TULISSIN 25- tulathromycin injection, solution

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

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Download Vara einkenni (SPC)
12-01-2022

Virkt innihaldsefni:

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

Fáanlegur frá:

Virbac AH, Inc.

Stjórnsýsluleið:

SUBCUTANEOUS

Gerð lyfseðils:

PRESCRIPTION

Ábendingar:

Swine TULISSIN 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 - TULISSIN 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 TULISSIN 25 Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug. RESIDUE WARNINGS Swine Swine intended for human consumption must not be slaughtered within 5 days from the last treatment. Calves Calves intended for human consumption must not be slaughtered within 22

Vörulýsing:

TULISSIN 25 (tulathromycin injection) Injectable Solution is available in the following package sizes: 50 mL vial 100 mL vial 250 mL vial

Leyfisstaða:

Abbreviated New Animal Drug Application

Vara einkenni

                                TULISSIN 25- TULATHROMYCIN INJECTION, SOLUTION
VIRBAC AH, INC.
----------
TULISSIN 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
TULISSIN 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 TULISSIN 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. TULISSIN 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-O-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)-ß-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-O-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)-
ß-D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one,
respectively.
INDICATIONS
SWINE
TULISSIN 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 - TULISSIN 25 In
                                
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