TULIEVE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TULATHROMYCIN

Available from:

NORBROOK LABORATORIES LTD.

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

TULATHROMYCIN 100MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic group:

CATTLE; SWINE (PIGS); SHEEP

Product summary:

Active ingredient group (AIG) number: 0151667001

Authorization status:

APPROVED

Authorization date:

2020-12-07

Patient Information leaflet

Tulathromycin Injection
English Insert (100ml/250ml)
Dimensions: 148 mm x 210 mm
Font Size: ≥ 5pt
Printed at 100%
DIN 02505401
TULIEVE
Tulathromycin Injection
VETERINARY USE ONLY
Sterile - Antibiotic
DESCRIPTION: Tulieve is a ready-to-use sterile parenteral preparation
containing tulathromycin, a
semi-synthetic macrolide antibiotic of the subclass triamilide. Each
mL of Tulieve contains 100 mg of
tulathromycin as the free base in a propylene glycol vehicle.
Tulieve 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 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-ribo-hexopyranosyl]
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
(2S, 3S, 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-[(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.
BOVINE RESPIRATORY DISEASE (BRD): Tulieve 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): Tulieve is indicated for
the treatment of IBK
associated with _Moraxella bovis._
FOOT ROT: Tulieve is indicated for the treatment of bovine foot rot
(interdigital necrobacillosis)
associated with _Fu