DRAXXIN- tulathromycin injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Zoetis Inc.

INN (Internationale Bezeichnung):

TULATHROMYCIN

Zusammensetzung:

TULATHROMYCIN 100 mg in 1 mL

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

PRESCRIPTION

Anwendungsgebiete:

BRD  – DRAXXIN Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis ; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis . IBK  – DRAXXIN Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis . Foot Rot  – DRAXXIN Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum  and Porphyromonas levii . BRD  – DRAXXIN Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica, P. multocida, H. somni,  and M. bovis. DRAXXIN Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoni

Produktbesonderheiten:

DRAXXIN Injectable Solution is available in the following package sizes: 50 mL vial 100 mL vial 250 mL vial 500 mL vial

Berechtigungsstatus:

New Animal Drug Application

Fachinformation

DRAXXIN- TULATHROMYCIN INJECTION, SOLUTION
ZOETIS INC.
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DRAXXIN
(TULATHROMYCIN INJECTION)
INJECTABLE SOLUTION
ANTIBIOTIC
100 mg of tulathromycin/mL
For use in beef cattle (including suckling calves), non-lactating
dairy cattle (including
dairy calves), veal calves, and swine. Not for use in female dairy
cattle 20 months of age
or older.
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
DRAXXIN 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 contains 100 mg of tulathromycin as the free base in a 50%
propylene
glycol vehicle, monothioglycerol (5 mg/mL), with citric and
hydrochloric acids added to
adjust pH.
DRAXXIN consists of an equilibrated mixture of two isomeric forms of
tulathromycin in a
9:1 ratio. Structures of the isomers are shown below.
Figure 1.
®
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-Ο-methyl-4-C-[(propylamino)
methyl]-α-L-ribo-hexopyrano-
syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-D-xylohexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-one
and
(2R, 3R,6R, 8R,9R,10S,11S,12R)-11-[[2,6-dideoxy-3-C-methyl-
3-Ο-methyl-4-C-
[(propylamino)methyl]-α-L-ribo-hexopyrano-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)-
β-D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one,
respectively.
INDICATIONS
BEEF AND NON-LACTATING DAIRY CATTLE
BRD – DRAXXIN Injectable Solution is indicated for the treatment of
bovine respiratory
disease (BRD) associated with _Mannheimia haemolytica_, _Pasteurella_
_multocida_, _Histophilus somni_, and _Mycoplasma bovis_; and for the
control of respiratory
disease in cattle at high risk of developing BRD associated with
_Mannheimia_
_haemolytica_, _Pasteurella multocida_, _Histoph