INCREXXA 25- tulathromycin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Elanco US Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Swine Increxxa 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 - Increxxa 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 Increxxa 25 Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.

Product summary:

Increxxa 25 (tulathromycin injection) Injectable Solution is available in the following package sizes: 50 mL vial 100 mL vial 250 mL vial Approved by FDA under ANADA # 200-665 Product of China. Distributed by: Elanco US Inc. Greenfield, IN 46140 To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact 1-800-428-4441 . For additional information about adverse drug experiences reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae. Increxxa, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2021 Elanco or its affiliates TAKE TIME OBSERVE LABEL DIRCTIONS Elanco ™ 8838840 PA230414X 100342

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

INCREXXA 25- TULATHROMYCIN INJECTION
ELANCO US INC.
----------
ELANCO™
INCREXXA™ 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
Increxxa 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 Increxxa 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. Increxxa 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-Ο-methyl-4-C-[(propylamino) methyl]
-α-L-ribohexopyrano-
syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-
hexamethyl-11-[[3,4,6-trideoxy-3-
(dimethylamino)-β-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-Ο-methyl-4-C-
[(propylamino)methyl]-
α-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)-
β-D-xylo-hexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one,
respectively.
INDICATIONS
SWINE
Increxxa 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 - Incr