ZACTRAN- gamithromycin injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Boehringer Ingelheim Animal Health USA Inc.

Via de administração:

SUBCUTANEOUS

Tipo de prescrição:

PRESCRIPTION

Indicações terapêuticas:

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.

Resumo do produto:

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.

Status de autorização:

New Animal Drug Application

Características técnicas

ZACTRAN- GAMITHROMYCIN INJECTION, SOLUTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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ZACTRAN
(GAMITHROMYCIN)
Approved by FDA under NADA # 141-328
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-xylo-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 th