AROVYN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TULATHROMYCIN

Available from:

INTERVET CANADA CORP

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

TULATHROMYCIN 100MG

Administration route:

SUBCUTANEOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic group:

CATTLE; CATTLE; SWINE (PIGS); SHEEP

Product summary:

Active ingredient group (AIG) number: 0151667001

Authorization status:

APPROVED

Authorization date:

2022-11-28

Patient Information leaflet

Arovyn proposed labelling
Arovyn label version October 20, 2022
1
Proprietary
ENGLISH INSERT
PR AROVYN
TM
DIN xxxxxxxx
Tulathromycin Injection
VETERINARY USE ONLY
Sterile antibiotic
DESCRIPTION: AROVYN is a ready-to-use sterile parenteral preparation
containing tulathromycin, a
semi-synthetic macrolide antibiotic of the subclass triamilide. Each
mL of AROVYN contains 100 mg of
tulathromycin as the free base in a propylene glycol vehicle.
AROVYN 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-[(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
(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-[(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): AROVYN 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): AROVYN is indicated for
the treatment of IBK associated
with _Moraxella bovis_.
FOOT ROT: AROVYN is indicated for the treatment of bovine foot rot
(interdigital necrobacillosis)
associated with _Fusobacterium necrophorum_ and _Porphyromonas