BOMACAINE LOCAL ANAESTHETIC

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

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Patient Information leaflet (PIL)

19-06-2017

Summary of Product characteristics (SPC)

01-07-2013

Active ingredient:

LIGNOCAINE HYDROCHLORIDE

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

lignocaine HCl(20mg/mL)

Pharmaceutical form:

INJECTION

Composition:

LIGNOCAINE HYDROCHLORIDE CAINE Active 20.0 mg/ml

Units in package:

100mL; 200mL

Class:

VM - Veterinary Medicine

Manufactured by:

BAYER AUSTRALIA

Therapeutic group:

Therapeutic area:

ANAESTHETICS/ANALGESICS

Therapeutic indications:

Product summary:

Poison schedule: 4; Withholding period: WITHHOLDING PERIODS Meat: Zero (0) day s Milk: Zero (0) days TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI establish ed.; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; DEER: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; GOAT: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIG - ADULT: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: WITHHOLDING PERIODS Meat: Zero (0) day s Milk: Zero (0) days TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI establish ed.; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; GOAT: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIG - ADULT: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANAESTHETIC - LOCAL/GENERAL]; CATTLE: [ANAESTHETIC - LOCAL/GENERAL]; DOG: [ANAESTHETIC - LOCAL/GENERAL]; GOAT: [ANAESTHETIC - LOCAL/GENERAL]; HORSE: [ANAESTHETIC - LOCAL/GENERAL]; PIG - ADULT: [ANAESTHETIC - LOCAL/GENERAL]; SHEEP: [ANAESTHETIC - LOCAL/GENERAL]; For epidural, nerve block and infiltration local anaesthesia in horses, cattle, deer, sheep, goats, pigs, dogs & cats.Avoid inadvertent intravenous injection and excessively high doses - may cause side effects (see label).

Authorization status:

Stopped

Authorization date:

2023-07-01

Patient Information leaflet

Australian
Government
Australian Pesticides
and
Veterinary Medicines Authority
TEMPLATE FOR RELEVANT
LABEL
PARTICULARS (RLPs)
(Veterinary
Products)
Select appropriate:
[]
New Product (include all applicable RLPs)
OR
181
Variation (highlight instructions that are being varied). Approval
no.
of label being varied:
40800/60547
Signal
heading:
Product name:
Active constituent/s:
Statement
of
claims:
Net
contents:
Directions
for
Use
Heading:
Restraints:
Contraindications:
Precautions:
Side
effects:
Dosage
&
administration:
General directions:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT
OF
REACH
OF
CHILDREN
FOR ANIMAL TREATMENT ONLY
BOMACAINE Local Anaesthetic
LIGNOCAINE HYDROCHLORIDE
20mg/mL
For epidural, nerve block and infiltration local anaesthesia in
horses, cattle,
deer,
sheep, goats, pigs, dogs and cats
100mL, 200mL
DIRECTIONS FOR USE
n/a
n/a
Administer
with
care
and
avoid
inadvertent
intravenous
administration
and
excessively high doses.
Central nervous disturbances, such as convulsions and excitement, can
occur with
inadvertent intravenous injection.
Use the contents within 24 hours
of
first broaching of the vial. Discard the unused
portion.
Epidural anaesthesia
Horses and Cattle
0.5-
1.5ml!
50kg
Sheep, Goats and Pigs
0.5-
1.0ml
I
10kg
Infiltration anaesthesia
Horses, Cattle and Deer
20-
100ml
Sheep, Goats and Pigs
10-
20ml
Dogs and Cats
1-
5ml
Dehorning and Velveting
Per Nerve Site
2
-10ml
Other Nerve Blocks
Per Nerve Site
5-15ml
n/a
18
Wormald Street, Symonston
ACT
2609
PO Box 6182, Kingston
ACT
2604 Australia
Tel:
+61
2 6210 4700 Fax:
+61
2 6210 4874
l/11'\rVW.apvma.gov.au
ABN 19 495 043 447
+
RLP
Approved
Withholding
Period/s:
MEAT: ZERO (0) DAYS
MILK: ZERO (0) DAYS
Trade
Advice:
EXPORT
SLAUGHTER
INTERVAL (ESI):
This
product
does
not
have
an
ESI
established. For advice
on
the ESI contact the manufacturer
on
1800 678 368 before
using this product.
Safety Directions:
N/A
First
Aid:
If poisoning occurs, contact a doctor or Poisons Information Centre.
Phone Australia
131126.
ADDITIONAL
USER
SAFETY:
N/A
ENVIRONMENTAL
n

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Summary of Product characteristics

PAGE 1 OF 6

SAFETY DATA SHEET

A18249/03/AUS


BOMACAINE LOCAL ANAESTHETIC INJECTION

SECTION 1 – IDENTIFICATION, CONTACTS

Bayer Australia Ltd
875 Pacific Highway
Pymble NSW 2073

EMERGENCY TELEPHONE NUMBER
1800 033 111
24 hour Emergency Service Australia Wide, Toll Free

CONTACT POINT (FOR NON-EMERGENCY CALLS)
Animal Health Division
(02) 9391 6000
Full Product Name
BOMACAINE LOCAL ANAESTHETIC INJECTION
Other Names
N/A

Product Use
FOR ANIMAL TREATMENT ONLY
For epidural, nerve block and infiltration local anaesthesia in
horses,
cattle, deer, sheep, goats, pigs, dogs and cats.

Creation Date
22
nd
March 2011

Revision Date
20 August 2013

SECTION 2 – HAZARDS IDENTIFICATION
Hazard Classification
CLASSIFIED AS A NON HAZARDOUS SUBSTANCE
CLASSIFIED AS NON DANGEROUS GOODS
according to criteria of NOHSC Australia and ADG Code.
Poison Schedule S4
Risk Phrases
None allocated
Safety Phrases
None allocated

SECTION 3 – COMPOSITION
INGREDIENTS
CAS NO
PROPORTION
Lignocaine hydrochloride

6108-05-0
2% w/v
This is a commercial product whose exact ratio
of components may vary slightly. Minor
quantities of other non
hazardous ingredients are also present.

A18249/03/AUS  BOMACAINE LOCAL ANAESTHETIC INJECTION

Page 2 of 6

SECTION 4 – FIRST AID MEASURES
Label Regulated First
Aid Statement
If poisoning occurs, contact a doctor or Poisons Information
Centre.
Phone Australia 131126.
Scheduled Poisons
Poison schedule S4.
Poisons Information Centres in each State capital city can
provide
additional assistance for scheduled poisons. Phone 131126.
Inhalation
Remove from further exposure and into fresh
air until recovered.
Give artificial
resuscitation if breathing has s

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