DRAXXIN 25- tulathromycin injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

TULATHROMYCIN (UNII: Q839I13422) (TULATHROMYCIN - UNII:Q839I13422)

Dostopno od:

Zoetis Inc.

INN (mednarodno ime):

TULATHROMYCIN

Sestava:

TULATHROMYCIN 25 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION

Terapevtske indikacije:

Swine DRAXXIN 25 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , Bordetella bronchiseptica , Haemophilus parasuis , and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae , Pasteurella multocida , and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed. Suckling Calves, Dairy Calves, and Veal Calves BRD - DRAXXIN 25 Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . The use of DRAXXIN 25 Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.

Povzetek izdelek:

DRAXXIN 25 Injectable Solution is available in the following package sizes: 50 mL vial 100 mL vial 250 mL vial

Status dovoljenje:

New Animal Drug Application

Lastnosti izdelka

DRAXXIN 25- TULATHROMYCIN INJECTION
ZOETIS INC.
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DRAXXIN 25
(TULATHROMYCIN INJECTION)
INJECTABLE SOLUTION
ANTIBIOTIC
25 mg of tulathromycin/mL
For use in suckling calves, dairy calves, veal calves, and swine. Not
for use in ruminating
cattle.
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
DRAXXIN 25 Injectable Solution is a ready-to-use sterile parenteral
preparation
containing tulathromycin, a semi-synthetic macrolide antibiotic of the
subclass triamilide.
Each mL of DRAXXIN 25 contains 25 mg of tulathromycin as the free base
in a 50%
propylene glycol vehicle, monothioglycerol (5 mg/mL), citric acid (4.8
mg/mL) with
hydrochloric acid and sodium hydroxide added to adjust pH. DRAXXIN 25
consists of an
equilibrated mixture of two isomeric forms of tulathromycin in a 9:1
ratio.
The chemical names of the isomers are
(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-
[[2,6- dideoxy-3-C-methyl-3--methyl-4-C-[(propylamino)
methyl]---L-ribohexopyrano-
syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-
-D-xylo-hexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-one and
(2R,3R,6R,8R,9R,10S,11S,12R)-11-[[2,6-dideoxy-3-C-methyl-3--methyl-4-C-
[(propylamino)methyl]---L-ribohexopyrano-syl]oxy]-2-[(1R,2R)-1,2-dihydroxy-1-
methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-
-
D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one,
respectively.
INDICATIONS
SWINE
DRAXXIN 25 Injectable Solution is indicated for the treatment of swine
respiratory
disease (SRD) associated with _Actinobacillus pleuropneumoniae_,
_Pasteurella multocida_,
_Bordetella bronchiseptica_, _Haemophilus parasuis_, and _Mycoplasma
hyopneumoniae_; and
for the control of SRD associated with _Actinobacillus
pleuropneumoniae_, _Pasteurella_
_multocida_, and _Mycoplasma hyopneumoniae _in groups of pigs where
SRD has been
diagnosed.
SUCKLING CALVES, DAIRY CALVES, AND VEAL CALVES
BRD - DRAXXIN 25 Injectable Solution is in