ILIUM TEMVET INJECTION

Krajina: Austrália

Jazyk: angličtina

Zdroj: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Aktívna zložka:

BUPRENORPHINE HYDROCHLORIDE

Dostupné z:

TROY LABORATORIES PTY LTD

INN (Medzinárodný Name):

buprenorphine as HCl(0.3mg/mL)

Forma lieku:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Zloženie:

BUPRENORPHINE HYDROCHLORIDE ANALGESIC Active 300.0 ug/ml

Počet v balení:

10mL

Trieda:

VM - Veterinary Medicine

Výrobca:

TROY LABORATORIES

Terapeutické oblasti:

ANAESTHETICS/ANALGESICS

Prehľad produktov:

Poison schedule: 8; Withholding period: ; Host/pest details: CAT: [PERI-OPERATIVE, POST-OPERATIVE]; DOG: [POST SURGICAL PAIN, POTENTIAL OF SEDATION]; Poison schedule: 8; Withholding period: MEAT WITHHOLDING PERIOD (HORSES): DO NOT USE in horses that may be used for huma n consumption; Host/pest details: CAT: [PERI-OPERATIVE, POST-OPERATIVE]; DOG: [POST SURGICAL PAIN, POTENTIAL OF SEDATION]; Poison schedule: 8; Withholding period: WHP: N/A; Host/pest details: CAT: [PERI-OPERATIVE, POST-OPERATIVE]; DOG: [POST SURGICAL PAIN, POTENTIAL OF SEDATION]; For peri-operative and post-operative analgesia in cats.This product should not be administered by the intrathecal or peridural route. This product should not be used pre-operatively for caesarian section. See Precautions on label also.

Stav Autorizácia:

Registered

Dátum Autorizácia:

2023-07-01

Príbalový leták

Product Name:
APVMA Approval No:
ILIUM TEMVET INJECTION
67612/138437
Label Name:
ILIUM TEMVET INJECTION
Signal Headings:
CONTROLLED DRUG
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
POSSESSION WITHOUT AUTHORITY ILLEGAL
READ SAFETY DIRECTIONS
Constituent
Statements:
300 µg/mL buprenorphine (as buprenorphine hydrochloride)
Claims:
For peri-operative and post-operative analgesia in cats.
For post-operative analgesia and potentiation of the sedative effects
of centrally acting
agents in dogs.
For the relief of post-operative pain in the horse, only in
conjunction with a sedative agent.
(Expanded Claims)
As an analgesic, ilium Temvet Injection is indicated for the relief of
moderate to severe pain
in cats and dogs. In cats, when administered pre-operatively as part
of pre-medication and
then again at wound closure, ilium Temvet Injection will reduce or
eliminate the amount of
analgesia required post-operatively.
Net Contents:
10 mL
Directions for Use:
Restraints:
DO NOT USE in horses that may be used for human consumption.
Contraindications:
Not to be administ
ered
by the intrathecal or peridural route.
No
t to be
use
d
pre-operatively for caesarean section.
Precautions:
Use with caution as buprenorphine may cause respiratory depression,
although this is
generally not clinically significant. As with other opioid drugs, care
should be taken when RLP APPROVED
treating animals with impaired respiratory function or animals that
are receiving drugs that
can cause respiratory depression.
Buprenorphine should be used with caution in animals with impaired
liver function or biliary
tract disease, as the substance is metabolised by the liver and its
intensity and duration of
action may be affected in such animals.
The safety of this product has not been demonstrated in dogs and cats
younger than
5 months of age. If administration to these animals cannot be avoided,
careful clinical
management may be required.
The safety of buprenorphine has not been demonstrated in horses
younger than 10 months
old and weighing less

Súhrn charakteristických

TROY LABORATORIES PTY LTD
Chemwatch Hazard Alert Code: 0
ILIUM TEMVET INJECTION
Chemwatch: 5398-98
Version No: 2.1.1.1
Safety Data Sheet according to WHS and ADG requirements
Issue Date: 13/05/2020
Print Date: 14/05/2020
L.GHS.AUS.EN
SECTION 1 IDENTIFICATION OF THE SUBSTANCE / MIXTURE AND OF THE COMPANY
/ UNDERTAKING
PRODUCT IDENTIFIER
PRODUCT NAME
Ilium Temvet Injection
SYNONYMS
APVMA number: 67612
OTHER MEANS OF IDENTIFICATION
Not Available
RELEVANT IDENTIFIED USES OF THE SUBSTANCE OR MIXTURE AND USES ADVISED
AGAINST
RELEVANT IDENTIFIED USES
For peri-operative and post-operative analgesia in cats.For
post-operative analgesia and potentiation of the sedative effects of
centrally acting
agents in dogs. To be used as directed on product label. Therapeutic
or pharmacologically-active agent. #28opan
DETAILS OF THE SUPPLIER OF THE SAFETY DATA SHEET
REGISTERED COMPANY NAME
TROY LABORATORIES PTY LTD
ADDRESS
37 Glendenning Road Glendenning NSW 2761 Australia
TELEPHONE
02 8808 3600
FAX
02 9677 9300
WEBSITE
www.Troylab.com.au
EMAIL
[e-mail]
EMERGENCY TELEPHONE NUMBER
ASSOCIATION / ORGANISATION
TROY LABORATORIES PTY LTD
EMERGENCY TELEPHONE
NUMBERS
02 8808 3600 (Office hours (8am – 4pm, Monday to Friday))
OTHER EMERGENCY TELEPHONE
NUMBERS
Not Available
SECTION 2 HAZARDS IDENTIFICATION
CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
POISONS SCHEDULE
S8
CLASSIFICATION
[1]
Not Applicable
LABEL ELEMENTS
HAZARD PICTOGRAM(S)
Not Applicable
SIGNAL WORD
NOT APPLICABLE
HAZARD STATEMENT(S)
Not Applicable
PRECAUTIONARY STATEMENT(S) PREVENTION
Not Applicable
PRECAUTIONARY STATEMENT(S) RESPONSE
Not Applicable
PRECAUTIONARY STATEMENT(S) STORAGE
Not Applicable
PRECAUTIONARY STATEMENT(S) DISPOSAL
Not Applicable
SECTION 3 COMPOSITION / INFORMATION ON INGREDIENTS
SUBSTANCES
PAGE 1 CONTINUED...
See section below for composition of Mixtures
MIXTURES
CAS NO
%[WEIGHT]
NAME
59-50-7
<1
53152-21-9
<1
Not Available
>60
Ingredients determined not to be hazardous
SECTION 4 FIRST AID MEASURES
DESCRIPTION OF FIRST AID MEASURES
EYE CONTACT
If th