CEVA KETAMINE INJECTION

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

KETAMINE AS KETAMINE HYDROCHLORIDE

Available from:

CEVA ANIMAL HEALTH PTY LTD

INN (International Name):

ketamine as HCl(100mg/mL)

Pharmaceutical form:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Composition:

KETAMINE AS KETAMINE HYDROCHLORIDE ANAESTHETIC Active 100.0 mg/ml

Units in package:

50mL

Class:

VM - Veterinary Medicine

Manufactured by:

CEVA ANIMAL HEALTH

Therapeutic group:

BIRDS | CAMEL | CAT | CATTLE | DEER | DOG | GOAT | HORSE | KANGAROO | KOALA | PIGS | REPTILE | SHEEP | WOMBAT | AVIARY BIRD | BE

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

DISSOCIATIVE ANAESTHETIC

Product summary:

Poison schedule: 8; Withholding period: MEAT: DO NOT USE less than 28 days befor e slaughter for human consumption. ME AT (HORSES): DO NOT USE in horses that m ay be used for human consumption. MEA T (poultry): DO NOT USE in birds that ma y be used or processed for human consump tion. MILK: Milk collected from treat ed animals within 7 days (14 milkings) f ollowing treatment MUST NOT BE USED or p rocessed for human consumption, or fed t o bobby calves. EGGS (poultry): DO NO T USE in birds that are producing or may in the future produce eggs that may be used or processed for human consumption. TRADE ADVICE - EXPORT SLAUGHTER INTERV AL (ESI): An ESI has not been establishe d for this product. Note—observing the m eat withholding period may not be suffic ient to mitigate potential risks to expo rt trade. Trade advice should be sought from the manufacturer on [phone] before using this product.; Host/pest details: BIRDS: [DISSOCIATIVE ANAESTHETIC]; CAMEL: [DISSOCIATIVE ANAESTHETIC]; CAT: [DISSOCIATIVE ANAESTHETIC]; CATTLE: [DISSOCIATIVE ANAESTHETIC]; DEER: [DISSOCIATIVE ANAESTHETIC]; DOG: [DISSOCIATIVE ANAESTHETIC]; GOAT: [DISSOCIATIVE ANAESTHETIC]; HORSE: [DISSOCIATIVE ANAESTHETIC]; KANGAROO: [DISSOCIATIVE ANAESTHETIC]; KOALA: [DISSOCIATIVE ANAESTHETIC]; PIGS: [DISSOCIATIVE ANAESTHETIC]; REPTILE: [DISSOCIATIVE ANAESTHETIC]; SHEEP: [DISSOCIATIVE ANAESTHETIC]; WOMBAT: [DISSOCIATIVE ANAESTHETIC]; Poison schedule: 8; Withholding period: WITHHOLDING PERIODS: MEAT: DO NOT USE less than 28 days before slaughter for human consumption. MEAT (poultry): DO N OT USE in birds that may be used or pro cessed for human consumption. MILK: Mi lk collected from treated animals withi n 7 days (14 milkings) following treatm ent MUST NOT BE USED or processed for h uman consumption. EGGS (poultry): DO NO T USE in birds that are producing or ma y in the future produce eggs that may b e used or processed for human consumpti on. TRADE ADVICE EXPORT SLAUGHTER INTE RVAL (ESI): This product does not have an ESI established. For advice on the E SI, contact the manufacturer on (02) 9 667 4411 before using this product.; Host/pest details: BIRDS: [DISSOCIATIVE ANAESTHETIC]; CAMEL: [DISSOCIATIVE ANAESTHETIC]; CAT: [DISSOCIATIVE ANAESTHETIC]; CATTLE: [DISSOCIATIVE ANAESTHETIC]; DEER: [DISSOCIATIVE ANAESTHETIC]; DOG: [DISSOCIATIVE ANAESTHETIC]; GOAT: [DISSOCIATIVE ANAESTHETIC]; HORSE: [DISSOCIATIVE ANAESTHETIC]; KANGAROO: [DISSOCIATIVE ANAESTHETIC]; KOALA: [DISSOCIATIVE ANAESTHETIC]; PIGS: [DISSOCIATIVE ANAESTHETIC]; REPTILE: [DISSOCIATIVE ANAESTHETIC]; SHEEP: [DISSOCIATIVE ANAESTHETIC]; WOMBAT: [DISSOCIATIVE ANAESTHETIC]; Poison schedule: 8; Withholding period: ; Host/pest details: BIRDS: [DISSOCIATIVE ANAESTHETIC]; CAMEL: [DISSOCIATIVE ANAESTHETIC]; CAT: [DISSOCIATIVE ANAESTHETIC]; CATTLE: [DISSOCIATIVE ANAESTHETIC]; DEER: [DISSOCIATIVE ANAESTHETIC]; DOG: [DISSOCIATIVE ANAESTHETIC]; GOAT: [DISSOCIATIVE ANAESTHETIC]; HORSE: [DISSOCIATIVE ANAESTHETIC]; KANGAROO: [DISSOCIATIVE ANAESTHETIC]; KOALA: [DISSOCIATIVE ANAESTHETIC]; PIGS: [DISSOCIATIVE ANAESTHETIC]; REPTILE: [DISSOCIATIVE ANAESTHETIC]; SHEEP: [DISSOCIATIVE ANAESTHETIC]; WOMBAT: [DISSOCIATIVE ANAESTHETIC]; A dissociative anaesthetic, for use singly or in combination with muscle relaxants and tranquillisers in horses, camels, dogs, cats, cattle, sheep, goats, deer, kangaroos, koalas, wombats, pigs, birds, and reptiles.Do not use in animals with renal insufficiency or with a history of epilepsy, or in poultry producing meat/eggs for human consumption. See other precautions on leaflet also.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

_CARTON – 10 FEBRUARY 2013 _
_ _
CONTROLLED DRUG
POSSESSION WITHOUT
AUTHORITY ILLEGAL
KEEP OUT OF REACH OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
CEVA KETAMINE
INJECTION
Active Constituent:
Ketamine (as Hydrochloride) 100
mg/mL
A dissociative anaesthetic for use
singly or in combination with muscle
relaxants and tranquilisers in horses,
camels, dogs, cats, cattle, sheep,
goats, deer, kangaroos, koalas,
wombats, pigs, birds and reptiles
.
(CEVA LOGO)
50 mL
READ ENCLOSED LEAFLET
BEFORE USING THIS PRODUCT.
DIRECTIONS FOR USE:
RESTRAINTS:
DO NOT USE IN BIRDS THAT MAY BE
USED OR PROCESSED FOR HUMAN
CONSUMPTION.
DO NOT USE IN BIRDS THAT ARE
PRODUCING OR MAY IN THE FUTURE
PRODUCE EGGS THAT MAY BE USED OR
PROCESSED FOR HUMAN CONSUMPTION.
CONTRAINDICATIONS: Consult
leaflet.
PRECAUTIONS: Consult leaflet.
SIDE EFFECTS: Consult leaflet.
DOSAGE AND ADMINISTRATION:
To avoid microbial contamination,
unused portions must be discarded
within 24 hours after reconstitution or
first broaching of the vial.
CATS: 5 - 6 mg/kg (0.25 - 0.3 mL/5 kg)
bodyweight intravenously or 15 - 20
mg/kg (0.75 - 1.0 mL/5 kg) bodyweight
intramuscularly.
OTHER SPECIES: Consult leaflet.
BARCODE
WITHHOLDING PERIODS:
MEAT: DO NOT USE LESS THAN 28
DAYS BEFORE SLAUGHTER FOR HUMAN
CONSUMPTION.
MEAT (POULTRY): DO NOT USE IN
BIRDS THAT MAY BE USED OR
PROCESSED FOR HUMAN CONSUMPTION.
MILK: MILK COLLECTED FROM TREATED
ANIMALS WITHIN 7 DAYS (14 MILKINGS)
FOLLOWING TREATMENT MUST NOT BE
USED OR PROCESSED FOR HUMAN
CONSUMPTION.
EGGS (POULTRY): DO NOT USE IN
BIRDS THAT ARE PRODUCING OR MAY IN
THE FUTURE PRODUCE EGGS THAT MAY
BE USED OR PROCESSED FOR HUMAN
CONSUMPTION.
TRADE ADVICE: EXPORT
SLAUGHTER INTERVAL (ESI): THIS
PRODUCT DOES NOT HAVE AN ESI
ESTABLISHED. FOR ADVICE ON THE ESI,
CONTACT THE MANUFACTURER 02 9652
7000 BEFORE USING THIS PRODUCT.
FIRST AID: If poisoning occurs
contact a Doctor or the Poisons
Information Centre. Phone Australia
13 11 26._ _
_ _
DISPOSE of empty container by
wrapping with paper and putting in
garbage.
STORE below 30°C (room
temperature).

Summary of Product characteristics

 
PRODUCT NAME: CEVA KETAMINE INJECTION
PAGE: 1 OF 5
THIS REVISION ISSUED: DECEMBER, 2012

SAFETY DATA SHEET 
Issued by: Ceva Animal Health Pty Ltd 
Phone: [phone] (office hours)
POISONS INFORMATION CENTRE: 13 1126 FROM ANYWHERE IN AUSTRALIA, (0800
764 766 IN NEW ZEALAND)

SECTION 1 - IDENTIFICATION OF THE MATERIAL AND SUPPLIER 
CEVA ANIMAL HEALTH PTY LTD 
PHONE: [phone] (OFFICE HOURS)
11 MOORES RD 
FAX: [phone]
GLENORIE, NSW  2157 
WWW.CEVA.COM.AU
CHEMICAL NATURE:  
Ketamine (as the hydrochloride) in water solution.

TRADE NAME:  
CEVA KETAMINE INJECTION 
APVMA CODE:  37711 
ACVM CODE (NEW ZEALAND) A5925 
PRODUCT USE:  
FOR ANIMAL TREATMENT ONLY. For veterinary use for induction of
anaesthesia; 
for use singly or in combination with muscle relaxants or
tranquillisers. 
NOTE THAT THIS PRODUCT IS A CONTROLLED DRUG. POSSESSION WITHOUT
AUTHORITY IS ILLEGAL. 
CREATION DATE: 
DECEMBER, 2012 
THIS VERSION ISSUED: 
DECEMBER, 2012 and is valid for 5 years from this date. 
SECTION 2 - HAZARDS IDENTIFICATION 
STATEMENT OF HAZARDOUS NATURE  
This product is classified as: Xn, Harmful. Hazardous according to
the criteria of SWA.  
Not a Dangerous Good according to the Australian Dangerous Goods
(ADG) Code.

RISK PHRASES: R22. Harmful if swallowed.  
SAFETY PHRASES: S20, S23, S36, S45, S1/2, S24/25. When using, do
not eat or drink. Do not breathe mists. Wear 
suitable protective clothing. In case of accident or if you feel
unwell, contact a doctor or Poisons Information Centre 
immediately (show this MSDS where possible). Keep locked up and out
of reach of children. Avoid contact with skin 
and eyes.  
SUSMP CLASSIFICATION: S8 
ADG CLASSIFICATION: None allocated. Not a Dangerous Good under the
ADG Code. 
UN NUMBER: None allocated 

GHS SIGNAL WORD: WARNING  
HAZARD STATEMENT: 
H302: Harmful if swallowed. 
H336: May cause drowsiness or dizziness. 
PREVENTION 
P201: Obtain special instructions before use. 
P264: Wa