DRAXXIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TULATHROMYCIN

Available from:

ZOETIS CANADA INC

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

TULATHROMYCIN 100MG

Administration route:

INTRAMUSCULAR

Units in package:

20/50/100/250/500ML

Prescription type:

Prescription

Therapeutic group:

CATTLE; SWINE (PIGS); SHEEP

Product summary:

Active ingredient group (AIG) number: 0151667001

Authorization status:

APPROVED

Authorization date:

2018-09-04

Patient Information leaflet

DIN 02285452
_TULATHROMYCIN STERILE INJECTABLE SOLUTION_
VETERINARY USE ONLY
antibiotic
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 Injectable Solution contains 100 mg of
tulathromycin as the free base in a propylene glycol vehicle.
DRAXXIN Injectable Solution 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-O-methyl-
4 - C - [ ( p r o p y l a m i n o ) m e t h y l ] - α - L- r i b o -
h e x o p y r a n o s y l ]
oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-
1 1 - [ [ 3 , 4 , 6 - t r i d e o x y - 3 - ( d i m e t h y l a m i n
o ) - β - D - x y l o -
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-ribo-hexopyranosyl]
oxy]-2-[(1S,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:
BOVINE
RESPIRATORY
DISEASE
(BRD):
DRAXXIN
Injectable
Solution is indicated for the treatment of BRD associated with
_Mannheimia _
_haemolytica, _
_Pasteurella _
_multocida, _
_Histophilus _
_somni (Haemophilus somnus)_ and _Mycoplasma bovis_ and for the
reduction of morbidity associated with BRD in feedlot calves
caused
by
_Mannheimia _
_haemolytica, _
_Pasteurella _
_multocida, _
_Histophilus somni _and_ Mycoplasma bovis_, during the first 14 days
in the feedlot when administered at the time of arrival.
INFECTIOUS
BOVINE
KERATOCONJUNCTIVITIS
(IBK):
DRAXXIN
Injectable
Solution
is
indicated
for
the
treatment
of
IBK
associated with _Moraxella bovis_.
FOOT
ROT:
DRAXXIN
Injectable
Solution