GAMITHROMYCIN INJECTION, SOLUTION
MERIAL, INC.
----------
ZACTRAN
(GAMITHROMYCIN)
NADA 141-328, Approved by FDA
150 MG/ML ANTIMICROBIAL
For subcutaneous injection in beef and non-lactating dairy cattle
only. Not for use in female dairy cattle
20 months of age or older or in calves to be processed for veal.
CAUTION: Federal (USA) law restricts this drug to use by or on the
order of a licensed veterinarian.
READ ENTIRE BROCHURE CAREFULLY BEFORE USING THIS PRODUCT.
DESCRIPTION
ZACTRAN Injection for Cattle is a ready to use sterile parenteral
solution containing gamithromycin,
a macrolide sub-class, 7a-azalide antimicrobial. Each mL of ZACTRAN
contains 150 mg of
gamithromycin as the free base, 1 mg of monothioglycerol and 40 mg of
succinic acid in a glycerol
formal vehicle.
The chemical name of gamithromycin is
1-Oxa-7-azacyclopentadecan-15-one,13-[(2,6-dideoy-3-C -
methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl)oxy]-2-
ethyl-3,4,10-trihydroxy 3,5,8,10,12,14-
hexamethyl- 7-propyl-11-{[3,4,6-trideoxy-3-(dimethylamino)-beta-D-x
ylo-hexopyranosyl]oxy}-,
[(2R*,3S*,4R*,5S*,8R*,10R*, 11R*,12S*,13S*,14R*)]-and the structure is
shown below.
INDICATIONS
ZACTRAN is indicated for the treatment of bovine respiratory disease
(BRD) associated with
®
®
_Mannheimia haemolytica_, _Pasteurella multocida, Histophilus somni_
and _Mycoplasma bovis_ in beef and non-
lactating dairy cattle. ZACTRAN is also indicated for the control of
respiratory disease in beef and
non-lactating dairy cattle at high risk of developing BRD associated
with _Mannheimia haemolytica_ and
_Pasteurella multocida_.
DOSAGE AND ADMINISTRATION
Administer ZACTRAN one time as a subcutaneous injection in the neck at
6 mg/kg (2 mL/110 lb) body
weight (BW). If the total dose exceeds 10 mL, divide the dose so that
no more than 10 mL is
administered at each injection site.
BODY WEIGHT (LB)
DOSE VOLUME (ML)
110
2
220
4
330
6
440
8
550
10
660
12
770
14
880
16
990
18
1100
20
Animals should be
appropriately restrained to
achieve the proper route of
administration. Use