VETORYL 30 MG CAPSULES

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

TRILOSTANE - MICRONISED

Available from:

DECHRA LTD

INN (International Name):

trilostane(30mg/Cp)

Pharmaceutical form:

ORAL CAPSULE

Composition:

TRILOSTANE - MICRONISED HORMONE Active 30.0 mg/Cp

Units in package:

#30; #capsules

Class:

VM - Veterinary Medicine

Therapeutic group:

DOG | BITCH | CASTRATE | PUPPY

Therapeutic area:

ENDOCRINE SYSTEM

Therapeutic indications:

CUSHINGS DISEASE | HYPERADRENOCORTISISM | PITUITARY DEPENDENT HYPERDRENO

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CUSHINGS DISEASE]; For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism (Cushing's syndrome) in dogs.Contraindications, Precautions, etc: See label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

For Official Use Only
E-LABEL APPLICATION (DRAFT)
COMPANY NAME:
DERMCARE-VET PTY. LTD
PRODUCT NAME:
VETORYL 30 MG CAPSULES
ELABEL APPLICATION NO:
DC14-54857834E117
APVMA APPROVAL NO:
60620/102544
PRODUCT NO:
60620
VERSION NO:
4.0
APPLICATION STARTED:
2015-May-04 15:00:57
VERSION CREATED:
2015-Oct-28 10:58:10
STARTED BY:
Yvette Risk
PRINTED:
2015-Oct-28 11:21:30
LABEL NAME:
VETORYL 30 MG CAPSULES
SIGNAL HEADINGS:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
CONSTITUENT
STATEMENTS:
Each capsule contains 30 mg TRILOSTANE
CLAIMS:
For the treatment of pituitary-dependent and adrenal-dependent
hyperadrenocorticism
(Cushing’s syndrome) in dogs.
NET CONTENTS:
30 capsules
DIRECTIONS FOR USE:
RESTRAINTS:
CONTRAINDICATIONS:
This product is contraindicated in animals suffering from primary
hepatic disease and/or
renal insufficiency.
This product is contraindicated in pregnant or nursing bitches or in
any animals intended for
breeding.
This product is contraindicated in dogs weighing less than 3 kg.
PRECAUTIONS:
An accurate diagnosis of hyperadrenocorticism is essential.
As the majority of cases of hyperadrenocorticism are diagnosed in dogs
between the
ages of 10-15 years, other pathological processes are frequently
present. It is particularly
important to screen cases for primary hepatic disease and renal
insufficiency as the
product is contraindicated in these cases.
The presence of diabetes mellitus and hyperadrenocorticism together
requires specific
monitoring.
If a dog has previously been treated with mitotane, its adrenal
function will have been
reduced. Experience in the field suggests that an interval of at least
a month should elapse
between cessation of mitotane and the introduction of trilostane.
Close monitoring of
adrenal function is advised, as dogs may be more susceptible to the
effects of trilostane. RLP APPROVED
For Official Use Only
The product should be used with extreme caution in dogs with
pre-existing anaemia as
further reductions in packed-cell volume and haemoglo

Summary of Product characteristics

MATERIAL SAFETY DATA SHEET 
DATE ISSUED:            1 MAY 2012 

VERSION: 01 

PAGE 1 OF 4 

VETORYL
®
 CAPSULES 

PRODUCT NAME 
VETORYL
®
 10MG, 30MG, 60MG OR 120MG CAPSULES 
OTHER NAME(S) 

SUPPLIER NAME 
DERMCARE-VET PTY LTD 
ADDRESS 
22 Aranda St, Springwood, QLD, AUSTRALIA, 4127 
TELEPHONE 
[phone] 
FAX  
[phone] 
EMERGENCY 
[phone] (Monday 
– Friday, 9:00am – 5:00pm) 
EMAIL 
[e-mail] 
WEB SITE 
http://www.dermcare.com.au 

SYNONYM(S)  
APVMA
REGISTRATION NOs: 120mg capsules - 60618,  60mg capsules - 60619,  30mg capsules - 
60620 

USE(S) 
VETERINARY APPLICATIONS 

Oral capsules for
the treatment of pituitary dependent and adrenal-dependent hyperadrenocorticism 
(Cushing’s Syndrome) in dogs. 

NOT CLASSIFIED AS HAZARDOUS ACCORDING TO NOHSC CRITERIA 

NOT CLASSIFIED AS A DANGEROUS GOOD BY THE CRITERIA OF
THE ADG CODE 
UN NO.  
None Allocated 
DG CLASS  
None Allocated  
SUBSIDIARY RISK(S)  
None Allocated 
PKG GROUP  None Allocated 
HAZCHEM CODE   None Allocated  
EPG  
None Allocated 

INGREDIENT 
FORMULA 
CAS NO. 
CONTENT 
Trilostane 
C
20
-H
27
-N-O
3

13647-35-3 
10mg or 
30mg or 
60mg or 
120mg per 
capsule 
Non Hazardous Ingredients 
Not Available 
Not Available 
remainder 

EYE  
If in eyes, hold eyelids apart and flush the eye continuously with running water.  Continue flushing until 
advised to stop by the Poisons Information Centre or a doctor, or
for at least 15 minutes. 
SKIN  
Gently flush affected areas with soap or mild detergent and plenty of water until no evidence of 
chemical remains (at least 15-20min).  Seek medical attention if irritation develops. 
INHALATION  
Remove from exposure area to fresh air.  If any symptoms persist�

Safety Data Sheet

Brand name height = height of Cool Gray 50% Dechra Device. Strength is
now 50% of initial brand name letter. Brand description is now 35% of
initial brand name
letter and has been moved up due to limited space. Brand name moved to
2 mm of cutter instead of letter width on front panel and tuck panel.
Brand name and
description moved down to accomodate warnings. Pictogram of dog made
smaller and moved down because of limited space.
Pantone reference guide
541
3395
CUTTER GUIDE
VARNISH FREE
7659
Cool Gray 3 - 50%
Cool Gray 3 - 20%
Not to be printed
Product:
..........................
VETORYL 30 MG - AU - CARTON
Dimensions:.............................................60 mm x 35 mm
x 111 mm
Primary brand name font size:
................................................. 36.8pt
Primary brand description font
size:..................................8pt and 9pt
Body text font size:
.......................................................................
8pt
Item code:
...............................................................................
G1725
Pharmacode:
...............................................................................
192
Regulatory
..................................................
Marketing
...................................................
Technical
....................................................
Date
...........................
Date
...........................
Date
...........................
Date:
Proof:
1 (NH)
2
3 (AD)
4 (NH)
5 (AD)
6 (CC)
7 (NH)
8 (NH)
9 (NH)
01-10-2014
01-10-2014
07-10-2014
09-10-2014
15-01-2016
22-01-2016
04-03-2016
04-03-2016
07-03-2016
Date:
Proof:
STYLE DEVIATIONS
541 - 50%
541 - 20%
541 - 30%
V
ETORYL
®
30 mg CAPSULES
V
ETORYL
®
30 mg
CAPSULES
30 CAPSULES
30 mg
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
Contraindications: This product is contraindicated in animals
suffering from primary hepatic disease
and/or renal insufficiency.
This product is contr