TELAZOL INJECTABLE ANAESTHETIC FOR DOGS AND CATS

Land: Australia

Språk: engelsk

Kilde: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Preparatomtale Preparatomtale (SPC)
20-06-2017

Aktiv ingrediens:

TILETAMINE HYDROCHLORIDE; ZOLAZEPAM HYDROCHLORIDE

Tilgjengelig fra:

ZOETIS AUSTRALIA PTY LTD

INN (International Name):

tiletamine as HCl(250mg/vial)+zolazepam as HCl(250mg/vial)

Legemiddelform:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Sammensetning:

TILETAMINE HYDROCHLORIDE AZEPINE-BENZODIAZEPINE Active 250.0 mg/Amp; ZOLAZEPAM HYDROCHLORIDE AZEPINE-BENZODIAZEPINE Active 250.0 mg/Amp

Enheter i pakken:

789mg/5mL

Klasse:

VM - Veterinary Medicine

Produsert av:

ZOETIS AUSTRALIA

Terapeutisk gruppe:

CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY

Terapeutisk område:

ANAESTHETICS/ANALGESICS

Indikasjoner:

ANAESTHETIC - LOCAL/GENERAL | GENERAL ANAESTHETIC | IMMOBILISER | LOCAL ANAESTHETIC | PREMEDICATION | SEDATIVE | TRANQUILLISER | TRAVEL SICKNESS

Produkt oppsummering:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; Anaesthetic for intramuscular use in dogs and cats only.DO NOT use TELAZOL in: dogs and cats with pancreatic disease, renal or hepatic failure, severe cardiac or pulmonary dysfunction, pregnant bitches or queens at any stage of pregnancy, caesarean section, severe hypertension.

Autorisasjon status:

Stopped

Autorisasjon dato:

2023-07-01

Informasjon til brukeren

                                FORT DODGE AUSTRALIA P
TY
L
IMITED
-
DRAFT LABEL
PRODUCT NAME: Telazol

Injectable Anaesthetic for Dogs and Cats
DATE: 16 June, 1998
PAGE 1 OF 8
PRODUCT SIZE: 5 mL
DESCRIPTION: folding carton
PRODUCT CODE: TEL5AFC1
VERSION: Australia
FILE NUMBER: telactn.doc
REVISION #: 6
NOTES: Additional label amendments received 1 June over and above
those minor amendments required
by NRA on 20 March (JB) Add contents (JB)
Text above this line and in italics between parallel lines is not
included in the label copy.
INFOPEST VERIFIES THAT THIS LABEL IS CONSISTENT WITH THE NRA
APPROVED TEXT LABEL OF 16/6/98 ________
_FRONT PANEL_
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY TELAZOL


 INJECTABLE ANAESTHETIC
FOR DOGS AND CATS
Active constituents:
tiletamine (as hydrochloride) 250 mg
zolazepam (as hydrochloride) 250 mg
Anaesthetic for intramuscular use in dogs and cats only
789 mg NET
_BACK PANEL_
DISPOSAL
Dispose of empty containers by wrapping with paper and putting in
garbage.
Store below 30ºC (room temperature). Protect from light. Discard
unused solution after 4 days
when stored at room temperature or after 14 days when kept
refrigerated (2 to 8
°
C. Do not
freeze).
(B)
EXP.
NRA Approval No: 50423/0698
_SIDE PANEL 1_
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
DIRECTIONS FOR USE:
Add 5 mL sterile water for injection to reconstitute. THE RESULTING
SOLUTION WILL CONTAIN
TILETAMINE 50 MG/ML, ZOLAZEPAM 50 MG/ML, and mannitol 57.7 mg/mL. Use
only clear
solution which may vary in colour from colourless to light amber.
Manufactured for
Fort Dodge Australia Pty Limited, 23 Victoria Avenue, Castle Hill NSW
2154 Australia.
Tel: (02) 9899 0444, Fax: (02) 9899 2151
FORT DODGE AUSTRALIA P
TY
L
IMITED
-
DRAFT LABEL
PRODUCT NAME: Telazol

Injectable Anaesthetic for Dogs and Cats
DATE: 16 June, 1998
PAGE 2 OF 8
PRODUCT SIZE: 5 mL
DESCRIPTION: folding carton
PRODUCT CODE: TEL5AFC1
VERSION: Australia
FILE NUMBER: telactn.doc
REVISION #: 6
NOTES: Additional label amendments recei
                                
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Preparatomtale

                                abcdefg
_ _
_FORT DODGE AUSTRALIA Pty Limited _
_ACN 000 074 902 _
_MATERIAL SAFETY _
_1 Maitland Place _
_DATA SHEET _
_Baulkham Hills NSW 2153 _
_ _
_Telephone: (02) 9899 0444 _
_ _
_Facsimile: _
_(02) 9899 2151 _
_ _
_Emergency: 1800 033 111_
_ _
WORK HAZARD ASSESSMENT
Hazardous according to the criteria of Worksafe Australia.
l IDENTIFICATION
Product Name: TELAZOL
®
Injectable Anaesthetic for Dogs
and Cats (50423).
Other Names:
None.
Product Code:
None.
UN No:
None allocated
Hazchem Code:
None allocated
Dangerous Goods Class:
None allocated
Sub Risk Class:
None allocated
Packaging Group:
None allocated
Poison Schedule:
S4
Chemical Family:
Blend of ingredients (see below). Tiletamine HCI is a member of the
phencyclidine family.
Zolazepam HCI is a benzodiazepine drug.
Uses:
Anaesthetic for use with cats and dogs.
Physical Appearance & Properties
Appearance & Odour:
White to off-white powder. No data re odour. Product is supplied in a
5 mL vial and is
reconstituted with water prior to use.
Melting/softening point:
No specific data. Solid at normal temperatures.
Boiling point and vapour pressure: No specific data. Expected to
decompose before boiling.
Volatile materials:
No specific data. Expected to be low at 100°C.
Flashpoint:
Not flammable.
Specific gravity:
No data.
Solubility in water:
Soluble.
Corrosiveness:
Not corrosive.
Ingredients
Worksafe Exposure Limits
Chemical Entity
CAS No
Quantity per vial
TWA, mg/m
3
STEL, mg/m
3
Tiletamine Hydrochloride
14176-50-2
250mg
not set
not set
Zolazepam Hydrochloride
33754-49-3
250mg
not set
not set
This is a commercial product whose exact ratio of components may vary.
Trace quantities of impurities are also likely.
Issued by: Fort Dodge Australia Pty Limited
Product: TELAZOL Injectable Anaesthetic for Dogs and Cats
(50423).
Phone: (02)9899 0444
Page 1 of 4
Issued: 4 Jul 2002
Revision 2
MATERIAL SAFETY DATA SHEET
Issued by: Fort Dodge Australia Pty Limited
Product: TELAZOL Injectable Anaesthetic for Dogs and Cats
(50423).
Phone: (02)9899 0444
Page 2 of 4
Issued: 4 Jul
                                
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